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Cephalon Inc – ‘8-K’ for 9/15/98 – EX-99.1

As of:  Wednesday, 9/23/98   ·   For:  9/15/98   ·   Accession #:  1036050-98-1628   ·   File #:  0-19119

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  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

 9/23/98  Cephalon Inc                      8-K:5,7     9/15/98    3:11K                                    Donnelley R R & S… 14/FA

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

EX-99.1TOCTopPreviousNextBottomJust 1st
 

Contact: Jason Rubin Liz Shanahan (Europe) Cephalon, Inc. Sante Communications 610-738-6302 011-44-1-71-379-7377 FOR IMMEDIATE RELEASE --------------------- 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West Chester, PA - September 15, 1998 - Cephalon, Inc. (NASDAQ: CEPH) announced today that Cephalon-Chiron B.V. has withdrawn its application to the European Medicines Evaluation Agency (EMEA) seeking clearance to market MYOTROPHIN (mecasermin) Injection in Europe for the treatment of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 ----------------------- 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
Filed on:9/23/98None on these Dates
For Period End:9/15/98
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Filing Submission 0001036050-98-001628   –   Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)

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