145 Brandywine Parkway
West Chester, PA 19380
Phone: (610) 344-0200
Contact Person: Jason Rubin, VP, Corporate Communications - 610-738-6302
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international
biopharmaceutical company dedicated to the discovery,
development and marketing of innovative products to treat
neurological disorders and cancer. The company is committed to
providing patients and the medical community with treatment
options for diseases where few or no adequate therapies
Headquartered in West Chester, Pennsylvania, Cephalon
currently employs approximately 300 people in the United
States and Europe. The company's European headquarters,
Cephalon U.K. Ltd., is located in Guildford, England and
supports offices in France, Germany and The Benelux (Belgium,
Luxemburg and The Netherlands).
The company's research and development efforts focus
primarily on neurodegenerative disorders, which are
characterized by the death of neurons, the specialized
conducting cells of the nervous system. The company utilizes its
technical expertise in molecular biology, molecular
pharmacology, biochemistry, cell biology and chemistry to
develope products in four core technology areas: neurotrophic
factors, protease inhibitors, signal transduction modulators and
gene transcription regulators. In addition, Cephalon has been
a leader in the development of transgenic and gene-targeted
animal models. Cephalon believes that its multidisciplinary
technology approach facilitates the development of a
portfolio of potential products for the treatment of neurological
disorders such as narcolepsy, amyotrophic lateral sclerosis (ALS,
or Lou Gehrig's disease), multiple sclerosis, peripheral
neuropathies, Alzheimer's disease and stroke. Certain aspects of
this technology have also allowed Cephalon to diversify its
therapeutic objectives to include novel approaches for the
treatment of cancer, especially prostate cancer.
The company has established sales organizations in the United
States, the United Kingdom and France focused on neurologists
and certain other specialists. In the United States, the company
is co-promoting two Bristol-Myers Squibb proprietary products,
Stadol NS® (butorphanol tartrate), and Serzone® (nefazodone
hydrochloride), as well as Intrathecal Baclofen Therapy (ITB™),
a product of Medtronic Inc. These products are trademarks of
Bristol Myers Squibb and Medtronic, Inc., respectively. In the
United Kingdom, the company is marketing PROVIGIL®
(modafinil) tablets. Under an exclusive sales and marketing
agreement with Laboratoire Aguettant S.A., the company
is marketing Apokinon® (apomorphine hydrochloride) in
A new drug application (NDA) has been filed and is pending with
the U.S. Food and Drug Administration (FDA) for the use of
PROVIGIL in treating the excessive daytime sleepiness associated
with narcolepsy. In May 1998, the company received authorization
to market PROVIGIL in the Republic of Ireland, and launch is
planned following regulatory clearance of U.S. manufacturing
arrangements. The company and Chiron Corporation have filed
an NDA, which is currently under review with the FDA for the
use of MYOTROPHIN® (mecasermin) Injection in the treatment of
ALS. Cephalon and Chiron are currently providing MYOTROPHIN
Injection to a limited number of patients with ALS in the United
States under a treatment investigation new drug (T-IND)
protocol (MYOTROPHIN Expanded Access Program), which allows
limited distribution of this unapproved drug.
Two ways. You can order
it under its original name of
" Modafinil " from several over sea's mail order companies
without a prescription.
Or. Secondly you can ask your Sleep Doctor, Neurologist, etc to
try and contact the company directly and request the
medication under the guidelines of " compassionate use ".
After researching this avenue a bit I made contact with the FDA
and asked about it further. In regards to Provigil. I spoke with
a representitive there who took my email address (I asked for
that since I'm at times hard to get ahold of by phone) and said
he ould look into it and find out what the FDA's position
would be on me having my Neurologist request the medication
from the company on these grounds. I wanted their position
first, in case the company, Cephalon Inc. stated that the FDA
would not allow such a thing so close to release date. I could
already have a proper response for my Neurologist to state.
Here's a cut 'n paste of a forwarded response made originally by
the representitive I spoke with who was asking via email to
the department in the FDA that handles and makes these kinds
"...From Division of Neuropharmacological Products:
The person who was asking about Provigil and requesting it
early before the release date may do so... "
"... for "compassionate use" of Provigil should have his physician
call Anna Marie Weickel Hommany, the project manager for this
drug, at (301) 594-5535. There shouldn't be any problem from our
"... assuming the company wants to supply the drug it would
be fine as far as we're concerned for them to do so...."
Basically your Doctor should make the
call only. The number
provided is for Doctors only. They are not there to answer
questions about the drug to the general public. They can't.
Since it's still considered a " drug " and not a " medication ", or
" medicine " as yet. There's a difference but only in the defining
of how it's treated with regards to it's access to the general
That's it for the basic instructions
on getting it now. It's up
to the company itself to provide it. And they can. But only if
they want to. Also note that there's things the company might
say as to the reason they might not want to. Like cost. Your
going to pay a bit more for it now, rather than if you wait.
Also, they may say there's not a lot made etc. This may be true
but also not. Remember, if you follow a link I'll provide at the
bottom of this article to my section on " Modafinil " a.k.a.
" Provigil " you'll see they provided it hundreds of times. But
to centers that have done studies on it with humans. So I'm sure
they have plenty already made and available just waiting for
the final " Go-Ahead " by the FDA this Janurary 1999.
If you want it that badly. Your going to have to be your own
health Advocate. Push. If like me, I don't find my medications
that are available to me, and have been prescribed to me really
help at all. I mean at all. So I'll try anything once. And why
should I wait if I don't have to. I little abrasive pushing never
hurt anyone. And I can be so from time to time. Life's too short.
Cephalon Inc. Company web site
Cephalon Inc. Talks about Narcolepsy
" Common Recommendations for Behavioral Therapy "
View the Movie here at these links....
A) View a QuickTime Movie (290 KB)
B) View an AVI using Netscape (1465 KB)
C) View an AVI using MSIE (1465 KB)
For more information about EDS and to receive brochures about
EDS and related sleep disorders, call toll-free EDS info line at:
American Sleep Disorders Association
National Sleep Foundation
[the] Sleep Medicine Home Page
Excessive Daytime Sleepiness (web site)
May 98 - Provigil
Approved In Republic Of Ireland For Narcolepsy
Mar-98 - Provigil Launched In U.K. For Narcolepsy
Electronic Telegraph - " Pill to help narcoleptics stay awake "
(04/03/1998) By David Fletcher, Health Correspondent
Wednesday 4 March 1998
Philadelphia Business Journal - Feb 9th 1998
" FDA nears OK on narcolepsy drug "
New Drug Info (web site)
Narcolepsy.org's Provigil Update
Cephalon Inc., Research & Developement (Provigil)
Narcolepsy & Importing (my main web site)
Hoover's Company Profiles (Cephalon Inc.)
Health Touch - Article - " Living with Narcolepsy "
Provigil talked about on Internet News Group Forums:
98/09/16 020 Re: narcolepsy and meds
98/09/25 019 Re: Exessive Daytime Sleepni alt.support.narcoleps
98/08/31 018 Re: Provigil alt.support.narcoleps
Articles on my web site you might find interesting:
- A new drug being developed by Cephalon, Inc. for
treatment of narcolepsy "
Fatigue & Modafinil (Provigil) (a section on my web site)
is it the Ultimate Stimulant? " (section on my web site)