Form: 8-K

Current report filing

September 30, 2004

PRESS RELEASE

Published on September 30, 2004

Exhibit 99.1

ACCESS NEWS

Contact: Company Contact: Investor Relations
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Kerry P. Gray Steve Laird
President & CEO Genesis Select
(214) 905-5100 (203) 341-0214

Donald C. Weinberger
Wolfe Axelrod
(212) 370-4500

ACCESS PHARMACEUTICALS, INC. ANNOUNCES
FDA APPROVAL OF ORADISC(TM) A
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DALLAS, TEXAS, September 30, 2004, ACCESS
PHARMACEUTICALS, INC. (AMEX: AKC) announced today
the receipt of approval of our new drug application
for OraDisc(TM) A from the United States Food and
Drug Administration (FDA).

OraDisc(TM) A is an improved delivery system for
amlexanox, which has previously been approved by the
FDA for the treatment of canker sores. The
OraDisc(TM) technology is a proprietary mucoadhesive
patch which gradually erodes and releases an active
ingredient when applied to the inside of the mouth.

The approval of this new drug application provides
for the use of the amlexanox mucoadhesive patch 2mg
for the treatment of aphthous ulcers in adults and
adolescents 12 years of age and older with a normal
immune system.

Commenting on the approval, Kerry P. Gray, President
and CEO of Access stated, "This is a landmark
accomplishment for Access, we are proud not only of
receiving the FDA approval but also the rapid
development of this product which has taken only 4
years from the initial inventive steps. Importantly,
we believe that gaining this approval is a
validation not only of our business model but also
the quality of our organization."

-More-

Access Pharmaceuticals, Inc.
Page 2

In the clinical program undertaken by Access for
OraDisc(TM) A, pediatric patients 12 years of age
and older were included in the studies. This has
enabled us to extend the potential use of amlexanox
to include patients 12-17 years of age which is
considered an important patient group for this
indication.

As previously reported, Access has expanded
development activities utilizing its OraDisc(TM)
technology to include a range of consumer products.
The approval of the amlexanox mucoadhesive patch is
a strong validation of the OraDisc(TM) technology
and the Company's ability to develop products in
compliance with the strict guidelines necessary to
conform with the FDA regulations.

Mr. Gray continued, "This is an important validation
of the OraDisc(TM) platform technology. Access is
currently developing numerous products which utilize
this technology. The approval of OraDisc(TM) A
represents an important event for potential
strategic partners."

Access Pharmaceuticals, Inc. is an emerging
pharmaceutical company focused on developing both
novel low development risk product candidates and
technologies with longer-term major product
opportunities. Access markets Aphthasol(R), the only
FDA-approved product for the treatment of canker
sores, and is developing products for mucositis and
other oral indications. Access is also developing
unique polymer platinates for use in the treatment
of cancer and has an extensive portfolio of advanced
drug delivery technologies including vitamin
mediated targeted delivery, oral delivery, and
nanoparticle aggregates.

This press release contains certain statements that
are forward-looking within the meaning of Section
27a of the Securities Act of 1933, as amended, and
that involve risks and uncertainties, including but
not limited to statements made relating to the
OraDisc(TM) program, the result of our polymer
platinate program, the results of preclinical and
clinical studies for our polymer platinate products,
the resumption of supply of Aphthasol(R), projected
milestone payments, our ability to achieve
milestones and our ability to obtain strategic
partnerships. These statements are subject to
numerous risks, including but not limited to the
uncertainties associated with research and
development activities, clinical trials, our ability
to raise capital, the timing of and our ability to
achieve regulatory approvals, dependence on others
to market our licensed products, collaborations,
future cash flow, the timing and receipt of
licensing and milestone revenues, projected future
revenue growth and our ability to generate near term
revenues, the future success of the Company's
marketed products Aphthasol(R) and products in
development including polymer platinate, OraDisc(TM)
and our Mucositis technology, our ability to develop
products from our platform technologies, our ability
to manufacture amlexanox products in commercial
quantities, our sales projections and the sales
projections of our licensing partners, our ability
to achieve licensing milestones and other risks
detailed in the Company's Annual Report on Form 10-K
for the year ended December 31, 2003, and other
reports filed by us with the Securities and Exchange
Commission.

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