Gilead to Topple GSK as the Top Player in the Anti-Infectives Drug Mark...( Stringent Yet Ill-Defined Approva...)

Stringent, Yet Ill-Defined, Approval Standards Make it Difficult for Companies to Bring Hospital Antibiotics to Market, According to a New Report from Decision Resources

WALTHAM, Mass., Nov. 12 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Gilead will topple GlaxoSmithKline (GSK) as the top player in the anti-infectives drug market in 2014. According to the new report entitled Commercial Outlook for Anti-Infectives: 2003-2014, GSK's fall will be due to generic erosion and a sparse anti-infectives pipeline. Gilead's rise will be due to its remarkable growth in HIV driven by its blockbuster products, Truvada and Atripla.

The report also finds that increasingly stringent, yet ill-defined, approval standards make it difficult for companies to bring hospital antibiotics to market. The FDA's heightened scrutiny of hospital antibiotics has resulted in extended review periods, cancelled advisory meetings, postponed PDUFA dates and the issuance of multiple consecutive approvable letters requesting further data.

"We believe there is discordance between the FDA's expectations and the submission data presented by drug developers," said Sylvia Eash, Ph.D., analyst at Decision Resources. "As a result, the lack of FDA guidance that clearly defines these standards has emerged as the greatest challenge for drug developers who are left to wonder how the approval process will change while their late-stage hospital antibiotic candidates await further regulatory decisions. Agents suffering from these regulatory uncertainties include J&J's Doribax, Pfizer's Zeven, Theravance's telavancin and J&J's ceftobiprole."

The report is the first of its kind from Decision Resources, outlining the entire drug market for anti-bacterials, anti-virals and anti-fungals. Each drug class is thoroughly dissected with robust data on major brands, supporting brands, lat
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