Wyeth Regulatory Woes Continue
The regulatory problems at Wyeth continue. The US Food and Drug Agency announced that it issued an approvable letter for Tygacil (Wyeth’s tetracycline-like antibiotic) to treat community acquired pneumonia (CAP). Apparently, FDA regulators want more data on the effectiveness and safety of Tygacil in severe cases of CAP and additional information on possible liver toxicity.
Tygacil, an intravenously administered antibiotic, won FDA approval in 2005 to treat adults with complicated intra-abdominal infections and complicated skin and skin-structure infections. Tygacil had about $138 million in sales last year; falling far short of the projected $500-$800 million in annual sales that it was expected to yield when it was first brought to market. If Wyeth gains approval for CAP, expect Tygacil sales to soar.
In other regulatory news, FDA granted Wyeth “fast-track approval” for a new version of its market-leading pediatric pneumococcal vaccine called Prevnar. The new 13-valent formulation will provide protection against 13 different pneumococcal serotypes. The older version only provided protection against 7 serotypes. Wyeth hopes to complete its filing for pediatric use of the new Prevnar vaccine in early 2009. Prevnar is Wyeth’s second-leading product with sales of about $2.5 billion in 2007.
The new Prevnar vaccine will likely go head-to-head with GlaxoSmithKline’s new 10-valent pneumococcal vaccine called SynflorixTm which is in late stage clinical development and is currently being reviewed for marketing approval in the EU. Unlike Wyeth’s vaccine, SynflorixTm was found to be effective in protecting against otitis media (ear infections) caused by Haemophilus influenzae.
Until next time,
Good Luck and Good Job Hunting (avoid Collegeville, PA)!!!!!!!!
