Forest Labs Files Linaclotide NDA


Forest Laboratories, Inc. (NYSE:FRX - News) and partner Ironwood Pharmaceuticals, Inc. (NasdaqGS:IRWD - News) recently announced that they have submitted a New Drug Application (:NDA) to the US Food and Drug Administration (:FDA) for linaclotide. The companies are seeking approval for the use of linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (:CC).

The NDA includes efficacy and safety data from a phase III program which included four double-blind placebo-controlled trials and two open-label long term safety studies. More than 2,800 patients participated in the four placebo-controlled clinical trials.

Results showed that patients in the linaclotide arm achieved statistically significant improvements in abdominal and bowel symptoms compared to placebo-treated patients for all primary and secondary endpoints.

Partnership with Ironwood Dates Back to Sep 2007

Forest Labs and Ironwood entered into an agreement for the co-development and marketing of linaclotide in Sep 2007. While the companies intend to co-promote linaclotide in the US, Almirall, SA has rights for the development and commercialization of linaclotide in Europe.

Meanwhile, Astellas Pharma is responsible for the development and commercialization of linaclotide in Japan, Indonesia, Korea, the Philippines, Taiwan and Thailand.

Linaclotide’s approval would be a major boost for Forest Labs. Roughly half the company’s top-line will be exposed to generic competition from March 2012 once Lexapro loses patent protection. Namenda will face generic competition in early 2015 -- this puts another $1+ billion at risk. Given the situation, Forest Labs needs new products in its portfolio which will help lessen the impact of generic competition.

Neutral on Forest Labs

We currently have a Neutral recommendation on Forest Labs, which carries a Zacks #3 Rank (short-term Hold rating).

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