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BIOSPECIFICS REPORT: RESEARCH AND DEVELOPMENT UPDATE 2001 LYNBROOK, NY, October 24, 2001 - BioSpecifics Technologies Corp. (Nasdaq:BSTC) is a major producer of collagenase for therapeutic purposes. Its research and development program for the last five fiscal years has involved expenditures averaging over 27% of revenues. This is management's first annual report on progress being made on applications for Dupuytren's disease, Peyronie's disease, frozen shoulder, lipomas to include "chemical liposuction," and other indications. Dupuytren's Disease: Phase 3 Design Underway As recently announced, Phase 2 trials for Cordase™ for the treatment of Dupuytren's disease have been concluded successfully, and BioSpecifics was informed that Phase 3 may proceed pending final approval of the clinical protocol. For the "end-of-Phase-2-meeting", the Food and Drug Administration ("FDA") reviewed the clinical trials, the pre-clinical laboratory and animal work, and detailed manufacturing methods. The Phase 2 submission included a double blind, placebo controlled study conducted at Stony Brook University Hospital and Medical Center and two additional double blind randomized placebo controlled dose response clinical investigations performed at Stony Brook and Stanford University Medical Center. Stony Brook University Hospital has been awarded a monetary grant from FDA to advance the Phase 3 clinical trials with Collagenase ABC enzyme, the active ingredient in Cordase™. During the meeting, the Pharmacology/Toxicology and manufacturing specifications and controls were discussed and were found to be satisfactory to proceed to Phase 3. FDA's regulations encourage "end-of-Phase-2" meetings in order to evaluate the plans for Phase 3, assess safety issues and determine the adequacy of completed studies. It is also an opportunity for the sponsor to agree on the criteria for the Phase 3 pivotal study on which the safety and efficacy of the drug will be judged for human use. These meetings are recognized by the pharmaceutical and biotechnology industry as a crucial milestone in the development of a new drug or biological product application. 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 has been submitted to the Agency. In addition to the planned Phase 3 trials, BioSpecifics will partner with an Australian pharmaceutical firm to initiate clinical investigations in Australia. Under the agreement, the Australian company will absorb the costs for the Australian clinical trials. A major university medical center located in Sydney will be the site for the planned study. Due to a genetic predisposition, Dupuytren's disease is a well-known disease entity in the Australian population. BioSpecifics has been granted patent #733208 issued on August 23, 2001 from the Commonwealth of Australia. 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. Currently the only proven therapy for Dupuytren's disease is surgery, which involves the removal of the cords responsible for the deformity. The cord that restricts the motion of the affected finger is composed of collagen, and thus its decomposition by BioSpecifics' enzyme Collagenase ABC can free the finger. This disease is particularly prevalent among people of northern European descent. Onset of the disease occurs mainly between the ages of 40 to 60 with a higher incidence in men than in women. This new injectable 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 former U.S. President Ronald Reagan and former British Prime Minister Margaret Thatcher. Peyronie's Disease: 50% of Patients Show Improvement in One Study BioSpecifics has completed a preliminary analysis of the long-term results of a study conducted with its collagenase in the treatment of Peyronie's disease at the Devine Tidewater Urology Clinic in Norfolk, Virginia. The Devine Tidewater clinic is the most active in the world for treatment of Peyronie's disease. Dr. Gerald Jordan one of the leading Peyronie's disease specialists conducted the clinical investigation. This treatment is in clinical trials. 19 patients completed the full therapeutic course and were available for evaluation at nine months post treatment. In this trial of the injectable, 52% of the patients who completed the treatment course were rated as successes by the investigator. Dr. Jordan believes that modifications of the injection technique and treatment regimen may improve this percentage considerably. The patients with positive responses generally showed improvement in angle of penile deviation as measured by photography under controlled vacuum as well as improved ability to have sex. A statistically significant change from baseline in penile plaque was observed in the group of responders. Side effects included penile bruising and swelling. These side effects resolved within 3 weeks post treatment. BioSpecifics is planning future clinical investigations to replicate these results and to optimize the treatment methodology in a controlled clinical trial. Peyronie's disease is a condition of disordered healing in which restrictive, hardened