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XOMA Corporation
, 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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