Cardinal Health to Manufacture, Distribute Eli Lilly and Company's Brain Imaging Agent Amyvid™ (Florbetapir F 18 Injection)

DUBLIN, Ohio, June 1, 2012 /PRNewswire/ -- Cardinal Health today announced that it will manufacture and distribute Amyvid, Eli Lilly and Company's new diagnostic imaging agent that aids in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. The commercial launch of Amyvid is scheduled for June 1, 2012.

Amyvid works by binding to amyloid plaques, one of the necessary pathological features of Alzheimer's Disease,[1,2,3] and is detected using PET scan images of the brain.[4] A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's Disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease.[1,5] A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.[3,4,6]

It is important to note that Amyvid is an adjunct to other diagnostic evaluations, and a positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or when used to monitor responses to therapies.[4]

Radioactive agents like Amyvid are often likened to "shrinking ice cubes," because once they are manufactured, their radioactivity quickly decays. Amyvid loses over half of its radioactivity every two hours, so the sites that manufacture it need to be located in close proximity to hospitals and health centers that will use it.

Cardinal Health will manufacture and distribute Amyvid at seven sites throughout the U.S. beginning in June 2012, with a potential expansion to 12 locations by the end of the calendar year.

Through its broad nationwide network of manufacturing facilities and radiopharmacies, Cardinal Health's Nuclear Pharmacy Services business can reach more than 90 percent of all U.S. hospitals within three hours' time – empowering the company to play a critical role in quickly expanding access to imaging agents. The company's sophisticated radiopharmaceutical manufacturing infrastructure, broad nuclear pharmacy scale, comprehensive fleet and logistics capabilities also enable it to play a critical role in supporting clinical trials of both proprietary and non-proprietary imaging agents.

"We are excited to play an important role in efficiently and safely getting this innovative imaging agent in the hands of clinicians and imaging professionals so they can expand their arsenal of tools to help in the evaluation of Alzheimer's Disease and other causes of cognitive decline," said John Rademacher, president of Cardinal Health's Nuclear Pharmacy Services business. "We consider it a privilege to have the opportunity to manufacture and distribute diagnostic agents like Amyvid because we know that each dose can aid our customers in the evaluation of patients."

About Cardinal Health

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while  reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day. The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #21 on the Fortune 500, Cardinal Health employs more than 30,000 people worldwide. More information about the company may be found at cardinalhealth.com and @CardinalHealth on Twitter.

About Amyvid

Amyvid is a radioactive diagnostic agent, tagged with a radioisotope called fluorine-18. Once Amyvid is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques. Amyvid produces a positron signal, which is detected by a PET scanner and used to create a brain image. A radiologist, who should have successfully completed Amyvid reader training, then interprets the image to evaluate for the presence or absence of significant amyloid plaques (i.e., moderate to frequent levels of neuritic plaques) in the brain. This information is reported back to the referring physician, who then determines the next steps in the evaluation and management of the patient.

Indications and Usage

Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-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 Amyvid 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 Amyvid 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. Amyvid is an adjunct to other diagnostic evaluations.

Limitations of Use:

A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.[1]

Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

Important Safety Information

Warnings and Precautions

Risk for Image Misinterpretation and Other Errors

Errors may occur in the Amyvid estimation of brain neuritic 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 Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image.

Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.

Radiation Risk

Amyvid, 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.

Most Common Adverse Reactions

The most common adverse reactions reported in clinical trials were headache (1.8 percent), musculoskeletal pain (0.8 percent), fatigue (0.6 percent), nausea (0.6 percent), anxiety (0.4 percent), back pain (0.4 percent), blood pressure increased (0.4 percent), claustrophobia (0.4 percent), feeling cold (0.4 percent), insomnia (0.4 percent), neck pain (0.4 percent).

Drug Interactions

Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results.

For Full Prescribing Information, visit http://pi.lilly.com/us/amyvid-uspi.pdf.  

AM HCP ISI 06APR2012  

[1] Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging–Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012;8:1–13.

[2] Mirra SS, Heyman A, McKeel D, et al; and participating CERAD neuropathologists. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD): part II. standardization of the neuropathologic assessment of Alzheimer's disease. Neurology. 1991;41(4):479–486.

[3] Thies W, Bleiler L; Alzheimer's Association. Alzheimer's Association report: 2012 Alzheimer's disease facts and figures. Alzheimers Dement. 2012;8:131–168.

[4] Amyvid Prescribing Information. April 6, 2012.

[5] McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's Disease. Alzheimers Dement. 2011;7:263–269.

[6] Sperling RA, Aisen PS, Beckett LA, et al. Toward defining the preclinical stages of Alzheimer's Disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's Disease. Alzheimers Dement. 2011;7(3):280–292.

Amyvid™ is a trademark of Eli Lilly and Company.

AM78848 05/2012

SOURCE Cardinal Health