February 09, 2009
BioSpecifics Technologies: (OTC: BSTC.pk)
35 Wilbur Street
Lynbrook, NY 11563
Phone: 516.593.7000 Fax: 516.593.7039
Strategic alliances are bringing new products to market
BioSpecifics Technologies, formerly a pharmaceutical concern manufacturing collagenase ABC enzyme for woundcare and ulcer applications, has remade itself into a research and development company developing products for Dupuytren's, Peyronie’s, and a host of other afflictions. BSTC has grown through strategic alliances, most recently, via a relationship with Auxilium Pharmaceuticals, which is managing the late-stage development of some of BioSpecifics' promising applications. Future royalty streams will generate significant revenues and profits.
Investor relations write to . . .
In June 2004 development and commercialization rights for certain collagenase therapeutic applications were licensed to Auxilium Pharmaceuticals (NASDAQ: AUXL)
Please SCROLL DOWN to read abstracts about
BioSpecifics Technologies and other information.
(numbers refer to bibliography entries that follow)
I. R&D is totally focused on future applications such as Dupuytren’s, Peyronie’s, frozen shoulder, and a host of other promising applications. Strategic alliances will prove critical to future growth.
Analysts initiate coverage of Auxilium with Outperform and Buy ratings; 85
New development and licensing agreement with Auxilium Pharmaceuticals; 80
BioSpecifics sells topical collagenase business; 82
New U.S. distribution agreement with Abbott Laboratories; 77
Smith & Nephew home site http://www.smith-nephew.com
FDA approves manufacturing facility; 75
Asante Partners to provide Strategic Advisory services; 52
Diabetic ulcers; 17
II. The Dupuytren's application, now in Stage III trials, is being aggressively managed by Auxilium, a strategic partner of the Company
Pfizer agrees to market XIAFLEX throughout Europe and Eurasia; 91
Analysts suggest Auxilium acquire BioSpecifics following successful Phase III Trial of XIAFLEX: 89
Biotechinsight.com, a biotechnology investment stock letter, recommends purchasing BioSpecifics; 87
Injectable collagenase efficacy reviewed in The Journal of Hand Surgery; 86
Auxilium raises $49.9 million to fund research, including AA4500 technology licensed from BioSpecifics; 84
Auxilium's Enzyme AA4500 for scar tissue effective in Phase III; 83
Shareholder Rights plan; 64
Wound Healing primer & list of Wound Healing concerns http://www.biospecifics.com/annualreport.html#primer
1. Financial Links
Wound Healing and Tissue Engineering Universe; 67
dbusiness.com's search engine for current stories
2. General Links
CEO/Chairman - Edwin H. Wegman; 12
E-Hand.com: an electronic textbook of hand surgery
Collagenase - wound debridement
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91. Pfizer to Market New Dupuytren's Drug
Company Press Release; December 18, 2008
BioSpecifics announced that its development partner Auxilium Pharmaceuticals has signed an agreement that will have Pfizer marketing XIAFLEX throughout the European Union and 19 other European and Eurasian countries. XIAFLEX is a “first-in-class, late-stage biologic” used for the treatment of Dupuytren’s and Peyronie’s diseases. According to the release, “BioSpecifics will receive $6.375 million of the $75 million upfront payment paid to Auxilium by Pfizer, as well as 8.5% of the $410 million in potential additional milestone payments that may be made by Pfizer to Auxilium. Of these additional milestones, $150 million are tied to regulatory milestones and $260 million are based on sales milestones.” BioSpecifics’ President, Thomas L. Wegman, comments, “We are pleased that Pfizer, the world’s largest pharmaceutical company, has committed major resources to the success of XIAFLEX, and believe that it is a demonstration of the drug’s important potential to help patients with these diseases.”
90. More Upside For BSTC From Auxilium
Analysts at Soleil Securities Group's research affiliate, Neponset Equity Research, have updated their outlook for XIAFLEX, a Dupuytren's treatment being developed by Auxilium Pharmaceuticals (AUXL) based on licensed technology from BioSpecifics Technologies (BSTC.ob). Due to what the analysts perceive as a disconnect between the royalty streams to BioSpecifics and BioSpecifics' $19 stock price, they suggest that Auxilium should purchase BioSpecifics. A present-value analysis of net income streams just from Dupuytren's treatments, BSTC is valued at $53/share. When including the potential for Peyronie's disease, the analysts put a present-value on BSTC north of $80. There are also other "potential indications, including lipomas, cellulite and glaucoma." The analysts conclude that their "conviction in both the deep ipieline of opportunities for XIAFLEX, and our stance that AUXL management should act quickly to capitalize on what we view as a major valuation disconnect for BSTC."
89. Analysts suggest Auxilium acquire BioSpecifics following successful Phase III Trial of XIAFLEX
Two recent research reports from Soleil/Neponset Equity Research and Piper Jaffray highlighted encouraging results of Phase III studies examining the efficacy of XIAFLEX in the treatment of Dupuytren’s. XIAFLEX is being developed by Auxilium Pharmaceuticals (AUXL) with BioSpecifics (BSTC) retaining a 12%-13% royalty. the Neponset Analysts estimate that BioSpecifics has the potential of capturing some 25% of XIAFLEX profits. Thus, given current market prices, they conclude that “the Street is ascribing ~$935 million in value to AUXL’s ownership of XIAFLEX profits (~75%).” And “by (their) math, this equates to ~$312 million for BSTC’s ownership of profits (~25%), or ~$43/share.” They go on to conclude, “With BSTC trading at $15, we believe that AUXL management could take advantage of a valuation disconnect and boost its own shareholder value via a targeted acquisition of BSTC.”
88. Study Confirms Injectable Collagenase effective in treating Peyronie’s Disease.
The Journal of Sexual Medicine -- Volume 5, Issue 1, page 180-187, January, 2008: by Gerald H. Jordan MD, FACS, FAAP
In the January 2008 issue of The Journal of Sexual Medicine, Dr. Gerald H. Jordon presents results of a study that provide further support to the effectiveness of collagenase injections in managing Peyronie’s disease, a disease indicated by an excess buildup of collagen that leads to a painful curvature of the penis. Significant improvements were achieved in both the primary efficacy measures of deviation angle and plague size. And more than 50% of the studies participants considered themselves either “very much” or “much” improved.
87. Biotechinsight Recommends BioSpecifics' Stock.
BiotechInsight -- September 4, 2007
Ron Garren MD of Biotechinsight recently wrote that he’s accumulating BioSpecifics Technologies’ stock on the basis of the long-term outlook for BioSpecifics’ Collagenase product, Xiaflex (AA4500), being developed by Auxilium Pharmaceuticals (AUXL) for the treatment of Dupuytren’s contracture and Peyronie’s disease. He writes, “I am very confident the product works.” He further concludes:
“Making very conservative assumptions of a 10% royalty to BSTC and 50,000 patients treated/yearly (the prevalence of Dupuytren’s is not known for sure but certainly between the US and Europe there are easily 500,000 patients and probably many more) at an average cost of $3000/patient would gross $150 million with $15 million to BSTC’s bottom line. At a 10x valuation I have revised my minimum target to a market cap of $150 million or around $25/share—this would of course depend on approval in ‘09.”
86. Injectable Collagenase Efficacy Reviewed In The Journal of Hand Surgery.
The Journal of Hand Surgery -- Vol. 32A No. 6 July-August 2007
The Journal of Hand Surgery (Vol. 32A No. 6 July-August 2007) published an article authored by Marie A. Badalamente, PhD, and Lawrence C. Hurst, MD that reviews results of two studies examining the “efficacy and safety of an injectable mixed subtype collagenase for the treatment of Dupuytren’s Contracture.” As way of background, the authors review evidence that Dupuytren’s is prevelant in between 3% to 40% of the global population. It is more prevalent among Northern European ancestry, but disease characteristics, including age of onset, predominant finger affected and association with other diseases, are similar among all groups evidencing the disease. It most frequently affects the ring and small finger.
The authors note that “contractures may be corrected surgically by dividing the cord or performing a fasciectomy to restore function and correct the deformity.” But while some three fourths of those treated show improvement, at 32 months post surgery, there is a recurrence rate as high as 65%. They write, “Surgery is not a cure, nor does it stop progression.” While a number of nonsurgical techniques have been studied, most are “generally found to be ineffective or not suitable for clinical use.” However, clinical trials using “injections of mixed collagenase subtype as treatment of Dupuytren’s Contracture have provided encouraging results.” Specifically, 88% of metacarpophalangeal (MCP) affected joints were corrected to within 5% of full extension, and 78% of proximal interphalangeal (PIP) joints were corrected to within 15% of full extension (44% to within 5%). In a mean two-year follow-up period for MCP joints there was one recurrence, and in a mean 12.5 month follow up for PIP joints, there was one recurrence. There were 34 MCP patients and nine PIP. The authors conclude that, “Results from these phase II trials suggest that collagenase injections are a safe and effective therapy for Dupuytren’s Contracture.”
In a subsequent phase III trial, long-term efficacy, tolerability and recurrence rates were further evaluated. Among their findings: “A mean of 1.4 injections was required to normalize affected joints, and clinical success was achieved in 1 to 29 days. Of 62 joints treated, 54 (87%) were clinical successes during the placebo-controlled and open-label phases. Contracture recurrence was relatively low occurring in 5 joints, 1 before 12 months, 2 at 12 months, and 2 at 24 months after treatment.” Further, “Adverse events were localized to the injection site, were generally of mild to moderate severity, and were transient in nature.” They conclude, “the data in this study are consistent with our earlier findings from phase II studies and provide additional evidence confirming the effectiveness of collagenase as a nonsurgical treatment for Dupuytren’s Contracture.”
For free abstract, see Abstract
85. Merrill, Cowen Positive Reports on Auxilium -- BSTC Partner.
Merrill Lynch -- May 16, 2007
Cowen & Company -- June 21, 2007
Merrill Lynch initiated coverage of Auxilium on May 16, 2007 with a Buy rating. Analysts’ Gregory Fraser and Gregg Gilbert like the balance that Auxilium brings via its approved testosterone replacement product and the development of its biologic compound AA4500 that they view as a “breakthrough” product for the treatment of Dupuytren’s disease, “a potentially debilitating condition of the hand.” They suggest that AA4500 has the potential to be a blockbuster drug on the basis of there annually being some 1million new patients in the U.S. and Europe. And there are considerable advantages to aa4500 over surgery, the only know treatment at this time. It may also be effective in treating Peyronie’s disease and frozen shoulder syndrome, the former alone representing a “potential market opportunity of almost $2 billion.” Manufacturing issues did arise in December 2006, but the analysts believe that modifications will allow the Phase III studies to restart by 4Q07.
Cowen & Company analyst Leland Gershell, M.D, Ph.D., initiated coverage of Auxilium on June 21, 2007 with an Outperform rating. His basic conclusion is that the manufacturing issues that arose in late 2006 have “kept a lid on AUXL’s stock performance.” But “discussions with process specialists suggest that the problems are resolvable, and that AUXL’s guidance of clinical re-entry is Q4:07 is reasonable.” Dr. Gershell expects that based on “the efficacy, safety, and the convenience of AA4500,” it will likely become the first choice of the some 140,000 patients seeking relief each year from Dupuytren’s disease. “At an estimated price of $3,600/patient, AA4500 could be worth $400 million+.” And other indications (Peyronie’s disease and frozen shoulder syndrome) currently in Phase II studies could add sales of another “$200 million to $300 million each.” Auxilium has the right to expand it licensing agreement with BioSpecifics Technologies, from which it has licensed AA4500.
84. Auxilium Issues $49.9 Million in Stock to Develop AA4500; Annual Market Could Reach $1 Billion.
BioWorld Today -- June 11, 2007
BioHealth Investor -- June 5, 2007
BioWorld Today, an online biotechnology news source, recently reported (volume 118, no. 112) that Auxilium Pharmaceuticals’ nearly $50 million stock sale will help the company develop AA4500, a product licensed from BioSpecifics Technologies that, according to Auxilium, has a potential annual market of $1 billion. In February, Auxilium provided Phase III data at the American Academy of Orthopedic Surgeons suggesting AA4500 is effective in treating Dupuytren’s, “a condition of thickened skin in the hand that can cause fingers to curl.” The company has had to deal with a manufacturing setback, but it doesn’t appear to be material. Auxilium’s research suggests that of the 1 million new cases in the U.S. and Europe each year, about 240,000 would be good candidates for AA4500. At three treatments per patient at somewhere around $1,600-$1,700 per treatment, the regime still compares favorably to $5,000 surgery, the only currently available treatment. According to BioWorld, “Auxilium plans to file a biologics license application in 15 or 16 months, and the AA4500 has been designated an orphan drug, so the firm will seek an expedited review.” AA4500 has also shown indications in treating Peyronie’s, a painful curvature of the penis. The company believes that about 210,000 of the 475,000 patients seeking relief from Peyronie’s every year in the U.S. and Europe would be candidates for AA4500. Each patient would require six to nine injections.
Over at BioHealth Investor, a journal/blog following biotech and medical technology, Steven Gold took notice of Auxilium’s prospects in a piece he titled: Auxilium Pharmaceuticals: Not A One-Trick Pony. He decided to take a look when a Bank of America analyst initiated coverage with a buy recommendation. Taking note of Auxilium’s injectable enzyme AA4500, he notes that it would be the first of its kind and, in addition to treating Dupuytren’s disease, it could lead to other potential applications, including Peyronie’s disease and Frozen Shoulder syndrome. He notes that the company is also developing three products based on technology licensed from Formulation Technologies.
