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Glaxo to put 4 new cancer drugs into final trials

November 30, 2005

By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON (Reuters) – GlaxoSmithKline Plc will put four new
cancer drugs into final-stage clinical trials next year, as it
sets its sights on a leading position in the drug industry’s
fastest-growing market.

Europe’s biggest drug maker said on Wednesday four products
– Tykerb, formerly known as lapatinib, eltrombopag, casopitant
and pazopanib — held substantial promise for fighting tumors
or helping patients overcome the side-effects of chemotherapy.

The expanded research program will give Glaxo a total of
seven cancer products in Phase III studies, the last stage of
testing before medicines are approved for commercial use.

The British-based group highlighted the potential of its
cancer pipeline at a seminar for investors in New York.

Until now, cancer has been a small area for Glaxo,
accounting for a modest 1 billion pounds or 5 percent of group
sales, mostly due to anti-nausea drug Zofran.

The enlarged Phase III line-up — which also includes
existing projects for cervical cancer vaccine Cervarix, Avodart
in prostate disease and bowel drug Entereg — could change
that.

“Glaxo are now potentially a player of serious magnitude in
oncology given the range of products that they’re profiling
here, from emetics (nausea) to platelet production drugs to
pure-play oncology products,” said Navid Malik, an analyst with
stockbroker Collins Stewart, who rates the stock a “buy.”

Other analysts, however, cautioned it would take several
years for the new drugs to reach their full potential, with
many unlikely to affect profits until after 2010.

One of the biggest hopes is eltrombopag, a treatment for
low levels of platelets in the blood, which Glaxo said had
produced good results in Phase II tests in patients with
idiopathic thrombocytopaenia purpura (ITP). It expects to file
the drug for regulatory approval by the end of 2006 or in 2007.

Analysts at Merrill Lynch believe eltrombopag could
eventually become a $2.8 billion-a-year seller, provided it is
shown to work in patients undergoing chemotherapy.

Eltrombopag was originally discovered by U.S. biotech firm
Ligand Pharmaceuticals Inc., which is entitled to a royalty on
any future sales.

Glaxo also has high hopes for Tykerb, a dual-action oral
cancer therapy, which has shrunk tumors or stabilized disease
in 40 percent of breast cancer patients in early tests.

FIGHTING BRAIN Tumors

New data showed the drug also helped fight tumors that had
spread to the brain, though results in kidney cancer were
mixed. Glaxo intends to file for U.S. approval of Tykerb at the
end of 2006 or in the first half of 2007.

It plans to start a large study next year of Tykerb in the
treatment of early stage breast cancer, potentially putting the
product on course to rival Herceptin, an injectable drug from
Genentech Inc. and Roche Holding AG.

Glaxo believes its drug, taken as a pill, will have an edge
as cancer becomes a chronic disease treated with daily
medication.

Casopitant for nausea has produced good results when
combined with Zofran, while pazopanib, a so-called VEGF
inhibitor, which works in a similar way to Genentech’s Avastin,
has demonstrated prevention of tumour growth.

Shares in Glaxo, which fell 5 percent on November 21 on
fears tougher U.S. rules would hit sales of its top-selling
asthma drug Advair, pared earlier losses to stand 1 percent
down on the day at 14.33 pounds by 1555 GMT in a weaker London
market.

Research and development head Tachi Yamada said Glaxo had a
strong line-up to compete in the cancer market, which he
expects to nearly double in size from $42 billion in 2004 in
five years.

“I believe that GSK, which currently ranks 11th in the
cancer therapeutic area, has the potential to really become one
of the leaders,” he told reporters on a conference call.

“From modest beginnings, we now have a pipeline which is
one of the largest in our industry with seven major assets
expected to be in Phase III development in the coming months,
including the four NCEs (new chemical entities) highlighted
today.”

Cancer is a hot area of research for many drug companies,
reflecting recent scientific breakthroughs in understanding the
disease and strong demand for better anti-cancer therapies.

According to health information firm IMS Health, cancer
drug sales will rise by 17 percent to 18 percent next year,
almost three times the overall drug market growth rate of 6-7
percent.

(Additional reporting by Mark Potter)


Source: reuters



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