Forest Laboratories, Inc. (NYSE:FRX) today announced that it will present data on aclidinium, aclidinium/formoterol combination, and roflumilast at the American Thoracic Society (ATS) 2014 International Conference scheduled for May 16-21, 2014, in San Diego. Ten posters and two poster discussion sessions will be presented for aclidinium and aclidinium/formoterol. Roflumilast data will be highlighted in four posters and one mini symposia presentation.

During the ATS session titled “It’s No Longer a Secret Service: Updates in COPD Pharmacotherapy” on Monday, May 19, from 2:00 pm-4:30 pm PDT, the following two poster discussions will take place:

“The Effect of Aclidinium/Formoterol Fixed-Dose Combination on COPD Symptoms and Health Status in Patients with COPD: Results from the ACLIFORM/COPD Study”

“Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination: Lung Function Improvements in the AUGMENT COPD Trial in Patients with Moderate to Severe COPD”

The roflumilast presentation will be included in the mini symposium “The Smoke is Clearing: Translational Discoveries on COPD Pathogenesis,” scheduled for Tuesday, May 20, from 8:15-10:45 am PDT:

“Roflumilast Aids Airway Surface Liquid Recovery after Cigarette Smoke Exposure in Primary Human Bronchial Epithelia Cultures”

Also being presented are the following posters:

Aclidinium and Aclidinium/Formoterol

Efficacy And Safety Of Formoterol Fumarate Via Pressair® Versus Foradil® Aerolizer® in Patients with Mild to Moderate Asthma (poster #B34; May 18, 10:45 AM - 12:30 PM PDT), authored by J.A. Bernstein, M.D.

Evaluation of the Psychometric Properties of the Nighttime Symptoms of COPD Instrument (NiSCI), (poster #C78; May 21, 10:45 AM - 12:30 PM PDT), authored by M. Mocarski

Aclidinium/Formoterol Fixed-Dose Combination Improves Bronchodilation and is Well Tolerated in Patients with COPD: Results from the ACLIFORM/COPD Study (poster #A114; May 21, 10:45 AM - 12:30 PM PDT), authored by D. Singh

Evaluation of Major Adverse Cardiovascular Events and COPD Exacerbations in a Long-Term Study of Aclidinium Bromide in Patients with Moderate to Very Severe COPD: ASCENT COPD Rationale and Design (poster #A129; May 21, 10:45 AM - 12:30 PM PDT), authored by R.A. Wise

Efficacy Of Fixed-Dose Combination Aclidinium Bromide/Formoterol Fumarate on Bronchodilation Over 1 Year: AUGMENT COPD Extension Trial in Patients with Moderate to Severe COPD (poster #A133; May 21, 10:45 AM - 12:30 PM PDT), authored by A.D. D’Urzo

Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Improve Breathlessness And Health Status In COPD Patients: AUGMENT COPD Trial (poster #A134; May 21, 10:45 AM - 12:30 PM PDT), authored by S.I. Rennard

Long-Term Safety of Fixed-Dose Combination Aclidinium Bromide/Formoterol Fumarate in Patients with Moderate to Severe COPD: The AUGMENT COPD Extension Trial (poster #A135; May 21, 10:45 AM - 12:30 PM PDT), authored by S.I. Rennard

Safety and Tolerability of Fixed-Dose Combination Aclidinium Bromide/Formoterol Fumarate: Results of Two 6-Month Studies in Patients with Moderate to Severe COPD (poster #A136; May 21, 10:45 AM - 12:30 PM PDT), authored by B.J. Make

Lung Function and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination: Results of a 1-Year Trial in Patients with COPD (poster #A137; May 21, 10:45 AM - 12:30 PM PDT), authored by B.J. Make

Cardiovascular Safety of Fixed-Dose Combination Aclidinium Bromide/Formoterol Fumarate: Results of Two 6-Month Studies in Patients with Moderate to Severe COPD (poster #A138; May 21, 10:45 AM - 12:30 PM PDT), authored by J.F. Donohue

Roflumilast

Healthcare Costs Associated with Roflumilast Treatment among Patients Hospitalized for COPD in a Managed Care Population (poster #J14; May 18, 10:45 AM - 12:30 PM PDT), authored by S.X. Sun

Impact of Roflumilast on COPD Exacerbations, Healthcare Utilization and Costs in a Medicare Advantage Population (poster #J19; May 18, 10:45 AM - 12:30 PM PDT), authored by J.J. Ellis

Anti-Inflammatory Effects Of Dexamethasone, Roflumilast N-Oxide, Formoterol and Their Combinations in Human Neutrophils From Healthy and Chronic Obstructive Pulmonary Disease Patients (poster #B58; May 19, 10:45 AM - 12:30 PM PDT), authored by J. Milara

Roflumilast Inhibits IL-13-Induced Mucous Metaplasia in Airway Epithelium (poster #G1; May 20, 10:45 AM - 12:30 PM PDT), authored by S.M. Kreda

About Aclidinium Bromide

TUDORZA PRESSAIR (aclidinium bromide inhalation powder) is an anticholinergic indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. When given by inhalation, Tudorza produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle.