scars (plaque) form on the erectile bodies of the penis which cause curvature and interfere with sex. The plaque consists of non-polarized collagen and in severe cases can cause the penis to bend at a 90° angle or more. The cause of the disease and its development are not well understood. Men with Peyronie's disease usually seek medical attention because of painful erections and difficulty with sex. It has been estimated that Peyronie's disease of varying severities may afflict up to 1% of the male population in the U.S. Although the disease occurs mostly in middle-aged men, men of all ages can acquire it. There is no approved pharmaceutical treatment for this disease. Currently, the only therapy recognized by the medical community is surgery. Common surgical techniques involve excision of the Peyronie's plaque followed by grafting or gathering and suturing penile tissue opposite the plaque to correct the deformity. Dr. Francois de la Peyronie, court physician to King Louis XIV, first described the condition in 1743. Frozen Shoulder A recent article appeared in the Health and Discovery section of Newsday titled "Promising New Treatments for Stiff-Shoulder Condition." Clinical investigators at Stony Brook have now initiated treatment under an FDA approved Investigational New Drug application ("IND") for the treatment of "frozen shoulder" also known as adhesive capsulitis. Frozen shoulder is a clinical syndrome of pain and severely decreased motion in the shoulder joint. Individuals with frozen shoulder frequently experience decreased function of the shoulder. Basic movements such as raising ones arm can become extremely difficult. The problem occurs following injury or for unknown reasons and is related to scarring of the ligaments in the shoulder joint. There are similarities to the histological changes associated with Dupuytren's disease. Since frozen shoulder is due to excessive deposition of collagen, it may be responsive to collagenase, an enzyme that hydrolyzes collagen. This syndrome afflicts up to 2,000,000 patients annually. The National Institutes of Health says that individuals with diabetes, stroke, lung disease, rheumatoid arthritis, and heart disease or have been in an accident are at greater risk for frozen shoulder. The American Academy of Orthopedic Surgeons reports that it affects 10-20% of diabetics. Although only a small number of patients have been treated so far, the October 2, 2001 Newsday article reported "dramatic release from pain" in the words of Dr. Marie Badalamente, one of the principal investigators. Lipomas and "Chemical Liposuction" The FDA has also granted an IND for the treatment of cutaneous lipomas with collagenase injectable. Lipomas are benign fatty tumors that occur as bulges in the skin. They usually manifest as painful or annoying lumps that are palpable and often visible in the subcutaneous tissues. Lipomas are extremely variable in size and shape and ranging from barely palpable to very large sizes of 15cm or more in diameter. The incidence of lipomas in the general population is unknown; however they are very common. Many lipomas are asymptomatic and are removed surgically for non-medical reasons. However, a significant number of them cause the patient pain and discomfort and may interfere with normal activity. A "proof of concept" study has resulted in promising early clinical results in a small series of patients and the clinical investigation is continuing. Dr. Anna Marie recently covered the story for ABC News and discussed the potential for "chemical liposuction." BioSpecifics cautions that much clinical work remains to be done. The company may consider a joint venture with a major pharmaceutical firm to develop this application. The European Patent Office ("EPO") has issued a notice that it intends to grant a patent for Lipolysin , which BioSpecifics would call the product for this potential use. Collagenase for Wound Healing BioSpecifics has been assigned rights to patents originating from research conducted at Dr Ira Herman's laboratory at Tufts University which describe the discovery that collagenase applied topically has the potential to accelerate wound healing. BioSpecifics has been assigned patent rights relating to two US Patents 5,851,522 and 5,718,897. Foreign patent applications have been filed in Japan, Australia, Canada, and the EPO (12 countries). The patents are based on laboratory studies, which demonstrate that BioSpecifics purified collagenase promotes cell migration following injury and induces proliferation of skin cells. BioSpecifics is collaborating with Smith & Nephew (NYSE:SNN) in ongoing studies designed to investigate this new potential application for BioSpecifics' collagenase. 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. Collagenase Santyl® Ointment is distributed in North America by Smith & Nephew (NYSE:SNN). It was the acquisition of the marketing rights to collagenase that propelled Smith & Nephew into the number one position worldwide in wound care management. BioSpecifics is 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. Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
