Amyvid™ (Florbetapir F 18 Injection) Approved in European Union for Use in Patients With Cognitive Impairment Being Evaluated

  Amyvid™ (Florbetapir F 18 Injection) Approved in European Union for Use in
Patients With Cognitive Impairment Being Evaluated for Alzheimer's Disease and
                     Other Causes of Cognitive Impairment

PR Newswire

INDIANAPOLIS, Jan. 15, 2013

INDIANAPOLIS, Jan. 15, 2013 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY)
and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly,
announced today that Amyvid (Florbetapir F 18 Injection) has received
marketing authorization from the European Commission as a diagnostic
radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging
of beta-amyloid neuritic plaque density in the brains of adult patients with
cognitive impairment who are being evaluated for Alzheimer's disease and other
causes of cognitive impairment. Amyvid should be used in conjunction with a
clinical evaluation.[1]

Alzheimer's Disease is one of many possible causes of cognitive impairment,
which can make diagnosis challenging.[2],[3] Alzheimer's Disease and other
causes of cognitive impairment share many overlapping symptoms, including
deficiencies in memory, visuospatial ability, executive function, behavior,
and language.[2],[3] It is estimated that up to one in five patients
clinically diagnosed with probable Alzheimer's Disease during life do not
exhibit Alzheimer's Disease pathology upon autopsy.[4],[5]

"We believe that Amyvid fills an unmet need in the medical community,
providing physicians with important information about the presence or absence
of beta-amyloid plaques that can help identify the cause of their patients'
cognitive symptoms," said Diane Bakaysa, Amyvid global brand development
leader. "This is important because, if, based on negative Amyvid findings and
clinical assessment, it is determined that Alzheimer's Disease is not the
cause of cognitive impairment, a physician can avoid unnecessary or
potentially harmful treatments associated with a misdiagnosis of Alzheimer's
Disease."[6],[7],[8]

Beginning in Q2 2013, Amyvid will be available in select areas within the
European Union.

Amyvid for intravenous use was approved by the U.S. Food and Drug
Administration (FDA) in April 2012 and is supplied in 10 mL, 30 mL, or 50 mL
multidose vials containing 500–1,900 MBq/mL Florbetapir F 18.[9] Amyvid is
indicated for 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.[9]

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.[9]

Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan
does not establish a diagnosis of AD or other cognitive disorder. Safety and
effectiveness of Amyvid have not been established for predicting development
of dementia or other neurologic condition, or monitoring responses to
therapies.[9]

About Amyvid

Amyvid is a radioactive diagnostic agent that is injected into the
bloodstream, where it crosses the blood-brain barrier and selectively binds to
amyloid plaques. The fluorine 18 (F 18) isotope produces a positron signal,
which is detected by a PET scanner.[9],[10] ^ Physicians who read Amyvid PET
scans should complete a comprehensive training program available through live
events or online at AmyvidTraining.com.[9]

Indications and Usage[9]

In the United States, 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.

Important Safety Information[9]

WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  oErrors may occur in the Amyvid estimation of brain neuritic plaque density
    during image interpretation
  oImage 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
  oAmyvid 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

  oAmyvid, 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

  oThe most common adverse reactions reported in clinical trials were
    headache (1.8%), musculoskeletal pain (0.8%), fatigue (0.6%), nausea
    (0.6%)

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

AM HCP ISI 05OCT2012

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers—through medicines and information—for some of the world's most urgent
medical needs. P-LLY

This press release contains certain forward-looking statements about Amyvid™
(Florbetapir F 18 Injection), a radioactive diagnostic agent indicated for
brain imaging of beta-amyloid plaques in patients with cognitive impairment
who are being evaluated for Alzheimer's Disease and other causes of cognitive
decline. This release reflects Lilly's current beliefs; however, as with any
pharmaceutical product, there are substantial risks and uncertainties in the
process of development and commercialization. There is no guarantee that
future study results and patient experience will be consistent with study
findings to date or that Amyvid will prove to be commercially successful. For
further discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.

©Lilly USA, LLC 2013. All rights reserved. AM81231 01/2013

Amyvid™ is a trademark of Eli Lilly and Company.

[1]Amyvid [package insert]. European Union. Eli Lilly & Co.; 2013.

[2]Balasa M, Gelpi E, Antonell A, et al; for the Neurological Tissue
Bank/University of Barcelona/Hospital Clínic NTB/UB/HC Collaborative Group.
Clinical features and APOE genotype of pathologically proven early-onset
Alzheimer disease. Neurology. 2011;76(20):1720–1725.

[3]Alzheimer's Association. 2012 Alzheimer's disease facts and figures.
Alzheimers Dement. 2012;8(2):131–168.

[4] Lim A, Tsuang D, Kukull W, et al. Clinico-neuropathological correlation of
Alzheimer's disease in a community based case series. J Am Geriatr Soc.
1999;47(5):564–569.

[5] Petrovitch H, White LR, Ross GW, et al. Accuracy of clinical criteria for
AD in the Honolulu-Asia Aging Study, a population-based study. Neurology.
2001;57(2):226–234.

[6]Alzheimer's Association. 2011 Alzheimer's disease facts and figures.
Alzheimers Dement. 2011;7(2):208–244.

[7] Boise L, Neal MB, Kaye J. Dementia assessment in primary care: results
from a study in three managed care systems. J Gerontol A Biol Sci Med Sci.
2004;59(6):621–626.

[8] Mendez MF, Shapira JS, McMurtray A, et al. Preliminary findings:
behavioral worsening on donepezil in patients with frontotemporal dementia. Am
J Geriatr Psychiatry. 2007;15(1):84–87.

[9] Amyvid [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012.

[10] Choi SR, Golding G, Zhuang Z, et al. Preclinical properties of
^18F-AV-45: a PET agent for Aβ plaques in the brain. J Nucl Med.
2009;50(11):1887–1894.

Refer to: Celeste Stanley, + 317-478-0263 (mobile),
stanley_celeste_a@lilly.com

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO)

SOURCE Eli Lilly and Company

Website: http://www.lilly.com
 
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