Actavis plc has agreed to acquire the specialty pharmaceutical company, ;Durata Therapeutics, for $23.00 per share in cash, or approximately $675 million in the aggregate, and 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) for injection. 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 (FDA) on May 23, 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 (sNDA) 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.     

“The acquisition of Durata is a strong strategic fit that strengthens Actavis’ emerging infectious disease franchise and aligns with our stated goal to make smart, targeted investments that complement our existing businesses and position the company for continued long-term growth,” said Brent Saunders , CEO and President of Actavis,’ in a company statement. “Dalvance is a novel antibiotic that can be used in multiple sites of care.  It complements our Teflaro product and ceftazidine-avibactam, currently in late-stage development, which are intended for use in the inpatient setting.”

Under the terms of the definitive merger agreement, it is anticipated that Actavis will promptly commence the cash tender offer to purchase all of the outstanding shares of Durata common stock for $23.00 per share in cash, plus CVRs of up to an additional $5.00 per share in the event certain developmental or commercial milestones are met. If Dalvance is approved in Europe for ABSSSI, holders of the CVR will receive $1.00 per share. If Dalvance is approved for single-dose administration by the FDA, holders of the CVR will receive $1.00 per share. If a net global Dalvance revenue threshold is met over a designated time period, holders of the CVR will receive $3.00 per share.

Under the terms of the definitive merger agreement, the completion of the tender offer is conditioned upon, among other things, satisfaction or waiver of customary terms and conditions, including a minimum tender condition requiring that the securities tendered in the tender offer represent at least one share more than 50 percent of the outstanding shares of Durata common stock on a fully-diluted basis.  In addition, the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.  Pending approvals, Actavis anticipates closing the transaction in late 2014 or early 2015. Following the completion of the transaction, Durata Therapeutics, Inc. will merge with and become a subsidiary of Actavis and Durata’s shares will be delisted from NASDAQ.

Source: Actavis

.