Forest and Almirall to Present Aclidinium Bromide Clinical Data at the American Thoracic Society (ATS) International Conference

ATS 2012

NEW YORK--()--Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) today announced that they will present aclidinium-related data in 1 poster discussion session and 3 poster presentations at the American Thoracic Society (ATS) International Conference scheduled May 18 - 23 in San Francisco, CA. Positive top-line results from the aclidinium pivotal double-blind placebo-controlled studies were first reported in 2011. Aclidinium bromide is a new, inhaled long-acting antimuscarinic agent currently under review by the FDA for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).

The poster discussion titled “Long-Term Efficacy And Safety of Twice-Daily Aclidinium Bromide in COPD Patients: A One-Year Study” will take place on Sunday, May 20 from 2:00 - 4:30 pm. This presentation will report the results from the long-term efficacy and safety study of aclidinium bromide in 600 patients over 52 weeks of treatment.

In addition, there will be the following poster presentations:

  • Long-Term Extension Study Of ACCORD COPD I: Effects Of Two Doses Of Twice-Daily Aclidinium Bromide In COPD Patients (Poster D43: Monday, May 21 from 8:15 am - 4:30 pm)
  • Nighttime Symptoms Of COPD And Associated Reductions In Quality Of Life In A Clinical Trial Population (Poster D56: Wednesday, May 23 from 8:15 am - 4:30 pm)
  • COPD Patients’ Experience Of Early Morning Symptoms: Results From Qualitative Research (Poster D57: Wednesday, May 23 from 8:15 am - 4:30 pm)

About aclidinium bromide

Aclidinium bromide is a novel, long-acting inhaled antimuscarinic agent, often referred to as an anticholinergic, that has a long residence time at M3 receptors and a shorter residence time at M2 receptors. When given by inhalation, aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Aclidinium is rapidly hydrolyzed in human plasma into two major inactive metabolites. Forest Laboratories, Inc. licensed U.S. rights for aclidinium from Almirall, while Kyorin Pharmaceutical Co., Ltd holds marketing rights in Japan and Daewoong Pharmaceutical Co., Ltd is licensed to market aclidinium in Korea. Almirall has recently given rights of joint commercialization in the majority of European member states and a number of non-EU countries to Menarini. Almirall maintains rights for the rest of the world. Almirall and Forest are jointly involved in the development of the compound.

Aclidinium bromide was administered to patients in trials using a novel, investigational state-of-the-art multi-dose dry powder inhaler (MDPI). This inhaler was designed with a feedback system which, through a ‘colored control window’ and an audible click, helps confirm that the patient has inhaled correctly. It contains multiple doses of aclidinium, includes a visible dose-level indicator, and also incorporates safety features such as an anti-double-dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

About COPD

COPD, or Chronic Obstructive Pulmonary Disease, is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe. 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 United States.

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 a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens. New therapies to treat this debilitating disease may be of value.

About Almirall

Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercializes its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.

Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD, gastrointestinal disorders, psoriasis and other dermatological conditions.

Almirall’s products are currently present in more than 70 countries while it has direct presence in Europe and Latin America through 12 affiliates.

For further information please visit: www.almirall.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, respiratory, gastrointestinal and pain management medicine. Forest’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.

Contacts

Forest Laboratories, Inc.
Frank J. Murdolo, 1-212-224-6714
Vice President - Investor Relations
Frank.Murdolo@frx.com

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Contacts

Forest Laboratories, Inc.
Frank J. Murdolo, 1-212-224-6714
Vice President - Investor Relations
Frank.Murdolo@frx.com