Current Report — Form 8-K
Filing Table of Contents
Document/Exhibit Description Pages Size
1: 8-K Form 8-K for Cephalon, Inc. 4 11K
2: EX-99.1 Press Release Dated September 15, 1998 1 8K
3: EX-99.2 Press Release Dated September 18, 1998 2± 10K
EX-99.1 — Press Release Dated September 15, 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announced today that Cephalon-Chiron B.V. has withdrawn its application to the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.
Dates Referenced Herein
This ‘8-K’ Filing | | Date | | Other Filings |
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| | |
Filed on: | | 9/23/98 | | None on these Dates |
For Period End: | | 9/15/98 |
| List all Filings |
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Filing Submission 0001036050-98-001628 – Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)
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