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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
May 8, 1997
(Date of earliest event reported)
Cephalon, Inc.
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C> <C>
Delaware 0-19119 23-2484489
(State or other jurisdiction (Commission (IRS Employer
of incorporation or organization) File Number) ID No.)
145 Brandywine Parkway
West Chester, Pennsylvania 19380
(Address of principal executive offices) (Zip Code)
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(610) 344-0200
(Registrant's telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year,
if changed since last report)
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ITEM 5. OTHER EVENTS.
On May 8, 1997, Cephalon, Inc. (the "Registrant") announced that the
Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food
and Drug Administration had found, by a vote of 6 to 3, that there was not
substantial evidence that MYOTROPHIN(R) (rhIGF-1 or mecasermin) Injection is
effective in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's
disease).
The Registrant hereby incorporates by reference the Press Release, which is
attached hereto as Exhibit 99.1 and made a part hereof, into this Item 5.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) Financial Statements of Business Acquired: None
(b) Pro Forma Financial Information: None
(c) Exhibits: Reference is made to the Exhibit Index annexed
hereto and made a part hereof.
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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 thereunto duly authorized.
CEPHALON, INC.
Date: May 8, 1997 By: /s/ Bruce A. Peacock
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Bruce A. Peacock
Executive Vice President and
Chief Operating Officer
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EXHIBIT INDEX
EXHIBIT PAGE
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99.1 Press Release dated May 8, 1997
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EXHIBIT 99.1
Contact: Jason Rubin Larry Kurtz
Cephalon, Inc. Chiron Corp.
(610) 344-0200 (510) 923-2476
FOR IMMEDIATE RELEASE
Cephalon and Chiron Announce Results of FDA
Advisory Committee Meeting
West Chester, Pa., and Emeryville, Calif. - May 8, 1997 - The U.S.
Food and Drug Administration's (FDA) Peripheral and Central Nervous Systems
Drugs Advisory Committee today found, by a vote of 6 to 3, that there was not
substantial evidence that MYOTROPHIN(R) (rhIGF-1 or mecasermin) Injection is
effective in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's
disease). The committee's finding was requested by the FDA in conjunction with
its review of a New Drug Application (NDA) submitted by Cephalon, Inc.
(NASDAQ:CEPH) and Chiron Corp. (NASDAQ:CHIR) for clearance to market MYOTROPHIN
Injection for the treatment of ALS.
In response to the committee's vote, Frank Baldino, Jr., Ph.D.,
Cephalon's president and chief executive officer, and William Rutter, Ph.D.,
Chiron's chairman, stated, "We are deeply disappointed with the committee's
finding about MYOTROPHIN Injection. We appreciate the many expressions of
support from patients, caregivers and physicians and will be reviewing with the
FDA the panel's recommendation."
Cephalon, Inc., headquartered in West Chester, PA, is an international
biopharmaceutical company that discovers, develops and markets products to treat
neurological disorders. The company is developing products for the treatment of
ALS, narcolepsy, peripheral neuropathies, Alzheimer's disease, head and spinal
injury, and stroke, and currently copromotes two products in the United States
for the treatment of neurological conditions.
Chiron Corporation, headquartered in Emeryville, Calif., near San
Francisco, is a science-driven, market-directed healthcare company that
combines diagnostic, vaccine and therapeutic strategies for controlling disease.
Chiron participates in four global healthcare markets: diagnostics, including
immunodiagnostics, critical care diagnostics and new quantitative probe tests;
therapeutics, with an emphasis on oncological, infectious, neurological and
cardiovascular disease; pediatric and adult vaccines; and ophthalmic surgical
products for the correction of vision. Chiron also conducts research and
development in the fields of biological proteins, gene therapy and combinatorial
chemistry.
This news release may contain forward-looking statements that involve
risks and uncertainties. A full discussion of the companies' operations and
financial condition, including factors that may affect their business and future
prospects, is contained in documents the companies file with the SEC, such as
form 10-Q and 10-K reports. These documents identify important factors that
could cause the companies' actual performance to differ from current
expectations.
