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Merck's Vioxx Successor Arcoxia Gets Knockout Punch From FDA Advisory Committee




April 12, 2007

(RTTNews)

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 The company's proposed arthritis painkiller Arcoxia, considered as a successor to the withdrawn drug Vioxx, received a knockout punch from the FDA's Arthritis Advisory committee.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 trials.

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 acute pain.

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.





Merck 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 billion.

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 million.

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."

Earlier 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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