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Company News Archives 1997 and 1998 Safe Harbor Statement Under
the Private Press Release:
Date: June 25, 1998 Biospecifics FY 1998: Earnings of $836,000 OR $.17 Per share R&D Program up 19% Press Release:
Date: March 16-19,1998 Press Release:
Date: February 27th, 1998 Press Release:
Date: October 1, 1997 Finding
a Cure For Crippling Hand Disorder
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| BIOSPECIFICS
ANNOUNCES STOCK REPURCHASE PROGRAM
LYNBROOK, NY, June 25, 1998 - BioSpecifics Technologies Corp. (Nasdaq\NM:BSTC) announced today that its Board of Directors has authorized a program for the repurchase of up to 500,000 shares of its common stock. BioSpecifics completed a repurchase program of 100,000 shares in February 1998. Chairman Edwin H. Wegman stated, "I am pleased to announce that our Board of Directors has authorized a new program for the repurchase of up to 500,000 shares of our common stock. We believe that the market price of the common stock of BioSpecifics does not reflect the present or future values of the Company. Consequently, we view the authorization of another open market stock repurchase program as good business and valuable to our shareholders." The last sale price of the common stock on June 24, 1998 was $5.00 per share. The Company has approximately 4.9 million shares outstanding. BioSpecifics reported earnings per share of $.05 for the quarter ended April 30, 1998 and $.17 for the fiscal year ended January 31, 1998. Cash and marketable securities approximated $6.7 million as of April 30, 1998. The program will be undertaken in accordance with Securities and Exchange Commission rules regarding such repurchases. The timing and terms of the purchases are to be determined by management based on market conditions. Repurchased shares will be held as treasury stock and will be available for general corporate purposes. BioSpecifics Technologies Corp. is a pharmaceutical company with a major 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® sold in the United States, and under other trademarks abroad. Based on BioSpecifics' proprietary understanding of collagenase production and its therapeutic potential, clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's disease, Peyronie's disease, and keloids. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Santyl* is a registered trademark of Knoll Pharmaceutical Company. BIOSPECIFICS
FY 1998: LYNBROOK, NY April 30, 1998 - BioSpecifics Technologies Corp. (Nasdaq\NMS:BSTC) reported net income for the fiscal year ended January 31, 1998 of $836,000 or $.17 per share compared to net income in fiscal 1997 of $1,126,000 or $.23 per share. Royalties from Collagenase Santyl® sales were up 18% to $2,436,000 in fiscal 1998 compared to $2,069,000 in fiscal 1997. Total revenues for fiscal year 1998 were $5,825,000 compared to $5,875,000 for fiscal year 1997. Net income for the fourth quarter of fiscal 1998 was $258,000 or $.05 per share compared to net income of $307,000 or $.06 per share for the fourth quarter of fiscal 1997. Total revenues for the fourth quarter of fiscal 1998 and 1997 were $1,577,000 and $1,226,000, respectively. Income from operations in the fourth quarter of fiscal 1998 was $162,000 versus a loss of ($41,000) in fiscal 1997's fourth quarter. Edwin H. Wegman, President and Chairman said "Fiscal 1998's total revenues were flat, as a surge in royalties from Collagenase Santyl® sales were offset by lower sales of our product Collagenase ABC, the active ingredient in Collagenase Santyl®, to our licensee Knoll Pharmaceutical Company ("KPC") due to the timing of their purchases. We believe there will be continued growth in our core product as a result of a 50% addition to KPC's Collagenase Santyl® sales force in 1997, the effect of which we believe has not yet been realized, and a co-promotion agreement reached in February 1998 between KPC and Ortho-McNeil (a Johnson & Johnson Company (NYSE:JNJ)). Fiscal 1998 earnings were affected by an increase of over $300,000 in R&D spending, to $1.9 million, versus $1.6 million in fiscal 1997. Fiscal 1998 was significant in terms of the progress we have made in the development of potential products, particularly Cordase™, our injectable collagenase for the treatment of Dupuytren's disease. Cordase™ is in Phase 2 trials, having achieved encouraging results in Phase 1. Generally, our aggressive R&D spending is buttressing our strong clinical program for developing new applications for collagenase." BioSpecifics Technologies Corp. is a pharmaceutical company with a major 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® sold in the United States, and under other trademarks abroad. Based on BioSpecifics' proprietary understanding of collagenase production and its therapeutic potential, clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's disease, Peyronie's disease, and keloids. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Santyl® is a registered trademark of Knoll Pharmaceutical Company. Biospecifics announces Dupuytren's Disease clinical results presented at 44th annual meeting of the Orthpaedic Research Society (March 16-19,1998) Lynbrook, NY April 21, 1998 - BioSpecifics Technologies Corp. (Nasdaq/NM:BSTC) announced today that favorable results in early clinical trials with Cordase*, BSTC's injectable collagenase for treatment of Dupuytren's disease were presented at the 44th Annual Meeting of the Orthopaedic Research Society in New Orleans (March 16-19, 1998). Dupuytren's disease is a deformity of the hand in which there is a contracture of the fingers toward the palm often resulting in functional disability. A high percentage of patients have been returned to full use of their fingers with a simple injection of Cordase* in these early results. Currently the only proven therapy for Dupuytren's disease is surgery, which involves the removal of the collagen bands responsible for the hand deformity. The presentation was titled Enzyme