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 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
(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 26, 2006
|
pSivida
Limited
|
||
| |
|
|
| By: | /s/ Michael J. Soja | |
|
Michael J. Soja |
||
| Vice President of Finance and Chief Financial Officer | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Press
Release: pSivida enters licensing negotiations with major global
pharma
for drug delivery technologies
|
| Media RELEASE |
26
December
2006
|
pSivida
enters licensing negotiations with major global pharma for drug delivery
technologies
pSivida
to receive US$990k for three months exclusive negotiation rights and additional
preclinical study
Boston, MA. and Perth, Australia - Global drug delivery company pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) is pleased to announce that it is has entered into an exclusive negotiation period with a major global pharmaceutical company, to acquire a worldwide, royalty bearing license to make, use and sell products using pSivida’s drug delivery technologies.
|
·
|
The
pharmaceutical company will make payments totalling US$990k (AU$1.3m)
to
pSivida for the right to exclusively negotiate a licensing agreement
with
the Company for a period of three months and to fund the cost of
a
preclinical study.
|
|
·
|
The
preclinical study will focus on an evaluation of pSivida’s drug delivery
technologies in
a very significant product opportunity.
|
|
·
|
This
announcement follows several 12 month evaluation agreements of pSivida’s
drug delivery technologies with large companies including this major
global pharmaceutical company.
|
|
·
|
pSivida
recently completed a placement
to
raise US$2.9m (AU$3.7m) before costs to Australian and European
investors.
|
|
·
|
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
(AU$5.1m) corporate investment in pSivida and a US$22.0m (AU$28.2m)
investment over time in a “Special Purpose Vehicle” (SPV) that is expected
to fully fund pSivida’s portion of costs to develop MedidurTM
for the treatment of the chronic eye disease diabetic macular edema
(DME).
|
Dr.
Roger
Brimblecombe, CEO and Chairman of pSivida Limited said, “We are delighted to be
working with this major global pharma and to build our relationship on the
positive findings from their initial pre-clinical evaluation of our drug
delivery technologies.”
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Director
of Investor Relations
pSivida
Limited
Tel:
+ 61 412 281 780
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™ 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
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 major global pharma’s acquiring a
license to pSivida’s drug delivery technology; 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:
the
failure of the company to successfully negotiate and sign a license agreement
with the major global pharma on advantageous terms or at all; failure of the
ongoing evaluation with the major global pharma to produce favorable results;
failure of the focus of the preclinical study to be in a very significant
product opportunity; 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.