The FDA approved 15 new molecular entities (NME) this year through the end of September, setting the stage to outpace last year’s NME approvals by nearly 20 percent, according to a recent study by Cutting Edge Information.

The Durham-based firm says increase in NME approvals shows the results of a growing trend in the industry to break down the barriers between research and development and marketing and unite the two functions toward achieving common goals.

Included in the report among the new drugs receiving FDA approval in 2003 are three potential blockbusters: Crestor, a drug from AstraZeneca used to lower high levels of fatty substances in the blood called lipids; Levitra, the new rival of Viagra marketed by Bayer and GSK for male impotence; and Iressa, a new treatment for cancers of the bowel, prostate, ovary and stomach, also from AstraZeneca..

Cutting Edge examines the increasing link between marketing and R&D in its new study, titled “Early-Stage Pharmaceutical Marketing: Uniting R&D and Commercialization,” available online at .

The study includes more than 250 metrics, including early-stage commercial budgets, staffing, strategies and tactics from 14 top pharmaceutical companies, also including Pfizer, Novartis, Merck, Aventis, and Eli Lilly.

In addition to market research spending patterns, the Cutting Edge report also includes financial and staffing allocations for brand teams, strategic marketing, medical and regulatory affairs, opinion leader management, competitive intelligence and advocacy management departments.

“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,” says Jon Hess, senior analyst at Cutting Edge. “This report shows companies what their competitors are spending and which commercial milestones they are hitting at each development stage from pre-clinical through NDA submission.”

The reports also showcases marketing metrics about spending on nearly a dozen commercial functions by development phase and product size, marketing headcounts by development phase and product size, and timing of commercial activities by development phase and relative to launch date.

Cutting Edge: