26 novembre, 2006 16:00
Merck Readies Vioxx Successor, Faces Class Suit in Canada
Linda A. Johnson
The Associated Press
11-14-2006
Merck & Co., which has been seeking U.S. approval for a successor to its withdrawn arthritis painkiller Vioxx for nearly three years, says it has given regulators new patient data about the drug and expects a decision by April.
Also, the drug maker has disclosed that a Canadian court has authorized a class action Vioxx lawsuit, and a major rating service reiterated that Merck's outlook is negative.
The Canadian suit, authorized by a Quebec judge, is the first personal injury class action suit authorized to date in the mushrooming Vioxx litigation. A New Jersey judge has authorized a class action on behalf of unions, health plans and other third-party payers who covered Vioxx prescriptions.
The Quebec case would include an undetermined number of Vioxx users from that Canadian province who alleged the drug harmed them. The judge excluded a much larger number of people who took Vioxx and want reimbursements but are not alleging harm, according to Merck.
"It's not a great precedent for Merck," said analyst Steve Brozak of WBB Securities, calling it "a slippery slope."
"This directly conflicts with Merck's successful strategy so far" of defending each lawsuit individually, he said, so Merck will have to fight vigorously to get the class action split into separate cases.
Meanwhile, the Whitehouse Station, N.J.-based drug maker said it has given the U.S. Food and Drug Administration data on its Arcoxia that includes results of the first study of arthritis patients focused on whether the drug increased risk of heart attack and stroke.
In August, Merck said a preliminary analysis showed Arcoxia didn't raise those risks, compared with an older anti-inflammatory drug, but that more patients on Arcoxia withdrew from the study due to high blood pressure and fluid retention.
Merck pulled the blockbuster Vioxx from the market on Sept. 30, 2004 after its own research showed Vioxx doubled risk of heart attack and stroke. The company now faces lawsuits covering about 42,000 plaintiff groups alleging harm, plus hundreds of potential class action suits claiming personal injury or financial losses. To date, Merck has reserved about $1.57 billion to cover Vioxx legal costs.
"Considering the baggage Merck has received over the last two years, this review is going to be a lot longer" than they expect because the FDA's actions also will be under intense scrutiny, Brozak said.
He expects Arcoxia eventually will be approved, but likely with some warnings and follow-up safety studies required. It won't become a blockbuster, he said.
The new study pools results of three trials with a total of more than 34,000 arthritis patients, one-third at increased risk of heart attack or stroke. The results are part of Merck's response to the FDA, which said in October 2004 -- the month after Vioxx was pulled -- that it needed more safety and effectiveness data before it could allow U.S. Arcoxia sales.
Merck currently is seeking approval to sell 30- and 60-milligram doses for people with osteoarthritis, caused by joint wear and tear. The company later will seek approval to sell it for other types of pain and in other doses, said spokeswoman Tracy Ogden.
Arcoxia, from the same drug class as Vioxx, already is sold in 62 countries in Europe, Asia and other regions, and had sales of $192 million over the first nine months of 2006.
Merck began developing Arcoxia in 1999, the year Vioxx went on sale. Ogden said the company viewed Arcoxia as a Vioxx alternative because painkillers don't help all patients the same way.
Merck on Monday was to release detailed results from the latest study at two major medical conferences. The study compared Arcoxia with diclofenac, the most widely used the anti-inflammatory drug in the world.
Some critics have said Merck rigged the study because diclofenac also carries a high risk of heart attack or stroke, according to an October study in the Journal of the American Medical Association.
FDA said in 2005 that all painkillers in the class with Vioxx and Arcoxia, known as Cox-2 inhibitors, plus traditional anti-inflammatory drugs such as diclofenac, ibuprofen and naproxen, increase risk of heart attack and stroke.
Also Friday, Moody's Investors Service said its rating outlook for Merck remains negative. Moody's said Merck's strong cash flow, profitability and return on investment are offset by high product concentration, patent explorations and "uncertain but potentially high Vioxx costs."
