Delay in Forest Drug FDA Action Date - Analyst Blog
March 30 2012 - 12:33PM
Zacks
Forest Laboratories, Inc. (FRX) will be facing
a delay where the approvability status of one of its pipeline
candidates is concerned. The company recently announced that the US
Food and Drug Administration (FDA) has extended its action date for
aclidinium bromide by three months.
Forest Labs and partner Almirall are looking to get aclidinium
bromide approved for the maintenance treatment of chronic
obstructive pulmonary disease (COPD).
We note that last month, aclidinium bromide had received a
positive recommendation from the FDA’s Pulmonary-Allergy Drugs
Advisory Committee (PADAC). The committee voted 12 to 2 in favor of
approving aclidinium bromide for the maintenance treatment of COPD.
The committee also voted unanimously in favor of the efficacy and
10-3 in favor of the safety of the 400 ug twice daily dose.
With the FDA pushing out the action date by three months, a
response regarding the approvability of the candidate should now be
out by July. The agency has not asked for additional data.
Forest Labs currently has another candidate, linaclotide, under
FDA review. Linaclotide, which is partnered with Ironwood
Pharmaceuticals (IRWD), is under review for the treatment
of constipation-predominant irritable bowel syndrome and chronic
constipation. A response on linaclotide should be out in June
2012.
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.
We currently have a Neutral recommendation on Forest Labs.
FOREST LABS A (FRX): Free Stock Analysis Report
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