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Biopharmaceuticals FDA

 News Release - March 1, 2011

Forest Announces FDA Approval of Daliresp(TM) (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

NEW YORK--(Healthcare Sales & Marketing Network)-- Forest Laboratories, Inc. (NYSE:FRX ) announced today 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.

“We are pleased with the FDA approval of Daliresp and we are looking forward to making this treatment available in the United States for the millions of patients suffering from severe COPD,” commented Howard Solomon, Chairman, Chief Executive Officer and President of Forest Laboratories. “The approval of Daliresp gives physicians and patients a much needed treatment option in a unique oral dosage form that can augment the existing armamentarium of inhaled therapies.”

“The introduction of Daliresp as an additional treatment option to reduce the risk of COPD exacerbations is an important development for patients with severe COPD associated with chronic bronchitis and a history of exacerbations,” said Professor Stephen Rennard, M.D., University of Nebraska Medical Center and clinical trial investigator.* “Reducing the risk of COPD exacerbations is an important goal of COPD treatment.”

Data Highlights

The efficacy and safety of Daliresp was evaluated in eight randomized double-blind, controlled, parallel group clinical trials involving 9,394 adult patients, of which 4,425 were treated with Daliresp 500 mcg.

1-Year Exacerbation Trials Supporting Approval

Of the eight trials, two 1-year trials supported approval and enrolled patients with severe COPD associated with chronic bronchitis, at least one COPD exacerbation in the previous year, and at least a 20 pack-year smoking history. In these trials, long-acting beta-agonists and short-acting anti-muscarinics were used by 44% and 35% of patients treated with Daliresp and 45% and 37% of patients treated with placebo, respectively. The rate of exacerbations (moderate or severe) was one of the co-primary endpoints. Moderate exacerbations were defined as requiring intervention with systemic glucocorticosteroids and severe exacerbations were defined as leading to hospitalization and/or to death. One of these trials randomized a total of 1525 patients (765 on Daliresp) and the other randomized a total of 1571 patients (772 on Daliresp). In both trials, Daliresp 500 mcg once daily demonstrated a significant reduction in the rate of moderate or severe exacerbations compared to placebo. Daliresp reduced the rate of moderate or severe exacerbations by 15% in one trial and by 18% in the other trial.

These trials also evaluated the effect of Daliresp on lung function as the other co-primary endpoint. Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

Summary of All Studies

Of the eight trials, two were placebo-controlled dose selection trials, four were placebo-controlled 1-year trials primarily designed to evaluate the efficacy of Daliresp on COPD exacerbations, and two were 6-month trials with Daliresp as add-on therapy to a long-acting beta-agonist or long-acting anti-muscarinic which provide safety support for the Daliresp COPD program. The initial two 1-year trials identified the patient population that could benefit from Daliresp; FDA approval of Daliresp was based on the results from the two subsequent 1-year exacerbation trials that are described above.

Safety

The most common adverse reactions, occurring in less than or equal to 10% of patients receiving Daliresp in the eight trials, included diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness, and decreased appetite.

About Daliresp

Daliresp (500 mcg) is a selective PDE4 inhibitor that is indicated as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Daliresp is a once-daily oral tablet and is the first and only selective PDE4 inhibitor approved by the FDA.

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. Daliresp is not a steroid, is not a bronchodilator, and is not indicated for the relief of acute bronchospasm.

Daliresp will be available nationwide in the second calendar quarter of 2011. In August 2009 Forest Laboratories and Nycomed entered into a definitive collaboration and distribution agreement pursuant to which Forest acquired an exclusive license for Daliresp in the United States.

Indication

Daliresp is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of use: Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

About COPD

COPD is an under-diagnosed, progressive, irreversible lung disease and is the third leading cause of death in the U.S. Approximately 12 million people in the U.S. are currently diagnosed with COPD and an additional 12 million are likely to have the disease and not know. Approximately half of COPD patients treated by a physician with controller medications have severe COPD. Of the patients diagnosed with severe COPD, almost three quarters, or 2.8 million, have chronic bronchitis.

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. Exacerbations can result in worsening health status, lung function decline, and increased risk of death.

Important Safety Information

Contraindications

Daliresp is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Warnings and Precautions

Acute Bronchospasm

Daliresp is not a bronchodilator and should not be used for the relief of acute bronchospasm.

Psychiatric Events including Suicidality

Treatment with Daliresp is associated with an increase in psychiatric adverse reactions (5.9% of patients treated with Daliresp versus 3.3% treated with placebo). Instances of suicidal ideation and behavior, including completed suicide, have been observed in clinical trials. Three patients treated with Daliresp experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) compared to one patient (suicidal ideation) treated with placebo. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Prescribers should carefully weigh the risks and benefits of treatment with Daliresp in patients with a history of depression and/or suicidal thoughts or behavior and evaluate the risks and benefits of continuing treatment if such events occur.

Weight Decrease

Weight loss was a common adverse reaction in Daliresp clinical trials (7.5% of patients treated with Daliresp vs 2.1% treated with placebo). In addition to being reported as adverse reactions, weight was prospectively assessed in two 1-year trials. In these studies, 20% of patients receiving Daliresp experienced moderate weight loss (5-10% of body weight) vs 7% receiving placebo and 7% receiving Daliresp vs 2% receiving placebo experienced severe weight loss (>10% body weight). During follow-up after treatment discontinuation, the majority of patients with weight loss regained some of the weight they had lost while receiving Daliresp. Patients treated with Daliresp should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of Daliresp should be considered.

Drug Interactions

Use of Daliresp with strong cytochrome P450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended. The risk of using Daliresp with inhibitors of CYP3A4 and/or CYP1A2 enzymes should be weighed carefully against benefit.

Adverse Reactions

The most common adverse reactions observed with Daliresp (incidence ≥ 2% and greater than placebo) were diarrhea (10% vs 3%), weight decreased (8% vs 2%), nausea (5% vs 1%), headache (4% vs 2%), back pain (3% vs 2%), influenza (3% vs 3%), insomnia (2% vs 1%), dizziness (2% vs 1%), decreased appetite (2% vs 0%).

Use in Specific Populations

There are no adequate and well controlled studies in pregnant women. Daliresp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Daliresp should not be used during labor and delivery.

Daliresp should not be used by women who are nursing as excretion of roflumilast and/or its metabolites into human milk is probable and there are no human studies that have investigated effects of Daliresp on breast-fed infants.

The safety and effectiveness of Daliresp have not been established in patients less than 18 years of age.

No overall differences were observed in safety or effectiveness between patients greater than or less than 65 years of age.

About Nycomed

Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio. Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy. Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets. Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion. For more information visit www.nycomed.com

About Forest Laboratories

Forest Laboratories’ (NYSE:FRX ) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

*Professor Stephen Rennard, M.D., University of Nebraska Medical Center is a paid consultant for Forest Laboratories.


Source: Forest Laboratories

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