2010 to be an active year for new drug applications, says Fitch Ratings

Fitch Ratings sees an active year for new drug applications to be registered to U.S. and European drug regulators considering recent updates to the pharmaceutical industry's late-stage R&D programs. According to Fitch's new Global Pharmaceutical R&D Pipeline report, the Fitch-rated pharmaceutical developers listed in the report plan on submitting marketing applications to the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMEA) during 2010 for approval of 22 novel drug therapies. Potential new cancer medicines top the list of anticipated regulatory submissions with a full list detailed in the report.

Fitch also notes in the report that the total of 25 FDA drug approvals in 2009 modestly exceeded the 2008 total, representing the second consecutive year of increasing marketing clearances. During the fourth quarter of 2009 alone, the FDA approved six new pharmaceuticals and vaccines while the EMEA cleared 10 new therapies. Over the next two quarters, Fitch-covered drug developers could see regulatory approvals of eight new medicines or vaccines.

The overall global pharmaceutical sector experienced a positive sales trend throughout 2009 as the negative effects of the global recession eased given the economic recovery in various countries. Most of the large pharmaceutical companies mentioned in the report experienced their most difficult sales period in the first quarter of 2009 and saw steady improvement thereafter. Fitch anticipates that this positive operational momentum will carry into the first quarter of 2010 in light of the less than optimal performance in the same period last year.

For detailed late-stage R&D pipeline developments, recent commercialization, and an in-depth fourth-quarter review of the global pharmaceutical sector, see the special report, 'Global Pharmaceutical R&D Pipeline - Fourth Quarter 2009' now available at 'www.fitchratings.com'.

SOURCE Fitch Ratings