-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VjLj1mRhJOVFPE0gYMV2JgtTWXa6RcILaD3lk+leg6M/+htVN7tmTALeLd5Z3hrl nTDoWSW6OVuQR09guaALDw== 0001036050-99-001274.txt : 19990615 0001036050-99-001274.hdr.sgml : 19990615 ACCESSION NUMBER: 0001036050-99-001274 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 19990601 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990614 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-19119 FILM NUMBER: 99645511 BUSINESS ADDRESS: STREET 1: 145 BRANDYWINE PKWY CITY: WEST CHESTER STATE: PA ZIP: 19380 BUSINESS PHONE: 2153440200 MAIL ADDRESS: STREET 1: 145 BRANDYWINE PARKWAY CITY: WEST CHESTER STATE: PA ZIP: 19380 8-K 1 CEPHALON, INC. FORM 8-K 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 ------------- (Date of earliest event reported) Cephalon, Inc. ---------------------------------------------------- (Exact name of registrant as specified in its charter)
Delaware 0-19119 23-2484489 - ----------------------------------- ----------- ------------- (State or other jurisdiction (Commission (IRS Employer of incorporation or organization) File Number) ID No.)
145 Brandywine Parkway West Chester, Pennsylvania 19380 -------------------------- ----------------- (Address of principal executive offices) (Zip Code) (610) 344-0200 -------------------------------------------------------------------- (Registrant's telephone number, including area code) Not Applicable ------------------------------------------------------------------------ (Former name, former address and former fiscal year, if changed since last report) 1 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 ------------------------------------------ (b) Pro Forma Financial Information: None -------------------------------- (c) Exhibits: Reference is made to the Exhibit Index annexed hereto and -------- 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 SIGNATURES ----------- 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. -------------- --------------------------------------- Frank Baldino, Jr. President and Chief Executive Officer 3 EXHIBIT INDEX ------------- 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 EX-99.1 2 PRESS RELEASE DATED JUNE 1, 1999 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. * * * * EX-99.2 3 PRESS RELEASE DATED JUNE 7, 1999 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. * * * * EX-99.3 4 PRESS RELEASE DATED JUNE 10, 1999 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. EX-99.4 5 PRESS RELEASE DATED JUNE 11, 1999 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. -----END PRIVACY-ENHANCED MESSAGE-----