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Relypsa Announces Data for Veltassa (patiromer) to be Presented at ASN Kidney Week 2015

  • OPAL-HK sub-group analysis in hyperkalemic chronic kidney disease (CKD) patients age 65 or older will be featured in oral presentation
  • Poster presentation will highlight data from OPAL-HK patients treated with Veltassa taking diuretics
  • Company to host webcasted investor event and corporate update with Matthew R. Weir, M.D. on November 5

REDWOOD CITY, Calif., Oct. 29, 2015 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that the results of sub-group analyses from the OPAL-HK study of Veltassa™ (patiromer) for oral suspension will be presented at the American Society of Nephrology’s (ASN) Kidney Week 2015, taking place November 3 - 8 in San Diego, Calif. Veltassa was recently approved by the U.S. Food and Drug Administration (FDA) as the first new medicine for the treatment of hyperkalemia in more than 50 years.

Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine will present results of a pre-specified sub-group analysis of hyperkalemic chronic kidney disease patients age 65 years or older who were receiving renin angiotensin aldosterone system (RAAS) inhibitor therapy during an oral presentation on Thursday, November 5, 2015. Separately, a poster presentation will highlight results of a sub-group analysis within the treatment phase of OPAL-HK, comparing the effects of Veltassa in patients taking different types of diuretics with patients not receiving diuretics.

Additionally, two new posters will be presented regarding variation of potassium levels prior to and during controlled dieting, and the association between antihypertensive medications and hyperkalemia in a large health system. Details for the oral presentation and posters are listed below.

Investor Event and Webcast, Thursday, November 5, 2015 at 3:00 p.m. PT (6:00 p.m. ET)

Relypsa will host an investor event during which Dr. Weir will share his perspective on hyperkalemia and Veltassa as a new therapeutic option. Relypsa management will also be in attendance. The presentation will be followed by a Q&A session and reception.

The event will take place Thursday, November 5, 2015 at 3:00 p.m. PT (6:00 p.m. ET). The webcast may be accessed by phone by calling (866) 410-4428 (domestic) or +1 (704) 908-0287 (international), conference code 60411058, or on the investor relations section of the Relypsa website at http://investor.relypsa.com. It will be archived for 30 days following the call.

Veltassa Oral Presentation
Abstract Title:Patiromer lowers serum K+ and prevents recurrent hyperkalemia in CKD patients ≥65 years of age on RAAS inhibitors
Presenter:Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine
Session:Clinical Trials in CKD: Pursuing a New Horizon
Number: TH-OR035
Date and Time:Thursday, November 5
Location:Room 25
Session Time:4:30 - 6:30 p.m. PT
Presentation Time:5:18 p.m. PT


Veltassa Poster Presentation
Abstract Title: Chronic diuretic therapy does not impair the effectiveness of patiromer in hyperkalemic patients with CKD
Presenter:Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine
Session: CKD: Clinical Trials
Number: TH-PO658
Date and Time:Thursday, November 5, 10 a.m. -- 12 p.m. PT


Hyperkalemia Poster Presentations of Interest
Abstract Title:Wide range in variation in serum potassium in hyperkalemic patients with CKD, response to a fixed 60 mEq potassium diet
Presenter: David Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and Chief of the Nephrology Division at the University of Rochester Medical Center
Session: Fluid, Electrolyte, and Acid-Base Disorders
Number: SA-PO924
Date and Time:Saturday, November 7, 10 a.m. – 12:00 p.m. PT
Abstract Title:Antihypertensive medications and the prevalence of hyperkalemia in a large health system
Presenter:Alex R. Chang, M.D., Geisinger Health System, Danville, Penn.
Session: Fluid, Electrolyte, and Acid-Base Disorders
Number: SA-PO923
Date and Time: Saturday, November 7, 10 a.m. – 12:00 p.m. PT


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 frequently 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 by the FDA 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, this new medicine 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

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/prescribring-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, VeltassaTM (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.

Contact:
Charlotte Arnold
Vice President, Corporate Communications
650.421.9352
IR@relypsa.com

Source:Relypsa, Inc.