Theravance Announces Fast Track Designation for Investigational

Press Release:

Theravance Announces Fast Track Designation for Investigational Antibiotic Telavancin

Press Release
News Article March 2005

SOUTH SAN FRANCISCO, Calif., March 28 /PRNewswire-FirstCall/ -- Theravance, Inc. 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.

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Of the six programs in development, two are in late stage -- telavancin and the Beyond Advair collaboration with GlaxoSmithKline. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, overactive bladder and gastrointestinal motility disorders. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at www.theravance.com.

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