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| FDA
Approves Tarceva™
for Non-Small Cell Lung Cancer...
What's Next for Biotech Investors? |
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Ed Wijaranakula, Ph.D.
Chief Investment Strategist, Infotix
Systems, Inc. - November 22, 2004
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Piper Jaffray analyst Thomas Wei
raised concerns about the
inclusion of the EGFR data in the package insert and suggested that the inclusion
could potentially
cause physicians to limit Tarceva usage to EGFR-positive
patients and therefore his previous estimation of
Tarceva sales may be too high. Dr. Susan
Desmond-Hellman, Genentech's president of product
development, emphasized during Genentech's conference call
last Friday that survival benefits were
observed in all patients and that they didn't pre- screen patients for
the EGFR protein. "The information included in the insert should be seen more as an aid to help doctors prescribe the drug to patients likely to receive the most
benefit", she added.
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The impacts
of smoking and
the EGFR expression status
on survival of lung cancer patients is not new. At the
39th Annual Meeting of the American Society of Clinical Oncology
(ASCO) last year, Dr. Vincent Miller, MD, of
New York, NY-based Memorial Sloan-Kettering Cancer Center,
the world's oldest and largest private
cancer research institution, has
concluded that erlotinib was more effective in patients who had never smoked. Last August, Dr. William Pao and his research team,
also of the Memorial Sloan-Kettering Cancer Center, confirmed that the never-smoker lung cancer
patients harbored more
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EGFR gene mutations than those in smoker
patients. In addition, the mutations in the EGFR gene appear to influence sensitivity to
gefitinib and erlotinib.
From our view, the combination of the survival data, 6.7 months compared to 4.7 months in patients who received placebo,
and the second and third-line label will allow Tarceva to compete effectively with
IRESSA®.
IRESSA®
(gefitinib),
which was
the first HER1TK/EGFR
inhibitor drug approved by FDA in
May 2003 for third-line treatment
on NSCLC patients,
has some ability to shrink tumors but failed to improve survival of patients who took the drug alone, without chemotherapy.
In
September this year,
AstraZeneca
announced a new clinical trial to evaluate the effectiveness of IRESSA®
versus semisynthetic chemotherapy drug Taxotere®
(docetaxel), in patients with locally advanced or metastatic
non-small cell lung cancer who have previously received platinum-based chemotherapy.
At the end of the trial, the company hopes to have some
additional overall survival data in order to compete effectively
with Tarceva. |
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According
to Randi F. Marshall, staff writer for the New York,
NY-based Newsdaily, patients who took part in the Tarceva's
clinical trials early this year were very satisfied with the
new drug. Dr. Abraham Chachoua, a New York University thoracic oncologist,
who just wrote his first prescription for Tarceva, is convinced
Tarceva will improve his patients' quality of life. "Your natural inclination would be to prescribe Tarceva above anything else.",
he added.
Tarceva, which was launched last Monday, is expected to
generate sales of $10 million in the fourth quarter for OSI
Pharmaceuticals
and Genentech. We have no doubt that Tarceva will become a
blockbuster drug for both companies. Based upon IRESSA®
worldwide
sales in the past
three quarters of this year, which reached
$266 million up 189 percent year over year, we
believe that Tarceva's sales could exceed well over $200
million in fiscal 2005. Peak sales could reach $1.4 billion in
2010, according to Merrill Lynch equity analyst Eric Ende.
Due to the present weak US currency exchange, we believe that
the near-term profit margin derived from Tarceva's sales
could be a slight advantage over that of IRESSA®.
These were not yet priced into OSI
Pharmaceuticals
and Genentech's share price.
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About NMS
Research Analysis:
NMS Research Analysis is a private independent research entity of
Infotix Systems, since 1999, bridging the gap between cutting-edge
scientific research and the investment community. We offer in-depth
research analysis of companies and emerging technology in sectors
ranging from semiconductors, biotech, nanotechnology, novel
materials for aerospace and energy industries. Dr. Wijaranakula's portfolio holds long positions
or controls in DNA and OSIP.
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