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biospecifics technologies (BSTC) Snapshot

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biospecifics technologies (BSTC) Details

BioSpecifics Technologies Corp., a biopharmaceutical company, is engaged in the development of an injectable collagenase for various indications primarily in the United States. It provides injectable collagenase under the XIAFLEX name for the treatment of Dupuytren’s contracture and Peyronie’s disease. The company also develops XIAFLEX injectable collagenase for frozen shoulder, cellulite, human lipoma, canine lipoma, and uterine fibroid indications, as well as for keloids, hypertrophic scars, scarred tendons, glaucoma, herniated intervertebral discs, and as an adjunct to vitrectomy indications. It has a development and license agreement with Auxilium Pharmaceuticals, Inc. The company was founded in 1957 and is headquartered in Lynbrook, New York.

5 Employees
Last Reported Date: 03/7/14
Founded in 1957

biospecifics technologies (BSTC) Top Compensated Officers

Chief Executive Officer, President, Principal...
Total Annual Compensation: $350.0K
Compensation as of Fiscal Year 2013.

biospecifics technologies (BSTC) Key Developments

BioSpecifics Technologies Corp. Announces Positive Opinion by CHMP for XIAPEX® for the Treatment of Peyronie's Disease

BioSpecifics Technologies Corp. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of XIAPEX for the treatment of adult men with Peyronie's disease with a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy. XIAPEX is approved in the EU for the treatment of Dupuytren's contracture in adult patients with a palpable cord. Swedish Orphan Biovitrum AB is the Marketing Authorization Holder for XIAPEX in 28 EU member countries, as well as Norway and Iceland, and holds the exclusive rights from BioSpecifics' strategic partner Auxilium Pharmaceuticals Inc. to commercialize XIAPEX for Dupuytren's contracture and Peyronie's disease indications subject to applicable regulatory approvals. The use of XIAPEX in men with Peyronie's disease is supported by positive safety and efficacy outcome data from two double-blind placebo-controlled studies, IMPRESS I and II (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies).

BioSpecifics Technologies Corp. Announces New Data on XIAFLEX for Peyronie's Disease Presented at SMSNA Scientific Meeting

BioSpecifics Technologies Corp. announced new data on XIAFLEX for the treatment of Peyronie's disease from the Phase 2 and the pivotal Phase 3 IMPRESS trials, presented by BioSpecifics' licensee, Auxilium Pharmaceuticals Inc. (Auxilium) at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) held in Miami, FL from November 20, 2014 to November 23, 2014. XIAFLEX is the first and only FDA-approved biologic therapy indicated for the treatment of Peyronie's disease in men with a palpable plaque and a penile curvature deformity of 30 degrees or greater at the start of therapy. New data were presented at SMSNA assessing the impact on female sexual partners of men treated for Peyronie's disease, suggesting that female bother by their partners' symptoms improved after their partners' treatment with XIAFLEX. To assess female bother, female sexual partners completed the Female Sexual Function Index (FSFI) and the Peyronie's disease Questionnaire (PDQ), a 12-item, investigational questionnaire adapted from the men's PDQ. Improvement in female sexual function was observed as measured by all six domains (scales of desire, arousal, lubrication, orgasm satisfaction, and pain as well as the full scale total scores) of the FSFI score. The proportion of female sexual partners who reported sexual dysfunction decreased from 75% at baseline to 33.3% after partner treatment. A post-hoc analysis of data from the IMPRESS studies suggests that improvements in Peyronie's disease bother correlates with improvements in Peyronie's disease penile curvature deformity, further reinforcing the previously demonstrated conclusion that Peyronie's disease bother is a valid clinical assessment. Data presented showed that greater improvement in penile curvature deformity was associated with greater reduction in Peyronie's disease symptom bother in XIAFLEX-treated patients. Analyses of data from the PDQ and the International Index of Erectile Function (IIEF) suggested several causal factors for Peyronie's disease bother, including penile curvature deformity, perceived penile shortening and pain during intercourse and that Peyronie's disease bother and pain during intercourse both appear to have a direct impact on erectile function. The post-hoc analysis of the IMPRESS studies in patients with Peyronie's disease for 6-12 months also suggest that further study of XIAFLEX treatment in the early months of Peyronie's disease should be considered. XIAFLEX demonstrated statistically significant mean % improvement in penile curvature deformity compared to placebo within each Peyronie's disease duration grouping (disease duration 6 to <12 months: p=0.08; disease duration >=12 months: p=0.004), between Peyronie's disease duration groupings, there were no statistically significant differences in improvement of penile curvature deformity or symptom bother improvement with XIAFLEX, an increased placebo effect was also observed in patients with Peyronie's disease duration of 6 to <12 months.

BioSpecifics Technologies Corp. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 02:25 PM

BioSpecifics Technologies Corp. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 02:25 PM. Venue: The Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Thomas L. Wegman, Chief Executive Officer, President, Principal Financial Officer, Principal Accounting Officer, Secretary, Director, President of ABC-Curacao, President of ABC-New York, Secretary of ABC-Curacao, Secretary of ABC-New York, Director - ABC-Curacao and Director of ABC-New York.


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