2nd UPDATE: Glenmark, Forest Say Their Drug Failed In Trials
19 August 2009 - 11:50PM
Dow Jones News
India's Glenmark Pharmaceuticals Ltd. (532296.BY) and U.S.-based
Forest Laboratories Inc. (FRX) said Wednesday their experimental
drug failed to meet desired targets during mid-stage trials in
patients with a breathing ailment.
Glenmark's shares tanked after the companies announced the
outcome of the study to treat chronic obstructive pulmonary
disease, or COPD, with oglemilast. The shares closed nearly 15%
down at INR223.20 on the Bombay Stock Exchange, compared with a
1.5% fall for the benchmark index.
A once-daily treatment with oglemilast didn't show "a
statistically meaningful" improvement in COPD patients compared
with a dummy drug during lung-function tests, the companies said in
a joint statement.
The study was to evaluate the efficacy and safety of the drug in
patients with moderate to very severe COPD, a condition that makes
it hard to breathe and seen mainly in cigarette smokers. It was
well-tolerated in all the doses studied, the statement added.
Glenmark is seen as a front-runner among India-based generic
drug makers who are now venturing into developing new drugs, often
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 company, which receives payments from research partners
based on the drugs meeting various targets during the course of
their development.
Eli Lilly & Co. and a division of Merck KGaA had last year
stopped their drug-development pacts with Glenmark.
"My reading is that Glenmark will not receive any further
payments for oglemilast," said Bino Pathiparampil, a pharma analyst
at IIFL.
Pathiparampil said the development will be negative for the
company's earnings. He has a "sell" rating and a target price of
INR161 on the stock.
Forest Laboratories had bought the U.S. license for oglemilast
in 2004. The New York company has already paid $35 million of the
total expected milestone and upfront payment of $190 million to
Glenmark.
Howard Solomon, chairman and chief executive of Forest
Laboratories, said in the statement his company was disappointed by
the results and, together with Glenmark, is considering "what
further action would be useful or appropriate."
The companies meanwhile said oglemilast is still being studied
for the treatment of asthma, with results expected during the first
quarter of 2010.
"If all goes well with the (asthma) trials, if things are
positive, we will continue to get milestones," Glenmark Chief
Executive Glenn Saldanha said during a conference call with
investors that was broadcast on news channel CNBC-TV18.
The Indian company had failed to meet its forecast of $69
million in milestone payments in the last financial year ended
March 31 after Eli Lilly and Merck Serono pulled out of their
agreements and Glenmark failed to attract new partners because of
the global economic slowdown.
Glenmark and Eli Lilly haven't yet said why they suspended the
agreement on a drug to treat osteoarthritis pain, while the Indian
company had cited Merck Serono's decision to quit diabetes research
for the termination of their pact on a diabetes treatment.
Glenmark, in an investor presentation, said it has received $117
million in upfront and milestone payments related to drug
developments over the last four years.
This includes $6 million from Teijin Pharma Ltd., which holds a
license to sell oglemilast in Japan. Glenmark had projected to
receive $53 million in milestone and upfront payments from Teijin
for the drug.
Saldanha had in July forecast a net profit of INR3 billion-INR4
billion for the current fiscal year, excluding potential milestone
payments or patent settlement proceeds.
Including oglemilast, Glenmark has seven experimental drugs in
different stages of clinical, or human, trials.
-By Rumman Ahmed, Dow Jones Newswires; 91-9845104173;
rumman.ahmed@dowjones.com