UPDATE: Bayer Drug Fails To Extend Lung Cancer Patients' Lives
June 14 2010 - 5:45AM
Dow Jones News
Germany's Bayer AG (BAYN.XE) said Monday that cancer treatment
Nexavar failed to reach its primary goal of extending the lives of
patients with a certain advanced form of lung cancer in a
late-stage clinical trial.
Co-developed with U.S.-based Onyx Pharmaceuticals Inc. (ONXX),
the oral drug did reach its secondary endpoint of progression-free
survival, where the disease didn't get worse, in patients with
non-squamous, non-small cell lung cancer, Bayer said.
Nexavar is already approved worldwide for the treatment of
advanced kidney cancer and liver cancer and is expected to generate
peak annual sales of EUR2 billion.
Merck Finck & Co. Analyst Carsten Kunold said in a note
Monday that it's now "rather unlikely that Nexavar will become
approved for the treatment of lung cancer."
The drug, which is also known as sorafenib, was compared in the
study with a placebo in combination with chemotherapy.
The result was "disappointing", Dimitris Voliotis, Vice
President, Global Clinical Development Oncology, Bayer HealthCare,
said in a statement.
Bayer estimates 1.4 million people worldwide are diagnosed with
lung cancer every year, and about 160,000 in the U.S. and 342,000
in Europe die from non-small cell lung cancer annually.
Nexavar aims to stop cancer cells from proliferating and block
the formation of new blood vessels that feed tumors.
The NExUS trial began in February 2007, but was amended in 2008
to exclude squamous cell patients, who were shown to have a higher
mortality rate in the trial than non-squamous cell patients.
The companies said they would continue to test the drug in lung
cancer, on its own as well as in combination with other treatments.
The drug is also being tested in patients with other cancers,
including thyroid, breast, ovarian, and colon cancer.
MM Warburg Analyst Ulrich Huwald interpreted the results of the
NExUS lung cancer study as neutral, given competing products have
also fell short in lung cancer trials. Only Tarceva, co-marketed by
OSI Pharmaceuticals Inc. (OSIP) and Switzerland's Roche Holding AG
(RHHBY), has been approved in the U.S. and Europe as a maintenance
treatment for non-small cell lung cancer.
"Clearly at a first glance it's disappointing, but we've seen
several signs that lead us to be cautious," Huwald said. He
therefore hasn't included the lung cancer indication in his
forecast model for Nexavar, in favor of more positive trial data
for other types of cancer, including breast cancer.
Last year Nexavar earned EUR604 million in sales.
Bayer's share price fell on the Nexavar news but later recovered
somewhat. At 1009 GMT, it was trading down EUR0.45 or 0.9% at
EUR47.37 while the overall DAX index was up 1.2%. The stock has
lost nearly 17% of its value so far this year.
-By Allison Connolly, Frankfurt Bureau; +49 69 29725513,
allison.connolly@dowjones.com
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