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 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
23, 2007
| PSIVIDA LIMITED | ||
| |
|
|
| By: | /s/Michael J. Soja | |
|
Michael J. Soja |
||
| Vice President, Finance and Chief Financial Officer | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Joint
Press Release: Alimera Sciences’ Medidur™ Trial Exceeds 500 Patient Mark
in Phase 3 Trial
Enrollment
|
 |
 |
FOR
IMMEDIATE RELEASE
Contact:
|
Lisa
Lake, Fleishman-Hillard
for
Alimera Sciences 404-739-0152
lisa.gibson@fleishman.com
|
Beverly
Jedynak
Martin
E. Janis & Company, Inc.
312-943-1100
ext. 12
bjedynak@janispr.com
Brian
Leedman, Director of Investor Relations
pSivida
Limited +61 412 281 780
brianl@psivida.com
|
ALIMERA
SCIENCES’ MEDIDUR™ TRIAL EXCEEDS 500 PATIENT MARK IN PHASE 3 TRIAL
ENROLLMENT
ATLANTA—April
23, 2007--Alimera Sciences, a privately held ophthalmic pharmaceutical company,
and global drug delivery company pSivida Limited (NASDAQ:PSDV, ASX:PSD,
Xetra:PSI) today
announced that enrollment for their Phase 3 global clinical trial, the FAME™
(Fluocinolone Acetonide in Diabetic Macular Edema) Study has exceeded 50
percent. FAME is a double masked, randomized, multi-center study that will
follow approximately 900 patients in the U.S., Canada, Europe and India for
36
months. The trial is studying the safety and efficacy of the novel treatment
currently referred to as Medidur for diabetic macular edema (DME).
Medidur,
a tiny, injectable intravitreal insert, is being studied as a way to deliver
a
very low dose of fluocinolone acetonide, a corticosteroid, to the retina for
up
to three years as a treatment for diabetic macular edema (DME). Using a
proprietary 25 gauge transconjunctival injector system, an eye care professional
injects the Medidur insert into the vitreous through a minimally invasive
procedure in an outpatient setting.
“Reaching
this milestone in the FAME trial is a significant accomplishment for Alimera
as
we continue our efforts to bring this next generation of retinal drug delivery
to market,” said Dan Myers, CEO of Alimera Sciences.
“pSivida
is delighted with the progress being made in this trial and we expect successful
completion of enrollment later this year,” said Dr. Paul Ashton, Managing
Director of pSivida Limited.
Alimera
Sciences and pSivida Limited announced in February 2005 a worldwide agreement
to
co-develop and market the insert for the use of fluocinolone acetonide to treat
DME. The agreement also includes the option to identify, prior to February
2008,
three other compounds not previously licensed by pSivida to a third party for
use in Medidur for ophthalmic diseases. This option has the potential to result
in a license to three additional products with the Medidur insert for Alimera.
Pfizer also recently reached an agreement with pSivida to commit up to US$155
million for development related to different ophthalmic applications of the
Medidur technology.
--
more
--
“As
our
work continues, we are pleased with recent announcements underscoring the
development interest and commitments by companies like Pfizer for this
technology,” said Myers. “It reinforces the confidence that we have in the
technology as well.”
Diabetic
retinopathy (DR), a complication of diabetes mellitus, is the leading cause
of
blindness in the working-age population of developed countries. At any
time during progression of diabetic retinopathy, patients can develop DME which
involves retinal thickening of the macular area. There are currently more
than 500,000 people with DME in the United States and this number is expected
to
exceed 700,000 by the year 2010; approximately 75,000 new cases of DME are
diagnosed each year.
About
Alimera Sciences Inc.
Alimera
Sciences Inc., a venture backed company, specializes in the development and
commercialization of over-the-counter and 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. For more information, please visit www.alimerasciences.com.
About
pSivida Limited
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 pancreatic cancer.
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.
###