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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) August 24, 1998
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CENTOCOR, INC.
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(Exact name of registrant as specified in its charter)
Pennsylvania 0-11103 23-2117202
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(State or other (Commission file (IRS Employer
jurisdiction of number) Identification No.)
incorporation)
200 Great Valley Parkway, Malvern, Pennsylvania 19355
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (215) 651-6000
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Not applicable
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(Former name or former address, if changed since last report)
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Item 5. Other Events.
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On August 24, 1998, Registrant was notified by the United States Food and Drug
Administration ("FDA") that the FDA has approved Remicade(TM) (infliximab),
formerly known as Avakine(TM), for sale in the United States for the treatment
of patients with moderately to severely active Crohn's disease for the reduction
of signs and symptoms, for whom conventional therapy is inadequate, and for the
treatment of patients with fistulizing Crohn's disease for reduction in the
number of draining enterocutaneous fistula(e). As required by the FDA, Centocor
will conduct a randomized, double blind, placebo-controlled clinical study
designed to evaluate safety and efficacy of continued use of Remicade(TM) for
maintaining a sustained clinical outcome in such patients. A copy of the
Registrant's press release with regard to the FDA approval of Remicade(TM) is
filed as an exhibit to this Form 8-K and incorporated herein by reference.
Item 7. Financial Statements and Exhibits.
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(c) Exhibits:
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(99.1) Press release, dated August 24, 1998.
SIGNATURES
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CENTOCOR, INC.
Registrant
Dated: August 25, 1998 By: /s/ George D. Hobbs
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George D. Hobbs, Vice President,
Corporate Counsel and
Secretary
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Exhibit 99.1
NEWS RELEASE
For Immediate Release
CONTACTS
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Media: Christopher Allman (610) 651-6546
Investors: Paul Wulfing (610) 889-4422
FDA APPROVES CENTOCOR'S REMICADE(TM)
TO TREAT CROHN'S DISEASE
First new product in 30 years indicated for this serious gastrointestinal
condition
MALVERN, Pa., August 24, 1998 - - The Food and Drug Administration (FDA) today
approved REMICADE(TM) (infliximab), Centocor's (Nasdaq: CNTO) treatment for
patients with Crohn's disease, a chronic and debilitating disorder of the
gastrointestinal tract that can greatly affect a patient's quality of life.
REMICADE was formerly known as Avakine.
REMICADE is the first of a new class of agents that blocks activity of a key
biologic response mediator called tumor necrosis factor alpha (TNF-alpha). It is
believed that REMICADE reduces intestinal inflammation in patients with Crohn's
disease by binding to and neutralizing TNF-alpha on the cell membrane and in the
blood and by destroying TNF-alpha producing cells. This action may explain why
REMICADE is a particularly effective inhibitor of TNF-alpha and why REMICADE has
a rapid and substantial clinical benefit.
REMICADE is indicated for treatment of moderately to severely active Crohn's
disease for the reduction of the signs and symptoms, in patients who have an
inadequate response to conventional therapy. It is also indicated as a
treatment for patients with fistulizing Crohn's disease for reduction in the
number of draining enterocutaneous fistula(s). The safety and efficacy of
REMICADE beyond the recommended duration of treatment have not been established.
As previously announced, on May 28, 1998, an FDA Advisory Committee unanimously
recommended REMICADE for approval.
"Based on results from clinical trials, REMICADE has been shown to have a rapid
and substantial effect in reducing the signs and symptoms of Crohn's disease,"
said Thomas Schaible, Ph.D., director, medical affairs, Centocor.
In a clinical trial of 108 patients with moderately to severely active Crohn's
disease who did not respond adequately to conventional therapies, 82 percent of
patients treated with REMICADE at the recommended dose (5 mg/kg) achieved a
clinical response at week 4 vs. 16 percent of patients who received placebo (p
less than 0.001). In this study, 48 percent of patients treated with REMICADE
went into clinical remission at week 4 vs. four percent of patients who received
placebo (p less than 0.001). Overall, 92 percent of patients enrolled in the
trial continued to receive stable doses of corticosteroids, antibiotics,
aminosalicylates or other immunomodulators.
REMICADE was also shown to be effective in reducing the number of open, draining
fistulas, a painful complication of Crohn's disease in which deep openings
burrow from the bowel wall through the surface of the skin, causing drainage of
mucous and/or fecal material. REMICADE is the first product documented to
reduce the number of open fistulas in a controlled clinical trial.
