Ironwood hits key milestone with NDA for blockbuster hopeful linaclotide

Cambridge, MA-based Ironwood ($IRWD) has hit an important milestone in its 13-year quest to emerge as a full-fledged drug developer with a reliable revenue stream. The biotech filed its application with the FDA for linaclotide, a potential blockbuster designed to produce a superior response for patients suffering from irritable bowel syndrome and chronic constipation.

"We've seen very clear evidence that the drug reduces the symptoms of abdominal pain, bloating and abdominal discomfort,'' Ironwood CSO Mark Currie tells The Boston Globe. And after years of research Ironwood and its partner Forest Labs plan to make their case to the FDA before launching a treatment with the potential to earn more than a billion dollars a year.

An acceptance at the FDA would mark a victory for Peter Hecht, the CEO who set out with an unusual commitment to build the company rather than angle for a buyout deal. When Hecht struck his pact with Forest 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. And the company, which has a staff of 250, has built up an impressive portfolio of late-stage data on linaclotide from six late-stage studies.

Ironwood--a 2009 Fierce 15 company--went public 18 months ago in the face of a stormy reception for biotech IPOs. And it's been able to rely on the backing of a long lineup of investors who have remained committed to Hecht's vision for the company.

- see the Ironwood release
- check the report from The Boston Globe

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