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BioSpecifics Announces Completion of Construction For State of the art Biopharmaceutical Production Facility

PRNewswire
LYNBROOK, N.Y.
Jun 25, 2001

BioSpecifics Technologies Corp. (NASDAQ: BSTC) announced today the completion of construction and commencement of first stage production runs at its advanced biopharmaceutical manufacturing facility. This dedicated facility was designed for production of Collagenase ABC, the active ingredient in the prescription drug Collagenase Santyl® Ointment marketed by Smith & Nephew, Inc. (NYSE: SNN). Improvements provide a highly controlled state of the art clean room environment with manufacturing areas, laboratories, and equipment designed for increased production capacity. The entire facility, including laboratories and offices, is more than 15,000 square feet featuring a modularized clean room zone consisting of eighteen rooms built to exacting specifications based on computer assisted design. The walls, ceilings, and floors are constructed of special materials for efficient cleaning. The microenvironment is controlled by computerized high efficiency air filtration systems engineered to prevent contamination from microbial and non-viable particulates. New custom built manufacturing equipment includes an innovative purified water system and an enhanced vacuum freeze-drying system. BioSpecifics has invested approximately $5 million to secure efficient production under stringent pharmaceutical manufacturing controls. 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, which is located in the Netherlands Antilles. There can be no assurance that FDA approval will be obtained in a timely fashion, if at all, or that additional funds will not be necessary in order to obtain FDA approval.

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. In January 2000, Smith & Nephew, Inc acquired the marketing rights for Collagenase Santyl® Ointment from Knoll Pharmaceutical Company. The acquisition of these rights propelled Smith & Nephew into the number one position as worldwide leader in sales for wound management.

BioSpecifics is also actively pursuing injectable applications of the enzyme for the treatment of a number of diseases. Phase 2 clinical trials for the use of its injectable collagenase (Cordase™) in treating Dupuytren's disease have been completed in the U.S., and reported to the FDA. BioSpecifics hopes to enter Phase 3 trials within the coming year. The FDA has made a financial grant to SUNY Stony Brook to support Phase 3 clinical trials for this drug. Among other potential uses of the injectable enzyme now being clinically explored are: Peyronie's disease, lipoma reduction, and keloid eradication. 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.,
516-593-7000; or Deborah Duke Passik of William Dunk Partners, 919-929-4100

Website: http://www.biospecifics.com/
http://www.biospecifics.com/forum
http://www.biospecifics.com/forum/index2