XOMA Corporation Seeks to Sublicense Drug

XOMA Corporation recently announced the 837-patient Phase III 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 6 weeks of treatment. This FDC, containing a patent-protected proprietary form of perindopril, was licensed by XOMA as part of a US commercial and development rights agreement signed with Servier for its perindopril franchise. Servier markets the fixed-dose combination product, COVERAM, in 91 countries outside the US.

“The perindopril/amlodipine FDC is an important asset in Servier’s cardiovascular franchise. We believe that based upon our previous conversations with the FDA, the positive PATH results combined with the body of existing clinical data for this FDC will support an NDA submission,” said 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 US 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 FDC 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 US. Because ACE inhibitors and CCBs target different cardiovascular functions, physicians often use them in combination to treat their hypertensive patients.

In January 2012, XOMA acquired US rights to the perindopril franchise from Les Laboratoires Servier, XOMA’s partner for its lead antibody product candidate, gevokizumab (formerly XOMA 052). The agreement includes the angiotensin-converting enzyme (ACE) inhibitor perindopril, currently marketed under the trade name of ACEON, and a portfolio of three fixed-dose combination product candidates in which perindopril is combined with other active ingredient(s). The proprietary form of perindopril in each of the combination product candidates provides patent protection until 2023. The first product candidate XOMA elected to develop is a fixed-dose combination of perindopril arginine and amlodipine besylate.

ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. In clinical studies, the most common adverse events (incidence greater than or equal to 5%) were cough, dizziness, and back pain.

ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. ACEON can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive, or lipid-lowering therapy. In clinical studies, the most common adverse events leading to discontinuation were cough, drug intolerance, and hypotension. Perindopril erbumine has been available as a generic product in the U.S. since November 2009.

XOMA combines a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research, with its recently launched commercial operations. XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases. For more information, visit www.xoma.com.