REDWOOD CITY, Calif., May 20, 2014 (GLOBE NEWSWIRE) -- Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that it has entered into a multi-year commercial manufacturing and supply agreement with DSM Fine Chemicals Austria NFG GMBH & Co. KG for the active pharmaceutical ingredient ("API") for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. DSM Fine Chemicals is a business unit of the newly formed DPx Holding B.V. which also owns Patheon Pharma Services and Banner Life Sciences.
"We are very pleased to add DSM Fine Chemicals, a well-established contract manufacturer with significant experience in efficiently manufacturing polymers for therapeutic use, as a supplier of API for patiromer," said Wilhelm Stahl, Ph.D., senior vice president pharmaceutical operations at Relypsa. "Engaging another supplier is an important milestone towards preparing to cover our projected commercial demand and improving our security of supplies."
In addition to DSM Fine Chemicals, the company also has an agreement with Lanxess Corporation, also a well-respected contract manufacturer, for the supply of API. Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during the company's clinical development program. Relypsa expects Lanxess will be the initial sole manufacturer named in its planned New Drug Application, or NDA. The company plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional manufacturer upon potential U.S. approval of patiromer.
About Hyperkalemia and Patiromer
Hyperkalemia, a life-threatening condition defined as abnormally elevated levels of potassium in the blood, is frequently prevalent in patients who suffer from chronic kidney disease, or CKD, hypertension, diabetes and/or heart failure. Hyperkalemia can lead to 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.
Patiromer (RLY5016 for Oral Suspension) is a high capacity non-absorbed, non-metal 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 trial, a 12-month Phase 2 trial and a 48-hour short-term Phase 1 onset-of-action trial. In all of those trials, patiromer met its efficacy endpoints and the treatment was well tolerated. The pivotal clinical trial for patiromer is complete and was conducted under a Special Protocol Assessment with the 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 the treatment of hyperkalemia, a life-threatening condition defined as abnormally elevated levels of potassium in the blood, has been completed and the primary and secondary endpoints were met. Relypsa has global royalty-free commercialization rights to patiromer, which has intellectual property protection in the U.S. until at least 2030. More information is available at www.relypsa.com.
About DPx Holding B.V.
DPx Holdings B.V. is the privately held parent company of the Patheon, Banner Life Sciences, and DSM Fine Chemicals businesses. The company is a leading provider of CDMO services, pharmaceutical products and products for other industries. Founded in 2014 as a result of a deal between JLL Partners and Royal DSM, DPx Holdings has three core business units, comprised of Patheon Pharma Services, DSM Fine Chemicals and Banner Life Sciences. With global headquarters in Durham, N.C., DPx Holdings has a footprint of more than 20 locations across North America, Europe, Latin America and Australia with more than 8,000 employees. DPx Holdings offers customers unsurpassed quality, integrated offerings and value through these three core business units. For more information visit www.patheon.com/DPx.
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 impact of engaging another supplier to prepare to meet projected demand for its lead product candidate, patiromer, and its plans to submit a NDA and NDA supplement. Such forward-looking statements involve substantial risks and uncertainties that relate to future events and the actual results could 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 the company's regulatory filings, the company's substantial dependence on patiromer, the company's commercialization plans and efforts and other matters that could affect the availability or commercial potential of patiromer. 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 the company in general, see Relypsa's current and future reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2014.