Ironwood Pharmaceuticals - 2009 Fierce 15

Based: Cambridge, MA
Founded: 1998
Website: www.ironwoodpharma.com [1]
CEO: Peter M. Hecht, Ph.D. (photo [2])

The Scoop: Ironwood wears its passion for drug development on its sleeve. Over the past 10 years the company has stayed private and kept a relatively low profile. But all that could change dramatically as its lead program--linaclotide--completes late-stage tests and its CEO moves closer to his goal of building one great pharma company.

What makes it Fierce: On the private side of the biotech industry, it's common for CEOs to hedge a lot about future plans. That's to be expected. Boards filled with venture execs have a lot of say over the future of a biotech. At Ironwood, though, Peter Hecht has always been blunt about the company's ambition.

"We want to build a standalone, great pharmaceutical company," says the CEO. "The ambition isn't size, its quality and making drugs that really matter."

Ironwood has raised a whopping $281 million in private equity and recently inked a deal with Spain's Almirall [3] for the European rights to linaclotide, a product that will start delivering pivotal data for irritable bowel syndrome with chronic constipation later this year. Almirall paid $40 million upfront for the European rights in a deal that can escalate to half the drug's market value. And Hecht stuck with the back-end focus throughout the talks. In the U.S., Forest Laboratories will split the market, and the CEO clearly wants to get started on building a commercial marketing operation as soon as it is practicable.

Ironwood gets to face its destiny in the coming months as the first late-stage clinical trials start delivering critical data. Phase II was a clear success, and these late-stage trials are confirmatory in nature. Hecht feels that linaclotide has the kind of market potential that better-known experimental meds like telaprevir are touted for. And Ironwood has other programs ready for the clinic; an ecumenical bunch of programs which all came out of its own lab.  

Careful FierceBiotech readers will remember that Ironwood was called Microbia [4] when we featured them in the 2006 Fierce 15. A biomanufacturing spinout took the name, but the developer has lost none of its zeal for developing into a key industry player.

What to look for: All eyes are turned to early fall, when researchers are scheduled to start delivering late-stage data. In 2010, Ironwood and its partners will have more Phase III results. And that should set the stage for an NDA. Hecht is also clear that Ironwood will go public at some stage in the near future, but don't try to pin him down on a date. In this market, nobody's crystal ball is working.

Venture backers: Fidelity Biosciences, Venrock Associates, Polaris Venture Partners and Morgan Stanley Private Equity.