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Cephalon Inc. Faces Federal Investigatory Probes Regarding Three Popular Drugs

Biopharmaceutical giant Cephalon Inc. reports that federal prosecutors in New York compelled the company's turnover of documents regarding its leukemia drug Treanda. The federal prosecutors' document request was apparently part of a larger probing effort into the Pennsylvania-based biopharmaceutical company. The feds used the Health Insurance Portability and Accountability Act (HIPAA) as the legal basis for issuing the document subpoena to Cephalon.

Probe to Investigate Off-Label Use of Treanda and Marketing Efforts for Nuvigil and Provigil

The federal prosecutors' subpoena issued to the Frazier, Penn.-based pharmaceutical manufacturer occurred right after the U.S. Department of Justice (DOJ) sought other unrelated information from the company. The DOJ was interested in investigating off-label use of Cephalon's popular drug Treanda. It seems as if Treanda has recently become known for and associated with the first-line treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Unfortunately for Cephalon and many interested patients facing these difficult medical diagnoses, Treanda is not FDA-approved for those types of treatment and usages.

Cephalon admits that, as of late September 2011, the DOJ has also compelled its turnover of documents relating to the company's marketing efforts for two narcolepsy drugs, Nuvigil and Provigil. The narcolepsy drug probe followed closely on the heels (just mere days, in fact) of the leukemia probe against the embattled pharmaceutical giant. The claims are that the drugs are being marketed and prescribed for behavioral and concentration disorders, far beyond the approved narcolepsy scope.

Cephalon Is the Target of Teva Pharmaceutical Industries Ltd for a Billion-Dollar Acquisition

Notwithstanding these federal investigatory probes into three popular drugs of drugmaker, Cephalon, a rival pharmaceutical juggernaut, Teva Pharmaceutical Industries Ltd. (Teva) stands poised to acquire Cephalon. Toward that aim, Teva plans to buy Cephalon for the hefty price tag of $6.8 billion. Federal subpoenas for document turnover do not seem to be dissuading Teva from moving forward with those acquisition plans either. Perhaps the $117 million in Treanda's staggering sales in the first quarter of 2011 alone are a large part of Teva's steadfast determination to proceed with its acquisition wrap-up efforts.

What Are Federal Authorities Seeking in the Document Probes?

Federal prosecutors and DOJ personnel working on the probes into Cephalon and three of its drugs seek clinical studies. Namely, the feds want any documents that relate to clinical studies that might be used as a basis to support the astronomically growing off-label use of Treanda. The DOJ is specifically seeking clinical study documentation that might exist for studies prior to their points of completion or submission to the U.S. Food and Drug Administration (FDA) for ultimate review and approval. Federal authorities are likewise interested in obtaining information on educational and speaker programs that recommend or refer in some way to off-label use. There are also clinical studies from a German university hospital hematology department and a test of whether Treanda was apt to fight advanced low-grade non-Hodgkin's lymphoma disease that interest authorities as part of this Cephalon probe.