Pharmacy News Article

CHICAGO(BUSINESS WIRE) Fitch Ratings expects the Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 as compared to 2011 while the industry faces several ongoing operational risks, according to a new report.

Fitch believes that the total of 30 new primary care and specialty medicines cleared for marketing in the U.S. during 2011 will be difficult to beat this year. Despite a strong first quarter with eight new molecular entities (NMEs) approved, the total of 14 new approvals in the first half of 2012 (1H'12) lags behind the 18 new approvals in the same period of 2011.

These trends come as the global pharmaceutical industry faces several risks over the course of 2012, including a historic zenith in the dollar amount of drug patent expirations. Four of the industry's once top-10 best-selling medications will have lost market exclusivity by the end of 3Q'12. Fitch anticipates little relief from the patent cliff this year, as key drug patents continue to lapse and the industry contends with 2011 losses.

Coupled with pressure from European austerity measures, Fitch-rated drug developers saw average weighted revenues fall modestly in the first quarter after adjusting for currency changes and consolidation activities within the past 12 months.

Fitch-covered pharmaceutical developers returned a total of $22.1 billion to shareholders in 1Q'12, comprising $15.3 billion in dividends and $6.8 billion of share buybacks. Fitch believes that share repurchases will exceed dividends as the year progresses.

The full report 'Global Pharmaceutical R&D Pipeline: First-Quarter 2012' is available at 'www.fitchratings.com.'

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

Applicable Criteria and Related Research: Global Pharmceutical R&D Pipeline: First-Quarter 2012

http://www.fitchratings.com/creditdesk/reports/report-frame.cfm?rpt-id=683176

ALL FITCH CREDIT RATINGS ARE SUBJECT TO CERTAIN LIMITATIONS AND DISCLAIMERS. PLEASE READ THESE LIMITATIONS AND DISCLAIMERS BY FOLLOWING THIS LINK: HTTP://FITCHRATINGS.COM/UNDERSTANDINGCREDITRATINGS. IN ADDITION, RATING DEFINITIONS AND THE TERMS OF USE OF SUCH RATINGS ARE AVAILABLE ON THE AGENCY'S PUBLIC WEBSITE 'WWW.FITCHRATINGS.COM'. PUBLISHED RATINGS, CRITERIA AND METHODOLOGIES ARE AVAILABLE FROM THIS SITE AT ALL TIMES. FITCH'S CODE OF CONDUCT, CONFIDENTIALITY, CONFLICTS OF INTEREST, AFFILIATE FIREWALL, COMPLIANCE AND OTHER RELEVANT POLICIES AND PROCEDURES ARE ALSO AVAILABLE FROM THE 'CODE OF CONDUCT' SECTION OF THIS SITE.

Fitch Ratings
Michael Zbinovec, +1-312-368-3164
Fitch, Inc.
70 W. Madison Street
Chicago, IL 60602
michael.zbinovec@fitchratings.com
or
Britta Holt, +00 44 20 3530 1335
britta.holt@fitchratings.com
or
Media Relations:
Brian Bertsch, New York, +1-212-908-0549
Email: brian.bertsch@fitchratings.com

Source: Fitch Ratings