BOSTON, Oct. 16 /PRNewswire-FirstCall/ -- Gaining a first-cycle approval for a new molecular entity (NME) is worth an estimated $640 million in incremental revenue on average, according to a new analysis from PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and leading global life sciences consultancy serving the biopharmaceutical and medical device industries. According to the PAREXEL Consulting analysis, 60 percent of sales for newly-approved drugs and biologics each year are derived from the top five-selling products. Therefore, first-cycle approval can potentially produce up to approximately $2 billion in additional revenue for each of these top-selling products.
The estimate, which appears in a new PAREXEL Consulting white paper entitled Getting to Approval: Emerging FDA Review Outcome Trends for New Drugs, is based on the NMEs approved in 2007 and during the first half of 2008. The analysis tracks the differences in review times between the new drugs that obtained first-cycle approval and those that did not. PAREXEL Consulting has analyzed the average review time gap between approved NMEs that the U.S. Food and Drug Administration (FDA) cleared in the first review cycle and those that took multiple review cycles to gain approval. The dollar value of the approval time gap is based on using five-year post-launch sales projections for recently approved NMEs from EvaluatePharma(R), which tracks and forecasts the performance of biopharmaceutical companies and their products, from early-stage R&D through post-marketing.
"Obtaining new product approvals is an important measure of the
industry's performance, and this first-cycle approval metric helps
companies calculate appropriate investments in ini
|SOURCE PAREXEL International|
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