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news.US-based pharmaceutical companies Microbia and Forest Laboratories are to partner in the co-development and co-marketing of chronic constipation and irritable bowel syndrome drug linaclotide.
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Under the terms of the agreement, Forest will initially pay Microbia $70 million in licensing fees. Microbia and Forest will jointly and equally fund development and commercialization of linaclotide in US, sharing profits equally.
Forest will have exclusive rights in Canada and Mexico and will pay Microbia a royalty on sales in these countries. Microbia retains all rights to the product outside of North America. Total licensing and milestone payments to Microbia if linaclotide is successfully developed and commercialized in the US could total $330 million over the term of the collaboration.
Linaclotide is currently undergoing Phase IIb clinical testing in patients with irritable bowel syndrome (IBS-C), chronic constipation (CC). In earlier clinical studies, linaclotide demonstrated improved bowel function in patients with IBS-C and CC. These studies also showed linaclotide was well tolerated with a low incidence of adverse events. Microbia and Forest intend to initiate Phase III studies in the second half of 2008.
Howard Solomon, CEO of Forest, said: “We are very pleased to have entered into this collaboration with Microbia. 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.”