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Microbia and Forest reveal IBS collaboration

Microbia and Forest Laboratories collaborate in the US to co-develop and co-market Microbia's first-in-class compound linaclotide, which is under investigation for the treatment of constipation-predominant irritable bowel syndrome

US-based pharmaceutical companies Microbia and Forest Laboratories have entered into a partnership in the US to co-develop and co-market Microbia's first-in-class compound linaclotide, which is under investigation for the treatment of constipation-predominant irritable bowel syndrome (IBS-C), chronic constipation (CC) and other gastrointestinal disorders.

Per the agreement, Forest will initially pay Microbia USD 70m in licensing fees. Both companies will jointly fund development and commercialisation of linaclotide in the US, sharing profits equally.

Forest will have exclusive rights in Canada and Mexico and pay Microbia a royalty on sales in these countries. Microbia retains all rights to the product outside of North America. Forest could pay a total of USD 330m in licensing and milestone payments to Microbia, if linaclotide is successfully developed and commercialised in the US.

Linaclotide is currently undergoing phase IIb clinical testing in patients with IBS-C and CC. In previous clinical studies, linaclotide demonstrated improved bowel function in patients with IBS-C and CC. The studies also demonstrated that linaclotide was well tolerated with a low incidence of adverse events.

Linaclotide is an agonist of the guanylate cyclase type-C receptor found in the intestine and acts by a mechanism distinct from previously developed products for IBS-C and CC. Linaclotide is administered orally but acts locally in the intestine with no measurable systemic exposure. Microbia and Forest intend to initiate phase III studies in H2 2008.

Howard Solomon, Forest's CEO, said: "Linaclotide offers the possibility of genuine relief for the millions of patients suffering from chronic constipation and IBS-C, for which there are currently few treatment options. Chronic constipation and IBS-C patients are treated largely by primary care physicians, where the Forest sales force has already built excellent relationships."

Peter Hecht, Microbia's CEO, added: "Joining forces with Forest is the best way to maximise linaclotide's value for patients and investors. Forest combines world-class primary care commercial capabilities and an entrepreneurial and collaborative culture.î

18th September 2007

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