FDAnews Drug Daily Bulletin


Dec. 6, 2005

The European Commission has approved Teva Pharmaceutical's bid to buy U.S. drug firm Ivax for $7.4 billion, bringing Teva one step closer to reclaiming its title as the world's largest generic drugmaker. The next step is for U.S. regulators to approve the deal, which would give Teva access to Ivax's line of respiratory drugs as well as marketing rights to blockbusters like Pfizer's antidepressant Zoloft.

"The companies continue to expect that the transaction will close in late 2005 or early 2006," the drug firms said in a recent statement.

Teva and Ivax received a request from the FTC in October for additional information about their proposed merger. Shareholders voted for the merger Oct. 27.

Teva announced its bid for Ivax in late July, less than a week after relinquishing its No. 1 spot to Novartis' generic unit Sandoz. Earlier that month, the FTC approved Novartis' bid for Germany's Hexal AG and Hexal's U.S. sister company Eon Labs. Combined, Teva and Ivax would have 2004 pro forma sales of roughly $5.6 billion, compared to sales of approximately $5 billion for the combined Novartis and Hexal.

The merger would be a happy ending for Teva's quest to market a generic version of Zoloft (sertraline HCl). In January, Teva lost its bid for a declaratory judgment against Pfizer for rights to market a version of the antidepressant. Zoloft, which generated 2004 sales of nearly $3.1 billion and 2005 sales of nearly $2.45 billion, is set to go off patent in June 2006.

Pfizer never sued Teva for applying to market generic Zoloft in 2002. Instead, Pfizer signed an agreement with Ivax, where Ivax would market Pfizer's authorized generic of Zoloft upon the expiration of Zoloft's patent in June 2006.