NEW YORK & MUMBAI, India--(BUSINESS WIRE)--Aug. 18, 2009--
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.
Source: Forest Laboratories, Inc.
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