BIOSPECIFICS SECOND QUARTER: REVENUES $2.2 MILLION, NET INCOME $130,000 DUPUYTREN'S PROGRESS, FACILITIES IMPROVEMENTS LYNBROOK, NY, September 19, 2001 - BioSpecifics Technologies Corp. (Nasdaq:BSTC) reported revenues for the second quarter ended July 31, 2001 of $2.2 million versus $2.1 million a year ago. Net income was $130,000 or $.03 per share compared to $87,400 or $.02 per share a year ago. For the six months ended July 31, 2001, revenues were $5.0 million versus $3.5 million a year ago. Net income for the six months ended July 31, 2001 was $305,000 or $.07 per share versus $21,500 or $.01 per share a year ago. Higher revenues during the six months ended July 31, 2001 were the result of the timing of deliveries of BioSpecifics' Collagenase ABC enzyme to Abbott Laboratories (NYSE:ABT), which acquired Knoll Pharmaceutical Company earlier this year. BioSpecifics is delivering to Abbott Collagenase ABC enzyme, the active ingredient in the topical prescription drug Collagenase Santyl® Ointment, from inventory that was produced prior to the voluntary closure and renovation of production facilities, as this inventory completes the final stage of processing. At the beginning of the six months ended July 31, 2001, BioSpecifics' delivered some of this inventory to Abbott to fulfill an order that had originally been scheduled for delivery during the fourth quarter of the prior fiscal year, which ended January 31, 2001. During the six months ended July 31, 2001, royalty revenue increased to $1.2 million versus $928,000 in the year ago period. Looking out to the current fiscal third quarter that ends October 31, 2001, BioSpecifics does not expect to make deliveries to Abbott because none of this inventory in process will be completed by then. We may make deliveries to Abbott during the fiscal fourth quarter of the year ending January 31, 2002, although there can be no assurance that this inventory will be completed by then. BioSpecifics will continue to earn royalties from sales by Smith & Nephew of Santyl Ointment during the third quarter that ends October 31, 2001. Smith & Nephew, Inc. (NYSE:SNN) acquired the right to market BioSpecifics' Santyl® Ointment in January 2000. Abbott compounds Santyl® Ointment from our active ingredient, which it then sells to Smith & Nephew for marketing in the United States and Canada. End of Phase 2 Conference with FDA for Treatment of Dupuytren's Disease Research and development progress on injectable Collagenase ABC is on schedule. As previously announced, BioSpecifics successfully concluded Phase 2 for its drug Cordase for the treatment of Dupuytren's Disease. This product is also in Phase 2 studies for the treatment of adhesive capsulitis (frozen shoulder). In addition, 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 also underway for collagenase treatment of lipomas. While these developments are encouraging, there can be no assurance that the FDA will approve this injectable Collagenase ABC enzyme. Production Facility Construction Completed As previously announced, BioSpecifics has completed construction and commenced first stage production runs at its advanced biopharmaceutical manufacturing facility for production of Collagenase ABC. Full-scale production is taking place in stages. BioSpecifics must submit to the FDA documentation for approval of the facility and new Collagenase ABC inventory being produced at the facility, which is located in the Netherlands Antilles, before this new inventory can be released to Abbott for use as a pharmaceutical. There can be no assurance that FDA approval will be obtained, 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. 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). Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
Note: Primarily orphan drug tax credits. Back to topBioSpecifics Technologies Corp. Announces End of Phase 2 Conference with FDA For Treatment of Dupuytren's Disease Lynbrook, NY September 10, 2001 - 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. 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). Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
BIOSPECIFICS APPOINTS ASANTÉ PARTNERS LLC AS FINANCIAL ADVISOR ASANTÉ TO ASSIST THE COMPANY IN EVALUATING STRATEGIC ALTERNATIVES Lynbrook, NY, July 1, 2001 - BioSpecifics Technologies Corp. (Nasdaq: BSTC) announced today that is has appointed Asanté Partners LLC, investment bankers, as a strategic advisor to the Company. Asanté Partners is specialized in the opportunities for biotech growth in the area of joint ventures and alliances. James McLaren, senior partner, stated that "BioSpecifics with its outstanding pipeline offers a number of very substantial marketing possibilities for domestic and international pharmaceutical companies." Mr. McLaren was head of Goldman Sachs international operations for a number of years and has now established his interest in the life sciences area. "BioSpecifics has reached a stage in its research efforts where a number of drugs with considerable potential are in human trials, and more on the way. We are anxious to expedite the process and believe that Asanté Partners will help us bring these efforts to fruition," said Edwin H. Wegman, Chairman and President of BioSpecifics. 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). Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
