Drug Approval Trends Remain Positive for 2010

by: Research Recap

So far in 2010, FDA approvals of new small molecule and biological therapies have paced ahead of those in the same period last year, when 27 new treatments, including two vaccines were authorized, according to Fitch Ratings.

More late-stage project delays as well as stoppages were seen from the pipelines for Fitch-covered drug developers since the start of the second quarter. In total, 16 new drug candidates were affected by negative events including unfavorable study results and drug application review extensions at government drug agencies. The lack of drug benefits versus risks and new clinical trial requests led to the cancellation of eight late-stage development programs, some in licensing partnerships.

Presently, of the 22 new drugs originally planned for registration in 2010, eight of these investigational pharmaceuticals are now under review by drug authorities.

On the flipside, two other drug projects have been discontinued and three more have been delayed into 2011. As anticipated, licensing agreements and smaller acquisitions have been favored over major corporate consolidation so far this year, as such, business development activities led to the expansion of late-stage pipelines with the addition of four new experimental drug projects since the start of the second quarter.

Despite reimbursement pressures, a positive revenue growth trend was sustained into the second quarter with Fitch-rated pharmaceutical companies experiencing a weighted average revenue growth decline to 1.5% in the second quarter from 6.2% in the first quarter, adjusting for currency changes and consolidation activities within the past 12 months involving Abbott Laboratories Inc. (NYSE:ABT), Merck & Co. Inc. (NYSE:MRK), and Pfizer Inc. (NYSE:PFE) Nine of the 13 Fitch-rated drug developers reported revenue increases from their pharmaceutical portfolios in the quarter. Future operational performances of these manufacturers are confronted by a slew of key U.S. drug patent expirations that started this year, lasting over the next three years. Over this timeframe, the drug portfolios with the highest exposure to patent expiry reside at Eli Lilly & Co. (NYSE:LLY), Bristol-Myers Squibb Co. (NYSE:BMY), Amgen Inc. (NASDAQ:AMGN) and Pfizer.

For details, see: Global Pharmaceutical R&D Pipeline – Second-Quarter 2010 (Premium)