The drug is Patiromer for Oral Suspension (Patiromer FOS). It is under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperkalemia. The drug has a Prescription Drug User Fee Act (PDUFA) action date of October 21, 2015. It can be submitted for regulatory approval in Europe in the first half of 2016.
“Hyperkalemia is a serious and potentially fatal medical complication,” said John Orwin, president and chief executive officer of Relypsa in a statement. “We are continuing to work toward our goal of bringing hyperkalemia patients the first new medicine in more than 50 years. 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.”
Patiromer FOS is a powder mixed with water that the patient drinks. It binds with excess potassium in the blood, which is common in patients with chronic kidney disease (CKD) and heart failure.
Relypsa will pay Sanofi (SNY) up to $10 million annually during the launch of Patiromer in the U.S., if it is approved in October. Relypsa’s sales force will focus on nephrologists, cardiologists and hospitals. Sanofi’s sales force, specializing in nephrology, will work with Relypsa in the U.S. for two years. Sanofi will receive a service fee, as well as potential incentive payments.
In the Fresenius deal, Relypsa receives $40 million in cash up front and will be eligible to receive up to $125 million in milestone payments. Relypsa will also receive tiered double-digit royalties on net sales in licensed territories, which are essentially worldwide except for the United States and Japan.
“Patiromer FOS has the potential to become an important new treatment option for hyperkalemia,” said Stefan Schulze, chief executive officer of Vifor Fresenius Medical Care Renal Pharma in a statement. “We are pleased about partnering with Relypsa to bring this exciting medicine to patients in Europe and other markets as soon as possible.”
Currently, Relypsa employs 200 people, but expects to hire as many as 200 more by year end. About 125 will be U.S. sales representatives focusing on hospitals and primary care physicians.
Relypsa recently disclosed its second quarter earnings. It reported a net loss of $39.3 million in the second quarter compared to a net loss of $16.7 million in the same period in 2014. Its six-month financials showed a net operating loss of $68.9 million this year compared to $32.8 million last year. Cash, cash equivalents and short-term investments totaled $299 million at the six-month mark, compared to $135.8 million at December 31, 2014.
“We continue to make excellent progress preparing for the potential launch of Patiromer for Oral Suspension,” said Orwin in a statement. “On the commercial side, we have filled all our key senior sales management positions. We are also progressing well with our manufacturing activities and have completed commercial validation of the active pharmaceutical ingredient, or API. We have a strong cash position and look forward to potentially bringing Patiromer FOS to patients later this year.”
Relypsa stock has been a little volatile the last year. Shares traded on Nov. 12, 2014 for $19.36, rose on Jan. 26, 2015 to $37.33 and again to $41.71 on Mar. 5, 2015. Shares dropped to $28.93 on April 30, 2015, rose again to $36.79 on May 29, 2015 and are currently trading for $28.38.
August 11, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Source: BioSpace Featured News