Actavis, a global specialty pharmaceutical company based in Dublin, Ireland, and Durata Therapeutics, an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, headquartered in Chicago, Ill., have entered into a definitive merger agreement.
A subsidiary of Actavis will acquire all of the outstanding shares of Durata common stock for $23 per share in cash, or approximately $675 million in the aggregate, and contingent value rights (CVRs) entitling the holder to receive additional cash payments of up to $5 per share if certain regulatory or commercial milestones related to Durata's lead product Dalvance are achieved. Actavis expects the acquisition to be accretive by the end of the first year.
The acquisition of Durata immediately enhances Actavis' infectious disease portfolio with the addition of Dalvance (dalbavancin) for injection, an IV antibiotic for acute bacterial skin and skin structure infections (ABSSSI) with once-a-week dosing for two weeks. Dalvance was approved by the FDA on May 23, 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 EMA, with a decision anticipated in the first half of 2015.
A single-dose regimen of Dalvance also is in late-stage development for ABSSSI, with a 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.
Brent Saunders, CEO and president of Actavis, said, "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. Dalvance also is a highly differentiated product with documented efficacy, safety and tolerability, and its acceptance by health care providers will be enhanced by Actavis' best-in-class commercial infrastructure and complementary product line."
For the six-month period of January to June 2010, an estimated 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17% of the diagnostic category presentations were for skin and skin structure infections (SSSI). With its once-a-week dosing for two weeks, and potential single-dose formulation, Dalvance's unique dosing regimen offers a more convenient and potentially less costly approach to the treatment of serious skin infections by allowing patients, healthcare professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions.
It is anticipated that Actavis promptly will commence the cash tender offer to purchase all of the outstanding shares of Durata common stock for $23 per share in cash, plus CVRs of up to an additional $5 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 per share. If Dalvance is approved for single dose administration by the FDA, holders of the CVR will receive $1 per share. If a net global Dalvance revenue threshold is met over a designated time period, holders of the CVR will receive $3 per share.