In a clinical study of 94 patients with fistulizing Crohn's disease (42 patients
had single fistula and 52 patients had multiple fistulas), 68 percent of those
treated at the recommended dose of REMICADE experienced closure of at least 50
percent of fistula(s) for four weeks or more compared with 26 percent of
placebo-treated patients (p equals 0.002). More than one-half (55 percent) of
patients with single or multiple fistula(s) treated with REMICADE experienced
closure of their fistula(s) compared with 13 percent of placebo-treated
patients. Six patients who had demonstrated a clinical response to REMICADE
developed an abscess in the area of the fistula between eight and 16 weeks after
the last infusion.
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"REMICADE represents a significant advance in the treatment of Crohn's disease,"
said Stephen B. Hanauer, M.D., University of Chicago Medical Center, Department
of Gastroenterology, and a principal investigator in the clinical trials.
"These patients suffer terribly and we physicians now have an important option
available to treat them."
Approximately five percent of Crohn's disease patients studied discontinued
REMICADE treatment. The most common reasons for discontinuation were infusion
reactions and infections. On rare occasions, these reactions were serious but
resolved with standard treatment for hypersensitivity reactions or
discontinuation of REMICADE therapy. The most common adverse reactions
occurring more frequently with REMICADE than placebo include nausea, upper
respiratory tract infections and abdominal pain. REMICADE therapy may result in
the development of autoantibodies. However, development of such autoantibodies
rarely leads to clinical symptoms or discontinuation of therapy.
The dosage for patients with non-fistulizing moderately to severely active
Crohn's disease is a single infusion of 5 mg/kg of REMICADE. The dosage for
patients with fistulizing disease is an initial dose of 5 mg/kg followed with
additional doses of 5 mg/kg at two and six weeks after the first infusion.
REMICADE will be shipped to distributors nationwide in late September or early
October (1998). Centocor will sell Remicade to wholesalers and distributors at
a list price of $450 per vial. The average Crohn's disease patient will require
3 to 4 vials of Remicade per infusion.
Centocor has retained exclusive marketing rights for REMICADE in the United
States. Following approval from global regulatory agencies, Tanabe Seiyaku Co.,
Ltd. will market the product in Japan and parts of the Far East, while Schering-
Plough Corporation will market REMICADE in all other countries throughout the
world.
"We will continue studying REMICADE in patients with Crohn's disease and have
plans to initiate a trial in patients with active disease to examine long-term
efficacy and steroid-sparing effects," said David P. Holveck, chief executive
officer. "We are also investigating the use of REMICADE in pediatric patients
with Crohn's disease. In addition, we continue to investigate the use of
REMICADE for other indications.
Together with our currently marketed cardiovascular products, ReoPro(R)
(abciximab) and Retavase(R) (reteplase), REMICADE will give Centocor three major
therapeutic products in its portfolio," said Holveck. He added that the
company continues its clinical research in rheumatoid arthritis and cancer.
Centocor is a biopharmaceutical company that develops or acquires and
commercializes novel therapeutic products that solve critical needs in human
healthcare. The company's primary technology focus is on monoclonal antibodies
and DNA-based products. For more information, visit Centocor's website at
WWW.CENTOCOR.COM.
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For additional information about Crohn's disease, contact the Crohn's and
Colitis Foundation of America at 1-800-343-3637 or visit its website at
WWW.CCFA.ORG.
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For a copy of the full prescribing information for REMICADE, call 800-753-0352
x709.
CERTAIN OF THE MATTERS DISCUSSED HEREIN WITH RESPECT TO FUTURE EARNINGS,
CLINICAL STUDIES AND THE COMPANY'S PRODUCTS MAY CONSTITUTE FORWARD-LOOKING
STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995. SUCH FORWARD-LOOKING STATEMENTS ARE BASED ON CURRENT
EXPECTATIONS, ESTIMATES AND PROJECTIONS ABOUT THE COMPANY'S INDUSTRY,
MANAGEMENT'S BELIEFS AND CERTAIN ASSUMPTIONS MADE BY THE COMPANY'S
MANAGEMENT. INVESTORS ARE CAUTIONED THAT MATTERS SUBJECT TO FORWARD-
LOOKING STATEMENTS INVOLVE RISKS AND UNCERTAINTIES, INCLUDING ECONOMIC,
COMPETITIVE, GOVERNMENTAL, TECHNOLOGICAL AND OTHER FACTORS DISCUSSED IN THE
COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION, WHICH MAY
AFFECT THE COMPANY'S BUSINESS AND PROSPECTS. MORE SPECIFICALLY, THERE CAN
BE NO ASSURANCE THAT THIS PRODUCT WILL ACHIEVE COMMERCIAL SUCCESS OR THAT
COMPETING PRODUCTS WILL NOT PREEMPT ANY MARKET OPPORTUNITY THAT MIGHT EXIST
FOR THE PRODUCT.
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REOPRO(R) IS A REGISTERED TRADEMARK OF ELI LILLY AND COMPANY.