83. Auxilium Updates on Development of AA4500, Injectable Collagenase Licensed From BioSpecifics Technologies.
Auxilium press releases -- November 2006
Auxilium Pharmaceuticals announced in an Oct. 18, 2006 press release that it “plans to reallocate resources to its lead development project, AA4500,” a formation of injectable collagenase. The company expects to start “a second Phase pivotal trial of AA4500 for the treatment of Dupuytren's Contracture by the end of 2006.” Armando Anido, Chief Executive Officer and President of Auxilium, “AA4500 is a company changing product opportunity that is our top priority.” In an early September release, Auxilium announced that it would be leasing a “biologics manufacturing facility for the production of AA4500” and that it planned “an expansion of its sales force to approximately 150 territories.” Mr. Anido comments, “As the manufacturing facility already contains most of the equipment necessary to produce AA4500, we believe that the required modifications can be completed in time to include the facility in our initial Biologics License Application for the treatment of Dupuytren's Contracture in 2007.”
In June, Auxilium announced, via press release, “positive results of a randomized, placebo-controlled double-blind study of AA4500 in the treatment of Dupuytren's Disease, also known as Dupuytren's Contracture. BioSpecifics Technologies Corp., licensor of AA4500, sponsored and monitored the study, and Auxilium conducted follow-up and data analyses.” According to the release, the “study showed that a local injection of AA4500 was highly effective in the treatment of Dupuytren's Contracture.” In a related story in BioWorld Today (June 22, 2006; Volume 17, No. 120), it was reported that the licensing agreement between BioSpecifics Technologies and Auxilium provides, “Auxilium worldwide rights to AA4500 in exchange for milestone payments and eventually low-double-digit royalties. Also, BioSpecifics Technologies receives a fee every time it supplies data on additional viable indications that Auxilium decides to pursue.” According to BioWorld, Auxilium's CFO, James Fickenscher, further states that, “What we’re talking about doing with this drug is scar remodeling,” and that “there are a number of follow-on indications for AA4500 that are pretty exciting.”
82. BioSpecifics Sells Topical Collagenase Business for $8 million
Healthpoint news release -- March 7, 2006
It was announced today that BioSpecifics Technologies has agreed to sell it topical collagenase business to Healthpoint, Ltd., including BioSpecifics manufacturing facility in Curacao for an upfront cash payment of $8 million and additional future payments related to services rendered and sales. Healthpoint plans to invest $1.5 million in facilities upgrades. According to BioSpecifics President Thomas Wegmen, “The purchase of the topical collagenase business allows BioSpecifics to focus our efforts on collagenase products for injection and the clinical development of new promising therapeutic indications.”
81. Venture Capitalists target wound-care market
BusinessWeek -- May 30, 2005; page 89
With an understanding that alligator and crocodile palates develop similarly to human palates and an interest in cleft palates, Mark W.J. Ferguson set out discover linkages. What he found was that reptiles' possess a noteworthy wound-healing ability. Discovering that a “protein known as transforming growth factor beta 3 (TGF-beta3)” was responsible for the unusual healing, Ferguson set out on a 20-year odyssey that led to the creation of Renovo. Venture capitalists have helped Renovo fund the development of a synthetic version of TGF-beta3 that, though at least four years off, has significant appeal for its wound-healing capabilities, including internal organs. Obviously, it is hard to know about the therapeutic value of many of the new wound-care drugs that are emerging. But the research activity they evidence suggests that drug companies are targeting the wound-care area for profitable expansion.
80. BioSpecifics signs development and licensing agreement with Auxilium Pharmaceuticals
Company press release -- June 7, 2004
Auxilium Pharmaceuticals has agreed to pay BioSpecifics license, milestone, royalty and manufacturing fees to help "develop and commercialize certain therapeutic applications for BioSpecifics' enzyme." Mr. Edwin Wegmen, BioSpecifics' Chairmen comments, "Auxilium is a growing pharmaceutical company with a track record of accomplishments that gives us confidence that they will aggressively pursue these outstanding opportunities. The agreement does not cover dermal applications of Santyl Ointment currently being distributed by the Ross Products division of Abbott Labs or the firm's patented wound-healing products.
For the full release, see http://biz.yahoo.com/iw/040607/068324.html
79. Michael Schamroth joins Board of Directors
Company press release -- May 17, 2004
Michael Schamroth was appointed interim Director of BioSpecifics Technologies at a special meeting of the Board of Directors, thus bringing the company into compliance with securities regulations requiring a minimum of three independent Directors. Mr. Schamroth brings "in excess of twenty years of experience as a Board Member of a major Long Island based health systems." BioSpecifics' Chairman and President, Edwin Wegmen, commented, "We are very pleased to have someone of Michael's stature join our Board of Directors. His broad-based understanding of business, combined with his over twenty years of involvement in healthcare, will provide the Company with insight as it looks to increase its production of collagenase ABC for Santyl ointment."
For the full release, see http://biz.yahoo.com/iw/040517/067419.html
78. BioSpecifics' stock to begin trading on OTC Bulletin Board; symbol BSTC
Company press release -- March 23, 2004
Management announced today that it has been notified by Nasdaq that the company's stock will be delisted from the Nasdaq exchange effective March 24 based on the firm's inability to maintain $2.5 million in shareholder equity as of December 31, 2003. The stock will begin trading on the OTC Bulletin Board under the symbol BSTC. Management plans to appeal the decision as the company "is in discussions with several potential licensees for its injectable collagenase product for the treatment of Dupuytren's disease, which is in Phase 3 clinical trials, and for Peyronie's disease, which is in Phase 2 trials. BioSpecifics anticipates that the proceeds from a license agreement will enable it to regain compliance with the $2.5 million shareholders' equity requirement."
For the full release, see http://biz.yahoo.com/prnews/040323/nytu202_1.html
77. Abbott Laboratories to Market BioSpecifics' Collagenase Santyl Ointment
Company press release -- November 3, 2003
Beginning in 2004, Abbott Laboratories will assume United States marketing responsibility of BioSpecifics' Collagenase Santyl Ointment, a prescription ointment used in treating chronic dermal ulcers and second- and third-degree burns. Abbott currently manufactures the ointment using BioSpecifics' collagenase ABC enzyme. Mr. Thomas L. Wegman, Executive Vice President of BioSpecifics, comments, "We are excited about this change in marketing and look forward to real growth in the marketplace . . . " due to Abbott's strong presence in the long-term care market and its growing presence in burn treatment units. Marketing efforts will be bolstered by the improving availability of collagenase ABC enzyme in 2004 resulting from the recent FDA approval of BioSpecifics' manufacturing facility in Curacao, Netherlands Antilles.
For the full release, see http://biz.yahoo.com/prnews/031103/nym210_1.html
76. BioSpecifics to trade under BSTC, having received listing exception
Company press release -- August 1, 2003
The Nasdaq Stock Market has provided BioSpecifics an exception to delisting. As a result, the company's common stock will trade without the "E" under the symbol BSTC beginning August 4, 2003. The exception requires the company to file its Forms 10-QSB for the June and September quarters in a timely manner.
For the full release, see http://biz.yahoo.com/prnews/030801/nyf098_1.html
75. FDA approves BioSpecifics manufacturing facility
Company press release -- July 29, 2003
BioSpecifics "has been notified by the US Food and Drug Administration that its request to supplement its biologics license application for Collagenase to include major renovations to the manufacturing facility, utility systems, and process equipment at its Curacao, Netherlands Antilles location has been approved."
For the full release, see http://biz.yahoo.com/prnews/030729/nytu200_1.html
74. BioSpecifics submits hearing request prior to Nasdaq delisting
Company press release -- May 29, 2003
In response to a Nasdaq staff determination recognizing that BioSpecifics had failed to file its Form 10-KSB for the year ending January 31, 2003, and its Form 10-QSB for the quarter ending March 31, 2003, and pay its annual SmallCap Market dues, BioSpecifics a hearing request to the Nasdaq Listing Qualifications Panel. The company previously announced the delay due to its negotiations to obtain financing to fund operations, and it anticipates that it can cure the deficiencies prior to actual delisting action.
For the full release, see http://biz.yahoo.com/prnews/030529/nyth176_1.html
73. Fiscal 2003 third-quarter results and facilities update
Company Press Release -- December 23, 2002
BioSpecifics reported a loss for its fiscal 2003 third quarter despite a slight rise in year-over-year revenues. Revenues came from stockpiled inventory of collagenase ABC enzyme used by Abbott Laboratories (NYSE: ABT) in the manufacture of Collagenase Santyl Ointment and from royalties on distribution of the ointment by Smith & Nephew (NYSE: SNN). There is enough product in the pipeline to supply Smith & Nephew through April 2003, but BioSpecifics has depleted its enzyme inventory.
Given the depletion of inventory and its reduced cash position, BioSpecifics is "engaged in various efforts to obtain liquidity." The company will resume shipment of its collagenase enzyme upon approval by the FDA of BioSpecifics' efforts at upgrading its Curacao manufacturing facility. Company management is hoping for approval by the end of February 2003.
Fiscal 2003 Third Quarter
Three Months Ended
October 31, 2002 October 31, 2001
$ 831,000 $
For the full release, see http://biz.yahoo.com/prnews/021223/nym058_1.html
72. Injectable collagenase appears effective in treating lipomas
Reuters -- December 17, 2002; by Bill Berkrot
Mr. Berkrot reports that Dr. Zachary Gerut, a plastic surgeon conducting experiments into the use of collagenase for treating lipomas, is "encouraged" by test results that show "Ten out of the 12 patients had a significant reduction in the size of the lipomas -- at least seven greater than 50 percent reduction." The treatment uses an injectable form of collagenase. Current treatment involves surgery. Given that fatty tissue within the body is the same as the fat inside a lipoma, it might eventually be possible that injectable collagenase could be used as an "off-label" treatment by plastic surgeons. FDA approval for lipomas would in itself be a major plus for BioSpecifics. The company acknowledges that approval might be five years off, and that it would welcome a large drug company that could provide a cash infusion to help fund development.
For the full release, see http://biz.yahoo.com/rc/021217/health_biospecifics_fatmelter_1.html
71. Former Knoll President, Gerald E. Bendele, joins BioSpecifics' Board of Directors
Company Press Release -- October 30, 2002
BioSpecifics announced that Gerald E. Bendele has joined its Board of Directors. Until his recent retirement, Mr. Bendele served as BASF Group Vice President Chemical Intermediates. Previously, Mr. Bendele served in a number of capacities with Knoll Pharmaceutical that culminated with his position as President. BioSpecifics' Chairman and President, Edwin H. Wegman, feels "fortunate" to have access to Mr. Bendele's "broad understanding of the pharmaceutical industry . . . particularly (helpful) now as we move in the direction of forming strategic alliances for second generation collagenase products in development, such as Cordase for the treatment of Dupuytren's disease and Plaquase for the treatment of Peyronie's disease."
For the full release, see http://biz.yahoo.com/prnews/021030/nyw140_1.html
70. Researchers report on Dupuytren's trials in The Journal of Hand Surgery
The Journal of Hand Surgery -- September 2002; volume 27, number 5
In the September 2002 issue of The Journal of Hand Surgery, Marie A. Badalamente, PhD, Lawrence Hurst, MD, and Vincent Hentz, MD review the status of their research into using an injectable form of collagenase to treat Dupuytren's disease. Dupuytren's was first described in the 17th century, but it wasn't until the 1970s that researchers were able to identify the underlying pathogenesis of the disorder. The researchers are encouraged that the nonoperative technique they are developing may have applications beyond Dupuytren's.
Surgery has been the only effectual way to treat Dupuytren's, but surgery leads to recurrence rates from 26% to 80% and potential prolonged and extensive postoperative therapy. But having shown the potential merit of using injectable collagenase, two clinical trials were conducted. With the first trial suggesting injectable collagenase had "substantial merit in restoring patients to normal hand function," the FDA authorized a second trial.
The results of the second study showed that "nonoperative collagenase injection therapy for Dupuytren's disease is both a safe and effective method of treating this disorder in the majority of patients as an alternative to surgical fasciectomy." The authors report that some of their patients who had had a fasciectomy on one hand felt "the less invasive injection treatment was far superior to their surgical experience." Phase 3 efficacy trials are now being planned to further examine the use of collagenase in an injectable form as a treatment of Dupuytren's.
For an abstract of the full article, click here
69. BioSpecifics' fiscal second-quarter results reflect facilities approval process
Company Press Release -- September 23, 2002
BioSpecifics reported quarterly results that reflect its having "delivered its remaining stockpiled inventory of Collagenase ABC enzyme" which is used by Abbott Laboratories (NYSE: ABT) to manufacture Collagenase Santyl ointment for distribution by Smith & Nephew (NYSE: SNN). BioSpecifics will receive royalties on the distribution of the Santyl ointment, and ABC enzyme production can be sold to international customers. But further delivery to ABC enzyme to Abbott will need to await final FDA approval of the firm's upgraded Curacao manufacturing facility. The FDA completed pre-approval inspection in July, and BioSpecifics is in the process of responding to FDA form 483 observations. BioSpecifics' plan is "aimed at . . . obtaining approval by this December."
On the R&D front, BioSpecifics reports the FDA has received the Phase 3 protocol for studying the use of Collagenase to treat Dupuytren's disease. For a background primer on Dupuytren's, click here. The results of the Phase 2 clinical trials were published in the September 2002 issue of The Journal of Hand Surgery -- www.jhandsurg.org.
Fiscal 2003 Second Quarter
Three Months Ended
July 31, 2002 July 31, 2001
For the full release, see http://biz.yahoo.com/prnews/020923/nym185_1.html
68. FDA completes pre-Approval Inspection of BioSpecifics' Curacao facility
Company Press Release -- August 15, 2002
BioSpecifics reported today that the FDA has completed a pre-Approval Inspection of the firm's upgraded manufacturing facility located in the Netherlands Antilles. Upon completion, the FDA submitted a list of observations that BioSpecifics will be responding to in coming weeks. Company management is hopeful that final approval will be obtained by December 2002.
For the full release, see http://biz.yahoo.com/prnews/020815/nyth026_1.html
67. Wound Healing and Tissue Engineering Companies
Following is a list of companies developing Wound Healing and Tissue Engineering products.
