DUBLIN, Ireland and MADISON, N.J., March 1 /PRNewswire-FirstCall/ -- Elan
Corporation, plc (NYSE: ELN) ("Elan") and Wyeth-Ayerst Laboratories, the
pharmaceutical division of American Home Products Corporation (NYSE: AHP)
("AHP"), announced today they have decided not to resume further dosing of
AN-1792, an experimental immunotherapeutic under development for the treatment
of mild to moderate Alzheimer's disease.
In early January, Wyeth and Elan suspended all clinical dosing with
AN-1792 in the exploratory Phase 2A study immediately after learning that four
patients in France were reported to have experienced clinical signs consistent
with inflammation in the central nervous system ("CNS"). Since the companies
halted dosing in January, eleven additional patients were reported with
symptoms associated with CNS inflammation.
The companies, in consultation with the independent Safety Monitoring
Committee, have concluded that no additional patients shall be treated with
AN-1792, but patients will continue to be followed to assess on-going safety.
The companies are continuing their pre-clinical and clinical investigations
into these cases and are in regular contact with regulatory agencies in the US
and Europe regarding the progress of this effort.
All patients who experienced this event have, or are, receiving medical
care and most have shown improvement or recovered. The companies are
aggressively collaborating with clinical investigators to better understand
the cause of this phenomenon. Information regarding these events will be
communicated to patients or their caregivers on an ongoing basis.
"We will continue to monitor all patients who have received drug in these
studies," says Dr. Ivan Lieberburg, Elan's Chief Scientific and Medical
Officer. "The well-being of patients is always our paramount concern. Our
decision to first suspend dosing, and now permanently discontinue dosing in
this exploratory phase of clinical research with this single compound, in our
opinion, remains in the best interest of the health and safety of patients.
There are additional compounds under preclinical evaluation as part of this
collaboration. We believe that these alternative therapeutic candidates may
result in a treatment for Alzheimer's disease."
AHP and Elan have formed one of the broadest research alliances in the
pharmaceutical industry to develop immunotherapeutic approaches to treat and
prevent Alzheimer's disease. AN-1792 represents the first in a series of
therapeutic approaches currently under development within this collaboration
that explore the clinical potential of immunotherapy for Alzheimer's disease.
Elan and Wyeth are committed to further research and to finding a cure for
Alzheimer's disease, an affliction that claims millions of lives each year.
"These developments are not uncommon in early clinical research with an
innovative compound like AN-1792," says L. Patrick Gage, President,
Wyeth-Ayerst Research. "Our immediate goals are two-fold - the safety of all
patients involved in these trials; and to gain a greater understanding of the
nature of these events. Both companies are committed to developing a
treatment for Alzheimer's disease and we are hopeful that our alternative
Alzheimer's approaches will continue to advance in development."
Clinical trials with AN-1792 were being conducted in the US and four
European countries in patients with Alzheimer's disease using AN-1792 (also
known as AIP-001). Approximately 360 patients had received multiple doses of
AN-1792. The Phase 2A study was designed to measure the immune response to
immunisation with the study drug, as well as changes in other parameters in
Alzheimer's patients with mild to moderate disease. Patients were enrolled and
evaluated by conventional cognitive tests and by other surrogate measures.
The results of this study were expected to provide additional information
regarding the immune response to AN-1792, as well as valuable information
useful for the design and evaluation of other therapeutic agents being studied
in the collaborative development program.
Alzheimer's disease is the most common cause of dementia, and the fourth
leading cause of death in developed countries. It is a major health problem
worldwide, and has an enormous impact on individuals, families, the health
care system, and society as a whole. It is estimated that more than four
million people in the U.S. currently have Alzheimer's disease, and its
prevalence doubles every five years beyond age 65.
Elan Corporation, plc is a leading worldwide, fully integrated
biopharmaceutical company headquartered in Ireland, with its principal
research, development, manufacturing and marketing facilities located in
Ireland and the United States. Elan is focused on the marketing of
therapeutic products and services in neurology, pain management, oncology,
infectious disease and dermatology and on the development and
commercialisation of products using its extensive range of proprietary drug
delivery technologies. Elan shares trade on the New York, London and Dublin
Stock Exchanges.
Wyeth-Ayerst Laboratories, a division of American Home Products
Corporation, is a major research-oriented pharmaceutical company with leading
products in the areas of women's health care, cardiovascular therapies,
central nervous system drugs, anti-inflammatory agents, infectious disease,
haemophilia, oncology, vaccines, and generic pharmaceuticals. American Home
Products is one of the world's largest research-based pharmaceutical and
health care products companies. It is a leader in the discovery, development,
manufacturing, and marketing of prescription drugs and over-the-counter
medications. It also is a leader vaccines, biotechnology and animal health
care.
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties including,
without limitation, risks associated with the inherent uncertainty of the
clinical development of AN-1792 and whether it will ever be approved for
commercialisation. Factors which could cause actual results to differ
materially from the companies' current expectations include the risk that
problems or delays may arise during preparations for clinical trials or in the
course of development, testing or manufacturing of the product, that results
in later stage or larger trials may be different than those safety profile in
subsequent trials or may not meet applicable regulatory standards as well as
the other risks and uncertainties described from time to time in the
companies' periodic reports filed with the Security and Exchange Commission.
SOURCE Elan Corporation, plc and Wyeth-Ayerst Laboratories
back to top
Related links: http://www.elan.com
Company News On-Call: http://www.prnewswire.com/comp/231593.html
CONTACT: Investors - U.S. - Jack Howarth, +1-212-407-5740 or +1-800-252-3526, jack.howarth@elan.com, Europe - Emer Reynolds, +353-1-709-4080 or +00800 28352600, emer.reynolds@elan.com, both of Elan; Justin Victoria of American Home Products, +1-973-660-5340; Media - Max Gershenoff of Elan, +1-212-407-5751, max.gershenoff@elan.com; Lowell Weiner of American Home Products, +1-973-660-5013, weinerl@ahp.com; Douglas Petkus of Wyeth-Ayerst, +1-610-902-7336, petkusd@labs.wyeth.com
|