Relypsa Enters Two-Year Detailing Agreement With Sanofi in the United States
REDWOOD CITY, Calif., Aug. 10, 2015 (GLOBE NEWSWIRE) — 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.”
Conference Call Today at 5:00 PM ET (2:00 PM PT)
The Relypsa management team will host a teleconference and webcast to discuss the partnership. The live call may be accessed by phone by calling (866) 410-4428 (domestic) or (704) 908-0287 (international), conference code 8382449. The webcast may be accessed live on the investor relations section of the Relypsa website at investor.relypsa.com and will be archived for 30 days following the call.
About Patiromer for Oral Suspension
Patiromer FOS is an oral potassium binder in development for the treatment of hyperkalemia. This investigational medicine has been studied in both treatment and prevention studies, primarily in patients with chronic kidney disease (CKD), also heart failure, patients with both, and those with diabetes and hypertension. The clinical program includes a two-part pivotal Phase 3 program conducted under Special Protocol Assessment with FDA, a 12-month Phase 2 trial and a 48-hour Phase 1 onset-of-action trial.
Hyperkalemia, or abnormally elevated levels of potassium in the blood, is a condition which can lead to life-threatening cardiac arrhythmia and sudden death. It is frequently prevalent in patients who suffer from CKD, hypertension, diabetes and/or heart failure. Patients with CKD or heart failure are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors, which can increase blood potassium levels in patients taking these medicines.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. The company’s two-part pivotal Phase 3 trial of its lead product candidate, Patiromer for Oral Suspension, has been completed and the primary and secondary endpoints were met. A New Drug Application for Patiromer for Oral Suspension for the treatment of hyperkalemia was accepted by the U.S. Food and Drug Administration and is currently under review. Relypsa has global royalty-free commercialization rights to Patiromer for Oral Suspension, which has intellectual property protection in the United States until at least 2030. More information is available at www.relypsa.com.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).
Forward-Looking Statements Related to Relypsa, Inc.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Relypsa, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential for, and timing of, approval and commercialization of Patiromer for Oral Suspension, or Patiromer FOS, the expected impact of the agreement with Sanofi, the therapeutic and commercial potential of Patiromer FOS, Relypsa’s commercial launch plans and the potential Prescription Drug User Fee Act action date. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Relypsa’s regulatory filings, Relypsa’s substantial dependence on Patiromer FOS, Relypsa’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of Patiromer FOS. Relypsa undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Relypsa in general, see Relypsa’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014, and its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015.
Vice President, Corporate Communications