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Relypsa Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced it has entered a two-year detailing agreement with Sanofi for Patiromer for Oral Suspension (Patiromer FOS). Patiromer FOS is Relypsa’s investigational medicine that is currently under review for the treatment of hyperkalemia with the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date of October 21, 2015.
Relypsa intends to commercialize Patiromer FOS, if approved, with its own dedicated U.S.-based commercial team and specialty sales force of approximately 120 sales representatives. Relypsa’s sales force will focus primarily on outreach to nephrologists, cardiologists and hospitals. Under the terms of the agreement, Sanofi’s nephrology sales force will complement Relypsa’s efforts by detailing Patiromer FOS in the United States for a two-year period. During the term of the agreement, Sanofi will be paid a service fee and is also eligible to receive incentive payments. The term may be extended by mutual agreement of both parties.
Relypsa will continue to be responsible for all regulatory, development, commercial, manufacturing and distribution activities for Patiromer FOS in the United States, including recording sales.
“Hyperkalemia is a serious and potentially fatal medical complication. We are continuing to work toward our goal of bringing hyperkalemia patients the first new medicine in more than 50 years,” said John A. Orwin, president and chief executive officer of Relypsa. “We believe this agreement will support a strong start for Patiromer FOS in the United States, if approved. Sanofi’s experienced nephrology sales force can be mobilized immediately upon potential approval and, combined with our own representatives, will enable more frequent and comprehensive outreach to nephrologists and cardiologists.”
“Sanofi is committed to helping people living with renal disease and is proud to partner with Relypsa, a company that shares our commitment,” said Nik Grund, senior vice president of the Specialty Care Division, Sanofi. “For nearly two decades, Sanofi has served the nephrology community with our portfolio of renal products and services. This agreement has the potential to help us build upon that legacy by bringing a new and innovative therapy to patients with hyperkalemia.”
