Biospecifics (BSTC) Receives Positive CHMP Opinion for XIAPEX; Aegis Capital Comments

Aegis Capital offered commentary on Biospecifics Technologies (NASDAQ: BSTC) following news 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.

Analyst Yi Chen commented, BioSpecifics Technologies announced yesterday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion on 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, supported by positive safety and efficacy outcome data from two double-blind placebo-controlled studies. Xiapex (collagenase clostridium histolyticum, or CCH), marketed as Xiaflex in the U.S., is an injectable collagenase approved in the EU for the treatment of Dupuytren's contracture in adult patients with a palpable cord. We note that the U.S. FDA approved Xiaflex for the treatment of Peyronie's disease in December 2013. The positive opinion of CHMP bodes well for potential EMA approval for this indication in 1Q 2015, in our view.

BioSpecifics had $17.5mm in cash and investments as of September 30, 2014. As the value of the CCH franchise continues to grow through indication and geographic expansion, the likelihood of Endo International plc (Nasdaq: ENDP)(Not Rated) acquiring BioSpecifics should increase, in our view. On October 9, 2014, Auxilium (Nasdaq: AUXL) entered into a definitive agreement under which Endo will acquire all of the outstanding shares of Auxilium at $33.25 per share. This transaction is expected to close in 1H 2015.

Aegis Capital has Biospecifics at Buy with a price target of $55.

For an analyst ratings summary and ratings history on BioSpecifics Technologies click here. For more ratings news on BioSpecifics Technologies click here.

BioSpecifics Technologies closed at $39.57 yesterday.

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