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 September 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 x 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
x
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: September 15, 2005 | ||
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
EXHIBIT
99.1: pSivida
Completes Manufacturing Infrastructure for BrachySilTM
Cancer
Therapy
-2-
| ASX/MEDIA RELEASE |
15
September
2005
|
pSivida
Completes Manufacturing Infrastructure for
BrachySil™
Cancer Therapy
|
BrachySil™
manufacturing process
completed at state-of-the-art Auriga Medical™
facility
|
Global
nanotechnology company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that it’s manufacturing partner QSA* has completed the
construction and validation of a state-of-the-art cleanroom facility, dedicated
to the supply of pSivida’s lead cancer therapy BrachySil™, at QSA’s Auriga
Medical™ facility in Braunschweig, Germany.
This
cGMP
facility will fulfil the final process in the manufacture of BrachySil™ for
future clinical and commercial use, and represents the crucial final stage
in
establishing the manufacturing and supply infrastructure to support BrachySil™
as it advances through clinical trials towards the market.
BrachySil™
(32-P BioSilicon™) has shown excellent results in Phase IIa clinical trials as a
radiotherapy for the treatment of inoperable primary liver cancer, where
it is
delivered directly into the tumors without surgery, a procedure known as
brachytherapy. pSivida is currently preparing to begin Phase IIb dose-profiling
studies with BrachySil™ in this indication and expects to treat its first
patient before the end of 2005. The Company is also planning Phase IIa trials
with BrachySil™ to evaluate its safety and efficacy in patients suffering from
pancreatic cancer. This trial is also on schedule to begin in late
2005.
pSivida
and QSA entered into an extendable three-year manufacturing agreement for
BrachySil™ in March 2004. Under the terms of the agreement, QSA’s specialist
brachytherapy and radioimmunotherapy business Auriga Medical™ was to design and
construct a dedicated facility, optimized for the processing of BrachySil™ (32-P
BioSilicon™). Auriga Medical™ will also manage the supply logistics for clinical
and commercial use.
pSivida’s
Managing Director, Gavin Rezos, said, “The completion of this facility marks a
significant step forward towards commercialising BrachySil™ and I am delighted
with the progress made by the team at Auriga Medical™. All key steps and
facilities involved in the BrachySil™ manufacturing process are now operating to
the essential GMP requirements necessary for regulatory approval. We are
now in
a very good position to rapidly advance our clinical development and
commercialisation programme for our exciting lead product.”
*AEA
Technology QSA GmbH is a subsidiary of AEA Technology plc (LSE: AAT.L), which
announced on 13 September 2005 that it had reached a conditional agreement
to
sell a portfolio of non-core assets, of which QSA is one of nine companies,
to
private equity company Coller Capital.
pSivida
Limited is currently in negotiations to acquire a US based drug delivery
company
with the potential to create a global drug delivery company specializing
in
nanotechnology, with revenues from existing products and generating long-term
value through its diversified late-stage product portfolio.
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverley
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 9 1100 ext. 12
bjedynak@janispr.com
|
UK
& Europe Public Relations
Mark
Swallow / Helena Podd
Citigate
Dewe Rogerson
Tel:
+44 (0)20 7638 9571
mark.swallow@citigatedr.co.uk
|
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, 33 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.
pSivida
is a founding member of the NASDAQ Health Care Index and the Merrill Lynch
Nanotechnology Index.
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