Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that delays in the U.S. approval and launch of Theravance/Astellas's Vibativ (telavancin) for the treatment of nosocomial pneumonia will reduce by more than half the commercial impact that it was previously forecasted to garner in the methicillin-resistant Staphylococcus aureus (MRSA) drug market.

The Pharmacor 2010 findings from the topic entitled Methicillin-Resistant Staphylococcus Aureus show that the lack of approval for nosocomial pneumonia will limit Vibativ's forecasted major-market sales to approximately $55 million in 2018. Decision Resources' had previously forecasted Vibativ would garner $140 million in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Last month, Theravance reported that the U.S. Food and Drug Administration (FDA) has indicated that Theravance's response late last year to the FDA's complete response letter issued in November 2009 is incomplete. According to Theravance, with regard to its new drug application for Vibativ, the FDA has indicated that adequate clinical trial data have not been provided to establish Vibativ's efficacy in treating nosocomial pneumonia.

"Vibativ, which was approved in the U.S. last year for complicated skin and skin structure infections, is the only new hospital antibiotic approved for MRSA infections since the approval of Pfizer's Tygacil in 2005," said Decision Resources Analyst Hemali Patel, Ph.D. "However, the FDA's suggestion that the agency has not received sufficient data to support Vibativ's regulatory approval could mean that an additional nosocomial pneumonia Phase III trial will be required—this would constitute a notable setback for Vibativ's label expansion in the U.S. market."

The Pharmacor 2010 findings also reveal that Forest/AstraZeneca/Takeda's ceftaroline and Johnson & Johnson/Basilea's ceftobiprole—two anti-MRSA cephalosporins—are among the most promising new agents for MRSA in late-stage development.

However, while ceftaroline is expected to launch next year for MRSA in the world's major pharmaceutical markets, the launch of ceftobiprole has been delayed as a result of the FDA's non-approval of ceftobiprole for complicated skin and skin structure infections in December 2009. The near-term uptake of ceftaroline, which will garner peak year sales of up to $200 million, will give the agent a competitive advantage over ceftobiprole, which is now expected to enter the MRSA market in 2015 at the earliest, owing to the FDA's recommendation that Johnson & Johnson conduct new Phase III clinical trials for ceftobiprole.