Forest Announces Phase IIb Study Results For Oglemilast in Chronic Obstructive Pulmonary Disease
August 18 2009 - 11:00PM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) 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) 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.
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