Pharma R&D Q3 Output Keeps Pace, But Revenue Slides

(USA.gov)

The financial research company Fitch Ratings said in a report issued today that the global pharmaceutical companies followed by the company maintained a modest, but steady pace of new product approvals and regulatory filings to U.S., European, and Japanese regulators in the third quarter of 2010.

The report, “Global Pharmaceutical R&D Pipeline: Third-Quarter 2010” (subscription required) says that the Food and Drug Administration in the U.S. and the European Medicines Agency each approved six new molecular entities (NMEs) during the third quarter 2010. Likewise, Japan’s Ministry of Health, Labor and Welfare cleared six new medicines for sale in the region.

The report says so far the companies have filed about half of the original 22 new therapeutics planned for 2010, while there have been three drug project cancellations and six extensions to those original goals. In the third quarter, the applications for four NMEs were filed to drug regulators in Europe or the U.S., keeping a steady pace throughout the year of around three per quarter.

The report indicates that the number of new drug development programs reaching late-stage clinical trials by the companies rated by Fitch have been offset by late-stage cancellations. Since the beginning of the third quarter, drug manufacturers added 11 NMEs. Of that number, five advanced from earlier-phase internal research programs, while the remaining six new candidates in late-stage pipelines have been added from licensing agreements from and acquisitions of other (mainly smaller) companies. At the same time, however, 12 investigational drug projects in the third quarter were canceled, most of which failed to achieve the primary objectives set in late-stage clinical studies.

In the third quarter, Fitch-rated pharmaceutical companies experienced a weighted average revenue decline of 1.5 percent, reversing revenue gains of 6.2 and 1.5 percent respectively in both the first and second quarters of the year. The report says only six of the 13 Fitch-covered drug developers saw revenue increases generated by their pharmaceutical portfolios in the quarter, of which three companies achieved very modest sales growth. Sales figures are adjusted for currency changes and consolidation activities within the past 12 months.

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