Date: Fri,  9 Jan 1998 16:25:18 EST
From: Chris Jenks <>
To: Multiple recipients of list <>
Subject: Summary of NDA's Case Against UM

  Dear Everyone,

  I have finally finished typing the court document for the case by NDA
against the University of Miami (UM), currently in progress. It is very
long, so I will attempt to summarize it here. Please correct me, Howard, if
I misinterpret or omit any key points.


  Howard Lotsof, president and founder of NDA, Inc., has devoted his life
since 1980, and over a million dollars, to the development of ibogaine
treatment for addiction, with the ultimate goal of gaining the approval of
the FDA and marketing it legally. To this end, Howard secured six patents
for the treatment of addiction using ibogaine or derivatives thereof.
  In March 1992, NDA and the UM signed a contract in which the UM would
study the metabolism of ibogaine in monkeys on the island of St. Kitts
using ibogaine provided by NDA.
  In June 1992, NDA and the UM signed a contract to conduct a Phase I
clinical trial of ibogaine in human volunteers at the UM. NDA needs the
results of this study to obtain a new drug application from the FDA, and
move closer to gaining approval for ibogaine treatment. According to this
contract, NDA would trust the UM with proprietary information regarding
ibogaine and its use, provide a source of ibogaine, demonstrate the
effectiveness of ibogaine treatment to UM representatives, and provide
general support and expertise. Meanwhile, the UM would conduct the Phase I
clinical trial at no cost to NDA, and would be free to apply for grants and
publish results from this work. The UM would also provide all data derived
from the study, and required by the FDA, to NDA promptly. Copies of
applicable communications with government agencies would also be provided.
Of key importance to NDA, stated in the contract, was maintaining ownership
and confidentiality of the proprietary ibogaine treatment method. Any
discoveries or improvements made regarding the method during this clinical
study were to belong to NDA. The UM agreed not to use this method for
anything besides the agreed upon clinical study. If NDA was compelled to
protect these interests from UM, then UM would reimburse the associated
legal costs.
  During this clinical trial a metabolite of ibogaine, called noribogaine,
was discovered. In 1994, NDA and the UM signed another contract whereby the
UM would receive 12% of any income derived from its sale. In return, Dr.
Deborah Mash, an employee of the UM and the key scientist involved with the
clinical trials, would participate in meetings with investors at NDA's
request. The UM would also pay for the patent application.

Howard's company NDA, Inc. is suing the University of Miami because:

  The UM has failed to complete the Phase I clinical trial as agreed to in
the June 1992 contract, and as a result, FDA approval of ibogaine has been
delayed, and income derived from its marketing has gone unearned.
  The UM has also failed to provide the promised results from work it has
done, and copies of the procedures it has developed.
  An employee of the UM named Dr. Deborah Mash has been conducting
treatments of addiction with ibogaine in St. Kitts, in competition with
NDA's treatment facility in Panama. In doing so, she is using proprietary
information the UM was entrusted with and promised not to use for profit,
according to the June 1992 contract. Dr. Mash has also obtained a patent
entitled "Bioactive Tricyclic Ibogaine, Analogs", derived from her work
under the June 1992 contract and in violation of it.
  Dr. Mash has failed to participate in meetings with investors at NDA's
request, as agreed in the 1994 contract, causing NDA to lose potential
investment from them.

Damages requested:

  NDA would like to receive a report of the income derived from the use of
the technology which was stolen from it, and eventually to receive that
  NDA would also like to be reimbursed for the cost of bringing this case.
  NDA would also like to receive punitive damages against the UM for being
so underhanded.