[AHP]Immunex Wins FDA Panel Backing for Arthritis Drug (Update3)
Bloomberg News
September 16, 1998, 3:45 p.m. ET
Immunex Wins FDA Panel Backing for Arthritis Drug (Update3)
(Adds second panel vote, analyst comment.)
Gaithersburg, Maryland, Sept. 16 (Bloomberg) -- Immunex
Corp., a money-losing biotechnology company, won the backing of
an expert government panel for its potential blockbuster drug to
treat a debilitating condition known as rheumatoid arthritis.
The U.S. Food and Drug Administration advisory panel voted
to back the drug's use in patients who had severe forms of the
disease and who weren't helped by other therapies. The panel then
voted against recommending approval for a wider use that would
have cleared the drug for rheumatoid arthritis patients,
regardless of prior drug therapy or the severity of the disease.
''It's not a clean sweep. The FDA panel has taken a
conservative approach, but they are very clearly willing to look
at this drug again,'' said Franklin Berger, a biotechnology
analyst with J.P. Morgan Securities. ''They were very explicit
about what they want to see.''
The company already has other studies underway that could
expand the approved uses, and once on the market the drug could
be prescribed to any patients that doctors determine should
receive it. Analysts' estimates for the drug range between $300
million and more than $1 billion in peak annual sales, making it
a crucial product for Immunex.
Trading in shares of Immunex was halted as the panel met.
The FDA typically follows the advice of its expert committees.
If approved, Immunex's Enbrel would be co-promoted by
Immunex and American Home Products Corp. -- the world's seventh
biggest drug maker by sales -- which owns a majority stake in the
biotechnology company.
Shares of Madison, New Jersey-based American Home fell 5/8
to 55 1/4.
Rival Drugs
Today's meeting also has ramifications for a rival
biotechnology company, Centocor Inc. The Malvern, Pennsylvania-
based developer of the heart drug ReoPro plans to seek approval
of its Remicade drug for rheumatoid arthritis as early as the end
of this year. Centocor's drug is already approved to treat a
condition known as Crohn's disease.
Enbrel and Remicade work in different ways to block the
activity of a naturally occurring compound called tumor necrosis
factor, or TNF, which plays a key role in inflammation. The drugs
act to halt a chain of events within cells that cause the body to
attack its own soft tissues and joints.
''There is a great deal of excitement out there among
patients that new drugs are coming,'' said Hiren Patel, a
healthcare analyst with Denver Investment Advisors, which manages
about $11 billion. ''Both drugs seem to be fairly effective and I
would suspect they're both going to end up on the market and
it'll just be a slugfest.''
Meanwhile, Hoechst AG just last week won FDA approval for
its Arava drug, the first oral treatment approved to slow the
progression of rheumatoid arthritis. Hoechst's Arava is part of
an older class of drugs that work later in the chain of events
that cause the disease, blocking the rapid multiplication of
immune cells that cause inflammation.
Centocor shares fell 7/8 to 35 7/8 in recent trading, while
American depositary receipts of Frankfurt, Germany-based Hoechst
rose 13/16 to 43 1/8.
Crucial for Immunex
Today's hearing is crucial for Immunex. Even by the most
conservative of sales estimates, Enbrel would bring in more than
eight times the revenue seen last year from all of the company's
seven drugs, which include the cancer treatments Novantrone,
Leukine and Thioplex.
Rheumatoid arthritis can strike young adults and even
children, unlike age-related osteoarthritis, and is a more
serious form of arthritis. Affecting some 2 million Americans,
the condition is characterized by pain, swelling and tenderness
in the joints.
Immunex presented three major studies to the panel, two of
which compared the drug to a placebo in patients with severe
disease who weren't helped by at least one other drug. The third
tested Enbrel in combination with a generic drug known as
methotrexate compared to methotrexate alone. In all three, Enbrel
produced significant improvements.
One patient, 65-year-old Elizabeth Petersen, told the panel
that she felt so good after beginning therapy with Enbrel that
she found herself skipping down an alley.
''I actually felt as if I had been released from prison,''
said Petersen, who was first diagnosed at age 29. ''It's like
getting a new wife,'' added her husband, Bert.
Mild Side Effects
Immunex officials said the only major side effect that could
be attributed to Enbrel was an increase of reactions at the site
where the drug is injected into the body. The company said the
reactions were mild and affected less than half of patients.
Still, FDA reviewer Jeffrey Siegel said the drug's role in
causing infections or autoimmune diseases is unknown. Enbrel-
treated patients appeared to have more infections, he said.
Both he and Immunex officials, however, noted that many
patients originally given placebo had dropped out of the
company's studies because they weren't seeing improvements in
their disease. That could skew the safety results, they said.
''It's difficult to reach definite conclusions,'' Siegel
said.
Separately, seven patients came down with some form of
cancer after taking Enbrel, though the company said that was
comparable with the rate expected in the general population.
Other Uses
Immunex is also testing Enbrel as a treatment for congestive
heart failure and conducting clinical trials of other drugs for
asthma, cancer and prevent of infections in patients with the
AIDS-causing virus HIV.
The FDA granted the drug so-called priority review status in
June, which means the agency plans to complete its review of
Immunex's application -- filed May 7 -- in six months rather than
the usual 12. That could clear the drug for sale at the beginning
November.
--Kristin Jensen in Gaithersburg, Maryland with reporting from |
