SANTA CLARA, Calif.--(BUSINESS WIRE)--Relypsa, Inc., a biopharmaceutical company advancing lead product candidate, patiromer (RLY5016) for the treatment of hyperkalemia, in a pivotal Phase 3 clinical study, announced today the appointment of John Orwin as Chief Executive Officer of Relypsa. Mr. Orwin brings over 20 years of diverse experience in the biotechnology and pharmaceutical industries, having held senior positions at leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Affymax, Rhone-Poulenc Rorer and Genentech. Previously, Relypsa has been headed by President and Founder Gerrit Klaerner, Ph.D., who will remain on as a consultant. Mr. Orwin's appointment will be effective no later than June 17th.
"John's background as a senior leader in the life sciences industry will be invaluable as Relypsa approaches completion of the Company's patiromer clinical program, being conducted under an agreed-upon SPA with the FDA," said Scott M. Rocklage, Ph.D., Relypsa's Chairman. "The Company currently is preparing to commercialize patiromer in the U.S., with an expected NDA submission in 1Q 2014, and I anticipate John's background in marketing, sales and general management will prove critical to the success of the potential launch of patiromer." Dr. Rocklage continued, "We are grateful for Gerrit's stewardship of the Company and his enduring commitment to Relypsa's success. No doubt his insights will continue to have a profound impact on the advancement of patiromer."
Mr. Orwin stated, "I am excited to join the Relypsa team, which is advancing a breakthrough product for areas of immense patient need – chronic kidney disease and heart failure. The team's accomplishments at Relypsa are extensive – innovative product design, creation of a strong, protective patent estate, proof-of-concept validation with positive Phase 2 data, and rapid execution of the Phase 3 program, among others. All of these were compelling reasons for me to join the team at Relypsa, and I look forward to continued progress of the clinical program and submission for commercial entry in the U.S. market."
About John Orwin
Mr. Orwin served as chief executive officer and a member of Affymax's board of directors starting in February 2011. From April 2010 to January 2011, he served as president and chief operating officer of Affymax. From 2005 to 2010, Mr. Orwin served as vice president and then senior vice president, BioOncology Business Unit, at Genentech, where he was responsible for all marketing, sales, business unit operations and pipeline brand management for Genentech's oncology portfolio in the United States. From 2001 to 2005, Mr. Orwin served in various executive-level positions at Johnson & Johnson, overseeing oncology therapeutic commercial and portfolio expansion efforts in the US. He has also held senior marketing and sales positions at Alza Pharmaceuticals, Sangstat Medical Corporation, Rhone-Poulenc Rorer Pharmaceuticals and Schering-Plough Corporation. Mr. Orwin holds an M.B.A. from New York University and a B.A. from Rutgers University.
About Patiromer and Hyperkalemia
Hyperkalemia is a condition frequently prevalent in patients that suffer from renal impairment, hypertension, diabetes and/or heart failure. It is characterized by elevated serum potassium levels, which can lead to cardiac arrhythmia and sudden death. Patients with chronic kidney disease are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors. Although RAAS inhibition has been shown to protect kidney and cardiac function, as well as prolong life, many patients who could benefit from RAAS inhibitors are untreated or undertreated due to the undesirable side effect of increasing serum potassium.
Patiromer (RLY5016) is a high capacity non-absorbed oral potassium binder being developed for the management of elevated serum potassium levels. Relypsa has completed several clinical trials of patiromer that have demonstrated the preliminary efficacy, safety and tolerability of patiromer for the treatment of hyperkalemia.
About Relypsa, Inc.
Relypsa, Inc. is a late clinical-stage biopharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a non-absorbed potassium binder for the treatment of hyperkalemia. Relypsa is pursuing the discovery of additional product candidates through use of its proprietary polymer platform. More information is available at www.relypsa.com.
Kristine Ball, SVP, Chief Financial Officer