Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc. announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC). Analyses of the data indicate that in both multicenter, randomized double-blind, placebo-controlled trials, statistical significance was achieved for the primary endpoint of 12-week complete spontaneous bowel movement (CSBM) overall responder at the two doses studied in each tria (133 mcg/day: p-values(LTE)0.0012 and 266 mcg/day: p-values<0.0001). In both trials, statistical significance (p<0.01) was achieved for all prespecified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs. These two trials are part of Ironwood and Forest's larger Phase 3 program investigating the effect of linaclotide treatment on patients with CC or irritable bowel syndrome with constipation (IBS-C). The companies are currently enrolling two additional pivotal Phase 3 trials in North America to assess the safety and efficacy of linaclotide in patients with IBS-C and expect results in the second half of calendar year 2010. Trial 01 was conducted in 633 patients meeting modified Rome II criteria for CC. The trial included a two-week pretreatment baseline period and a 12-week treatment period. The primary efficacy endpoint was 12-week CSBM overall responder. A 12-week CSBM overall responder is a patient who had three or more CSBMs per week and an increase of at least one CSBM per week over baseline for at least nine of the 12 weeks of the treatment period.

Forest Laboratories Inc. and Gedeon Richter plc announced positive top-line results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia. For the primary endpoint, the Positive and Negative Syndrome Scale (PANSS), the data showed that patients with schizophrenia treated with cariprazine experienced significant symptom improvement compared to placebo patients within the first week of treatment and at each subsequent time point studied. Based on this latest schizophrenia data, subject to a complete review of the full results, and the previously announced Phase II results in patients suffering from acute mania associated with bipolar I disorder, the companies intend to initiate Phase 3 trials for both indications in early 2010. Cariprazine is currently also undergoing Phase II clinical trials in patients with Bipolar Depressive Disorder and as adjunctive therapy in Major Depressive Disorder.

Forest Laboratories Inc. announced consolidated earnings results for the second quarter and six months ended September 30, 2009. For the quarter, the company reported net income of $186.66 million or $0.61 per diluted share on net revenue of $1,063.93 million compared to net income of $244.08 million or $0.80 per diluted share on net revenue of $992.50 million for the same period a year ago. Income before income tax expense was $254.77 million compared to $314.89 million for the same period a year ago. Non-GAAP diluted earnings per share was $0.85 compared to $0.80 for the same period a year ago. For the six months, the company reported net income of $449.56 million or $1.48 per diluted share on net revenue of $2,072.09 million compared to net income of $487.01 million or $1.59 per diluted share on net revenue of $1,959.35 million for the same period a year ago. Income before income tax expense was $587.24 million compared to $629.32 million for the same period a year ago. Non-GAAP diluted earnings per share was $1.72 compared to $1.67 for the same period a year ago. The company now expects that diluted earnings per share for the fiscal year ending March 31, 2010, excluding the net one-time charges in the current quarter of $0.24 per share, will be in the range of $3.40 to $3.50. The revised guidance maintains total revenues of $4.1 billion excluding the AstraZeneca license payment, and reflects incremental SG&A expense attributable to pre-launch spending for Daxas and total R&D spending, excluding the Daxas license payment, of $610 million, including a third Phase III study for aclidinium and total milestone expense of $80 million.