Analysts: Merck's Cox-2 Drug Vioxx To Win FDA Panel Support
By Otesa Middleton
04/09/99
Dow Jones News Service
WASHINGTON (Dow Jones)--Analysts expect that when Merck & Co. (MRK) takes its highly anticipated drug Vioxx before a federal panel April 20, it will win the panel's favor and eventually become a hit drug.
The U.S. Food and Drug Administration advisory panel will review the drug and recommend whether the agency should approve it for sale in the U.S. The FDA usually follows the advice of its outside panels.
Merck is seeking to have Vioxx approved as a treatment for osteoarthritis and pain. If approved, Vioxx would be the second Cox-2 inhibitor on the market.
Monsanto Co.'s (MTC) Celebrex became the nation's first Cox-2 drug when it went on sale in January. Celebrex , approved for osteoarthritis and rheumatoid arthritis, took off immediately and recorded 1.2 million prescriptions in its first two months, according to the pharmaceutical information service IMS Health Inc. (RX).
Both drugs fall into the class of popular treatments: nonsteroidal anti-inflammatory drugs, known as NSAIDs. Vioxx and Celebrex are believed to cause fewer gastrointestinal side effects because they only block the Cox-2 enzyme, which is responsible for inflammation, while leaving the Cox-1 enzyme intact to protect the stomach lining.
Other NSAIDs, including aspirin and ibuprofen, attack both Cox enzymes.
Celebrex , however, still carries the standard ulcer warnings found on all NSAID labels because the FDA said it needs more data to prove the drug was safer.
As for Vioxx, analysts say there is room on the market for it and Celebrex .
"There is a 90% or better chance for the advisory committee to say yes to Vioxx," said Gruntal & Co. pharmaceutical analyst David Saks.
If the panel backs the drug, Saks expects a quick FDA approval and a launch soon after.
"This is the biggest, most significant event for Merck in terms of potential drugs," Saks said. "The drug will ramp up extremely rapidly. Arthritis pain is real and people want immediate relief."
If Approved, Big Sales Expected From Vioxx
Being second to the market won't hurt Vioxx. The first drug in a category, in this case Celebrex , builds up a noise level by creating a demand, Saks said.
He said Warner-Lambert Co.'s (WLA) cholesterol-lowering drug Lipitor was sixth in its class to hit the market.
"Now it has overtaken all five before it," Saks said. "The bottom-line winner is the patient."
Saks projects in its first 18 months on the market, Vioxx will generate $1.2 billion in U.S. sales.
Carl Gordon, an analyst at Orbimed Advisors, also expects Vioxx to be endorsed by the panel and subsequently approved by the FDA.
Gordon said Vioxx's label will probably contain the same warnings found on Celebrex .
"I expect both drugs to do well," Gordon said. "We expect both drugs to be very big."
Dr. David Pisetsky, a medical advisor to the Arthritis Foundation, said physicians treating patients with osteoarthritis will probably start with Tylenol or its generic acetamenophen for pain relief. If that doesn't work, then the doctor will turn to one of the many NSAIDs on the market.
Doctors will prescribe Cox-2 drugs for those patients considered to be at a higher risk of developing ulcers, said Pisetsky, who is also chief of rheumatology at Duke University.
Where the Cox-2 drugs fit in the medicine cabinet will be "determined over time based on efficacy and cost," Pisetsky said. "For people with a history of ulcers, Cox-2 drugs are a very good alternative."
In studies of both Celebrex and Vioxx, a lighted device called an endoscope was used to see if patients developed microscopic bleeding ulcers.
Pisetsky said bleeding found by an endoscope is considered minor compared with a serious peptic ulcer.
To prove the drugs prevent peptic ulcers, which are much less common, would require larger studies, he said.
According to the Arthritis Foundation, 15.8 million people have osteoarthritis.
Pisetsky said the disease is the most common form of degenerative arthritis.
"It usually occurs as people age and affects cartilage initially," Pisetsky said.
The painful disease limits joint movement and can require joint replacement.
A company release said Merck studied 1,427 osteoarthritis patients, comparing Vioxx with an inactive placebo and with ibuprofen. After 12 weeks, an endoscope showed 7.3% of patients on placebo had ulcers. Of those on Vioxx's 25 milligram dose, 4.7% had ulcers and 8.1% on Vioxx's 50 milligram dose developed ulcers. Of the ibuprofen patients, 28.5% had ulcers.
Merck also studied Vioxx in patients with menstrual and dental surgery pain.
The menstrual pain studies of 190 women showed Vioxx relieved pain within an hour, similar to another pain killer, naproxen sodium.
In Merck's dental pain study of 151 patients, Vioxx relieved pain in the same amount of time - 45 minutes - as ibuprofen.
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