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Vioxx Successor Arcoxia Gets Knockout Punch From FDA Advisory Committee
April 12, 2007
April 12, 2007 is a black letter day for
Merck & Co. Inc.(MRK | charts | news | PowerRating). The
company's proposed arthritis painkiller Arcoxia, considered as a
successor to the withdrawn drug Vioxx, received a knockout punch from
the FDA's Arthritis Advisory committee. Ever since Merck's Vioxx
debacle, the FDA has taken a more cautious stance in approving new
drugs by toughening its requirements for certain types of clinical
Expressing concern over the cardiac safety
of Arcoxia, the FDA panel voted 20 to 1, opposing the approval of the
drug. Though the FDA usually follows the advice of its panels, it need
not be so always. The FDA is expected to make a final decision on the
drug by April 27, 2007. A number of health experts are also against the
drug being approved in the U.S.
Arcoxia had been under review by the FDA
as an investigational selective COX-2 inhibitor ever since Merck
submitted the New Drug Application in December 2003. Merck again filed
separate New Drug Applications for a 60 mg once daily dose of Arcoxia
in December 2003 and 30 mg once daily dose of Arcoxia in April 2004.
The New Drug Applications for Arcoxia were
based on a comprehensive and robust clinical program that included
efficacy and safety findings for Arcoxia 30 mg and 60 mg once daily
from 11 studies in patients with osteoarthritis; safety findings from 7
additional studies in other patient populations; and results from a
study called Medal which enrolled 34,000 arthritis patients with a
range of cardiovascular risks.
The Medal Trial, which compared Arcoxia
and standard treatment diclofenac, a non-steroidal anti-inflammatory
drug demonstrated that patients taking Arcoxia had a similar number of
heart attacks and strokes as those taking diclofenac. However, the
number of arthritis patients who developed congestive heart failure
after taking the highest dose of Arcoxia- 90 mg was nearly double the
number of patients who developed congestive heart failure after taking
diclofenac. In addition, more number of patients developed edema, or
fluid retention, and a higher incidence of heart failure after taking
the 90-mg dose of Arcoxia.
When Merck initially submitted its New
Drug Application for Arcoxia, it had sought FDA approval of the drug in
treating osteoarthritis and six other conditions, including rheumatoid
arthritis, a spinal inflammation called ankylosing spondylitis, and
Merck's Vioxx, which was also a COX-2
inhibitor - the same as that of Arcoxia was pulled off the market in
September 2004 after clinical trials showed that long-term use of the
painkiller Vioxx doubled a person's risk of heart attack and stroke.
Vioxx racked up $2.5 billion in 2003 accounting for 11% of the
company's $22.49 billion in revenue. The withdrawal of the drug sent
Merck's stock down 27%, erasing $25 billion from its market value on
September 30, 2004.
has reserved about $1.57 billion to cover Vioxx related lawsuits. There
are over 27,200 lawsuits nationwide related to Vioxx. According to the
company, about 3,000 cases, or 11% of the total number of the cases
have been dropped. Merck has now won four federal and six state cases.
The company has lost one case in the federal court and four in the
state court. There are two unresolved mistrials.
The recall of Merck's Vioxx in 2004, cast
a cloud immediately over the other COX-2 drugs, including Celebrex and
Bextra, made by Pfizer. In April 2005, Pfizer had to withdraw its drug
Bextra from the market at the behest of the FDA, which found that
Bextra in addition to having higher risks of heart attack and strokes
caused far more serious skin problems than Celebrex. Bextra fetched
$1.2 billion in sales in 2004.Celebrex remains the only COX-2 inhibitor
available on the U.S. market, but with a revised warning label.
Celebrex is approved for the treatment of osteoarthritis, adult and
juvenile rheumatoid arthritis, acute and menstrual pain, ankylosing
spondylitis and familial adenomatous polyposis. Last year, Celebrex
generated U.S. sales of $1.57 billion and global sales of $2.039
Arcoxia is currently available in 63
countries in Europe, Latin America, the Asia-Pacific region and Middle
East/Northern Africa. Last year, Arcoxia ringed in sales of $265
Peter Kim, president, Merck Research
Laboratories said, "We are disappointed in today's outcome. We continue
to believe that Arcoxia has the potential to become a valuable
treatment option for many Americans suffering from osteoarthritis. We
are committed to continuing to work with the FDA to discuss the
application in an effort to gain U.S. regulatory approval for Arcoxia."
this week, the FDA proposed that
new prescription painkillers that belong to the category of COX-2
inhibitors should not be approved if other safer alternatives are
available. The agency noted that any nonsteroidal anti-inflammatory
drugs, or NSAIDs, would merit approval only if they fill an unmet need
for a particular group of patients who have no other "relatively safer"
alternatives. Under such a tough regulatory environment, it remains to
be seen whether the FDA will give green signal to Arcoxia - the
successor to the banished arthritis painkiller Vioxx.
MRK closed Thursday's regular trade up
$0.71 at $46.36 on a volume of 11.82 million shares. In after-hours,
the stock gained 3.32% or $1.54 and was at $47.90.
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