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BioSpecifics Receives European Patent Notice for 'Chemical Liposuction'

PRNewswire
LYNBROOK, N.Y.
May 24, 2001

BioSpecifics Technologies Corp. (NASDAQ: BSTC) announced today that the European Patent Office ("EPO") has issued a notice that it intends to grant a patent for Lipolysin™, an injectable enzyme manufactured by BioSpecifics that reduces adipose fat in tissue. The enzyme has undergone extensive pre-clinical testing which demonstrated its ability to liquefy fat deposits in animals. The Company refers to the action as chemical liposuction and is exploring whether it can produce the same result in humans without the blood loss or trauma of conventional liposuction. The president of BioSpecifics, Edwin H. Wegman said, "Based on the animal tests there is reason to believe that this material will break up fatty deposits in particular areas. It must be emphasized, however, that this effect has only been tested in animals which, we like to think, are different from humans." BioSpecifics has applied for a patent in the U.S. as well as other countries outside Europe.

After the EPO grants a patent, there is a nine-month period from publication of the patent grant during which opposition to the patent may be made by third parties. BioSpecifics intends to extend the patent to national patents in up to 15 European countries.

In a related development, the U.S. Food and Drug Administration has reviewed an IND (Investigational New Drug) application by Zachary Gerut, M.D., F.A.C.S. and authorized Dr. Gerut (a plastic surgeon) to proceed with a study of the use of BioSpecifics' enzyme in the treatment of lipomas, which are encapsulated fatty deposits.

The material used for this purpose is the same as Cordase™, which is being used for the investigational treatment of Dupuytren's disease. The Phase 2 trials for Dupuytren's disease have been successfully completed and a report is being prepared for submission to the FDA, detailing the product's safety and efficacy. The FDA has already granted financial assistance for the Phase 3 trial of Cordase™ for the treatment of Dupuytren's disease.

BioSpecifics Research and Development Program

According to Edwin H. Wegman, "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."

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. Phase 2 clinical trials are completed in the U.S. for the use of injectable collagenase in treating Dupuytren's disease, which restricts the extension of one or more fingers. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity for Peyronie's disease which restricts penile erection and in wound healing are being pursued.

Santyl® is a registered trademark of Knoll Pharmaceutical Company, a division of Abbott Laboratories since March 2001.

                     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 complete renovation at its production 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: Edwin H. Wegman of BioSpecifics Technologies Corp.,
516-593-7000; or Deborah Duke Passik of William Dunk Partners, 919-929-4100

Website: http://www.biospecifics.com/