Microbia, Inc. said it had entered into a 50/50 partnership with Forest Laboratories, Inc. to co-develop and co-market Microbia's gastrointestinal drug (GI) linaclotide.
According to a statement from the Cambridge, Massachusetts-based Microbia, linaclotide is currently being investigated for the treatment of constipation-predominant irritable bowel syndrome (IBS-C), chronic constipation (CC), and other gastrointestinal disorders.
Under the terms of the agreement, New York-based Forest will initially pay Microbia $70 million in licensing fees and the companies will jointly and equally fund development and commercialization of the drug in the United States, sharing profits equally.
Forest will have exclusive rights in Canada and Mexico and will pay Microbia a royalty on sales from these countries. Microbia retains all rights outside of North America.
According to a company statement, total licensing and milestone payments to Microbia if linaclotide is successfully developed and commercialized in the United States could total $330 million over the term of collaboration.
"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. We are particularly excited to be working closely with Microbia, an innovative pharmaceutical company with a strong and proven management and scientific team," said, Howard Solomon, chairman and chief executive officer, Forest
Linaclotide is currently undergoing phase 2b clinical testing in patients with IBS-C and 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. 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 3 studies in the second half of 2008, a company press release said.
"Joining forces with Forest is the best way to maximize linaclotide's value for patients and investors. Forest uniquely combines world-class primary care commercial capabilities and an entrepreneurial and collaborative culture. Our companies share a common vision and commitment for getting linaclotide to IBS-C and CC sufferers," said, Peter Hecht, chief executive officer, Microbia.