Cephalon

Cephalon, Inc. was a U.S. biopharmaceutical company co-founded in 1987 by Dr. Frank Baldino, Jr., pharmacologist, Dr. Michael Lewis, neuroscientist and Dr. James C. Kauer, organic chemist, all three former scientists with the DuPont Company. Dr. Baldino served as the company's chairman and chief executive officer until his death in December 2010.^[1] The company's name comes from the adjective "cephalic" meaning "related to the head or brain," and it was established primarily to pursue treatments for neurodegenerative diseases.

In the early years, Cephalon initially avoided involving itself in activities that would require maintaining a sales staff, managing clinical trials, and shepherding new drugs through the Food and Drug Administration (FDA) approval process. With no product to sell, Cephalon's only asset was its scientific expertise. That expertise proved sufficient to attract investors, and the company managed to fund its operations through research grants and contracts with larger pharmaceutical firms.^[2]

Sales revenues reached $2.8 billion in 2010, ranking Cephalon among the leading biopharmaceutical companies in the world. In 2006, industry publication MedAd News named the company one of the ten most respected biotechnology firms in the world. Cephalon employs more than 3,700.

Cephalon was first included in the Fortune 1000 list of U.S. companies based upon annual revenues for 2006.

On May 2, 2011, Teva announced its acquisition of Cephalon.^[3]

Background

The company's early research efforts were focused on the development of IGF-1, an insulin-like growth factor, under a collaboration with Chiron Corporation to treat amyotrophic lateral sclerosis, or Lou Gehrig's Disease, but the product has never been approved.

The company developed and commercialized products for the treatment of sleep disorders, pain, addiction and cancer, establishing the "wake franchise" on the basis of Provigil (Modafinil) and later Nuvigil, with the R-enantiomer of modafinil. In addition to conducting research on kinase inhibitors and other small molecules, it has licensed compounds and acquired both products and other companies, including CIMA Labs, Anesta, and Laboratoire Lafon. It was from the latter company that Cephalon obtained the rights to modafinil, which it marketed under the trade name Provigil for the treatment of excessive daytime sleepiness associated with narcolepsy, sleep apnea and shift work sleep disorder.^[1] Sales of Provigil reached nearly one billion dollars in 2008, by which time the company had acquired Lafon.

In February 2009, Cephalon announced its intention to acquire Australian biotechnology firm Arana Therapeutics, a move that represented one of the largest changes in the Australian life sciences landscape. The acquisition of Arana brought Cephalon its lead biologic candidate ART621 for inflammatory diseases. Moreover, Cephalon acquired biologics for the treatment of cancers. In February 2010, Cephalon exercised its option to acquire Ception Therapeutics, following receipt of positive data from a clinical study in adults with eosinophilic asthma. Commenting on this Frank Baldino, Jr, the CEO of Cephalon, said “The acquisition of Ception is consistent with our strategy to diversify into biologics and provides us with an important phase three asset for further development.” ^[4]

Cephalon acquired ChemGenex Pharmaceuticals, which provided Cephalon with marketing rights to Omapro, a therapeutic agent for drug-resistant CML.^[5]

Locations

The company was headquartered west of Philadelphia in Frazer, Pennsylvania and had research operations in nearby West Chester, as well as manufacturing and other operations in suburban Minneapolis, Minnesota and Salt Lake City, Utah; its European operations were based near Paris, France.

Management

Longtime chief financial officer J. Kevin Buchi succeeded Baldino as CEO in 2011. Members of the board included venture capitalist William Egan, former COR Therapeutics CEO Vaughan Kailian, prominent healthcare economist Dr. Gail Wilensky, former SmithKline Beecham executive Dr. Martyn Greenacre, former Harvard physician and Glaxo USA head Dr. Charles Sanders and former Ambassador Kevin Moley.

Legal Issues

Cephalon settled a lawsuit for $17 million in which it faced claims that Baldino and other company executives had overstated the potential for a drug aimed at treating amyotrophic lateral sclerosis (known informally as Lou Gehrig's disease).^[6] The Federal Trade Commission claimed that Cephalon had made improper deals to postpone the availability of generic versions of modafinil.^[1] In September 2008, Cephalon paid $425 million to the federal government to settle four whistleblower lawsuits and a criminal charge alleging Cephalon had marketed Actiq, Gabitril and Provigil for “off-label” (unapproved) uses.^[7]

Products

Select products that Cephalon manufactures and markets include:

• Actiq (fentanyl citrate) - Cancer pain
• Amrix (cyclobenzaprine) - Muscle relaxant
• Fentora (fentanyl) - Cancer pain
• Gabitril (tiagabine) - Seizures
• Nuvigil (armodafinil) - Narcolepsy
• Provigil (modafinil) - Narcolepsy
• Treanda (bendamustine) - Indolent B-cell non-Hodgkin's lymphoma (NHL) and Chronic lymphocytic leukemia
• Trisenox (arsenic trioxide) - Acute promyelocytic leukemia treatment

References

External links

• Official website