BIOSPECIFICS ANNOUNCES COMPLETION OF CONSTRUCTION FOR STATE OF THE ART BIOPHARMACEUTICAL PRODUCTION FACILITY Lynbrook, NY, June 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). Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
BIOSPECIFICS FIRST QUARTER: REVENUES $2.8 MILLION, NET INCOME $175,000 PROGRESS ON NEW APPLICATIONS FOR COLLAGENASE LYNBROOK, NY June 18, 2001 - BioSpecifics Technologies Corp. (Nasdaq:BSTC) reported revenues for the first fiscal quarter ended April 30, 2001 of $2,800,000 as compared to $1,439,000 in the prior year's first quarter. For the quarter, the Company had net income of $175,000 or $.04 per share. In the prior year's first quarter, the Company had a net loss of ($66,000) or ($.01) per share. Edwin H. Wegman, President stated: "We are very pleased with our progress to date with the renovation of our facilities, which will resume normal production upon FDA approval. We are pleased with our research progress in general, our progress in clinical trials for Dupuytren's and Peyronie's diseases, and construction of production facilities for the injectable product. At the same time, we continue to work with Smith & Nephew (NYSE:SNN) in developing the marketing of Collagenase Santyl Ointment." 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 trials investigating the use of injectable collagenase in the treatment of lipoma reduction have been initiated. 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 since March 2001. Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
Back to top BIOSPECIFICS TO LIST ON THE NASDAQ SMALLCAP MARKET LYNBROOK, NY, May 25, 2001 - BioSpecifics Technologies Corp. (Nasdaq:BSTC) announced today that its common stock commenced listing on The Nasdaq SmallCap Market under its trading symbol: BSTC. 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 being summarized for submission to the FDA in support of proceeding to Phase 3 for the use of injectable collagenase (Cordase ) 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 in wound healing are being pursued, as are other earlier stage therapeutic uses. Santyl* is a registered trademark of Knoll Pharmaceutical Company, a division of Abbott Laboratories since March 2001. Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
BIOSPECIFICS RECEIVES EUROPEAN PATENT NOTICE FOR "CHEMICAL LIPOSUCTION" LYNBROOK, NY, 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." Santyl* is a registered trademark of Knoll Pharmaceutical Company, a division of Abbott Laboratories since March 2001. Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Contact:
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. Back to topBIOSPECIFICS FY 2001: REVENUES $5,532,000 COMPLETION OF FIRST YEAR WITH SMITH & NEPHEW AS SANTYL MARKETER LYNBROOK, NY May 17, 2001 - BioSpecifics Technologies Corp. (Nasdaq\NMS:BSTC) reported net loss for the fiscal year ended January 31, 2001 of $(1,468,000) or $(.32) per share compared to net income the fiscal year ended January 31, 2000 of $160,000 or $.04 per share. Total revenues for fiscal year 2001 were $5,532,000 compared to $6,621,000 for fiscal year 2000, including royalties from Collagenase Santyl® which were $2,095,000 in fiscal 2001 compared to $2,947,000 in fiscal 2000. Effective January 31, 2000, Santyl marketing and distribution rights were sublicensed from Knoll Pharmaceutical Company ("KPC") to Smith & Nephew, Inc. ("S&N"). The transfer of marketing effort resulted in a period of transition and lower sales of Santyl during the Company's fiscal year 2001 versus the fiscal year 2000. Net loss for the fourth quarter ended January 31, 2001 was $726,000 or $(.16) per share compared to net income of $147,000 or $.03 per share for the fourth quarter of fiscal 2000. Total revenues for the fourth quarters of fiscal 2001 and 2000 were $1,455,000 and $1,839,000 respectively including royalties from Collagenase Santyl®, which were $663,000 in fiscal 2001's fourth quarter compared to $909,000 in fiscal 2000's fourth quarter, and license fee income, of which there was none in fiscal 2001's fourth quarter, compared to $130,000 in fiscal 2000's fourth quarter. It should be pointed out that the Company shipped approximately $900,000 of its product to KPC in February 2001, which had been scheduled for shipment in the fiscal year ended January 31, 2001. During the fourth quarter ended January 31, 2001, the Company took a non-cash valuation allowance charge of approximately $372,000 for Orphan Drug tax credits which had been capitalized as deferred tax assets in previous periods. The valuation allowance pertains to uncertainties with respect to the timing of future utilization of these tax credits. Biopharmaceutical companies with products in development generally record tax credit valuation allowances. Thomas L. Wegman, Executive Vice President