Injection As A Non Operative Treatment For Dupuytren's Disease: A Clinical Trial Of Injectable Clostridial Collagenase by Drs. Marie Badalamente and Lawrence Hurst, Chairman of SUNY Stony Brook Department of Orthopaedics. This open label study involved 22 patients who had severe enough symptoms to qualify for surgery. The first six patients injected during a dose finding protocol had unsuccessful results, due to an inadequate dose. After an increased dose had been selected, 20 affected fingers were injected (16 patients). Seventeen out of 20 (85%) of these treated fingers responded successfully in the short term follow-up. Long term follow-up is ongoing to determine if these preliminary results will be maintained over a longer period of time. The use of injectable collagenase for the treatment of Dupuytren's disease has previously received Orphan Drug Designation from the Food and Drug Administration. A survey of hand surgeons indicates a positive predisposition towards this innovative approach to the disease. Clinical trials with Cordase* at SUNY Stony Brook Hospital are being funded in part by a grant from the FDA. Funding is also being provided by the New York State Center for Advanced Technology in Medical Biotechnology at State University at Stony Brook. In November 1997, BioSpecifics announced that Phase 2 trials had begun. The Phase 2 clinical trial is in progress and patients are continuing to receive treatment. Description of Dupuytren's Disease BIOSPECIFICS ANNOUNCES JOHNSON & JOHNSON AND KNOLL REACH PROMOTION AGREEMENT FOR COLLAGENASE SANTYL® AND REGRENEX® LYNBROOK, NY February 27, 1998 - BioSpecifics Technologies Corp., (Nasdaq/NM:BSTC) announced today its understanding that Ortho-McNeil Pharmaceutical, Inc. (a Johnson & Johnson company) and Knoll Pharmaceutical Company, BSTC's licensee, have reached an agreement for the promotion of BioSpecifics' Collagenase Santyl® ointment and Ortho-McNeil's Regranex® growth factor gel for the treatment of diabetic foot ulcers. This arrangement could significantly expand the market for Collagenase Santyl®, although BioSpecifics cannot give any assurances as to when or to what extent such an arrangement could impact its operations. BioSpecifics Technologies Corp. is a pharmaceutical company with a major 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. As an injectable, collagenase is under intensive clinical study for Dupuytren's disease, Peyronie's disease, and keloids. BioSpecifics produces Collagenase ABC, the essential ingredient in the prescription drug Collagenase Santyl® sold in the United States, and under other trademarks abroad. Based on BioSpecifics' proprietary understanding of collagenase production, its extensive patent position, and the therapeutic potential of collagenase, clinical trials are underway in the U.S. for the use of injectable collagenase in treating Dupuytren's disease, Peyronie's disease, and keloids. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Santyl® is a registered trademark of Knoll Pharmaceutical Company. Regranex® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnsons Company. To the extent that any of the statements
contained herein relating to the Company's products and operations are
forward looking, such statements are based on current expectations that
involve a number of uncertainties and risks. These risk and uncertainties
are described in the Company's filing on Form 10-KSB for the year ended
January 31, 1997. The Company does not undertake to update or revise its
forward-looking statements even if experience or future changes make it
clear that any projected result or outcome expressed or implied therein
will not be realized.
LYNBROOK, NY, October 1, 1997- BioSpecifics Technologies Corp. (Nasdaq/NM: BSTC) announced today that investigators in the Dept. of Orthopaedics at SUNY Stonybrook Hospital have received a grant from the FDA to conduct clinical trials with collagenase manufactured by BioSpecifics for treatment of Dupuytren's disease. The funding will cover a two year period during which expanded clinical investigations will be performed to determine safety and efficacy. Dupuytren's disease results in a deformity of the hand and patients suffer from a contracture of the fingers which limits normal function. This disease is particularly prevalent among older people of Northern European descent. Well known people with Dupuytren's disease include former U.S. President Ronald Reagan and former British Prime Minister Margaret Thatcher. Currently the only available and proven therapy for Dupuytren's disease is surgery involving the removal of the collagen bands responsible for the hand deformity. The surgery is tedious, often unsatisfactory, costs as much as $8000, and involves a painful post operative recovery period. In contrast, the experimental collagenase therapy involves an injection which can be performed in the doctors office. Preliminary experimental data developed by Dr. Lawrence Hurst, Chairman of the Department and Marie Badalamente Ph.D. based on about 30 patients indicates a very high order of success with one injection. Patients with Dupuytren's disease who are interested in being considered for the study may call Dr. Badalamente at (516) 444-2215. BioSpecifics Technologies Corp. is a pharmaceutical company with a major focus on wound healing, tissue regeneration, 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® sold in the United States, and under other trademarks abroad. Based on BioSpecifics' proprietary understanding of collagenase production and its therapeutic potential, clinical trials are underway in the U.S. for the use of injectable collagenase in treating Peyronie's disease, Dupuytren's disease, and keloids. Clinical and laboratory investigations further profiling the potential role of collagenase and its pharmacological activity in wound healing are being pursued. Santyl® is a registered trademark of Knoll Pharmaceutical Company.
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