×

Vifor Fresenius Medical Care Renal Pharma and Relypsa Announce Submission of Marketing Authorization Application Requesting European Approval of Veltassa® for the Treatment of Hyperkalemia

ST. GALLEN, Switzerland and REDWOOD CITY, Calif., April 25, 2016 (GLOBE NEWSWIRE) -- Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP), a common company of Galenica and Fresenius Medical Care, and Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that VFMCRP has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Veltassa® (patiromer) for oral suspension. VFMCRP is seeking approval of Veltassa for the treatment of hyperkalemia, or elevated blood potassium levels, in the European Union (EU) through the EU centralized procedure.

Veltassa was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first new medicine in more than 50 years for people with elevated serum potassium.

“The MAA submission for Veltassa represents an important milestone in our efforts to bring hyperkalemia patients in Europe a new treatment option as soon as possible,” said Stefan Schulze, chief executive officer of VFMCRP. “Relypsa has been an excellent partner supporting the preparation of this robust submission, which is based on positive efficacy and safety results from an extensive clinical development program that included many patients from Europe.”

“As a recognized global leader in nephrology, VFMCRP shares our commitment to bringing Veltassa to hyperkalemia patients around the world,” said John A. Orwin, president and chief executive officer of Relypsa. “This MAA submission brings us another step closer to achieving that goal for people with hyperkalemia in Europe.”

The European submission for Veltassa is supported by data from a comprehensive clinical development program that included:

  • The pivotal Phase 3 OPAL-HK study, which was conducted under a FDA Special Protocol Assessment and evaluated Veltassa in hyperkalemic patients with chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors;
  • The Phase 2 AMETHYST-DN trial, which evaluated the use of Veltassa over 52 weeks in hyperkalemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors;
  • An open-label, uncontrolled, Phase 1 study that evaluated the onset-of-action of Veltassa in hyperkalemic CKD patients.

The European submission will undergo a formal acceptance and validation phase by the EMA during May 2016. After this period, an official regulatory review will be undertaken.

About the VFMCRP and Relypsa Partnership
In August 2015, VFMCRP and Relypsa announced that the companies had entered into an exclusive collaboration and license agreement for the development and commercialization of Veltassa outside the United States. Under the terms of the agreement, VFMCRP obtained an exclusive marketing right for Veltassa from Relypsa in worldwide territories except the United States and Japan, where Relypsa retains all commercial rights. Relypsa and VFMCRP are currently collaborating on ongoing development of Veltassa.

About Hyperkalemia
Approximately 3 million people in the United States with stage 3 or 4 CKD and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include RAAS inhibitors such as ARBs (angiotensin receptor blockers), AAs (aldosterone antagonists) and ACE (angiotensin-converting-enzyme) inhibitors.

About Veltassa
Veltassa is a potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (90 milliliters or 3 ounces) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

IMPORTANT SAFETY INFORMATION
The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.

Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.

Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.

Adverse Reactions
The most common adverse reactions (incidence ≥2 percent) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.

For additional Important Safety Information and Veltassa's full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.

About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.

About Vifor Fresenius Medical Care Renal Pharma Ltd.
Vifor Fresenius Medical Care Renal Pharma Ltd., a common company of Galenica and Fresenius Medical Care, develops and commercialises innovative and high quality therapies to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55 percent by Galenica and 45 percent by Fresenius Medical Care.

Forward-Looking Statements Related to Relypsa, Inc.
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 EMA approval of Veltassa, the commercial plans for Veltassa in Europe, the commitment to bringing Veltassa to hyperkalemia patients around the world, the expected EMA formal acceptance and validation phase, and the timing thereof, and the expected official regulatory review. 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 and commercialization process, including regulatory requirements, Relypsa's substantial dependence on Veltassa, Relypsa's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Veltassa. 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, 2015.



VFMCRP Contact:
Relypsa Contact:
Beatrix Benz Charlotte Arnold
Head of Global Communications & Public Affairs Vice President, Corporate Communications
+41 58 851 80 16 650.421.9352
communications@viforpharma.com ir@relypsa.com


Source:Relypsa, Inc.