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Ironwood Makes Commercial Debut; Outlines Linzess Plans

By Marie Powers
Staff Writer

SAN FRANCISCO – Ironwood Pharmaceuticals Inc. played to a packed house Monday afternoon following the luncheon keynote by journalist Bob Woodward at the J.P. Morgan Healthcare Conference.

Though the celebrated Woodward drew a capacity crowd in the Grand Ballroom at the Westin St. Francis, Ironwood CEO Peter Hecht, along with Thomas McCourt, chief commercial officer and senior vice president of marketing and sales, attracted their own respectable following as attendees filled every available chair and stood three-deep at the back of the room, craning for a view of the slides in the company's first J.P. Morgan appearance as a commercial entity.

The executives offered an overview of future plans for the company's guanylate cyclase-C agonist pipeline and painted a clear picture about their strategy for Linzess (linaclotide), the irritable bowel syndrome drug (IBS) approved by the FDA last August ahead of its PDUFA date. (See BioWorld Today, Aug. 31, 2012.)

McCourt said Cambridge, Mass.-based Ironwood was "extremely pleased" with the broad label granted by the FDA, but Hecht hinted that "we believe we can do a number of things to strengthen the label" in other pain-related and constipation-related indications. For example, Ironwood may seek to create combination products, Hecht suggested, noting the company has early stage assets and continues to review in-licensing options.

"We've worked extensively with collaborators across the globe on commercialization and manufacturing," he said. "We're working hard to be good collaborators."

Working with U.S. partner Forest Laboratories Inc., of New York, the company hired and integrated a dedicated sales force of 1,300 reps, stocked more than 40,000 U.S. pharmacies with product and in mid-December began promoting Linzess to 80,000 physicians, according to McCourt. So far, feedback has been positive and the company is fielding requests for samples. "But, keep in mind, it's two weeks of data," McCourt said.

Roughly 44 million individuals in the U.S. suffer from IBS and/or chronic constipation and a continuum of related symptoms, he explained. Out of the gate, Ironwood is targeting the 10 million patients who suffer from both indications, actively seek medical treatment – virtually all with prescription or over-the-counter laxatives – yet remain unsatisfied with their care. Another 15 million patients self-medicate for those conditions, according to McCourt.

The group that seeks treatment accounts for more than 100 days each year of individual symptoms and consumes more than 30 million laxative units annually. "If we convert all of them to Linzess, which is our ambition, that's a $6 billion market," McCourt said.

Physicians are the key to that conversion, and they typically don't distinguish between prescription and over-the-counter laxatives. Even patients tend to use the drugs as rescue medications, cycling through them on a weekly or monthly basis.

"It's critical that we educate health care professionals and patients about the benefit of the drug, since this is something that's not been seen before," McCourt said. "We've been able to show that patients respond within the first week and response continues through the treatment period."

The company is framing Linzess as a drug that transforms the episodic and often unsuccessful treatment of IBS into a successfully managed chronic condition. In addition to physician education, this month Ironwood plans to launch a patient education campaign largely in the digital space that will target the core market of 20-year-old to 55-year-old women.

"Our number one priority is to get as many patients experienced on the drug as possible," McCourt said.

At the same time, Ironwood is seeking to sell payers on the "value proposition" of Linzess to ensure reasonable access and reimbursement. The once-daily drug is priced at about $7 per day, and the company has implemented a copay assistance program across multiple pharmacy chains.

Outside the U.S., Ironwood has inked deals with a variety of partners, including AstraZeneca plc, of London, Almirall SA, of Barcelona, Spain, and Astellas Pharma Inc., of Tokyo. (See BioWorld Today, Oct. 24, 2012.)

Ironwood officials "feel good about our capital position" to accomplish the company's near-term mission, Hecht said. Just last week, the biotech completed a debt offering of $175 million, with proceeds to fund R&D efforts and to support the commercial launch of Linzess, as well as for general corporate purposes. Under the terms, Ironwood issued $175 million in aggregate principal amount of Linaclotide PhaRMA 11 percent notes due on or before June 15, 2024. Before the transaction, the company ended 2012 with about $168 million on its balance sheet.

"We're largely focused on the Linzess launch, and that's appropriate in the near term," Hecht told conference attendees, "but we're laying the groundwork for substantial and sustained long-term growth."