[May 13, 2014]

Fitch: U.S. Pharmaceutical Approvals Decline Significantly with Mixed Outlook for R&D

The number of U.S. pharmaceutical approvals continued to decline in the first quarter of 2014 (1Q'14), with the outlook for research and development (R&D) mixed for the remainder of the year, according to a Fitch Ratings report.

The FDA approved six new molecular entities (NMEs) during 1Q'14 compared with nine approvals in the prior year period. This is the lowest number of approvals in a quarter since before 2000. The FDA cleared 27 novel medicines for U.S. marketing during 2013 in comparison to 37 in 2012. The five-year average at the end of 2013, however, was approximately 28.6 approvals.

On the positive side, several pharmaceutical companies have increased activity in the oncological segment, a move Fitch views as constructive, since some combination-therapy approaches may lead to more effective cancer treatment paradigms.

Fitch's full 'Global Pharmaceutical R&D Pipeline' is available at 'www.fitchratings.com'. The report provides a full list of medications in development by the major harmaceutical companies and their stage in the development process.

Additional information is available at 'www.fitchratings.com'.

Applicable Criteria and Related Research: Global Pharmaceutical R&D Pipeline - Evolving Trends in Diabetes and Cancer Treatments

http://www.fitchratings.com/creditdesk/reports/report_frame.cfm?rpt_id=748020

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