66. BioSpecifics granted European patent for chemical liposuction
Company Press Release -- June 27, 2002
The European Patent Office has granted BioSpecifics patent EP0721781B1 for "Reduction of Adiopose Tissue Using Collagenase." This patent stems from work demonstrating that injected collagenase, Lipolysin, is capable of dissolving fat in genetically obese rats without significant damage to the surround areas. Results of a study were "presented at the 35th Anniversary Meeting of the American Society for Aesthetic Plastic Surgery in Las Vegas http://Surgery.org." Results of pre-clinical studies led to further examination by Dr. Zachary Gerut into the treatment of encapsulated fatty deposits called lipomas. The company cautions that while "results on a small number of patients treated with Lipolysin have been very encouraging, . . . extensive clinical investigations must be performed before it is known if this treatment is safe and effective in humans." ABC News' Dr. Anna Marie's coverage of the story can be found at http://abcnews.go.com/sections/living/DailyNews/chemicallipo010620.html
For the full release, see http://biz.yahoo.com/prnews/020627/nyth011_1.html
65. BioSpecifics' fiscal first-quarter revenues $902,000 and $938,000 loss; progress reported on facilities upgrade and new applications
Company Press Release -- June 18, 2002
BioSpecifics Technologies' fiscal first-quarter results reflect no deliveries of its Collagenase ABC enzyme to Abbott Laboratories, while last year's quarter included the delivery of a large backorder. The company expects to make one delivery during the fiscal second quarter that will deplete its inventory. New product being produced at the firm's upgraded Curacao facility awaits inspection by the FDA, which the company expects to be completed by the end of July. The company "continues to earn royalties on the distribution of Collagenase Santyl Ointment by Smith & Nephew" (NYSE: SNN). Inventories of Santyl are sufficient to "generate royalties for BioSpecifics at least through the fiscal year ended January 31, 2003."
The company also announced "excellent progress" on clinical investigations. The "FDA has directly funded the Phase 3 Trials for the use of collagenase for Dupuytren's disease (http://www.fda.gov/orphan/grants/awarded.htm)," which the company expects to begin this fall. "Also, a May 2002 article in Archives of Ophthalmology titled 'Non-Surgical Sclerostomy Demonstrates Potential as New Treatment for Glaucoma' describes how our purified collagenase reduced intraocular pressure and relieved symptoms in patients with primary open-angle glaucoma. (http://www.medscape.com/viewarticle/433727)"
Fiscal 2003 First Quarter
Three Months Ended
April 30, 2002 April 30, 2001
For the full release, see http://biz.yahoo.com/prnews/020618/nytu152_1.html
64. BioSpecifics' Board of Directors Approves Shareholder Rights plan
Company News Release -- May 20, 2002
BioSpecifics Technologies' Board of Directors has approved a Shareholder Rights plan under which shareholders of record on May 31, 2002, will receive a right to purchase a newly issued junior participating preferred stock for each share of common held. The rights will allow the purchase of one one-thousandth of a share of the preferred. They will become exercisable following the announcement that anyone has accumulated or made a tender for 15% or more of the then outstanding shares of the company's common. The rights "are intended to enable all BioSpecifics Technologies corp. stockholders to realize the long-term value of their investment in the company."
The full release can be found at http://biz.yahoo.com/prnews/020520/nym191_1.html
63. Fiscal 2002 revenues pass $8 million; facility upgrade and clinical trials progress
Company News Release -- May 2, 2002
BioSpecifics reported today that revenues for fiscal 2002 ended January 31, 2002, rose more than 48% to $8.21 million and the yearly loss was cut to $0.06 per share from last year's $0.32 per-share loss. Collagenase Santyl royalties rose about 8% to $2.269 million for the year. For the fiscal fourth quarter, shipments of Collagenase ABC to Abbott Laboratories boosted revenues by 69% over the year-earlier period to $2.464 million. A $726,000 loss for the quarter included a non-cash valuation allowance charge of about $372,000 for Orphan Drug tax credits which had previously been capitalized as deferred tax assets. The company also reported that it expects the FDA to inspect its Curacao, Netherlands Antilles production facility, and it hopes "to have approval of the facility in the fiscal year that will end January 31, 2003." The facility is in operation, but product is being held pending FDA approval.
Clinical trials continue into Dupuytren's disease, Peyronie's disease, frozen shoulder, and cutaneous lipomas. Preparations for Phase 3 studies examining the ability of Cordase to treat Dupuytren's disease are underway; the FDA has agreed that the company can conclude Phase 2. Stony Brook University Hospital has received an FDA monetary grant to help with the Phase 3 trials. Early clinical studies are underway into the use of the collagenase enzyme for treating lipomas -- benign fatty tumors that occur as bulges under the skin. Collagenase may also have applications as a chemical liposuction. And BioSpecifics continues to collaborate with Smith & Nephew (NYSE: SNN) in studying the ability of collagenase to accelerate wound healing.
Fiscal 2002 Fourth Quarter
Three Months Ended January 31,
The full release can be found at http://biz.yahoo.com/prnews/020502/nyth008_1.html
62. BioSpecifics presents positive clinical trial results with minimal adverse effects using Cordase
Company Press Release -- March 1, 2002
It was reported today that in early February, Dr. Marie Badalamente of Stony Brook University and Medical Center, Stony Brook, NY (Department of Orthopaedics), presented the results of a Phase 2 placebo controlled double blind dose response trial. The occasion of the announcement was the 48th annual meeting of the Orthopaedic Research Society in Dallas, TX. The following table highlights the results of the study. In addition to the positive outcomes, "Adverse events appeared to be minimal and local . . . (with) all effects resolved within 5 to 14 days of injection." BioSpecifics has submitted the results to the FDA in support of ending Phase 2 trials while at the same time it is making preparations for Phase 3 trials.
The following tables represent the number of patients who experienced a return to normal extension one month following the injection of Cordase, BioSpecifics' injectable collagenase.
Injectable collagenase is also in Phase 2 studies of adhesive capsulitis (frozen shoulder). Last October, the company reported on the progress of long-term clinical studies examining injectable collagenase's ability to treat Peyronie's disease. And early phase clinical studies have begun into its effectiveness in treating lipomas and as a form of chemical liposuction.
For the full release, see http://biz.yahoo.com/prnews/020301/nyf002_1.html
61. Smith & Nephew reports strong gains, including Wound Management
Smith & Nephew Press Release -- February 7, 2002
Smith & Nephew (NYSE: SNN) announced today that the firm's "three main businesses performed well ahead of their markets and are now demonstrating the momentum to achieve sustainable future growth." The firm's "major global businesses, Orthopaedics, Endoscopy and Wound Management, all accelerated their sales and profit growth." Regarding their Wound Management division, a major customer of BioSpecifics Technologies, Smith & Nephew reports that in 2001 they "became the world leader in advanced treatments for hard-to-heal wounds."
For the full release, see http://biz.yahoo.com/bw/020207/72052_1.html
60. Revenues rise and loss narrows in fiscal third quarter
Company Press Release -- December 21, 2001
BioSpecifics reported that revenues rose in its fiscal third quarter to $794,000. The "implementation of new production controls," however, resulted in a loss of $0.12 per share, albeit a smaller loss than in the year-earlier period. The implementation of the new controls led to delivery delays of the firm's Collagenase ABC to its licensee. Management anticipates that deliveries will be made in the fiscal fourth quarter ending January 31, 2002. Revenues rebounded as the firm's new distributor -- as of January 31, 2000 -- achieved higher sales of Santyl. Having spent $1.5 million over the course of the first three-quarters on facilities renovation and research and development, BioSpecifics reports that it has $775,000 in cash and marketable securities. Construction on the Curacao facility is completed and "the company hopes to have made substantial progress in the approval process for the upgraded Curacao facility" by mid 2002. Management continues to explore strategic alternatives, including raising new capital and accelerating the development of products in its research pipeline (see citation for complete R&D update).
Fiscal 2002 Third Quarter
Three Months Ended
October 31, 2001 October 31, 2000
$794,000 $ 573,000
For the full release, see http://www.quicken.com/investments/news/story/pr/?story=/news/stories/pr/20011221/NYF004.htm&symbol=BSTC
59. BioSpecifics appoints new certifying accountant
Company Press Release -- December 12, 2001
Stating that "there were no disagreements with Grant Thornton LLP on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures," BioSpecifics has appointed BDO Seidman, LLP as its principal accountants.
For the full release, seehttp://www.quicken.com/investments/news/story/djbn/?story=/news/stories/dj/20011213/BT20011213003244.htm&symbol=BSTC
58. Smith & Nephew reports strong quarterly results due, in part, to gains in Wound Healing
Company Press Release -- August 2, 2001
Smith & Nephew (NYSE: SNN) reported a "Strong first half - underlying sales up 12%" saying "the acceleration in growth from our repositioned advanced wound management business is particularly pleasing." The gains in its wound-management business came, in part, due to "the roll-out of Collagenase products in Europe." The company also acquired Beiersdorf's advanced woundcare business. Acquisitions have led to Smith & Nephew having "the largest dedicated advanced wound management sales force in the world."
For the full release, see http://www.smith-nephew.com/news/item.jsp?id=72
57. BioSpecifics Reports on R&D achievements
Company Press Release -- October 24, 2001
In "management's first annual report on" the state of research and development activities of the therapeutic applications of Collagenase, BioSpecifics updates the status of research targeting Dupuytren's disease, Peyronie's disease, frozen shoulder, lipomas including "chemical liposuction," and wound healing.
As previously announced, the company has concluded Phase-II trials examining the use of injectable collagenase, Cordase, in the treatment of Dupuytren's disease. "Phase III may proceed pending final approval of the clinical protocol;" during an "end-of-Phase-2-meeting," the Pharmacology/Toxicology and manufacturing specifications and controls were found to be satisfactory to proceed to Phase III. BioSpecifics plans to partner with "an Australian pharmaceutical firm to initiate clinical investigations in Australia" where Dupuytren's is well known due to a genetic predisposition. The Commonwealth of Australia granted BioSpecifics patent #733208 on August 23, 2001. BioSpecifics has already secured U.S. patent 6,086,872. Dupuytren's disease is a genetically inherited disorder evidenced by a large buildup of collagen deposits in the palm or fingers that restrict the ability to bend the fingers. BioSpecifics' enzyme, Collagenase ABC, decomposes the collagen buildup and thus frees the finger. "The only proven therapy for Dupuytren's disease is surgery, which involves the removal of the cords responsible for the deformity."
Following a "completed preliminary analysis of the long-term results" of treating Peyronie's disease with injectable collagenase, "BioSpecifics is planning future clinical investigations to replicate" the results showing 52% of patients being treated successfully. Dr. Gerald Jordon, "one of the leading Peyronie's disease specialists," conducted the preliminary study at the Devine Tidewater Urology Clinic in Norfolk, Virginia. Peyronie's disease is evidenced by a buildup of collagen that forms a plaque that can cause the penis to bend more than 90 degrees during erection. The only therapy currently recognized by the medical community is surgery.
Frozen shoulder, adhesive capsulitis, is another condition caused by an excessive buildup of collagen. It is a "clinical syndrome of pain and severely decreased motion in the shoulder joint." Clinical investigators at Stony Brook are examining the efficacy of treatment using an injectable collagenase "under an FDA approved Investigational New Drug application." Upwards of 2 million patients a year are afflicted; 10%-20% of diabetics are reported to be affected. An October 2, 2001 Newsday article quoted Dr. Marie Badalamente as saying that patients have reported a "dramatic release from pain."
Lipomas and "Chemical Liposuction"
The FDA granted an Investigational New Drug application for a study examining the use of injectable collagenase to treat cutaneous lipomas, benign fatty tumors that occur as bulges in the skin. "Early clinical results in a small series of patients" have shown promise. In covering the story for ABC News, Dr. Anna Marie considered the potential of injectable collagenase to be used as a "chemical liposuction." The company, cautioning "that much clinical work remains to be done," may consider teaming "with a major pharmaceutical company to develop this application."
Collagenase for Wound Healing
U.S. Patents 5,851,522 and 5,718,897 reflect the successful research of Dr. Ira Herman at Tufts University demonstrating the effectiveness of topically applied collagenase to accelerate wound healing. BioSpecifics has been assigned the patent rights. Patent applications "have been filed in Japan, Australia, Canada, and the EPO (12 countries)." The company "is collaborating with Smith & Nephew (NYSE: SNN) in ongoing studies designed to investigate this new potential application for BioSpecifics' collagenase."
For the full release, see http://biz.yahoo.com/prnews/011024/nyw012_1.html
56. Dupuytren's Research Moves onto Phase 3; FDA Approves Phase 2 Results
Company Press Release -- September 11, 2001
BioSpecifics Technologies has completed Phase 2 trials examining the ability of Cordase (injectable Collagenase) to treat Dupuytren's disease. The results were announced following an "end-of-phase-2-meeting" with the FDA. Pharmacology/Toxicology and manufacturing specifications and controls "were found satisfactory to proceed to Phase 3." The FDA has awarded a monetary grant to Stony Brook University Hospital "to help advance the Phase 3 clinical trials of Collagenase ABC." Dupuytren's disease is evidenced by an excessive buildup of collagen in the palm or fingers resulting in the fingers contracting "into a flexed or bent position." The ability of patients to be treated in the doctor's office with injectable Collagenase compares favorably with surgery, the only proven therapy for Dupuytren's disease.
Mr. Thomas Wegman, Executive Vice President, praised the efforts of "Drs. Lawrence Hurst and Marie Badalamente, (Professor and Chairman of Orthopedics, and Professor, Orthopedics respectively, at Stony Brook) and Dr. Vincent Hentz, Professor and Chief of Hand Surgery at Stanford University." Injectable Collagenase "is also in Phase 2 studies for the treatment of adhesive capsulitis (frozen shoulder). Long-term clinical results of Collagenase treatment of Peyronie's disease are being analyzed and expanded trials are planned within the next year. Early phase clinical studies are underway for Collagenase treatment of lipomas."
