Forest Labs Files Linaclotide NDA - Analyst Blog
August 12 2011 - 11:50AM
Zacks
Forest Laboratories, Inc. (FRX) and partner
Ironwood Pharmaceuticals, Inc. (IRWD) 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).
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
Zacks Investment Research
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jul 2023 to Jul 2024