DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Vibativ (telavancin)
12 MAR 2013
Clinigen Group and Theravance have signed an exclusive commercialization agreement for Vibativ (telavancin) in the EU and few other countries located in Europe.
The bactericidal, once-daily injectable lipoglycopeptide antibacterial agent is indicated for nosocomial pneumonia, including ventilator-associated pneumonia, believed to be caused by methicillin resistant Staphylococcus aureus when no other alternatives are suitable.
Clinigen chief executive officer Peter George said, “VIBATIV is a second product for Clinigen’s Specialty Pharmaceuticals (SP) portfolio, complementing the division’santi-viral product, Foscavir.”
Under the deal, Clinigen will make 5m upfront payment to Theravance that is even entitled to earn sales based royalties.
The agreement is signed for a minimum of 15 years, with an option to extend exercisable by Clinigen.
Theravance chief executive officer Rick Winningham said, “We look forward to working with Clinigen in making VIBATIV available to patients with nosocomial pneumonia in the EU.”
Telavancin (trade name Vibativ) is a bactericidal lipoglycopeptide for use in MRSA or other Gram-positive infections. Telavancin is a semi-synthetic derivative of vancomycin.[1][2]
The FDA approved the drug in September 2009 for complicated skin and skin structure infections (cSSSI).[3]
On 19 November 2008, an FDA antiinfective drug advisory committee concluded that they would recommend telavancin be approved by the FDA.
The FDA approved the drug on 11 September 2009 for complicated skin and skin structure infections (cSSSI).[3]
Theravance has also submitted telavancin to the FDA in a second indication, nosocomial pneumonia, sometimes referred to as hospital-acquired pneumonia, or HAP. On 30 November 2012, an FDA advisory panel endorsed approval of a once-daily formulation of telavancin for nosocomial pneumonia when other alternatives are not suitable. However, telavancin did not win the advisory committee’s recommendation as first-line therapy for this indication. The committe indicated that the trial data did not prove “substantial evidence” of telavancin’s safety and efficacy in hospital-acquired pneumonia, including ventilator-associated pneumonia caused by Gram-positive organisms Staphylococcus aureus and Streptococcus pneumoniae.[5]
Like vancomycin, telavancin inhibits bacterial cell wall synthesis by binding to the D-Ala-D-Ala terminus of the peptidoglycan in the growing cell wall (see Pharmacology and chemistry of vancomycin). In addition, it disrupts bacterial membranes by depolarization.[2][6]
Telavancin has a higher rate of kidney failure than vancomycin in two clinical trials.[7] It showed teratogenic effects in animal studies.
- Astellas, Inc. VIBATIV prescribing information, 9/2009.
- Higgins, DL; Chang, R; Debabov, DV; Leung, J; Wu, T; Krause, KM; Sandvik, E; Hubbard, JM et al. (2005). “Telavancin, a Multifunctional Lipoglycopeptide, Disrupts both Cell Wall Synthesis and Cell Membrane Integrity in Methicillin-Resistant Staphylococcus aureus”. Antimicrobial Agents and Chemotherapy 49 (3): 1127–1134. doi:10.1128/AAC.49.3.1127-1134.2005. PMC 549257.PMID 15728913.
- “Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections” (Press release). Theravance, Inc. and Astellas Pharma US, Inc.. 2009-09-11. Retrieved 16 September 2009.
- “Drugs.com, FDA Accepts for Review Response to Approvable Letter for Telavancin”. Retrieved 2008-03-08.
- [1] FDA advisory group gives mixed review of Theravance pneumonia treatment . American City Business Journals/San Francisco/BiotechSF blog (11/30)
- H. Spreitzer (2 February 2009). “Neue Wirkstoffe – Telavancin” (in German). Österreichische Apothekerzeitung (3/2009).
- Saravolatz LD, Stein GE, Leonard B. Johnson LB. “Telavancin: a novel lipoglycopeptide”. Clinical Infectious Diseases 49 (12): 1908–1914. doi:10.1086/648438.
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