Actavis plc, a leading global specialty pharmaceutical company, and Durata Therapeutics, Inc., an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, have entered into a definitive merger agreement under which a subsidiary of Actavis will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23.00 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 $5.00 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, the first and only IV antibiotic for 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. "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 is also 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. With the addition of Dalvance, we deliver on our commitment to build an anti-infective franchise with true scale. Actavis will be in an enviable position to offer innovative solutions to physicians while providing value to hospitals and healthcare systems in advancing the treatment of patients in the outpatient and inpatient settings."
For the six-month period of January to June 2010, an estimated 9.2 million patients were treated in US hospitals for infections of any type, and nearly 17 per cent 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.
"Actavis recognizes Dalvance as a strong development asset with significant potential. By joining Actavis, we gain additional resources, commercial reach and scale to expand patient access and realize the full potential of Dalvance in the marketplace," said Paul R. Edick, Durata's chief executive officer. "This transaction will provide Durata shareholders with a strong immediate return on their investment with meaningful longer-term opportunities to participate in the future upside of Dalvance through the CVRs. We look forward to working with the highly experienced Actavis team as we continue the successful launch of Dalvance."
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.
BofA Merrill Lynch is serving as financial advisor to Durata, and Wilmer Cutler Pickering Hale and Dorr LLP is serving as Durata's legal advisor. Debevoise & Plimpton LLP is serving as Actavis' legal advisor.
Dalvance for injection is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. Dalvance is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. Dalvance demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species. On May 23, 2014 the FDA approved Dalvance for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
There were more than 4.8 million hospital admissions of adults with ABSSSI from 2005 through 2011, which included patients with cellulitis, erysipelas, wound infection and major cutaneous abscess. In fact, hospital admissions for ABSSSI significantly increased by 17.3 per cent during this timeframe. The majority of all skin and soft tissue infections in hospitalized patients are caused by streptococci and Staphylococcus aureus, and approximately 59 per cent of these S. aureus infections in the US are estimated to be caused by MRSA. Early and effective treatment of ABSSSI is critical to optimize patient recovery and for certain patients may also help to avoid potentially lengthy and costly hospital stays.