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June 30, 2008 BioSpecifics Technologies: (OTC: BSTC.pk) |
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35 Wilbur Street Lynbrook, NY 11563 Phone: 516.593.7000 Fax: 516.593.7039 |
Strategic alliances are bringing new products to market |
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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)
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Please SCROLL DOWN to read abstracts about BioSpecifics Technologies and other information. |
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Important Trends |
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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 Collagenase Santyl; 80, 77, 73, 65, 63, 60, 55, 54, 51, 50, 46, 45, 41, 36, 27, 20, 12, 10 New U.S. distribution agreement with Abbott Laboratories; 77 Smith & Nephew on Collagenase Santyl; 73, 69, 65, 63, 61, 60, 58, 57, 55, 54, 50, 46, 44, 41, 36, 33, 32 Smith & Nephew home site http://www.smith-nephew.com Importance of Collagen and Collagenase; 55, 40, 12, 10, 1 FDA approves manufacturing facility; 75 Asante Partners to provide Strategic Advisory services; 52 Peyronie's Disease; 88, 62, 57, 55, 54, 41, 36, 34, 26, 23, 12, 10, 9, 2 Wound Management; 81, 63, 61, 58, 57, 55, 46, 44, 36, 33, 32, 22, 17, 12, 10, 1 Diabetic ulcers; 17 Herniated Spinal Disks; 12, 10, 4 II. The Dupuytren's application, now in Stage III trials, is being aggressively managed by Auxilium, a strategic partner of the Company 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 Research Grants; 65, 63, 56, 44, 13, 8 Shareholder Rights plan; 64 Injectable Collagenase use as 'Chemical Liposuction'; 72, 66, 63, 62, 57, 55, 54, 53, 49, 47 Injectable Collagenase research on Frozen Shoulder; 62, 57, 55, 54, 43, 42 Cordase for Dupuytren's Disease 70, 69, 65, 63, 62, 57, 56, 55, 54, 47, 44, 43, 41, 36, 29, 23, 18, 17, 15, 14, 12, 10, 6 Wound Healing primer & list of Wound Healing concerns http://www.biospecifics.com/annualreport.html#primer Important Links 1. Financial Links Earnings reports; 73, 69, 65, 63, 60, 54, 50, 46, 45, 41, 37, 36, 30, 27, 24, 23, 17, 10 Wound Healing Analysts, Financial Newsletters, and Industry Observers; 87, 85, 55, 53, 35 Wound Healing and Tissue Engineering Universe; 67 dbusiness.com's search engine for current stories 2. General Links Biographies: CEO/Chairman - Edwin H. Wegman; 12 New Directors; 80, 71, 31, 25, 23
Biotechnology database of 8,500 companies Site for pharmaceutical and biotech licensing executives DUPUYTREN'S: BioSpecifics sponsored chat room for Dupuytren's E-Hand.com: an electronic textbook of hand surgery Non Surgical Treatment of Dupuytren's Disease Association PEYRONIE'S: American Academy of Family Physicians BioSpecifics sponsored chat room for Peyronie's WOUND MANAGEMENT: BioSpecifics' wound healing patent Collagenase - wound debridement DISCLOSURE STATEMENT William Dunk Partners, Inc. is totally responsible for the editorial content in Investor's Digest. Click Disclosure Statement for full details. TO CONTACT William Dunk Partners, email Ms. Deborah Passik at advisors@beecom.net |
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89. Analysts suggest Auxilium acquire BioSpecifics following successful Phase III Trial of XIAFLEX Soleil/Neponset Equity Research; June 12, 2008 & PiperJaffray; June 3, 2008 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.” return to top of this page -- return to globalprovince.com
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. return to top of this page -- return to globalprovince.com
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.” return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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. return to top of this page -- return to globalprovince.com
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. return to top of this page -- return to globalprovince.com
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.” return to top of this page -- return to globalprovince.com
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.” return to top of this page -- return to globalprovince.com
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. return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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
Revenues
$ 831,000 $
794,000 For the full release, see http://biz.yahoo.com/prnews/021223/nym058_1.html return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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
Revenues
$1,523,000 $2,159,000 For the full release, see http://biz.yahoo.com/prnews/020923/nym185_1.html return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
67. Wound Healing and Tissue Engineering Companies Following is a list of companies developing Wound Healing and Tissue Engineering products.
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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 return to top of this page -- return to globalprovince.com
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
Revenues
$902,000 $2,792,000 For the full release, see http://biz.yahoo.com/prnews/020618/nytu152_1.html return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 January 31 2002 2001
Revenues
$8,210,000
$5,532,000 Fiscal 2002 Fourth Quarter Three Months Ended January 31, 2002 2001
Revenues
$2,464,000
$1,455,000 The full release can be found at http://biz.yahoo.com/prnews/020502/nyth008_1.html return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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 return to top of this page -- return to globalprovince.com
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).
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