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XOMA Announces Perindopril and Amlodipine Fixed-Dose Combination Meets Primary Endpoint in Phase 3 PATH Trial20/11/2012
Berkeley, CA – Nov. 20, 2012 (GLOBE NEWSWIRE) – XOMA Corporation (Nasdaq: XOMA) today announced the 837-patient Phase 3 PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) has demonstrated the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. This FDC containing a patent-protected proprietary form of Perindopril was licensed by XOMA as part of a U.S. commercial and development rights agreement signed with Servier for their perindopril franchise. Servier markets the fixed-dose combination product, COVERAM®, in 91 countries outside the U.S.
“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,” stated John Varian, Chief Executive Officer of XOMA. “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.”
The drugs appeared to be well tolerated in the trial and there were no unexpected serious adverse events reported. The most common adverse events included mild to moderate edema, cough and headache, which are known side effects of the individual components of the FDC. .
Perindopril, an angiotensin converting enzyme inhibitor (commonly called an ACE inhibitor), has been studied in seven landmark clinical trials involving more than 54,000 patients. This body of clinical evidence supports its beneficial impact in treating essential hypertension and stable coronary artery disease. Amlodipine, a calcium channel blocker (commonly called a CCB), is the most-prescribed antihypertensive in the U.S. Because ACE inhibitors and CCBs target different cardiovascular functions, physicians often use them in combination to treat their hypertensive patients.