EXHIBIT
99.1
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| ASX RELEASE |
29th
July
2005
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pSivida
Quarterly Cashflow - June 2005
Commentary
and Highlights
Global
nanotechnology company pSivida Limited, is pleased to release its quarterly
cashflow statement for the quarter ending 30th
June
2005.
Highlights
and Announcements for the Quarter
Top
5 Global Pharma - significant progress in drug delivery
evaluation
pSivida
announced that the evaluation of selected compounds from an undisclosed top
five
global pharmaceutical company has progressed successfully. The collaboration
agreement covers a staged evaluation of the pharmaceutical company’s proprietary
compounds in pSivida’s porous silicon, controlled release platform
(BioSiliconTM).
The
initial stage of the planned 12-month programme has concluded meeting the agreed
technical success criteria, and in turn triggering the next payment to pSivida
under the terms of the agreement.
BrachySilTM
pancreatic cancer product
Pancreatic
cancer is one of the most prevalent cancers with over 232,000 new cases on
a
global basis per annum (Globocan 2002 statistics) and approximately 60% of
new
cases occurring in the developed world. With an average five year survival
of
4%, pancreatic cancer represents a significant unmet clinical need.
A
full
development programme of pSivida’s proprietary BrachySilTM
product
in a second key cancer indication was commenced to evaluate the efficacy and
safety of this brachytherapy product in pancreatic cancer, with the clinical
programme scheduled to commence before the end of 2005. Selection of this second
key indication has resulted from significant independent market research and
medical opinion leader feedback and therefore represents a judicious, robust
and
viable development option.
BrachySil™
cancer therapy achieves primary endpoint in Phase IIa clinical trials liver
cancer -
Significant efficacy shown
The
primary endpoint of the trial was achieved in its key first indication in that
BrachySil™ (32-P BioSilicon™) was found to be both safe and well tolerated. The
trial was conducted at the Singapore General Hospital on eight patients with
advanced liver cancer who were evaluated after three and six months following
treatment. Among other key findings of the trial was the finding that BrachySil™
also reduced significantly the size of tumors treated and by up to 100% for
smaller tumors even on low dose as determined by CT scanning. These combined
results pave the way for a multi-centre Phase IIb dose-profiling study for
BrachySil™ in this indication, which is scheduled to begin in the second half of
2005 and for which funding is already in place. This trial will lead to the
final registration of BrachySil™ as an approved treatment for liver cancer in
2007.
pSivida
and Epitan successfully complete first stage of Proof of Concept
Study
The
in
vivo study conducted at the Institute of Medical and Veterinary Science in
Adelaide, South Australia, indicated that a single injection of pSivida’s porous
BioSiliconTM
technology successfully released MELANOTAN™ over a sustained period. The outcome
of this collaboration may lead to a second-generation liquid-based injectable
MELANOTAN™ product.
pSivida
is granted its first patent in China
This
first patent grant in China is important as China has the highest incidence
of
primary liver cancer in the world with 345,844 cases in 2002. The potential
lower cost of the Chinese registration pathway and the vast need of
BrachySilTM
like
products make China an important commercial target.
Roche
Diagnostics VP joins pSivida Board
Wholly
owned subsidiary AION Diagnostics Limited, appointed Dr. Jörg Schreiber PhD as a
Non-executive Director in May. Dr. Schreiber has over 20 years experience in
the
diagnostics industry principally with Roche Diagnostics and Boehringer Mannheim
in Germany and brings with him leadership and expertise in the commercialisation
of world class diagnostic products.
pSivida
is granted its first patent in South Korea
This
is
an important patent covering the electronic-based properties of BioSilicon™ in
the stimulation of orthopaedic tissue repair and re-engineering where scaffolds
are required to support new bone growth. The technology also has application
for
treatment of fractures that do not heal, such as “bone non-union”. Korea is a
key global player in the design and manufacture of micro-components for the
electronics industry. This technology, provides the opportunity to capitalize
on
Korea’s technology strengths as well as the higher margins associated with
healthcare products.
Post
Quarter Highlights and Announcements
pSivida
becomes the founding member of the NASDAQ Health Care
Index
pSivida’s
inclusion on the Health Care Index is recognition of pSivida’s increased
visibility in the United States, the world’s largest health care and financial
market and follows its recent listing on the Merrill Lynch Nanotechnology Index.
