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 April 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
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; (iii) the Registrant's
Registration Statement on Form F-3, Registration No. 333-135428; (iv)
the Registrant's Registration Statement on Form F-3, Registration
No. 333-141083; and (v) the Registrant's Registration Statement on
Form F-3, Registration No. 333-141091.
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:
April
4, 2007
| PSIVIDA LIMITED | ||
| |
|
|
| By: | /s/ Michael J. Soja | |
|
Michael
J. Soja
Vice
President, Finance and Chief Financial Officer
|
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EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
ASX
Release: pSivida signs A$203 million (US$165 million) Collaborative
Research and License Agreement with
Pfizer
|
 |
|
| ASX/Media RELEASE |
4
April
2007
|
pSivida
signs A$203 million (US$165 million) Collaborative Research and Licensing
Agreement with Pfizer
Boston,
MA. and Perth, Australia - pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI),
today announced it has signed an exclusive worldwide Collaborative Research
and
License Agreement with Pfizer Inc. (PFE: NYSE) for pSivida’s controlled drug
delivery technologies, including the MedidurTM
technology, in ophthalmic applications.
Under
the
terms of the agreement, pSivida will receive up to A$191m (US$155m) in
development and sales related milestones. The
two
companies will work together on a joint research program aimed at developing
ophthalmic products using pSivida’s sustained drug delivery technology. In
addition to milestone payments, Pfizer will fund the cost of the joint research
program. Pfizer will have an exclusive license to market all products developed
as part of this research collaboration in ophthalmic applications and will
pay
pSivida a royalty on net sales of those products. Pfizer may terminate the
agreement on 60 days notice without cause.
In
addition to the development and sales milestones and payment of the cost of
the
joint research program, Pfizer has agreed to invest A$6.1m (US$5m) in ordinary
shares of pSivida upon entering into the License Agreement, the proceeds of
which will be held in escrow until such proceeds can be used (together with
other cash available to pSivida) to redeem an outstanding convertible note.
If
pSivida does not repay the full amount outstanding under the convertible note
prior to June 4, 2007, Pfizer may elect during the 90 day period following
June
9, 2007 to cause pSivida to return the A$6.1m (US$5m) held in escrow, in which
case the license agreement would terminate. Pfizer has also agreed to
invest
an
additional A$6.1m (US$5m)
in
pSivida common equity in the future, subject to certain conditions.
“We
believe this collaboration is another significant validation of the drug
delivery systems that pSivida has been developing since its founding,” said Dr.
Paul Ashton, Managing Director, pSivida Limited. “pSivida
plans to pursue development and additional collaborations exploiting our
innovative drug delivery technologies in other parts of the body.”
|
Medidur™
is
a tiny, injectable device designed for the sustained release of drugs
and
is currently being studied for the treatment of Diabetic Macular
Edema
(DME), the leading cause of blindness for Americans under the age
of 65.
MedidurTM
in
combination with Fluocinolone Acetonide is in Phase III clinical
trials in
DME in
collaboration with Alimera Sciences Inc.,
a
specialty pharmaceutical company focused on the ophthalmic
industry.
|
 Injectable
Medidur
|
-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:
+1 (312) 943 1100 ext. 12
bjedynak@janispr.com
|
European
Public Relations
Eva
Reuter
Accent
Marketing Limited
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. The most advanced BioSilicon™ product, BrachySil™ delivers a
therapeutic, P32 directly to solid tumors and is presently in Phase II clinical
trials for the treatment of liver and pancreatic cancers.
pSivida’s
intellectual property portfolio consists of 71 patent families, 99 granted
patents, including patents accepted for issuance, and over 300 patent
applications.
pSivida
conducts its operations from facilities near Boston in the United States,
Malvern in the United Kingdom and Perth in Australia.
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
release contains forward-looking statements that involve risks and
uncertainties,
including the risk that we may not meet any of the milestones in the Pfizer
agreement or may not successfully develop or commercialize the products under
development; the risk that Pfizer terminates the license agreement; the risk
that we will not be able to exploit our drug delivery technologies outside
of
the eye; the risk that our
evaluation agreements for our products may not produce favorable results and/or
result in license agreements; and
the
risk that we will be unable to repay all amounts outstanding under our
convertible notes or other liabilities.
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
that 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.