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 February 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:
February 21, 2006
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Uveitis
long term trial results positive
|
|
EXHIBIT
99.2:
|
Diabetic
Macular Edema trial with Retisert
|
-2-
|
ASX/MEDIA
RELEASE
|
21
February 2006
|
pSivida:
Uveitis long term trial results positive for pSivida
Second
set of follow-up trial results announced today
Global
bio-nanotech company pSivida Limited (NASDAQ:PSDV,
ASX:PSD, Xetra:PSI)
today
announced that preliminary three year follow-up data from Bausch
and Lomb’s
multi-center, randomized, dose-masked clinical trial of Retisert™
for the
treatment of chronic non-infectious posterior
segment uveitis has
been
published. Global
eye health company, Bausch and Lomb (NYSE: BOL), exclusive licensee
of
Retisert™,
conducted the study that showed the recurrence rate was significantly lower
in
eyes
receiving Retisert™
than in
non-implanted eyes. This study involved 278 patients from 27 hospitals in
the
United States and one in Singapore.
pSivida
receives royalties from sales of Retisert™ which is presently priced at
US$18,250. Covered in the United States by Medicare and Medicaid, Retisert™ is
co-marketed in the United States by Bausch & Lomb and Novartis.
 Surgically implantable RetisertTM
|
Posterior uveitis is the third leading cause of blindness in the United States where it afflicts an estimated 175,000 people. Approximately 800,000 people have the disease worldwide. Uveitis is a chronic auto-immune disease in which the bodies own defences attack the inner lining of the eye (the uvea). Retisert™, approved by the FDA in April 2005, is the only FDA approved drug for this disease. Retisert™ is surgically implanted into the eye and is approved to release a constant amount of the drug, fluocinolone acetonide, over a treatment period of 30 months. |
The
study
concluded that at three years control of uveitis in eyes implanted with
Retisert™
was
still significantly better than in non-implanted eyes, but was less effective
than at two years and that some eyes may need to be re-implanted between
24 and
36 months.
“These
results confirm the long term benefits of Retisert™ in
the
treatment of this devastating disease,” said Mr Gavin
Rezos, CEO of pSivida Limited. “The possible need for an additional implant at
between 24 and 36 months is consistent with the 30 month label from the FDA”.
In
this
study, patients were randomised to receive either a 0.59 mg or a 2.1 mg
Retisert™ device. Data presented was the aggregate of the two doses. At three
years, the recurrence rate of uveitis was 33% in the eye receiving Retisert™
compared to 57% of fellow eyes (p< 0.001). A greater number of eyes receiving
Retisert™ experienced an improvement in vision of at least 15 letters (three
lines on an eye chart) compared to fellow eyes (22% versus 6%, p<0.001). 45%
of eyes receiving Retisert™ required an operation to relieve elevated
intraocular pressure and 92% developed a cataract. Cataract
surgery is a relatively uncomplicated and established procedure with a high
success rate.
The
abstract (#1523) detailing this data is available on the website of the
Association for Research in Vision and Ophthalmology www.arvo.org.
Fuller
data will be presented at the ARVO conference in May 2006.
-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. It can
be caused
by diseases such as multiple sclerosis, rheumatoid arthritis
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
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. 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.
|
ASX/MEDIA
RELEASE
|
|
21
February
2006
|
pSivida:
Diabetic Macular Edema trial with RetisertTM
Positive
Results for
pSivida
Global
bio-nanotech company pSivida Limited (NASDAQ:PSDV,
ASX:PSD, Xetra:PSI)
today
announced the publication of preliminary three year follow-up data from
Bausch
and Lomb’s
multi-center, randomized, controlled clinical trial of Retisert™
for the
treatment of diabetic macular edema (DME).
Global eye health company, Bausch and Lomb (NYSE: BOL), exclusive licensee
of
Retisert™
from
pSivida, conducted the study
in
hospitals in the United States in which 197 patients were randomised to receive
either standard of care (repeat laser or observation) or a Retisert™
implant.
The study concluded that significantly more patients receiving a
Retisert™
implant
had improved visual acuity (of three or more lines on an eye chart) than
those
receiving standard of care.
DME,
a
common complication of Diabetic Retinopathy (DR), is the leading cause of
vision
loss in people under the age of 65 in the United States with an estimated
500,000 treatable cases. DME is characterized by swelling of the retina and
loss
of vision. 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. There are no approved
drug therapies for the treatment of either DME or DR. Retisert™ for DME is
surgically implanted into the eye and releases a constant amount of the drug,
fluocinolone
acetonide.
RetisertTM
is FDA
approved for the treatment of posterior uveitis with a duration of 30 months
and
is
licensed to Bausch & Lomb and co-promoted by Novartis.
|
Injectable MedidurTM
|
Medidur™ is pSivida’s next generation product. It is a tiny, injectable device that can release the same drug as RetisertTM. Unlike RetisertTM, which is surgically implanted, MedidurTM is injected into the eye during an office visit. MedidurTM is in Phase III clinical trials in DME in collaboration with Alimera Sciences Inc., a specialty pharmaceutical company focused on the ophthalmic industry. |
 Surgically implantable RetisertTM
|
“As
Retisert™
and
Medidur™
can
deliver
the same
drug, at a similar rate, to the back of the eye, we hope the Medidur™
trials
in DME show a very similar improvement in visual acuity to that shown in
the
Retisert™
DME
trial. Medidur™
differs
from Retisert™
in that
it is a smaller device that can be inserted without the need for
surgery,”
said Mr
Gavin
Rezos, CEO of pSivida Limited.
Results
of
the Bausch & Lomb study has shown that a statistically significant number of
eyes treated
with Retisert™
had an
improvement of visual acuity of three
or
more lines on an eye chart compared
to eyes receiving standard of care (28% versus 15%, p<0.05).
Additionally, a
statistically significant number of eyes treated
with Retisert™
showed
an improvement in their diabetic retinopathy severity score, a measure of
the
severity of their disease
(13%
versus 4% p<0.001).
More
eyes receiving Retisert™
also
showed a reduction in their edema and there was
also
no evidence of edema in 58% of eyes receiving the implant versus 30% of eyes
receiving standard of care (p<0.001).
Side-effects
of Retisert™ in patients with DME were similar to those reported in patients
with uveitis for which Retisert™ is approved. Of the patients with DME receiving
Retisert™,
at
three years 33% required an operation to relieve elevated intraocular pressure
(IOP) and 95% required cataract surgery. Cataract
surgery is a relatively uncomplicated and established procedure with a high
success rate. The
abstract (#5442) detailing the DME data is available on the website of the
Association for Research in Vision and Ophthalmology www.arvo.org.
The
three year uveitis data is available at the same website (abstract #1523).
Fuller data will be presented at the ARVO conference in May 2006.
pSivida
receives royalties from sales of Retisert™ 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. The product is
presently priced at US$18,250 and is approved as a 30 month treatment. Covered
in the United States by Medicare and Medicaid, Retisert™ is co-marketed in the
United States by Bausch & Lomb and Novartis.
In
the
event that Retisert™
is
approved for DME and Bausch & Lomb decide to market Retisert™
for DME,
then pSivida will receive royalty payments from Bausch & Lomb for
Retisert™
sales
for DME.
-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 Diabetic Retinopathy?
Diabetic
Retinopathy is a complication of diabetes and a leading cause of blindness.
It
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
the 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.
|
|
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. 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-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: 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. 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.