The full report can be obtained at http://biz.yahoo.com/prnews/010911/nytu021_1.html
55. Mr. Edwin Wegman lays out Investment Case for BSTC in The Wall Street Transcript Interview
The Wall Street Transcript -- August 6, 2001
Mr. Edwin H. Wegman, President, Chairman, and CEO of BioSpecifics Technologies, began an interview with The Wall Street Transcript by describing his firm's "principal concentration" as the enzyme Collagenase, "the only enzyme that will dissolve collagen." As "the framing matrix for each individual cell," collagen is described as "the most important protein in the body, it makes up to one-third of total protein and something like 75%-80% of skin." The company "pioneered this product and we have approval from the FDA for its use as a topical ointment." BioSpecifics is also "very actively researching the use of Collagenase in an injectable form for the treatment of various local and systemic diseases."
As an ointment, Collagenase is used in "the treatment of chronic skin ulcers and second and third degree burns." Research conducted at Tufts University has indicated that Collagenase has a "remarkable healing effect, . . . some six times the rate at which the tissue the growth factors expedite healing of the wound." Mr. Wegman believes "the ultimate market for this is enormous, and we are busily exploring it with our principal licensee," Smith & Nephew (NYSE: SNN). Smith & Nephew is "the leading wound healing company in the world."
As an injectable, the company is researching the use of Collagenase "in the treatment of various local and systemic diseases that require the administration of Collagenase below the skin." Research into the use of Collagenase for the treatment of Dupuytren's is "the furthest along." (see citation #56) Dupuytren's "is the contracture of the fingers towards the palm which can't be released because it's the result of the growth of a collagen cord in the palm of the hand which restricts the movement of the joint." Dupuytren's is particularly prevalent in the Northern European population, which "represents two-thirds of the American population in terms of ethnic origin." Indications are "that something like 60% of the Scots over age 60 have Dupuytren's disease." Injectable Collagenase is also being examined as a treatment for Peyronie's disease, "where a plaque forms on the side of the penis and prevents full erection. This can be a problem in intercourse, cosmetically as well as mechanically, and a source of anxiety for men who are afflicted." Just recently, the company announced that it is examining the use of injectable Collagenase "for the destruction of fatty deposits, particularly the lipomas, which are encysted fatty volumes and can be disfiguring and uncomfortable." It may be effective "as a substitute for liposuction although that will require further work." It may also be useful for treating Keloids or hypertrophic scars, "heaped-up scars that sometimes occur after wounding, particularly burns, and can be disfiguring, painful and irritating in many cases."
Commenting on the company's financials, Mr. Wegman points out "We have cash, and we are generating cash because of our approved product," Santyl ointment, but the firm is "interested in exploring possibilities of expediting these clinical research programs through licensing and joint efforts, joint ventures with potential marketers." Regarding management, Mr. Wegman believes "our people are head and shoulders above some of the others and are able to manipulate and purify the enzyme and to manufacture it according to FDA standards." Given the firm's full plate of research activities, Mr. Wegman doesn't anticipate that mergers or acquisitions will receive a very high priority. He expresses his encouragement that "the likelihood of success for Dupuytren's disease is fairly compelling. And the foreseen profits are substantial on into the future." He further states that given "the fact that this is a biological drug, . . . it comes under a section of law which does not allow for generic competition. So not only is our patent position good, but because of the sheer weight of the years of research and development, if anybody wanted to come in, they couldn't simply copy the drug." He concludes by stating, "The possibilities of profit are simply very great."
The Wall Street Transcript's home site is http://www.twst.com/
54. BioSpecifics Reports Rising Sales and Continued Profitability in Fiscal Second Quarter
Company Press Release -- September 19, 2001
BioSpecifics reported a jump in revenue and earnings for the three- and six-month periods ended July 31. The first half of fiscal 2002 benefited from the timing of delivery of the firm's Collagenase ABC enzyme to Abbott Laboratories (Abbott acquired Knoll Pharmaceutical earlier this year). Abbott "compounds" the ABC enzyme into Santyl Ointment for delivery to Smith & Nephew (NYSE: SNN). Smith & Nephew markets Santyl in the United States and Canada. The first six months benefited from an increase in royalty revenue from the sale of Santyl. BioSpecifics does not expect to deliver product to Abbott during the fiscal third quarter because it will not have completed product for delivery. Full-scale production of the firm's Collagenase ABC is "taking place in stages" at the firm's recently completed biopharmaceutical manufacturing facility in the Netherlands Antilles. "BioSpecifics must submit to the FDA documentation for approval of the facility and new Collagenase ABC inventory being produced at the facility."
R&D efforts that are examining the use of injectable Collagenase are "on schedule." The company recently completed Phase II trials examining the use of Cordase in the treatment of Dupuytren's disease, and it continues Phase II studies for the treatment of adhesive capsulitis -- frozen shoulder. Expanded trials examining the use of injectable Collagenase on Peyronie's disease are being planned later this year. And "early phase clinical studies are also underway for collagenase treatment of lipomas."
Fiscal 2002 Second Quarter
Three Months Ended
July 31, 2001 July 31, 2000
The full release can be found at http://biz.yahoo.com/prnews/010919/nyw065_1.html
53. BioSpecifics Picked as 'Company of the Month' by The Bowser Report
The Bowser Report -- August, 2001
Picking up on the fact that "BSTC's products have many applications," that "BSTC is strong enough financially (to have financed $5 million production facility upgrades) through internal funds," and that the balance sheet has "no long-term debt," The Bowser Report recently spotlighted BioSpecifics Technologies as its 'Company Of The Month.' BioSpecifics' "bread-and-butter product" is its collagenase ABC enzyme used in the production of a prescription ointment (sold in the U.S. under the Santyl trademark) used to treat "dermal ulcers, pressure sores (bedsores) and second and third degree burns." BioSpecifics' product "dissolves collagen, a protein that makes up one-third of the human body and 76% of skin." BioSpecifics' enzyme is being studied for the treatment of Dupuytren's and Peyronie's diseases. More recently, "New York City plastic surgeon Zachary Gerut was researching different uses of enzyme collagenase. By accident, he found the enzyme liquefies fat in lab animals." The FDA has OK'd the testing of "collagenase in the treatment of lipomas, which are encapsulated fatty deposits." The "European patent office intents to grant a patent fort Lipolysin -- an injectable enzyme manufactured by BSTC for the reduction of adipose fat in tissue." The expectation is that BSTC has come upon a substance "that may melt away fat non-surgically," thus providing an alternative to surgical liposuction.
The Bowser Report home page is http://www.thebowserreport.com
52. BioSpecifics Partners with Asante Partners to Evaluate Strategic Opportunities
Company Press Release -- July 18, 2001
BioSpecifics Technology has chosen as its strategic advisor Asante Partners LLC, a merchant Banker who provides "sophisticated investment banking and strategic advisory services to the healthcare industry." Asante Partners has "extensive experience in biotechnology joint ventures and alliances." Senior Managing director of Asante Partners, James McLaren, believes that with the end-user market for BioSpecifics' development products "in excess of $1 billion . . . significant opportunities for long term strategic alliances" exist with major domestic and international pharmaceutical companies. BioSpecifics' Chairman and President, Edwin H. Wegman, is "anxious to expedite the process" of bringing the firm's products to market.
The full release can be found at http://biz.yahoo.com/prnews/010718/nyw019.html
51. Construction Completed on Biopharmaceutical Production Facility
Company Press Release -- June 25, 2001
BioSpecifics has completed improvements to its biopharmaceutical manufacturing facility located in the Netherlands Antilles. The company has instituted "first stage production runs" of Collagenase ABC, the active ingredient in Collagenase Santyl ointment. Santyl is currently being marketed by Smith & Nephew (NYSE: SNN). BioSpecifics has spent about $5 million upgrading the more than 15,000 square-foot facility, including a modularized clean room with custom built manufacturing equipment. "The first shakedown runs have been completed and full-scale production will take place in stages. BioSpecifics must submit to the FDA documentation for approval of the improvements to the facility and production at the facility."
The full release can be found at http://biz.yahoo.com/prnews/010625/nym004.html
50. BioSpecifics Posts Strong Fiscal First Quarter Revenue Gain and Profitability
Company Press Release -- June 18, 2001
BioSpecifics, "pleased with our" progress on facilities renovation and clinical trials and continued efforts in developing the market for Collagenase Santyl with Smith & Nephew (NYSE: SNN), reported a nearly doubling in revenues for the fiscal first quarter and a return to profitability.
Fiscal 2002 First Quarter
Three Months Ended
April 30, 2001 April 30, 2000
The full release can be found at http://biz.yahoo.com/prnews/010618/nym026.html
Management's discussion and Analysis of financial condition and results from SEC form 10QSB http://biz.yahoo.com/e/010619/bstc.html
49. Chemical Liposuction; A Chance Discovery
InsideBaltimore.com -- May 30, 2001; by Dr. Anna Marie
2News Medical Reporter Dr. Anna Marie reports on the accidental finding that collagenase is able to liquefy fat in lab animals. Dr. Marie reports that plastic surgeon Dr. Zachery Gerut "was researching the enzyme collagenase to see if it broke down scar tissue or adhesions," but in the process found it liquefied fat. Dr. Marie reports that, "The government has given the OK to start researching the enzyme in humans. Now, the first goal is to see if it can effectively melt non-cancerous fatty tumors, but the ultimate goal may be non-surgical." It appears quite possible that injectable collagenase may be capable, in a procedure described as chemical liposuction, of eliminating the need for surgical liposuction, a procedure chosen annually by more than 800,000 people in the U.S. to remove fat from their body. If you would like information about participating in the research -- you must have a benign fatty tumor at least 2-inches in size not located on your face or breast -- call 212-734-4100.
The full release can be found at http://www.wmar.com/news/health/2yh/chem-lipo0530.shtml
48. BioSpecifics' Common Stock Listed on The Nasdaq SmallCap Market
Company News Release -- May 25, 2001
It was announced today that BioSpecifics' common stock has commenced listing on The Nasdaq SmallCap Market under its trading symbol BSTC.
The full release can be found at http://biz.yahoo.com/prnews/010525/nyf014.html
47. BioSpecifics To Receive European Patent for Lipolysin; a 'Chemical Liposuction'
Company News Release -- May 24, 2001
BioSpecifics Technologies announced today that it expects the European Patent Office to issue a patent for the firm's injectable enzyme, Lipolysin. "The enzyme has undergone extensive pre-clinical testing which demonstrated its ability to liquefy fat deposits in animals." The company is exploring whether Lipolysin, in an action described as a 'Chemical Liposuction,' is capable of achieving the same results in humans as conventional liposuction without the associated blood loss and trauma. Patents have been applied for in the United States as well as countries outside Europe.
The company also announced that the U.S. Food & Drug Administration has authorized Dr. Gerut, a plastic surgeon, to proceed under the approval of an Investigational New Drug (IND) application to study the use of "BioSpecifics' enzyme in the treatment of lipomas, which are encapsulated fatty deposits." The enzyme used for this purpose is the same as used in the firm's Cordase product, which has successfully completed Phase II trials investigating its ability to treat Dupuytren's disease. BioSpecifics is preparing a report for the FDA "detailing the product's safety and efficacy. The FDA has already granted financial assistance for the Phase III Trial . . ."
BioSpecifics' President, Edwin H. Wegman, comments that, "This patent award and IND are among the fruits of the ongoing research and development program of BioSpecifics'. The cost of this basic research has aggregated over $23 million and includes endeavors in the area of Dupuytren's disease, Peyronie's disease, keloids, frozen shoulder, and glaucoma, among other conditions."
The full release can be found at http://biz.yahoo.com/prnews/010524/nyth022_2.html
46. Fiscal 2001 Results Reflect Transitional Effect of Move to New Marketing Partner
Company News Release -- May 17, 2001
Recognizing that, "The transfer of marketing effort resulted in a period of transition and lower sales of Santyl during the company's fiscal year 2001," BioSpecifics Technologies reported declining sales and per-share losses for the fiscal fourth quarter and year ended January 31, 2001. The marketing and distribution rights of Collagenase Santyl were transferred from Knoll Pharmaceutical to Smith & Nephew Inc. as of January 31, 2000. BioSpecifics' Executive Vice President, Thomas L. Wegman, states, "We are thoroughly pleased with Smith & Nephew (NYSE: SNN), the new marketer of Santyl, and their strong strategic commitment to the wound healing market." Smith & Nephew is "the world's leader in wound management," and they plan "to invest behind the brand to confirm the clinical benefit of Collagenase for new therapeutic indications." Mr. Wegman believes that Smith & Nephew's "determined and focused marketing approach will result in accelerated product growth in the coming years."
Fiscal 2001 Fourth Quarter
Three Months Ended January 31,
The full release can be found at http://biz.yahoo.com/prnews/010517/nyth110.html
45. Fiscal Third Quarter Results Reflect Transitions
Company News Release -- December 15, 2000
BioSpecifics reported results for its fiscal third quarter ended October 31, 2000. Revenues declined to $573,000 and a net loss was realized of $764,000 or $0.17 per share. Results were adversely impacted by lower royalty revenue from the sale of Collagenase Santyl Ointment. Marketing and distribution rights of Collagenase Santyl Ointment were transferred to a new distributor as of January 31, 2000; "The new distributor has advised the Company that it believes it will achieve higher sales of Santyl in calendar 2001." The quarterly loss was primarily due to BioSpecifics initiating new production controls "that resulted in a delay of delivery of the company's product Collagenase ABC to its licensees." A longer production cycle resulted; the company expects to renew deliveries in the fiscal fourth quarter. In other news, BioSpecifics reported it had $2.1 million in cash and marketable securities, and that it expects to complete construction at its Curacao facility in January 2001. They also believe that expenses related to "addressing FDA concerns have peaked and should have less influence on succeeding periods." "Phase II clinical trials are near completion in the U.S. for the use of injectable collagenase in treating Dupuytren's disease. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity for Peyronie's disease and in wound healing are being pursued."
