Xoma said today it transferred U.S. development and commercialization rights for its perindopril franchise to Symplmed Pharmaceuticals, in return for an equity stake in Symplmed of undisclosed percentage, and up to double-digit royalties on sales of a drug containing perindopril arginine and amlodipine besylate, subject to the fixed-dose combination (FDC) being approved by FDA.
The FDC is marketed in 91 countries outside the U.S. by Servier, under the name Coveram® Symplmed said it intends to complete a New Drug Application for the FDC and submit it to the FDA by year’s end. At that point, Symplmed would pay all future FDC development costs, while Xoma would have no further financial obligations related to the FDC product or Symplmed operations.
Three former Xoma employees co-founded Symplmed: Erik Emerson, who is now its president and CEO; Jeffrey Feldstein, M.D., now its senior vp and CMO; and August J. Troendle, M.D., a director of the company and the founder and CEO of the contract research organization Medpace.
Emerson and Dr. Feldstein oversaw the 837-patient Phase III Perindopril Amlodipine for the Treatment of Hypertension (PATH) trial, which demonstrated that the FDC of perindopril arginine combined with amlodipine besylate showed statistically significant improvement in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment compared with either compound alone.
Also under its sublicense agreement with Xoma, Symplmed will immediately take over U.S. marketing responsibility for blood-pressure reducing treatment ACEON® (perindopril erbumine), while XOMA will continue to manage and be reimbursed for sales and distribution.