×

Relypsa Announces Commercial Manufacturing Agreement With Patheon, Inc.

REDWOOD CITY, Calif., Sept. 9, 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 Patheon, Inc. for finished product manufacture of patiromer, Relypsa's novel polymer in development for the treatment of hyperkalemia. Patheon, the pharmaceutical services business unit of DPx Holdings B.V., is a global provider of development and commercial manufacturing services for prescription drugs.

"With this Patheon agreement completed as well as our contracts with Lanxess Corporation and DSM Fine Chemicals, we have now solidified the commercial manufacturing commitments for patiromer active pharmaceutical ingredient and finished product that we believe can support our projected launch and commercialization of patiromer," said Wilhelm Stahl, Ph.D., senior vice president Pharmaceutical Operations at Relypsa. "Having multiple, well-respected and proven global pharmaceutical suppliers gives us confidence in meeting potential demand and providing a high quality product to patients."

In addition to Patheon for finished product, Relypsa also has agreements with Lanxess Corporation and DSM Fine Chemicals (supplier of DPx Holdings' API business) for the supply of active pharmaceutical ingredient, or API. Lanxess, DSM Fine Chemicals and Patheon manufactured drug supplies that were used during Relypsa's clinical development program. Patheon and Lanxess are planned to be the initial manufacturers named in Relypsa's planned New Drug Application, or NDA. Currently, Relypsa plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional API manufacturer upon potential U.S. approval of patiromer.

About Hyperkalemia and Patiromer

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.

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 study, a 12-month Phase 2 trial and a 48-hour short-term Phase 1 onset-of-action study. In all of those studies, patiromer met its efficacy endpoints and the treatment was well tolerated. The pivotal clinical study 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 Holdings B.V.

DPx Holdings B.V. is the privately held parent company of the Patheon, DSM Fine Chemicals and Banner Life Sciences businesses. The company is a leading provider of CDMO services, pharmaceutical products and products for other industries. DPx Holdings B.V. was founded in 2014 as a result of a deal between JLL Partners and Royal DSM. With a global headquarters in Durham, N.C., DPx Holdings B.V. has a footprint of more than 20 locations across North America, Europe, Latin America and Australia with more than 8,000 employees. DPx Holdings B.V. offers customers unsurpassed quality, integrated offerings and value through these three business units. For more information visit www.patheon.com/DPx.

About Patheon

Patheon is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms. Patheon, a DPx Holdings B.V. business unit, encompasses the combined CMO capabilities and pharmaceutical product development services (PDS), as well as the Biosolutions and Biologics (BIO) business. For more information visit www.patheon.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 impact of our supply contracts on our projected launch and commercialization of patiromer and our ability to meet demand and provide a high quality product to patients, our plan to submit an NDA and name certain suppliers in our NDA, our plan to submit an NDA supplement and potential U.S. approval of patiromer. 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 our regulatory filings, our substantial dependence on patiromer, our 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 June 30, 2014.

CONTACT: Sylvia Wheeler V.P. Investor Relations and Corporate Affairs 650-421-9504 IR@relypsa.com

Source:Relypsa, Inc.