Fiscal 2001 Third Quarter
Three Months Ended October 31,
44. Funding Grant Received For Cordase Phase III Clinical Trial
Company News Release -- November 13, 2000
In a company news release disseminated by PRNewswire today, BioSpecifics' reported that the FDA's office of Orphan Drug Product Development has approved a Phase III clinical-trial testing grant to the University Hospital Medical Center at Stony Brook for a study examining the effectiveness of Cordase in treating Dupuytren's disease. Cordase is an injectable form of Collagenase. The company expects that Phase III trials will begin in 2001, following a favorable FDA review of the results of a Phase II Clinical trial conducted at Stony Brook. Expanded dose studies are already being conducted at Stony Brook and at Stanford University Medical Center. Marie Badalamente, PhD, and Lawrence C. Hurst, MD, submitted a review article on the Phase II study that appeared in the July 2000 issue of The Journal of Hand Surgery.
Dupuytren's disease is a condition whereby one or more fingers are permanently contracted into a flexed or bent position. It is caused by an excessive amount of collagen. "Cordase is an injectable enzyme that breaks up this collagen and so acts to free the fingers." Surgery is the only proven therapy for Dupuytren's disease, a procedure potentially avoided by the use of Cordase.
The news release also touched on the September announcement that the University Hospital Medical Center at Stony Brook had expected to begin Phase I clinical trials using injectable collagenase to treat adhesive capsulitis, or Frozen Shoulder. Frozen Shoulder is a condition evidenced by pain and severely decreased motion in the shoulder. It has histological changes similar with Dupuytren's disease.
43. Frozen Shoulder Syndrome Potential Goldmine For BioSpecifics
Long Island Business News -- November 3-9, 2000; byStuart Markus
Mr. Markus begins his article, "BioSpecifics Drug Could Be Goldmine," by commenting that BioSpecifics' injectable Collagenase is targeting a "potentially profitable niche." The firm's injectable Collagenase, Cordase, received orphan drug status by the FDA because its targeted market for Dupuytren's disease affects a very small number of people in America. But injectable Collagenase is also being examined as a treatment for adhesive capsulitis, known as Frozen Shoulder. Dupuytren's disease and Frozen Shoulder syndrome are both problems of excessive collagen, "a protein that makes up one third of the human body and 75% of skin." But "too much of the protein leads to trouble." Frozen Shoulder "affects an estimated 2% of the population, . . . which could eventually open it up to a market of 5 million people." While reluctant to estimate the size of the market, Tom Wegman, BioSpecifics' Executive Vice President, is quoted as saying, "There's an incredible market for it." Marie Badalamente, scientist at SUNY Stony Brook, is looking for test subjects as she seeks to begin Phase II trials.
Currently, drugs, used to bring down inflammation and intense physiotherapy are used to treat Frozen Shoulder. Arthroscopic surgery may also be prescribed to remove scar tissue. Dr. David Dines, Chairman of Orthopedics at Long Island Jewish-North Shore University Hospital's Albert Einstein School of Medicine, "does between 20 and 25 such surgeries a year, but only one in five sufferers opt for the operation." Dr. Dines states, "You parlay that across the country, that's a pretty significant number."
The market for Dupuytren's may be larger than statistics show, as Dr. Badalamente reports that "a lot of patients don't want surgery," and thus Dupuytren's victims may be under reported in national statistics. Mr. Markus also mentions other maladies resulting from excessive collagen including Lederhose disease, essentially Dupuytren's of the foot, and Peyronie's disease, which results in a bent penis. Too much collagen is also a factor in glaucoma, and Marie Badalamente "said she would also like to study the use of Cordase for treating scarring in the knee, a common side effect of injury or surgery."
Collagenase Santyl ointment has been BioSpecifics' principal product. It is "used in clearing dead flesh out of second- and third-degree burns, hospital bedsores, and other skin ulcers." Mr. Wegman anticipates that a January agreement for England-based Smith & Nephew to distribute Santyl in North America will expose Collagenase Santyl to more of the world wound care market "calculated at about $10 billion worldwide."
42. Injectable Collagenase Research Expands Into "Frozen Shoulder"
Company News Release -- October 20, 2000
BioSpecifics announced that University Hospital and Medical Center at Stony Brook plans to expand its research efforts at discovering additional uses for BioSpecifics' injectable Collagenase. Having just submitted results of Phase 1 and 2 trials examining the use of BioSpecifics' Cordase injectable Collagenase to treat Dupuytren's disease to the U.S. FDA, Stony Brook University plans to begin "a Phase 1 clinical trial with injectable Collagenase treatment for adhesive capsulitis," also known as frozen shoulder. Frozen shoulder is evidenced by severely decreased motion and pain in the shoulder. "Since frozen shoulder is due to excessive Collagen deposition, it may be responsive to collagenase." "Some reports estimate there is a 2% incidence of frozen shoulder in the population."
The full release can be found at http://www.biospecifics.com/companynews.html#anchor14
41. Fiscal Second Quarter Revenue Up 19% And R&D Shows Progress
Company News Release -- September 14, 2000
BioSpecifics reported today that deliveries of its Collagenase ABC enzyme to Knoll Pharmaceutical more than offset a decline in royalty revenue from the sale of Collagenase Santyl ointment. Knoll Pharmaceutical continues to manufacture the ointment, but Smith & Nephew has been marketing it in the U.S. since January. It is this marketing transition from Knoll to Smith & Nephew that BioSpecifics believes led to the lower royalty revenue during the three and six month periods ending July 31. Commenting, "Research and development progress is encouraging," BioSpecifics reports that a Phase II trial has been completed for an injectable Collagenase enzyme, Cordase, for Dupuytren's disease. They also report on "positive preliminary results" in a clinical trial examining the use of an injectable Collagenase enzyme, Plaquase, for treating Peyronie's disease. The company spent about $1.7 million in upgrades for its Curacao facility, a state-of-the-art biopharmaceutical facility that BioSpecifics "is committed to investing in" in order to increase capacity and improve efficiencies. The company reports that it continues to direct resources toward addressing FDA concerns.
Fiscal 2001 Second Quarter
Three Months Ended July 31,
40. Online Interview Spotlights Importance of Collagenase
CEOcast (www.ceocast.com) -- September 13, 2000
Edwin H. Wegman, BioSpecifics Technologies' President and CEO, was recently interviewed in an online forum at CEOcast. Mr. Wegman commented that he like to view BioSpecifics as a "one area company." That being the area of Collagenase, "the most important protein in the body;" by weight 1/3 of all protein; 80% of skin. "The area of the application of Collagenase is very very wide, indeed."
While the body is capable of producing enzymes that break down excessive collagen, "there (are) no circulating enzymes in the body for this purpose." Collagen is a critical structural enzyme, "and if it were to be attacked willy nilly the body would collapse." Collagenase is produced locally "under certain specific conditions." But sometimes the body needs help. BioSpecifics is the only approved Collagenase manufacturer in the U.S. It makes the active ingredient while its licensees "compound and market" the end product.
Several double blind experiments have been completed for a condition known as Dupuytren's disease, a disease that "causes the fingers to bend toward the palm." It is a condition that is surprisingly prevalent among Northern Europeans; something like 60% of Scots over 60 have Dupuytren's. It is also widespread among the Scandinavians, English, and Germans. While BioSpecifics will continue to use its partnerships, the fact that there are only 2,500 hand surgeons in the country provides an opportunity to sell direct. "The next milestone, particularly for Dupuytren's, will be the approval of the FDA to proceed to Phase III, which we hope that we'll have by the end of this year."
BioSpecifics was recently named to the 2,000 Long-Island Technology Fast by Deloitte & Touche LLP. Mr. Wegman commented that time is the biggest factor in BioSpecifics becoming a substantially larger company.
39. BioSpecifics Named As One Of Long Island's Fifty Fastest Growing Technology Companies
Company Press Release -- September 11, 2000
BioSpecifics Technologies received a measure of acclaim by being "named as one of the fifty fastest growing technology companies on Long Island." An organization, headed by the international accounting firm Deloitte & Touche, LLP, sponsored the 2000 Long Island Fast 50. BioSpecifics will be recognized at an awards event and will also be profiled in Newsday and Long Island Business News. In addition, BioSpecifics "has been nominated for consideration in the technology Fast 500, which honors the 500 fastest growing U.S, technology companies."
The full release can be found at http://biz.yahoo.com/prnews/000911/ny_biospec.html
38. BioSpecifics Spotlighted By Internet Website Global Province
Business Writers -- July 19, 2000
BioSpecifics received attention today as the latest addition to the research offerings of Global Province, an Internet website venture of William Dunk Partners, Inc., a counselor on corporate governance, share valuation, revenue growth, international commerce, and executive performance. BioSpecifics' addition may be found at http://www.globalprovince.com under Investor's Digest. BioSpecifics' Executive Vice President, Thomas L. Wegman, stated, "We are delighted to be included on Investor Digest . . . it correctly spells out our simultaneous commitment to consistent financial performance and long-term investment in new product areas."
37. Fiscal First Quarter Revenues Up 12.5% And Loss Narrows
Company Press Release -- June 15, 2000
BioSpecifics reported fiscal first-quarter results for the period ended April 30, 2000. Revenues rose nearly 13%, while a $0.01 per-share loss compared favorably with the year-earlier loss of $0.03 per share. Edwin H. Wegman commented, "We are very pleased with our research progress on three new applications for Collagenase, for Dupuytren's and Peyronie's diseases and glaucoma. At the same time, we continue to work closely with Smith & Nephew in developing the marketing of Santyl."
Fiscal 2001 First Quarter
Three Months Ended April 30,
The full release can be found at http://www.biospecifics.com/companynews.html#anchor13
36. Smith & Nephew "Highly Significant Development" In Fiscal 2000
Company Press Release -- April 28, 2000
BioSpecifics today reported fiscal year 2000 and fourth-quarter results for the period ended January 31, 2000. While recognizing that expenses related to the renovation of manufacturing facilities crimped its bottom line, BioSpecifics remained profitable and maintained its strong commitment to research and development.
Commenting on the year, Thomas L. Wegman, Executive Vice President, stated that BioSpecifics partnering with Smith & Nephew in January 2000 was a "highly significant development." Smith & Nephew, a global medical-device company with 12,000 people in 36 countries, agreed to become the "active marketer and promoter of our FDA licensed product, Collagenase Santyl ointment, in North America." Mr. Wegman went on to state that, in Smith & Nephew's opinion, a marketing agreement will be a "transforming step" for Smith & Nephew and help "propel them into a leading position in the world in the area of advanced wound healing therapy."
Fiscal 2000 was also important on the research and development front. Cordase, an injectable Collagenase treatment of Dupuytren's disease, completed a phase II trial. Dose-ranging studies are underway. Plaquase, an injectable Collagenase treatment of Peyronie's disease, was highlighted at the August 1999 annual meeting as providing encouraging clinical results that would lead to additional trials.
Fiscal 2000 Fourth Quarter
Three Months Ended January 31,
The full release can be found at http://www.biospecifics.com/companynews.html#anchor12
35. Wound Healing Analysts, Financial Newsletters, and Industry Observers
Alexander Arrow; currently of the Patent & License Exchange, Inc. -- http://www.pl-x.com, has been quoted widely on issues related to wound healing. As Vice President of Research for Wedbush Morgan Securities, Mr. Arrow led the firm's medical technology analysts. Mr. Arrow is quoted in the following articles:
Wound-care companies on biotech's cutting edge:
Robert Metz 5
TechVest, LLC; Investment research, consulting and investment banking firm specializing in the healthcare sector. TechVest sponsors an Annual Conference on Tissue Repair, Replacement, and Regeneration: http://www.techvestllc.com
The Low Priced Stock Survey; 4
34. U.S. Patent Office Issues Patent For BioSpecifics' Injectable Collagenase For Peyronie's Disease
Company Press Release -- March 9, 2000
BioSpecifics "has won patent number 6,022,539 from the U.S. Patent Office for the use of its injectable Collagenase enzyme to treat Peyronie's disease." BioSpecifics had previously procured Orphan Drug status for the use of its injectable Collagenase treatment. Last August, Dr. Gerald H. Jordan, Medical Director of Divine-Tidewater Urology, Norfolk, Virginia, reported on the "highly encouraging" results of a 27-patient trial that concluded in July 1999.
The development of Peyronie's disease is "not well understood." Peyronie's is known to consist of hardened scars or plaques consisting of "non-polarized collagen" located on the penis. In severe cases, these plaques "can cause the penis to bend at a 90 degree angle or more." BioSpecifics' injectable Collagenase treatment would be the first approved pharmaceutical treatment for this disease.
BioSpecifics maintains a patient discussion forum at http://www.biospcifics.com/forum/index2
33. Smith & Nephew Purchases Collagenase Product of BASF Pharma
Smith & Nephew Press Release -- February 1, 2000
Smith & Nephew has purchased the Collagenase product of BASF Pharma. Branded as Santyl in North America, the BASF product is know as Iruxol and Novuxol in the rest of the world. It "is one of the three largest wound-care products globally. The product is an enzyme that cleanses and debridges (removes dead tissue from) chronic wounds and burns." Smith & Nephew believes that sales for Iruxol and Nuvuxol to be "growing at an approximate underlying rate of 8%." BioSpecifics "has given consent to this agreement and will continue to supply the active ingredient for the product sold in North America." Smith & Nephew goes on to say that "Collagenase adds one of the three largest global products to Smith & Nephew's Wound Management business and establishes it in a leading position in the pharmaceutically active segment of the wound care market. This sector is expected to continue to grow strongly."
