Lantheus Holdings announced the signing of a definitive license agreement (the “definitive agreement”) for the continued Phase III development and worldwide commercialization of flurpiridaz F 18, an investigational positron emission tomography (PET) myocardial perfusion imaging (MPI) agent that may improve the diagnosis of coronary artery disease (CAD), the most common form of heart disease. The definitive agreement follows the signing of a term sheet previously announced in late February 2017.
Under the definitive agreement, GE Healthcare will lead and fund the development program of flurpiridaz F18, including the second Phase III clinical study. GE Healthcare will also have exclusive worldwide rights for the commercialization of flurpiridaz F18. Lantheus will collaborate in both the development and commercialization process through a joint steering committee. Lantheus also maintains the option to co-promote the agent in the U.S.
Lantheus will receive a USD 5 million upfront cash payment and, if successful, up to USD 60 million in regulatory and sales milestones payments, plus double-digit royalties on U.S. sales and single-digit royalties on sales outside of the U.S.
Separately, the companies have also extended and expanded their current commercial agreement under which Lantheus will continue to supply GE Healthcare with TechneLite® (Technetium Tc99m Generators), Gallium-67 (Gallium Citrate Ga 67 Injection), and Xenon-133 (Xenon Xe 133 Gas) through December 31, 2020.
Mary Anne Heino, President and CEO of Lantheus commented, “With our definitive agreement for flurpiridaz F 18 in place, we look forward to collaborating with GE Healthcare to complete the development and commercialization efforts to bring this novel PET cardiac imaging agent to market. On the nuclear medicine products contracting strategy front, we are excited to extend and expand our longstanding commercial relationship with GE through a multi-year supply agreement.”
Emmanuel Ligner, General Manager of Core Imaging for GE Healthcare said, “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. I’m thrilled to bring GE Healthcare’s proven track record of new product development and commercialization to this agreement as well as the quality and reliability that our customers expect globally.”
