Ironwood Pharmaceuticals, Inc. today announced that a new drug application (NDA) seeking approval of linaclotide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) in Japan was filed with the Japanese Ministry of Health, Labor and Welfare by Astellas Pharma Inc., Ironwood’s partner for linaclotide in Japan.
Linaclotide is a guanylate cyclase‐C (GC‐C) receptor agonist currently approved, and is the branded prescription market leader, for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC) in the United States, where more than 40 million patients are estimated to suffer from these conditions. To date, more than 1 million unique U.S. patients have filled a linaclotide prescription since its launch in December 2012, according to IMS Health. Linaclotide is also approved for adults with IBS-C or CIC in more than 30 other countries.
“Today’s filing for regulatory approval in Japan by our partner Astellas, and our recent filing for regulatory approval in China with our partner AstraZeneca, are important achievements by Ironwood and our global partners toward bringing linaclotide to appropriate patients around the world,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “In Japan, 2.9 percent of adults are estimated to suffer from IBS-C, with no prescription medicines currently approved for this disease. We hope to help address this unmet need, and we continue to explore further innovation with linaclotide across a broad spectrum of patient needs.”
The NDA submission in Japan is based mainly on the results obtained from the double-blind, placebo-controlled, parallel-group comparative Phase III study conducted in Japan in adults with IBS-C, which demonstrated linaclotide’s clinical efficacy and safety profile, and which were announced by the companies in November 2015.
Ironwood and Astellas entered into a licensing agreement in 2009 to develop and commercialize linaclotide in Japan for the treatment of IBS-C, chronic constipation and other gastrointestinal conditions. Per the agreement, Astellas paid Ironwood a $30 million upfront licensing fee and a $15 million development milestone payment upon enrollment of the first patient in the Phase III IBS-C trial. These payments are in addition to the $15 million milestone payment earned by Ironwood upon the NDA submission announced today. The agreement also includes an additional $15 million milestone payment for Ironwood upon receipt of approval of linaclotide by the Japan regulatory authority. The agreement also provides for Ironwood to receive royalties, which escalate based on sales volume, if linaclotide is approved in Japan.
Filed Under: Drug Discovery