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 Staphylococcus aureus).
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.About Dalbavancin 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.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV