CAMBRIDGE, Mass. and NEW YORK, Sept. 17 Microbia, Inc. and Forest Laboratories, Inc. (NYSE: FRX), today announced thatthey have entered into a 50/50 partnership in the United States to co-developand co-market Microbia's first-in-class compound linaclotide. Linaclotide iscurrently being investigated for the treatment of constipation-predominantirritable bowel syndrome (IBS-C), chronic constipation (CC), and othergastrointestinal disorders.
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Under the terms of the agreement, Forest will initially pay Microbia $70million in licensing fees. Microbia and Forest will jointly and equally funddevelopment and commercialization of linaclotide in the United States, sharingprofits equally. Additionally, Forest will have exclusive rights in Canada andMexico and will pay Microbia a royalty on sales in these countries. Microbiaretains all rights to the product outside of North America. Total licensingand milestone payments to Microbia if linaclotide is successfully developedand commercialized in the United States could total $330 million over the termof the collaboration.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said, "Weare very pleased to have entered into this collaboration with Microbia.Linaclotide offers the possibility of genuine relief for the millions ofpatients suffering from chronic constipation and IBS-C, for which there arecurrently few treatment options. Chronic constipation and IBS-C patients aretreated largely by primary care physicians, where the Forest sales force hasalready built excellent relationships. We are particularly excited to beworking closely with Microbia, an innovative pharmaceutical company with astrong and proven management and scientific team."
Linaclotide is currently undergoing Phase 2b clinical testing in patientswith IBS-C and CC. In earlier clinical studies, linaclotide demonstratedimproved bowel function in patients with IBS-C and CC. These studies alsoshowed linaclotide was well tolerated with a low incidence of adverse events.Linaclotide is an agonist of the guanylate cyclase type-C receptor found inthe intestine and acts by a mechanism distinct from previously developedproducts for IBS-C and CC. Linaclotide is administered orally but acts locallyin the intestine with no measurable systemic exposure. Microbia and Forestintend to initiate Phase 3 studies in the second half of 2008.
"Joining forces with Forest is the best way to maximize linaclotide'svalue for patients and investors," said Peter Hecht, Microbia's ChiefExecutive Officer. "Forest uniquely combines world-class primary carecommercial capabilities and an entrepreneurial and collaborative culture. Ourcompanies share a common vision and commitment for getting linaclotide toIBS-C and CC sufferers."
About Irritable Bowel Syndrome (IBS)
One out of six adults in developed countries suffers from IBS, a chroniccondition marked by abdominal pain and disturbed bowel function. IBS accountsfor 12% of adult visits to primary care physicians and is the most commondisorder diagnosed by gastroenterologists. Health care costs associated withIBS exceed $25 billion annually. IBS patients fall into three subgroups-constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), andalternating (IBS-A)-and 30% to 40% of these patients suffer from IBS-C. Thereare currently few available therapies to treat the nine million U.S. patientsdiagnosed with IBS-C.
About Chronic Constipation (CC)
As many as 26 million Americans suffer from CC. Patients with CC oftenexperience hard and lumpy stools, straining during defecation, a sensation ofincomplete evacuation, and fewer than three bowel movements per week. Thediscomfort of CC significantly affects patients' quality of life by im