Navigation Links
Lilly Advances Second Alzheimer's Disease Treatment Candidate Into Late-Stage Testing by Launching Two Global Trials

Both Phase III pivotal trials begin enrollment in May 2009; Reinforces Lilly's commitment to Alzheimer's disease and biotech product research

INDIANAPOLIS, May 21 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) today announced it will begin enrolling patients this month in two separate but identical Phase III clinical trials of solanezumab(i), previously referred to as LY2062430, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The trials, called EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries.

In 2008, Lilly began enrolling patients in two Phase III clinical trials called IDENTITY and IDENTITY 2 for a different potential treatment for Alzheimer's disease, a gamma-secretase inhibitor that also affects amyloid beta, which is believed to be one of the underlying pathologies of the disease. Patients or caregivers interested in learning how to enroll in either EXPEDITION trial or the IDENTITY trials should visit or call 1-877-CTLilly (1-877-285-4559). In combination, the EXPEDITION and IDENTITY trials will include approximately 4,600 patients with Alzheimer's disease in over 30 countries around the world.

EXPEDITION and EXPEDITION 2 - EXPanding AlzhEimer's Disease InvestigaTIONs

The EXPEDITION clinical trials are identical multicenter, randomized, double-blind, placebo-controlled trials. Patients enrolled in the trials will be randomized in a 1:1 ratio (500 patients in each trial arm) to receive intravenous infusions of either placebo or 400 mg of solanezumab once every four weeks. Patients who are taking currently available symptomatic treatments for Alzheimer's disease can continue treatment during their participation in the EXPEDITION trials. The primary objective of both trials is to test whether solanezumab will slow the cognitive and functional decline of Alzheimer's disease patients as compared with placebo. These outcomes will be analyzed using measures of the Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-COG(11)), which measures cognitive function with an emphasis on memory, and the Alzheimer's Disease Cooperative Study - Activities of Daily Living scale (ADCS-ADL), which measures the ability to independently perform daily activities such as eating, bathing, and using the telephone. Secondary objectives of the trials include different clinical benefits as measured by several brain-scanning and biochemical biomarkers and ratings scales, and quality of life impact.

"Current therapies available to treat Alzheimer's disease may help with symptoms, but they haven't been proven to change the disease progression," said Eric Siemers M.D., Medical Director, Alzheimer's disease research for Eli Lilly and Company. "Biomarker results from a Phase II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimer's disease."

EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan, and United States. EXPEDITION 2 will be conducted in Australia, France, Germany, Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, United Kingdom, and United States.

About Alzheimer's Disease

Alzheimer's disease is a progressive neurodegenerative condition that is the most common cause of dementia, accounting for 60 to 80 percent of cases(ii). Estimates show that 6-8 percent of people over age 65 are affected by Alzheimer's disease(iii), totaling approximately 5.3 million people in the United States alone(ii). Every 70 seconds, an American is developing Alzheimer's disease(ii), and it is the sixth-leading cause of death in the United States(ii). The direct and indirect health care costs associated with Alzheimer's disease and other dementias in the U.S. are estimated to be about $150 billion(ii). In 2005, the total cost worldwide of dementia, of which Alzheimer's disease is the most common cause, was estimated at $315.4 billion(iv). The burden to caregivers and health care costs can increase dramatically in the late stages of Alzheimer's disease, when patients cannot maintain independent function and are frequently bedridden(ii).

About Solanezumab

Alzheimer's disease theory suggests that amyloid beta clumps together and eventually kills brain cells. Solanezumab binds specifically to soluble amyloid beta and thereby may draw the peptide away from the brain through the blood. In short-term clinical studies, solanezumab appeared to have dose-dependent effects on amyloid beta in blood and cerebrospinal fluid. The clinical studies to date have been too short to evaluate any potential delay in the progress of Alzheimer's disease. To date, the only side effect experienced in clinical studies that appeared to be associated with solanezumab treatment has been mild chills consistent with an infusion reaction; other side effects reported in the Phase II study include nausea, vomiting, headache, back pain, and cough. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document.

