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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
September 15, 1998
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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 September 15, 1998, Cephalon, Inc. (the "Registrant") announced that
Cephalon-Chiron B.V. has withdrawn its application to the European Medicines
Evaluation Agency (EMEA) seeking clearance to market MYOTROPHIN(R) (mecasermin)
Injection in Europe for the treatment of amyotrophic lateral sclerosis (ALS or
motor neuron disease).
On September 18, 1998, the Registrant announced the first findings from
preclinical studies of its compound, CEP-701, for the treatment of pancreatic
ductal adenocarcinoma (PDAC). The results presented on September 18, 1998 at
the Baltic Pancreas Meeting in Germany demonstrate that CEP-701 can
significantly decrease tumor growth as well as inhibit tumor cell invasion in
PDAC animal models.
The Registrant hereby attaches both releases as Exhibits 99.1 and 99.2,
respectively, which are thereby made a part of this Item 5.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) Financial Statements of Business Acquired: None
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(b) Pro Forma Financial Information: None
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(c) Exhibits: Reference is made to the Exhibit Index annexed hereto and
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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: September 23, 1998 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 September 15, 1998
99.2 Press Release dated September 18, 1998
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Contact: Jason Rubin Liz Shanahan (Europe)
Cephalon, Inc. Sante Communications
610-738-6302 011-44-1-71-379-7377
FOR IMMEDIATE RELEASE
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Cephalon and Chiron Withdraw Application to
Market Myotrophin in Europe
West Chester, PA - September 15, 1998 - Cephalon, Inc. (NASDAQ: CEPH)
announced today that Cephalon-Chiron B.V. has withdrawn its application to the
European Medicines Evaluation Agency (EMEA) seeking clearance to market
MYOTROPHIN (mecasermin) Injection in Europe for the treatment of amyotrophic
lateral sclerosis (ALS or motor neuron disease). This decision was based on
difficulties in resolving issues raised by the Rapporteurs concerning the
differences in response seen in the two pivotal studies, and whether a benefit
measured by slowing disease progression, using a functional rating scale, is
considered clinically relevant.
"It is not possible to resolve these issues within the timeframe allotted
to the review process," stated Frank Baldino, Jr., Ph.D., Cephalon's president
and chief executive officer. "Until these important issues are resolved, we do
not believe it is worthwhile to proceed further towards a decision on this
application."
Cephalon, Inc., headquartered in West Chester, PA, is an international
biopharmaceutical company dedicated to the discovery, development and marketing
of products to treat neurological disorders and cancer.
In addition to historical facts, this press release may contain forward-
looking statements that involve risks and uncertainties that could cause actual
results to differ materially from those reflected in the forward-looking
statements. These statements are based on the company's current belief as to
the possibility and timing of future events. Actual results could differ
materially from those reflected in the forward-looking statements. Factors
which could cause actual results to differ from the company's expectations
include, without limitation, the nature of regulatory decisions, the pricing of
competitive products, the impact of litigation, risks commonly associated with
development and commercialization of drugs and other specific factors that could
cause the company's performance to differ from current expectations. These
risks are described in documents the company files with the SEC, such as the
most recent reports on Form 8-K, Form 10-Q and/or Form 10-K.
NOTE: Cephalon's press releases are posted on the Internet at the
company's Web site at http://www.cephalon.com. They are also available by fax
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24 hours a day at no charge by calling PR Newswire's Company News On-Call at
800-758-5804, extension 134563.
<PAGE>
Contact: Sandra Menta
610-738-6376
FOR IMMEDIATE RELEASE
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Cephalon Presents Research Results
from Pancreatic Cancer Studies
West Chester, PA - September 18, 1998 - Cephalon, Inc. (NASDAQ: CEPH)
announced today the first findings from preclinical studies of its compound,
CEP-701, for the treatment of pancreatic ductal adenocarcinoma (PDAC). The
results presented today at the Baltic Pancreas Meeting in Germany demonstrate
that CEP-701 can significantly decrease tumor growth as well as inhibit tumor
cell invasion in PDAC animal models.
Pancreatic cancer is the fifth most common cause of cancer deaths in the
United States. The mean survival time of this highly aggressive cancer is four
to six months after diagnosis. Current treatments including chemotherapy,
radiation therapy and surgery, either separately or in combination, are not
sufficient to significantly increase patient survival time.
As reported at today's meeting by Cephalon's Dr. Bruce A. Ruggeri, CEP-701
demonstrated anti-tumor activity in five of six pancreas tumors transplanted
into mice (xenografts). Four out of six of these xenografts also demonstrated
inhibition of in vivo tumor cell invasion. Cephalon scientists tested CEP-701
alone and in combination with the drug, gemcitabine, finding that dual treatment
with gemcitabine was more effective in inhibiting growth of PDAC xenografts than
either compound alone.
CEP-701 is one of a series of specific receptor trk kinase inhibitors
derived from the indolocarbazole K252a, which was originally synthesized by
Kyowa Hakko Kogyo Co., Ltd., Tokyo, Japan. PDAC specimens overexpress receptor
trk kinases which bind to growth factors associated with tumor growth and
invasiveness. Thus, inhibition of these receptor trk kinases allows for the
opportunity of therapeutic intervention. Although the findings presented today
are preliminary, they provide the impetus to further investigate the role of
CEP-701 as a potential therapy for pancreatic cancer.
In its agreement with Kyowa Hakko, Cephalon has rights to a series of
molecules, including CEP-701, in the United States and Europe. Cephalon has
been developing these molecules for the potential use in treating prostate and
other cancers, of which CEP-701, as an orally-active molecule, is currently in
Phase 1 clinical studies in the U.S.
Cephalon, Inc., headquartered in West Chester, PA, is an international
biopharmaceutical company dedicated to the discovery, development and marketing
of products to treat neurological disorders and cancer.
In addition to historical facts or statements of current condition, this
press release may contain forward-looking statements. Such statements may be
identified by, among other things, the use of forward-looking terminology such
as "believes," or by discussions of strategy or intention. These forward-
looking statements, such as any statements regarding present or anticipated
scientific progress, development of potential pharmaceutical products,
manufacturing development and capabilities, and other statements regarding
matters that are not historical facts, or otherwise involve beliefs or
predictions. The company's performance and financial results could differ
materially from those reflected in the forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries as well as more specific risks and
uncertainties such as those set forth in documents filed by the company with the
SEC (including, but not limited to, its most recent reports on Form 8-K, Form
10-Q and Form 10-K). Given these uncertainties, current or prospective
investors are cautioned not to place undue reliance on any such forward-looking
statements. Furthermore, the company disclaims any obligation or intent to
update any such factors or forward-looking statements to reflect future events
or developments.
NOTE: Cephalon's press releases are posted on the Internet at the
company's Web site at http://www.cephalon.com. They are also available by fax
-----------------------
24 hours a day at no charge by calling PR Newswire's Company News On-Call at
800-758-5804, extension 134563.
