XOMA Transfers Perindopril Franchise Rights to Symplmed
XOMA Corporation (NASDAQ: XOMA), a leader in the discovery and development of therapeuticantibodies, announced today it has transferred U.S. development and commercialization rights to the perindopril franchise to Symplmed Pharmaceuticals, LLC ("Symplmed"). Under the terms of the agreement, XOMA will receive an equity position in Symplmed and up to double-digit royalties on sales of the fixed-dose combination ("FDC") containing perindopril arginine and amlodipine besylate, if it is approved by the U.S. Food and Drug Administration ("FDA"). Symplmed will, under a sublicense agreement, immediately assume U.S. marketing responsibilities for ACEON(R) (perindopril erbumine), and XOMA will continue to manage and be reimbursed for sales and distribution within its established commercial infrastructure.
Symplmed was founded by former XOMA employees, Erik Emerson and Jeffrey Feldstein, MD, who serve as Chief Executive Officer and Chief Medical Officer, respectively, and Dr. August J. Troendle. Both Mr. Emerson and Dr. Feldstein have significant experience developing and marketing FDA-approved cardiovascular therapeutics and have been directly involved with the ACEON commercialization activities. In addition, Mr. Emerson and Dr. Feldstein managed the 837-patient Phase 3 PATH trial (Perindopril Amlodipine for the Treatment of Hypertension), which demonstrated that the 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. Servier markets the FDC product, COVERAM(R) , in 91 countries outside the U.S. Symplmed intends to complete the New Drug Application for the FDC and submit it to the FDA for review by year-end 2013. Symplmed will be responsible for all future FDC development costs, and XOMA will have no further financial obligations related to the FDC product or Symplmed's operations.
"Our partner, Servier, and we recognize the importance of this valuable franchise. Erik and Jeff have demonstrated strong dedication to the perindopril franchise and are leaving XOMA to launch Symplmed and move the franchise forward in a focused manner. This structure provides XOMA the opportunity to share in their success, while retaining our focus on developing innovative therapeutic options for the specialist prescriber under the leadership of Tom Klein, our newly appointed Chief Commercial Officer," commented John Varian, Chief Executive Officer of XOMA. "The experience the XOMA team gained by establishing a commercial infrastructure backbone will serve the company well as we move closer to commercializing novel therapeutics discovered by XOMA's scientists."
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