Actavis has moved closer to completing its acquisition of the specialty pharmaceutical company, Durata Therapeutics. The US Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 with respect to Actavis’ pending acquisition of Durata.

The early termination of the HSR waiting period satisfies one of the conditions to the closing of the pending acquisition, which remains subject to other customary closing conditions.  Both companies expect the transaction to be completed in the fourth quarter of 2014.

Actavis had agreed to acquire Durata in October 2014 for $23.00 per share in cash, or approximately $675 million in the aggregate, with contingent value rights (CVRs) entitling Durata Therapeutics to receive additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata’s lead product, Dalvance (dalbavancin), are met.

Dalvance is an antibiotic for treating acute bacterial skin and skin structure infections (ABSSSI) with once-a-week dosing for two weeks. Dalvance was approved by the US Food and Drug Administration in May 2014 and was the first drug approved as a Qualified Infectious Disease Product (QIDP). A marketing authorization application (MAA) for dalbavancin is under review with the European Medicines Agency with a decision anticipated in the first half of 2015. A single-dose regimen of Dalvance is also in late-stage development for ABSSSI, with a supplemental new drug application filing expected by mid-2015.  Durata also has plans to continue the development of Dalvance for additional indications, such as hospitalized community-acquired pneumonia and pediatric osteomyelitis.

Source: Actavis