· Veltassa is the first FDA-approved medicine for hyperkalemia in more than 50 years
· Veltassa will be distributed to patients via two nationally-recognized specialty pharmacies
· Hospitals will receive Veltassa through a network of authorized specialty distributors
· Relypsa's centralized patient support center, Veltassa Konnect, will provide a variety of services to patients who have been prescribed Veltassa
· All Relypsa sales representatives are now hired and are introducing Veltassa to healthcare professionals across the United States
REDWOOD CITY, Calif., Dec. 21, 2015 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that VeltassaTM (patiromer) for oral suspension is now available for prescription to patients with hyperkalemia in the United States. Veltassa was approved by the U.S. Food and Drug Administration (FDA) on October 21, 2015. It is the first new medicine for the treatment of hyperkalemia, or elevated blood potassium levels, in more than 50 years.
"We are very pleased to announce that Veltassa is now available for the millions of Americans who have hyperkalemia," said John A. Orwin, president and chief executive officer of Relypsa. "We are committed to ensuring people living with the burden of hyperkalemia have access to this important new medicine and the team at our patient support center, Veltassa Konnect, is ready to support patients who have been prescribed Veltassa."
About Veltassa K+onnectSM
Veltassa Konnect is a centralized patient support center with a dedicated team of specialists that provides a variety of services, including helping patients understand their insurance coverage and start taking Veltassa quickly, and providing assistance to eligible patients who need help with their co-pay or who are uninsured and may qualify for free drugs.
For more information regarding the availability of Veltassa and the patient support program, patients and doctors can call 1-844-870-7597 (9:00 a.m. — 8:00 p.m. ET) or visit https://www.veltassa.com.
Veltassa Konnect is being managed by RxCrossroads.
Veltassa Authorized Specialty Pharmacies and Distributors
Relypsa has partnered with two national specialty pharmacies to fill and deliver Veltassa prescriptions to patients. Patients who have been prescribed Veltassa will receive the medicine via mail order directly from one of the authorized specialty pharmacies:
· ACS Specialty Pharmacy, a CVS Pharmacy
· Walgreens Specialty Pharmacy
Veltassa will be distributed to hospitals through a network of authorized specialty distributors, including:
· ASD Healthcare, a subsidiary of AmerisourceBergen
· Cardinal Health Specialty Distribution, a subsidiary of Cardinal Health
· McKesson Plasma and Biologics, LLC
About the Veltassa Sales Team
All of Relypsa's sales representatives have now been hired and are calling on nephrologists, cardiologists and relevant hospitals to introduce them to Veltassa. Approximately one-third of Relypsa's sales representatives and all of Sanofi's nephrology sales force, pursuant to the Detailing Agreement between Sanofi and Relypsa, began calling on doctors following approval. By late November 2015, a second group of Relypsa representatives was hired and calling on doctors. The final group of Relypsa representatives started calling on doctors as of December 21, 2015.
Approximately 3 million people in the United States with stage 3 or 4 chronic kidney disease (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 renin angiotensin aldosterone system (RAAS) inhibitors such as ARBs (angiotensin receptor blockers), AAs (aldosterone antagonists) and ACE (angiotensin-converting-enzyme) inhibitors.
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, 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.
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.
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
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 visitwww.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, 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.
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 services to be provided by Veltassa Konnect and the plans to fill and deliver Veltassa prescriptions to patients and distribute Veltassa to hospitals. 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, the timing of Relypsa's regulatory filings, 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, 2014 and its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2015.