Astellas Pharma is paying Ironwood Pharmaceuticals a $30 million licensing fee for Asian rights to its late-stage treatment for irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC), linaclotide. The exclusive development and commercialization deal covers Japan, Indonesia, Korea, the Philippines, Taiwan, and Thailand.
The deal is valued at $75 million in up-front and precommercial milestones plus escalating royalties on linaclotide sales. Astellas will lead clinical development in Japan and will be responsible for all activities and expenses relating to clinical development, regulatory approval, and commercialization in the licensed territories.
In May Laboratorios Almirall took over European rights to linaclotide in IBS-C and other gastrointestinal indications for $55 million in near-term payments. In the U.S., the drug is being developed and will be marketed under a 50/50 partnership with Forest Laboratories. In September 2007, when the agreement was signed, Forest paid $70 million in licensing fees. Forest retains exclusive rights in Canada and Mexico and will pay Ironwood a royalty on sales in these countries.
Linaclotide demonstrated proof of concept in two Phase II studies in over 700 patients with either IBS-C or CC. In patients with IBS-C, linaclotide significantly reduced abdominal pain and bloating as well as improved bowel function throughout the 12-week treatment period. In patients with CC, linaclotide reduced constipation throughout the four-week treatment period. In both studies the most common adverse event was diarrhea.
Linaclotide is a once-daily, orally delivered peptide that acts locally in the gut with no detectable systemic exposure at therapeutic doses. Linaclotide is an agonist of guanylate cyclase type-C, a receptor found on the lining of the intestine. Issued composition of matter patents for linaclotide in the U.S. and Europe provide protection beyond 2024.