DalvanceTreatment for Skin and Structure Infection
Update: Dalvance (dalbavancin) Now FDA Approved - May 23, 2014
Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office
KING OF PRUSSIA, Penn., June 2, 2005 -- Vicuron Pharmaceuticals Inc. today announced that the United States Patent and Trademark Office issued patent number 6,900,175 entitled "Methods of Administrating Dalbavancin For Treatment Of Bacterial Infections." The patent, which will expire in December 2023, relates to a novel dosing regimen for dalbavancin. The dalbavancin New Drug Application (NDA) for the treatment of complicated skin and soft tissue infections (cSSTIs) including the most difficult to treat strain of staphylococcus, methicillin-resistant staphylococcus aureus (MRSA) is currently under review with the U.S. Food and Drug Administration (FDA).
Dalbavancin is a novel second-generation lipoglycopeptide agent that belongs to the same class as vancomycin. Vancomycin is one of the few treatments available to hospital patients infected with difficult-to-treat strains of Staphylococcus bacteria, or Staph known as MRSA (methicillin- resistant Staphylococcus aureus) and MRSE (methicillin-resistant Staphylococcus epidermidis). Dalbavancin has been specifically designed as an improved alternative to vancomycin.
About Vicuron Pharmaceuticals
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients. The company has two New Drug Applications pending with the U.S. Food and Drug Administration for its lead products, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, and anidulafungin, a novel antifungal agent. Vicuron's versatile research engine integrates industry-leading expertise in functional genomics, mechanism-based drug design and combinatorial and medicinal chemistry. These approaches are yielding promising novel and next-generation compounds, many of which are in the later stages of preclinical development. In addition, the company has research collaborations with leading pharmaceutical companies, such as Pfizer.
Posted: June 2005
- Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin) - January 21, 2016
- FDA Approves Dalvance (dalbavancin) to Treat Skin Infections - May 23, 2014
- FDA Advisory Committee Unanimously Recommends Approval of Dalvance (dalbavancin) - March 31, 2014
- Durata Therapeutics Announces FDA's Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride) - November 26, 2013
- Durata Therapeutics Announces NDA Submission for Dalbavancin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) - September 26, 2013
- Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial - September 9, 2008
- Pfizer Receives Approvable Letter from FDA for Dalbavancin - December 21, 2007
- Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application - May 11, 2005
- Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections - February 24, 2005
- Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration - December 21, 2004