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Drug approvals slow in '13.

NEW YORK -- The Food and Drug Administration approved 27 new drugs in 2013, down from 39 in 2012. The agency said the drop was due to fewer applications. Just 32 had been filed as of December 11, the FDA said, compared to 41 in 2012 and an average of 35 annually over the past five years.

Last year's total did include three drugs approved under the new "breakthrough therapy designation" introduced in July 2012 as part of the Food and Drug Administration Safety and Innovation Act. That designation is intended to help speed drugs that treat serious conditions to market when there is evidence that they may work better than existing treatments.

The three products approved under the program are Gazyva, a leukemia drug from Roche Holding AG, Imbruvica, a treatment for mantle cell lymphoma from Johnson & Johnson, and Sovaldi, a hepatitis C drug from Gilead Science Inc.

The drop in drug approvals and applications comes at a time when the cost of developing new medicines is rising, yet average internal rate of return for pharmaceutical research and development is falling.

A recent report from Tufts University's Center for the Study of Drug Development (CSDD) contends that the medium- and long-term success of drug companies will depend on their ability to use more efficient R&D models.

"Pharmaceutical and biotech companies--large and small, established and early stage--are forging strategic alliances, collaborative partnerships and multi-company consortia," Tufts CSDD director Kenneth Kaitin said this month. "Early results indicate that sharing knowledge and leveraging resources is helping sponsors find new drugs to treat many of today's most challenging and complex indications."

Kaitin noted that the drug development model has not fundamentally changed since the Kefauver-Harris Amendments of 1962 established the current standard for the clinical testing of investigational drugs.

"Perhaps the greatest gain from clinical design improvements and new partnership models will be the development of industry best practices, which will enable companies to maximize their formidable R&D investment and help ensure future commercial success."

The Tufts CSDD Outlook 2014 report on pharmaceutical and biopharmaceutical trends also predicted that growing concern over expensive, late stage clinical development failures will lead firms to reassess their use of meta-analyses and subgroup analysis and make more realistic assessments about the likelihood that candidate drugs will succeed.

Adoption of adaptive clinical trial designs will also likely accelerate, as cross-functional teams within the sponsoring companies look to increase their program success rates while lowering their costs and reducing the disruptions from protocol amendments, the report said.

The recent pace of investments in new biotech companies will be difficult to sustain in 2014, the report predicted, which should spur further use of alternative financing approaches.

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Title Annotation:Focus
Publication:Chain Drug Review
Date:Jan 20, 2014
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