for the development and commercialization oftelavancin worldwide except Japan

Food and Drug Administration (FDA) fortelavancin, a novel, bactericidal, once-daily injectable investigationalantibiotic, for the proposed indication to treat nosocomial pneumonia(also known as hospital-acquired pneumonia, or HAP) caused byGram-positive bacteria such as methicillin-resistant Staphylococcusaureus (MRSA)."The submission of the telavancin NDA for HAP is another importantmilestone for the telavancin program," said Rick E Winningham, ChiefExecutive Officer "There is a significant unmet medical need in HAP. MRSApneumonia is becoming an increasingly serious health threat as theincidence of infection is growing and bacterial resistance is evolving,mortality rates are high and there are few treatment options. We lookforward to working closely with the FDA on their review of our HAP NDAsubmission."About TelavancinTelavancin is a bactericidal, once-daily injectable investigationalantibiotic with a multifunctional mechanism of action. Telavancin wasdiscovered by Theravance in a research program dedicated to finding newantibiotics for serious infections due to Staphylococcus aureus, includingMRSA, and other Gram-positive bacteria.

The FDA is currently reviewingthe telavancin marketing application for the treatment of cSSSI.About ATTAIN 1 and ATTAIN 2 Clinical StudiesThe telavancin NDA is based on data from two large, multi-center,multinational, double-blind, randomized Phase 3 clinical studies, ATTAIN 1and ATTAIN 2, in which 1,503 patients were enrolled and treated, 464 ofwhom were infected with MRSA. Patients with HAP suspected or proven to becaused by Gram-positive bacteria were randomized (1:1) to receive eithertelavancin 10 mg/kg IV once daily or vancomycin 1 g IV every 12hr (theprotocols allowed vancomycin dosage to be modified per site-specificguidelines). For patients with suspected or proven polymicrobialinfections involving Gram-negative and/or anaerobic bacteria in additionto the Gram-positive organisms for which study medication therapy wasused, aztreonam, piperacillin-tazobactam, and/or metronidazole wasallowed. The objective of each study was non-inferiority of telavancinversus vancomycin in clinical cure rate at the test-of-cure visit.Determination of clinical cure was based upon physician-judged resolutionof clinical signs and symptoms of HAP.In both studies, telavancin achieved the objective of non-inferiority inthe all-treated (AT) and clinically evaluable (CE) patient populations. Inthe ATTAIN studies, 82 of telavancin-treated patients and 81 of thosewho received vancomycin experienced one or more treatment-emergent adverseevents.

The most common adverse events were diarrhea, constipation, anemiaand renal adverse events. With regard to changes in the QTc interval,there were similar proportions of patients in each group who experienced apost-baseline maximum value of greater than 500 milliseconds or a maximumchange from baseline of greater than 60 milliseconds.About the Telavancin CollaborationIn November 2005, Theravance entered into a collaboration arrangement withAstellas Pharma Inc. for the development and commercialization oftelavancin worldwide except Japan. In July 2006, Theravance and Astellasexpanded the collaboration to include Japan.

Under the terms of thecollaboration, Theravance will lead the development of and U.S. regulatoryactivities for telavancin for the treatment of cSSSI and HAP, and willcollaborate substantially with Astellas in marketing in the United Statesfor the first three years. Astellas will lead all other development,regulatory, manufacturing, sales and marketing activities.About TheravanceTheravance is a biopharmaceutical company with a pipeline of internallydiscovered product candidates. Theravance is focused on the discovery,development and commercialization of small molecule medicines across anumber of therapeutic areas including respiratory disease, bacterialinfections and gastrointestinal motility dysfunction.