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 May 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
18, 2005
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
| ||
| Aaron Finlay Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1: |
Excellent
Results from First Stage of POC Study with Epitan |
-2-
| ASX/MEDIA RELEASE |
18th
May 2005 |
pSivida
and EpiTan Successfully Complete First Stage of Proof of Concept Study
Global
nanotechnology company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is
pleased to announce that excellent results have been received from the proof of
concept study being performed in collaboration with EpiTan
Limited (ASX: EPT, ADR: EPTNY, XETRA:UR9).
Recent
data obtained from 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.
In
February 2005 EpiTan announced that it had filed a patent application for
discoveries surrounding the increased efficacy (ie increase in melanin) of
MELANOTAN™ when given at significantly lower dose levels in a sustained
manner.
Previously
MELANOTAN™ has been delivered as a daily injection which required significantly
higher quantities of drug. The collaboration work by EpiTan and pSivida is
covered by this patent. The next stage of development will progress towards a
commercially viable version of this formulation.
The
proof-of-concept study tested four different formulations of the MELANOTAN™/
BioSilicon™ combination in a model system (in vivo). A sustained-release solid
injectable implant, as used in other recent studies by EpiTan, was used to
compare the two methods. The blood was then measured over a 14-day period to
test the levels of MELANOTAN™.
The
results showed sustained levels of MELANOTAN™ in the blood for all four
formulations. Importantly, the results also showed that in vitro experiments
closely mimic the in vivo responses.
Mr Gavin
Rezos, pSivida’s Managing Director said, “These results further validate the
potential value of BioSiliconTM in the
improved delivery of drugs. The BioSiliconTM drug
delivery system represents a truly unique and extremely versatile solution to
satisfy the growing ‘drug delivery needs’ of pharmaceutical, drug and device
companies globally.”
“The
outcome of this collaboration could lead to a second-generation injectable
MELANOTAN™ product,” said Iain Kirkwood, EpiTan’s Managing Director. “As this
product would be a liquid-based sustained-release product delivered after a
single dose, it would give consumers further choice as to how they could have
MELANOTAN™ administered. They could now conceivably have the choice of a solid
implant or a liquid injection.”
|
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
EpiTan
Limited
EpiTan
Limited is a Melbourne-based specialty pharmaceutical company with a strategy
focused on growing a business centred on dermatology products.
The
company’s leading drug candidate, for which EpiTan holds exclusive worldwide
rights, is MELANOTAN™ which is in clinical development. MELANOTAN™ is EpiTan’s
brand name for [Nle4,D-Phe7]-alpha-MSH,
a synthetic analogue of the naturally occurring hormone alpha-MSH, which
stimulates eumelanin production. EpiTan holds the rights to four other products
for Australia and New Zealand; Linotar®,
Exorex®,
Zindaclin® and
OraDiscTM A.
Linotar and Exorex are in market. Zindaclin and OraDisc A are scheduled to be
launched in late 2005 and 2006 respectively.
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.