Important Safety Information

TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (i.e., rescue therapy).

Inhaled medicines, including TUDORZA, may cause paradoxical bronchospasm. In addition, immediate hypersensitivity reactions may occur after administration of TUDORZA. If either of these occurs, treatment with TUDORZA should be stopped and other treatments considered.

TUDORZA should be used with caution in patients with narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop.

Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to TUDORZA. Use with caution in patients with severe hypersensitivity to milk proteins.

The most common adverse reactions (≥3% incidence and greater than placebo) were headache (6.6% vs. 5.0%), nasopharyngitis (5.5% vs. 3.9%), and cough (3.0% vs. 2.2%), for TUDORZA vs. placebo, respectively.

About Aclidinium/Formoterol

Aclidinium bromide/formoterol fumarate is an investigational fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action and similar pharmocodynamic profiles. Aclidinium bromide is an anticholinergic or long-acting muscarinic antagonist (LAMA) that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation.

Both aclidinium bromide (TUDORZA®/ EKLIRA®) and formoterol fumarate are approved separately for the maintenance treatment of COPD in the United States and Europe.

About Roflumilast

DALIRESP (roflumilast) 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 not a bronchodilator and is not indicated for the relief of acute bronchospasm.

Important Safety Information

Contraindications

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

Warnings and Precautions

Treatment of Acute Bronchospasm

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

Psychiatric Events including Suicidality

Prescribers should advise patients, their caregivers, and families 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 evaluate the risks and benefits of continuing treatment if such events occur. Before using DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with DALIRESP.

Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. In controlled clinical trials 5.9% of patients treated with DALIRESP reported psychiatric adverse reactions vs. 3.3% treated with placebo. The most common psychiatric adverse reactions were insomnia (2.4% vs. 1.0%), anxiety (1.4% vs. 0.9%), and depression (1.2% vs. 0.9%). 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.

Weight Decrease

Patients should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated and treatment discontinuation considered.

In addition to weight loss being reported as a common adverse reaction (7.5% of patients treated with DALIRESP vs. 2.1% placebo), weight was prospectively assessed in two 1-year clinical trials. In these studies that compared DALIRESP to placebo, 20% vs. 7% experienced moderate weight loss (5-10% of body weight) and 7% vs. 2% experienced severe weight loss (>10% body weight). During the follow-up period after discontinuing DALIRESP, the majority of patients regained some of the weight they had lost.

Drug Interactions

Use with strong cytochrome P450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended, as they decrease the exposure and may reduce the therapeutic effectiveness of DALIRESP.

Adverse Reactions

In clinical trials the most common adverse reactions (≥2% and greater than placebo) were diarrhea (9.5% vs. 2.7%), weight loss (7.5% vs. 2.1%), nausea (4.7% vs. 1.4%), headache (4.4% vs. 2.1%), back pain (3.2% vs. 2.2%), influenza (2.8% vs. 2.7%), insomnia (2.4% vs. 1.0%), dizziness (2.1% vs. 1.1%), and decreased appetite (2.1% vs. 0.4%).

About COPD

The World Health Organization (WHO) has described COPD as a global epidemic; an estimated 64 million people have COPD worldwide. More than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke. WHO predicts that COPD will become the third leading cause of death worldwide by 2030. COPD is already the third leading cause of death in the U.S.

In patients with COPD the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness (or a "need for air"), abnormal sputum (a mix of saliva and mucus in the airway), and chronic cough. As the condition worsens and breathlessness increases, daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult. New therapies to treat this debilitating disease may be of value.

About Forest Laboratories, Inc.

Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Forest’s strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows Forest to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. In January 2014, Forest acquired Aptalis Pharmaceuticals for $2.9 billion in cash in order to gain access to its GI and Cystic Fibrosis products, including treatments for Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic Insufficiency. In February 2014, Forest and Actavis plc announced an agreement where Forest would be acquired for about $25 billion in cash and stock. The acquisition of Forest by Actavis is contingent upon regulatory and shareholder approvals.

Forest is headquartered in New York, NY.

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 potential that the presentations identified above are not given at all or at the times or locations specified, in addition to the risk factors listed from time to time in each of Forest's and Ironwood's Annual Reports on Form 10‐K, Quarterly Reports on Form 10‐Q, and other SEC filings. Neither Forest nor Ironwood undertakes any obligation to update these forward-looking statements to reflect events or circumstances occurring after this press release. These forward looking statements speak only as of the date of this press release. All forward‐looking statements are qualified in their entirety by this cautionary statement.