Relypsa, Inc. 's RLYP lead candidate, Veltassa gained approval in the U.S. for the treatment of hyperkalemia. Shares which should have been up with the positive news were, however, down 27.2% due to the inclusion of a box warning.
We note that the prescribing information includes a boxed warning stating that Veltassa binds with other orally administered medications, thereby decreasing their absorption and reducing their effectiveness.
The company expects to launch Veltassa by the first week of Jan 2016. Veltassa will be the company's first product to be commercialized.
According to information provide by the company, in the U.S., approximately 3 million people with stage III & IV chronic kidney disease and/or heart failure have hyperkalemia.
Meanwhile other companies are also looking to bring their hyperkalemia treatments to market. Currently, ZS Pharma, Inc.'s ZSPH ZS-9 is under FDA review. A response from the FDA is expected by May 26, 2016.
We remind investors that in Aug 2015, Relypsa entered into an exclusive partnership with Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) to commercialize Veltassa in Europe and additional territories. Under the terms of the agreement, Relypsa received an upfront cash payment of $40 million.
The company is also entitled to receive payments up to $125 million upon achieving certain regulatory and sales milestones. In addition, for commercial sale in the licensed territories, Relypsa will receive tiered double-digit royalties.
As per the agreement terms, VFMCRP will be responsible for marketing Veltassa in the world except the in U.S. and Japan, where Relypsa retains all commercial rights. A marketing application for Veltassa is expected to be filed in the EU in the first half of 2016.
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