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 November 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:
November 13, 2006
|
PSIVIDA
LIMITED
|
||
| |
|
|
| By: | /s/ Michael Soja | |
|
Michael Soja |
||
|
Vice
President, Finance and
Chief
Financial
Officer
|
||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
pSivida
and Nordic Biotech sign MOU for A$33.7M (US$26M) for development
funding
and equity investment
|
 |
|
|
13
November
2006
|
pSivida
and Nordic Biotech sign MOU for A$33.7M (US$26M) for development funding and
equity investment
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is
pleased to announce that it has signed a non-binding Memorandum of Understanding
(MOU) with Nordic Biotech Advisors.
The MOU
provides for Nordic Biotech II K/S or affiliates and co-investors (Nordic)
to
make an AU$5.2m (US$4.0m) corporate investment in pSivida and an A$28.5m
(US$22.0m) investment over time in a “Special Purpose Vehicle” (SPV) to fund the
expected amount of pSivida’s portion of costs to develop its lead ophthalmic
development product, MedidurTM
for the
treatment of the chronic eye disease diabetic macular edema (DME). At closing,
the Company will receive a total of A$6.5m (US$5.0m) consisting of the A$5.2m
(US$4.0m) equity investment and a payment by the SPV to pSivida of A$1.3m
(US$1.0m). The transaction is subject to completion of due diligence and final
documentation.
Upon
closing, Nordic will invest A$5.2m (US$4.0m) in pSivida Limited by purchasing
newly issued shares of preferred stock. The preferred stock will be convertible
into American Depository Shares (ADSs) at a conversion price of US$2.00 per
share and will contain anti-dilution protection. pSivida will issue warrants
to
Nordic with a face amount equal to $A2.6m (US$2.0m), an exercise price of
$US2.00 per ADS and anti-dilution protection. An additional A$4.5m (US$3.5m)
will be invested in the SPV at closing, of which A$1.3m (US$1.0m) will be paid
to pSivida by the SPV. The remaining A$24.0m (US$18.5m) of SPV investment by
Nordic will be made in regular instalments to fund the expected amount of
pSivida’s share of development costs.
pSivida
and Alimera Sciences are currently co-funding the development and will co-share
in the profits of MedidurTM
for DME,
which is currently in Phase III multi-national clinical trials. After this
transaction closes, the SPV will receive pSivida’s profit share payments under
the Alimera co-development agreement and will distribute the payments to Nordic
and pSivida. Revenues distributed by the SPV would initially be paid 75% to
Nordic and 25% to pSivida, subject to certain adjustments. After cumulative
revenues paid to Nordic equal four times their investment in the SPV, the split
of revenues will become 50% to both Nordic and pSivida. After cumulative
revenues paid to Nordic equal eight times their investment in the SPV, 80%
of
the SPV revenues will be paid to pSivida and 20% to Nordic.
After
closing, at an Extraordinary General Meeting at a date to be confirmed, pSivida
will seek shareholder approval to give Nordic a full exchange right on the
A$28.5m (US$22.0m) SPV interest into pSivida ADSs at US$2.00 per share. If
approved, Nordic will have the option to either share SPV revenues or convert
all or part of their SPV investment into ADSs, in which case forfeiting that
portion of their share of the SPV revenues.
If
shareholders do not approve the full exchange right, Nordic may elect to stop
funding, in which case Nordic’s interest in the SPV revenues will be reduced.
pSivida’s
lead FDA approved ophthalmic product is Retisert™
for the
treatment of uveitis, a leading cause of blindness in the United States.
MedidurTM
essentially differs from RetisertTM
in that
it is injected behind the eye in a simple office procedure, whereas
RetisertTM
is
surgically inserted in a hospital procedure. MedidurTM
and
Retisert can deliver the same steroid (fluocinolone acetonide or FA), at a
similar rate to the back of the eye. Sustained delivery of FA to the back of
the
eye has previously been shown to reduce edema in patients with DME, reduce
the
progression of their diabetic retinopathy, and most importantly, at three years
provides a clinically significant increase in many patients vision. These
results were generated in a 198 patient clinical trial conducted in the United
States by Bausch & Lomb, licensee of Retisert™.
MedidurTM
is being
evaluated by several companies, including global pharmas and smaller biotech
companies, for the delivery of their proprietary compounds to treat other eye
diseases. The Company expects that one of these evaluations will lead to a
license for pSivida’s drug delivery products.
“We
believe this MOU demonstrates strong commercial interest in MedidurTM
for DME,
our lead ophthalmic product in development, and this transaction, once closed,
will eliminate most of the financial risk for the Company associated with this
project,” said Dr Roger Brimblecombe, Chairman and CEO of pSivida Ltd. “The
closing of this transaction
will allow MedidurTM
for DME
Phase III studies to continue while freeing up funds to permit us to progress
our other clinical development studies and exploit our various drug delivery
technologies. Additionally, we believe this transaction further validates the
synergies between pSivida and Alimera Sciences and highlights the respective
strengths of each organization. pSivida’s research expertise in drug delivery
and Alimera’s global drug development capabilities will, we believe, result in
an innovative treatment for patients suffering from DME.”
This
release does 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 absent registration or an applicable exemption from registration
requirements.
-ENDS-
NOTES:
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 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.
Nordic
Biotech
Nordic
Biotech Advisors ApS is the investment advisor to Nordic Biotech K/S and Nordic
Biotech Venture Fund II K/S, and was founded in 2001. The company is associated
with a large number of advisors and consultants from the pharmaceutical
industry, clinical, academic and financial sectors, and draws on the experience
and network of San Francisco-based Biotechnology Value
Fund. www.nordicbiotech.com
This
document contains forward-looking statements that involve risks and
uncertainties including with respect to the closing of the transaction on the
terms described in the MOU; pSivida’s portion of the costs to develop Medidur™
for DME; 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 contemplated by the MOU with the Nordic Biotech; the
failure of the Company to obtain the requisite shareholder approval to give
the
Nordic Biotech a full exchange right; failure of pSivida’s share of Medidur
development costs to be no more than US$22m; failure of this MOU to demonstrate
strong commercial interest in Medidur for DME; failure of the Nordic Biotech
transaction, when closed, to eliminate most of the risk for the Company;
inability to progress other clinical development studies and to exploit
pSivida’s other drug delivery technologies; failure of there to continue to be
synergies between pSivida and Alimera Sciences; failure of Medidur for DME
to be
an innovative treatment for DME; 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
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; 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.