<PAGE>
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
June 1, 1999
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(Date of earliest event reported)
Cephalon, Inc.
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(Exact name of registrant as specified in its charter)
<TABLE>
<CAPTION>
<S> <C> <C>
Delaware 0-19119 23-2484489
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(State or other jurisdiction (Commission (IRS Employer
of incorporation or organization) File Number) ID No.)
</TABLE>
145 Brandywine Parkway
West Chester, Pennsylvania 19380
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(Address of principal executive offices) (Zip Code)
(610) 344-0200
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(Registrant's telephone number, including area code)
Not Applicable
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(Former name, former address and former fiscal year,
if changed since last report)
1
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ITEM 5. OTHER EVENTS.
On June 1, 1999, Cephalon, Inc. (the "Registrant") publicly announced that
it has entered into a collaborative agreement with H. Lundbeck A/S to discover,
develop and market products to treat neurodegenerative diseases.
On June 7, 1999, the Registrant announced that it has agreed to the terms
of a proposed settlement of securities litigation filed in 1996 following the
announcements of results of clinical studies of MYOTROPHIN(R) (mecasermin)
Injection for the treatment of amyotrophic lateral sclerosis (ALS or Lou
Gehrig's disease).
On June 10, 1999, the Registrant announced that it has entered into a
collaborative agreement with Abbott Laboratories to market and further develop
GABITRIL(R) (tiagabine hydrochloride), one of Abbott's anti-epileptic drugs, in
the United States.
On June 11, 1999, the Registrant announced that Bruce A. Peacock, executive
vice president and chief operating officer will leave the company to become
president and chief operating officer of Orthovita Inc. in Malvern, PA..
The Registrant hereby incorporates by reference the press releases attached
hereto as Exhibits 99.1, 99.2, 99.3 and 99.4 respectively, and made a part of
this Item 5.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) Financial Statements of Business Acquired: None
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(b) Pro Forma Financial Information: None
--------------------------------
(c) Exhibits: Reference is made to the Exhibit Index annexed hereto and
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made a part hereof. All material agreements entered into in connection with the
referenced transaction will be filed by the Registrant as exhibits to its Annual
Report on Form 10-K.
2
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SIGNATURES
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CEPHALON, INC.
Date: June 11, 1999 By: /s/ Frank Baldino, Jr.
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Frank Baldino, Jr.
President and Chief Executive Officer
3
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EXHIBIT INDEX
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EXHIBIT PAGE
- --------- ----
99.1 Press Release dated June 1, 1999
99.2 Press Release dated June 7, 1999
99.3 Press Release dated June 10, 1999
99.4 Press Release dated June 11, 1999
4
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Exhibit 99.1
Contact: Sandra Menta Hans Henrik Munch-Jensen
Cephalon, Inc. H. Lundbeck A/S
610-738-6376 011-45-3630-1311
FOR IMMEDIATE RELEASE
- ---------------------
Cephalon Announces R&D Collaboration with Lundbeck
to Develop Products for Neurodegenerative Diseases
- Target Diseases include Parkinson's Disease and Alzheimer's Disease -
West Chester, PA -- June 1, 1999 -- Cephalon, Inc. (NASDAQ: CEPH)
announced today that it has entered into a collaborative agreement with H.
Lundbeck A/S to discover, develop and market products to treat neurodegenerative
diseases, such as Parkinson's disease and Alzheimer's disease.
The collaboration will focus on the development of receptor tyrosine
kinase (RTK) inhibitors, a novel class of orally active, small molecules which
inhibit specific kinases associated with the death of neurons. In preclinical
studies, these molecules have been shown to promote neuronal survival in animal
models of Parkinson's disease and Alzheimer's disease. Initially, the program
will seek to advance Cephalon's lead molecule, CEP-1347, into clinical
development for the treatment of Parkinson's disease.
"Cephalon's technology represents a significant advance in the development
of compounds to treat neurodegenerative diseases," stated Dr. Claus Braestrup,
Lundbeck's executive vice president, research and development. "This
collaboration enhances our research and development pipeline and complements our
efforts to provide new and innovative pharmaceuticals to treat diseases of the
central nervous system."
Under the terms of this agreement, Cephalon is to receive from Lundbeck
approximately $40 million, which includes an upfront license fee, research and
milestone payments, and an equity investment of 1 million shares of Cephalon
Common Stock at a price of $12.00 per share, which is the average market price
for the five trading days prior to closing. Lundbeck will support research and
share the costs of developing CEP-1347 and any other molecules that emerge from
the research program. Lundbeck will obtain Cephalon's commercial rights in
Europe and certain other territories, and will pay Cephalon a royalty on sales
in those territories. Cephalon will retain exclusive rights in the United
States. Kyowa Hakko Kogyo Co. Ltd. remains Cephalon's partner for CEP-1347 in
the rest of the world.
"A key component to our strategy is to commercialize products in the U.S.
market, and to form alliances with pharmaceutical companies that have
significant experience in commercializing products in other markets of the
world," stated Frank Baldino, Jr., Ph.D., Cephalon's president and chief
executive officer. "We are pleased to co-develop these novel compounds for the
neurology market with Lundbeck, a well-established organization whose
development and marketing capabilities makes it one of the world's leading
companies in the treatment of psychiatric and neurological diseases."
A New Approach to Neurodegenerative Diseases
- --------------------------------------------
In Alzheimer's and Parkinson's diseases, as in other neurodegenerative
disorders, the underlying pathology is a profound and irreplaceable neuronal
death. Such neuronal loss is critically influenced by activation of the stress-
activated protein (SAP) kinase pathway. CEP-1347 and Cephalon's RTK inhibitors
selectively and potently inhibit key kinases within the SAP kinase pathway,
thereby blocking cell death in neurons. In preclinical models of
neurodegenerative diseases, these molecules enhance neuronal survival, support
normal neurological function, and represent the first orally active molecules
that have the potential to halt the progression of these devastating disorders.