commented, "We are thoroughly pleased with Smith & Nephew (NYSE:SNN), the new marketer of Santyl , and their strong strategic commitment to the wound healing market. Although fiscal 2001 sales were slower than anticipated, we are very comfortable with the fact that the marketing is now in the hands of the world's leader in wound management. It was the acquisition of collagenase that propelled S&N into the number one position worldwide in the field of wound care. S&N plans to invest behind the brand to confirm the clinical benefit of collagenase for new therapeutic indications, which is in line with our strategy to expand the use of collagenase to a variety of conditions. We would expect that S&N's determined and focused marketing approach will result in accelerated product growth in the coming years." 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 North America, and under other trademarks abroad. Clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's and Peyronie's diseases. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Smith & Nephew (NYSE:SNN) is a global medical device company whose main product categories are wound management, orthopedics, and endoscopy. It develops, manufactures, and markets a wide range of innovative and technologically advanced tissue repair products. Santyl* is a registered trademark of Knoll Pharmaceutical Company, a division of Abbott Laboratories since March 2001. Contact:
Stony Brook Announces New Clinical Trial With BioSpecifics' Injectable Collagenase For Adhesive Capsulitis The Second Therapeutic Indication Using Injectable Collagenase In Clinical Trials Initiated At Stony Brook University Hospital LYNBROOK, NY October 20, 2000 - University Hospital and Medical Center at Stony Brook announced on September 1, 2000 that a Phase 1 clinical trial with injectable collagenase treatment for adhesive capsulitis (frozen shoulder) will begin shortly. This is the second indication to go to human clinical trials at Stony Brook University using BioSpecifics Technologies Corp.'s (Nasdaq/NM:BSTC) injectable collagenase. Frozen shoulder is a clinical syndrome of pain and severely decreased motion in the shoulder joint. Individuals with frozen shoulder frequently experience decreased function of the shoulder. The problem occurs following injury or for unknown reasons and is related to scarring of the ligaments in the shoulder joint. There are similarities to the histological changes associated with Dupuytren's disease (see below). Since frozen shoulder is due to excessive collagen deposition, it may be responsive to collagenase, an enzyme that hydrolyses collagen. Some reports estimate there is a 2% incidence of frozen shoulder in the general population. Phase 1 and 2 trials have been completed at State University of New York at Stony Brook using BioSpecifics' Cordaseä injectable collagenase for Dupuytren's disease, and the results have been submitted to the U.S. Food and Drug Administration for evaluation. Based on BioSpecifics' evaluation of the results of the first Phase 2 trial, it initiated expanded dose response studies at Stony Brook and Stanford University Medical Center, which are in progress. Dupuytren's 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 slightly 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. The investigational use of Collagenase involves an injection into the affected fingers. This 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 5,589,171 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. 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. Clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's disease and Peyronie's disease. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Visit BioSpecifics' website at its Dupuytren's Disease patient discussion forum at and its Peyronie's Disease patient discussion forum at Santyl* is a registered trademark of Knoll Pharmaceutical Company. Back to topBIOSPECIFICS FIRST QUARTER: REVENUES $1.4 MILLION, NET LOSS $66,000 PROGRESS ON NEW APPLICATIONS FOR COLLAGENASE LYNBROOK, NY June 15, 2000 - BioSpecifics Technologies Corp. (Nasdaq\NMS:BSTC) reported revenues for the first fiscal quarter ended April 30, 2000 of $1,439,000 as compared to $1,279,000 in the prior year's first quarter, an increase of 13%. For the quarter, the Company had net loss of $66,000 or $.01 per share. In the prior year's first quarter, the Company had a net loss of $137,100 or $.03 per share. Research and development expenses during the three months ended April 30, 2000 were $411,000 versus $506,000 in the year ago period. Edwin H. Wegman, President stated: "We are very pleased with our research progress on three new applications for collagenase, for Dupuytren's and Peyronie's diseases, and glaucoma. At the same time, we continue to work closely with Smith & Nephew (NYSE:SNN) in developing the marketing of SantylÒ . 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 North America, and under other trademarks abroad. Clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's and Peyronie's diseases. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued.
