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Relypsa (RLYP) Announces Data On The Treatment And Impact Of Hyperkalemia To Be Presented At ASN Kidney Week 2016



11/4/2016 8:51:10 AM

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REDWOOD CITY, Calif., November 3, 2016 – Relypsa, Inc., a Vifor Pharma Company, today announced five posters, including new analyses from studies of Veltassa® (patiromer) for oral suspension and new data on the impact of hyperkalemia, will be presented at the American Society of Nephrology's (ASN) Kidney Week 2016, taking place November 15-20, 2016 in Chicago, Illinois.

The Veltassa data being presented include:

• A new post-hoc analysis from the pivotal Phase 3 OPAL-HK study that examined the effects of Veltassa on potassium, aldosterone, plasma renin activity and blood pressure levels in patients with hyperkalemia (elevated blood potassium levels) and chronic kidney disease (CKD) who were stratified based on levels of aldosterone and plasma renin activity at baseline. All patients were taking renin angiotensin aldosterone system (RAAS) inhibitors.

• Results from a pooled post-hoc analysis of Phase 2 and 3 Veltassa trials evaluating whether there was evidence of adverse pharmacodynamic interactions after initiation of Veltassa in patients receiving blood pressure (antihypertensive) medicines.

Three additional posters highlight the impact of hyperkalemia:

• A meta-analysis of approximately 419,000 people evaluating the relationship between blood potassium levels, death rates and end-stage renal disease.

• An analysis evaluating the association between blood potassium levels, hospitalization, death and emergency room visits in hemodialysis patients and how these outcomes were impacted by the day of the week.

• An analysis showing the cost of healthcare rises exponentially as CKD progresses to later stages.

The ASN 2016 abstracts are available at www.asn-online.org. Details for the poster presentations during ASN Kidney Week 2016 are listed below.

Veltassa Posters

Abstract Title: Aldosterone, renin and blood pressure during patiromer treatment of hyperkalemia in CKD

Presenter: Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine

Session: Fluid, Electrolyte, Acid-Base Disorders

Number: TH-PO479

Date and Time: Thursday, November 17, 10:00 a.m. – 12:00 p.m. CST

Abstract Title: Evaluation of potential pharmacodynamic interactions with antihypertensive drugs given concomitantly with patiromer: Pooled analysis of Phase 2/3 clinical trials

Presenter: Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine

Session: Fluid, Electrolyte, Acid-Base Disorders

Number: TH-PO480

Date and Time: Thursday, November 17, 10:00 a.m. – 12:00 p.m. CST

Hyperkalemia & Chronic Kidney Disease Posters

Abstract Title: Serum potassium and the risk of adverse outcomes: A CKD Prognosis Consortium meta-analysis

Presenter: Csaba P. Kovesdy, M.D., Fred Hatch Professor of Medicine, director, Clinical Outcomes and Clinical Trials Program, Division of Nephrology, University of Tennessee Health Science Center

Session: Fluid, Electrolyte, Acid-Base Disorders

Number: TH-PO475

Date and Time: Thursday, November 17, 10:00 a.m. – 12:00 p.m. CST

Abstract Title: Serum potassium and clinical outcomes among hemodialysis patients: Impact of the long interdialytic interval

Presenter: Steven Brunelli, M.D., vice president and medical director, Health Economics and Outcomes Research, DaVita Clinical Research

Session: Dialysis: Noncardiovascular Outcomes–II

Number: FR-PO974

Date and Time: Friday, November 18, 10:00 a.m. – 12:00 p.m. CST

Abstract Title: Healthcare cost rises exponentially by stage of chronic kidney disease

Presenter: Ladan Golestaneh, M.D., M.S. associate professor of clinical medicine, Montefiore Medical Center, Albert Einstein College of Medicine

Session: CKD: Health Services, Disparities, Prevention

Number: SA-PO911

Date and Time: Saturday, November 19, 10:00 a.m. – 12:00 p.m. CST

Exhibitor Spotlight

Title: Dietary and pharmacologic management of electrolyte disorders in chronic kidney disease

Presenter: Anjay Rastogi, M.D., Ph.D., associate clinical professor of medicine, University of California Los Angeles Division of Nephrology

Location: Exhibit Hall Theatre #1

Date and Time: Friday, November 18, 12:00 – 1:00 p.m. CST

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 angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) 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 (one-third of a cup) 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. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company. More information is available at www.relypsa.com.

About Vifor Pharma

Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world. For more information about Vifor Pharma, please visit www.viforpharma.com.

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