Johnson & Johnson's MS Drug Panel Hearing Canceled
Bloomberg News
January 13, 1999, 1:37 p.m. PT
Washington, Jan. 13 (Bloomberg) -- Johnson & Johnson, the
world's fifth-biggest drugmaker, won't push for a recommendation
of its multiple sclerosis drug by a government panel on Jan. 29,
as it was scheduled to do.
The U.S. Food and Drug Administration confirmed that the
advisory panel meeting has been canceled, though neither agency
nor company officials were available to explain why. The next
tentatively scheduled meeting for the advisory panel in charge of
such drugs is in late April, according to the FDA's hotline.
It's unusual for the FDA to schedule an advisory committee
meeting and then cancel it. Reasons can range from timing
conflicts to an agency decision that it doesn't need the advice
of experts because it's already decided for or against a drug.
''My suspicion is that it's bad'' that the hearing was
canceled, said Ira Loss, an analyst with HSBC Washington Analysis
who covers the FDA. ''It's just the latest in what seems to be a
consecutive strike-out string here.''
Good News Needed
In the last two years, Johnson & Johnson has faced a series
of drug setbacks at the FDA and the loss of a near-monopoly on a
profitable heart device known as a stent. Last month, it
announced it would cut 4,100 jobs and close 36 plants amid
sluggish sales growth.
''They are going through a very rough period,'' said Sergio
Traversa, an analyst with Mehta Partners. A drug approval would
''be good for the image and the morale. They need something good
happening,'' he said.
Shares of the New Brunswick, New Jersey-based company fell 1
1/8 to 78 11/16.
Still, analysts aren't expecting big sales from the drug,
known as cladribine, even if it does win approval for MS.
The drug is currently approved to treat a form of leukemia
and has side effects similar to anti-cancer drugs that would make
it a second-tier option for MS, Traversa said. ''The potential
for this kind of drug is really limited,'' said Traversa, who has
a ''neutral'' rating on the company.
The $1 billion MS market is currently dominated by Biogen
Inc. and Schering AG. Biogen, one of the world's largest
biotechnology companies, said yesterday that fourth-quarter sales
of its Avonex drug for MS exceeded $120 million.
$150 Million Sales
Traversa predicted Johnson & Johnson's entry would have peak
annual sales of about $150 million and would probably be used by
patients who aren't helped by the Biogen or Schering drugs.
Ares-Serono SA also sells a MS treatment known as Rebif
outside the U.S., and Israel's Teva Pharmaceuticals Ltd. has FDA
approval to sell its Copaxone MS treatment in the U.S.
The disease destroys the insulation that protects and
transmits impulses around nerve fibers in the spinal cord, brain
and optic nerves, so that nerve impulses to and from the brain
are distorted and interrupted. Scientists are stymied about what
causes the disease, which often strikes people in their 20s or
30s and is found most frequently among women in colder climates.
There is no cure. |
