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 January 2006
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:
January 4,
2006 |
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pSivida Limited |
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By: |
/s/
Aaron Finlay |
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Aaron
Finlay |
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Chief
Financial Officer and Company
Secretary |
EXHIBIT
INDEX
EXHIBIT
99.1:
|
Several
new pharma drug delivery evaluation agreements for US
subsidiary
|
ASX/MEDIA RELEASE |
5
January
2006
|
Several
new pharma drug delivery
evaluation
agreements for US subsidiary
Global
bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that its wholly owned subsidiary pSivida Inc. (formerly
Control Delivery Systems, Inc.) has recently entered into a number of new
evaluation agreements with various companies including large global
pharmaceutical companies, to evaluate pSivida’s proprietary platform technology
for their developmental compounds.
The
terms
of the new evaluation agreements vary,
but
are typically 12 months in duration with the costs being borne by the
counterparty. With these new agreements, pSivida Limited now has evaluation
agreements with three of the five largest pharmaceutical companies in the
world.
In
December 2005, pSivida completed the acquisition of Control
Delivery Systems, a private US drug delivery company located in the Boston,
Massachusetts area. Control Delivery Systems in
collaboration with Alimera Sciences initiated a Phase III clinical trial in
October 2005 to
study
diabetic macular edema (DME) patients treated using its Medidur™ platform
technology to deliver fluocinolone acetonide. DME
is
the leading cause of vision loss for Americans under the age of 65 with
approximately 500,000 treatable cases in the US alone. Medidur™
for DME is
an
injectable, non-erodible intravitreal device that is administered
in an
office procedure as opposed to a surgical procedure. This implant is designed
to
release a constant amount of drug to the back of the eye for a duration of
between 18 months and 3 years.
Medidur™
is the next generation product to RetisertTM
which is
administered in a surgical procedure and licensed to Bausch & Lomb for the
treatment of chronic, non-infectious uveitis, a sight threatening inflammatory
eye disease affecting approximately 175,000 people in the US.
RetisertTM is
the
only FDA approved back of the eye treatment for uveitis. Bausch & Lomb told
investors and analysts in December 2005 that they believe the future for
RetisertTM
is
bright.
“We
believe these new evaluation agreements come at a time when the ophthalmology
market is growing strongly and are a reflection of growing interest in pSivida's
technologies,” said Mr Gavin Rezos, MD and CEO of pSivida Limited. “We expect to
enter into further agreements for pSivida’s drug delivery products in
2006.”
-ENDS-
pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 943 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
is a global bio-nanotech company committed to the biomedical sector and the
development of drug delivery products in particular in oncology and
ophthalmology.
pSivida
owns or has the exclusive rights to use the intellectual property pertaining
to
BrachySil™, Medidur™, Retisert™ and Vitrasert®.
The
company’s IP portfolio consists of 70 patent families, 74 granted patents and
over 290 patent applications.
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structrured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopaedics, and tissue
engineering. pSivida has granted an exclusive licence to its subsidiary, AION
Diagnostics Limited to develop and commercialise diagnostic products using
BioSilicon™, and has also granted an exclusive licence to its subsidriary,
pSiNutria Limited to develop and commercialise food technology applications
using BioSilicon™.
pSivida
conducts its operations from offices and facilities near Boston in
Massachusetts, Malvern in the United Kingdom, Perth in Western Australia and
Singapore.
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 is a founding member of the NASDAQ Health Care Index and the Merrill
Lynch Nanotechnology Index.
The
Company's largest shareholder and a strategic partner is QinetiQ, a leading
international defence, security and technology company, formed in July 2001
from
the UK Government's Defence Evaluation & Research Agency
(DERA). QinetiQ was instrumental in discovering BioSilicon(TM)
and
pSivida enjoys a strong relationship with it having access to its cutting edge
research and development facilities. For more information visit www.QinetiQ.com
For
more
information, visit www.psivida.com
This
document contains forward-looking statements that involve risks and
uncertainties. The statements are indicated by the use of words such as
"believes", "expects", "anticipates" and similar words and phrases.
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, our inability to successfully integrate
CDS’ operations and employees; the failure of the CDS’ products to achieve
expected revenues and the combined entity’s inability to develop existing or
proposed products. 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.