European Medicines Agency Accepts Marketing Authorization Application for Dalbavancin
CHICAGO, Dec. 23, 2013 (GLOBE NEWSWIRE) — Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for dalbavancin. Durata is seeking approval for the marketing and sale of dalbavancin for the treatment of patients with complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microorganisms, including Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species. The start of the review procedure begins December 26, 2013. The Company anticipates a decision in 1H2015.
“We are pleased the EMA has accepted our marketing authorization application submission for a potential new treatment option for patients with cSSTI. If approved, dalbavancin will be the first drug for cSSTI with unique once-weekly dosing given in a short, 30-minute IV infusion time, which may help reduce the overall burden of care without sacrificing patient outcome,” said Paul R. Edick, Durata Therapeutics Chief Executive Officer.
The submission, which was announced on December 3, 2013, included results from the two Phase 3 trials, DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study (VER001-9). In the DISCOVER trials, cSSTI was defined as cellulitis, wound infection, or major cutaneous abscess with an associated area of surface erythema measuring at least 75 cm2 accompanied by at least two other local signs of infection and at least one of the following systemic signs of infection: fever, leukocytosis, or increased immature neutrophils.
The EMA acceptance follows the US Food and Drug Administration’s (FDA) acceptance for priority review of the New Drug Application (NDA) for Dalvance™ (dalbavancin hydrochloride) with an action date of May 26, 2014.
Dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides. When compared to vancomycin, dalbavancin has a longer half-life resulting in a duration of antibacterial activity of 5-7 days per dose.i If approved by EMA, dalbavancin would be the first drug for cSSTI requiring only two once-weekly 30-minute intravenous doses (1000 mg on Day 1 and 500 mg on Day 8). This may shorten the length of stay for patients who are hospitalized and, for appropriate patients, enable therapy in an outpatient setting eliminating the hospital admission altogether.ii Ultimately, this may lower the overall cost of care for these patients.
About Durata Therapeutics, Inc.
Durata Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with complicated skin and soft tissue infections, or cSSTI (or, in the US, acute bacterial skin and skin structure infections – ABSSSI).
Statements contained in this press release contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Forward-looking statements in this press release include statements about the EMA approval of dalbavancin and the potential impact of dalbavancin’s dosing schedule on hospital costs and readmissions. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the “Risk Factors” section of our most recent quarterly report on Form 10-Q, which is on file with the SEC and is also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.