Needham & Company Maintains a 'Hold' on Forest Labs (FRX); FDA Overwhelmingly Backs Approval of Aclidinium

February 24, 2012 8:30 AM EST
Get Alerts FRX Hot Sheet
Price: $12.00 --0%

Rating Summary:
    10 Buy, 12 Hold, 0 Sell

Rating Trend: = Flat

Today's Overall Ratings:
    Up: 13 | Down: 14 | New: 11
Join SI Premium – FREE
Needham & Company maintains a 'Hold' on Forest Laboratories (NYSE: FRX).

Analyst, Elliot Wilbur, said, "The FDA’s Pulmonary-Allergy Drugs Advisory Committee (AdCom) convened on Thursday (2/23/2012) to review the efficacy/safety of aclidinium (proposed brand name: Tudorza Pressair) as a treatment for COPD. Given the benign background documents released prior to the meeting, it was no surprise that the AdCom voted overwhelmingly (12-2) in support of FDA approval for aclidinium in its proposed indication."

"Aclidinium successfully met its primary endpoint (improvement in baseline FEV1) in three pivotal studies (COPD I, COPD II and ATTAIN) at weeks 12 and 24. The magnitude of FEV1 improvement with aclidinium 400 mg BID ranged from 72 mL to 124 mL across the three trials. The AdCom voted 12-0 in support of aclidinum’s efficacy in treating COPD. Some committee members expressed support for the strong bronchodilatory effect of aclidinium but believed other efficacy endpoints such as exacerbations were favorable but not compelling."

For an analyst ratings summary and ratings history on Forest Laboratories click here. For more ratings news on Forest Laboratories click here.

Shares of Forest Laboratories closed at $32.21 yesterday.


Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Analyst Comments, FDA

Related Entities

Needham & Company