Ironwood provides investor update for second-quarter 2010

Ironwood PharmaceuticalsAug 7 2010

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its business activities for the second quarter of 2010.

Second Quarter 2010 Highlights

Linaclotide

• Both confirmatory Phase 3 clinical trials being carried out by Ironwood and its U.S. partner, Forest Laboratories, Inc., assessing the efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation (IBS-C), are fully enrolled. Ironwood and Forest anticipate reporting top-line results from the two trials separately in the fourth quarter of 2010. Subsequent to each top-line data release, Ironwood and its European partner, Almirall, S.A., will report top-line results on the same data measured against the E.U. co‐primary efficacy endpoints which evaluate abdominal pain/ abdominal discomfort and IBS degree of relief. Ironwood and Forest are targeting a New Drug Application submission to the U.S. Food and Drug Administration (FDA) in the middle of 2011.
• The FDA issued draft guidance earlier this year on the design of clinical trials for IBS-C. Among other recommendations, the draft guidance recommends primary efficacy endpoints assessing abdominal pain (≥ 30 percent average weekly reduction vs. baseline) and stool frequency (increase of one or more complete spontaneous bowel movements (CSBMs) per week vs. baseline). Ironwood and Forest are amending the clinical trial protocols in both ongoing Phase 3 IBS-C clinical trials and have proposed to the FDA to add an additional primary efficacy endpoint that is consistent with the draft FDA guidance. This additional endpoint is as follows:
  • Six out of 12-week abdominal pain and CSBM responder: a patient who, for at least six of the 12 weeks of the treatment period, (a) has at least a 30 percent average weekly reduction in abdominal pain from baseline and (b) has an increase of one or more CSBMs per week from baseline.

Adding this endpoint to the clinical trial protocols will ensure that the studies include analyses that conform to the FDA's most current thinking as reflected in the draft guidance. This endpoint is in addition to the original primary efficacy endpoints, which are as follows:

• Nine out of 12-week abdominal pain and CSBM responder: a patient who, for at least nine of the 12 weeks of the treatment period, meets the both the abdominal pain and CSBM responder criteria listed below;
• Nine out of 12-week CSBM responder: a patient who, for at least nine of the 12 weeks of the treatment period, has three or more CSBMs per week and an increase of one or more CSBMs per week from baseline; and
• Nine out of 12-week abdominal pain responder: a patient who, for at least nine of the 12 weeks of the treatment period, has at least a 30 percent average weekly reduction in abdominal pain from baseline.

Corporate

• 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 securities.