Cephalon, Inc., an international biopharmaceutical company, engages in the discovery, development and marketing of products in four core therapeutic areas: central nervous system (CNS) disorders, pain, cancer and addiction. In addition to conducting an active research and development program, the company markets six products in the United States and various products in various countries throughout Europe.
Central Nervous System Disorders
The company's CNS disorders portfolio includes two marketed products: PROVIGIL, for improving wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSA/HS) and shift work sleep disorder (SWSD), and GABITRIL, for use as adjunctive therapy in the treatment of partial seizures in epileptic patients. It is also seeking approval to market NUVIGIL for improving wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, OSA/HS and SWSD.
Modafinil Products and Product Candidates
PROVIGIL: Modafinil, the active ingredient in PROVIGIL, is a new class of wakefulness-promoting agents. The FDA approved PROVIGIL to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. It also received FDA approval to expand the label for PROVIGIL to include improving wakefulness in patients with excessive sleepiness associated with OSA/HS and SWSD. In June 2006, the company entered into a co-promotion agreement with Takeda Pharmaceuticals North America, Inc. with respect to PROVIGIL in the United States.
Outside of the U.S., modafinil is approved in approximately 30 countries, including France, the United Kingdom, Ireland, Italy and Germany, for the treatment of excessive daytime sleepiness associated with narcolepsy. In certain of these countries, the company also has approval to market modafinil to treat excessive daytime sleepiness in patients with OSA/HS and/or SWSD.
NUVIGIL: NUVIGIL is a single-isomer formulation of modafinil. In March 2005, the company filed a new drug application (NDA) with the FDA seeking approval to market NUVIGIL with the same labeled indications as PROVIGIL. In May 2006, the company received an approvable letter from the FDA. In 2007, the company intends to initiate clinical studies of NUVIGIL in bi-polar depression, cognition in schizophrenia and excessive sleepiness and fatigue in conditions such as Parkinson’s Disease and cancer.
Competition: The company's products PROVIGIL, and, if approved, NUVIGIL, competes with methylphenidate products, such as RITALIN by Novartis Pharma AG.
GABITRIL: GABITRIL is a selective GABA (gamma-aminobutyric acid) reuptake inhibitor approved for use as adjunctive therapy in the treatment of partial seizures in epileptic patients. The company has worldwide product rights to GABITRIL, excluding Canada and Latin America, and it markets GABITRIL in the United States, France, the United Kingdom and Germany. The company has one third-party manufacturer of the active drug substance in GABITRIL and finished commercial supplies of the product in the United States and one third-party manufacturer of the active drug substance and finished commercial supplies outside the United States.
PAIN
The company’s pain therapeutics portfolio includes three marketed products, FENTORA, ACTIQ and generic OTFC, focused on treating breakthrough cancer pain.
FENTORA: The company launched the FENTORA in the United States in October 2006. FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. FENTORA delivers fentanyl, a Schedule II opioid analgesic, through the oral mucosa (the lining of the mouth) utilizing its proprietary, enhanced absorption technology, ORAVESCENT. The company is focusing on developing FENTORA for patients with breakthrough pain associated with other conditions, including neuropathic pain and back pain.
ACTIQ/Generic OTFC: ACTIQ is approved in the United States for the management of breakthrough cancer pain in opioid tolerant patients. ACTIQ uses an oral transmucosal delivery system (OTS) to deliver fentanyl citrate, a Schedule II opioid analgesic. ACTIQ is available in six dosage strengths to allow individualization of dosing. The company markets ACTIQ under a risk management program of educational and safe use messages that inform health care professionals, patients and their families of proper use, storage, handling and disposal of the product.
To secure FTC clearance of its acquisition of CIMA LABS, INC., the company agreed to license to Barr Laboratories, Inc. (Barr) its U.S. rights to intellectual property necessary to manufacture and market a generic OTFC. The rights the company granted to Barr became effective on September 5, 2006 and Barr entered the United States market with generic OTFC on September 27, 2006. On this same date, the company also entered the market with a generic OTFC. Under its agreement with Barr, the company also agreed to sell to Barr generic OTFC for resale in the United States.
Competition: The company's FENTORA, and ACTIQ or generic OTFC products compete with Johnson & Johnson’s DURAGESIC and Purdue Pharmaceuticals’ OXYCONTIN and MS-CONTIN.
