Theravance Offers FDA Briefing Documents for Panel Meeting on VIBATIV(R)

Theravance, Inc.

today announced that the US FDA has posted on its website briefing documents for the November 29, 2012 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. The AIDAC will be asked to review and discuss Theravance's New Drug Application (NDA) for VIBATIV(R) (telavancin), a bactericidal, once-daily injectable antibiotic, for the proposed indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia, caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) or Streptococcus pneumonia (penicillin susceptible strains). The Theravance Briefing Document and the FDA Briefing Document are now available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti- InfectiveDrugsAdvisoryCommittee/ucm329476.htm.