About Lilly Biotech Efforts

Lilly is the 5th largest biopharmaceutical company in the world, with global biotech sales of more than $5.3 billion in 2008. Today, 40 percent of Lilly's drug pipeline - and 50 percent of its late stage pipeline - is comprised of biotech compounds spanning potential treatment options for diabetes, cancer, Alzheimer's disease, osteoporosis, multiple sclerosis and inflammation.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class 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

This press release contains forward-looking statements about the potential of the investigational compound LY2062430 and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

i. USAN (United States Adoptive Name council) adopted, INN (International Non-proprietary Name) pending

ii. "2009 Alzheimer's Disease Facts and Figures." Alzheimer's Association. Available at: May 13, 2009.

iii. Small, GW, Rabins, PV, Barry, PP, Buckholtz, NS, DeKosky, ST, Ferris, SH, Finkel, SI, Gwyther, LP, Khachaturian, ZS, Lebowitz, BD, McRae, TD, Morris, JC, Oakley, F, Schneider, LS, Streim, JE, Sunderland, T, Teri, LA, Tune, LE. Diagnosis and Treatment of Alzheimer's Disease and Related Disorders: Consensus Statement of the American Association for Geriatric Psychiatry, the Alzheimer's Association, and the American Geriatrics Society. JAMA 1997; 278: 1363-1371.

iv. Wimo A., Winblad B., Jonsson L. An estimate of the total worldwide societal costs of dementia in 2005 (2007) Alzheimer's and Dementia, 3 (2), pp. 81-91


(Logo: )

SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly
2. Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research
3. FDA Issues a Complete Response Letter for Lillys Olanzapine LAI for Treatment of Schizophrenia in Adults
4. Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain
5. Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application
6. Lilly and Deciphera Pharmaceuticals Announce Licensing and Collaboration Agreement
7. Lilly Announces Initiation of Second Global Phase III Trial of Investigational Alzheimers Disease Compound
8. Insulin Analogues From Novo Nordisk, Eli Lilly and Sanofi-Aventis Will Drive Growth in the Type 1 Diabetes Drug Market
9. Phase II Data on Lillys Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimers Disease
10. FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
11. Lilly and TransPharma Medical Announce Licensing and Development Agreement
Post Your Comments:
(Date:11/26/2015)... , Nov. 26, 2015 Research and ... of the "2016 Future Horizons and Growth ... Market: Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> --> ... of the Italian therapeutic drug monitoring market, including ...
(Date:11/25/2015)... Nov. 25, 2015  Amgen (NASDAQ: AMGN ) ... (BLA) with the United States ... a biosimilar candidate to Humira ® (adalimumab). Amgen ... submitted to the FDA and represents Amgen,s first BLA ... E. Harper , M.D., executive vice president of Research ...
(Date:11/25/2015)... MINNEAPOLIS , Nov. 25, 2015  ARKRAY ... care products, continues to provide evidence demonstrating the accuracy ... the World Congress on Insulin Resistance, Diabetes and Cardiovascular ... showed that both the Company,s GLUCOCARD ® 01 ... met high accuracy requirements. The ability to accurately measure ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... ... direct sauna parts and accessories. , Sauna accessories help improve the bather experience ... and personality. From basic styles for the purist looking for simplicity in design ...
(Date:11/25/2015)... ... 2015 , ... For the first time, Vitalalert is donating half of its ... The partnership between the two groups began in 2014 with Vitalalert pledging a portion ... International was founded in 1954 and is an international Christian-based health organization whose mission ...
(Date:11/25/2015)... , ... November 25, 2015 , ... On November 25, ... center for the Narconon network, announced the release of a new cutting edge recovery ... Narconon organization has been working with drug- and alcohol-addicted individuals with the purpose to ...
(Date:11/25/2015)... ... 2015 , ... Smiles by Stevens is pleased to announce the ... While many patients are aware of the benefits of Botox® in the treatment of ... suffering with discomfort, soreness, and pain as a result of Jaw Tension, TMJ (temporo-mandibular ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... In an ... Resurrection Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy of ... and surgical intensive care units (totaling 30 beds) from May 2014 through October 2015 ...
Breaking Medicine News(10 mins):