Axonyx Co-Sponsors Successful Symposium on: 'Alzheimer's Disease: Modification and Measurement of Progression'.

Business Editors/Health/Medical Writers

NEW YORK--(BUSINESS WIRE)--Dec. 17, 2003

Leading Worldwide Alzheimer's Authorities Featured In

Discussion On Disease Modification

Axonyx Inc. (NASDAQ: AXYX) today announced that its co-sponsored symposium on "Alzheimer's disease: Modification and Measurement" held from December 11th-14th in Zurs, Austria was deemed a success by presenters and attendees alike. Invited speakers at this meeting were some of the leading authorities in the Alzheimer's disease (AD) field including representatives from the European regulatory authorities.

The small mountain village of Zurs played host to a remarkable scientific event that not only summarized current AD pharmacological science and data about the longer-term effects of existing and future Alzheimer drugs, but also provided a platform for unusually creative discussions among the top basic researchers and clinical researchers in the field of AD.

The key points that evolved from this meeting include:

-- Many of the symptomatic treatment paradigms for AD are still

valid but there is an urgent medical need to treat the

underlying disease.

-- The currently marketed products for Alzheimer's may only

provide very modest and indirect benefits in terms of

disease-modifying effects.

-- Most of the next-generation drugs under development, including

Axonyx's lead compound Phenserine that is currently in a Phase

III clinical trial, target brain beta-amyloid. Beta-amyloid is

the principal component of the senile plaques, which are the

hallmark of Alzheimer's disease, and believed to be causally

implicated in its pathology.

-- Brain-scanning techniques such as MRI and potentially Positron 

Emission Tomography (PET) have recently become available and

could potentially allow a direct assessment of a drug's effect

on modifying disease progression.

The symposium attracted scientists and clinical researchers of the highest calibre:

-- Professor Bengt Winblad of the Karolinska Institute in

Stockholm discussed the need for disease modification products

for AD and the apparent lack of any such effect with the

currently marketed products.

-- Dr. Ezio Giacobini, a world authority on cholinesterase 

inhibitors, presented data on Magnetic Resonance Imaging (MRI)

and the ability of that diagnostic modality to detect

structural changes associated with acetylcholinesterase 

inhibition (AchE-I).

-- Dr. Giacobini also highlighted various mechanisms of reducing

amyloid levels through AchE-I.

-- Dr. Martin Farlow of the Department of Neurology, Indiana

University School of Medicine, presented the data to date on

the potential of AchE-I to inhibit AD progression and various

clinical trial designs that have the potential to measure

disease progression.

-- Dr. Nigel Greig, Chief of Drug Design and Development at the

U.S. National Institutes of Aging in Baltimore and Dr. Kumar

Sambamurti, Medical University of South Carolina presented on

the mechanisms of action that underlie Phenserine's ability to

potentially inhibit disease progression.

-- Dr. Christoph Hock of the University of Zurich, Switzerland

presented data from the Elan/Wyeth-Ayerst active immunization

trial in mild-to-moderate AD patients that appeared to confirm

the association between reducing amyloid levels and AD patient

cognitive decline.

-- Dr. Stefan Ropele of Graz presented on the recent advances of

MRI to detect subtle changes in brain morphology that may

allow the detection of drug treatment effects on AD disease

progression.

-- Dr. Cristina Sampaio, Professor of Clinical Pharmacology and

Therapeutics at the University of Lisbon and Member of the

CPMP, European Medicines Evaluation Agency, as well as Dr.

Karl Broich of the German Federal Institute for Drugs and

Medical Devices (BfArM), the German regulatory authority

discussed regulatory requirements and the approach to clearly

defining patient populations as well as to show evidence of

clinical benefit associated with any disease modification

claim.

The other featured presenters discussed and showed studies on additional mechanisms of modifying AD progression both at the research and clinical trial level.

Axonyx wishes to thank the Austrian Alzheimer's Disease Society for hosting the event as well as JSW Research of Graz, Austria for co-sponsoring and organizing this symposium.

About Axonyx

Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds and new technologies useful in the diagnosis and treatment of Alzheimer's disease, human memory disorders and prion-based illnesses such as Mad Cow disease. Its leading Alzheimer's disease drug candidate is Phenserine, a dual action acetylcholinesterase and beta amyloid precursor protein ((Beta)-APP) inhibitor, and currently in Phase IIB and Phase III clinical trials. A previously completed Phase II trial showed that Phenserine was well tolerated and effective in improving the memory of mild-to-moderate AD patients.

The ongoing Phase IIB clinical study is designed to evaluate Phenserine's ability to lower the levels of the beta-amyloid precursor protein ((Beta)-APP) and Amyloid beta (A-(Beta)) in the plasma and cerebrospinal fluid of mild-to-moderate AD patients. The presence of toxic beta-amyloid in the brains of AD patients is considered by many experts to be a key pathological event in the causation as well as the progression of AD. A reduction of these levels may be able to slow the progression of AD.

This press release may contain forward-looking statements or predictions. These statements represent our judgment to date, and are subject to risks and uncertainties that could materially affect the Company including those risks and uncertainties described in the documents Axonyx files from time to time with the SEC, specifically Axonyx's annual report on Form 10-K. Axonyx cannot assure that the Phase IIB and/or the Phase III clinical trial, or others, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the previous small Phase II trial will remain the same in the Phase IIB and Phase III clinical trials, or future clinical trials, if any, that the preclinical results related to the regulation of beta-APP will be substantiated by the Phenserine Phase IIB clinical trial and that Phenserine will be able to slow the progression of Alzheimer's disease, that the Phase IIB clinical trial data will differentiate Phenserine from the currently marketed drugs, that the efficacy results of the Phase III trial will prove pivotal, that the efficacy data from the Phase IIB clinical trial will be able to be used in the Phase III trial efficacy data, that Axonyx will obtain the necessary financing to complete the Phase III Phenserine trials, that the Company's development work on Phenserine will support an NDA filing, that the results of the Phase III trials will allow Phenserine to be approved by the FDA, that the FDA will grant marketing approval for Phenserine, that if Phenserine is approved by the FDA, it will prove competitive in the market, and that Axonyx will obtain licensing or corporate partnership agreements that will enable acceleration of the development of and optimize marketing opportunities for, Phenserine, or that Axonyx will be able to advance any other potential memory enhancing compound toward IND status. Axonyx undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.