UPDATE: Glenmark, Forest Say Oglemilast Failed In Key Study
August 19 2009 - 2:53AM
Dow Jones News
India's Glenmark Pharmaceuticals Ltd. (532296.BY) and U.S.-based
Forest Laboratories Inc. (FRX) said Wednesday their drug to treat a
breathing ailment failed to meet desired targets in a mid-stage
trial.
The results of the study to treat chronic obstructive pulmonary
disease, or COPD, with oglemilast sent Glenmark's shares down more
than 17% in initial trading. The shares pared some losses and were
down 12.5% at INR228.90 on the Bombay Stock Exchange at 0655
GMT.
A once-daily treatment with oglemilast didn't show "a
statistically meaningful" result in COPD patients compared with a
dummy drug during lung-function tests, the companies said in a
joint statement. The drug was well-tolerated at all doses studied,
it added.
The study was to evaluate the efficacy and safety of the drug
which was given to patients with moderate to very severe COPD, a
disease that makes it hard to breathe and seen mostly in cigarette
smokers.
Glenmark is seen as a front-runner among Indian drug makers
which are working on developing new drugs, typically under
licensing deals with foreign pharmaceutical companies that help
finance costly and lengthy research.
The failure of the drug is the latest in a string of bad news
for the Indian pharmaceutical company's new drug research and
development business.
In October last year, Eli Lilly & Co. suspended clinical
development of a Glenmark experimental drug to treat osteoarthritis
pain without giving any reasons. Merck Serono, a division of Merck
KGaA, earlier last year terminated a licensing pact for diabetes
treatment melogliptin, saying it is getting out of diabetes
research.
In 2004, Glenmark had sold the U.S. rights for oglemilast to New
York-based Forest Laboratories. Teijin Pharma Ltd., which signed a
deal with Glenmark in 2005, holds the license for selling the drug
in Japan.
"We are, of course, disappointed that oglemilast has not been
successful in this study," Howard Solomon, chairman and chief
executive of Forest Laboratories, said in a statement.
Solomon said oglemilast is still being studied for the treatment
of asthma, with results expected during the first quarter of
2010.
"This is a big blow for Glenmark as oglemilast was its lead
experimental molecule," said Ranjit Kapadia, vice president of
institutional research at HDFC Securities. "The company had pinned
a lot of hopes on a positive outcome."
Angel Broking's Sarabjit Kour Nangra said Glenmark is still
eligible to receive milestone payments from Forest Laboratories as
the U.S. company had bought the license for oglemilast to treat
both COPD and asthma.
Forest Laboratories's Solomon said his company is considering,
together with Glenmark, "what further action would be useful or
appropriate."
Glenmark has already received $35 million from the total
expected milestone payments of $190 million from Forest
Laboratories for oglemilast.
-By Rumman Ahmed, Dow Jones Newswires; 91-9845104173;
rumman.ahmed@dowjones.com