Study finds encouraging data for drug class

PAREXEL International Corp. said today that US marketing applications for drug candidates made with new molecular entities, or NMEs, surged 33 percent in 2007.

PAREXEL is a biopharmaceutical services organization with headquarters in Waltham.

Despite a surge of applications in this category of drug candidates, approvals for drugs in the category in 2007 "reached a many-year low of 16" in the United States, PAREXEL said.

The company also looked at drug candidates that use new a active substance, or NAS.

Global launches for this category declined 19 percent to 25 during 2007, but marketing applications for NMEs increased to 28 in 2007, up from 21 filed in 2006, according to PAREXEL's newly-released The US Drug Approval Trends and Yearbook 2008/2009.

"NME and NAS approvals are key measures of new drug productivity in the biopharmaceutical industry, and these measures tend to improve based on the volume of new drug submissions," Mark Mathieu, director of publications at PAREXEL and editor of The US Drug Approval Trends and Yearbook 2008/2009, said in a statement. "The recent increase in the number of NME submissions is an encouraging sign. NMEs are a closely watched category because they are medicines that have never before been approved for any use."
(By Chris Reidy, Globe staff)