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Despite regulatory hurdles, PET drugs may give molecular imaging a boost

by Olga Deshchenko, DOTmed News Reporter | June 27, 2011
From the June 2011 issue of HealthCare Business News magazine

“Some of the drivers for the increasing costs have been increased regulatory standards for the demonstration of safety and the efficacy of new products,” he explains, which call for additional partnerships and longer, larger trials.

To bring Amyvid to where it is today, Avid raised $70 million from venture capital investors as a startup company, and that’s before the Eli Lilly deal enabled access to additional resources.

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And yet, compared to a pharma product, bringing a PET drug to market is relatively inexpensive and quick. “But because there are so few precedents, the challenge with an imaging drug is that it’s more difficult to understand what the market outlook is for it and how it will be used by doctors,” says Skovronsky.

Plut also says that although it’s somewhat cheaper to develop an imaging agent compared to a therapeutic drug, the volume of utilization for most therapeutic products would far exceed that of a PET drug once approved. “When compared to therapeutic drug products, there’s a mismatch between the development costs for an imaging agent and the potential volume or procedures that will be performed in the marketplace with that imaging product once approved,” he says.

The fact that imaging agents are held to the nearly same standard as classic therapeutic products drives this mismatch between development costs and potential procedure volumes.

For instance, classic outcome studies performed with traditional pharmaceutical products, measuring an improvement in overall survival, are quite challenging with diagnostic imaging, explains Plut. But an imaging agent can be shown to improve diagnostic accuracy, stratify patients and influence change in patient management.

That’s why there should be an “equitable development pathway” specific for imaging agents, “that takes the unique properties of molecular imaging biomarkers and the distributed manufacturing requirements of PET into account,” says Plut.

“There are molecular imaging agents which are very close to approval and we’re eagerly looking to them as precedents,” he adds.

Making it personal
One of the biggest promises of molecular imaging is its ability to drive the care model towards personalized medicine. Experts say that additional PET drugs will aid clinicians in identifying the right patients for particular therapies, and do so early and accurately.

“A lot of the hope for personalized medicine and molecular imaging biomarker development is to use molecular imaging to help stratify patients, to help determine which patients might benefit from particular types of therapy, rather than one size fits all treatment,” says Plut.

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