Company news: Auxilium and GSK; J&J's Janssen
Auxilium Pharmaceuticals and GSK will co-promote Testim 1% testosterone gel in the US. “While the Auxilium sales force has consistently performed well in an increasingly competitive environment, adding the strength and breadth of GSK's US commercial organization will further enhance our sales efforts with US physicians who treat [hypergonadism],” said Auxilium CEO and president Adrian Adams. The agreement grants GSK exclusive rights to co-promote the drug with Auxilium through September 2015. GSK will leverage its relationships with current testosterone replacement therapy prescribers, the companies said, particularly primary care docs. GSK's urology portfolio includes Avodart and Duodart for treatment of benign prostratic hyperplasia (BPH).
J&J's blood thinner Xarelto (Rivaroxaban) is up for review by an FDA advisory panel Wednesday. The drugmaker's Janssen unit is looking to expand the drug's indication for use among patients with acute coronary artery disease. It is approved to prevent deep vein thrombosis and to reduce stroke risk for patients with nonvalvular atrial fibrillation. Preview documents show that board is divided and skeptical about the patient pool, reported Reuters. Among the concerns: that J&J excluded three patients from the headcount even though they'd died during the study, and that it puts patients at an elevated risk for bleeding. Reuters notes that the panel's clinical reviewer stood up for the data and said J&J saw data was missing and tried to fix things.