The NASDAQ Health Care Index is a market value weighted index that contains
NASDAQ-listed companies classified, according to the FTSE Global Classification
System, as "Health," "Pharmaceutical" or "Biotechnology." These classifications
include health maintenance organisations, hospital management and long-term
care, medical equipment and supplies, other health care, biotechnology, and
pharmaceutical companies.
pSivida
appoints two US based non-Executive Directors in July
Dr.
David
J. Mazzo was appointed as a Non-executive Director of the company, based in
New
Jersey, USA. He is President and CEO of Chugai Pharma USA, part of the Roche
group of companies and is a subsidiary of Chugai Pharmaceutical Company Limited
(Japan), a global research-based pharmaceutical company with sales in 2001
of
US$1.7 billion. Dr. Mazzo brings his significant business development experience
and pharmaceutical network to the Board and is recognized
for his strong scientific and regulatory expertise with broad technical and
managerial experience gained from working in a variety of multi-cultural and
multi-lingual environments in the USA, Europe and Asia.
Mr.
Michael W. Rogers was appointed as a Non-executive Director of the company,
based in Massachusetts,
USA. He
is the Executive Vice-President, Chief Financial Officer and Treasurer of
Indevus Pharmaceuticals Incorporated, a biopharmaceutical company based in
Lexington, MA. which is engaged in the acquisition, development and
commercialisation of products targeting certain medical specialty areas,
including urology and infectious diseases. Mr. Rogers brings his significant
financing, acquisition, investment banking, and partnering experience relating
to pharma and biotech companies to the pSivida Board and will Chair the Audit
Committee.
-ENDS-
Released
by:
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pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
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US
Public Relations
Beverley
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 9 1100 ext. 12
bjedynak@janispr.com
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UK
& Europe Public Relations
Mark
Swallow, PhD / Helena Podd
Citigate
Dewe Rogerson
Tel:
+44 (0)20 7282 2948 / 2867
mark.swallow@citigatedr.co.uk
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NOTES
TO EDITORS:
pSivida
Limited
pSivida
is a global nanotechnology company committed to the biomedical sector and the
development of products in healthcare. The company’s focus is the development
and commercialisation of a modified form of silicon (porosified or
nano-structured silicon) known as BioSilicon™. As a new and exciting
biocompatible material, BioSilicon™ offers multiple potential applications
across the high growth healthcare sector, including controlled release drug
delivery, targeted cancer therapies (including brachytherapy and localized
chemotherapy), tissue engineering and orthopedics. Potential diagnostics
applications are being developed through its subsidiary AION Diagnostics
Limited.
pSivida
owns the intellectual property rights to BioSilicon™ for use in or on humans and
animals. The IP portfolio consists of 26 patent families, 29 granted patents
and
over 80 patent applications. The core patent, which recognises BioSilicon™ as a
biomaterial was granted in the UK in 2000 and in the US in 2001.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and in
Germany on the Frankfurt Stock Exchange on the XETRA system (German Symbol:
PSI. Securities Code (WKN) 358705).
pSivida’s shares also trade in the United Kingdom on the OFEX International
Market Service (IMS) under the ticker symbol PSD.
The
Company’s strategic partner and largest shareholder is the QinetiQ group, the
largest science and technology company in Europe. QinetiQ is the former UK
government Defence Evaluation Research Agency and was instrumental in
discovering BioSilicon™. pSivida enjoys a strong relationship with QinetiQ
having access to its cutting edge research and development facilities. For
more
information on QinetiQ visit www.qinetiq.com.
For
more
information visit www.psivida.com
This
document contains forward-looking statements that involve risks and
uncertainties. Although we believe that the expectations reflected in such
forward-looking statements are reasonable at this time, we can give no assurance
that such expectations will prove to be correct. Given these uncertainties,
readers are cautioned not to place undue reliance on such forward-looking
statements. Actual results could differ materially from those anticipated
in
these forward-looking statements due to many important factors including:
our
failure to develop applications for BioSiliconTM due to regulatory,
scientific or other issues. Other reasons are contained in cautionary statements
in the Registration Statement on Form 20-F filed with the U.S. Securities
and
Exchange Commission, including, without limitation, under Item 3.D, "Risk
Factors" therein. We do not undertake to update any oral or written
forward-looking statements that may be made by or on behalf of
pSivida.