FDA Designates Durata Therapeutics’ Dalbavancin a Qualified Infectious Disease Product (QIDP)

Durata Therapeutics (NASDAQ: DRTX) today announced that the U.S. Food and Drug Administration (FDA) has designated dalbavancin as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides Durata priority review by the FDA, eligibility for fast-track status, and extension of statutory exclusivity periods for an additional five years upon FDA approval of the product for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Dalbavancin is Durata’s lead product candidate, currently under investigation for the treatment of ABSSSI caused by susceptible Gram-positive bacteria, including MRSA (methicillin resistant .

Dalbavancin is among the first anti-infective agents to receive QIDP designation through the new Generating Antibiotic Incentives Now (GAIN) statute, created by Congress to encourage the development of therapies for drug-resistant organisms known to cause serious or life-threatening infections. The GAIN provisions are included in the FDA Safety and Innovation Act (FDASIA) that was signed into law by President Obama in July 2012.

“By expediting the FDA review process, the QIDP designation will help us bring dalbavancin to patients who face serious skin infections more quickly. QIDP status also complements the intellectual property protections provided by our underlying patents. If the FDA approves dalbavancin for the treatment of ABSSSI, we would receive 10 years of exclusivity in the U.S., the same duration provided by regulatory agencies in Europe,” said Durata Therapeutics CEO Paul R. Edick.

In September 2012 the FDA announced the formation of an internal task force “…that will support the development of new antibacterial drugs, a critical health care goal and a priority for the agency.” Durata continues to work closely with clinical investigators and the FDA with the goal of bringing dalbavancin to healthcare professionals and their patients by 2014.

Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient’s hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.

Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses.

Durata has completed enrollment in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI, caused by susceptible Gram-positive bacteria.

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 U.S. Food and Drug Administration review process and Durata’s goal for market availability. 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.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

Suggested Articles

Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously.

Japanese pharma Astellas is looking to offload a series of unwanted research projects ahead of Thanksgiving; if you want one, it’s made it very easy.

A re-engineered adenovirus prolonged survival in mouse models of metastatic lung cancer and cleared tumors in about 35% of the animals.