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 January 2007
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- ___.
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:
January 9, 2007
|
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 signs drug delivery licensing agreement with Faber
Research LLC
|
| ASX/Media RELEASE |
9
January
2007
|
pSivida
signs drug delivery licensing agreement with Faber Research
LLC
pSivida
also begins licensing negotiations with large global
pharma
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is pleased to announce that it has entered into a
licensing agreement with US-based Faber Research LLC (Faber) to develop
pSivida’s proprietary Durasert™, Zanisert™ and Co-Drug™ drug delivery
technologies for infectious diseases and diseases of the ear.
This
announcement follows an announcement on 26 December 2006, that pSivida
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
commencement of licensing negotiations follows a 12 month evaluation of
pSivida's technologies by the large global pharmaceutical
company.
Under
the
terms of the Faber licence, Faber receives exclusive rights to pSivida’s
technologies for diseases of the ear and for five specific infectious diseases,
namely malaria, HIV/AIDS,
influenza, tuberculosis, and osteomyelitis. All
costs
of development will be born by Faber and its operating company Auritec
Pharmaceuticals Inc (Auritec) and pSivida will receive royalties and milestones
payments.
In
addition, pSivida has granted Faber co-exclusive rights to the Durasert™,
Zanisert™ and Co-Drug™ drug delivery technologies for other infectious diseases.
Under this arrangement pSivida and Faber can elect to convert their co-exclusive
rights to exclusive rights for a specific infectious disease indication(s).
We
believe this maximises the potential to commercialize these technologies in
the
development of novel anti-infective drugs, a market which reached *US$44 billion
in 2005.
pSivida’s
Durasert™ controlled release technology is already validated in that it forms
the basis of the company’s ophthalmic drug delivery products, Retisert™, which
is FDA approved, and Medidur™, which is currently in Phase III clinical
trials.
Auritec
has developed novel approaches to extended release drug delivery with
implications for indications including; HIV microbicides, the treatment of
malaria and the prevention of pandemic influenza. Auritec also has an active
program for the delivery of drugs to the inner ear.
Dr
Roger
Brimblecombe, Chairman and CEO at pSivida said, “We believe this represents a
significant opportunity for our drug delivery technologies to be exploited
in
another therapeutic area - that of infectious diseases and it will be done
at no
direct cost to us”.
Dr
Thomas
J Smith MD, Chairman and Chief Executive Officer at Auritec said, “We look
forward to the opportunities for synergies between our companies in the
treatment of infectious diseases”.
Dr
William H. Slattery MD, Clinical Professor of Otolaryngology at the University
of Southern California, and Director of Otology Research at Auritec said, “The
ability to utilize pSivida’s drug delivery technologies will accelerate our
otology program significantly”.
Faber
Research LLC and Auritec Pharmaceuticals
Faber
is
the intellectual property holding company for Auritec, a private company based
in Pasadena, California specializing in innovative, extended release drug
delivery systems. Auritec was co-founded by Dr Thomas J Smith, MD who was
previously Chairman and co-founder of Control Delivery Systems, Inc., the
Boston, MA. based drug delivery company pSivida acquired in January
2006.
*CHA
Advances Reports, 2006
-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
|
For
Auritec
|
Auritec
Pharmaceuticals
Gary
Ransom
Vice-President
Corporate Development
Tel:
+ 1 (626) 376 4070
gransom@auriecpharma.com
www.auritecpharma.com
|
US
Public Relations
Sayuri
D. Hanna
Oak
Crest Institute of Science
Tel:
+1 (626) 817 0886
s.hanna@oak-crest.org
|
NOTES
TO EDITORS:
pSivida
is
a global bio-nanotech company committed to the biomedical sector and the
development of drug delivery products. pSivida has developed proprietary drug
delivery technology which it had previously referred to as its AEON technology.
pSivida now has identified two somewhat distinct avenues for such technology:
non-biodegradable implants for focused drug delivery (Durasert™) and
biodegradable implants for focused drug delivery (Zanisert™).
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 Faber’s development of pSivida’s
technologies for infectious diseases and disesase of the ear; 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 Faber to develop pSivida’s drug delivery technologies for infectious
diseases and diseases of the ear; failure of the election to convert
co-exclusive rights to exclusive rights to maximise the potential to
commercialize pSivida’s technologies in the development of novel anti-infective
drugs; inability of any products developed under the license to Faber to
penetrate the novel anti-infective drug market;
failure of novel anti-infective drug market to
continue to remain at US$44 billion; failure of Auritec’s novel approaches to
extended release drug delivery to have implications for indications including;
HIV microbicides, the treatment of malaria and the prevention of pandemic
influenza; failure of Auritec to continue its active program for the delivery
of
drugs to the inner ear; 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.