NME approvals on the rise?

Related tags Erectile dysfunction Astrazeneca Fda

The US Food and Drug Administration (FDA) approved 15 New Molecular
Entities in the current year to 30 September, 2003, setting the
stage to outpace last year's registrations by nearly 20 per cent,
says a report from Cutting Edge Information.

NME approvals are widely used as a yardstick of R&D productivity, and have been on the decline since the late 1990s. But does not interpret the uptick as any evidence of improved R&D productivity. Rather, it signifies "the increase shows the results of a growing trend in the industry to break down the barriers between R&D and marketing and unite the two functions toward achieving common goals,"​ it said.

Included among the drugs receiving FDA approval in 2003 are potential blockbusters including AstraZeneca's cholesterol-lowerer Crestor (rosuvastatin) and lung cancer drug Iressa (gefitinib) and Bayer/GlaxoSmithKline's Levitra (vardenafil), a competitor to Pfizer's Viagra (sildenafil) for erectile dysfunction.

Several of the pharmaceutical industry's leading firms have taken steps in recent years to eliminate the geographical, cultural, and political barriers between their R&D and commercial functions, having found that these were significantly hindering productivity in the 1990s, says the study.

"One of the greatest strategic challenges facing project teams today, particularly in the early development stages, is setting a commercial activity plan and backing it with adequate budgets and staff to do the job,"​ said Jon Hess, senior analyst at Cutting Edge​.

Related topics Preclinical Research Ingredients

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