Forest Laboratories
(
FRX
) is facing another delay where the approval of one of its pipeline
candidates is concerned. The company and its partner,
Ironwood Pharmaceuticals, Inc.
(
IRWD
) recently announced that the FDA has extended the review period
for their new drug application for linaclotide.
Forest Labs and Ironwood are looking to get linaclotide approved
for the treatment of irritable bowel syndrome with constipation
(IBS-C) and chronic constipation (CC). The FDA has extended the
review period by three months which means a decision should be out
by September 2012. The FDA was previously scheduled to respond in
June 2012.
Why the Delay?
The FDA had recently asked Forest Labs and Ironwood to provide
an additional analysis of existing data. With the analysis being
presented within three months of the FDA action date, the agency
extended the review period by three months in accordance with the
rules. The companies mentioned that they were not asked to submit
new data.
Second Delay for Forest Labs
This is the second time this year that Forest Labs is facing a
delay in the approval of its pipeline candidates. A few weeks back,
Forest Labs had announced a three-month extension of the FDA action
date for aclidinium bromide.
Forest Labs and partner Almirall are looking to get aclidinium
bromide approved for the maintenance treatment of chronic
obstructive pulmonary disease (COPD). With the FDA pushing out the
action date by three months, a response regarding the approvability
of aclidinium bromide should be out by July. The agency has not
asked for additional data.
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 needs to build its portfolio as the company is
facing a major patent cliff now that its key revenue generator,
Lexapro, is facing generic competition. While
Teva
(
TEVA
) launched its generic version of Lexapro recently,
Mylan
(
MYL
) is marketing an authorized generic version of the product.
Moreover, Forest Labs' Namenda will face generic competition in
early 2015 putting another $1+ billion at risk. That puts a lot of
pressure on the pipeline to come through.
FOREST LABS A (
FRX
): Free Stock Analysis Report
IRONWOOD PHARMA (
IRWD
): Free Stock Analysis Report
MYLAN INC (
MYL
): Free Stock Analysis Report
TEVA PHARM ADR (
TEVA
): Free Stock Analysis Report
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