Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM:MC) today announced that they will delay the planned Q4 2013 submission of a New Drug Application (NDA) for the combination of aclidinium bromide, a long acting muscarinic antagonist and formoterol fumarate, a long acting beta agonist, for the indication of Chronic Obstructive Pulmonary Disease (COPD). This decision was based on comments provided by the FDA at a recent pre-NDA meeting.
The delay is related to resolving chemistry, manufacturing and control (CMC) specifications associated with the combination formulation. Forest and Almirall are working with the FDA regarding the CMC related comments provided at the pre-NDA meeting to determine the appropriate next steps, and expects to provide an update when more information becomes available. The decision to delay the NDA filing for the combination does not affect the Tudorza® (alcidinium bromide) monotheraphy product.
Forest and Almirall recently announced positive phase III results from two pivotal clinical trials for aclidinium/formoterol. The combination was administered twice a day and primary end points were met which demonstrated statically significant improvements versus placebo. In addition, aclidinium/formoterol was well tolerated in both studies.
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 for the maintenance treatment of COPD in the United States and Europe.
Almirall is a pharmaceutical company committed to provide valuable medicines from our own R&D, external partnerships, licenses and collaborations. In 2012, Almirall invested over 23% of its sales in R&D. Through seeking innovative medicines we aim to become a relevant player in respiratory and dermatology diseases with also a strong interest in gastroenterology and pain. With more than 3,000 employees in 22 countries, Almirall generated total revenues of 900 million euros in 2012.
The company was founded in 1943 and is headquartered in Barcelona, Spain. The stock is traded in the Spanish stock exchange (ticker: ALM). For more information please visit www.almirall.com.
Tudorza™, Eklira®, Genuair® and Pressair™ are registered trademarks of Almirall S.A.
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. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.
Ana Gonzalez, +34 660 673 173
Jordi Molina, +34 93 291 30 87
Frank J. Murdolo, 1-212-224-6714
Vice President - Investor Relations
Sard Verbinnen & Co
Hugh Burns / Lesley Bogdanow / Pamela Blum
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