32. Smith & Nephew, A $1.7 Billion Global Medical Device Concern, Markets Collagenase Santyl
Company Press Release -- February 1, 2000
BioSpecifics announced that Smith & Nephew (NYSE:SNN) has acquired the North-American marketing rights to BioSpecifics' FDA-licensed product Collagenase Santyl Ointment. Collagenase Santyl Ointment is used to treat chronic dermal ulcers and severely burned areas. North-American sales of Santyl, previously marketed by Knoll Pharmaceuticals, were in excess of $37 million in 1999. Knoll Pharmaceuticals will continue to manufacture the final ointment for the North-American market. They will do so using BioSpecifics' active ingredient, Collagenase ABC.
Smith & Nephew is a leader in the global healthcare industry. Wound management products accounted for 20% of its1998 revenues. Smith & Nephew will also assume control over Knoll Pharmaceuticals' Santyl selling resources, thus adding "significant critical mass to its sale and marketing capability." As a result, Smith & Nephew will field a "full-time sales force of 190, the second largest in the advanced wound management sector." Thomas L. Wegman, BioSpecifics Vice President, stated, "We are very enthusiastic about partnering with Smith & Nephew since they are a leader in wound-healing therapies, especially in North America. Smith & Nephew plans to invest behind the bran to confirm the clinical benefit of Collagenase for new therapeutic indications, which is in line with our strategy to expand the use of Collagenase to a variety of conditions."
31. John T. Lane Appointed To Board Of Directors
Company Press Release -- January 10, 2000
John T. Lane, Managing Director and Head of U.S. Clients at J.P Morgan & Company, has joined BioSpecifics' Board of Directors. Edwin H. Wegman, BioSpecifics President and Chairman, remarks, "We are very fortunate to have John join our Board of Directors. His broad based understanding of mergers and acquisitions, security offerings, and business development will be great value to BioSpecifics."
30. BioSpecifics Posts Third Quarter Revenue Gain and Positive Phase II Cordase Trial Results
Company Press Release -- December 15, 1999
For the Fiscal third quarter ended October 31, BioSpecifics reported a $0.02 per-share profit on $1.8 million in revenues. Profitability was achieved in conjunction with making "considerable progress in addressing FDA concerns." Management believes that expenses for addressing FDA concerns has peaked. Research and Development expenses (nearly 23% of total revenues) continue to bear fruit. "Phase II trial of injectable Collagenase enzyme Cordase for Dupuytren's disease has been completed and recently reported." In summary, 18 of 25 patients receiving a single injection of Collagenase saw the return of their restricted joint to within 0-5 degrees of normal range of motion. The news release also highlighted "the positive preliminary results in a clinical trial of injectable Collagenase enzyme Plaquase for Peyronie's disease" that were presented at the company's August 4 annual meeting.
Fiscal 2000 Third Quarter
Three Months Ended October 31,
29. BioSpecifics' Injectable Collagenase, Cordase, Proves Effective in Treating Dupuytren's Disease
Company Press Release -- November 2, 1999
Results are available from a 49-patient, "double blind, randomized, placebo controlled study of a single injection of Collagenase into the cord that restricts motion of the effected finger." Fully 18 of the 25 patients receiving a single injection had "a return of their restricted joint to within 0-5 degree normal range of motion and flexion at seven and 14 days and one month." The placebo group showed minimal improvement in two patients. Cordase's effectiveness stems from its ability to decompose a "cord that restricts the motion of the effected finger (that) is composed of collagen."
Dupuytren's disease, named after a French surgeon to Louis XVI and Charles X, results from large deposits of collagen that build up in the palm or fingers and results in one or more fingers contracting in a flexed or bent position. Well-known people with Dupuytren's disease include former U.S. President Ronald Reagan and British Prime Minister Margaret Thatcher. BioSpecifics President said, "We believe that this is a real advance in patient care. It is hoped to be a much less intrusive and much less expensive alternative to surgery, which is currently the only acceptable treatment."
28. FDA Approves State-Of-The-Art Manufacturing Facility For Collagenase Santyl
Company Press Release -- October 6, 1999
BioSpecifics reported today that a sate-of-the-art manufacturing facility for Collagenase Santyl Ointment received approval from the FDA. The facility is located at the site of its licensed distributor. BioSpecifics produces Collagenase ABC, the essential ingredient in the prescription drug product Collagenase Santyl. It is currently used most notably for dermal ulcers, pressure sores (bed sores), and second- and third-degree burns.
27. Plaquase And Cordase Make Way Through R&D Pipeline During Fiscal Second Quarter
Company Press Release -- September 15, 1999
The move to a new ointment compounding facility and a record July quarter a year ago led to difficult comparisons for the Fiscal second quarter ending July 31, 1999. Nevertheless, BioSpecifics achieved profitability of $0.02 per share on revenues of $1.736 million. Profitability was achieved despite the company's directing "significant resources in response to inspectional observations made by the FDA."
BioSpecifics' revenues are derived primarily from the sale of Collagenase ABC, an enzyme product sold to licensees who then manufacture and sell prescription ointments (Collagenase Santyl in the U.S.), the sale of which generates royalties to BioSpecifics. The news release states the company's confidence that "sales of Collagenase Santyl ointment for the year ended January 31, 2000 will be greater than those achieved last year."
Brief comments are made regarding the positive preliminary results that were presented in August of a trial examining the effectiveness of an injectable Collagenase enzyme, Plaquase, for Peyronie's disease. BioSpecifics announced that a report is being compiled and prepared for submission to the FDA regarding the results of a Phase II trial of the firm's injectable Collagenase enzyme, Cordase, for Dupuytren's disease.
Fiscal 2000 Second Quarter
Three Months Ended July 31,
26. Dr. Gerald H. Jordan Reviews Positive Preliminary Results For Plaquase Injectable Collagenase
Company Press Release -- August 9, 1999
Dr. Jordan is Medical Director of Devine-Tidewater Urology, Norfolk, Virginia, considered to be "one of the most active centers in the world for the treatment of this (Peyronie's) disease." In comments made at BioSpecifics' August 4 annual meeting, Dr. Jordan reported "highly encouraging" results of an open-label trial of 27 patients treated with BioSpecifics' injectable Collagenase enzyme, Plaquase. The release states, "BioSpecifics anticipates that the cost of its product, if approved, would be substantially less than the cost of surgery."
25. Dr. Lasagna Joins BioSpecifics' Board of Directors
Company Press Release -- June 29, 1999
Regarding the Board appointment of Louis Lasagna, MD, Thomas Wegman, BioSpecifics' Executive Vice President, states, "We are fortunate to have Dr. Lasagna on our Board of Directors. His exhaustive knowledge and experience in so many areas of drug research will be particularly helpful in our clinical efforts." "Dr. Lasagna is the Academic Dean of the Medical School and Dean of the Sackler School of Graduate Biomedical Sciences at Tufts University." He is currently "a member of BioSpecifics' Board of Scientific Advisors." Dr. Lasagna has operated in a range of consulting roles and serves on a number of Editorial Boards. He has "written extensively in the areas of clinical trial methodology, analgesics, hypnotics, medical ethics, and the placebo effect."
24. BioSpecifics Reports Lower Revenues and Net Income
Company Press Release -- June 22, 1999
BioSpecifics reports that lower net sales for the fiscal first quarter ended April 30, 1999, is "not indicative of any change in demand for" Collagenase ABC. For the quarter, revenues of $1.279 million were accompanied by a net loss of $137,100 or $0.03 per share. BioSpecifics maintained its aggressive research and development by spending $506,000 on product development, up from $422,000 in the year-ago period. Company President, Edwin H. Wegman, states "we are very pleased with our progress on the two new applications for Collagenase, for Dupuytren's and Peyronie's diseases."Fiscal 2000 First Quarter
Three Months Ended April 30,
23. Continuing Profitability Accompanied By Productive Research And Development
Company Press Release -- June 28, 1999
BioSpecifics' President and Chairman, Edwin H. Wegman, summarizes the company's fiscal 1999 performance by opening his letter to shareholders, "It was a good year." While reporting that the company earned $1.2 million or $0.26 per share on $7.1 in total revenues, Mr. Wegman states, "More importantly, our research programs are proving very productive."
While final results are not yet available, the company is "extremely encouraged by the progress" from a double-blind Phase II clinical trial using the firm's injectable Collagenase in the treatment of Dupuytren's disease. Dupuytren's disease is a deformity of the hand featuring the contraction of fingers toward the palm. Currently, surgery is the only proven therapy. While awaiting submission of the results of a double blind Phase II trial to the FDA, the company continues to support trials at two major university centers.
While not providing specifics, Mr. Wegman states that "an open-label trial using our Collagenase injection on 22 patients suffering from Peyronie's disease has produced excellent initial results." In Peyronie's disease, "collagen plagues form on the shaft of the penis and interfere with erection and sexual intercourse." Surgery is the only proven therapy. Mr. Wegman states, "We believe our injectable Collagenase holds real promise as an alternative."
Research efforts in the area of wound healing led to BioSpecifics and Tufts University receiving U.S. patent 5,851,522. The patent is for a formulation of BioSpecifics' Collagenase enzyme and a growth factor that enhances cell migration and growth "to accelerate the healing of normal and abnormal wounds." Results suggest that the technology "can accelerate normal would healing . . . as well as prove beneficial to healing chronic wounds such as bed sores and diabetes-related lesions."
Mr. Wegman is "pleased" with the appointment of Louis Lasagna, MD to BioSpecifics' Board of Directors. Dr. Lasagna is an expert on drug development, especially "clinical trial methodology and the placebo effect." Dr. Lasagna, Dean for Scientific and Academic Affairs and Dean of the Sackler School of Graduate Biomedical Sciences at Tufts University School of Medicine, is a leading industry consultant.
A new regulatory environment has led BioSpecifics to correct a number of issues raised by the FDA. The upgrades are being made with an eye toward the firm's desire to produce "injectable Collagenase for the Dupuytren's and Peyronie's applications now under development."
Mr. Wegman concludes by stating: "Demand for our product is strong and consistent. Our balance sheet is healthy . . . our research and development (29% of revenues) is focused, realistic, and on schedule."Fiscal 1999
twelve Months Ended January 31,
22. U.S. Patent On Promising Wound Healing Technology Awarded BioSpecifics and Tufts University
Company Press Release -- June 11, 1999
BioSpecifics Technology and Tufts University announced that they've received U.S. Patent No. 5,851,522 for "an enzyme formulation that in laboratory tests enhances cell migration and cell growth, which are key to allowing wounds to heal." Research led by Ira Herman, Ph.D., Professor of Physiology, Cell and Molecular Biology and Ophthalmology at Tufts University School of Medicine, has demonstrated that wounds treated with a formulation of BioSpecifics' Collagenase enzyme and hbEGF, a growth factor found in the human epidermis, would "heel up to six times faster than those that are untreated." The research suggests that the enzyme formulation will not only accelerate normal wound healing, but will "prove beneficial to healing chronic wounds such as bed sores and diabetes-related lesions."
21. BioSpecifics Updates FDA Advisory
Company Press Release -- May 12, 1999
BioSpecifics reports that on May 10 the FDA advised BioSpecifics to submit "a detailed, comprehensive plan" detailing the actions BioSpecifics will take to address "noted inspectional observations" that came from the FDA's latest inspection of BioSpecifics' facilities. The company intends to comply and is preparing a "corrective action plan." BioSpecifics believes that it "has the financial resources and the necessary professional expertise" to achieve compliance.
20. Sales Up 21%; Net Income Up 48%; And Progress Achieved in R&D In Fiscal 1999
Company Press Release -- May 7, 1999
Total revenues in fiscal 1999 were considerably higher due to a surge in demand from Knoll Pharmaceutical for BioSpecifics' Collagenase ABC, the active ingredient in Collagenase Santyl. For the fiscal year ended January 31, 1999, revenues rose 21% to just over $7 million, and profits of $0.17 per share were higher by 48% for the year.
"Fiscal 1999 was significant in terms of the progress we have made in the development of other products." Cordase, an injectable Collagenase treatment for Dupuytren's disease is in Phase II trials. Plaquase, an injectable Collagenase treatment for Peyronie's disease, is in Phase I trials. It is "proceeding very well." For the year, spending on research and development increased to just over $2 million or 29% of total revenues. BioSpecifics finished the year with $7.19 million in cash and marketable securities.
19. BioSpecifics Announces Plant Improvement Program
Company Press Release -- April 23, 1999
BioSpecifics announced its intention to address "a number of observations" made by the FDA in a recent inspection of the firm's facilities. The release states "it is important to emphasize that this effort will not interfere with the company's active pursuit of ongoing clinical development programs for Cordase and Plaquase," the firm's injectable Collagenase treatments for Dupuytren's and Peyronie's diseases, respectively.
18. President Ronald Reagan and Prime Minister Margaret Thatcher Put Spotlight on Dupuytren's
Washington Post -- April 23, 1999; by Thomas V. Dibacco
Thomas V. Dibacco chronicles the history of Dupuytren's disease from its beginnings when it was confused with ganglia -- a common tumorous condition of the hand -- to current clinical studies examining the efficacy of drug injections as an alternative to surgery, the most widely used form of therapy since Baron Guillaume Dupuytren first prescribed it in the early 1800's. While surgery is not prescribed early in the diagnosis of Dupuytren's, there comes a point when delay will result in more complicated surgery, greater scarring, and more lengthy postoperative therapy.
Dupuytren's disease is a hand disorder that effects "between 2 and three percent of the world's population." But the disease received widespread publicity "about a decade ago when two of the world's most prominent leaders, President Ronald Reagan and British Prime Minister Margaret Thatcher, were its victims."
