BioSpecifics Technologies Corp, a bio-pharmaceutical company with headquarters at 35 Wilbur Street in Lynbrook, has announced FDA approval for XIAFLEX, an in-office, biologic for the treatment of Peyronie's disease. The disease causes severe curvature of the penis, which can make it difficult and extremely painful for men to achieve an erection, according to MayoClinic.
XIAFLEX, which was developed by BioSpecifics, 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 curvature of 30 degrees or greater at the start of therapy", BioSpecifics said in a release.
"Patients with Peyronie's have been very eager for an effective minimally invasive therapy and we believe that the sBLA approval represents tremendous advance in the treatment for this physically and psychologically devastating disease," said Thomas L. Wegman, President of BioSpecifics.
The drug treatment will be marketed by Auxilium Pharmeceuticals. Under the terms of BioSpecifics' agreement with Auxilium, BioSpecifics will receive a $2 million milestone payment from Auxilium in connection with this approval.
In addition, BioSpecifics will receive “low double-digit royalties” based on net sales by Auxilium of XIAFLEX for the treatment of the disease, the company said in a release.
Shares of Biospecifics trade on the NASDAQ under the symbol BSTC. Shares are trading 3.4% higher Monday.
For more information, please visit www.biospecifics.com.