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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 7, 1996
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(Date of earliest event reported)
Cephalon, Inc.
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(Exact name of registrant as specified in its charter)
Delaware 0-19119 23-2484489
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(State or other jurisdiction (Commission (IRS Employer
of incorporation or organization) File Number) ID No.)
145 Brandywine Parkway
West Chester, Pennsylvania 19380
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(Address of principal executive offices) (Zip Code)
(215) 344-0200
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(Registrant's telephone number, including area code)
Not Applicable
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(Former name, former address and former fiscal year,
if changed since last report)
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ITEM 5. OTHER EVENTS.
On May 7, 1996, Cephalon and its partner, Chiron Corporation, announced
that the U.S. Food and Drug Administration (FDA) has scheduled Myotrophin
(rhIGF-1) for review by the FDA's Peripheral and Central Nervous System Drugs
Advisory Committee on June 7, 1996.
The companies plan to present findings from two completed clinical studies
which evaluated Myotrophins utility in treating amyotrophic lateral sclerosis
(ALS, or Lou Gehrig's disease). Data from these studies have been submitted to
the FDA in support of a Treatment Investigational New Drug application. The
companies plan to submit a New Drug Application (NDA) based upon these studies
later this year for clearance to market the drug in the United States.
This announcement contains forward-looking statements that involve risks
and uncertainties. A full discussion of the companies' operations and financial
condition, including factors that may affect future operating results, 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 our current expectations.
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
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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 thereunto duly authorized.
CEPHALON, INC.
Date: May 7, 1996 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
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EXHIBIT PAGE
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99.1 Press Release dated May 7, 1996. 5
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[LOGO]
Cephalon, Inc.
Contact: Jason Rubin or Larry Kurtz
Mary Fisher Chiron Corp.
Cephalon, Inc. (510) 601-2476
(610) 344-0200
145 Brandywine Parkway
West Chester, PA 19380-4245
(610) 344-0200
Fax (610) 344-0065
Myotrophin Scheduled for June FDA
Advisory Panel Meeting
West Chester, PA and Emeryville, CA -- May 7, 1996 -- Cephalon, Inc.
(NASDAQ: CEPH) and its partner, Chiron Corporation (NASDAQ: CHIR), announced
today that the U.S. Food and Drug Administration (FDA) has scheduled
Myotrophin(R) (rhIGF-1) for review by the FDA's Peripheral and Central Nervous
System Drugs Advisory Committee on June 7, 1996.
The companies plan to present findings from two completed clinical studies
which evaluated Myotrophin's utility in treating amyotrophic lateral sclerosis
(ALS, or Lou Gehrig's disease). Data from these studies have been submitted to
the FDA in support of a Treatment Investigational New Drug application. The
companies plan to submit a New Drug Application (NDA) based upon these studies
later this year for clearance to market the drug in the United States.
"We appreciate the FDA's invitation to bring these data to an advisory
committee at the earliest available date, even before we submit our NDA," said
Frank Baldino, Jr., Ph.D., Cephalons president and chief executive officer. "We
will continue to work with the agency toward our ultimate goal to have
Myotrophin reviewed and cleared for patients with ALS as soon as possible."
"The FDA's willingness to review the data at the next available panel
meeting demonstrates the agency's commitment to meeting the needs of patients
with serious diseases such as ALS," added William J. Rutter, Ph.D., chairman of
Chiron. "We look forward to presenting our case for Myotrophin to the advisory
committee."
Chiron Corporation is a science-driven healthcare company that combines
diagnostic, vaccine and therapeutics strategies for controlling disease.
Headquartered in Emeryville, near San Francisco, and with operations on four
continents, Chiron had revenues in 1995 of more than $1 billion.
Cephalon discovers, develops and markets pharmaceutical products for the
treatment of neurological disorders. The company's principal focus is on
diseases such as ALS, narcolepsy, peripheral neuropathies, Alzheimer's disease,
head and spinal injury, and stroke.
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Myotrophin Scheduled for June Panel Meeting
Page 2
This news release contains forward-looking statements that involve risks
and uncertainties. A full discussion of the companies' operations and financial
condition, including factors that may affect future operating results, 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 our current expectations.
* * * *
