Unassociated Document
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
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:
April 03,
2006 |
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pSivida
Limited |
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By: |
/s/ Aaron
Finlay |
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Aaron
Finlay |
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Chief
Financial Officer and Company
Secretary |
EXHIBIT
INDEX
EXHIBIT
99.1:
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RetisertTM slows
progression of Diabetic Retinopathy in Diabetic Macular Edema
trials
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Unassociated Document
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ASX/MEDIA
RELEASE |
3
April
2006
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RetisertTM slows
progression of Diabetic Retinopathy in Diabetic Macular Edema
trials
Perth,
Australia and Boston, MA - Global bio-nanotech company pSivida Limited
(NASDAQ:PSDV,
ASX:PSD, Xetra:PSI)
today
announced additional two year trial results of Bausch & Lomb’s two
randomized trials to evaluate the safety and efficacy of the
RetisertTM
implant
in releasing fluocinolone acetonide in the management of Diabetic Macular Edema
(DME). Bausch & Lomb, exclusive licensee of RetisertTM
from
pSivida conducted the studies in hospitals in the United States involving 277
patients. The trial results were presented at 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.
The
two
year trial results demonstrated that 30% of eyes receiving standard of care
(repeat laser treatment) had a worsening of their Diabetic Retinopathy compared
with only 10% of eyes receiving a RetisertTM
implant.
This was statistically significant. RetisertTM
also
reduced retinal thickening involving the fovea (the centre most part of the
macula responsible for sharp, central vision) and led to a statistically
significant three line improvement in vision.
Diabetic Retinopathy
(DR) is the
leading cause of vision loss of people in the United States under
the age
of 65 with an estimated 1,000,000 treatable cases. DR occurs when
diabetes
damages the tiny blood vessels inside the retina, the light-sensitive
tissue at the back of the eye. DR usually affects both eyes. Currently
the
only FDA approved treatment is laser therapy in which holes are
burned
into the macula with a laser. This treatment is often ineffective
or
generally provides only temporary benefit. DME is a common complication
of
DR. There are no approved drug therapies for the treatment of either
DME
or DR. |
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Surgically
implantable RetisertTM
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“We
believe the finding that sustained release fluocinolone acetonide can slow
or
reduce the progression of Diabetic Retinopathy is important and may have
significant implications for RetisertTM
and
MedidurTM,”
said
Mr
Gavin
Rezos, CEO of pSivida Limited.
pSivida
receives royalties on Retisert™ sales. Retisert™ is presently priced at
US$18,250 and is approved as a 30 month treatment for chronic non-infectious
posterior segment uveitis, a sight threatening condition that affects an
estimated 175,000 people in the United States and an estimated 800,000 people
worldwide. Covered in the United States by Medicare and Medicaid, Retisert™ is
co-marketed in the United States by Bausch & Lomb and Novartis.
Three
year results of the Retisert™ in DME trial will be presented at ARVO
conference in May 2006 www.arvo.org.
-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
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NOTES
TO EDITORS:
What
is Diabetic Retinopathy?
Diabetic Retinopathy occurs when diabetes damages the tiny
blood vessels
inside the retina, the light-sensitive tissue at the back of
the eye. A
healthy retina is necessary for good vision. Diabetic Retinopathy
usually
affects both eyes.
What
is Diabetic Macular Edema?
Diabetic Macular Edema, a subset of diabetic retinopathy, is
a leading cause of vision loss for Americans under the age
of 65. Retinal
blood vessels in diabetic’s eyes deteriorate and leak, causing the retina
to swell. A minority of cases receive long-term benefit from
laser
treatment.
What
is Uveitis? An
autoimmune condition, uveitis manifests itself as an inflammation
inside
the eye, that can lead to sudden or gradual vision loss.
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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 registered trademarks;
Vitrasert® and Retisert™. pSivida has licensed the technologies underlying both
of these products to Bausch & Lomb. The technology underlying Medidur™, 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™, 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: the 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;
inability to recruit patients for the Phase
III
Medidur™
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™ implant to
have significant implications for Retisert™ and Medidur™. 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.