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Telavancin Gains Fast Track Designation

SOUTH SAN FRANCISCO, Calif., March 28 /PRNewswire-FirstCall/ -- Theravance, Inc. (Nasdaq: THRX - News) today announced that the U.S. Food and Drug Administration has granted "fast track" designation to telavancin for the treatment of Hospital Acquired Pneumonia (HAP) and complicated skin and skin structure infections (cSSSI).

The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs.

The FDA granted fast track designation for the following reasons:

-- Telavancin is being developed for treatment of HAP including those infections due to methicillin-resistant strains of Staphylococcus aureus (MRSA) and multi-drug resistant strains of Streptococcus pneumoniae. These infections are serious because of the virulence of the associated pathogens, the resistance of these pathogens to multiple antimicrobials and the morbidity and mortality associated with HAP.

-- Telavancin is being developed for treatment of cSSSI due to MRSA. These infections are serious because of the virulence of the associated pathogens, the resistance of these pathogens to multiple antimicrobials, the potential for extension of these pathogens to other anatomic sites, and the morbidity and mortality associated with cSSSI.

-- Telavancin has the potential to address an unmet medical need because of its in vitro activity against Staphylococcus aureus including methicillin-resistant and vancomycin-tolerant strains. It may therefore provide alternative therapy for HAP and cSSSI due to these pathogens, thereby meeting an unmet medical need.

Telavancin, a rapidly bactericidal injectable antibiotic, is a novel lipoglycopeptide that was discovered by Theravance through the application of multivalent drug design. Previously presented data demonstrated that telavancin has a unique multifunctional mechanism of action that the company believes speeds bacterial killing and reduces the risks of inducing resistance. This antibacterial activity results from interaction with D-Ala- D-Ala-containing peptidoglycan intermediates that leads, at submicromolar concentrations, to inhibition of the transglycosylation step of peptidoglycan synthesis during cell wall synthesis. Also, at higher, clinically-achievable concentrations, direct effects on bacterial plasma membrane function, such as membrane potential depolarization and increased permeability, are observed. Telavancin is currently in Phase 3 studies for the treatment of HAP and cSSSI.

Source: Theravance, Inc.

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