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Ironwood Pharmaceuticals Provides First Quarter 2010 Investor Update

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Cambridge, MA, May 11, 2010 -

First Quarter 2010 Highlights

Linaclotide

In March, the final patients were enrolled into each of the two confirmatory Phase 3 clinical trials being carried out by Ironwood and its U.S. partner, Forest Laboratories, Inc., to assess the efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation (IBS‐C). Ironwood and Forest anticipate that the top‐line data from the two trials will be reported separately in the fourth quarter of 2010. Ironwood and Forest are targeting a New Drug Application submission for both IBS‐C and chronic constipation (CC) in the middle of 2011.
At the end of March, the U.S. Food and Drug Administration (FDA) issued draft guidance on the design of clinical trials for IBS‐C. The draft guidance calls for coprimary efficacy endpoints assessing abdominal pain (≥ 30 percent average weekly reduction versus baseline) and stool frequency (increase of one or more complete spontaneous bowel movements per week versus baseline). The co‐primary endpoints in the above‐mentioned Phase 3 IBS‐C clinical trials are closely aligned with the draft guidance.
The European Medicines Agency (EMA) has indicated that Ironwood’s European partner, Almirall, S.A., can utilize the U.S. IBS‐C Phase 3 clinical trials as a basis for a Market Authorisation Application. For that reason, no additional E.U. Phase 3 clinical trials are contemplated. The primary endpoint will be different in Europe, but both the EMA and the FDA have agreed to allow separate and independent statistical analysis plans of the primary data sets for the two territories. For the E.U., the co‐primary efficacy endpoints will evaluate abdominal pain/abdominal discomfort and IBS degree of relief.

Corporate

In early February, Ironwood executed the initial public offering (IPO) of its Class A common stock, which raised net proceeds of approximately $203 million with less than 17 percent dilution to its pre‐IPO stockholders on a fully‐diluted basis. In addition, the IPO provided Ironwood with the opportunity to discuss, with many of the biotechnology industry’s most highly‐regarded investors, linaclotide’s potential to improve the lives of millions of Americans who are suffering from IBS‐C or CC. Including proceeds from the IPO, Ironwood closed the first quarter with approximately $299 million of cash, cash equivalents, and available‐for‐sale securities.
Based on its current operating plan, Ironwood anticipates ending fiscal year 2010 with greater than $220 million of cash, cash equivalents, and available‐for‐sale.

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