Cephalon Gets Subpoena For Treanda Marketing

Cephalon Gets Subpoena For Treanda Marketing

September 27th, 2011 // 12:11 pm @

The other shoe has dropped in the probe into Cephalon and its Treanda medication, which is used to treat chronic lymphocytic leukemia. The drugmaker has officially received a subpoena from the US Attorney in New Yrok requesting documents “pursuant to its authority” under the Health Insurance Portability and Accountability Act, according to a filing with the US Securites and Exchange Commission. Cephalon says it intends to cooperate fully.

As we reported two months ago, Cephalon received a notice from the US Department of Justice concerning paperwork pertaining to off-label issues, including off-label use of Treanda for first-line treatment of non-hodgkin’s lymphoma (the med is not approved for this purpose – read this), according to sources familiar with the request. The feds also want clinical studies that could be used to support off-label use before the studies were completed or submitted to the FDA for review (back story).

At the time, we wrote that the feds are also interested in educational and speaker programs that reference off-label use; uncompleted clinical studies that may be used to support off-label use; documents pertaining to a clinical study being conducted by to Mathias Rummel, who is the head of hematology at the University Hospital in Giessen, Germany, and has previously studied Treanda (look here); and documents related to a study called Bright, which is designed to test whether the drug could combat advanced low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma in patients who have not yet received treatment (read here).

Cephalon declined to comment on the request. In any event, the probe may complicate life for Cephalon, which is already operating under a so-called Corporate Integrity Agreement in connection with its 2007 plea to a misdemeanor violation of the Food, Drug and Cosmetic Act for improper marketing of several meds, notably its Provigil narcolepsy drug, which docs were prescribing to treat depression and ADHD . The drugmaker paid a $375 million fine as well.

Then, there is that $6.8 billion Teva Pharmaceutical has agreed to pay in order to buy Cephalon. What, if any, implications this may cause for the deal is unclear. Teva, which is one of the biggest generic suppliers in the world, wants Cephalon in order to blunt competition to its brand name Copaxone multiple sclerosis med and expand further into the brand-name medicine world. The deal is still awaiting regulatory approval, although sources say the integration process is already under way.

Source: Pharmalot

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