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 May 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:
May 16, 2007
PSIVIDA
LIMITED
By: /s/Michael
J.
Soja
Michael
J. Soja
Vice
President, Finance and Chief Financial Officer
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
ASX
Release: pSivida Redeems Convertible Note
Debt
|
|
ASX/Media
RELEASE
|
16
May
2007
|
pSivida
Redeems Convertible Note Debt
Boston,
MA. and Perth, Australia -
pSivida
Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI), is pleased
to announce that it is redeeming in full the convertible note held by Sandell
Asset Management
Corp. (Sandell) in a single payment of A$16.5m (US$13.7m) today and in
accordance
with the early redemption terms as announced to the ASX on the 4th
of
April,
2007.
This
Note
is being repaid in accordance with the recently announced Pfizer agreement
that
the Note be repaid prior to June 4, 2007.
A
30 day
irrevocable notice of redemption has been issued to the holder of the Company's
only other
remaining convertible note. With a payment of A$1.1m (US$880k), as adjusted
for
any conversions
occurring over the next 30 days, the Company will have retired all of its
debt.
In
recent
weeks, the Company has met a number of key milestones, including:
| · |
Redeeming
in full the Sandell convertible
note.
|
| · |
Exclusive
worldwide licensing agreement with Pfizer Inc. for ophthalmic applications
of our
leading drug delivery system with development and sales related milestone
payments
of up to A$187m (US$155m) and equity investments of up to A$12.0
(US$10m).
|
| · |
Sale
of subsidiary, AION Diagnostics for A$3.6m
(US$3.0m).
|
| · |
Enrolment
of over 500 patients in the approximately 900 patient Phase III clinical
study of
MedidurTM for
the treatment of diabetic macular edema
(DME).
|
Key
milestones to be met in the remainder of the 2007 calendar year:
| · |
Completion
of recruitment of the MedidurTM for
DME Phase III clinical study.
|
| · |
Results
of our Phase II clinical study for BrachySilTM in
the treatment of inoperable pancreatic
cancer.
|
“The
repayment of all of our convertible notes will greatly simplify our balance
sheet and is another
important milestone for pSivida,” said Dr. Paul Ashton, Managing Director,
pSivida Limited.
This
press release does not constitute an offer to sell or a solicitation of an
offer
to buy any
securities
-ENDS-
|
Released
by:
|
||
|
pSivida
Limited
|
US Public Relations | European Public Relations |
|
Brian
Leedman
|
Beverly Jedynak | Eva Reuter |
|
Vice
President, Investor Relations
|
President | Accent Marketing Limited |
|
pSivida
Limited
|
Martin E. Janis & Company, Inc | Tel: +49 (254) 393 0740 |
|
Tel:
+ 61 8 9226 5099
|
Tel: +1 (312) 943 1100 ext. 12 | e.reuter@e-reuter-ir.com |
|
brianl@psivida.com
|
bjedynak@janispr.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 owns the trademarks
Vitrasert® and Retisert®. pSivida has licensed the
technologies underlying both of these products to Bausch & Lomb. The
technology underlying MedidurTM for diabetic macular edema is
licensed to Alimera Sciences and is in Phase III clinical trials. pSivida has
a
worldwide collaborative research and license agreement with Pfizer Inc. for
other ophthalmic applications of the
MedidurTM technology.
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 BioSiliconTM product,
BrachySilTM delivers a therapeutic, P32 directly to solid tumors
and is presently in Phase II clinical trials for the treatment of pancreatic
cancer.
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 (PSI).
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 with respect to our ability to raise sufficient funds, our ability
to
repay all of our outstanding convertible notes, our ability to capitalize on
our
technology and intellectual property base or grow our business, our potential
products, including clinical development and trials of these potential products
and our partnerships. 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 risk that we will not be able to raise additional funds at
favorable terms or at all; the risk that we will be unable to repay all of
our
convertible notes; 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 be unable to complete recruitment for the Medidur for DME
Phase III clinical study; the risk that our Phase II clinical study for
BrachySil in the treatment of inoperable pancreatic cancer will not yield
positive results;. 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.