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October
23, 2001
POLYDEX
RETAINS INDUSTRY EXPERTS TO AID PROGRESS OF USHERCELL
TORONTO,
Ontario, October 23, 2001 --
Polydex Pharmaceuticals Ltd. (Nasdaq: POLXF) (BSE:
PXL) is pleased to announce the retention of key industry
experts to aid in the development of Ushercell,
a patented novel polysaccharide which has shown, in vitro,
to provide contraceptive activity and, more importantly, to
protect against the transmission of sexually transmitted diseases,
including: herpes simplex virus, chlamydia trachomatis and
human immunodeficiency virus (HIV).
Polydex
has bolstered its Ushercell development team beginning with
the engagement of the services of William J. Tillman, PhD,
who brings 40 years of pharmaceutical product development
experience within the drug industry to this project. Dr. Tillman
is well-versed with the FDA requirements for drug substance
and drug product formulation, analysis, stability, and NDA
filings, as well as the FDA-required Good Manufacturing Practice
(GMP) regulations. Dr. Tillman's extensive experience in product
development has previously been utilized by McNeil Consumer
Healthcare Company (a subsidiary of Johnson & Johnson)
and SmithKline Beecham. He is a co-founder and member of the
American Association of Pharmaceutical Scientists, a member
of the Alliance for Microbicide Development and is working
closely with CONRAD for the continuing development of Ushercell.
Dr.
Tillman offered these comments: "The development of the
microbicide product, Ushercell, is a major step forward in
potentially providing the global community with a safe and
effective means to control and prevent the spread of HIV and
other sexually transmitted diseases. The synthesis of unique
derivatives of cellulose, the active constituents of Ushercell,
by Polydex, that are both bioactive and easily formulated
for human use, is a major step forward in this worldwide endeavor.
It is a special honor to be associated with this project.
It isn't often that one has the opportunity to be involved
with a new product that can have such a significant impact
on a major health problem affecting so many people around
the world."
Additionally,
in the specialized area of business development within the
pharmaceutical industry, Polydex has retained the services
of Richard A. Olson. Mr. Olson has been developing marketing
and business development strategies in the Pharmaceutical
and Biotech industry for more than twenty years. He brings
extensive experience in deal structuring between emergent
and major pharmaceutical companies for the development, licensing,
and commercialization of pharmaceutical and OTC drugs. Mr.
Olson is a member of the Licensing Executives Society, and
has provided his professional expertise to a wide variety
of pharmaceutical clients. As a senior industry executive,
he served as the Vice President -- Business Development for
Schering-Plough Healthcare Products, and Executive Vice President
and General Manager of Fisons Consumer Health following a
lengthy career in new business development and product marketing
for Richardson-Vicks Inc. He has also advised on International
expansion and strategy transfer in Europe, Latin America and
Far Eastern markets. Mr. Olson believes that "the development
of microbicides is critically important in the fight against
the spread of HIV/AIDS and other Sexually Transmitted Diseases,
and that Ushercell has the potential to be a significant breakthrough
in this area."
Another
important milestone, which has been achieved in the development
of Ushercell, was the complete physical and chemical characterization
of Ushercell, completed with the assistance and guidance of
Calvin J. Chany II, PhD from Rush University in Chicago. Dr.
Chany is a chemist working in the Section of Obstetrics and
Gynecology Research at Rush, specifically on the development
of new vaginal products. He is closely involved with synthesis
scale-up and analytical methods development of Ushercell by
bulk manufacturing producers.
The
strategic alliance which Polydex has with The Contraceptive
Research and Development Program (CONRAD), as well as the
licensing partnership with TOPCAD and Rush University has
enabled Polydex to make significant strides forward in the
development of this important compound, bringing extensive
intellectual and financial resources devoted to the development
of microbicides to bear on this project. Through these alliances,
Polydex has been able to engage the services of specialty
contractors to assist in the GMP synthesis and scale-up of
Ushercell as an active pharmaceutical ingredient, the development
and supply of product required for large scale human phase
III clinical studies and ultimately commercial use.
Under
the terms of the strategic alliance with CONRAD, CONRAD is
funding and conducting all the required clinical research
studies for the development of Ushercell as a pharmaceutical
product, and securing FDA approvals for all necessary IND
protocols. CONRAD provides critical project management expertise.
CONRAD is also funding the pre-NDA toxicology studies, the
GMP synthesis and scale-up of Ushercell as an active pharmaceutical
ingredient and the GMP development and supply of product for
the clinical studies. Polydex retains all rights to commercialization
in the private sector for Ushercell, and will supply product
on a reasonable cost basis for the public sector requirements.
Polydex
Pharmaceuticals Ltd., based in Toronto, Ontario, Canada, is
engaged in the research, manufacturing and marketing of biotechnology-based
products for veterinary and human pharmaceutical industries
worldwide. It is Polydex's mandate to research, develop and
market veterinary pharmaceutical products in a hands-on (concept
to consumer) fashion. However, the business approach differs
with development of their human pharmaceutical pipeline. Here,
the mandate is to research and license out potential products
to valued partners for development, thereby minimizing R&D
expenditures while retaining a royalty revenue stream from
successful products. This is the reason that the search for
development partners is so important, and is ongoing relative
to all of the potential human pharmaceutical products in the
Polydex pipeline.
NOTE:
This press release may contain forward-looking statements,
within the meaning of Section 27A of the United States Securities
Act of 1933, as amended, and the United States Securities
Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals
Limited. Actual events or results may differ materially from
the Company's expectations, which are subject to a number
of known and unknown risks and uncertainties including but
not limited to changing market conditions, future actions
by the U.S. Food and Drug Administration or equivalent foreign
regulatory authorities as well as results of pending or future
clinical trials. Other risk factors discussed in the Company's
filings with the United States Securities and Exchange Commission
may also affect the actual results achieved by the Company.
CONTACT:
Polydex Pharmaceuticals Limited
George G. Usher, President
(416) 755-2231
or e-mail: gu-dextran@rogers.com
Investor
Relations
North Arm Capital Services
Linda Hughes, Toll-free 1-877-945-1621
or e-mail: Linda@northarm.com
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