Almirall and Forest Laboratories to Expand Respiratory Collaboration with LAS100977
NEW YORK & BARCELONA, Spain, Dec 17, 2009 (BUSINESS WIRE) -- Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) today announced that they have entered an agreement to develop, market and distribute LAS100977 in the United States. LAS100977 is an inhaled, once-daily administered long-acting beta2 agonist (LABA) that until now has been developed by Almirall to treat bronchoconstriction in asthmatic patients. Forest and Almirall will develop LAS100977 in combination with an undisclosed corticosteroid using Almirall's proprietary GENUAIR(R) inhaler for the treatment of both asthma and Chronic Obstructive Pulmonary Disease (COPD).
Under the terms of the agreement, Forest will make an upfront payment to Almirall of $75 million and will pay future, undisclosed milestone payments and sales based royalty payments. Forest will assume responsibility for the United States regulatory approval and commercialization.
"We are very pleased with this new agreement. Extending our collaboration with Forest is an excellent opportunity to maximize the value of LAS100977 for patients and investors," said Jorge Gallardo, Chairman and Chief Executive Officer of Almirall. "Forest has first class development and commercial capabilities and both parties can leverage from the current EKLIRA(R) (aclidinium bromide) collaboration to move forward these exciting respiratory compounds. This agreement is also a milestone in our aim to offer society innovative medicines to fulfill unmet medical needs," he added.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said, "We are pleased to have entered into this second major collaboration with Almirall, one of the premier innovators in the respiratory field. This agreement represents an exciting extension of the strong collaboration established with aclidinium bromide for COPD three years ago between Forest and Almirall and which will be completing Phase III studies in 2010. LAS100977 has shown very encouraging results in the completed Phase II studies, and we believe it will be a very competitive entrant in this large drug class. With the addition of LAS100977, Forest rounds out a broad COPD pipeline that was recently augmented with DAXAS(R) (roflumilast)and will also gain access to the larger asthma market with a once-daily inhaled corticosteroid/LABA combination."
LAS100977 is a highly potent novel once daily LABA that in early Phase II testing demonstrated fast onset and long-lasting (24-hour) efficacy with a very good tolerability profile in patients with stable asthma after multiple dosing.
With sales of over five billion dollars in the United States generating double digit annual growth, the combination LABA/ICS product class is one of the largest segments in the pharmaceutical industry. A once daily LAS100977/corticosteroid combination in the GENUAIR(R) device could be an attractive alternative to currently available LABA/corticosteroid combinations delivered twice daily.
The GENUAIR(R) inhaler*
LAS100977 will be developed using GENUAIR(R), a novel, state-of-the-art, multi-dose dry powder inhaler (MDPI). GENUAIR(R) was designed with an intuitive click and color feedback system which, through a colored control window and an audible click, indicates that the patient has inhaled correctly. The GENUAIR(R) inhaler incorporates significant safety features such as a visible dose indicator, an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.
Asthma is a chronic disease characterized by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. In affected individuals, symptoms may occur several times in a day or week, and for some people become worse during physical activity or at night.
The World Health Organization (WHO) estimates that 300 million people suffer from asthma and 255,000 people died of asthma in 2005. It is an under-diagnosed and under-treated disease that creates a substantial burden to individuals and families and possibly restricting individuals' activities for a lifetime.
COPD is not one single disease but an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow including 'chronic bronchitis' and 'emphysema.' 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.
COPD is preventable but not curable, although treatment can slow the progress of the disease. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases. COPD has a significant impact on quality of life for patients and their families and WHO estimates that 210 million people suffer from COPD and predicts that this disease will become the third leading cause of death worldwide by 20302.
Almirall is an international pharmaceutical company based on innovation and committed to health, headquartered in Barcelona, Spain. The company researches, develops, manufactures and commercializes its own R&D and licensed medicines 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 other dermatology indications.
Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 11 affiliates.
For further information: http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.almirall.com&esheet=6123002&lan=en_US&anchor=www.almirall.com&index=1&md5=121d4c63686e1d9444ef1374e3b3cd86
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 http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.FRX.com&esheet=6123002&lan=en_US&anchor=www.FRX.com&index=2&md5=999c6e2a8d7197c7f4d28ed4f96a83bc.
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.
*GENUAIR(R) and EKLIRA(R) are registered trademarks of Laboratorios Almirall, S.A and are pending approval from the appropriate regulatory authorities.
+DAXAS(R) is a registered trademark of Nycomed GmbH Corporation and is pending approval from the appropriate regulatory authorities.
1 Extracted from http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.who.int&esheet=6123002&lan=en_US&anchor=www.who.int&index=3&md5=eb6091f6a8d8408ff160c6b7a1650b12 - Fact sheet No 307, May 2008
2 World Health Organization (WHO): Chronic obstructive pulmonary disease (COPD), Fact Sheet 315. Website page available at: http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.who.int%2Fmediacentre%2Ffactsheets%2Ffs315%2Fen%2F&esheet=6123002&lan=en_US&anchor=http%3A%2F%2Fwww.who.int%2Fmediacentre%2Ffactsheets%2Ffs315%2Fen%2F&index=4&md5=3f9428236c8366d1034e1d1a84fa7de3
SOURCE: Forest Laboratories, Inc.