GE Healthcare and Lantheus Medical Imaging signed a term sheet for the continued Phase III development and global commercialization of Lantheus’s flurpiridaz F 18, a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent for diagnosing coronary artery disease.

The proposed deal, which the firms announced late yesterday, would see GE Healthcare take over all funding for the program, including a second Phase III study, and global commercialization. Priority territories include the U.S., Canada, Europe, and Japan. If the deal is ratified as detailed, Lantheus will receive $5 million upfront and potentially another $60 million in regulatory and sales milestones, plus sales royalties. The Lantheus Holdings subsidiary would also retain an option to co-promote flurpiridaz F 18 in the U.S.

“We are excited about the prospect of GE Healthcare being our global partner to complete the development of flurpiridaz F 18 and bring this next-generation agent to market, as they touch every level of the PET diagnostic delivery continuum and share our commitment to serving the nuclear medicine community,” stated Mary Anne Heino, president and CEO at Lantheus. “The collaboration would enable us to participate in the long-term economic success of flurpiridaz F 18. LMI will also continue to advance our other pipeline assets and pursue additional near-term business development opportunities to drive growth.”

Lantheus Medical Imaging’s lead candidate flurpiridaz F 18 is a fluorine-18–labeled agent that binds to mitochondrial complex 1 (MC-1). A first Phase III study demonstrated that flurpiridaz F 18 resulted in better coronary artery disease detection and lower radiation exposure compared with standard single photon emission computed tomography (SPECT).

Lantheus Medical Imaging has a marketed portfolio of nine products that are used to diagnose diseases, including coronary artery disease, congestive heart failure, and stroke. The firm’s clinical pipeline includes LMI 1195, a fluorine-18–based PET cardiac neuronal imaging agent, which is in development to help to identify patients at risk of sudden cardiac death and fatal arrhythmias. A preliminary Phase I study has been carried out.

LMI 1174 is a gadolinium-based magnetic resonance imaging (MRI) agent designed to identify the protein elastin in arterial walls and atherosclerotic, and so help to stratify patients at risk of heart attack and stroke. The vascular remodeling imaging candidate is in late preclinical development. 

Yesterday, Lantheus Holdings reported 2016 revenues of $301.9 million, up from $293.5 in 2015. Net income for 2016 was $26.8 million, compared with a 2015 net loss of $14.7 million. The firm said the increase in income for 2016 was due to operational improvements, decreased interest expenses, and one-time activities in 2015 associated with its IPO and debt refinancing.  

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