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 August 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: August 22, 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: Enrollment Begins on Human PK Study for MEDIDUR™
FA
|
|
|
| ASX/Media RELEASE |
22
August
2007
|
|
Lisa
Lake, Fleishman-Hillard
for
Alimera Sciences
+1
404-739-0152
lisa.lake@fleishman.com
|
Brian
Leedman
Vice
President, Investor Relations
pSivida
Limited
+61
8 9226 5099
brianl@psivida.com
|
ENROLLMENT
BEGINS ON HUMAN PK STUDY FOR MEDIDUR™ FA
ATLANTA,
August 22, 2007-- Alimera Sciences, a privately held ophthalmic pharmaceutical
company, and pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI) today
announced that
enrollment has begun for the first human *pharmacokinetic (PK) study of
fluocinolone acetonide (FA) in Medidur™, the companies’ investigational product
for the treatment of diabetic macular edema (DME).
Medidur
is a tiny insert, injected intra-vitreally during an in-office procedure, which
is being studied as a way to deliver a very low dose of fluocinolone acetonide
(FA), a corticosteroid, to the retina for up to three years as a treatment
for
DME. Medidur FA is currently in a Phase III global clinical trial, the FAME™
(Fluocinolone
Acetonide
in Diabetic Macular
Edema)
Study that will follow approximately 900 patients in the U.S., Canada, Europe
and India for three years with safety and efficacy assessed at two years.
Enrollment for this study has currently exceeded 750 patients.
This
PK
study is designed to support the FAME trial by providing
pharmacokinetic/pharmacodynamic correlation data from DME patients. Sixteen
patients are planned to be enrolled in this three-year, open label study.
Samples of blood and aqueous humor (the fluid in the front of the eye)
will be periodically taken to assess systemic and anterior chamber drug levels,
respectively.
“Enrolling
the same population in this study as in our FAME trial for DME will provide
another important opportunity to learn more about the effect of FA on various
aspects of this condition, as well as assess systemic drug levels,” said Ken
Green, PhD, Chief Scientific Officer for Alimera. “This study will also provide
information on the location of Medidur FA in the eye after insertion and drug
levels in the anterior chamber.”
Alimera
Sciences and pSivida Limited have a worldwide agreement to co-develop and market
the Medidur insert for the use of FA to treat DME. The agreement also includes
the option to identify other compounds for ophthalmic diseases, potentially
resulting in three additional products with the Medidur insert.
“The
open
label PK study that has begun is designed to provide additional pharmacokinetic,
safety and efficacy data next year,” said Dr Paul Ashton, PhD, Managing
Director of pSivida Limited. “Additionally, by determining anterior chamber drug
levels, we will gain important knowledge related to one of the key attributes
of
the Medidur technology, namely minimizing corticosteroid levels in the front
of
the eye.”
*The
study
of
absorption, distribution, metabolism and excretion of a drug.
--
more
--
About
Alimera Sciences Inc.
Alimera
Sciences Inc., a venture backed company, specializes in the development and
commercialization of prescription ophthalmology pharmaceuticals. Founded by
an
executive team with extensive development and revenue growth expertise, Alimera
Sciences’ products are focused on improving the delivery of therapeutic agents
to enhance patient’s lives and to strengthen physicians’ ability to manage
ocular conditions. Alimera
is currently conducting a 900-patient Phase III clinical trial of fluocinolone
acetonide in the Medidur™ drug delivery system for the treatment of diabetic
macular edema. For more information, please visit
www.alimerasciences.com.
About
pSivida Limited
pSivida
is a global drug delivery company committed to the biomedical sector. 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 has a worldwide collaborative research and license
agreement with Pfizer Inc. for other ophthalmic applications of the Durasert™
technology which underpins the Medidur product.
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 pancreatic cancer.
For more
information, please visit www.psivida.com.
This
document contains forward-looking statements that involve risks and
uncertainties including with respect to the efficacy of pSivida’s drug delivery
technology and the final results of the clinical trials described above.
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 those 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.
###