Teva gets EU clearance for Cephalon acquisition; negative review on Azilect

Following US antitrust clearance last week, Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) has received approval from the European Commission to proceed with its $6.8 billion acquisition of US biotech firm Cephalon (Nasdaq: CEPH), but again with conditions (The Pharma Letter October 10).

In connection with this approval, Teva is required to divest Cephalon's marketing authorization of generic modafinil in France and grant to the purchaser of this MA certain additional rights with respect to the entire European Economic Area, including a covenant not to sue effective as of October 2010.

The US Federal Trade Commission also required Teva, the world’s largest generic drugs maker, to enter into a supply agreement that will allow a competing firm to sell a generic version of Cephalon’s narcolepsy drug modafinil - which the company markets under the brand name Provigil and had branded US sales of around $1.1 billion - in 2010. The FTC also required Teva to divest two Abbreviated New Drug Applications for fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix.