Unassociated Document
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 March 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
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:
March 20,
2006 |
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pSivida
Limited |
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By: |
/s/ Aaron
Finlay |
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Aaron
Finlay
Chief
Financial Officer and Company
Secretary
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EXHIBIT
INDEX
EXHIBIT
99.1:
|
MedidurTM
Manufacture Certified to be GMP Equivalent to EU
Standards
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ASX/MEDIA RELEASE |
20
March
2006
|
MedidurTM
Manufacture Certified to be GMP
Equivalent to EU
Standards
Global
bio-nanotech company pSivida Limited (NASDAQ:PSDV,
ASX:PSD, Xetra:PSI)
today
announced that following an independent audit of its Boston, Massachusetts
facility by a European Qualified Person (QP), the QP issued a certificate that
MedidurTM
is
manufactured to a standard of GMP (Good Manufacturing Practice) equivalent
to
that in the European Union, as set out in directive 2003/94/EC and the EC Guide
to Good Manufacturing Practice.
Medidur™
is
a tiny, injectable device designed for the sustained release of the
drug
fluocinolone
acetonide and is being studied for the treatment of Diabetic Macular
Edema
(DME), the leading cause of blindness for Americans under the age of
65.
MedidurTM
is
in Phase III clinical trials in DME in
collaboration with Alimera Sciences Inc.,
a
specialty pharmaceutical company focused on the ophthalmic
industry. |
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Injectable
Medidur
|
-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. Retisert™ is FDA approved for the
treatment of uveitis. Vitrasert® is FDA approved for the treatment of
AIDS-related CMV Retinitis. The technologies underlying both of these products
are licensed to Bausch & Lomb.
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’s subsidiary, AION Diagnostics Limited is developing
diagnostic products and the subsidiary pSiNutria is developing food technology
products both using BioSilicon™.
pSivida’s
intellectual property portfolio consists of 70 patent families, 74 granted
patents and over 290 patent applications.
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
the operations and employees related to our December 2005 acquisition of Control
Delivery Systems (CDS); the failure of the CDS’ products to achieve expected
revenues and the combined entity’s inability to develop existing or proposed
products; the failure of the Bausch & Lomb/ Novartis co-promotion
arrangement to provide faster royalty growth; failure to continue to manufacture
MedidurTM
to the
European Union standard of GMP; inability to manufacture MedidurTM
to the
United States standard of GMP. 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.