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 July 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; (v) the Registrant's Registration Statement on
Form F-3, Registration No. 333-141091; and (vi) the Registrant's
Registration Statement on Form F-3, Registration
No. 333-143225.
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:
July
18, 2007
PSIVIDA
LIMITED
By:
/s/ Michael
J. Soja
Michael
J. Soja
Vice
President, Finance and Chief Financial Officer
EXHIBIT
INDEX
|
Press
Release: pSivida Strengthens its Position in Drug Delivery
Sector
|
pSivida
Strengthens its Position in Drug Delivery Sector
Boston,
MA and Perth, Australia (July 18, 2007) -- pSivida Limited (NASDAQ:PSDV;
ASX:PSD, Xetra:PSI), today announced key achievements of the company during
the
past seven months as it has strengthened its balance sheet and refocused its
efforts in the drug delivery area to better reflect its strategy for future
growth. Since the beginning of 2007 pSivida has:
|
·
|
Raised
more than $40 million, net of cost.
|
|
·
|
Eliminated
$19 million in long term debt. The company now has approximately
US $20
million of cash and no debt.
|
|
·
|
Signed
a licensing agreement with Pfizer for up to $165 million in development
and sales related milestones, including an equity investment of $11.5
million, which has resulted in Pfizer becoming the company’s largest
shareholder holding approximately 10.2 percent of pSivida’s outstanding
shares.
|
|
·
|
Completed
a major cost cutting effort which included a reduction in head count
by
over 30 percent, the sale of non-strategic assets and the discontinuation
of certain early stage research.
|
|
·
|
Transitioned
from a nano-bio materials science company to a drug delivery company
with
two FDA-approved products, a late stage pipeline and several partnerships.
|
During
the second half of this year the company anticipates the following
milestones:
|
·
|
Completion
of enrollment for its Phase III clinical trial for Medidur™ for Diabetic
Macular Edema.
|
|
·
|
Release
of results from pancreatic cancer Phase IIa BrachySil
trials
|
|
·
|
Further
evaluation agreements for the company’s multiple drug delivery
technologies.
|
Released
by:
|
pSivida
Limited
Brian
Leedman
Vice
President, Investor Relations
pSivida
Limited
Tel:
+ 61 8 9327 8905
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
(312) 943 1103
bjedynak@janispr.com
|
European
Public Relations
Eva
Reuter
Accent
Marketing Limited
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
|
pSivida
is a global drug delivery company with two FDA-approved products. Retisert® is
approved for the treatment of uveitis and Vitrasert® is approved for the
treatment of AIDS-related CMV Retinitis. Both are licensed to Bausch & Lomb,
who owns the trademarks on Retisert® and Vitrasert®. The company’s technology
underlying Medidur™ for diabetic macular edema is licensed to Alimera Sciences
who is co-sponsoring the Phase III clinical trials with pSivida. Other
ophthalmic applications of pSivida technology have been licensed to
Pfizer.
pSivida
also owns the rights to develop and commercialize a modified form of silicon
(porosofied or nano-structured silicon) called BioSilicon™, which has
applications in drug delivery as well as 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 IIa clinical
trials for the treatment of pancreatic cancers.
pSivida’s
intellectual property portfolio consists of 71 patent families, 99 granted
patents, including patents accepted for issuance and more than 300 patent
applications. pSivida conducts its operations from facilities near Boston,
Massachusetts; Malvern in the United Kingdom and Perth, Australia.
pSivida
is an Australian company whose ordinary shares trade on the Australian Stock
Exchange. The company’s ADRs trade on NASDAQ. Each ADR “share” is equal to 10
Australian ordinary shares. The Company 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. 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 may not meet
any
of the milestones in the Pfizer agreement or may not successfully develop or
commercialize the products under development or our proposed
products;
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 or partnerships and the risk of our failure to
otherwise establish partnerships; 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 or
the phase II BrachySil trials; failure to develop applications for
BioSiliconTM
due to
regulatory, scientific or other issues; failure of the pSivida Inc’s products to
achieve expected revenues;failure to achieve cost savings generally;
our
inability to penetrate the Uveitis or other markets, our inability to continue
to develop products currently in our pipeline or to continue to feed our
product pipeline;
our
failure to achieve our stated 2007 milestones or to execute on our stated U.S.
growth strategy. 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.
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