Xoma says it hit its primary endpoint in a late-stage test of a blood pressure combo including Servier's perindopril, setting the stage for an NDA as the biotech goes hunting for a partner to market the therapy in the U.S.
Investigators say that a fixed dose combo of perindopril arginine combined with amlodipine besylate batted down sitting systolic and diastolic blood pressure after 6 weeks of treatment, proving superior to either of the active ingredients alone. And the side effect profile included no big surprises, which should be no shocker as Servier already markets the drug as Coveram in 91 markets around the world. Xoma shares ($XOMA) surged 6% on the news.
"The perindopril/amlodipine FDC is an important asset in Servier's cardiovascular franchise. We believe that based upon our previous conversations with FDA, the positive PATH results combined with the body of existing clinical data for this FDC will support an NDA submission," said Xoma CEO John Varian in a statement. "We are extremely proud of our team for completing this trial ahead of schedule and now will be working to identify appropriate potential ways to move this FDC forward to the U.S. market. XOMA does not intend to directly market this FDC, but rather intends to sublicense this product to a third-party organization that is dedicated to commercializing products for the cardiovascular marketplace."
Perindopril--an angiotensin converting enzyme inhibitor commonly called an ACE inhibitor--has now been studied in seven clinical trials involving more than 54,000 patients. Xoma nabbed the U.S. rights back in January, essentially looking to flip it to another company once it was nearing the market.
"The next thing we expect is for the company to get a partnership for this drug. The terms could include an upfront payment and possible royalties on product sales," RBC Capital Markets analyst Adnan Butt told Reuters. Butt added that the next big catalyst for Xoma will be late-stage data on the anti-inflammatory drug gevokizumab for non-infectious uveitis.
- here's the press release
- read the story from Reuters