BIOGENETIC SCIENCES ISSUES 2000 ANNUAL REPORT
New York, May 24, 2001 - American Biogenetic Sciences,
Inc. (ABS) (NASDAQ:MABA) announced today its annual
report for 2000 highlights commercial and scientific
achievements during the past year and sets forth the
framework for enhancing the companys partnering
and licensing programs in the current year.
text of the report is available on the companys
website at www.mabxa.com.
described in the report include status updates on
programs involving the companys two neurological
drug candidates and partnering of its patented Antigen-Free
technology for producing monoclonal antibodies.
/ Abbott Laboratories
2000, ABS signed a license agreement with Abbott Laboratories
for ABS neurological compound, called ABS-103,
a small molecule being developed for the treatment
of epilepsy, mania associated with bipolar depression
and the prevention of migraine headache. Under the
terms of the agreement, ABS is entitled to milestone
payments of $17 million, as the compound progresses
through development and regulatory approval as well
as royalties on ultimate sales of the drug when approved.
has indicated that ABS-103 is one of the candidates
being evaluated to become the next generation version
of Depakote, Abbotts best selling U.S. drug
and the one which underpins its $700+million franchise
in anticonvulsant, bipolar, and migraine therapies
has issued progress reports on the studies using ABS-103,
particularly ABS-103R. The Abbott preclinical reports
indicate the program is steadily proceeding with efforts
to focus on evaluating formulations for a clinical
product, determining optimum dosing ranges and dosing
schedules, and further toxicology and metabolism studies.
studies conducted by ABS, ABS-103, has shown anticonvulsant
activity without sedation, is not associated with
increased incidence of birth defects, has lower side
effects and a better safety profile than valproic
to biopharmaceutical consultants Paisley and Habermas,
sales of an enhanced Depakote by Abbott could reach
$450 million in the second year of introduction, growing
to peak sales of $3 billion. This could provide an
exceptionally strong royalty stream for ABS. The full
report from Paisley & Habermas is available on
our website at www.mabxa.com/research.html.
neurological product being developed by the company
is ABS-205, which is the leading compound under investigation
as a potential treatment for neurodegenerative disorders
such as Alzheimer's disease, stroke and head trauma.
have uncovered impressive results and meritorious
properties in ABS-205, a small molecule compound which
crosses the blood brain barrier. Evidence suggests
that the drug promotes rapid improvements in learning
and memory tests by enhancing the efficiency of information
processing for long-term memory. Chronic administration
has been shown to markedly improve cognitive function.
A study conducted by Dr. Ciaran Regan at University
College Dublin, Ireland, and funded by the Institute
for the Study of Aging demonstrated improved cognitive
abilities (memory) in aged animals.
the ABS scientist who co-invented ABS-205, Dr. Heinz
Nau of the University of Hanover, Germany, fast-tracked
the development of an efficient production and purification
system to produce optically pure ABS-205R and ABS-205S.
The compounds have been synthesized and purified in
sufficient quantities to perform three additional
important studies, human liver toxicity, and comparative
cognition and efficacy studies. The results of the
liver toxicity study indicated that ABS-205 was similar
to valproic acid (VPA) which is currently being used
in humans. Drug activity studies performed by Dr.
Nau indicate that the effective dose of ABS-205 may
be one fifth that of VPA. Therefore, the toxicity
at the effective dose is expected to be better than
VPA. ABS now intends to seek pharmaceutical partners
to develop this compound through clinical trials.
of ABS research and development remains its
patented antigen-free mouse technology. This enabling
technology is designed for the production of monoclonal
antibodies of high affinity and specificity that are
used in diagnostics and therapeutics for a variety
of diseases. The antigen-free (AF) technology is superior
to conventional techniques in generating highly specific
antibodies exhibiting high-affinity for difficult
Thrombus Precursor Protein test (TpPTM)
and Functional Intact Fibrinogen Assay (FiF®)
tests which have been cleared by the U.S. Food &
Drug Administration (FDA), both utilize antibodies
that were produced by the AF mouse colony. The two
tests utilize ABS most notable and commercially
successful monoclonal antibodies: MH1, the antibody
that targets soluble fibrin is used in the TpP test;
and 45J, an antibody that binds to fibrinogen is used
in the FiF and TpP tests.
to year-end, we completed a non-exclusive agreement
with Biosite Diagnostics, Incorporated under which
Biosite will validate our TpP diagnostic marker and
antibodies for potential use with its rapid, quantitative
Triage Meter testing platform. Should Biosite decide
to include TpP as a marker on its highly successful
panel, it will purchase antibodies from ABS and pay
milestone fees and royalties. Part of Biosites
validation work will be done in collaboration with
a study group at Brigham and Womans Hospital
in Boston, MA, an investigative team that has been
at the forefront of clinical research of acute coronary
syndromes for the past two decades.