Visit BioSpecifics' Dupuytren's Disease patient discussion forum at Santylâ is a registered trademark of Knoll Pharmaceutical Company. Contact:
BioSpecifics Technologies Corp. and Subsidiaries Results of Operations
Note : Cash and marketable securities at January 31, 2000 were $5,173,000. Back to topBIOSPECIFICS FY 2000 RESULTS: REVENUES $6,621,000; NET INCOME $160,000; R&D PROGRESS LYNBROOK, NY April 28, 2000 - BioSpecifics Technologies Corp. (Nasdaq\NMS:BSTC) reported net income for the fiscal year ended January 31, 2000 of $160,000 or $.03 per share compared to net income in fiscal 1999 of $1,240,000 or $.26 per share. Total revenues for fiscal year 2000 were $6,621,000 compared to $7,062,000 for fiscal year 1999, including royalties from Collagenase Santyl® which were up 18% to $2,947,000 in fiscal 2000 compared to $2,506,000 in fiscal 1999. Net income for the fourth quarter ended January 31, 2000 was $147,000 or $.03 per share compared to net income of $434,000 or $.09 per share for the fourth quarter of fiscal 1999. Total revenues for the fourth quarters of fiscal 2000 and 1999 were $1,839,000 and $1,702,000 respectively. Selling, general and administrative expenses for the fiscal year ended January 31, 2000 amounted to $2,972,000 versus $1,776,000 the prior year. The fiscal 2000 amount includes approximately $1 million expended to address FDA concerns with the Company's good manufacturing practices. Thomas L. Wegman, Executive Vice President commented "We ended fiscal 2000 with a highly significant development. On January 31, 2000, Smith & Nephew (NYSE:SNN) became the active marketer and promoter of our FDA licensed product, Collagenase SantylÒ Ointment, in North America. Smith & Nephew is a global medical device company employing 12,000 people in 36 countries whose main product categories are wound management, orthopedics, and endoscopy. It develops, manufactures, and markets a wide range of innovative and technologically advanced tissue repair products. Smith & Nephew aims to achieve worldwide leadership in the advanced wound management market in the year 2000. We are very enthusiastic about partnering with Smith & Nephew since they are a market leader in wound management therapies, especially in North America. We look forward to a long period of collaboration. Smith & Nephew in their press release characterized the acquisition of marketing rights to Collagenase ointment as a transforming step that will distinguish S&N as a global leader in wound management. Smith & Nephew has stated that the acquisition of Collagenase will propel them into a leading position in the world in the area of advance wound healing therapy. "In terms of research, fiscal 2000 was significant in terms of the progress we have made in the development of other products, Cordase™, our injectable collagenase for the treatment of Dupuytren's disease, and Plaquase™, our injectable collagenase for the treatment of Peyronie's disease. Cordase™ completed a Phase 2 trial after having achieved encouraging results in Phase 1, and dose-ranging studies are underway. At our August 1999 Annual Meeting, the clinical investigator for Plaquase™ presented encouraging results and additional trials are planned." As previously reported, renovation of the Company's manufacturing facilities in Curacao, Netherlands Antilles and Lynbrook, NY is now ongoing and most production has been suspended during this period. Final stage production of in-process inventory and testing continues at the Lynbrook facility. There can be no assurance that the FDA will not require the Company to take further actions that could have an adverse effect on production. As a result of the renovation, the Company recorded a charge of $200,000 in the fourth quarter ended January 31, 2000. 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 North America, and under other trademarks abroad. Clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's and Peyronie's diseases. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Visit the BioSpecifics
Contact:Dupuytren's Disease patient discussion forum at www.biospecifics.com/forum/ and its Peyronie's Disease patient discussion forum at www.biospecifics.com/forum/index2 Santyl® is a registered trademark of Knoll Pharmaceutical Company.
