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Dupuytren's Clinical Trial Results Announced at 48th Annual Orthopedic Research Society Meeting in Dallas

Mar 1, 2002

BioSpecifics Technologies Corp. (NASDAQ: BSTC) announced today that results of a Phase 2 placebo controlled double blind dose response trial using its product candidate Cordase™ were presented at the 48th Annual Meeting of the Orthopaedic Research Society ( in Dallas, TX. Dr. Marie Badalamente of the Department of Orthopaedics at Stony Brook University Hospital and Medical Center, Stony Brook, NY ( presented the results of the clinical trial on February 11. A total of eighty patients (64 male and 16 females) were treated in two centers; Stony Brook University Medical Center (Drs. Marie Badalamente and Lawrence Hurst) and Stanford University Medical Center (Dr. Vincent Hentz). Patients had a mean baseline fixed flexion deformity of 49 degrees. Patients were treated with either 2,500, 5,000, or 10,000 units of collagenase or placebo. 13 of the 16 patients treated in the MP joint who received 10,000 units of collagenase appeared to return to normal extension (0-5 degrees) at one-month post treatment as compared to 6 of 15 in the 5,000-unit group, 7 of 14 in the 2,500-unit group, and 0 of 10 in the placebo group. 5 of 7 patients treated in the PIP joint who received 10,000 units of collagenase appeared to return to normal extension at one month post treatment as compared to 4 of 7 patients in the 5,000 unit group, 2 of 4 in the 2,500 unit group and 0 of 7 in the placebo group. Adverse events appeared to be minimal and local, including pain to pressure at the injection site, volar and dorsal edema, minimal hematoma and occasional ulnar border tenderness which extended to the elbow and/or axilla. All effects resolved within 5 to 14 days of injection. There were no clinically adverse immune effects. The results of this trial were submitted to FDA in support of ending the Phase 2 trials. BioSpecifics Technologies Corp. previously announced the completion of Phase 2, results of the "end-of-Phase 2 meeting", and the preparations for Phase 3 trials.

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Dupuytren's disease is a genetically inherited disorder, which is named after the French surgeon to Louis XVI and Charles X. The disease causes large deposits of collagen to build up mainly in the palm or fingers resulting in one or more of the fingers progressively contracting into a flexed or bent position. The cord that restricts the motion of the afflicted finger is composed of collagen, and thus its decomposition by the enzyme collagenase frees the finger. The disease is particularly prevalent among people of Northern European descent with onset of the disease occurring between the ages of 40 to 60 with a slightly higher incidence in men than women.

Currently the only proven therapy for Dupuytren's disease is surgery that involves the removal of the collagen cords responsible for the hand deformity. The investigational use of Collagenase involves an injection into the affected fingers. This treatment can be performed in the doctor's office. BioSpecifics has secured U.S. patent number 6,086,872 for Collagenase for this use. Well-known people with Dupuytren's disease include U.S. President Ronald Reagan and former British Prime Minister Margaret Thatcher. A survey of hand surgeons in the United States indicates an active willingness to accept this innovative approach to the disease.

The study was supported by grants from the Food and Drug Administration, National Institutes of Health and Advance Biofactures Corp, a subsidiary of BioSpecifics.

This injectable product is also in Phase 2 studies for the treatment of adhesive capsulitis (frozen shoulder). Long-term clinical results of collagenase treatment for Peyronie's disease were announced by BSTC on October 24, 2001 and because of the positive results, expanded trials are planned within the next year. Early phase clinical studies are underway for collagenase treatment of lipomas. Dr Ann Marie previously covered the lipoma treatment for ABC News and discussed the potential for chemical liposuction. (

Founded in 1990, BioSpecifics Technologies Corp. is a biopharmaceutical company with a focus on wound healing and tissue remodeling. It has pioneered the application of collagenase for several disease conditions, notably dermal ulcers, pressure sores (bedsores), and second and third degree burns. BioSpecifics produces Collagenase ABC, the essential ingredient in the prescription drug Collagenase Santyl® Ointment sold in the United States, and under other trademarks abroad.

BioSpecifics is also actively pursuing injectable applications of the enzyme for the treatment of a number of diseases. Clinical, pre-clinical, and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity for wound healing are being pursued.

Santyl® is a registered trademark of Knoll Pharmaceutical Company, a division of Abbott Laboratories (NYSE: ABT).

                     BioSpecifics' main website is at
           its Dupuytren's Disease patient discussion forum at
          and its Peyronie's Disease patient discussion forum at

Forward-looking statements in this release involve a number of risks and uncertainties including, but not limited to, government regulation, the ability of the Company to obtain approval of renovations at its manufacturing facilities and adequately address concerns of the FDA, adequate funding, product demand, pricing, marketing acceptance, changing economic conditions, risks in product and technology development, the effect of the Company's accounting policies, and other risk factors detailed in the Company's filings with the Securities and Exchange Commission.


SOURCE: BioSpecifics Technologies Corp.

Contact: Thomas L. Wegman of BioSpecifics Technologies Corp.,
+1-516-593-7000; or Deborah Duke Passik of William Dunk Partners,
+1-919-929-4100, for BioSpecifics Technologies Corp.