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New Cephalon probe comes with Teva deal yet unapproved PDF Print E-mail
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Saturday, 01 October 2011 00:05

Cephalon Inc. is under investigation again for alleged off-label marketing of a drug.

The Frazer, Pa.-based pharmaceutical company told the Securities and Exchange Commission in a filing Monday that it received a subpoena from the U.S. Attorney's Office for the Southern District of New York, seeking records related to the leukemia drug Treanda.


A spokeswoman for the U.S. Attorney's Office in Manhattan said the office does not comment on cases unless charges are filed.

A Cephalon spokeswoman declined comment.

In May, Israel-based Teva Pharmaceutical Companies Ltd., agreed to buy Cephalon for $6.8 billion, but that sale has not yet closed. A Teva spokeswoman declined comment on whether the latest investigation would have any effect on the sale.

Cephalon is operating under a Corporate Integrity Agreement with the federal government after agreeing to pay $425 million in 2008 to settle charges brought by the U.S. Attorney's Office in Philadelphia for its off-label promotion of three drugs: Actiq, Gabitril and Provigil.

Doctors are free to prescribe any medicine they want for patients, but pharmaceutical companies are only allowed to promote drugs that have been approved by the U.S. Food and Drug Administration.

The pharmaceutical blog Pharmalot reported in July that Cephalon received inquiries from the Justice Department about its promotion of Treanda for uses not approved by the FDA, including non-Hodgkin lymphoma.

In an SEC filing dated June 29, Cephalon said it "announced to its employees that more than 28,000 patients have been prescribed Treanda for CLL (chronic lymphocytic leukemia) and indolent B-cell non-Hodgkin lymphoma (iNHL) and that it has achieved U.S. gross sales of $1 billion since its launch in 2008."

Teva, which has U.S. headquarters in North Wales, Pa., was wrestling with the Cephalon deal last week, as European Commission regulators pushed back the date for a possible approval of the sale until Oct. 16. Reuters reported that Teva had made unspecified concessions. A Teva spokeswoman declined comment about the EC approval process.

Meanwhile, Teva announced Monday that it bought out a Japanese partner for $150 million to gain full ownership of what it called Japan's fifth largest generic drug company. This was Teva's second Japanese move in three months. In July, Teva completed the $934 million purchase of Taiyo Pharmaceutical Industry Co. Ltd., Japan's third largest generics manufacturer with sales of approximately $530 million in 2010. Teva said it expects its Japanese operations to generate annual sales in excess of $800 million.

The expansion continues in Philadelphia Tuesday, when company officials will join Mayor Nutter for the ceremonial groundbreaking of a new facility.

Announced last October, the facility will be on 136 acres at the former site of the Budd Co., which made rail cars until the 1980s. The state of Pennsylvania chipped in $4.7 million in grants and tax credits to help convince Teva to put the facility in the city, after the company also considered two Bucks County, Pa., sites.

source:Cephalon Inc.


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