Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP), a common company of Galenica and Fresenius Medical Care, and Relypsa, Inc., a biopharmaceutical company, have entered into an exclusive partnership to commercialise Patiromer for Oral Suspension (Patiromer FOS), Relypsa’s investigational medicine for the treatment of hyperkalemia.
Under the terms of the agreement, Relypsa will receive an upfront cash payment of $40 million and will be eligible to receive payments of up to $125 million upon achieving certain regulatory and sales based milestones. In addition, Relypsa will receive tiered double-digit royalties on net sales of Patiromer FOS in the licensed territories. VFMCRP will obtain an exclusive marketing right from Relypsa in worldwide territories except the United States and Japan, where Relypsa retains all commercial rights. VFMCRP and Relypsa will collaborate on ongoing development of Patiromer FOS, including submission of a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA).
Patiromer FOS is an oral potassium binder being developed for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood. Hyperkalemia occurs most frequently in patients with chronic kidney disease (CKD) and 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. A New Drug Application (NDA) for Patiromer FOS for the treatment of hyperkalemia is under review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of October 21, 2015. A MAA for Patiromer FOS is expected to be submitted with the EMA in the first half of 2016.
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“We are excited to partner with Vifor Fresenius Medical Care Renal Pharma, which has a well-established commercial organisation with a proven track record in cardiorenal diseases. If approved, Patiromer FOS will be promoted by the largest dedicated renal and heart failure sales forces in Europe,” said John A. Orwin, president and chief executive officer of Relypsa.
“We are confident they will be an excellent partner to commercialise and develop Patiromer FOS outside the United States and look forward to working with them to bring this medicine to patients around the world.”
“Patiromer FOS has the potential to become an important new treatment option for hyperkalemia. We are pleased about partnering with Relypsa to bring this exciting medicine to patients in Europe and other markets as soon as possible,” said Stefan Schulze, chief executive officer, Vifor Fresenius Medical Care Renal Pharma.
“The agreement with Relypsa is a recognition of Vifor Fresenius Medical Care Renal Pharma’s growing leadership in nephrology as we continue to expand our renal pharma product portfolio and commercial organisation.”