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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 22, 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 22, 1997, Celgene Corporation (the "Company") issued a
press release announcing that it has received an "approvable letter" from the
U.S. Food and Drug Administration for thalidomide in the treatment of the
cutaneous manifestations of 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 22, 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 23, 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
Celgene Receives FDA Approvable Letter for Thalidomide
First-Line Treatment for Complications of Leprosy
WARREN, N.J. Sept. 22, 1997--Celgene Corporation (NASDAQ: CELG) today announced
it has received an "approvable letter" from the U.S. Food and Drug
Administration (FDA) for thalidomide in the treatment of the cutaneous
manifestations of erythema nodosum leprosum (ENL), a severe and debilitating
condition associated with leprosy.
"This represents a significant milestone in the development of Celgene as an
integrated pharmaceutical research, development and marketing company," said
John W. Jackson, chairman and CEO of Celgene.
The approvable letter was sent to Celgene only 17 days after the company
presented its New Drug Application (NDA) for thalidomide to the Dermatologic and
Ophthalmic Drug Advisory Committee, an FDA appointed panel of medical experts.
When asked whether the benefits of thalidomide outweigh the risks in the
treatment of systemic ENL syndrome, the committee voted eight-to-one in the
affirmative, with one abstention. Advisory panels provide the FDA with advice
and recommendations on questions posed by the FDA, including whether a product
should be cleared for use in the U.S. Following the recommendations of the
advisory committee, the FDA and Celgene have begun discussions aimed at
identifying possible means for limiting or restricting distribution of the drug
in line with the agency's Accelerated Approval regulations (21 CFR 314 Subpart
H). Celgene has proposed a unique and comprehensive patient/physician education
program and distribution system designed to support safe and appropriate use of
the drug.
ENL is a severe and painful complication of leprosy. Thalidomide has been used
to treat ENL patients in the U.S. for more than twenty years through a U.S.
Public Health Service compassionate use program. The drug was designated as the
treatment of choice for ENL by the World Health Organization in 1994.
Introduced in Europe in the 1950s, thalidomide was first prescribed as a
sedative. It was withdrawn in 1962 when it was found to cause birth defects. The
product was never approved for prescription use in the United States.
Celgene Corporation 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
actions by the FDA and other regulatory authorities.
CONTACT: Robert Butler Maria Favorito Brian Gill
Celgene Corporation Makovsky & Co. Financial Relations Board
(732) 271-1001 (212) 508-9600 (212) 661-8030
