SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT OF
FOREIGN ISSUER
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
the month of April 2005
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level 12
BGC Centre
28 The
Esplanade
Perth WA
6000
(Address
of principal executive offices)
(Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F).
Form 20-F
ý Form
40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate
by check mark whether the registrant by furnishing the information contained in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o No
ý
If "Yes"
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82- ___.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant,
pSivida Limited, has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Date: May
10, 2005
| pSivida Limited | ||
| By: | /s/ Aaron Finlay | |
|
| ||
| Aaron Finlay | ||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1: |
Chinese
Patent Granted |
-2-
| ASX/MEDIA RELEASE |
8th
May 2005 |
Chinese
Patent Granted
Planned
Early Commercialisation of BioSiliconTM
in China
China
is the largest global market for BrachySilTM
in liver cancer
Global
nanotechnology company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is
pleased to announce that it has been 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 and is a logical
target market for BrachySilTM. The
potential lower cost of the Chinese registration pathway and the vast need of
BrachySilTM
like
products make China an important commercial target.
pSivida
is currently in exploratory discussions with commercialisation partners for the
Chinese market for its lead product BrachySil™ and is investigating the optimum
regulatory process to launch this product in China. It is expected that pSivida
would enter into a supply agreement with a local distributor responsible for
obtaining regulatory approval, sales and marketing.
pSivida
Managing Director Gavin Rezos said, “China is a massive market offering pSivida
significant opportunities for commercial expansion. In recent years China has
opened its ‘commercial doors’ to many western products, healthcare being no
exception. Although our main short term interest is to launch BrachySil™ in
China, we believe other products in the drug delivery arena will also be good
candidates for this rapidly growing market.”
Chinese
Patent Number ZL 99807447.0 provides protection for silicon implants comprising
tissue compatible biodegradable silicon for drug delivery. This invention was
based on the demonstration in model systems, that long term BioSilicon™ implants
lack toxicology and degrade in the body in a controllable manner. It also claims
the loading of BioSilicon™ implants of varying porosity and structure with
different drugs.
The
pSivida Intellectual Property portfolio consists of 26 patent families, 29
granted patents and over 80 patent applications.
Products
protected by patents and patent applications owned by pSivida include materials
comprising bioactive, resorbable and biocompatible silicon that are of value in
the fabrication of new generations of intelligent drug delivery devices,
orthopaedic implants and intelligent diagnostic tools.
-ENDS-
|
Released
by: |
|
| In Australia: | In US: |
| Josh Mann, CFA | Beverly Jedynak |
| Investor Relations | President |
| pSivida Limited | Martin E. Janis & Company, Inc. |
| Tel: + 61 8 9226 5099 | Tel: 312-943-1100 ext. 12 |
| joshuamann@psivida.com | bjedynak@janispr.com |
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.