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FDA Grants Durata Therapeutics a Special Protocol Agreement (SPA) for Its Phase 3 Study of DALVANCE(TM) in Hospitalized Community-Acquired Pneumonia

CHICAGO, Oct. 3, 2014 (GLOBE NEWSWIRE) -- Durata Therapeutics (Nasdaq:DRTX) today announced that the Company has received a Special Protocol Agreement (SPA) from the Food and Drug Administration (FDA) on the design of its Phase 3 study of DALVANCE (dalbavancin) for injection using a 1500 mg single dose for the treatment of patients with community-acquired pneumonia requiring intravenous therapy.

The study is designed to compare a 1500 mg single IV dose of dalbavancin with linezolid; patients randomized to linezolid can switch to oral therapy after an initial period of IV treatment. All patients will also receive a single IV dose of azithromycin.

"The Special Protocol Agreement ensures alignment of the trial objectives with the FDA and helps to delineate the path to registration," said Michael Dunne, MD, Durata's Chief Medical Officer. "If successful, DALVANCE would provide a single-dose treatment alternative for patients with community acquired pneumonia effective against the most common bacterial respiratory pathogens, including those resistant to other classes of antibiotics."

"Durata remains committed to the continued development of DALVANCE in other indications," said Paul R. Edick, Durata's Chief Executive Officer. "In addition to pneumonia and the 1500 mg single dose study in ABSSSI, which is already underway, we look to begin our Phase 3 pediatric osteomyelitis study next year. Important bone penetration data in support of our osteomyelitis development program will be presented in an abstract at IDWeek on Thursday, October 9th."

About Durata Therapeutics

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

ABOUT DALVANCE

DALVANCE 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

WARNINGS and PRECAUTIONS

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE; exercise caution in patients with known hypersensitivity to glycopeptides.

Rapid intravenous infusion of glycopeptide antibacterial agents can cause reactions, including flushing of the upper body, urticaria, pruritus and rash.

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. Evaluate if diarrhea occurs.

ADVERSE REACTIONS

The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%).

USE IN SPECIFIC POPULATIONS

In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended two-dose regimen for DALVANCE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.

Forward-looking statements

Any statements in this press release about Durata's future expectations, plans and prospects constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended. Actual results may differ materially from those indicated by such forward-looking statements. Durata anticipates that subsequent events and developments will cause its views to change. However, while Durata may elect to update these forward-looking statements at some point in the future, Durata specifically disclaims any obligation to do so.

CONTACT: Allison Wey Durata Therapeutics, Inc. Vice President, Investor Relations and Public Affairs (312) 219-7017 awey@duratatherapeutics.com

Source:Durata Therapeutics, Inc.