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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
September 5, 1997 0-16132
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Date of Report Commission File Number
(Date of earliest event reported)
CELGENE CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 22-2711928
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(State or other jurisdiction of (I.R.S. Employer Identification Number)
incorporation or organization)
7 Powder Horn Drive
Warren, New Jersey 07059
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(Address of Principal Executive Offices) (Zip Code)
(908) 271-1001
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(Registrant's telephone number, including area code)
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Item 5. Other Events.
On September 5, 1997, Celgene Corporation (the "Company") issued a
press release announcing that thalidomide had received a positive recommendation
from a U.S. Food and Drug Administration advisory committee for the treatment of
certain complications inherent in erythema nodosum leprosum, a severe and
debilitating condition associated with leprosy. The press release is filed as an
exhibit hereto and is hereby incorporated by reference.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(a) not applicable
(b) not applicable
(c) Exhibits
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99 Press Release, dated September 5, 1997.
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SIGNATURES
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.
Date: September 18, 1997 CELGENE CORPORATION
By: /s/ John W. Jackson
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Name: John W. Jackson
Title: Chairman of the Board and
Chief Executive Officer
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EXHIBIT 99
Thalidomide Recommended for FDA Approval by U.S. FDA Advisory Committee
First-Line Treatment for Leprosy Awaits FDA Approval
BETHESDA, Md. Sept. 5, 1997-- Celgene Corp. (NASDAQ:CELG) today announced that
thalidomide has received a positive recommendation from a U.S. Food and Drug
Administration (FDA) advisory committee for the treatment of certain
complications inherent in erythema nodosum leprosum (ENL), a severe and
debilitating condition associated with leprosy.
The Dermatologic and Opthalmic Advisory Committee (DOAC), which has met over the
last two days here, determined that the efficacy of thalidomide in the treatment
of fever and skin lesions, two of the more serious manifestations of ENL, has
been demonstrated. When asked by DOAC chairman, Joseph Maguire, Jr., M.D.,
professor of dermatology and pediatrics at Stamford University School of
Medicine, whether the benefits of thalidomide outweigh its risks in the
treatment of systemic ENL syndrome, the committee voted eight-to-one in the
affirmative, with one abstention.
"This is a significant step forward toward bringing Celgene's thalidomide to the
many patients for whom there are few, if any alternatives," said John W.
Jackson, chairman and CEO of Celgene Corp. "This action confirms studies which
have shown thalidomide to be an effective treatment for ENL." The committee also
considered a variety of issues concerning the efficacy, safety and commercial
distribution of thalidomide for the treatment of ENL, casting individual votes
on each, while making additional recommendations for continued study of the
product.
ENL is a severe and painful complication of leprosy, a disease which afflicts
several thousand persons in the U.S. with 200 new cases reported each year.
Thalidomide has been used to treat the disease worldwide for nearly 30 years
with major improvement in approximately 90% of patients. The drug has been
recommended by the World Health Organization as the treatment of choice for ENL.
If the FDA approves marketing of thalidomide, ENL patients in the U.S. will be
assured safe, regulated access to this effective treatment. "Health care
practitioners in the U.S. have had restricted access to thalidomide which has
been shown to effectively treat ENL in leprosy patients," said Leo Yoder, M.D.,
recently retired from the U.S. Public Health Service, who specializes in the
treatment of leprosy. "The clinical and historical research indicates that, when
properly used, thalidomide is a safe and effective treatment and this has now
been confirmed."
While not binding, the committee's recommendations are carefully considered by
the FDA, the agency which clears pharmaceutical products for marketing in the
United States. "Given the significance and complexity of bringing regulated
thalidomide into the U.S. market, we would like to recognize and applaud the
determined effort put forth by both the FDA and the committee," said Celgene's
President, Sol Barer, Ph.D. "We look forward to continuing our work with the FDA
to ensure safe and appropriate use and distribution of thalidomide in the United
States."
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To ensure the safe and effective delivery of thalidomide to patients who require
it for the treatment of ENL, Celgene has developed a detailed patient/physician
education program designed to prevent fetal exposure to the drug. Introduced in
Europe in the 1950's, thalidomide was first prescribed as a sedative. It was
withdrawn from the European market in 1962 when it was found to cause
phocomilia, a birth defect characterized by shortened or missing limbs in the
offspring of women who took the drug while pregnant. The product was never
approved in the United States. Celgene Corp. uses proprietary expertise in small
molecule chemistry to develop novel therapeutic agents and fine chemicals for
the pharmaceutical, agrochemical, and allied industries.
This release contains certain forward-looking statements which involve known and
unknown risks, delays, uncertainties and other factors not under the company's
control which may cause actual results, performance or achievements of the
company to be materially different from the results, performance or other
expectations implied by these forward-looking statements. These factors include
results of current or pending clinical trials and actions by the FDA and other
regulatory authorities.
CONTACT: Celgene Corporation, Bruce Williams, 732/271-1001
or Makovsky & Co., Maria Favorito, 212/508-9600
or Financial Relations Board, Brian Gill, 212/661-8030
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