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AMERICAN
BIOGENETIC SCIENCES SECURES
VACCINE AGREEMENTS WITH RUSSIAN FEDERATION ENTITIES
Copiague, New York, January 9, 2002 ‚ American
Biogenetic Sciences, Inc. (ABS or Company) (Symbol:MABA)
announced today that it has executed two new ten-year
agreements with Russian entities, granting ABS exclusive
rights to distribute in specified markets certain
vaccines to be manufactured in Russia.
ANTHRAX
VACCINE:
ABS has
entered into a ten-year agreement, dated January 14,
2002, with a Russian Association (Association) which
represents over thirty manufacturers, enterprises,
and scientific research institutes located in the
Russian Federation. The Association has the exclusive
right to sell and distribute worldwide an anthrax
vaccine produced by a Russian manufacturer. Under
the agreement between ABS and the Association, ABS
has been granted the exclusive right to act as a distributor
for the anthrax vaccine in the territory consisting
of the United States, Canada, Mexico, countries of
Central and South America and China. The anthrax vaccine
is presently being marketed outside of the ABS territory
by the Association.
The agreement
between ABS and the Association also grants ABS the
first priority right to purchase a broad range of
other immunobiological preparations including other
human vaccines (biological products). The volumes,
terms of delivery, price, and specifications related
to the biological products will be negotiated separately
with the Association. Under the agreement, ABS plans
to make certain biological products available to pharmaceutical
companies, government agencies and regulatory authorities
for testing and evaluation.
SMALLPOX
VACCINE:
ABS has
also entered into a separate ten-year agreement, dated
January 15, 2002, with a Russian Federation manufacturer
(Manufacturer) which grants ABS rights to act as the
Manufacturers exclusive worldwide distributor
(with the right to assign sub-distributors and agents)
for smallpox vaccine for human use outside of the
Commonwealth of Independent States (the Russian Federation
and eleven other independent countries formerly part
of the Soviet Union). This manufacturer has been operating
for over 100 years, and was a supplier of smallpox
vaccine used by the World Health Organization during
the global eradication of smallpox in the 1970s.
Under
the agreement with the Manufacturer, ABS plans to
market the smallpox vaccine by first making it available
for testing and evaluation by pharmaceutical companies,
the U.S. Food and Drug Administration and other government
agencies and regulatory authorities outside of the
Commonwealth of Independent States. The terms of the
sale of and specifications related to the smallpox
vaccine will be negotiated with the Manufacturer.
With respect
to both agreements, ABS plans to market the vaccines
through one or more sub-distributors, or to form collaborative
agreements with pharmaceutical companies that may
arrange necessary testing and evaluation. The ability
of the Company, and any of its sub-distributors or
collaboratives, to sell the vaccines is subject to
the results of testing and evaluation and the approval
of government agencies and regulatory authorities
in the relevant country or jurisdiction. ABS has not
yet signed any agreements with a sub-distributor or
pharmaceutical companies. ABS cannot predict if and
when it will receive any revenues from sales of the
vaccines. Each party is responsible for its own expenses
and costs in connection with the agreements. ABS
exclusivity under these agreements is contingent upon
meeting certain obligations, including ABS effort
to obtain necessary regulatory approvals for use in
humans, and for the import and distribution of the
vaccines. In the interest of confidentiality and security,
the Association and the Manufacturer have asked not
to be identified in press materials, but their identities
will be available to the appropriate government authorities.
American
Biogenetic Sciences, Inc., based in Copiague, NY,
is a development stage company engaged in researching
and developing diagnostic tests for cardiopulmonary
conditions and treatments for neurological disorders,
including epilepsy, migraine, mania, and Alzheimer's
disease. As a developer of biogenetic technologies
and compounds, ABS to date has been issued over 75
patents, both US and foreign, and there are over 100
patents pending.
Note
Regarding Forward-Looking Statements
"Safe
Harbor" Statement under the Private Securities
Litigation Reform Act of 1995: Certain statements
contained in this press release that are not historical
facts are forward-looking statements that involve
a number of known and unknown risks, uncertainties
and other factors that could cause the actual results,
performance or achievements of the Company to be materially
different from any future results, performance or
achievement expressed or implied by such forward-looking
statements. These risks and uncertainties include,
but are not limited to: the results of testing and
evaluation of the vaccines; the ability of the Company
to obtain necessary government agency and regulatory
approvals of any of the vaccines and the extended
time and expense necessary to obtain such approvals;
the resulting time required to obtain revenues from
vaccines; the ability of vaccine manufacturing facilities
in Russia to meet all quality and manufacturing practices
required for distribution; the presence of potentially
negative side-effects and concerns regarding the efficacy
of and lack of experience by the regulators with the
specific human vaccines which may inhibit approval
for sale in the United States or certain other countries;
the Companys lack of experience with these types
of vaccines; the ability to consummate necessary agreements
with additional manufacturers and with sub-distributors,
and to make sales of the vaccines and other biological
products; the activities of competitors; changes in
regulations applicable to biological products and
human vaccines and the administration of such regulations;
the general condition of the economy; and other risks
detailed in the Company's Securities and Exchange
Commission (SEC) filings. In addition, a discussion
of the risks and uncertainties related to the Company's
other areas of business are detailed in the Company's
SEC filings, including its annual report or Form 10-K.
The words "intend," "expect,"
"anticipate," and "plan" and similar
expressions identify forward-looking statements. Readers
are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of
the date the statement was made.
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