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BioSpecifics Technologies Corp. Announces End of Phase 2 Conference with FDA For Treatment of Dupuytren's Disease

PRNewswire
LYNBROOK, N.Y.

BioSpecifics Technologies Corp. (NASDAQ: BSTC) announced today the successful conclusion of Phase 2 for its drug Cordase™ for the treatment of Dupuytren's disease. The Phase 2 clinical trials were reviewed by the FDA prior to an "end-of-Phase-2-meeting" with the Agency. The Phase 2 submission included a double blind, placebo controlled study conducted at Stony Brook University Hospital and Medical Center and an additional double blind randomized placebo controlled dose response clinical investigation performed at Stony Brook and Stanford University Medical Center. Stony Brook University Hospital has been awarded a monetary grant from FDA to help advance the Phase 3 clinical trials with Collagenase ABC. During the meeting the Pharmacology/Toxicology and manufacturing specifications and controls were discussed and were found to be satisfactory to proceed to Phase 3.

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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 affected finger is composed of collagen, and thus its decomposition by the enzyme collagenase frees the finger. This 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 higher incidence in men than in 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. This new treatment can be performed in the doctor's office. The use of Collagenase for the treatment of Dupuytren's disease has received Orphan Drug Designation from FDA. BioSpecifics has secured U.S. patent number 6,086,872 for Collagenase for this use. Well-known people with Dupuytren's disease include former U.S. President Ronald Reagan and former British Prime Minister Margaret Thatcher.

The Agency made recommendations to modify the protocol for the Phase 3/Pivotal studies which will involve expanded numbers of patients and additional study centers. The Agency's policies leading to the development of a label for the drug suggested as well some detailed changes in the study design for Phase 3. A protocol incorporating these recommendations will be submitted to the Agency shortly.

Thomas L. Wegman, Executive Vice President stated, "We could not be more pleased with the results of the meeting. 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, deserve full credit for their work in advancing this treatment. It was their work on the patients treated in the Phase 2 studies which produced the highly promising results that were crucial in bringing us to this new level."

This 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 are being analyzed and expanded trials are planned within the next year. Early phase clinical studies are underway for collagenase treatment of lipomas.

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 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
                       http://www.biospecifics.com/

           its Dupuytren's Disease patient discussion forum at
                    http://www.biospecifics.com/forum/

          and its Peyronie's Disease patient discussion forum at
                 http://www.biospecifics.com/forum/index2

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, market 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.

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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

Web site: http://www.biospecifics.com/