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 December 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
Australia
(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- ___.
The
document attached as Exhibit 99.1 to this Report on Form 6-K is hereby
incorporated by reference herein and into the following registration statements:
(i) the Registrant's Registration Statement on Form F-3, Registration
No. 333-132776; (ii) the Registrant's Registration Statement on
Form F-3, Registration No. 333-132777; and (iii) the Registrant's
Registration Statement on Form F-3, Registration
No. 333-135428.
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:
December
20, 2006
|
PSIVIDA
LIMITED
|
||
| |
|
|
| By: | /s/Michael J. Soja | |
|
Michael J. Soja |
||
| Vice President, Finance and Chief Financial Officer | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Press
Release: pSivida completes US$2.9m placement; Dr. Roger Aston reappointed
to the pSivida Board
|
pSivida
completes US$2.9m placement
Dr
Roger Aston reappointed to the pSivida Board
Boston,
MA. and Perth, Australia (December 20, 2006) - Global bio-nanotech company
pSivida Limited (NASDAQ:PSDV, ASX:PSD,Xetra:PSI) today announced the placement
of 14,230,768 million fully paid ordinary shares to Australian and European
investors issued at AU$0.26 (US$2.00 ADR equivalent) each to raise US$2.9m
before costs.
Each
share was purchased with two free attaching options at an exercise price of
AU$0.26 and a term of four years. This raising is an interim financing measure
prior to the expected closing of the definitive documents with Nordic Biotech
Advisors for a US$4.0m corporate investment in pSivida and a US$22.0m investment
over time in a “Special Purpose Vehicle” (SPV). The SPV is expected to fully
fund pSivida’s portion of costs to develop its lead ophthalmic development
product, MedidurTM
for the
delivery of a steroid (fluocinolone acetonide) for the treatment of the chronic
eye disease diabetic macular edema (DME). The Company is committed to reducing
its cash burn with cost cutting measures to begin at the end of this
month.
pSivida
is also announced the reappointment of Dr. Roger Aston to the pSivida Board
of
Directors. Dr. Aston is a founding director of the Company and returns to the
Board following his departure in November 2005. Dr. Aston has more than twenty
years’ experience in the pharmaceutical and biotechnology industries and is a
welcome addition to the Board. Dr. Aston is also a director of Clinuvel Limited
and Halcygen Limited.
“This
capital raising places the Company in a stronger financial position with
opportunities to accelerate R&D commercial activities, particularly in the
area of controlled slow release drug delivery technologies,” said Dr. Roger
Brimblecombe, Executive Chairman and CEO of pSivida Limited. “I am particularly
pleased by the reappointment of Dr. Aston to the pSivida Board as we move toward
significant commercial opportunities in the near term.”
As
required by NASDAQ regulatory rules, pSivida also announced that its independent
registered public accounting firm's report on its financial statements for
the
fiscal year ended June 30, 2006 includes an explanatory paragraph regarding
the
Company's ability to continue as a going concern. The independent auditor’s
opinion noted that the Company has suffered recurring losses from operations,
has had significant recurring negative cash flows from operations and has
determined that there may be a risk of default associated with a loan covenant
that requires the company to maintain a minimum net cash balance and those
raise
substantial doubt about its ability to continue as a going concern.
Since
the
independent registered public accounting firm's report appeared in the 2006
Annual Report, the Company is taking steps to reduce the cash burn and
successfully raised additional capital as detailed above as well as entered
into
a significant capital raising initiative with Nordic Biotech
Advisors.
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Director
of Investor Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
(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™ for diabetic
macular edema is licensed to Alimera Sciences and is in Phase III clinical
trials.
pSivida
owns the rights to develop and commercialize a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopedics, 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 76 patent families, 95 granted
patents, including patents accepted for issuance, and over 300 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.
This
document contains forward-looking statements that involve risks and
uncertainties including with respect to the potential signing of definitive
agreements with Nordic on the terms described; the amount of pSivida’s portion
of the costs to develop Medidur™ for DME; the potential size of certain markets;
and 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:
Failure
of
the company to successfully close the transaction with Nordic contemplated
by
the MOUs with Nordic; the failure of the Company to obtain the requisite
shareholder approvals to complete the Nordic transactions; failure of pSivida’s
share of Medidur™ development costs to be no more than US$22m; 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; our inability to raise
additional funds at favourable terms or any terms; our inability to repay the
amended notes and new convertible notes; 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 produce favorable results and/or 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 program
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 of the findings of the pancreatic cancer
Phase IIa trial to provide a platform for further multicenter efficacy and
safety trials; and failure of there to be optimisation and standardisation
between our two pancreatic cancer study centres. 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.