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 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
x 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
x
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: April 6, 2006 | ||
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Positive
European trial results for RetisertTM
|
2
| ASX/MEDIA RELEASE |
6
April 2006
|
Positive
European trial results for RetisertTM
Perth,
Australia and Boston, MA - Global bio-nanotech company pSivida Limited
(NASDAQ:PSDV,
ASX:PSD, Xetra:PSI)
today
announced that global eye health company Bausch & Lomb (NYSE:
BOL)
recently
released two year results from their European clinical trial of Retisert(TM)
for the
treatment of chronic non-infectious posterior
segment uveitis.
Bausch
& Lomb, exclusive licensee of
Retisert(TM),
conducted the randomised study that showed the recurrence rate for uveitis
was
significantly lower in
eyes
receiving Retisert(TM)
than in
eyes receiving standard of care (systemic
corticosteroid or other immunosuppressive agents).
The
study involved 146 patients across ten countries in Europe and the Middle East.
The
abstract (#1220) detailing this data is available on the website of the
prestigious
6th
International Symposium on Ocular Pharmacology and Therapeutics in Berlin,
that
commenced on 30 March 2006. http://www.kenes.com/isopt/index.asp
 |
Uveitis
is a leading cause of blindness affecting an estimated *200,000 persons
in
the EU. It is also estimated to affect ^175,000 people in the US
and
approximately ^800,000 people worldwide.
Uveitis is a chronic auto-immune disease in which the body’s own defences
attack the inner lining of the eye (the uvea). Retisert(TM),
approved by the FDA in April 2005, is the only FDA approved drug
for this
disease. Retisert(TM) is surgically implanted into the eye and is
approved
to release a constant amount of the drug, fluocinolone
acetonide,
over a treatment eriod of 30 months.
|
| Surgically implantable RetisertTM |
pSivida
receives royalties from sales of Retisert(TM) which is presently priced at
US$18,250. Covered in the United States by Medicare and Medicaid, Retisert(TM)
is co-marketed in the United States by Bausch & Lomb and
Novartis.
“We
believe a positive result such as this in a European study is an important
step
towards registration in Europe, enabling Retisert(TM)
to be
made available to a much wider market,”
said Mr
Gavin
Rezos, CEO of pSivida Limited.
*Source:
European Medicines Agency
^Source:
Bausch & Lomb
-ENDS-
|
pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 943 1100 ext. 12
bjedynak@janispr.com
|
UK
& Europe Public Relations
Mark
Swallow / Helena Podd
Citigate
Dewe Rogerson
Tel:
+44 (0)20 7638 9571
mark.swallow@citigatedr.co.uk
|
NOTES
TO EDITORS:
|
What
is Uveitis? An
autoimmune condition, Uveitis manifests itself as an inflammation
inside
the eye, that can lead to sudden or gradual vision loss.
pSivida
is a global bio-nanotech company committed to the biomedical sector
and
the development of drug delivery products. Retisert(TM) is FDA
approved
for the treatment of uveitis. Vitrasert(R) is FDA approved for
the
treatment of AIDS-related CMV Retinitis. Bausch & Lomb own the
trademarks; Vitrasert(R) and Retisert(TM). pSivida has licensed
the
technologies underlying both of these products to Bausch & Lomb. The
technology underlying Medidur(TM), a treatment for diabetic macular
edema,
is licensed to Alimera Sciences and is in Phase III clinical
trials.
|
 |
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon(TM), 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(TM).
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 from the UK
Government's Defence Evaluation & Research Agency (DERA). QinetiQ was
instrumental in discovering BioSilicon(TM)
and
pSivida enjoys a strong relationship with them. 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: the failure of Retisert
to
be registered in Europe; 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(TM) for DME trial; failure of the
Medidur(TM)
trials
in DME to show a very similar improvement in visual acuity and diabetic
retinopathy severity score as Retisert(TM)
for
DME;
inability to recruit patients for the Phase
III
Medidur(TM) for DME trial; our failure to develop applications for
BioSiliconTM
due to
regulatory, scientific or other issues, our inability to successfully integrate
CDS’ operations and employees; 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 of the slower progression
or reduction of diabetic retinopathy resulting from the Retisert(TM) implant
to
have significant implications for Retisert(TM) and Medidur; failure of our
evaluation agreements to result in license agreements; failure of Medidur(TM)
to
release the same drug as Retisert(TM) at the same rate; failure of the
Medidur(TM)
trials
in DME to show a very similar stabilization or improvement diabetic retinopathy
as Retisert(TM)
for DME.
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.