"Cephalon's highly selective kinase inhibitors represent a novel approach
to treating neurodegenerative disorders," stated Thomas N. Chase, Ph.D., Chief
of Experimental Therapeutics, National Institute of Neurological Disorders and
Stroke. "Available therapies today are limited to symptomatic relief. If
effective in man, Cephalon's molecules could become the first therapy to modify
the course of these debilitating diseases."
Parkinson's disease is a progressive disorder of the central nervous system
caused by the degeneration of the pigmented neurons in the Substantia Nigra of
the brain, resulting in decreased dopamine availability. Clinically, the
disease is characterized by a decrease in spontaneous movements, gait
difficulty, postural instability, rigidity and tremor. Over one million people
in the United States are afflicted with Parkinson's disease.
Alzheimer's disease is an intractable, chronic, and progressively
incapacitating disease characterized by the presence of core neuritic plaques,
neurofibrillary tangles and gliosis in the brain which is believed to result in
the observed death of several types of neurons. Patients affected with this
disease become severely demented. Over four million Americans are afflicted
with Alzheimer's disease, with more than 100,000 new cases diagnosed each year.
The age-dependent nature of these neurodegenerative diseases suggests that
an increasing percentage of the population may be affected as the population
ages.
Lundbeck is one of the leading providers of drugs for the treatment of
diseases in the central nervous system. The company deploys significant
resources into research and development, and markets its highly specialized
products in 70 countries. Total revenue reached DKK 3.2 billion in 1998. The
Lundbeck Group has 3,000 employees, half of which is domiciled in Denmark. The
Group offers attractive working conditions, and human resource policies stresses
respect for the individual and her/his contribution to the success of the
Company. The Lundbeck Group (www.lundbeck.com) is headquartered at Ottiliavej
----------------
9, DK-2500 Valby, Copenhagen, Denmark, +45 3630 1311.
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.
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.
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.
* * * *
<PAGE>
Exhibit 99.2
Contact: Sandra Menta
610-738-6376
FOR IMMEDIATE RELEASE
- ---------------------
CEPHALON TO SETTLE SECURITIES LITIGATION
West Chester, PA June 7, 1999 Cephalon, Inc. (Nasdaq: CEPH) announced today
that it has agreed to the terms of a proposed settlement of securities
litigation filed in 1996 following the announcements of results of clinical
studies of MYOTROPHIN(R) (mecasermin) Injection for the treatment of amyotrophic
lateral sclerosis (ALS or Lou Gehrig's disease). The settlement is conditioned
upon final approval of the U.S. District Court for the Eastern District of
Pennsylvania.
The agreement requires that the company pay a total of $17.0 million in
full settlement of the action, inclusive of attorneys fees and expenses. Of this
amount, $7.5 million will be paid by the company's directors' and officers'
liability insurance carriers; the remaining $9.5 million will be paid by the
company, which may issue up to 500,000 shares of its common stock in connection
with the settlement. The company has incurred charges to earnings during prior
reporting periods sufficient to cover the costs of the settlement.
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.
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.
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.
* * * *
<PAGE>
Exhibit 99.3
FOR IMMEDIATE RELEASE
- ---------------------
Contact:
Abbott Laboratories
Melissa Brotz
(847) 935-3456
Cephalon, Inc.
Sandra Menta
(610) 738-6376
ABBOTT 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 Abbott Laboratories
and Cephalon, Inc. have entered into a collaborative agreement to market and
further develop Gabitril(R) (tiagabine hydrochloride), one of Abbott's 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 Frank Baldino, Jr., Ph.D., Cephalon'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 Cephalon,"
said Arthur Higgins, 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 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.
This collaboration with Cephalon enhances Abbott's more than 50-year
commitment to the treatment of epilepsy. Abbott introduced its first
antiepilepsy drug in 1946, and has since launched nine more.
Abbott 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.
Abbott's news releases and other information, including Gabitril product
labeling, are available on the company's web site at http://www.abbott.com.
----------------------
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.
<PAGE>
Exhibit 99.4
Contact: Sandra Menta
610-738-6376
FOR IMMEDIATE RELEASE
- ---------------------
CEPHALON ANNOUNCES EXECUTIVE CHANGE
West Chester, PA June 11, 1999 Cephalon, Inc. (Nasdaq: CEPH) today
announced that Bruce A. Peacock, executive vice president and chief operating
officer will leave the company to become president and chief operating officer
of Orthovita Inc. in Malvern, PA.
"We appreciate Bruce's significant contributions during his tenure at
Cephalon," stated Frank Baldino, Jr., Ph.D., Cephalon's president and chief
executive officer. "He has an opportunity to be president of a good company, and
we wish him well."
Cephalon also announced that Robert P. Roche, Jr., will be appointed senior
vice president, sales and marketing. Over the past four and one half years,
Roche has managed the sales and marketing organization as vice president of that
department. Previously, Roche was director and vice president, worldwide
strategic product development, for SmithKline Beecham's (SB) $1.6 billion
central nervous system and gastrointestinal products business. He also was
managing director of SB's pharmaceutical operations in the Phillipines, and held
senior marketing positions in Canada and Spain and product planning
responsibility for SB in Latin America. Roche began his pharmaceutical career in
1982 as a U.S. pharmaceutical sales representative. Roche graduated from Colgate
University and received his MBA degree from The Wharton School, University of
Pennsylvania.
"Bob has been instrumental in building and managing a significant portion
of our commercial organization, and we look forward to his contributions in his
new capacity as senior vice president," said Dr. Baldino.
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.
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.
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.