Baron Dupuytren also achieved prominence, having risen from "dire poverty" to become one of the most famous surgeons of his day. "He was surgeon to King Louis XVIII, who made him a Baron, and to Charles X." Dupuytren's disease overwhelmingly effects "white men with ancestors from Northern Europe, especially Scots, Irish and Scandinavians." It "is associated with Diabetes mellitus, Tuberculosis, epilepsy, alcoholism, and liver disease." The disease, also known as Dupuytren's contracture, "begins as a small lump in the palm that extends into a cord beneath the skin and stretches into the fingers; in time, the fingers are bent by the growth and cannot be fully extended."
17. Collagenase Santyl Becomes Top Selling Product For Wound Management
Company's 1998 Annual Report
The theme of this year's Letter to Shareholders is marketing, clinical advances, increased research and development spending, and a solid earnings performance. During the year, Collagenase Santyl ointment surpassed Elase as the leading product used for wound management. The gain was due, in part, to BioSpecifics' U.S. distributor having expanded its geographic reach, and in the process, increasing clinical nurse sales representatives. In February 1998, an agreement was reach by which a unit of Johnson & Johnson will co-promote Collagenase Santyl ointment with its Regranex, a treatment for Diabetic foot ulcers. BioSpecifics' President and Chairman, Edwin H. Wegman, states, "This arrangement could significantly expand the market for Collagenase Santyl." Efforts at licensing the firm's wound management product continue throughout Europe and the Middle and Far East.
Spending on research and development increased from $1.6 million last year to $1.9 million. Clinical trials for injectable products for treating three conditions are spotlighted, including Dupuytren's disease (Phase II), Peyronie's disease (Phase II multi-center), and keloids (Phase I). BioSpecifics' research efforts are bolstered by grants from the FDA and New York State. The Letter to Shareholders is followed by reports written by distinguished researchers in the areas of Dupuytren's disease, glaucoma, and wound healing (see below). Mr. Wegman goes on to update "significant progress" in the areas of Dupuytren's disease and glaucoma. BioSpecifics' injectable Collagenase treatment of Dupuytren's disease, Cordase, was found to be quite effective in restoring the fingers in Dupuytren's patients. "A positive response was found in approximately 90% of the cases."
Regarding glaucoma, Mr. Wegman reports that BioSpecifics' collaborative research investigation with Bausch & Lomb "is continuing and is confirming previously promising studies." Despite spending nearly 33% of revenues on research and development, BioSpecifics reported earnings of $836,000 or $0.17 per share on revenues of $5.825 million. The board of directors has authorized the company to tap its $6.8 million in cash, cash equivalents, and marketable securities to repurchase 500,000 shares of BioSpecifics common stock.
In 1830, Napoleon's surgeon, Baron Dupuytren, permanently attached his name with a disease by accurately identifying "the connective tissue of the hand as the predominately involved tissue" that leads to a deformity of the hand whereby the ring and little fingers are contracted toward the palm. Dupuytren's often appears as bumps or nodules in the palm that are accompanied by an excessive build-up of collagen. While Dupuytren's sufferers have sought non-operative remedies, surgery remains the standard treatment, despite its painful and lengthy rehabilitation.
An open-label trial showed that 33 of 35 patients responded to Cordase injection therapy, "regaining full active extension of their affected fingers." The side effects were minimal and lasted at most a couple of weeks. Cordase injection therapy is currently being studied in "a randomized placebo controlled, double blind clinical trial." The authors state that "based on the data now available, it appears that Cordase injection therapy as a non-operative treatment for Dupuytren's disease has merit as a safe and effective alternative to surgery, which is not only cost effective but non-traumatic."
Enzymatic Sclerostomy: A minimally Invasive Approach For The Treatment Of Glaucoma.By Jacob Dan, M.D., Ph.D. Consultant, Weizmann Institute of Science.
In the U.S. alone, the direct costs of glaucoma exceed $500 million and, indirectly, more than $2 billion. "The World Health Organization estimates the total worldwide number of suspect cases of glaucoma at around 105 million." Glaucoma is a condition of increased pressure within the eye that is caused by its inability to drain properly. While treatment exists, the author states that "the development of a new ambulatory procedure with limited complications would represent an important therapeutic advantage." Positive results from studies on rabbits, including "no systemic or ocular effects," combined with positive results from existing uses of purified Collagenase led to the approval for limited experiments on humans by "Review Boards at the Beilinson Medical Center, Israel, California Pacific Medical Center San Francisco CA, USA; Aravind Eye Hospital and L. V. Prasad Eye Institute India."
The first clinical studies looked at the sclera in the eyes of five patients. "Focal scleral excavation accompanied by percolation of fluid was seen in all cases." The next step evaluated the intraocular of enzymatic sclerostomy of eleven patients. "Partial thickness sclerostomy accompanied by reduction of intraocular pressure was seen in all cases with open angle glaucoma." The appearance of the treated eyes, and "the effect on intraocular pressure showed an average 44% immediate pressure drop and a lasting effect of 30% pressure drop for another six months." Studies are ongoing, including a search for an improved method of delivering Collagenase to the eye.
Stimulation Of Wound Healing: Implications For Exogenous Collagenase.By Ira M. Herman, Ph.D. Professor Of Cellular And Molecular Physiology, Tufts University School Of Medicine, Boston.
Dr. Herman describes what scientists are finding relative to the importance of Collagenase to the body's process of healing wounds. Biomedical researchers have established that a group of enzymes play a critical role in stimulating "cell migration and proliferation," events critical to the healing process. Dr. Herman was led to "test the hypothesis that supplementing the body's own Collagenase with an added bacterial Collagenase" might speed the rate of and improve the quality of the healing process. Results of his work "convincingly demonstrate the efficacy of clostridial pharmaceutical Collagenase (over mammalian Collagenase) in promoting would healing."
Other studies "demonstrate that BioSpecifics' purified clostridial Collagenase . . . promotes cell migration . . . (and) also their growth." The author concludes by stating that "not only do these exciting findings suggest that clostridial Collagenase should significantly accelerate normal wound healing, . . . but, in addition, it seems highly likely that clostridial Collagenase will also prove beneficial for healing chronic wounds."Fiscal 1998
twelve Months Ended January 31,
16. BSTC's Major Product Brings Relief To Many Thousands; Promise Is Unlimited
Jolly Rodgers Hot Stocks -- December, 1998
Recognizing the important role of Collagenase in the metabolism of collagen, "the most important protein in the body," the author writes that BioSpecifics' "science is tested, BSTC's major product is giving relief to many thousands, our profit is more than adequate to our needs and growing." Collagen plays a role in many diseases, with "major importance in wound-healing, tissue-regeneration, and tissue-remodeling."
15. Favorable Early Clinical Cordase Trial Results Reported AT Trade Show
Company Press Release -- April 21, 1998
The 44th Annual meeting of the Orthopedic Research Society in New Orleans (March 16-19, 1998) provided BioSpecifics a forum for presenting "favorable results in early clinical trials with Cordase, BSTC's injectable Collagenase for treatment of Dupuytren's disease." Drs. Marie Badalamente and Lawrence Hurst reported that after adjusting an initial dose, 20 affected fingers were injected. "Seventeen out of 20 of the treated fingers responded successfully in the short-term follow-up period." The patients' symptoms, a contracture of the fingers toward the palm, were severe enough to qualify for surgery. Surgery, however, is tedious, often unsatisfactory, can cost as much as $8,000 and involves a painful post-operative period." BioSpecifics' therapy involves an injection into the fingers performed in the Doctor's office; recovery is prompt.
14. Phase II Trial Of Dupuytren's Disease With Cordase Injectable Collagenase Underway
Company Press Release -- November 20, 1997
BioSpecifics announced that a Phase II trial examining the efficacy of its injectable Collagenase treatment, Cordase, for the treatment of Dupuytren's disease is now underway. Phase I trial results were "very encouraging." Lawrence Hurst, M.D., Chairman, and Marie Badalamente, Ph.D., of the department of Orthopedics are conducting the trial at SUNY Stony Brook Hospital. BioSpecifics' President, Edwin H. Wegman, stated "we believe this is a real advance in patient care. It is projected to be a much less intrusive and less expensive alternative to surgery, which is currently the only accepted treatment."
13. BioSpecifics Announces FDA Grant
Company Press Release -- October 1, 1997
BioSpecifics announced that researchers in the department of Orthopedics at SUNY Stony Brook Hospital have received a grant from the FDA to conduct clinical trials with Collagenase manufactured by BioSpecifics for Dupuytren's disease. "The funding will cover a two-year period during which expanded clinical investigations will be performed to determine safety and efficacy."
12. FDA Approved Ointment Helps Fund New Injectable Products
Wall Street Corporate Reporter -- September 15-21, 1997; by Diane Mayoros
Interview With Company Chairman, President and CEO, Edwin H. Wegman
BioSpecifics Chairman, President, and CEO, Edwin H. Wegman, chronicles the history of BioSpecifics from his early days at the City College of New York and Harvard to starting a company called Agricultural Biologics. BioSpecifics, itself the successor company to Advance Biofactures Corp., came public in 1990. The company produces an enzyme called Collagenase that "liquefies" or eliminates collagen, a protein that accounts for about one third of the total protein found in one's body. It is "the connective tissue that attaches bone to teach other, the muscles to the bones, and is involved in most cells and organs of the body." While obviously important, the body at times overproduces collagen, thus creating the need for a counteracting agent such as Collagenase. The FDA has approved the use of Collagenase as a topical ointment for the treatment of wounds or ulcers that are "common and costly problems in acute care, nursing home, and home care populations." The cost of treating pressure ulcer and chronic skin ulcers is estimated by the U.S. Government to exceed $1.3 billion annually.
BioSpecifics is targeting four injectable Collagenase products in its research and development efforts: herniated spinal disks, Dupuytren's disease, Peyronie's disease, and keloids or hypertrophic scars. All these conditions are identified by an excessive buildup of collagen. A herniated spinal disk, or 'slipped disk,' consists primarily of collagen. "We have used this (injectable Collagenase) in some 1,500 patients worldwide with about a 75% success rate." Dupuytren's disease is a condition whereby a collagen 'cable' in the palm of the hand prohibits proper finger extension. Surgery, currently the only existing solution, runs between $8,000 and $10,000 and is accompanied by weeks of disability and considerable pain. The company expects its injectable treatment will cost around $2,000 and has, thus far, found "a 90% relief of the condition." Peyronie's disease is a condition where excessive collagen, or plaque, on the penis prohibits normal erection; Keloids or hypertrophic scars result from an excessive buildup of collagen, or scar tissue, "that can be unsightly, bothersome, and limit function." Another area of examination is for the use of Collagenase in the treatment of glaucoma, an area where BioSpecifics is working closely with Bausch & Lomb.
The company's extensive patent position provides a strong competitive advantage, but, more importantly, is the fact that the FDA restricts generic drug competition for what are called biologicals. As Collagenase is a biological, any competitor would be faced with the complex and lengthy laboratory, animal and human testing cycles.
11. Bausch & Lomb Collaborates With BioSpecifics On Glaucoma Studies
Company Press Release -- June 23, 1997
Preliminary trials have provided sufficient encouragement for Bausch & Lomb to enter into collaboration with BioSpecifics on clinical trials for the use of BioSpecifics' treatment for glaucoma. In the trials, BioSpecifics' Collagenase will be applied through a patented delivery device for the controlled release of collagen to the eye. Researchers at the Weizmann Institute of Israel developed the delivery device. BioSpecifics and Bausch & Lomb hope that successful trials will lead to the therapy being used as an alternative to surgery.
Glaucoma is caused by a "gradual closing of the valves that drain fluid from the anterior chamber of the eye." Because the effected area of the eye is a composition of collagen, the companies anticipate that the use of Collagenase, the only enzyme that can break down the collagen molecule, may be an attractive alternative therapy to surgery for glaucoma patients. It is estimated that three million Americans suffer from glaucoma, accounting for 50,000 cases of blindness per year.
10. Continued Profitability Facilitates 25% Of Revenues Invested In R&D And Stock Buyback
Company's 1997 Annual Report -- June 9, 1997
In BioSpecifics' letter to its stockholders, the company's President and Chairman, Mr. Edwin H. Wegman, spotlights the firm's profitability, expanded marketing capabilities, successes on the research and development front, and the board of directors approval of a 100,000-share stock repurchase program.
BioSpecifics returned to profitability in fiscal 1997 by earning $1.126 million, or $0.23 per share, on $5.875 million in revenues. By the third quarter of fiscal 1998, BioSpecifics expects to be benefiting from its U.S. distributor, Knoll Pharmaceutical Company, having expanded the number "of clinical nurse consultants who act as expert sales representatives for our product Collagenase Santyl ointment." A licensing agreement for the ointment is being pursued with a German company, and discussions are ongoing with other companies for licensing the ointment in Europe and the rest of the world.
Significantly, over 25% of revenues were spent on research and development. Activities primarily revolve around the development of injectable products "for Peyronie's Disease (Phase II multi-center), for Dupuytren's Disease (Phase I), and for keloids (Phase I)." Of particular interest is progress on Dupuytren's disease. Clinical results have been positive, a U.S. patent has been obtained, Orphan Drug designation was awarded by the FDA, and a research grant was obtained that will fund continued clinical investigations. Mr. Wegman observes that "ongoing work is very active" in a trial examining the use of Collagenase for keloids, and an agreement was reached with Bausch & Lomb to collaboratively pursue the use of Collagenase for the treatment of glaucoma.
What's Collagen and Why Collagenase?
Collagen Is The Main Protein Constituent Of Skin, Cartilage, Bone, And Other Connective Tissue.
