Forest Laboratories : FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD...

Mar 01, 2011 - Forest Announces FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD Associated with Chronic Bronchitis and a History of Exacerbations - Forest Laboratories, Inc. (NYSE: FRX) announced that Daliresp [TM] (roflumilast) was approved by the U.S. Food and Drug Administration (FDA) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The efficacy and safety of Daliresp was evaluated in eight clinical studies including 9,394 adult patients.

COPD is an under-diagnosed, progressive, irreversible lung disease. Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms - called an exacerbation - can last several weeks and often requires substantial medical intervention, including hospitalization.

Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved and is an oral tablet taken once daily. While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells. Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011... Forest Laboratories' Press Release -

Forest Laboratories and Almirall : Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With COPD

Sept. 3, 2008 - Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD).

In both the ACCLAIM/COPD I&II (AClidinium CLinical Trial Assessing Efficacy and Safety In Moderate to Severe COPD Patients) studies, once-daily aclidinium bromide showed a statistically significant difference vs. placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in moderate to severe COPD patients... Forest Laboratories' Press Release -

Almirall & Forest : Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD

May 20, 2008 - Forest Laboratories, Inc. and Laboratorios Almirall, S.A. presented results from four clinical trials assessing the efficacy and safety of aclidinium bromide, an investigational treatment for chronic obstructive pulmonary disease (COPD). Data from four preclinical studies further describing the properties of aclidinium were also presented at the meeting.

Presentations included data from a 464-patient randomized, double-blind, four-week, Phase IIb study that evaluated both the efficacy and tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or 400 mcg) or placebo in patients with moderate to severe COPD. An open-label tiotropium (18 mcg) arm was included as an active control... Forest Laboratories' Press Release - Almirall's Press Release -

Glenmark, USD 15 million as milestone payments from Forest for Oglemilast, GRC 3886

February 06, 2008 – Glenmark Pharmaceuticals Ltd. [Glenmark], announced that its wholly owned Swiss subsidiary Glenmark Pharmaceuticals SA (GSA), has received a milestone of USD 15 Million from Forest Labs, which is Glenmark’s North American partner for Oglemilast (GRC 3886). This follows a favourable response from USFDA, allowing Forest to initiate an additional Phase II study in COPD for Oglemilast. Glenmark and Forest Labs are working together closely to initiate additional studies for further longer term development of Oglemilast, including a Phase II study in Asthma... [PDF] Glenmark Pharmaceuticals' Press Release -

Forest Laboratories, single doses of inhaled aclidinium produced a significant bronchodilatory response in 17 patients with COPD

Sept. 18, 2007 - Forest Laboratories (NYSE: FRX) announced today that single doses of inhaled aclidinium produced a significant bronchodilatory response in 17 patients with COPD according to results of a phase IIa trial presented today at the European Respiratory Society (ERS) Annual Congress in Stockholm... Forest Laboratories' Press Release -