NEW YORK & MUMBAI, India--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX - News) and Glenmark Pharmaceuticals S.A. (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL) today announced top-line results from a Phase IIb dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD). Once-daily treatment with oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in patients with COPD. Oglemilast was well tolerated at all doses studied.
“Oglemilast is an orally administered PDE 4 inhibitor, which we believe to be an important and novel therapeutic target for COPD. We are, of course, disappointed that oglemilast has not been successful in this study,” said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. “Oglemilast is still being studied for the treatment of asthma, with results expected during the first calendar quarter of 2010. We are considering together with Glenmark what further action would be useful or appropriate.”
Oglemilast Phase IIb Study Design
This was a twelve-week randomized, double-blind, placebo-controlled, multi-center Phase IIb study that evaluated the efficacy and safety of once-daily oglemilast at doses of 200 mcg, 400 mcg and 800 mcg in patients with moderate to very severe COPD. Patients were at least forty years of age with a history of ten or more pack-years of smoking. During the study period 428 patients were randomized to receive one of three doses of oglemilast (n=320) or placebo (n=108) and assessed at eight visits. The primary endpoint was defined as change from baseline in pre-bronchodilator (morning/trough) FEV1 at Week 12.
About Oglemilast
Oglemilast is a potent and selective inhibitor of phosphodiesterase 4 (PDE4). Oglemilast is currently in development for the treatment of COPD and asthma. Forest Laboratories licensed US rights for oglemilast from Glenmark Pharmaceuticals.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. The company is listed on India’s two premier stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5500 people across its global operations over 85 countries. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], and metabolic disorders [Diabetes, Obesity, etc.]. The Company is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals.
About Forest Laboratories
Forest Laboratories (NYSE: FRX - News) 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.
Contact:
Glenmark Jason D’Souza | Medha Satam [+91 22] 40189919 / 40189993 connect@glenmark-generics.com or Forest Laboratories, Inc Frank J. Murdolo, +1-212-224-6714 Vice President - Investor Relations Frank.Murdolo@frx.com
