LEL Lilly(Eli)

 
TIDMLEL 
 
Date: June 1, 2012 
 
For Release: Immediately 
 
Refer To: Keri McGrath-Happe, +1 (317) 370-8394, mcgrath_happe_keri_s@lilly.com 
 
   Amyvidtm (Florbetapir F 18 Injection) Now Available in Select U.S. Markets 
 
    Training program launched to help physicians interpret scans using the 
    first-and-only radioactive diagnostic agent approved for PET imaging of 
               beta-amyloid neuritic plaques in the living brain 
 
INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, 
Inc., a wholly owned subsidiary of Lilly, today announced that Amyvid is 
available to imaging centers in markets surrounding 16 manufacturing sites 
located in Atlanta; Charlotte, N.C.; Chicago; Colton, Calif; Columbus, Ohio; 
Dallas; Fort Lauderdale, Fla.; Hartford, Conn.; Houston; Jacksonville, Fla.; 
North Wales, Pa.; Orlando, Fla.; Palo Alto, Calif.; Phoenix; Seattle; and St. 
Louis. 
 
Because Amyvid loses over half of its radioactivity every two hours, it must be 
distributed directly to imaging centers from the specialized radiopharmacies 
where it is produced. Patients should speak to their health care provider to 
determine if Amyvid is an appropriate option for them and to determine if it is 
available in their area. 
 
"In the roughly two months since the approval of Amyvid, we have been working 
closely with imaging centers to ensure they are prepared to provide Amyvid to 
their customers," said Daniel Skovronsky, M.D., Ph.D., president and CEO of 
Avid, and global brand development leader for Amyvid at Lilly. "We are 
committed to providing Amyvid to physicians, patients and their families in as 
many areas as possible as quickly as we can." 
 
To coincide with the availability of Amyvid, Lilly is also announcing the 
launch of their reader training program. An online training program, developed 
by Lilly and Avid, is now available at AmyvidTraining.com. The companies also 
collaborated with the American College of Radiology to present a live, 
in-person training program, which will be launched on June 11, 2012, in Miami. 
These reader training programs were developed to provide training for 
radiologists and nuclear medicine physicians who will be responsible for 
reading Amyvid scans. Amyvid images should be interpreted only by readers who 
have successfully completed the Amyvid reader training. Errors may occur in the 
estimation of plaque density during image interpretation. 
 
Amyvid is the first-and-only radioactive diagnostic agent approved by the U.S. 
Food and Drug Administration 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 and other causes of 
cognitive decline. 
 
Amyvid works by binding to amyloid plaques, one of the necessary pathological 
features of Alzheimer's Disease,,, and is detected using PET scan images of the 
brain.1 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.2, 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.1,4, 
 
It's important to note that Amyvid is an adjunct to other diagnostic 
evaluations. 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 monitoring responses to therapies.1 
 
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 
 
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. Additional 
information about Lilly is available at www.lilly.com. 
 
This press release contains certain forward-looking statements about Amyvidtm, 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 the product 
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. 
 
P-LLY 
 
 
 
Eli Lilly and Company 
 
Lilly Corporate Center 
 
Indianapolis, Indiana 46285 
 
U.S.A. 
 
www.lilly.com 
 
Amyvid Prescribing Information. April 6, 2012. 
 
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. 
 
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. 
 
Thies W, Bleiler L; Alzheimer's Association. Alzheimer's Association report: 
2012 Alzheimer's disease facts and figures. Alzheimers Dement. 2012;8:131-168. 
 
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. 
 
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. 
 
©Lilly USA, LLC 2012. All rights reserved. AM77832 5/2012 
 
Amyvidtm is a trademark of Eli Lilly and Company. 
 
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