Targanta Announces FDA Acceptance of Oritavancin New Drug Application
Wednesday April 9, 7:58 am ET
Targanta to Host Conference Call & Webcast at 4:30 pm ET TODAY
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its New Drug Application (NDA) for its lead antibiotic candidate, oritavancin. The Company also announced it will hold a conference call and webcast today at 4:30 pm ET to discuss recent corporate achievements.
By granting standard review status to oritavancin, the FDA has established a target date to act on the NDA filing by December 8, 2008. The oritavancin NDA was submitted in early February seeking approval of the intravenous antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA. These types of resistant infections have created a market that IMS Health estimated to be over one billion dollars in the U.S. in 2007 and growing rapidly.
“With an expected FDA response date in December, we have begun the exciting task of building a commercial infrastructure to position the company to begin marketing oritavancin in the U.S. in the first half of 2009," said Mark Leuchtenberger, President and CEO of Targanta. “In the meantime, we will continue to work closely with the FDA to facilitate its review of our NDA while preparing for an advisory committee meeting in the fall of 2008. In addition, we are on track to submit a Marketing Authorization Application for European Union approval of oritavancin by mid-2008 for the treatment of complicated skin and soft tissue infections, the European name for cSSSI, and, given our preliminary discussions with EU regulatory authorities and standard review times, we hope to receive approval of oritavancin in the EU in late 2009.”
Mona Haynes, Targanta’s Chief Commercial Officer commented on the news as well: “We are very excited about the possibility of bringing a new choice to physicians treating patients with serious gram-positive skin and skin structure infections. We believe that the unique combination of characteristics of oritavancin could make it an attractive option for clinicians in both the hospital and outpatient settings, should it gain approval.”
The oritavancin NDA submission includes data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of oritavancin in the treatment of cSSSI, both of which met their primary endpoints. The NDA dossier also includes data from more than 2,100 individuals and in vitro activity data on oritavancin against more than 9,000 clinical bacterial isolates, including a broad range of gram-positive strains resistant to commonly used antibiotics such as oxacillin, methicillin, vancomycin, daptomycin, and linezolid.
surf's up......crikey
