Auxilium's Xiapex Gets CHMP Nod for Peyronie's Disease - Analyst Blog

Auxilium Pharmaceuticals Inc. (AUXL) and partner Swedish Orphan Biovitrum AB (Sobi) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the approval of Xiapex. The companies are looking to get Xiapex approved in the EU for the treatment of adult men suffering from Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Xiapex is currently approved in the EU for the treatment of Dupuytren's contracture (DC) in adults with a palpable cord. Auxilium has a long-term collaboration with Sobi for the development, supply and commercialization of Xiapex for the treatment of DC and PD in 28 EU member countries including Norway and Iceland.

With the CHMP in favor of approving Xiapex, we believe chances of approval are high. A decision from the European Commission should be out in the coming months.

We note that Xiapex is marketed in the U.S. under the trade name, Xiaflex. Xiaflex is already approved in the U.S. for the PD indication and for the treatment of up to two DC joints in the same hand during a single treatment visit.

Xiaflex generated sales of $77.5 million in the U.S. in the first nine months of 2014 compared with $42.8 million in the first nine months of 2013. Approval for additional indications should boost sales over the long term.

Meanwhile, Auxilium Pharma is all set to be acquired by Endo International (ENDP) for $2.6 billion ($33.25 per share) in cash as well as stock. The transaction is expected to close by the first half of 2015 (read more: Endo to Buy Auxilium for $2.6B, Diversify Portfolio).

Auxilium Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Biodel Inc. (BIOD) and Cubist Pharmaceuticals Inc. (CBST). Both stocks carry a Zacks Rank #1 (Strong Buy).