Navigation Links
Forest Laboratories, Inc. and Laboratorios Almirall, S.A. Provide an Update on the Aclidinium Bromide Clinical Development Program
Date:3/6/2009

NEW YORK, March 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. today announced after consultation with the U.S. Food and Drug Administration (FDA), that additional clinical studies of aclidinium bromide for the treatment of chronic obstructive pulmonary disease (COPD) will be conducted to provide further support for the selected regimens, including higher and/or more frequent doses. This decision follows a meeting with the FDA to review the previously reported ACCLAIM/COPD I and II studies. The Companies originally anticipated filing a New Drug Application (NDA) in the fourth quarter of 2009 or the first quarter of 2010, pending FDA feedback. Timelines for the development of the additional clinical studies and the future filing date of an NDA, including the ACCLAIM studies, are being determined.

(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

About COPD

The World Health Organization (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and 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.

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(1). There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function and control exacerbations.

About aclidinium bromide and Genuair(R)

Aclidinium bromide is a novel, long-acting inhaled anticholinergic bronchodilator which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors. Aclidinium is rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest Laboratories licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound.

Aclidinium bromide is administered to patients using a novel, state-of-the-art multidose dry powder inhaler (MDPI), Genuair(R)(2). Genuair(R) was designed with an intuitive feedback system, which through a 'colored control window' and an audible click indicates that the patient has inhaled correctly. The Genuair(R) inhaler contains multiple doses with a visible dose level indicator and also incorporates significant 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 Forest Laboratories

Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, 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 Report on Form 10-Q, and any subsequent SEC filings.

About Almirall

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

The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology in general.

Almirall is currently present in over 70 countries with direct presence in Europe and Latin America through 11 affiliates.

For further information please visit the website at: www.almirall.com

        (1) WHO fact sheet 315. May 2008. Chronic obstructive pulmonary
            Disease (COPD).

        (2) Genuair is a registered trademark of Laboratorios Almirall, S.A.
            It is the proposed registered trademark for the Multiple-Dose Dry
            Powder Inhaler (MDPI) and is pending regulatory approval.


'/>"/>
SOURCE Forest Laboratories, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Management of Fibromyalgia
2. Ironwood and Forest Present Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
3. Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder
4. Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific Conference
5. Forest Laboratories Announces Positive Results from Phase III Clinical Studies of Ceftaroline for the Treatment of Complicated Skin and Skin Structure Infections
6. Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
7. Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD
8. Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
9. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
10. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
11. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... Summary This report provides all the information ... interests and activities since 2010. Description The Partnering Deals ... the partnering activity of one of the world,s leading life ... upon purchase to ensure inclusion of the most up to ... be delivered in PDF format within 1 working day of ...
(Date:3/27/2017)... VANCOUVER, British Columbia , March 27, 2017 /PRNewswire/ ... of Directors has appointed William "Bill" Dubiel as President ... Dubiel was also elected to the Board of Directors ... serve as the Executive Chairman of LightIntegra. ... become LightIntegra,s next President and Chief Executive Officer. We,ve ...
(Date:3/27/2017)... VANCOUVER, British Columbia, March 27, 2017  Sophiris ... "Company" or "Sophiris"), a clinical late-stage biopharmaceutical company ... with urological diseases, today reported fourth quarter and ... highlights. Key Corporate Highlights: ... for Localized Prostate Cancer. During 2016, the Company ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... Public relations pros work ... a variety of business channels. , While many results are clear, much of PR ... program. , When it comes to measurement, firms should always take an all-inclusive ...
(Date:3/28/2017)... ... 2017 , ... Oily skin is a common and unwelcomed occurrence in people of all ages, ... to offer to the discussion of dealing with excess skin oil. “Oily skin is a ... remedies that can help remove the oily shine while keeping the skin fresh and clean,” ...
(Date:3/28/2017)... ... ... and fungi are probably not the first ingredients that come to mind when thinking about ... your diet can actually improve health outcomes. And the good news is they may be ... new peer-reviewed paper led by Maria Marco, Ph.D. , University of California, ...
(Date:3/27/2017)... Ohio (PRWEB) , ... March 27, 2017 , ... New ... OH to replace their missing teeth can now have them placed by Dr. Manju ... the latest i-CAT® Cone Beam technology to increase the accuracy of each dental implant ...
(Date:3/27/2017)... TX (PRWEB) , ... March 27, 2017 , ... A ... Edward Buckingham MD, and his colleague, Sudeep Roy, MD, was recently published in ... Bipolar Electrocautery Efficacy in Rhytidectomy” details Drs. Buckingham and Roy’s study on the use ...
Breaking Medicine News(10 mins):