|Peter Hecht, CEO of Ironwood Pharmaceuticals|
Cambridge, MA-based Ironwood ($IRWD) cleared a major milestone in its development this morning, winning an FDA approval for linaclotide and paving the way for its big leap into commercialization.
Regulators OK'd linaclotide--now dubbed Linzess--for chronic idiopathic constipation and to treat irritable bowel syndrome with constipation. Morgan Stanley has estimated potential peak sales at $2 billion.
"No one medication works for all patients suffering from these gastrointestinal disorders," said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research. "With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition."
The approval won't come as a big surprise to analysts who have been watching the company develop over its 14 years in business (Ironwood was a Fierce 15 company in 2009). Under the direction of CEO Peter Hecht--who carefully nurtured a vision for the company as a full-fledged marketer and drug developer--Ironwood presented a complete set of promising data for the drug.
When Hecht struck his marketing pact with Forest Laboratories--which has been bullish about linaclotide's prospects--he was careful to hang on to co-promotion rights in the U.S. Almirall acquired the rights to Europe while Astellas inked an Asian deal.
In the lead-up to the approval, Ironwood has been in-licensing new products for development.
- here's the press release from the FDA
Special Reports: Ironwood Pharmaceuticals - 2009 Fierce 15 | Bionomics and Ironwood Pharmaceuticals - Top 20 biotech licensing deals in H1 2012
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