* Drug improved response rate in lung cancer patients
* Co plans to file for approval in lung cancer in 2011
* Shares rise as much as 36 pct
(Adds analyst comments; updates stock movement)
By Esha Dey
BANGALORE, March 17 (Reuters) - Abraxis BioScience Inc
(ABII.O: Quote, Profile, Research) said a late-stage study testing its cancer drug
Abraxane in non-small cell lung cancer met the main trial goal,
sending its shares up as much as 36 percent.
The trial, which was comparing the drug with Taxol
injection, showed Abraxane significantly improved overall
response rate in first-line treatment of advanced non-small
cell lung cancer patients. Both the drugs were administered in
combination with chemotherapy drug carboplatin.
Abraxane is a chemotherapy treatment that is already
approved for use in metastatic breast cancer. Taxol -- sold by
Bristol-Myers Squibb Co (BMY.N: Quote, Profile, Research) -- is also known as paclitaxel
and is generically marketed by various other drugmakers.
"The issue is that Taxol is generic, so a drug that beats
Taxol on response rate doesn't really help a lot if it can't
have some other kind of benefit," Merriman Curhan Ford analyst
Michael King said.
"So I believe, Abraxane will have to show a benefit either
in progression-free survival or overall survival ... something
better than just response rate in order to have a commercially
attractive opportunity," he said.
Abraxis expects to file for an approval of the drug as a
treatment for non-small cell lung cancer during 2011.
Abraxane uses albumin, a human protein, to deliver the
chemotherapy, as opposed to other chemotherapy drugs that use
chemical solvents.
This eliminates the need for premedication with steroids or
antihistamines for hypersensitivity reactions that are caused
by chemical solvents.
The trial with 1,052 patients was done according to a
special protocol assessment with the U.S. health regulator, the
company said in a statement.
The special protocol assessment (SPA) provides a company
with a written agreement that the design and analysis of the
trial are adequate to support a marketing application
submission with the U.S. health regulator.
"The likelihood of approval is high as the study was done
according to an SPA ... but without a progression-free survival
the clinical utility is limited given a premium cost,"
Merriman's King said.
"So in a cost-conscious environment, if you have a generic
Taxol, which works well and is very cheap, there is no real
incentive to use a drug that costs much more than Taxol," he
said.
Lung tumours are the most common form of cancer worldwide
and non-small cell lung cancer is the most common form of lung
tumours.
"The shares are up as it is a significant commercial
opportunity, it could be half a billion dollars or more," King
said. "But the question is, does the reality meet the potential
and without the survival data we don't know."
Data from the late-stage trial will be submitted for
consideration as a late breaking presentation at the upcoming
American Society of Clinical Oncology meeting, the company
said.
Abraxis shares were up 30 percent to $51.79 in midday trade
on Nasdaq. They touched a high of $54.03 earlier.
(Reporting by Esha Dey in Bangalore; Editing by Ratul Ray
Chaudhuri)
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