The FDA is anticipated to decide on 11/26/09 for Vibativ (telavancin) as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP). But both the market and myself are expecting a delay in approval from the FDA. On November 5, 2009, Theravance, Inc. (NASDAQ:THRX) announced that the company, in collaboration with Astellas Pharma Inc. (OTCPK:ALPMF) will launch the first stock of VIBATIV™ in the US market. The announcement follows the approval of the drug by the U.S. Food and Drug Administration (FDA) on September 11.
Theravance is a leading biopharmaceutical company, Its development programs mostly focus on respiratory diseases, bacterial infections, and gastrointestinal disorders. It entered into collaboration with Astellas in November 2005. The terms of the collaboration specify that Astellas will manufacture and sell VIBATIV while Theravance will help in marketing the drug for the first three years post approval.
However, VIBATIV likely will face tough competition from other antibiotic drugs, such as ViroPharma’s Vancocin and Johnson & Johnson (NYSE:JNJ) ceftobiprole. The market analyst also predicted “an initial slow sales ramp of VIBATIV”.
But what is really interesting for THRX is the next generation COPD program, in collabration with GSK. This is a potential blockbuster drug, and the phase II data so far has been very impressive.
Tuesday, 27 Oct 2009 08:03am EDT
GlaxoSmithKline plc (NYSE:GSK) and Theravance, Inc. announced that the first patient has commenced treatment as part of the Phase III program being undertaken to develop a combination treatment for patients with chronic obstructive pulmonary disorder (COPD), a leading cause of chronic illness and death. The program, 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 program, 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 program, GSK and Theravance remain committed to the progression of the Horizon program 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.
Disclosure: Looking to enter positions for THRX on dip.