REDWOOD CITY, Calif., May 26, 2015 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced the appointment of Charlotte Arnold to the position of Vice President, Corporate Communications. Ms. Arnold joins Relypsa with more than 15 years of experience in corporate and product communications.
"With our continued focus on the potential launch of our lead compound, Patiromer for Oral Suspension (Patiromer FOS) later this year, we are very pleased Charlotte will lead our communications efforts," said John A. Orwin, President and Chief Executive Officer of Relypsa. "Charlotte has extensive commercial-stage communications experience and she will bring additional strength and leadership to our management team as we work towards bringing Patiromer FOS to patients with hyperkalemia."
Ms. Arnold joins Relypsa from Genentech, where she worked since 2006. Most recently, she led the corporate and cross-portfolio communications team, covering a wide breadth responsibilities including policy issues, managed care, distribution and access, as well as supporting corporate branding. In addition, she led the team supporting Genentech's industry-leading portfolio of cancer medicines and co-chaired the Genentech Women Professionals group. Prior to Genentech, Ms. Arnold worked at public relations firms, including Chandler Chicco Agency, where she managed public relations activities for several medicines and implemented disease awareness and public education campaigns for various pharmaceutical companies. Ms. Arnold holds a Bachelor of Science in Physiology from the University of Bristol in the United Kingdom.
About Hyperkalemia
Hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood, is frequently prevalent in patients who suffer from chronic kidney disease, hypertension, diabetes and/or heart failure. Hyperkalemia can lead to life-threatening cardiac arrhythmia and sudden death. Patients with chronic kidney disease or heart failure are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors such as ARBs (Angiotensin Receptor Blockers), AAs (Aldosterone Antagonists), and ACE (Angiotensin-Converting-Enzyme) inhibitors. Although RAAS inhibition has been shown to protect kidney and cardiac function, many patients who could benefit from RAAS inhibitors are untreated or undertreated due to the undesirable side effect of increasing serum potassium.
About Patiromer FOS
Patiromer FOS is an oral potassium binder being developed for the treatment of hyperkalemia. The compound has been evaluated in CKD patients with hyperkalemia, including a two-part Phase 3 program, a 12-month Phase 2 trial and a 48-hour Phase 1 onset-of-action trial. In all of those trials, Patiromer FOS met its efficacy endpoints and the treatment was well tolerated. The pivotal clinical trial for Patiromer FOS was conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA).
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, for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood, has been completed and the primary and secondary endpoints were met. A New Drug Application (NDA) for Patiromer for Oral Suspension for the treatment of hyperkalemia was accepted by the FDA and is currently under review. The FDA assigned a Prescription Drug User Fee Act action date of October 21, 2015 for completion of the review of the NDA. 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.
Forward Looking Statements
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 approval and launch of Patiromer for Oral Suspension, or Patiromer FOS, the experience and expected impact of the Vice President, Corporate Communications 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 March 31, 2015.