Notes: Cash and marketable securities at October 31, 1999 was $4,929,000. BIOSPECIFICS ANNOUNCES SMITH & NEPHEW MARKETING ALLIANCE FOR COLLAGENASE SANTYL® OINTMENT IN NORTH AMERICA FOR IMMEDIATE RELEASE LYNBROOK, NY, February 1, 2000 - BioSpecifics Technologies Corp. (Nasdaq National Market:BSTC) announced today that Smith & Nephew (NYSE:SNN) has become the active marketer and promoter of its FDA licensed product, Collagenase Santyl® Ointment, in North America. Smith & Nephew is a global medical device company employing 12,000 people in 36 countries. Smith & Nephew's main product categories are orthopedics, endoscopy, and wound management. It develops, manufactures, and markets a wide range of innovative and technologically advanced tissue repair products. Smith & Nephew aims to achieve worldwide leadership in the advanced wound management market in the year 2000. Collagenase Santyl® Ointment was previously marketed in North America by Knoll Pharmaceutical Company ("KPC") under license from BioSpecifics. Collagenase SantylÒ Ointment is indicated for debriding chronic dermal ulcers and severely burned areas. In 1999, North American sales of Santyl® were in excess of $37 million. Smith & Nephew has obtained from KPC the exclusive marketing rights to Santyl® with the agreement of BioSpecifics. Smith & Nephew will also be taking over the Santyl® selling resource from KPC, which will add significant critical mass to its sales and marketing capability. In the US alone, this will give Smith & Nephew an effective full time sales force of 190, the second largest in the advanced wound management sector. KPC will continue to contract manufacture the final ointment product for the North American market, using BioSpecifics' active ingredient, Collagenase ABC. Thomas L. Wegman, BioSpecifics Executive Vice President, stated "We are very enthusiastic about partnering with Smith & Nephew since they are a leader in wound healing therapies, especially in North America. We look forward to a long period of collaboration. Smith & Nephew is now a recognized leader in the area of advanced wound healing therapy and our product will significantly add to this position. Smith & Nephew plans to invest behind the brand to confirm the clinical benefit of collagenase for new therapeutic indications, which is in line with our strategy to expand the use of collagenase to a variety of conditions. It is our hope that among the outcomes of this arrangement is greater recognition of the benefits of collagenase in a variety of conditions, which is the primary goal at BioSpecifics." Jim Dick, Smith & Nephew's President of the global business unit for wound management said "We are delighted to be adding this important established brand to our strong wound management portfolio which will both enhance our market presence in North America and continue the growth of Santyl®." About Smith & Nephew: Smith & Nephew plc. is a global medical device company with worldwide revenues of $1.7 billion. In 1998, 45% of these revenues came from North America and 20% were attributed to wound management products. The company employs 12,000 people with operations in 36 countries. It markets technically advanced products, principally in areas of orthopaedics, endoscopy and wound management to deliver cost effective solutions, significant physician advantage and real patient benefits. A continuous process of supplying new and innovative products is supported by substantial R&D investment, which includes the development of biological solutions to deliver new levels of healing to patients throughout the world. Smith & Nephew is listed on the New York Stock Exchange. Shares of Smith & Nephew are traded in the form of American Depositary Receipts (ADRs) under the ticker symbol SNN. About Smith & Nephew, Inc. Wound Management Division The Wound Management business of Smith & Nephew has its headquarters in the UK where its main manufacturing unit is located. The Wound Management Division of Smith & Nephew in the U.S. is an important part of Smith & Nephew with a strong U.S. business. Based in Largo, Florida, it combines products manufactured on site with those from the UK to offer the leading chronic wound range available in the world today. Smith & Nephew is known for pacesetting educational programs that substantiate the Company's dedication to the science of wound healing. With its wide range of specialty products and educational services supporting advanced wound, skin and I.V. site care products, Smith & Nephew has established a leadership position in the healthcare industry. The Wound Management team based in Largo, Florida includes specialists in customer service, sales, marketing, quality assurance, regulatory affairs, operations, manufacturing, product development, finance, information services and human resources and supports a dedicated sales team whose members are located in major cities throughout the United States. About BioSpecifics: 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 North America, and under other trademarks abroad. Clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's and Peyronie's diseases. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Visit the main Smith & Nephew website at www.Smith-Nephew.com and its wound management division website at www.snwmd.com Santyl® is a registered trademark of Knoll Pharmaceutical Company. Contacts:
