A number of news reports recently have been published regarding an experimental treatment for Alzheimer's disease by using Enbrel® (etanercept), a potent anti-inflammatory agent. This off-label, unapproved usage administered by Dr. Edward Tobinick, is not supported nor endorsed by Amgen.

Amgen's mission is to serve patients by aggressively pursuing research to help fight grievous illnesses. We fully recognize that Alzheimer's disease is a relentless neurological disease for which there is currently no cure. Our hearts truly go out to brave patients and families who are dealing with this disease. Amgen will continue to review data on the use of ENBREL and other anti-inflammatory agents for the treatment of Alzheimer’s disease.

While Amgen and others have long recognized the potential role of inflammation in neurological conditions, we have carefully examined these reports and believe that there is insufficient and unsubstantiated scientific data to support the use of ENBREL as a means of treating Alzheimer's disease. For example:

• We are not aware of any human data demonstrating that ENBREL reaches either the cerebrospinal fluid or the central nervous system in sufficient concentrations to inhibit the action of TNF when administered by Dr. Tobinick's method.
• In addition, we are not aware of any placebo-controlled data for Dr. Tobinick’s method. Thus, it is not possible to determine whether the clinical benefit that Dr. Tobinick reports is due to treatment with ENBREL.
• Furthermore, we believe the reported rapidity of response to be biologically improbable when considering the time required for resolution of an active inflammatory response and the potential impact that this could have on cognition.

Case studies alone are not sufficient scientific evidence to support treatment of Alzheimer's disease with ENBREL, and Amgen does not support this or any off-label use of ENBREL.

Additional Information:

The Alzheimer's Association (www.alz.org) has additional information regarding Alzheimer's research and patient/family support groups, as well as a statement regarding these case reports.

For more information about the approved indications for ENBREL, including important safety information, please visit www.enbrel.com.