FYI - 4AP Info from Other LIST

RCookHook(AT)aol.com
Wed, 14 Oct 1998 12:15:56 EDT

I wrote Dr. Cohen of Acorda Therapeutics (http://www.acorda.com/) to ask =
how
to obtain 4-AP in Tampa, Florida area. From Acorda site: Acorda has
exclusive, worldwide licenses to patents covering uses of 4-aminopyridine
("4-AP"; "fampridine"), a nerve-conduction-enhancing compound which is th=
e
first ever shown to restore some function to people with SCI. Acorda has
also entered into an agreement with Elan Corporation of Athlone, Ireland,
concerning Elan=92s patented, sustained-release oral tablet formulation o=
f
4-AP. Under this agreement Acorda has an exclusive, worldwide license to
Elan=92s 4-AP patents for SCI markets, and is responsible for all clinica=
l
development and marketing. Elan will manufacture and supply the product t=
o
Acorda. Acorda also has received an "orphan product" designation from the
U.S. Food and Drug Administration (FDA) for the use of 4-AP in SCI.

Here is Acorda response to my letter:

Dear Stephen,

Dr. Cohen asked me to respond to your request for information on
obtaining a prescription for 4-AP.

As you may know, 4-AP has not yet been approved by the FDA; in fact,
Acorda Therapeutics is in the process of conducting human clinical
trials of 4-AP to demonstrate both it's safety and efficacy in order to
obtain FDA approval.

This is an extremely detailed, rigorous, and and exacting process, and
we simply are not able to make our formulation of 4-AP available to
anyone outside of these clinical trials. We are currently completing
the analysis of our most recent trials, and expect to begin additional
clinical trials in early 1999. We have not yet decided on the locations
of the trials or the patient profile we will be looking for, but I will
be happy to give that information out as soon as it is decided. You may
want to contact me by email or phone in early January.

In addition, if you send me your address, I will be happy to send you
some information about Acorda Therapeutics and the other therapies we
are developing.

We are also aware that there are several pharmacies in the country that
will compound and dose 4-aP to individuals with a physician's
prescription. We have had no direct contact with these pharmacies
ourselves, and they are not using the Acorda formulation of 4-AP. I
hope you understand that we also cannot recommend any physicians who may
be willing to prescribe 4-AP, but if your physician was willing to do
so, I would be happy to pass along any information I have received about
these pharmacies to him or her.

Sincerely,

Tierney Saccavino
Acorda Therapeutics
914-347-4300 x104