Exhibit 99.3
FOR IMMEDIATE RELEASE
---------------------
Contact:
Xxxxxx Laboratories
Xxxxxxx Xxxxx
(000) 000-0000
Cephalon, Inc.
Xxxxxx Xxxxx
(000) 000-0000
XXXXXX LABORATORIES AND CEPHALON SIGN COLLABORATION AGREEMENT FOR GABITRIL(R)
(TIAGABINE HYDROCHLORIDE) IN THE UNITED STATES
ABBOTT PARK, Ill. and WEST CHESTER, Pa., June 10, 1999 Xxxxxx Laboratories
and Cephalon, Inc. have entered into a collaborative agreement to market and
further develop Gabitril(R) (tiagabine hydrochloride), one of Xxxxxx'x anti-
epileptic drugs, in the United States.
"We are pleased a leading pharmaceutical company such as Abbott has chosen
Cephalon as its partner to further commercialize Gabitril in the United States,"
stated Xxxxx Xxxxxxx, Xx., Ph.D., Xxxxxxxx's president and chief executive
officer. "Cephalon has been calling on sleep specialists and neurologists to
sell Provigil(R) (modafinil) Tablets [C-IV], Cephalon's new product for the
treatment of excessive daytime sleepiness associated with narcolepsy. We are
expanding our sales force to fully support Gabitril and to increase our Provigil
sales efforts."
"This agreement capitalizes on the strengths of both Abbott and Xxxxxxxx,"
said Xxxxxx Xxxxxxx, senior vice president, pharmaceutical operations at Abbott.
"This increase of commercial and development resources behind Gabitril will
enable us to realize the full potential of the drug as we continue to
aggressively focus on other areas of our neuroscience business."
Cephalon and Abbott will promote Gabitril primarily to neurologists, as
well as conduct additional clinical research with Gabitril in epilepsy, and
other potential therapeutic areas.
Terms of the agreement were not disclosed, however as part of the
agreement, Cephalon is required to provide a certain number of details,
promotional and clinical development expenditures, and will share in the growth
of product sales beyond a contractually established baseline. In addition,
Abbott has a right of first negotiation to develop and promote Provigil should
Cephalon elect to collaborate with a third party in the United States.
The precise mechanism of action by which Gabitril exerts its antiseizure
effect is unknown, although it is believed to be related to its ability,
documented in in vitro experiments, to enhance the activity of gamma
aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central
nervous system. In vitro experiments have shown that Gabitril binds to
recognition sites associated with the GABA uptake carrier. It is thought that,
by this action, Gabitril blocks GABA uptake into presynaptic nerve cells,
permitting more GABA to be available for receptor binding on the surfaces of
post-synaptic nerve cells. This suggests that Gabitril prevents the propagation
of neural impulses that contribute to seizures by GABA-ergic action.
Gabitril is an adjunctive antiepilepsy drug used for the treatment of
partial seizures, a form of epilepsy, in adults and children 12 years and older.
Studies have shown that Gabitril is effective in reducing the frequency of
partial seizures when added to an existing regimen of at least one other
antiepilepsy drug (adjunctive therapy). Double-blind, placebo-controlled,
parallel group add-on trials showed a significant reduction in median seizure
rates versus placebo. Gabitril has been shown to be well- tolerated with the
most common adverse events being dizziness/light-headedness, asthenia/lack of
energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain and
thinking abnormal/difficulty with concentration or attention. As with other
antiepileptics, Gabitril should not be stopped abruptly unless medically
indicated. Adverse events most often associated with Gabitril were related to
the central nervous system.
Provigil is a unique, wake-promoting agent. In landmark clinical trials
involving more than 550 patients with narcolepsy, Provigil was found to be
efficacious in improving daytime wakefulness. Patients also 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.
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, sleep disorders and cancer.
Cephalon's press releases are posted on the internet at the company's web
site at xxxx://xxx.xxxxxxxx.xxx. They are also available by fax 24 hours a day
-----------------------
at no charge by calling PR Newswire's Company News On-Call at (000) 000-0000,
extension 134563.
This collaboration with Cephalon enhances Xxxxxx'x more than 50-year
commitment to the treatment of epilepsy. Abbott introduced its first
antiepilepsy drug in 1946, and has since launched nine more.
Xxxxxx Laboratories is a global, diversified health care company devoted to
the discovery, development, manufacture and marketing of pharmaceutical,
diagnostic, nutritional and hospital products. The company employs 56,000 people
and markets its products in more than 130 countries.
Xxxxxx'x news releases and other information, including Gabitril product
labeling, are available on the company's web site at xxxx://xxx.xxxxxx.xxx.
----------------------
Cephalon Forward-looking Statement
----------------------------------
In addition to historical facts or statements of current condition, this press
release may contain forward-looking statements. Forward-looking statements
provide our current expectations or forecasts of future events. These may
include statements regarding anticipated scientific progress on our research
programs, development of potential pharmaceutical products, prospects for
regulatory approval, manufacturing development and capabilities, market
prospects for our products, sales and earnings projections, and other statements
regarding matters that are not historical facts. You may identify some of these
forward-looking statements by the use of words in the statements such as
"anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or
other words and terms of similar meaning. Our performance and financial results
could differ materially from those reflected in these 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 below and in our
reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these forward-
looking statements may prove to be incorrect. Therefore, you are cautioned not
to place too much reliance on any such factors or forward-looking statements.
Furthermore, we do not intend (and we are not obligated) to update publicly any
forward-looking statements, whether as a result of new information, future
events or otherwise. This discussion is permitted by the Private Securities
Litigation Reform Act of 1995.