ONCOLOGY
The company’s U.S. oncology portfolio includes one marketed product and two product candidates to treat patients with hematologic cancers: TRISENOX, an intravenous arsenic-based targeted therapy marketed in the U.S., as well as in Europe; CEP-701 (lestaurtinib), an oral small molecule tyrosine kinase inhibitor; and TREANDA (bendamustine hydrochloride), a multi-functional hybrid cytotoxic. In Europe, the company has two commercialized oncology products in its portfolio: MYOCET (liposomal doxorubicin), a cardio-protective chemotherapy agent used to treat late-stage breast cancer and TARGRETIN (bexarotene), a treatment for cutaneous T-cell lymphoma. In addition, the company markets and sells ABELCET (amphotericin B lipid complex), an anti-fungal product used by cancer patients.
TRISENOX: In 2005, the company acquired the assets related to the TRISENOX injection business from Cell Therapeutics, Inc. TRISENOX is approved for marketing in the United States and Europe for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL), a life threatening hematologic cancer.
Competition: The company's TRISENOX product competes with therapeutics, such as VESANOID by Roche in combination with chemotherapy.
CEP-701: CEP-701 is under development as a treatment for flt-3-mutated AML, a hematologic cancer characterized by uncontrolled growth of myeloid cells of the blood and bone marrow. The company is conducting a Phase 2/3 study of approximately 200 patients with AML who bear a flt-3 activating mutation at first relapse from standard induction chemotherapy. The company is planning to initiate studies of CEP-701 in patients with myeloproliferative disorder in 2007.
Competition: The company's competitors include Novartis and Millennium Pharmaceuticals.
TREANDA: TREANDA is an investigational therapeutic under development for the treatment of indolent (slowly progressing) non-Hodgkin’s lymphoma (NHL). TREANDA is a hybrid cytotoxic alkylating agent. In addition to killing cells by damaging their DNA and triggering apoptosis—which is typical of alkylating agents—researchers demonstrated that TREANDA also causes the disruption of cell division. The company is conducting a Phase 3 trial of TREANDA in indolent NHL refractory to rituximab at sites in the United States and Canada. The company is also planning to study TREANDA for the treatment of CLL, mantle cell lymphoma and small cell lung cancer.
Competition: TREANDA would compete with traditional methods of treating indolent NHL, including treatments involving chemotherapy with a combination of drugs, such as cyclophosphamide, vincristine and prednisolone and with drugs marketed (such as BEXXAR (131-I tositumomab) by GlaxoSmithKline) or being developed to treat indolent NHL refractory to rituximab.
ADDICTION
The company’s addiction therapeutic focus consists of one product, VIVITROL. In June 2006, the company launched VIVITROL. VIVITROL is indicated for alcohol dependent patients who are able to abstain from alcohol in an outpatient setting and are not actively drinking when initiating treatment. Treatment with VIVITROL should be used in combination with psychosocial support, such as counseling or group therapy. VIVITROL utilizes Alkermes’ proprietary Medisorb drug delivery technology in a once-a-month injectable formulation of naltrexone. The company has a license and collaboration agreement with Alkermes, Inc. to develop and commercialize VIVITROL in the United States for the treatment of alcohol dependence.
Competition: VIVITROL faces competition from CAMPRAL by Forest Laboratories and marketed drugs also formulated from naltrexone, such as REVIA by Duramed Pharmaceuticals, NALOREX by Bristol-Myers Squibb and DEPADE by Mallinckrodt.
EUROPEAN OPERATIONS
Commercial Products
The company markets and sells approximately 25 products in approximately 20 European markets. Its primary products include SPASFON (phloroglucinol), PROVIGIL, MYOCET, ACTIQ and ABELCET. Its other products include FONZYLANE (buflomedil), GABITRIL (tiagabine hydrochloride), NAXY and MONO-NAXY (clarithromycin); and TARGRETIN (bexarotene). The company has a presence in the five key European pharmaceutical markets: France, Germany, Italy, Spain and the United Kingdom.
Customers
The company’s primary customers are wholesale drug distributors. Three major wholesale drug distributors include Cardinal Health, Inc., McKesson Corporation and AmerisourceBergen Corporation.
History
Cephalon, Inc. was founded in 1987.
