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 March 2006
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12
BGC Centre
28
The
Esplanade
Perth
WA
6000
(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- ___.
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: March
21, 2006
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
DSMB
Recommends Continuation of MedidurTM
Clinical Trials
|
Exhibit
99.1
 |
 |
Mike
Greenwell FOR
IMMEDIATE RELEASE
Fleishman
Hillard
404.739.0155
greenwem@fleishman.com
Brian
Leedman
pSivida
Limited
+61
8
9226 5099
brianl@psivida.com
DATA
SAFETY MONITORING BOARD RECOMMENDS CONTINUATION
OF
MEDIDUR™ PHASE III CLINICAL TRIAL
ATLANTA,
GEORGIA AND BOSTON, MASSACHUSETTS (March 21, 2006) - Alimera Sciences Inc.,
an
emerging ophthalmic pharmaceutical company, and pSivida Limited, a global
bio-nanotech company, announced today that following a planned interim review,
an independent Data Safety Monitoring Board (DSMB) has recommended the
continuation of its Phase III clinical trial of Medidur™.
The
DSMB
met March 16, 2006 to review the Medidur™ Phase III clinical trial
data.
Medidur™,
a tiny, injectable device, is being studied as a way to deliver fluocinolone
acetonide, a corticosteroid, to the retina for up to three years as a treatment
for diabetic macular edema (DME).
After
reviewing the preliminary safety data from the initial U. S. patients enrolled
in the Medidur™ trial, the DSMB agreed that enrollment should accelerate in the
Phase III trial under the current protocol. A DSMB provides independent
evaluation of study data to identify potential safety issues that might warrant
modification or early termination of ongoing studies.
“We
are
very pleased with the DSMB’s conclusions and see this as a positive step toward
the development of this novel treatment for DME,” said Dan Myers, CEO of Alimera
Sciences. “We will now expand this phase of the masked,
randomized, multi-center clinical trial
in
the U.S., Canada, Europe and India.”
Gavin
Rezos, CEO of pSivida, commented, “We anticipate Medidur™ will provide DME
patients with a safe, effective and long-lasting therapeutic treatment that
can
be provided non-surgically by eye care professionals in their offices.”
-more-
DME,
a
common complication of diabetic retinopathy, is the leading cause of vision
loss
in people under the age of 65 in the U.S. where it impacts an estimated 500,000
people. It is caused by a fluid build-up in the central vision portion of the
retina.
At
present, the
only
approved method for treating DME involves laser photocoagulation therapy, which
can leave irreversible blind spots. While there are no drugs approved by the
FDA
for DME, there is recent clinical evidence that corticosteroids reduce edema
associated with DME.
About
Alimera Sciences Inc.
Alimera
Sciences Inc. 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 address both the anterior (front) and posterior (back)
segments of the eye, as well as underserved and overlooked areas of the
ophthalmic market. The company is headquartered in Alpharetta,
Georgia.
www.alimerasciences.com
About
pSivida Limited
pSivida
Limited is a global bio-nanotech company committed to the biomedical sector
in
the development of drug delivery products. pSivida conducts its operations
from
offices and facilities near Boston in Massachusetts, Malvern in the United
Kingdom, Perth in Australia and Singapore.
www.psivida.com
-end-
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. The technologies underlying both of these products
are licensed to Bausch & Lomb.
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structrured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopaedics, and tissue
engineering. pSivida’s subsidiary, AION Diagnostics Limited is developing
diagnostic products and the subsidiary pSiNutria is developing food technology
products both using BioSilicon™.
pSivida’s
intellectual property portfolio consists of 70 patent families, 74 granted
patents and over 290 patent applications.
pSivida
conducts its operations from offices and facilities near Boston in
Massachusetts, Malvern in the United Kingdom, Perth in Western Australia and
Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and in
Germany 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.
The
Company's largest shareholder and a strategic partner is QinetiQ, a leading
international defence, security and technology company, formed in July 2001
from
the UK Government's Defence Evaluation & Research Agency
(DERA). QinetiQ was instrumental in discovering BioSilicon(TM)
and
pSivida enjoys a strong relationship with it having access to its cutting edge
research and development facilities. For more information visit www.QinetiQ.com
For
more
information, visit www.psivida.com
This
document contains forward-looking statements that involve risks and
uncertainties. The statements are indicated by the use of words such as
"believes", "expects", "anticipates" and similar words and phrases.
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: our failure to develop
applications for BioSiliconTM
due to
regulatory, scientific or other issues, our inability to successfully integrate
the operations and employees related to our December 2005 acquisition of Control
Delivery Systems (CDS); the failure of the CDS’ products to achieve expected
revenues and the combined entity’s inability to develop existing or proposed
products; the failure of the Bausch & Lomb/ Novartis co-promotion
arrangement to provide faster royalty growth; failure to continue to manufacture
MedidurTM
to the
European Union standard of GMP; inability to manufacture MedidurTM
to the
United States standard of GMP. Other reasons are contained in cautionary
statements in the Registration Statement 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.