Biopharmaceutical company Ardelyx Inc. (ARDX:NASDAQ), which concentrates its efforts on the development of medicines to treat kidney and cardiorenal diseases, today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (4151:TSE) "has initiated four Phase 3 clinical studies in Japan evaluating tenapanor for hyperphosphatemia."
The firm noted that by Kyowa Kirin's moving forward into the various clinical trials, under the terms outlined in the agreement between the companies, Ardelyx is now entitled to receive a $5 million payment for reaching this important development milestone.
The company stated that the four planned Phase 3 clinical studies evaluating tenapanor will include a multi-center comparative trial study, a phosphate binder-combination comparative study and a study focused on hyperphosphatemia patients on peritoneal dialysis. The fourth planned Phase 3 trial was described as "a long-term study evaluating serum phosphorus in patients who switch from one or more phosphate binders to tenapanor for hyperphosphatemia in Japan."
Ardelyx's President and CEO Mike Raab commented, "As we approach our April 29 PDUFA date for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis and prepare for potential commercialization in the U.S., we are pleased to see the significant progress made by our partner Kyowa Kirin...We are thrilled to have key strategic partners like Kyowa Kirin, along with our partners in Canada and China, to support development of, and once approved, patient access to, tenapanor globally."
The firm advised that in 2017 it entered into a license agreement with Kyowa Kirin for tenapanor. The agreement included a one-time upfront payment from Kyowa Kirin in the amount of $30 million and included additional payments of up to $55 million if certain specified development milestones are achieved. In addition to the clinical development incentives, Ardelyx is also eligible to receive as much as 8.5 billion yen in the event certain commercialization milestones are met and is also eligible to receive future high-teen royalties on sales made over the life of the agreement.
The report indicated that "Kyowa Kirin has been granted the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan."
The firm stated that it discovered and developed tenapanor, a "first-in-class, proprietary, oral medicine for which an NDA is under review by the FDA for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption. "
Ardelyx is a biopharmaceutical company based in Fremont, Calif., that is focused creating, developing and marketing medicines to treat kidney and cardiorenal diseases. The firm is currently focused on "advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company's NDA is currently under review by the FDA, with a PDUFA date of April 29, 2021."
The firm noted that it is also engaged in advancing RDX013, which it listed is a potassium secretagogue being developed for the possible treatment of elevated serum potassium, or hyperkalemia. The company said that hyperkalemia is observed in some patients with kidney and heart disease. Additionally, Ardelyx mentioned that in its development pipeline it has another early-stage program in metabolic acidosis, which it explained is a serious electrolyte disorder in patients with CKD.
Ardelyx advised that in September 2019 it received approval from the U.S. Food and Drug Administration (FDA) for IBSRELA® (tenapanor). The company pointed out that it has entered into agreements to develop and commercialize tenapanor in Japan with Kyowa Kirin, in China with Fosun Pharma and in Canada with Knight Therapeutics.
Ardelyx started the day with a market capitalization of around $774 million with approximately 98.7 million shares outstanding and a short interest of about 9.0%. ARDX shares opened slightly higher today at $7.90 (+$0.06, +0.76%) over yesterday's $7.84 closing price and reached a new 52-week high this morning of $9.23. The stock has traded today between $7.86 and $9.23 per share and is currently trading at $8.70 (+$0.86, +10.97%).
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