LILLY (ELI) & COMPANY: Amyvid Recommended for Approval in EU

Date: October 19, 2012                                                          
For Release: Immediately 
Refer to: Morry Smulevitz +1 (317) 457-3294 (mobile), 
Maya Robotti +1 (347) 446-1208 (mobile), 
Amyvid (Florbetapir 18F) Solution for Injection Recommended for Approval in   

    Europe as a Diagnostic Tool for Imaging Beta-Amyloid Plaques - a Common    
               Neuropathological Feature of Alzheimer's Disease                

    Milestone reflects Eli Lilly and Company's commitment to bring          
new diagnostic tool to physicians evaluating patients' cognitive decline     
INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals,
Inc., a wholly owned subsidiary of Lilly, today announced a positive opinion
from the Committee for Medicinal Products for Human Use (CHMP) in Europe. The
CHMP recommended approval of Amyvid (Florbetapir 18F) solution for injection 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 (AD) and other causes of cognitive impairment. Amyvid should be used in
conjunction with a clinical evaluation. 
A negative scan indicates sparse or no plaques, which is not consistent with a
diagnosis of AD. 
A positive scan does not independently establish a diagnosis of AD or other
cognitive disorder since neuritic plaque deposition in grey matter may be
present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy
body dementia, Parkinson's disease dementia). Additional limitations exist for
use in patients with mild cognitive impairment (MCI) and are included in the
Image interpretation errors in the estimation of brain beta-amyloid neuritic
plaque density, including false negatives, have been observed. Amyvid images
should only be interpreted by readers trained in the interpretation of PET
images with florbetapir (18F). The efficacy of Amyvid for predicting
development of AD or monitoring response to therapy has not been established. 
The positive opinion is now referred for final action to the European
Commission, which has the authority to approve medicines for the European Union
(EU). The Commission usually decides on CHMP recommendations within three
"The potential benefit of an Amyvid scan is that it enables physicians to
assess the density of beta-amyloid plaques in the brain," said Diane Bakaysa,
Amyvid global brand leader. "If approved by the European Commission, Amyvid
used in conjunction with a clinical evaluation may provide valuable information
for doctors when evaluating patients suspected of having Alzheimer's disease or
other causes of cognitive decline." 
Confirming the absence or presence of beta-amyloid plaques in patients being
evaluated for AD and other causes of cognitive impairment is important because
there are many causes of cognitive impairment, including AD, neurological
disorders, blood vessel-related disorders causing vascular dementia, movement
disorders, such as Parkinson's and Huntington's diseases, brain tumors, normal
pressure hydrocephalus, traumatic brain injury and infections such as HIV. 
The positive opinion was based on data submitted by Lilly, including several
trials supporting the safety, technical and diagnostic performance of Amyvid.
In the pivotal study involving end of life patients, the diagnostic performance
of Amyvid to detect the cortical neuritic plaque density (no or sparse versus
moderate or frequent) was evaluated in 59 subjects who underwent an Amyvid PET
scan and subsequently had neuropathological evaluation of beta-amyloid
deposition in the brain post-mortem. In the 59 subjects, a blinded PET reading
by five nuclear medicine physicians resulted in a majority read sensitivity of
92 percent (95 percent CI: 78 - 98 percent) and specificity of 100 percent (95
percent CI: 80 - 100 percent). In a study of 47 young (<40 years), healthy
volunteers, presumed to be free of beta-amyloid, all Amyvid PET scans were
Adverse reactions have been collected in clinical studies involving 555
subjects and 665 administrations of Amyvid solution for injection. No serious
adverse reactions related to Amyvid administration have been reported. The only
adverse reaction considered to be common (defined as ≥1/100 to <1/10) is
headache. Uncommon (defined as ≥1/1,000 to <1/100) adverse reactions reported
included dysgeusia, flushing, nausea, pruritis, urticarial and infusion site
Amyvid was approved by the United States (U.S.) Food and Drug Administration
(FDA) for use in the U.S. in April 2012. 
About Alzheimer's Disease 
Alzheimer's disease, the most common form of dementia, causes progressive
decline in memory and other aspects of cognition. Alzheimer's disease is a
fatal illness, accounting for 60 to 80 percent of dementia cases. Researchers
do not know exactly what causes AD and there are currently no approved
treatments shown to slow the progression of this devastating disease, only
treatment options that reduce certain symptoms of the disease.2 Alzheimer's
Disease International (ADI) estimates that there are currently 35.6 million
people with dementia worldwide, with 7.7 million new cases each year (which
implies one new case every four seconds). The number of people affected is
estimated to be over 115 million by 2050. 
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
This press release contains forward-looking statements about the potential of
Amyvid. However, as with any pharmaceutical product under development, there
are substantial risks and uncertainties in the process of development,
commercialization and regulatory review. There is no guarantee that the product
will receive additional regulatory approvals. There is also no guarantee that
Amyvidwill continue 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. 
Eli Lilly and Company 
Lilly Corporate Center 
Indianapolis, Indiana 46285 
                                 - 3 -                                      
National Institute of Neurological Disorders and Stroke. "Dementia: Hope
Through Research." Available at:
detail_dementia.htm #1908919213. Accessed on October 18, 2012. 
Thies W, Bleiler L; Alzheimer's Association. Alzheimer's Association report:
2012 Alzheimer's disease facts and figures. Alzheimers Dement. 2012;8:131-168. 
Alzheimer's Disease International, World Health Organization. Dementia: a
public health priority. Available at:
2012/9789241564458_eng.pdf. Published 2012. Accessed on October 18, 2012. 
-0- Oct/19/2012 13:01 GMT
Press spacebar to pause and continue. Press esc to stop.