FDA Panel Unanimously Oks Approval For Two Antibiotics, Dalvance And Sivextro

(RTTNews) - Shares of Durata Therapeutics, Inc. (DRTX) rallied a little more than 5 percent in extended hours trading on Monday after the pharmaceutical company said that an advisory panel of the U.S. Food and Drug Administration has unanimously recommended approval of the company's investigational antibiotic, Dalvance (dalbavancin) for injection, for the treatment of adult patients with acute bacterial skin and skin structure infections or ABSSSI.

"We are pleased with the positive outcome of today's Advisory Committee meeting, and the confidence that was expressed regarding the safety and effectiveness of Dalvance. If approved by the FDA, Dalvance would be the first once-weekly antibiotic for ABSSSI, providing an alternative to current once- or twice-daily treatments. We look forward to continuing to work with the FDA on its evaluation of our product," CEO Paul Edick said in a statement.

The FDA's Anti-Infective Drugs Advisory Committee has unanimously voted 12 to 0, recommending the approval of the New Drug Application for Dalvance for injection. The committee found that the company has provided substantial evidence of the safety and effectiveness of the investigational drug.

Dalvance (dalbavancin hydrochloride) for injection is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides.

The drug is indicated for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The NDA, submitted in late September 2013, was based on the entire data set from Durata Therapeutics' clinical development program, including results from two Phase 3 trials DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study.

The company noted that two Phase 3 trials, DISCOVER 1 and DISCOVER 2 (Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response"), were conducted under a Special Protocol Assessment (SPA) with the FDA and included more than 1,300 patients with ABSSSI.

It added that a total of 21 clinical trials have been conducted with dalbavancin in the entire clinical program, with the five Phase 3 trials evaluating nearly 3,000 patients.

In late December 2013, the Marketing Authorization Application for Dalbavancin, seeking approval in the indication of complicated skin and soft tissue infections, has been accepted for review by the European Medicines Agency. The regulatory agency's decision is expected in the first half of 2015.

Additionally, the same FDA panel also voted to unanimously recommend approval for Cubist Pharmaceuticals, Inc.'s (CBST) investigational antibiotic Sivextro. The Committee voted 14 - 0 after finding that substantial evidence of the safety and effectiveness of Sivextro for the treatment of ABSSSI was provided.

Sivextro is a once daily oxazolidinone being developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus.

The company's NDA submission for Sivextro was based on positive data from two global Phase 3 clinical studies, which met the primary and secondary endpoints defined by the FDA and European Medicines Agency.

Though the FDA is not bound by the committee's recommendation, it will consider the panel's deliberations as part of its review of the NDA for Dalvance and Sivextro. The Dalvance NDA was accepted for priority review by the FDA in November 2013 with an action date of May 26, while the Sivextro NDA was also accepted for priority review by the FDA with an action date of June 20.

DRTX closed Monday's regular trading session at $13.47, down $0.03 or 0.25% on a volume of 0.59 million shares. However, the stock gained $0.68 or 5.08% in after-hours trading. CBST closed at $73.15, up $3.05 or 4.35% on a volume of 0.96 million shares.