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 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:
April 13, 2006
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
|
Chief
Financial Officer and Company
Secretary
|
||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
pSivida
issues PFIC Annual Information
Statement
|
–2–
13
APRIL 2006
pSivida
issues
PFIC
Annual Information Statement
pSivida
Limited believes that the IRS would consider it to have been a passive foreign
investment company, or PFIC, under U.S. tax laws in its fiscal year ended
June
30, 2005. As such, pSivida has released the following information statement
in
order to allow U.S. Holders to make an election to treat pSivida as a qualified
electing fund, or QEF if so desired.
U.S.
HOLDERS ARE ADVISED TO CONSULT THEIR TAX ADVISERS ABOUT THE PFIC RULES,
INCLUDING THE CONSEQUENCES TO THEM OF MAKING A QEF ELECTION OR A MARK-TO-MARKET
ELECTION WITH RESPECT TO PSIVIDA’S ORDINARY SHARES.
April
13,
2006
PFIC
ANNUAL INFORMATION STATEMENT
|
1.
|
PFIC
information applies to the year beginning July 1, 2004 and ending
June 30,
2005 (the “Subject Year”) of pSivida Limited (the
“Company”).
|
|
2.
|
No
cash or other property was distributed to shareholders during the
Subject
Year.
|
|
3.
|
During
the Subject Year, the Company had no net ordinary income and no
net
capital gain.
|
|
4.
|
The
Company will permit U.S. shareholders to inspect and copy the Company’s
permanent books of account, records and such other documents maintained
by
the Company that are necessary to establish that the Company’s ordinary
earnings and net capital gain are computed in accordance with U.S.
income
tax principles, and to verify these amounts and the shareholder’s pro rata
share thereof.
|
Signed:
/s/Aaron
Finlay
Aaron
Finlay, Chief Financial Officer and Company Secretary
-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. Bausch & Lomb own the trademarks; Vitrasert® and
Retisert™. pSivida has licensed the technologies underlying both of these
products to Bausch & Lomb. The technology underlying Medidur™, a treatment
for diabetic macular edema, is licensed to Alimera Sciences and is in Phase
III
clinical trials.
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structured 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 involve potential applications of
BioSilicon, potential indications for our other technologies, the number
of our
potential patents and other aspects of out busines. 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: the failure of the results of the Retisert
for DME trial to be a good indicator of
the
results of pSivida’s ongoing Phase III
Medidur™
for DME trial; failure of the
Medidur™
trials
in DME to show a very similar improvement in visual acuity and diabetic
retinopathy severity score as Retisert™
for
DME;
inability to recruit patients for the Phase
III
Medidur™
for DME trial; 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; the failure of the Bausch & Lomb/Novartis co-promotion
arrangement to provide faster royalty growth; failure of the slower progression
or reduction of diabetic retinopathy resulting from the Retisert™ implant to
have significant implications for Retisert™ and Medidur; failure of our
evaluation agreements to result in license agreements; failure of Medidur™ to
release the same drug as Retisert™ at the same rate; failure of the
Medidur™
trials
in DME to show a very similar stabilization or improvement diabetic retinopathy
as Retisert™
for DME.
and
the
failure of certain of our patent applications to result in granted
patents.
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.