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Lauren Dubinsky, Senior Reporter | April 26, 2017
GE Healthcare and Lantheus announced on Tuesday a definitive agreement to continue phase III development and global commercialization of flurpiridaz F 18.
This news follows the signing of a term sheet, that was
announced in February. At the time, there was no guarantee the deal would happen on the proposed terms.
But now, as part of the definitive agreement, GE will lead and fund the development program of flurpiridaz F 18, including the second phase III clinical study. They will also have exclusive rights to commercialize the agent worldwide.
“We are committed to strengthening and expanding our nuclear portfolio through this strategic partnership with Lantheus, and potentially offer a new diagnostic option to clinicians and patients in CAD," Emmanuel Ligner, general manager of core imaging for GE Healthcare, said in a statement.
Lantheus will participate in the development and commercialization process through a joint steering committee. The company also has the option to co-promote the agent in the U.S.
Through the deal, Lantheus will receive $5 million upfront in cash. If the launch is successful, they will also get up to $60 million in regulatory and sales milestone payments, as well as double-digit royalties on U.S. sales and single-digit royalties on sales outside the U.S.
Flurpiridaz F 18 is a fluorine 18-labeled PET agent that's designed to evaluate patients with known or suspected coronary artery disease. It has a 110-minute half-life and can be used in combination with treadmill exercise, which is not feasible with other PET tracers, for myocardial perfusion imaging.
The first phase III study,
which was announced in May 2015, found that flurpiridaz F 18 improved CAD detection and reduced radiation exposure compared to SPECT imaging. Subgroup analyses revealed that flurpiridaz F 18 PET imaging seems to work best in women, obese patients and those with multi-vessel disease.
In other news, the companies have also expanded their current commercial agreement, in which Lantheus will supply GE with TechneLite Technetium Tc99m Generators, Gallium-67 and Xenon-133 through December 31, 2020.
