Full Description

Cephalon, Inc. is an international biopharmaceutical company engaged in the discovery, development and commercialization of products in three therapeutic areas: central nervous system (CNS), pain and oncology. In addition to conducting an active research and development program, the Company markets seven products in the United States and numerous products in countries throughout Europe and the world. Its principal product is PROVIGIL (modafinil) Tablets [C-IV], which consisted 51% of its total consolidated net sales, during the year ended December 31, 2008, of which 94% was in the United States market. PROVIGIL is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSA/HS) and shift work sleep disorder (SWSD). Its other principal products are FENTORA (fentanyl buccal tablet) [C-II] and ACTIQ (oral transmucosal fentanyl citrate) [C-II] (including its generic version of ACTIQ (generic OTFC)). During 2008, these products accounted for 22% of its total consolidated net sales, of which 87% was in the United States market. In August 2009, Cephalon, Inc. completed the acquisition of Arana Therapeutics Limited.

Central Nervous System Disorders

Cephalon’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. Modafinil, the active ingredient in PROVIGIL, is the first in a new class of wake-promoting agents. Outside of the United States, modafinil is approved in more than 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 is a single-isomer formulation of modafinil. The Company is conducting clinical studies of NUVIGIL in a variety of areas. The Company has third party agreements with four companies to supply it with modafinil (which requirements include certain minimum purchase requirements) and two companies to supply it with finished commercial supplies of PROVIGIL. With respect to NUVIGIL, it has three third parties who manufacture the active drug substance armodafinil and one qualified manufacturer of finished supplies of NUVIGIL tablets. At its manufacturing facility in Mitry-Mory, France, the Company produces modafinil for use in the production of PROVIGIL.

GABITRIL is a selective gamma-aminobutyric acid (GABA) 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, among other countries. It has one third-party manufacturer of the active drug substance in GABITRIL and finished commercial supplies of the product.

Pain

The Company’s pain therapeutics portfolio includes four marketed products in the United States. It markets AMRIX, a once-a-day, extended-release version of cyclobenzaprine hydrochloride, the active ingredient in the brand FLEXERIL. AMRIX is indicated for relief of muscle spasm associated with acute, painful musculoskeletal conditions. The Company also markets three products, FENTORA, ACTIQ, and generic OTFC, which focus on treating cancer pain in opioid-tolerant patients. FENTORA is indicated for the management of pain in patients with cancer who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. In April 2008, the Company received marketing authorization from the European Commission for EFFENTORA for the same indication as FENTORA and launched the product in certain European countries in January 2009.

ACTIQ is approved in the United States for the management of cancer pain in opioid-tolerant patients. ACTIQ uses an oral transmucosal delivery system (OTS) to deliver fentanyl citrate, a Schedule II opioid analgesic. The OTS delivery system consists of a drug matrix that is mounted on a handle. ACTIQ is available in six dosage strengths to allow individualization of dosing. The Company has third party agreements with one company to supply it with AMRIX capsules and another company to package the AMRIX capsules for commercial sale. At its facility in Salt Lake City, Utah, the Company manufactures FENTORA, ACTIQ and generic OTFC for its sale in the United States and international markets, EFFENTORA for its sale in certain countries in Europe, as well as generic OTFC bulk units for Barr.

Oncology

The Company’s Untied States oncology portfolio includes two marketed products and one product candidate to treat patients with hematologic cancers: TREANDA, a bi-functional hybrid cytotoxic; TRISENOX, an intravenous arsenic-based targeted therapy marketed in the Untied States, as well as in Europe, and CEP-701 (lestaurtinib), an oral small molecule tyrosine kinase inhibitor. In Europe, it has two commercialized oncology products in its portfolio: MYOCET (liposomal doxorubicin), a cardio-protective chemotherapy agent used to treat metastatic 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.

TREANDA is a hybrid cytotoxic alkylating agent that differs from conventional compounds in its apparent multi-functional mechanism of action. The Company has one third party supplier of the active drug substance bendamustine hydrochloride and one third party supplier of finished supplies of TREANDA. It has one third-party manufacturer that produces the active drug substance arsenic trioxide for the Company, and one third-party manufacturer that provides finished commercial supplies of TRISENOX to it in the United States and Europe. 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, and the blockage of the production of normal cells, resulting in a deficiency of red cells, platelets and normal white cells.

The Company competes with Johnson & Johnson, Purdue Pharmaceuticals, GlaxoSmithKline, Bayer Healthcare Pharmaceuticals and Roche Laboratories Inc.