Collagen, a word whose Greek root means "glue producing," is described by the company as being "the most important building block in the entire animal world." As scientists have moved down to the molecular level of study, they have discovered that cells are held together by a mesh-like screen that consists primarily of collagen. The company states that "more than one -third of the body's protein is collagen and it can account for an even higher percentage in other parts of the body. Collagen makes up 75% of our skin." While some variability of collagen molecules exists, all collagen middles are identical. Collagen weaves into coils "like small steel wires braided into the cables of a mighty suspension bridge. In fact, collagen has a greater tensile strength than steel." Collagen also plays a uniquely important role in the healing process by providing the blueprint, "the roadmap and the way," to facilitate bone regeneration and wound healing.
Problems do develop with collagen. The body can make too much, produce it where it is not needed, or fail to eliminate it when no longer needed. As a result, there is a need to manage the presence of collagen. But this is no easy task, "and here is where modern biotechnology and BioSpecifics come in." The body naturally manages the presence of collagen through "the action of a remarkable protein enzyme we call Collagenase." When Collagenase production is inadequate, collagen needs to be "resculpted and regrown" by additional Collagenase. "BioSpecifics has learned how to make it in a concentrated, purified form. This is the technology that we own."
Collagenase is increasingly being used to clean and treat severe burns by reducing the "tough dead collagen." Dead collagen is also removed to treat bedsores and improve wound management. In Europe, continued success is being experienced for treatment of herniated spinal disks. In the U.S., trials are in progress for Collagenase treatment of keloids, Hypertrophic scars, Peyronie's disease, and Dupuytren's disease. There are "early hints of Collagenase's value in treating glaucoma. Research goes on to discover additional uses."
Collagenase - Precision Therapy
The production and sale of the firm's Collagenase ABC provided most of the revenues for fiscal 1997 ended January 31. The worldwide use of Collagenase in the treatment of chronic dermal ulcers and severe burns "has been increasing steadily as its value continues to impress wider segments of the healing profession." BioSpecifics' research program is focusing on a number of uses for the Collagenase enzyme. Of particular interest is the development of injectable forms of Collagenase ABC.
Dupuytren's Disease "is a deforming condition of the hand in which one or more fingers, usually the ring finger and pinkie, contract toward the palm, often resulting in functional disability." Prior to the use of injectable Collagenase, surgery, involving "anesthesia, hospitals costs, some pain, and a cost of about $8,000," was the only effective treatment. Preliminary studies, including total success in 15 of 17 patients treated at Stony Brook Medical Center, is very promising. "The FDA has accorded Orphan Drug status to this usage, and a U.S. patent has been granted." In addition, the New York State Center for Advanced Technology in Medical Biotechnology has awarded BioSpecifics a research grant for continued clinical investigations.
Peyronie's Disease describes a condition of excessive collagen "that causes the penis to bend in a way that makes intercourse difficult, frequently painful, and even impossible in severe cases." As with Dupuytren's disease, surgery has been the only form of treatment. "Orphan Drug designation has also been received from the FDA, and a Phase II multi-center trial is now being conducted at some of the leading neurology centers in the U.S." Favorable results were reported from a Phase I trial being conducted at University Hospital of the Albert Einstein School of Medicine for use of injectable Collagenase in the treatment of keloids. Keloids is a condition of "heaped up scars that appear when normal healing is disturbed; keloids can very in size from one to several centimeters in thickness." As well as disfiguring, keloids can interfere with functionality as well as being irritating and painful.
There are additional potential uses for Collagenase. BioSpecifics entered a collaborative agreement with Bausch & Lomb to examine the use of Collagenase in treating glaucoma. "Glaucoma occurs when the ducts that drain fluid from the anterior chamber of the eye are restricted as a result of abnormal buildup of collagen." Upwards of three million Americans have glaucoma, a condition accounting for about 14% of world blindness.
The annual report continues to briefly reports on other applications that have surfaced over the years. In vitro studies on wound healing have shown that the regeneration of skin cells is enhanced by treatment with Collagenase. Work is also advancing in the area of spinal disk disease, also know as "slipped disk." Application for approval of an injectable purified Collagenase ABC for nonsurgical treatment is advancing in Germany and Italy. "Treatment of burns using Collagenase Santyl is already FDA approved." A 79-patient study demonstrated Collagenase's effectiveness in "faster cleaning and healing" in deep second-degree burns over standard treatment. Results were reported in the Journal of the American Burn Association.
twelve Months Ended January 31,
9. Tiny Tears Lead To Peyronie's Disease And Reduced Penile Function
Men's Confidential -- May 19, 1997; by C.E. Brietzke and Sheryl Palese
The effects of Peyronie's disease have been observed for more than a thousand years, as far back as Byzantine Emperor Heraclius in 610 A.D. But it wasn't until 1747 that Francis de LaPeyronie observed the "rosary beads" consistent with the observance of what is now know as Peyronie's disease. The penile deformities of Peyronie's disease are now believed to "be the result of an impairment in wound healing following a penile injury." While significant stress on an erect penis can result in penile fracture and immediate and severe pain, it is "the small penile stresses that lead to Peyronie's disease." As the body seeks to repair itself, a "haphazard placement of tissue (know as plaque) prevents the penis from expanding fully, creating either a bend or a narrowing around the scar."
Age is a factor, as "75% of the two million men afflicted with the disease are over 45." There is also a genetic aspect that "has to do with deficient tissue-healing." That is why there is a correlation between Peyronie's disease and a similar healing-related condition called Dupuytren's disease. "Dupuytren's appears to be a disease of wound healing -- only in Dupuytren's, the tissues that becomes scarred and inelastic are on the palm of the hand." Despite the genetic link, it appears that the onset of Peyronie's requires a triggering effect. Dr. Irwin Goldstein, M.D., professor of urology at Boston University states that "one of the most common means of injury is the penetrating thrust that misses."
The article briefly reviews the use of Verapamil and Colchicine but states "only one drug, with government backing under the Orphan drug banner, is currently in development specifically for Peyronie's disease." Phase II clinical trials are under way regarding the use of Collagenase. There are two surgical alternatives. One is called the Nesbit Procedure where an incision is made on the penis opposite the curve. A gathering of skin counteracts the pull of the scar tissue. The other surgical option involves cutting the scar and grafting skin taken from the abdomen.
8. New York State Biotechnology Center Funds Collagenase Research For Dupuytren's Disease
Company Press Release -- May 8, 1997
The New York State Center for advanced Technology in Medical Biotechnology at State University at Stony Brook has awarded BioSpecifics a grant to support ongoing research into the use of Collagenase treatment for Dupuytren's disease. The grant was awarded "based on the early, very successful clinical results that have been achieved by Dr. Lawrence Hurst and Dr. Marie Badalamente." Diane Fabel, Interim Director of the center, went on to say, "It is anticipated there will be a substantial market for this product if it is ultimately approved by the FDA."
7. Positive Preliminary Results For Keloids Treatment Presented At Industry Conference
Company Press Release -- February 25, 1997
Dr. Robert Goldstein reported positive preliminary results from a Phase I study examining the effectiveness of Collagenase in the treatment of keloids and hypertrophic scars at the annual International Burn Foundation conference in Maui, Hawaii. Keloids are raised scars that emerge as a wound heals; they can be as small as an olive or as large as a banana. Hypertrophic scars are often the result of deep burns; they are disfiguring and interfere with normal function of the effected area. BioSpecifics' purified enzyme Collagenase digests collagen, an excessive amount of which forms the keloids or hypertrophic scar. "This is the second study which has reported beneficial results from Collagenase treatment of keloids and hypertrophic scars. It has been estimated that the market for this product may be $50 million annually."
6. BioSpecifics Granted Patent For Collagenase Enzyme Treatment Of Dupuytren's Disease
Company Press Release -- February 7, 1997
BioSpecifics announced that it has received from the U.S. Patent Office patent number 5,589,171. This latest patent, the ninth awarded for the use of Collagenase in humans, is for the use of BioSpecifics' Collagenase enzyme in the treatment of Dupuytren's disease. The use of Collagenase for Dupuytren's had previously received Orphan Drug Designation from the FDA. Dupuytren's disease, a deforming condition of the hand, evidenced by a fixed contraction of the fingers toward the palm, "predominately effects elderly male Caucasians, often is linked to heredity, and has strong association with diabetes, alcohol consumption, cigarette smoking, and HIV infection." A Phase I clinical study has been initiated, and patients interested in participating may call Dr. Marie Badalamente, Ph.D. or Lawrence Hurst, M.D. at 516-444-2215.
5. Tiny Biotechnology Company Unusual For Profits And Plain Talk
Shaking The Money Tree -- January 6, 1997; by Robert Metz
In an article titled "BioSpecifics: Give Me Some Skin," Mr. Robert Metz takes note of BioSpecifics Technologies' ability to turn out profits, a condition unusual for a small biotechnology company. Another characteristic setting BioSpecifics apart from other biotechnology companies is the readability of its annual report, Mr. Metz commenting that BioSpecifics' "annual report won't have you reaching for a medical dictionary for help."
In a play on words, Mr. Metz states that BioSpecifics "is in the skin game legitimately." BioSpecifics provides its Collagenase ABC powder to Knoll Pharmaceuticals, who then, under license, converts it into a topical ointment, Collagenase Santyl. Collagenase Santyl "is used primarily to treat pressure sores, those ghastly bedsores that develop when a hospital patient lies in bed too long," as well as for second- and third-degree burns. The ointment "debridges" the wounded area by removing dead or damaged tissue, a "process critical in preventing disease." Collagenase Santyl is in the early stages of growth; Mr. Metz puts the "market for Collagenase products" at about $185 million per year in the U.S. alone. Mr. Metz quotes an investment newsletter, The Low Priced Stock Survey, as commenting that BioSpecifics has "several opportunities for Collagenase in both ointment and injectable form." They include Peyronie's disease, keloids, herniated spinal discs, and would healing.
For the whole release, see http://www.talks.com/library/rm010697.html
4. BioSpecifics: Connecting Collagen To Profits
The Low Priced Stock Survey -- October 14, 1996; Randall R. Roeing, CFA
In a Fact Sheet write-up, the investment newsletter, The Low Priced Stock Survey, recommends BioSpecifics on the basis of the company being "unique not only for its technology, but also for having earnings, a trait not normally found in developing biotechnology concerns." Collagenase Santyl, an ointment made by Knoll Pharmaceuticals under license from and with the ingredient Collagenase ABC provided by BioSpecifics, is in the early stage of market acceptance. The Survey expects BioSpecifics will "capture a strong" presence in the market for Collagenase products estimated to run to $175 million annually. While BioSpecifics' patent relating to the manufacture of Collagenase has expired, it nevertheless has a number of patents and "is protected indirectly, however, by a laborious and expensive regulatory process others would have to face should they desire to develop a competitive product." Research and development activities are targeting Peyronie's disease, keloids, and herniated spinal disks. One of the largest market opportunities appears to be in wound healing "whereby Collagenase goes beyond removing damaged tissue to actually accelerating the healing process." The write-up concludes that the stock "may be accumulated."
3. Reforms At FDA Spur Biotech Development
Long Island Business News -- June 10, 1996; by Lorraine LaFemlna
In a review of regional biotech companies, the author writes, "One of the most encouraging trends in the biotech industry" is reforms effecting the U.S. Food and Drug Administration. A tangible result of this trend is BioSpecifics' receipt of Orphan Drug Designation for its injectable Collagenase treatment of Peyronie's disease. Orphan Drug status provides several advantages, including "a seven year period of exclusivity after approval for marketing, the ability to apply for clinical research grants, possible tax credits for costs of clinical trials, and assistance from the FDA in protocol development."
2. FDA Awards Orphan Drug Designation For Injectable Collagenase Treatment of Peyronie's Disease
Company Press Release -- April 1, 1996
BioSpecifics announced today that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation for the use of injectable Collagenase for the treatment of Peyronie's disease. Orphan Drug designation provides "a seven year period of exclusivity after approval for marketing, the ability to apply for clinical research grant funds, possible tax credits for costs of clinical trials, assistance from FDA in protocol development, and likely exemption from 'user fees' charged by FDA after drug approval. Orphan drugs have in general received faster approvals than drugs without this designation." Peyronie's disease is a disfiguring condition of the penis that results from an excessive build-up of collagen. Collagenase's ability to break down collagen is what has attracted researchers to its therapeutic potential. A successful double blind clinical trial using Collagenase was reported in the Journal of Urology in 1993. A second Phase II multi center clinical trial sponsored by BioSpecifics has now been initiated at five major urology centers specializing in Peyronie's.
1. Collagenase Santyl Cleans Wounds Faster And With Less Pain
Highlights From The 9th Congress of the International Society of Burn Injuries -- 1994
Dr. John Hansbrough, Professor of surgery and director of the UCSD Regional Burn Center, University of California, San Diego Medical Center, states that "the use of Collagenase Santyl ointment with Polysporin powder has proven to be effective and safe in the treatment of limited-extent partial-thickness burns." Results of a pilot study showed that partial-thickness burns "achieved a clean wound bed" more quickly when treated with Collagenase Santyl as compared with silver sulfadiazine. The findings were subsequently confirmed by a multi-center study of 79 patients. He also reported that patients experienced a reduction in pain, Dr. Hansbrough stating, "there was no increased discomfort in the Santyl treated patients." The results have encouraged Dr. Hansbrough and his staff to become comfortable with using the preparation to include "the hands, feet, face, and limbs," areas not tested for the sake of conservatism.
Wendy Hansbrough, RN department of surgery, University of California, San Diego, writes more extensively on Santyl's ability to reduce pain. She explains that "an advantage of using enzymatic agents such as Santyl" is an ability to speed the healing process, even facilitating a more rapid diagnosis of the need for surgery. "A key disadvantage . . . is the lack of antimicrobial action in enzymatic debridging agents." Ms. Hansbrough has used enzymatic agents reluctantly due to high pain levels. But as trials progressed, patients treated with Collagenase Santyl exhibited less pain than those treated with silver sulfadiazine. Ms. Hansbrough states "our theory when we started was that there would be pain in the Santyl sites, . . . we were pleasantly surprised to find that this was not the case."
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