Almirall and Forest Laboratories announce FDA has extended the review period for Aclidinium Bromide
- Three months extension to complete the review of Aclidnium NDA
- No additional data requested by the agency
- FDA action expected by July 2012
Barcelona and New York, 29 march 2012.- Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE:FRX) announced today that the U.S. Food and Drug Administration (FDA) will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). No additional data has been requested by the agency to complete the review. FDA action is now expected by July 2012.
This FDA notification follows the Pulmonary-Allergy Drugs Advisory Committee (PADAC) February 2012 meeting in which the committee endorsed the efficacy and safety of twice-daily aclidinium bromide 400ug with a positive 12 to 2 vote in favor of approval.
The efficacy and safety of aclidinium was studied in a clinical trial program including 2,717 COPD patients in 9 studies. In these trials, aclidinium demonstrated significant improvement in lung function and symptoms, with a low incidence of side effects, comparable to placebo.
Aclidinium was also submitted to EMA for approval in July 2011. The regulatory process in on track and response is expected during 2012.
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 was administered to patients in trials using a novel, investigational state-of-the-art multidose 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.
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.
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.
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 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.
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