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 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.
| pSivida Limited | ||
| |
|
|
| Date: September 18, 2006 | By: | /s/ Aaron Finlay |
|
Aaron Finlay |
||
| Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
pSivida
completes agreement with existing Convertible Note
Holder
|
-2-
| ASX/MEDIA RELEASE |
15
September
2006
|
pSivida
completes agreement with existing
Convertible Note Holder
Convertible Note Holder
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is pleased to announce that the definitive documentation
related to the previously announced renegotiated terms of the Convertible
Note
dated 16 November 2005 between the Company and Castlerigg Master Investments
Ltd. has been completed.
The
renegotiated terms provided for the lifting of restrictions on future sales
of
securities enabling the Company to enter into additional capital raising
transactions, which the Company will be seeking to do.
The
renegotiated terms also provided for an extension to October 15, 2006 of
the
registration deadline under the Company’s registration rights agreement with the
note holder. The delays in the registration statement being declared effective
have been a direct result of complex accounting issues associated with the
Company’s recent acquisition and the convertible note, the change-over in
Australia from Australian GAAP to Australian IFRS and the reconciliation
of the
Company’s financial statements prepared under that new accounting scheme to U.S.
GAAP.
The
Company will hold an Extraordinary General Meeting in Perth on 19 September
2006
to consider resolutions relating to the ratification of the renegotiation
of
Convertible Notes and the approval of other pending financing
transactions.
THIS
RELEASE SHALL NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER
TO
BUY ANY SECURITIES DESCRIBED HEREIN.
THE
SECURITIES DESCRIBED HEREIN HAVE NOT BEEN REGISTERED UNDER THE U.S. SECURITIES
ACT OF 1933, AS AMENDED, AND MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES
ABSENT REGISTRATION OR AN APPLICABLE EXEMPTION FROM REGISTRATION
REQUIREMENTS.
-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
|
European
Public Relations
Accent
Marketing Limited
Eva
Reuter
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
|
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 the United
States, Malvern in the United Kingdom, Perth in Australia and Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and 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 2001 from
the
UK Government's Defence Evaluation & Research Agency (DERA). QinetiQ (QQ.)
was instrumental in discovering BioSiliconTM
and
pSivida’s strong relationship with QinetiQ includes access to its cutting edge
research and development facilities.
This
document contains forward-looking statements that involve risks and
uncertainties. The statements reference potential products, applications
and
regulatory approvals. 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 inability to raise additional funds at favourable terms or
any
terms; our inability to repay the amended notes; issues relating to share
registration in the U.S. that may delay our registration; our inability to
develop proposed products, including without limitation, in the drug delivery,
wound healing, orthopaedics, and tissue engineering, diagnostics and food
technology fields; failure of our evaluation agreements to result in license
agreements; failure to develop applications for BioSilicon™ due to regulatory,
scientific or other issues; failure to complete negotiations for new centers
for
the BrachySil™ phase IIb clinical trial for inoperable primary liver
cancer; failure of our discussions with the FDA for BrachySil™ to continue or to
lead to FDA approval; failure of the BrachySil™ phase IIb clinical trial
for inoperable primary liver cancer to determine the optimal dose, provide
key
safety data or support future pivotal efficacy trials or product registration
or
approval; failure of the BrachySil™ primary liver programme that is in
phase IIb clinical trials to provide a valuable platform for the
development and commercialisation of BrachySil™ for pancreatic cancer and other
indications; failure to commence phase IIa BrachySilTM trials for the
treatment of pancreatic cancer; failure of the findings of the pancreatic
cancer phase IIa trial to provide a platform for further multicentre
efficacy and safety trials; failure of there to be optimisation and
standardisation between our two pancreatic cancer study centres;
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; failure of
Medidur™ to release fluocinolone acetonide at the same rate as Retisert™; our
inability to recruit patients for the phase III Medidur™ for DME trial.
Other reasons are contained in cautionary statements in the Annual Report
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.