Company Overview of Relypsa, Inc.
Relypsa, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of polymeric medicines for patients with conditions that are overlooked and undertreated and can be addressed in the gastrointestinal tract primarily in the United States. The company offers Veltassa (patiromer), a non-absorbed potassium binding polymer for the treatment of hyperkalemia. It has license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. for developing and commercializing Veltassa outside the United States and Japan. The company was founded in 2007 and is headquartered in Redwood City, California. As of August 31, 2016, Relypsa, Inc. operates as a subsidiary of V...
100 Cardinal Way
Redwood City, CA 94063
Founded in 2007
Key Executives for Relypsa, Inc.
Chief Executive Officer and Director
Chief Financial Officer, Principal Accounting Officer and Senior Vice President
Chief Scientific Officer and Senior Vice President
Chief Medical Officer and Senior Vice President
Compensation as of Fiscal Year 2016.
Relypsa, Inc. Key Developments
Relypsa, Inc. Presents Veltassa® Phase 4 Data Showing Consistent Efficacy and Safety Whether Taken with or without Food in Patients with Hyperkalemia
Apr 19 17
Relypsa, Inc. has announced that data from its Phase 4 TOURMALINE study of the effect of Veltassa® (patiromer) for oral suspension on hyperkalemia when taken with or without food were presented in a poster session at the National Kidney Foundation (NKF) 2017 Spring Clinical Meetings in Orlando, Fla. The results presented at the NKF meeting by Dr. Pergola showed no statistically significant difference in the percentage of patients achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L) between the groups taking Veltassa with or without food at either week 3 or week 4 follow-up (p=0.7893). Among study participants taking Veltassa with food, 87.3% achieved and maintained a potassium level in the target range as did 82.5% of those taking Veltassa without food. Results were consistent when evaluated by baseline potassium, race, eGFR (an assessment of kidney function) and type 2 diabetes. Patients with higher baseline potassium values generally had greater potassium reductions. Rates of adverse events were consistent with previous clinical trials of Veltassa and were similar between study participants who took Veltassa with food (48.2%) and those who took it without food (42.1%). The TOURMALINE study randomly assigned 114 patients with blood potassium levels greater than 5.0 mEq/L to receive Veltassa once-a-day at a starting dose of 8.4 g either with or without food. Patients were treated for four weeks and followed for two weeks after completing Veltassa treatment. The primary endpoint was a comparison of the proportion of patients with blood potassium in the target range (3.8 to 5.0 mEq/L) at week 3 or week 4 between the two treatment groups. Of the 112 evaluable patients, 65% were male, 65% were age 65 or older, and 62% had stage 3b-5 chronic kidney disease.
Relypsa Announces Executive Changes
Mar 14 17
Relypsa, Inc. announced the promotion of Scott Garland to president, effective March 31, 2017. Mr. Garland joined Relypsa in October 2014 as senior vice president and chief commercial officer and has been instrumental in the U.S. commercial launch of Veltassa (patiromer) for oral suspension for the treatment of hyperkalemia. John A. Orwin, who is currently president and chief executive officer, will remain as chief executive officer until June 30, 2017, and after that date will continue in an advisory role with the U.S. Committee of the Vifor Pharma Board of Directors.
Relypsa Announces Publication of Results of Veltassa Drug-Drug Interaction Studies
Feb 13 17
Relypsa, Inc. announced that results of drug-drug interaction studies of Veltassa® (patiromer) for oral suspension were published online by the Journal of Cardiovascular Pharmacology and Therapeutics. Results from 12 individual Phase 1 studies in healthy volunteers of 12 oral medications showed there were no clinically meaningful or statistically significant interactions between Veltassa and the 12 oral medications when taken at least three hours apart. Based on these study results, the U.S. Food and Drug Administration (FDA) recently approved a supplemental New Drug Application (sNDA) for Veltassa with important updates to the label. Veltassa’s updated label no longer includes a Boxed Warning that Veltassa binds to many orally administered medications and now recommends that patients take Veltassa at least 3 hours before or 3 hours after other oral medications. Veltassa was approved by the FDA for the treatment of hyperkalemia in the United States in October 2015, becoming the first medicine in more than 50 years for people with elevated blood potassium levels. Previously, Relypsa tested 28 drugs likely to be used in chronic kidney disease (CKD) patients with hyperkalemia to determine the potential for interaction with Veltassa. Drug-drug interaction tests conducted in vitro (in test tubes) showed that 14 drugs did not bind with Veltassa. Of the 14 drugs that did show an interaction, 12 were selected for further testing in Phase 1 studies. They are amlodipine, cinacalcet, ciprofloxacin, clopidogrel, furosemide, levothyroxine, lithium, metformin, metoprolol, trimethoprim, verapamil and warfarin. Two drugs were not tested: thiamine, as it is readily available in food, and quinidine, which is not commonly used. Dr. Lesko and colleagues studied the 12 drugs in 12 separate randomized, open-label Phase 1 studies in a total of 370 healthy volunteers. The studies had a three-way crossover design in which each study participant received the test drug alone, Veltassa and the test drug administered at the same time, and Veltassa administered 3 hours after the test drug. Each study evaluated the concentration of the test drug in the blood over time and peak blood concentration of the test drug. Results showed that Veltassa did not alter the extent of systemic absorption of nine of the 12 drugs when co-administered. Veltassa reduced absorption of three drugs when co-administered. However, there was no clinically significant interaction when Veltassa and these three drugs were taken 3 hours apart. Across all 12 studies, Veltassa was generally well tolerated with safety findings consistent with U.S. prescribing information.
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