NEW YORK and BARCELONA, Spain, April 10 /PRNewswire-FirstCall/ -- Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. and Almirall, a privately held pharmaceutical company headquartered in Barcelona, Spain, announced today that the two companies have entered an agreement to develop, market and distribute Almirall's novel inhaled, long-acting muscarinic antagonist, LAS34273, in the United States.
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The innovative LAS34273 is now entering Phase III studies in the United States and Europe for chronic obstructive pulmonary disease (COPD). LAS34273 has been evaluated in Phase II studies that demonstrate that it has a fast onset of action and provides 24 hours of bronchodilation. LAS 34273 is designed to have a very specific action in the lungs resulting in a low level of systemic exposure. Studies to date including cardiovascular safety studies support a favorable side effects profile. The product is being developed in a Multi Dose-Dry Powder Inhaler (MDPI) which represents an improvement in drug delivery over currently available devices.
This new treatment promises to provide relief for the many sufferers of COPD. According to the World Health Organisation, COPD is the 5th leading cause of death worldwide and the fourth in the US. Affecting over 12 million adults in the US, it is also estimated that a further 24 million show some evidence of impaired lung function highlighting a clear under diagnoses of COPD.(1) The condition, which is mainly caused by smoking, results in damage to the airways which triggers symptoms such as cough, breathlessness, excess sputum and chest infections.
Under terms of the agreement, Forest will make an upfront payment of $60 million to Almirall and will pay future undisclosed milestone payments. In addition, Almirall will receive royalty payments based on LAS34273 sales. Forest and Almirall will jointly oversee the development and regulatory approval of LAS34273 and share all expenses for current and future development programs. Almirall has granted Forest the rights of first negotiation for other Almirall respiratory products that could be combined with LAS34273.
Forest will be responsible for sales and marketing of LAS34273 in the US and Almirall has retained an option to co-promote the product in the future while retaining commercialization rights for the rest of the world. In addition to five years of Hatch-Waxman exclusivity granted upon approval, LAS34273 is protected by an issued US composition of matter patent expiring in 2020. Extension of exclusivity under Hatch-Waxman legislation is expected.
Howard Solomon, Chairman and Chief Executive Officer of Forest commented: "We are very pleased to be entering into this partnership with Almirall, which is the largest and a highly successful independent pharmaceutical company in Spain. We expect LAS34273 to become an important product in the treatment of COPD, a major respiratory disease that affects over 12 million people in the United States and is the nation's fourth leading cause of death. We have been very impressed by the clinical profile of the drug based on the Phase II study results as well as its convenient inhalation delivery system. LAS34273 is another later stage product that augments our growing pipeline and validates again our unique position and our business strategies."
"We are very pleased to be working with Forest to launch LAS34273 into the fast growing COPD market", said Dr. Jorge Gallardo, Chairman and Chief Executive Officer of Almirall. "Through this agreement we will collaborate with a strong and experienced partner who has a successful track record in building successful brands in the United States. We are confident that this will be a successful partnership leveraging Forest's proven skills in clinical development and marketing in the competitive US market. Both companies believe LAS34273 is a compelling product that has promising potential to become a leading treatment for patients suffering from COPD."
(1) American Lung Association
About Forest Laboratories
Forest Laboratories (http://www.frx.com ) is a US-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl- D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, each indicated for the treatment of hypertension; and Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities 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 the Forest Laboratories' SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2005, and on form 10-Q for the periods ended June 30, September 30, 2005 and December 31, 2005.
Almirall is an international pharmaceutical company that researches, develops and commercialises its own R&D and licensed specialties with the aim of improving health and quality of life. Almirall research products include AXERT9(R) (Almotriptan) for the treatment of migraine which was approved by the FDA in 2001 and is marketed by Ortho-McNeil, a division of Johnson & Johnson.
Almirall is to invest 750 million euros in R&D over the next five years. Almirall, whose headquarters are in Barcelona (Spain), has a staff of over 3,200 people, approximately 500 of whom work in R&D and with approximately 1000 working internationally in Almirall affiliate companies.
The therapeutic areas on which Almirall focuses its research resources are related to the treatment of COPD, asthma, psoriasis and rheumatoid arthritis. Almirall is currently present in approximately 100 countries with its own products and licensed products from other companies. The company is strengthening its direct presence in Europe and Latin America via affiliates in France, Germany, Italy, Portugal, Belgium and Mexico.
For more information: http://www.almirall.es
COPD is the 4th leading cause of death in the U.S. and is projected to be the 3rd leading cause of death for both men and women by 2020. In 2000 about 119.000 deaths in the US were due to COPD and in 2002 $18 billion direct cost and 14 billion indirect costs were caused by COPD. Data from National Heart Blood and lung Institute COPD fact sheet. (www.nhlbi.nih.gov/health/public/lung/other/copd_fact.pdf)
Forest Laboratories, Inc.; Almirall