Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like granting of new designations to investigational candidates, filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.
Positive news flowed in for BioSpecifics Technologies Corp. (BSTC) when Swedish Orphan Biovitrum AB (Sobi) received approval from the European Commission to market Xiapex (trade name:Xiaflex in the U.S.) for an additional indication.
Xiaflex is approved for the treatment of adult men suffering from Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
We note that Xiapex is already approved in the EU for the treatment of Dupuytren's contracture in adult patients with a palpable cord. Its approval for Peyronie's disease in Europe will further boost sales.
Xiaflex was approved in the U.S. for Peyronie's disease in Dec 2013 and marketed by erstwhile Auxilium Pharmaceuticals, which was later acquired by Endo International plc (ENDP) in Jan 2015.
The company is looking to get the drug approved in Japan for Dupuytren's contracture.
Meanwhile, Sobi has exclusive rights to commercialize Xiapex for Dupuytren's contracture and Peyronie's disease indications in 28 EU member countries.
As per the terms of the agreement between BioSpecifics’ and erstwhile Auxilium, the former is entitled to receive a certain percentage of milestone payments that Sobi pays to the latter, along with royalties from net sales of Xiaflex for Dupuytren's contracture and Peyronie's disease.
Xiaflex is also being evaluated for frozen shoulder syndrome (in a phase IIB study), cellulite and canine lipoma, human lipoma and uterine fibroids. We expect investor focus on updates on further label expansion of the drug.
Investors interested in the healthcare sector may consider stocks such as Biodel Inc. (BIOD) and Sucampo Pharmaceuticals (SCMP). Both carry a Zacks Rank #1 (Strong Buy).
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