Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM:MC) announced today that Tudorza™ Pressair™ (aclidinium bromide inhalation powder) 400mcg is now available in pharmacies throughout the United States. Tudorza is a long-acting anticholinergic recently approved by the U.S. Food and Drug Administration (FDA) for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tudorza is the first long-acting inhaled anticholinergic approved by the FDA in over 8 years for COPD and is administered twice daily through the preloaded, multidose Pressair inhaler. Almirall granted commercialization rights in the U.S. for aclidinium to Forest Laboratories, Inc., Forest and Almirall will co-promote aclidinium in Canada. Almirall maintains rights for the rest of the world. Visit www.tudorza.com for more information about Tudorza Pressair. About Tudorza Pressair Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is an anticholinergic 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. Tudorza provides statistically significant improvements in bronchodilation, as measured by change from baseline in morning pre-dose trough FEV 1 at 12 weeks (the primary endpoint) and 24 weeks compared to placebo. Mean peak improvements in lung function (FEV 1) assessed after the first dose of Tudorza were similar to those observed at week 12. Tudorza is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy). Tudorza is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide powder for inhalation. The Pressair inhaler has a colored control window which confirms successful inhalation of the full dose and a dose indicator to let patients know how many doses remain in the inhaler. For a complete description of how to use the Tudorza Pressair inhaler and when to get a new inhaler, see the step-by-step Instructions for Use within the Prescribing Information.
About COPDCOPD, 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 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. IMPORTANT SAFETY INFORMATION
- TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, 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 and placebo, respectively.
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. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.