BIOSPECIFICS TECHNOLOGIES CORP. APPOINTS JOHN T. LANE TO BOARD OF DIRECTORS FOR IMMEDIATE RELEASE LYNBROOK, NY, January 10, 2000 - BioSpecifics Technologies Corp., (Nasdaq\NM: BSTC) announced today that John T. Lane has been appointed to its Board of Directors. Mr. Lane served as Managing Director, Head of U.S. Private Clients, at J.P. Morgan & Co.His previous posts included Managing Director, Head of U.S. Investor Services Group and Senior Vice President, Head of Eastern U.S. Corporate Finance, all at J.P. Morgan & Co. Mr. Lane, a consultant, is a director for a number of companies and hospitals, including Medix Resources Inc., Acme Metals, Toyo Trust Company of New York, Vytra HealthCare, Winthrop University Hospital, and South Nassau Communities Hospital. Edwin H. Wegman, BioSpecifics Chairman and President: "We are very fortunate to have John join our Board of Directors. His broad based understanding of mergers and acquisitions, security offerings, and business development will be great value to BioSpecifics. I have had the privilege of working with John on community matters for the last few years and find his acumen and judgment outstanding." 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. Clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's and Peyronie's diseases. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Visit Dupuytren's Disease Patient Discussion at www.biospecifics.com/forum/ Santyl® is a registered trademark of Knoll Pharmaceutical Company. Contact: BioSpecifics Technologies Corp. Contact:
BIOSPECIFICS THIRD QUARTER: REVENUES $1.8 MILLION, NET INCOME $76,600; PROGRESS ON DUPUYTREN'S AND PEYRONIE'S DISEASES LYNBROOK, NY, December 15, 1999 - BioSpecifics Technologies Corp. (Nasdaq National Market:BSTC) reported revenues for the third quarter ended October 31, 1999 of $1.8 million, versus $1.6 million for the third quarter ended October 31, 1998. Net income was $76,600 or $.02 per share for the third quarter ended October 31, 1999, compared to $228,300 or $.05 per share for the third quarter ended October 31, 1998. For the nine months ended October 31, 1999, revenues were $4.8 million versus $5.4 million for the nine months ended October 31, 1998. Net income for the nine months ended October 31, 1999 was $13,000 or $.00 per share, versus $806,100 or $.17 per share for the nine months ended October 31, 1998. The Company continues to direct significant resources to addressing observations made by the FDA and to facility improvements. The Company and its consultants believe that it has made considerable progress in addressing FDA concerns. Selling, general and administrative costs were up $795,000 during the nine months ended October 31, 1999 versus the nine months ended October 31, 1998 primarily as a result of expenditures for addressing FDA concerns and for a facility improvements program. Management believes that the expenses for addressing FDA concerns have peaked and should have less influence on succeeding periods. Dupuytren's and Peyronie's Diseases Research and development continued on several fronts. A Phase 2 trial of injectable collagenase enzyme CordaseTM for Dupuytren's disease has been completed and recently reported. This Phase 2 trial in 49 patients was a double-blind, randomized, placebo controlled study of a single injection of collagenase into the cord that restricts motion of the affected finger. Of the 25 patients who received a single injection of collagenase, 18 appeared to have a return of the restricted joint to within 0-5º normal range of motion and flexion at 7 and 14 days and at 1 month, as compared to the placebo treatment group where 2 of the patients appeared to show minimal improvement. The most common side effects observed to date are tenderness to pressure at the injection site, edema and minimal hematoma (approximately half the patients experienced one or more of these events). The reported events were mild and transient, and most seemed to be localized reactions at the injection site. Dose ranging studies for this indication are underway. Positive preliminary results in a clinical trial of injectable collagenase enzyme Plaquase? for Peyronie's disease were presented by the clinical investigator, Dr. Gerald H. Jordan, at the Company's annual meeting August 4, 1999. 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, pressu | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||