Centocor Wins FDA Approval of Remicade for Crohn's (Update5)
Bloomberg News
August 24, 1998, 2:57 p.m. ET
Centocor Wins FDA Approval of Remicade for Crohn's (Update5)
(Adds comment from CEO, background on drug, disease.)
Washington, Aug. 24 (Bloomberg) -- Centocor Inc., one of a
handful of profitable biotechnology companies, won U.S. approval
to sell its Remicade drug for Crohn's disease, a hard-to-treat
condition involving inflammation of the gastrointestinal tract.
The U.S. Food and Drug Administration approved Remicade for
patients with moderate-to-severe forms of Crohn's who aren't
helped by current treatments such as steroids and antibiotics.
''This truly is an unmet medical need,'' said Kris Jenner,
an analyst with T. Rowe Price. ''I think there will be very high
usage of Remicade.''
With the FDA's approval of Remicade in hand, Centocor joins
a select group of biotechnology companies such as Amgen Inc. and
Genentech Inc. with several products on the market. Centocor also
markets heart drugs ReoPro and Retavase in the U.S.
Centocor shares rose 1 5/8 to 39 3/8 in trading of nearly
5.5 million shares, making the stock one of the top 10 most
actively traded on U.S. markets.
News of the approval comes just after researchers reported
strong results from a study of ReoPro at a European heart
conference.
''It's a lot of good news,'' said Jay Silverman, an analyst
with BancAmerica Robertson Stephens. With the Crohn's approval
alone, Remicade should have U.S. sales of around $36 million in
1998, and worldwide sales of about $135 million in 1999,
Silverman said.
Wider Use for Arthritis
Today's approval could also help the Malvern, Pennsylvania-
based company in its eventual bid to sell Remicade for treating
rheumatoid arthritis, a much wider use that could boost its
annual sales to as much as $500 million, analysts said.
That would bolster the company as it faces competition from
Seattle-based Immunex Corp.'s Enbrel drug for rheumatoid
arthritis. Immunex will face an FDA advisory panel review for its
Enbrel next month. Centocor hasn't yet submitted its application
for the drug's use in rheumatoid arthritis, though that could
come as early as the end of this year, a company spokesman said.
''It will be helpful to be out there at least and to
establish a following'' for Remicade, said David Holveck, chief
executive of Malvern, Pennsylvania-based Centocor. The company
will present a major study of the drug in arthritis patients in
November, he told the Bloomberg Forum.
In the meantime, the drug offers a rare new option for
patients with Crohn's disease, named after B. B. Crohn, one of
the doctors who first identified the condition in 1932.
The FDA approval would extend to about 200,000 patients,
Holveck said. Under the terms of the approval, the company is
required to do more long-term studies to figure out how best to
use the drug and understand its long-term effects.
Also called infliximab, Remicade is part of a new class of
drugs that neutralizes a naturally occurring compound called
tumor necrosis factor, which can trigger a cascade of destructive
activity in the body, including gastrointestinal inflammation.
It's a so-called monoclonal antibody, which means the drug
comes from a specially designed antibody engineered to seek out
and bind to a particular target. An endless number of clones are
then made from the engineered antibody and processed to make
enough of the drug. Engineered antibodies may be used to fight
cancer by attacking tumor cells, to rally the immune system
against an invader, or to neutralize toxins.
In studies, the company found that patients taking Remicade
suffered less from the symptoms of the disease, such as severe
diarrhea with blood, abdominal pain, and unnatural amounts of
bowel movements. In many patients, Remicade also healed fistulae
-- ulcers or long-term inflammation that eats through tissue and
creates wounds in the body.
Since fistulae are particularly difficult to treat, the
study that found Remicade could heal them was hailed as
groundbreaking when it was first released last year. The FDA
formally approved use of the drug to treat fistulae, though the
drug's label notes that it has been tested in three doses and the
safety and efficacy of the drug beyond those doses is unknown.
Safety Questions
Indeed, members of an FDA advisory panel that reviewed the
drug in May said there were still safety issues to consider.
In its studies of both Crohn's and rheumatoid arthritis
patients, the company found a higher incidence of infections and
reactions at the drug infusion site among patients taking the
drug compared with those on placebo. In addition, there were
several cases of malignancies, including lymphomas, among
patients in the Remicade group.
The drug's label contains warnings about the development of
lupus-like symptoms, though it notes that the symptoms were
temporary and stopped after treatment. The drug has also been
associated with a potentially dangerous allergic reaction known
as hypersensitivity, according to the label.
Still, the approval and the wording of the labeling should
lay to rest lingering questions about the short-term safety of
the drug, Silverman said.
''It's exactly what the company was trying to get when they
went into the panel meeting,'' he said. Longer term studies will
determine the long-term safety of the drug, he said.
Crohn's, an as-yet incurable disease, most often is treated
with steroids, which are effective in quickly reducing flare-ups
and alleviating the intensity of symptoms. Steroids aren't ideal,
however, because they can result in dangerous side effects after
long-term use.
Schering-Plough Corp. has the rights to sell Remicade in
much of the world. Centocor maintained its right to sell the drug
in the U.S. and licensed marketing rights for Japan, Taiwan,
Indonesia, and China to Tanabe Seiyaku Co.
--Kristin Jensen and Kristin Reed in Washington (202) 624-1843 |
