GE Healthcare acquires Zionexa and its FDA-approved PET imaging agent

125

GE Healthcare announced the acquisition of Zionexa, a leading innovator of in-vivo oncology and neurology biomarkers that help enable more personalized healthcare. The company aims to develop and bring to market Zionexa’s pipeline biomarkers, as well as the recently FDA-approved PET imaging agent, Cerianna™ (fluoroestradiol F-18), which is used as an adjunct to biopsy for the detection of estrogen receptor (ER) positive lesions to help inform treatment selection for patients with recurrent or metastatic breast cancer.

It is estimated that 168,000 people have metastatic breast cancer (“Stage 4”) in the U.S.[1], with a five-year survival rate of 28 percent[2]. Cerianna has been commercially available in the U.S. since December 2020 and today is accessible to approximately 25 percent of the relevant patient population. By leveraging its Molecular Imaging Supply Chain, R&D, Medical Affairs, Market Access, Regulatory, Quality and Commercial expertise, GE Healthcare’s Pharmaceutical Diagnostics business – the global leader in pharmaceutical imaging agents – aims to scale Cerianna to be accessible to a minimum of 75 percent of patients by 2023.

Kevin O’Neill, President and CEO of GE Healthcare Pharmaceutical Diagnostics, said: “Like GE Healthcare, Zionexa’s products are aimed at enabling more precise diagnosis, improved treatment decision-making and ultimately better clinical outcomes for patients. This acquisition further demonstrates our commitment to enabling precision health and providing innovations that support oncologists, nuclear medicine specialists and other physicians throughout a cancer patient’s journey, from initial screening and diagnosis to informing therapy selection and monitoring the effectiveness of treatment.”

Zionexa, a privately owned company, formed in 2018 and headquartered in Aubière, France, employs 24 people in France and the U.S., all of whom will transfer to GE Healthcare. Additionally, GE Healthcare will hire approximately 70 new dedicated employees within the company’s U.S. Pharmaceutical Diagnostics team, headquartered in Marlborough, Massachusetts.

Olivier Carli, President of Denos, the majority owner of Zionexa, said: “We expect GE Healthcare Pharmaceutical Diagnostics’ acquisition to allow Zionexa to accelerate the development of its promising R&D pipeline as well as its commercial footprint, while providing Zionexa’s team with access to global and complementary expertise.”

Currently, when treating metastatic breast cancer patients, oncologists base clinical decisions on biopsy results which only represent the sampled area of the tumor. However, estrogen receptor (ER) expression – one of the most common breast cancer biomarkers – can vary both within the primary tumor and across different lesions[3]. Cerianna, an adjunct to biopsy, widens the diagnostic lens for oncologists with a whole-body view of ER positive lesions, helping to provide the patient with a more informed diagnosis, potentially enabling more targeted and individualized treatment plans and avoiding the selection of inappropriate or less effective therapies.

Dr. Hannah M Linden, Breast Medical Oncologist, UW Medicine, University of Washington Fred Hutchison Cancer Research Center and Seattle Cancer Care Alliance in Seattle, who has conducted research and authored multiple papers on fluoroestradiol F-18, explained: “Making Cerianna more widely available is an important moment for cancer patients and a significant step forward for molecular imaging. We test ER expression in a metastatic biopsy once at the beginning of the patient’s journey and we make decisions all along – when to give chemotherapy, when to use endocrine therapy, whether or not to use targeted agents – based on that one measurement. Since we know that ER expression can change with time and treatment, imaging with 18F-fluoroestradiol at critical decision points could help clinicians predict response to endocrine therapy and select optimal treatment timing and sequencing.”

About GE Healthcare:

GE Healthcare is the $18 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 47,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. Follow us on Facebook, LinkedIn, Twitter, and Insights for the latest news, or visit our website www.gehealthcare.com for more information.

About Zionexa:

Zionexa is an international and innovative company developing and commercializing in-vivo biomarkers for guiding targeted therapies in oncology, to improve patients’ pathway and provide them a better quality of life.

About Cerianna:

Cerianna (fluoroestradiol F-18) is a new molecular imaging agent approved by the Food and Drug Administration (FDA) indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Cerianna (fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer.