Teva wraps Cephalon buy, agrees to sell Provigil copy

Good news for Teva Pharmaceutical Industries ($TEVA): It's wrapped up its $6.2 billion merger with Cephalon ($CEPH). European Union authorities gave the go-ahead for the deal just a few days after U.S. regulators did the same. In Europe, however, Teva has to sell off a generic version of Cephalon's wakefulness drug. In the U.S., the FTC required the company to give generics maker Par Pharmaceutical ($PRX) one-year rights to the copycat medication.

The European Commission said requiring Teva to divest its Provigil knockoff completely "will allow a competitor to emerge and compete effectively," Bloomberg reports. And as the news service points out, EU antitrust regulators may have been predisposed to take the Provigil generic off Teva's hands. They've been investigating Teva and Cephalon for some time, focusing on a 2005 patent settlement they believe may have unduly delayed generic Provigil.

The narcolepsy drug brings in more than $1 billion annually at Cephalon, but as it nears the patent cliff, the company has been promoting a follow-up drug, Nuvigil.

But there's also not-so-good news for Teva. The company's drug Azilect, which is used to treat Parkinson's disease symptoms, didn't impress FDA reviewers much as a method to slow disease progression. The agency raised questions about the studies Teva submitted to support its application specifying it can decelerate Parkinson's progress.

One reviewer saw "no demonstrated benefit" for Azilect in staving off advancement of the disease. But the agency also acknowledged that it doesn't know exactly what sort of data would show it modified the disease course.

- get the release from Teva
- see the story from Globes
- read the Dow Jones coverage
- check out the Reuters article

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