Key Developments For Theravance, Inc.
Theravance, Inc. (THRX.O) (Consolidated Issue listed on NASDAQ Global Market)
Astellas Pharma Inc. and Theravance, Inc. Announces Submission of Telavancin MAA for Treatment of Nosocomial Pneumonia
Astellas Pharma Inc. and Theravance, Inc. announced that Astellas Pharma Europe B.V. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for telavancin, a bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the treatment of nosocomial pneumonia (NP), including ventilator-associated pneumonia, and complicated skin and soft tissue infections (cSSTI) in adults.
GlaxoSmithKline plc And Theravance, Inc. Commence Phase III Horizon Programme To Develop Treatment For COPD
GlaxoSmithKline plc and Theravance, Inc. announced that the first patient has commenced treatment as part of the Phase III programme being undertaken to develop a combination treatment for patients with chronic obstructive pulmonary disorder (COPD), a leading cause of chronic illness and death. The programme, referred to as 'Horizon', comprises a broad range of large scale Phase III studies to evaluate the investigational once-a-day long-acting beta agonist (LABA), 642444 ('444), in combination with the once-a-day inhaled corticosteroid (ICS), fluticasone furoate (FF) for the treatment of COPD. The overall programme, which will study more than 6,000 patients, includes two 12-month exacerbation studies, two 6-month efficacy and safety studies, a detailed lung function profile study, and studies to assess the potential for superiority of the fixed combination of '444 and FF versus other treatments for COPD. In addition to the COPD development programme, GSK and Theravance remain committed to the progression of the Horizon programme for the treatment of asthma and look forward to announcing further details in the coming months. Dosing in the first of the two 12-month exacerbation studies has already commenced and patient screening is underway in a further three studies.
Astellas Pharma Inc.'s Astellas Pharma Canada, Inc. And Theravance, Inc. Announce Approval Of VIBATIV (telavancin) In Canada For Treatment Of Complicated Skin
Astellas Pharma Inc.'s Astellas Pharma Canada, Inc. (Astellas) and Theravance, Inc. announced that Health Canada has approved VIBATIV (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance. VIBATIV will be marketed and sold by Astellas and is expected to be commercially available in Canada in early 2010.
Theravance, Inc. and Astellas Pharma Inc. Announce FDA Approval of VIBATIV (telavancin)
Theravance, Inc. and Astellas Pharma US, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VIBATIV (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance. VIBATIV will be marketed and sold by Astellas and is expected to be commercially available in the United States during the fourth quarter of 2009. Theravance will collaborate with Astellas in marketing in the United States for the first three years following approval.
FDA Accepts for Review Theravance, Inc.'s Complete Response Submission for Telavancin for the Treatment of Complicated Skin
Theravance, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 16, 2009.
