Thursday, May 24, 2007

Large Molecules: Antidote to a Toxic FDA

AstraZeneca is out aggressively explaining why it committed so much of its investment capital on the $15.6 billion acquisition of MedImmune.

The Wall Street Journal’s May 22 story “AstraZeneca Thinks Bigger” highlights the strategic effort to broaden AZ’s pipeline into large molecules. Seen in the larger industry context, AZ’s MedImmune deal stands out only by its size: the land rush into large molecules by big pharma has been underway for over two years.

Beyond the goals of pipeline balance and keeping ahead of the pack in the race into biologicals, there is an important note in AZ’s public defense of the acquisition that resonates deeply about the current drug development climate. AZ Chief Executive David Brennan is quoted by the The Journal’s Jeanne Whalen as being attracted to large molecules because they “have demonstrated that they’re not just symptomatic treatments but that they actually alter the course of the disease.” (IN VIVO's own far-reaching interview with Brennan, pre-MedImmune deal, is available here.)

That marks an important change in big pharma’s development objectives and one that responds directly to signals from the Food & Drug Administration on what types of projects are likely to get favorable reviews from the agency. AZ’s willingness to reach deep into its financial resources to retool its development projects won’t bring fast results but it begins to align AZ more appropriately with FDA’s developing hierarchy of drug projects.

The dean of FDA’s drug regulatory policy, Office of Medical Policy Director Robert Temple, MD, has openly cautioned drug sponsors about a shift in attitude at the agency away from products that rely on symptomatic improvements for approval.

Temple told a meeting sponsored by The Institute of Medicine in March that there are “reasons for industry to worry” about a continuing evolution in requirements from FDA for new drug applications aimed at products for symptomatic relief. If Temple’s frank assessment is not enough, sponsors need only look at the rejection of Merck’s etoricoxib (Arcoxia) despite a vaccine-size clinical trial database of about 40,000 patients.

Focusing on disease-modifying projects also will have benefits for drug sponsors as they continue to try to win places on formularies and favorable ratings from a payer community that is increasingly focused on comparative assessments of treatments.

In the long-run, AZ and the other major pharma companies have few options other than to try to read the signs from FDA. They need to replenish their pipelines with projects that are likely to demonstrate clear disease modifying properties. That type of approach may mean lean days for some of the big players for the next few years, but it is clearly worth a big time bet to stay in the game for the long-term.

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