Cephalon Inc – ‘8-K’ for 12/28/98 – EX-99

As of:  Monday, 12/28/98   ·   For:  12/28/98   ·   Accession #:  1036050-98-2183   ·   File #:  0-19119

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Current Report   —   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Current Report                                         4     10K 
 2: EX-99       Press Release                                          4     15K 

EX-99   —   Press Release

EX-99
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Cephalon, Inc.                           Porter Novelli                         
Scott Melville (media) 610-738-6270        Mara Goldfarb (media) 212-601-8342   
Sandra Menta (investors) 610-738-6376    Burns McClellan                        
                                         Lisa Burns (investors) 212-213-4281
FOR IMMEDIATE RELEASE                                                           
---------------------                                                           

CEPHALON RECEIVES FDA APPROVAL OF PROVIGIL(R) (MODAFINIL) TABLETS [C-IV], 
A NOVEL, WAKEFULNESS-PROMOTING TREATMENT FOR  
EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY 

CEPHALON'S FIRST U.S. APPROVAL IS MILESTONE FOR COMPANY 

West Chester, PA  December 28, 1998  Cephalon, Inc. (NASDAQ: CEPH) today        
announced that it has received approval from the U.S. Food and Drug             
Administration (FDA) to market PROVIGIL(R) (modafinil) Tablets, a new, non-     
amphetamine drug to improve wakefulness in patients with excessive daytime      
sleepiness (EDS) associated with narcolepsy.  PROVIGIL is a first-line treatment
that is well-tolerated.                                                         

"PROVIGIL is a significant advance in sleep medicine and exemplifies Cephalon's 
commitment to addressing unmet medical needs with innovative therapies," said   
Frank Baldino, Jr., Ph.D., President and Chief Executive Officer of Cephalon,   
Inc.  "Because PROVIGIL is our first product to receive marketing approval in   
the United States, and is the first new non-amphetamine wakefulness-promoting   
drug indicated to treat the excessive daytime sleepiness associated with        
narcolepsy in 40 years, today's announcement marks a milestone for Cephalon and 
for the narcolepsy community.  We are pleased to have worked collaboratively and
productively with the FDA to complete the review of our marketing application in
a timely manner."                                                               

PROVIGIL will be available by prescription shortly after final scheduling is    
announced by the U.S. Drug Enforcement Administration (DEA).  The DEA has       
proposed that PROVIGIL be placed into Schedule IV of the Controlled Substances  
Act.  The company's sales force, established in 1994, will market the product to
sleep centers, sleep specialists, and neurologists.                             

Narcolepsy is a chronic, lifelong neurological sleep disorder of unknown origin 
afflicting an estimated 125,000 Americans.  Narcolepsy can strike people of both
sexes and all races, with symptoms most commonly appearing in a person's teens  
and early twenties.  The most common and disabling symptom is EDS, which is     
characterized by daytime sleep attacks and persistent drowsiness.               

"Narcolepsy is a tremendously debilitating sleep disorder that impacts patients 
and their families in countless ways," said William C. Dement, M.D., Ph.D.,     
director of the Sleep Disorders Clinic and                                      

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Research Center at Stanford University. "PROVIGIL offers physicians an important
new therapy to improve wakefulness in patients with EDS associated with         
narcolepsy."                                                                    

Clinical trials involving more than 550 patients found PROVIGIL to be           
efficacious in improving daytime wakefulness.  Patients demonstrated overall    
clinical improvement in the severity of their disease symptoms.  PROVIGIL has   
been found to be generally well-tolerated, with a low incidence of adverse      
events relative to placebo.  In controlled clinical trials, most adverse events 
were mild to moderate.  The most commonly observed were headache, infection,    
nausea, nervousness, anxiety, and insomnia.  No specific symptoms of withdrawal 
were observed after discontinuation of PROVIGIL therapy.                        

"We've been anxiously awaiting the approval of PROVIGIL," said Merrill M.       
Mitler, Ph.D., professor at The Scripps Research Institute in La Jolla, Calif., 
and a PROVIGIL clinical trial investigator.  "There has been a real need for an 
effective EDS treatment that is well-tolerated."                                

PROVIGIL EFFICACY                                                               
-----------------                                                               
The efficacy of PROVIGIL was established in two Phase 3, double-blind, placebo- 
controlled, nine-week multicenter studies that were conducted with more than 550
patients who met the American Sleep Disorders Association criteria for          
narcolepsy. Subjects in both studies were randomized to a daily dose of PROVIGIL
200 mg, PROVIGIL 400 mg, or placebo.                                            

Both studies demonstrated improvement in objective and subjective measures of   
excess daytime sleepiness for both the 200 mg and 400 mg doses compared to      
placebo. Subjects treated with PROVIGIL experienced a statistically significant 
greater ability to remain awake as measured by the Maintenance of Wakefulness   
Test (MWT), an objective test of a person's ability to stay awake over time, and
a statistically significant improvement in disease symptom severity as measured 
by the Clinical Global Impression of Change (CGI-C) Scale, an independent       
researcher's assessment of changes in the severity of a patient's illness from  
the time of study entry.                                                        

Patients taking PROVIGIL also experienced statistically significant treatment-  
related improvements on other standardized measures, including a decrease in the
propensity to fall asleep as measured by the Multiple Sleep Latency Test (MSLT),
an objective test in which subjects are asked to try to fall asleep and time to 
sleep onset is measured.  In addition, patients experienced a decreased level of
daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), a         
subjective measure in which patients are asked to rate their likelihood of      
falling asleep during normal daily activities.  Nighttime sleep measured with   
nocturnal polysomnography was not affected by PROVIGIL.                         

The FDA approved dosing is 200 mg once daily.  Once-daily dosing will simplify  
treatment for patients.                                                         

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PROVIGIL SAFETY AND TOLERABILITY                                                
--------------------------------                                                

PROVIGIL has been evaluated for safety in more than 2,200 subjects.  In         
controlled clinical trials, most adverse events were mild to moderate in        
severity.  Only five percent of patients taking PROVIGIL discontinued therapy   
due to an adverse event.  The most commonly observed adverse events associated  
with the use of PROVIGIL more frequently than placebo-treated patients in       
controlled U.S. and foreign studies were headache, infection, nausea,           
nervousness, anxiety, and insomnia. There were no clinically meaningful         
differences in vital signs, body weight or ECG recordings among treatment       
groups.                                                                         

PROVIGIL is contraindicated in patients with known hypersensitivity to          
modafinil.                                                                      

It is recommended that PROVIGIL not be used in patients with a history of left  
ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other
clinically significant manifestations of mitral valve prolapse in association   
with central nervous system stimulant use.                                      

Full prescribing information about PROVIGIL is available from Cephalon          
Professional Services (1-800-896-5855).  Consumers can also obtain more         
information about excessive daytime sleepiness and narcolepsy by calling 1-888- 
41-AWAKE.                                                                       

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, and may include      
statements regarding present or anticipated scientific progress, development of 
potential pharmaceutical products, manufacturing development and capabilities,  
sales and marketing 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 risks and uncertainties, any or all of these forward-looking   
statements may prove to be incorrect.  Therefore, current or prospective        
investors are cautioned not to place undue reliance on any such forward-looking 
statements.  Furthermore, the company has no intent, and disclaims any          
obligation, to update any such factors or forward-looking statements to reflect 
future events or developments.                                                  

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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.                                                               

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Dates Referenced Herein

				Referenced-On Page
This ‘8-K’ Filing		Date		First		Last			Other Filings
Filed on / For Period End:		12/28/98		1					None on these Dates
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