Approval of Tenapanor in China
Ardelyx, Inc. is thrilled to announce that tenapanor has received regulatory approval from China's Center for Drug Evaluation of the National Medical Products Administration. This groundbreaking decision allows tenapanor to be prescribed specifically for controlling serum phosphorus levels in patients with chronic kidney disease (CKD) who are undergoing dialysis and have either not responded adequately to phosphorus binders or cannot tolerate them.
Milestone Achievements and Future Prospects
As part of this approval process, Ardelyx is set to receive a $5 million milestone payment from Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., its collaboration partner in China. This partnership not only supports the launch of tenapanor but also positions Ardelyx to benefit from potential additional developmental and commercialization milestones that could total up to $100 million. Furthermore, the company will earn tiered royalties on net sales, which are estimated to be between the mid-teens and 20 percent.
Commitment to Global Health
“The approval of tenapanor in China represents a notable step forward in our mission to provide innovative therapeutics to patients worldwide,” expressed Mike Raab, Ardelyx's president and CEO. He highlighted the importance of collaboration with providers like Fosun Pharma, who are equipped with the expertise to successfully market cardiorenal medicines across the region. Their shared commitment to improving patient outcomes showcases a united front in tackling hyperphosphatemia in China.
Understanding Hyperphosphatemia and Its Impact
With over one million patients undergoing maintenance hemodialysis in China and an annual growth rate of approximately 12%, the prevalence of hyperphosphatemia among these individuals is concerning. Studies indicate that 76% of these patients are affected, yet only 39% manage to achieve the target phosphate levels set by the country’s hemodialysis quality control standards. When the target range is more strictly defined, the success rate drops to a mere 26.7%.
Supporting Clinical Data
The New Drug Application approval for tenapanor was bolstered by substantial clinical data, comprising a pharmacokinetic study along with pivotal trials conducted by Fosun Pharma in collaboration with Ardelyx. These studies established the efficacy and safety of tenapanor in effectively managing phosphate absorption in CKD patients undergoing dialysis.
The Role of Fosun Pharma
Under the terms of their agreement, Fosun Pharma holds exclusive rights to market and distribute tenapanor in China, Hong Kong, and Macau. The medication will be marketed under the Chinese trade name Wan Ti Le, expanding accessibility for the target patient population.
About Tenapanor
Tenapanor, marketed as XPHOZAH, is a first-in-class phosphate absorption inhibitor. It employs a unique mechanism of action, working locally in the gut to limit phosphate absorption by targeting the sodium hydrogen exchanger 3. Patients are instructed to take this medication twice daily, with clinical trials indicating that diarrhea was the most frequently reported side effect.
About Ardelyx
Ardelyx, Inc. is dedicated to the discovery, development, and commercialization of innovative medications tailored to meet critical healthcare needs. In addition to tenapanor, Ardelyx has two commercial products approved in the United States, which further illustrates their commitment to addressing the complexities of chronic diseases. Their partnerships for the development of tenapanor in international markets highlight their strategic approach to global health efforts.
Investor Relations Contact
For additional details, please reach out to Caitlin Lowie at clowie@ardelyx.com.
Frequently Asked Questions
What is Tenapanor and what is its purpose?
Tenapanor is a phosphate absorption inhibitor designed to aid patients with chronic kidney disease in managing serum phosphorus levels effectively.
Why was Tenapanor approved in China?
The approval was granted due to significant clinical data showcasing its efficacy in controlling hyperphosphatemia in dialysis patients.
What financial milestones are associated with this approval?
The approval triggers a $5 million milestone payment to Ardelyx, with potential for additional milestones and royalties on sales.
What is the significance of this approval for patients?
This approval provides a new therapeutic option for dialysis patients suffering from hyperphosphatemia, enhancing their treatment choices.
How does Ardelyx support patient care?
Ardelyx commits to innovation and collaboration with healthcare partners to bring forward next-generation treatments that address critical patient needs.
