Improved supply capabilities of Neuraceq® to
provide better patient access to beta-amyloid PET
BOSTON, July 9, 2024
/PRNewswire/ -- Life Molecular Imaging (LMI) and Jubilant
Radiopharma, a global company that offers radiopharmaceuticals and
radiopharmacies for nuclear medicine, announce the expansion of
their strategic partnership and licensing agreement to provide and
distribute Neuraceq® from Jubilant's single photon emission
computed tomography (SPECT) and Positron Emision Tomography (PET)
radiopharmaceutical manufacturing site located in Mobile, AL. The first doses have been made
available on July 9th,
2024.
Neuraceq® is an FDA-approved imaging agent for the detection of
beta-amyloid plaques in the brain of adult patients with cognitive
impairment who are being evaluated for Alzheimer's disease and
other causes of cognitive decline. Neuraceq® is used in clinical
routine and is also a powerful imaging biomarker for the
appropriate characterization of subjects assessed for treatment
eligibility with newly approved anti-amyloid drugs, or for
enrollment in clinical trials to further support drug development
in neurodegenerative diseases.
"Expanding Neuraceq® manufacturing in Mobile in collaboration with Jubilant, further
reinforces Life Molecular Imaging's commitment to meeting the
increasing demand for amyloid detection to confirm eligibility for
new therapies. We are excited to support the growing needs of the
customers in the region, and to provide Neuraceq® access for the
benefit of physicians, patients, and our pharma partners," said
Colleen Ruby, US Country and Chief
Operating Officer, Americas and APAC.
"More than 6.2 million Americans are currently living with
Alzheimer's disease. A progressive brain disorder that impacts
memory, thinking and language skills, and the ability to carry out
the simplest tasks. The Jubilant Radiopharma Team is excited to
bring Neuraceq® to physicians and patients in the Mobile, AL area," said Renato Leite, President, Jubilant
Radiopharmacies. "The availability of Neuraceq® offers new hope
through the detection of beta-amyloid plaques in the brain of adult
patients with cognitive impairment who are being evaluated for
Alzheimer's disease."
About Neuraceq (florbetaben 18F)
Indication
Neuraceq® is a radioactive diagnostic agent indicated for
Positron Emission Tomography (PET) imaging of the brain to estimate
β-amyloid neuritic plaque density in adult patients with cognitive
impairment who are being evaluated for Alzheimer's Disease (AD) and
other causes of cognitive decline. A negative Neuraceq® scan
indicates sparse to no neuritic plaques and is inconsistent with a
neuropathological diagnosis of AD at the time of image acquisition;
a negative scan result reduces the likelihood that a patient's
cognitive impairment is due to AD. A positive Neuraceq® scan
indicates moderate to frequent amyloid neuritic plaques;
neuropathological examination has shown this amount of amyloid
neuritic plaque is present in patients with AD, but may also be
present in patients with other types of neurologic conditions as
well as older people with normal cognition. Neuraceq® is an adjunct
to other diagnostic evaluations.
Limitations of Use
- A positive Neuraceq® scan does not establish the diagnosis of
AD or any other cognitive disorder.
- Safety and effectiveness of Neuraceq® have not been established
for:
- Predicting development of dementia or other neurologic
conditions
- Monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Errors
may occur in the Neuraceq® estimation of brain neuritic β-amyloid
plaque density during image interpretation. Image interpretation
should be performed independently of the patient's clinical
information. The use of clinical information in the interpretation
of Neuraceq® images has not been evaluated and may lead to errors.
Errors may also occur in cases with severe brain atrophy that
limits the ability to distinguish gray and white matter on the
Neuraceq® scan. Errors may also occur due to motion artifacts that
result in image distortion. Neuraceq® scan results are indicative
of the presence of brain neuritic β-amyloid plaques only at the
time of image acquisition and a negative scan result does not
preclude the development of brain neuritic β-amyloid plaques in the
future.
Radiation Risk
Neuraceq®, similar to other
radiopharmaceuticals, contributes to a patient's overall long-term
cumulative radiation exposure. Long-term cumulative radiation
exposure is associated with an increased risk of cancer. Ensure
safe handling to protect patients and health care workers from
unintentional radiation exposure.
Common Adverse Reactions
The overall safety profile of
Neuraceq® is based on data from 1,090 administrations of Neuraceq®
to 872 subjects. No serious adverse reactions related to Neuraceq®
administration have been reported. The most frequently observed
adverse drug reactions in subjects receiving Neuraceq® were
injection site reactions consisting of erythema (1.7%), irritation
(1.1%) and pain (3.4%).
For more information please visit: neuraceq.com
About Life Molecular Imaging (LMI)
Life Molecular
Imaging (LMI) is an international pharma company dedicated to
developing and offering novel cutting-edge PET radiopharmaceuticals
for imaging of neurodegenerative and cardiovascular diseases. The
organization strives to be a leader in the molecular imaging field.
Our mission is to pioneer innovative PET products that improve
early detection and characterization of chronic and
life-threatening diseases, leading to better therapeutic outcomes
and improved quality of life. By advancing novel PET
radiopharmaceuticals for molecular imaging, LMI is focusing on a
key field of modern medicine. LMI is an affiliate of Life
Healthcare Group – an international people-centered, diversified
healthcare organization with four decades of experience in the
South African private healthcare sector. To learn more, please
visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a
global people-centered, diversified healthcare organization listed
on the Johannesburg Stock Exchange. Life Healthcare has over 40
years' experience in the South African private healthcare sector,
and currently operates 64 healthcare facilities in southern
Africa. Services include acute
hospital care, acute physical rehabilitation, acute mental
healthcare, renal dialysis, oncology, diagnostic and molecular
imaging and health risk management services which include
occupational health and wellness services. The Group also owns Life
Molecular Imaging, a radiopharmaceutical business dedicated to
developing and globally commercializing innovative molecular
imaging agents for use in PET-CT diagnostics to detect specific
diseases. Visit: https://www.lifehealthcare.co.za/ |
https://life-mi.com/
About Jubilant Radiopharma
Jubilant Radiopharma, a division of Jubilant Pharma Ltd., is an
industry-leading radiopharmaceutical business that comprises
development, manufacturing and commercialization of products
through its Radiopharmaceuticals business and distribution through
its national network of Radiopharmacies. The division's
Radiopharmacies business is the second largest radiopharmacy
network in the US with 46 pharmacies distributing nuclear medicine
products to the largest national Group Purchasing Organisations
(GPOs), regional health systems, stand-alone imaging centres,
cardiologists and hospitals. This business has over 30 years of
experience in serving the US nuclear medicine community and its
current geographical reach enables it to serve over four million
patients yearly. Jubilant Radiopharma is focused on "Improving
Lives through Nuclear Medicine".
For media queries
Brittany
Hahn | Marketing Communications Manager | Life Molecular
Imaging
Tel: +1.484.735.2840 | b.hahn@life-mi.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/life-molecular-imaging-and-jubilant-radiopharma-announce-neuraceq-availability-in-mobile-al-302192607.html
SOURCE Life Molecular Imaging