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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
July 16, 1998 0-16132
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
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification Number)
7 Powder Horn Drive
Warren, New Jersey 07059
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(Address of Principal Executive Offices) (Zip Code)
(732) 271-1001
(Registrant's telephone number, including area code)
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Item 5. Other Events.
On July 16, 1998, Celgene Corporation (the "Company") received
clearance from the U.S. Food and Drug Administration to market
and sell Thalomid (TM)(Thalidomide)for the treatment of erythema
nodosum leprosum (ENL), a severe and debilitating condition
associated with leprosy.
Item 7. Financial Statements, Unaudited Pro Forma Financial
Information and Exhibits.
(a) Not applicable.
(b) Not applicable
(c) Exhibits
99 Press Release, dated July 16, 1998.
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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: July 21, 1998 CELGENE CORPORATION
By: /s/ John W. Jackson
Name: John W. Jackson
Title: Chairman of the Board and
Chief Executive Officer
EXHIBIT 99
HEADLINE: Celgene Announces FDA Clears Thalidomide For Sale in
U.S.
DATELINE: WARREN, N.J., July 16
BODY:
Celgene Corporation (Nasdaq: CELG) today announced it has
received clearance from the U.S. Food and Drug Administration
(FDA) to market and sell THALOMID (TM) (thalidomide) for the
treatment of erythema nodosum leprosum (ENL), a severe and
debilitating condition associated with leprosy.
Celgene licensed rights to thalidomide from The Rockefeller
University in 1992 and began developing the drug for a range of
potential indications. These include AIDS related,
dermatological and cancer related conditions. Celgene submitted
a new drug application (NDA) for THALOMID (TM) in December 1996.
"Making THALOMID (TM) available to the American people
required a concerted and cooperative effort between Celgene and
the FDA," said Celgene's Chairman and Chief Executive Officer,
John W. Jackson. "Celgene is committed to the continued
development of THALOMID (TM) as a therapy for people suffering
from serious and debilitating diseases."
In order to support the safe and appropriate use of the
drug, Celgene has developed a unique and comprehensive patient,
physician and pharmacist education and distribution system to be
called the System for Thalidomide Education and Prescribing
Safety (STEPS).
Celgene Corporation, headquartered in Warren, NJ, is engaged
in the development of human pharmaceuticals and agrochemicals.
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,
actions by the FDA and other regulatory authorities, and those
factors detailed in the Company's filings with the Securities and
Exchange Commission.
