Pfizer Announces Co-Primary Clinical Endpoints Not Met In Second Phase 3
Bapineuzumab Study In Mild-To-Moderate Alzheimer’s Disease Patients Who Do
Not Carry The Apoe4 Genotype
Pfizer and Janssen Alzheimer Immunotherapy Discontinue Bapineuzumab IV Phase 3
NEW YORK -- August 06, 2012
Pfizer Inc. (NYSE: PFE) announced today that the co-primary clinical
endpoints, change in cognitive and functional performance compared to placebo,
were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led
Phase 3 trial of intravenous (IV) bapineuzumab in patients with
mild-to-moderate Alzheimer’s disease who do not carry the ApoE4
(apolipoprotein E epsilon 4) genotype (Study 301). Pfizer and Janssen AI are
partners in the Alzheimer’s Immunotherapy Program (AIP).
Based on the topline results of this study, together with the topline results
of a Janssen AI-led Phase 3 study in patients who carry the ApoE4 genotype
(Study 302)announced on July 23^rd, the Janssen AI and Pfizer Joint Steering
Committee for the AIP has decided to discontinue all other bapineuzumab IV
studies in patients with mild-to-moderate Alzheimer’s disease. This includes
not only the Pfizer-led, Phase 3 studies (Study 3000 and Study 3001), but also
all follow-on extension studies in patients with mild-to-moderate Alzheimer’s
disease receiving bapineuzumab IV. All patients in the discontinued studies
will have a follow-up evaluation and the Alliance will conduct final data
These clinical findings and the decision to discontinue the bapineuzumab IV
program in patients with mild-to-moderate Alzheimer’s disease have been shared
with regulatory authorities and study investigators.
“We are obviously very disappointed in the outcomes of this trial. We are also
saddened by the lost opportunity to provide a meaningful advance for patients
afflicted with mild-to-moderate Alzheimer’s disease and their caregivers,”
said Steven J. Romano, M.D., senior vice president, head, Medicines
Development Group, Global Primary Care Business Unit, Pfizer Inc. “Yet these
data, and the subgroup and biomarker analyses underway, will further inform
our understanding of this complex disease and advance research in this field.”
No new safety concerns were identified in Study 301. The most commonly
observed serious adverse events which occurred in bapineuzumab-treated
patients more commonly than in placebo-treated patients, and with an incidence
of at least 1 percent in the combined 0.5 mg/kg and 1.0 mg/kg group, were
pneumonia, ARIA-E (amyloid-related imaging abnormalities-edema or effusion),
syncope, hip fracture and convulsion.
Data from both Study 302 and Study 301 have been accepted as a late-breaker
and will be presented in September at the European Federation of Neurological
Societies (EFNS) meeting in Stockholm.
About the Bapineuzumab IV Phase 3 Studies
Four placebo-controlled Phase 3 studies comprised the bapineuzumab IV clinical
development program. Janssen AI led the two completed 18-month, Phase 3,
multicenter, randomized, double-blind, placebo-controlled, parallel-group,
efficacy and safety studies of patients who are ApoE4 carriers (Study 302) and
ApoE4 non-carriers (Study 301). The two co-primary clinical endpoints were
change in the Alzheimer's Disease Assessment Scale-Cognitive subscale
(ADAS-Cog), a validated measure of cognition, and the Disability Assessment
for Dementia (DAD), a validated instrument to measure function. Study 302
included approximately 1,100 patients who carry the ApoE4 genotype.
Additionally, Study 301 reported here included approximately 1,300 patients
who do not carry the ApoE4 genotype.
In addition to the Janssen AI-led studies, Pfizer led two primarily ex-North
American 18-month, Phase 3, multicenter, randomized, double-blind,
placebo-controlled, parallel-group, efficacy and safety studies of patients
with mild-to-moderate Alzheimer’s disease who are ApoE4 non-carriers (Study
3000) and carriers (Study 3001).
About Bapineuzumab IV
Bapineuzumab IV, an investigational therapy studied for the treatment of
mild-to-moderate Alzheimer’s disease, is an antibody that targets beta-amyloid
(Aβ), a protein that can exert toxic effects in the brain and is believed to
play a central role in the pathology of Alzheimer’s disease.
About Alzheimer’s disease
Alzheimer’s disease, the most common form of dementia, is a degenerative brain
disease that is not a normal part of aging. Currently there is neither a cure
nor a treatment that delays the course of Alzheimer’s disease, which gradually
destroys a person’s cognitive and functional abilities, including memory and
the ability to perform activities of daily living, such as bathing and eating.
Alzheimer’s disease is the sixth leading cause of death in the United States,
estimated to affect more than five million people. It is estimated that there
were 35.6 million people with dementia, including Alzheimer’s disease,
worldwide in 2010. This number is projected to nearly double every 20 years,
increasing to 65.7 million in 2030 and 115.4 million in 2050 worldwide.
Furthermore, the total worldwide costs of dementia, including Alzheimer's
disease, were estimated around one percent of global gross domestic product
(GDP) in 2010, at more than US$600 billion. This includes costs attributed to
informal unpaid care, community or residential-based care and treatment.
About the Alzheimer’s Immunotherapy Program (AIP)
The Alzheimer's Immunotherapy Program (AIP) of Janssen Alzheimer Immunotherapy
and Pfizer Inc. is an equal collaboration committed to researching and
developing selective products for the treatment and/or prevention of
neurodegenerative conditions, including Alzheimer’s disease.
We believe that it may be possible to reduce the burden of disease through
early intervention in the illness. The AIP is dedicated to delivering
comprehensive and integrated solutions that help address the needs of people
impacted by Alzheimer’s disease.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals. Our diversified global health care portfolio includes
human and animal biologic and small molecule medicines and vaccines, as well
as nutritional products and many of the world’s best-known consumer products.
Every day, Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge the most
feared diseases of our time. Consistent with our responsibility as the world’s
leading biopharmaceutical company, we also collaborate with health care
providers, governments and local communities to support and expand access to
reliable, affordable health care around the world. Formore than 150
years,Pfizer has worked to makea difference for all who rely on us.
DISCLOSURE NOTICE: The information contained in this release is as of August
6, 2012. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or
This release contains forward-looking information about a product candidate,
bapineuzumab, that involves substantial risks and uncertainties including,
among other things, the uncertainties inherent in research and development. A
further description of risks and uncertainties can be found in Pfizer’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2011 and in its
reports on Form 10-Q and Form 8-K.
Victoria Davis, 347-558-3455
Suzanne Harnett, 212-733-8009
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