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 May 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: May 30, 2006 |
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pSivida
Limited
|
|
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|
|
By: |
/s/
Aaron Finlay |
|
Aaron
Finlay
Company
Secretary
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EXHIBIT
INDEX
EXHIBIT
99.1:
|
BrachySilTM
Pancreatic Program: Regulatory Approval for European Human
Trial
|
EXHIBIT
99.1:
|
BrachySilTM
Liver Programme: Expansion of Multicentre Clinical
Trial
|
EXHIBIT
99.1:
|
Despatch
for Rights Issue Prospectus
|
ASX/MEDIA
RELEASE
|
30
May 2006
|
BrachySilTM
Pancreatic Program: Regulatory Approval for European Human
Trial
Boston,
MA. and Perth, Australia – Global
bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that the Regulatory Agency in the U.K. (The Medicines and
Healthcare Products Regulatory Agency or MHRA) has granted approval to proceed
with the first human study of BrachySil™ in pancreatic cancer through a phase
IIa clinical trial.
Pancreatic
cancer is a second clinical indication for BrachySilTM,
currently in Phase IIb clinical trials for the treatment of inoperable primary
liver cancer. Pancreatic cancer has one of the lowest cancer survival rates
(5
year overall survival rate of approximately 5%). There is significant clinical
and market demand for effective therapies to treat this aggressive form of
cancer. According to *GLOBOCAN, there were over 230,000 new cases and nearly
as
many deaths from pancreatic cancer worldwide in 2002. Approximately 50% of
these
new cases were in North America and Europe.
The
six
month clinical study which has been approved to proceed by the MHRA is a phase
IIa trial in patients with inoperable pancreatic cancer and will be undertaken
at two leading centres for cancer treatment, Guys & St Thomas’ Hospital in
London (UK) and Singapore General Hospital. The trial represents the
“first-in-Man” safety study for BrachySil™ in this indication and is designed to
enrol a total of 15 patients. The primary objective is to determine the safety
of the targeted image-guided implantation of pSivida’s BrachySil™ product.
Efficacy, as determined by CT scanning of the tumour size and overall survival,
will be secondary endpoints. The findings will provide a platform for further
multicentre efficacy and safety trials.
Pre-clinical
evaluation of BrachySil™
into
pancreatic cancers
has
provided the teams involved in the clinical trial with valuable feedback
allowing optimisation of BrachySil™ for this indication and standardisation
between the
two
study centres. The
clinical program will utilise product sourced from the same GMP manufacturing
process and supply chain which is currently being utilised for the liver cancer
program. The manufacturing process is established and scaled up to support
clinical development and early launch volumes.
A
phase
IIa study for advanced inoperable liver cancer completed in June 2005 on eight
patients showed BrachySil™ to be both safe and well tolerated. All patients
experienced a decrease in the size of their tumours, with some experiencing
complete tumour regression.
“We
have
recently announced progress with the development of BrachySil™, our targeted
oncology product, in primary liver cancer. We believe that because the
BrachySil™ primary liver program is in Phase IIb clinical trials, it will
provide valuable clinical information for the development and commercialisation
of BrachySil™ for pancreatic cancer and other indications,” said pSivida CEO, Mr
Gavin Rezos. “We also believe that gaining regulatory agency approval in Europe
to begin the first clinical study for the pancreatic cancer indication
represents a very positive milestone towards broader value generation from
BrachySil™.”
*GLOBOCAN
is a worldwide database of cancer incidence and
mortality rates.
-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:
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™, 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 the United
States, Malvern in the United Kingdom, Perth in Australia and Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and 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 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, including access to its cutting
edge
research and development facilities.
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: failure to complete negotiations for new
centers for the BrachySil™ phase IIb clinical trial for inoperable primary liver
cancer; the failure of our discussions with the FDA for BrachySil™ to continue
or to lead to FDA approval; the failure of the BrachySil™ phase IIb clinical
trial for inoperable primary liver cancer to determine the optimal dose, provide
key safety data or support future pivotal efficacy trials or product
registration or approval; failure to commence Phase IIa BrachySilTM
trials
for the treatment of pancreatic cancer; 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
pSivida Inc’s operations and employees; the failure of the pSivida Inc’s
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™; failure of our evaluation agreements to result in license agreements;
failure of Medidur™ to release the same drug as Retisert™ at the same rate;
failure of the
Medidur™
trials
in DME to show a very similar stabilization or improvement diabetic retinopathy
as Retisert™
for
DME;
failure
to achieve cost savings; failure to execute on US growth strategy; failure
of
the findings of the pancreatic cancer phase IIa trial to provide a platform
for further multicentre efficacy and safety trials; failure of there to be
optimisation and standardisation between the two pancreatic
cancer study centres; failure of the BrachySil™ primary liver program
that is in Phase IIb clinical trials to provide a valuable platform for the
development and commercialisation of BrachySil™ for pancreatic cancer and other
indications. Other
reasons are 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.
ASX/MEDIA
RELEASE
|
25
May 2006
|
BrachySilTM
Liver Programme: Expansion of Multicentre Clinical Trial
Boston,
MA. and Perth, Australia – Global
bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that the scope of the BrachySil™ phase IIb clinical trial
for inoperable primary liver cancer has expanded to encompass a roll-out to
further clinical centres in new Asian territories. In addition to the five
centres currently active in Singapore, and centres in Vietnam and Malaysia,
new
centres are being negotiated in the Philippines and Taiwan.
A
phase
IIb clinical trial commenced in October 2005 with BrachySil™ (32-P BioSilicon™)
as a potential new treatment for inoperable primary liver cancer (hepatocellular
carcinoma, HCC). pSivida is also progressing a formal dialogue with the FDA
relating to the U.S. programme for HCC and pancreatic cancers. This active
discourse has provided valuable information for pSivida to advance its programme
planning in the U.S. market.
The
study, which was designed in collaboration with Singapore General Hospital
(SGH)
and approved by the Singaporean regulatory authority (Health Sciences
Authority), is designed to determine the optimal dose of BrachySil™ in treating
inoperable HCC. Patients will be evaluated up to 12 months after treatment.
The
endpoints will be based on evaluations of patient safety and target tumour
responses, as well as overall survival.
A
phase
IIa study conducted at SGH that commenced in June 2004 on eight patients with
advanced liver cancer showed BrachySil™ to be both safe and well tolerated. All
patients experienced a decrease in the size of their tumours, with some
experiencing complete regression. To date, six of the eight patients are still
alive.
Phase
IIa
BrachySilTM
trials
for the treatment of pancreatic cancer to be conducted in hospitals in London
and Singapore are expected to commence next month. Pancreatic cancer typically
has one of the lowest cancer survival rates and represents a further important
clinical indication for BrachySilTM
with a
high unmet need.
“We
are
delighted to announce that the liver cancer programme will now be supported
by a
larger number of clinical centres in the key Asian region, and that clinical
evaluation of the BrachySilTM
product
in pancreatic cancer remains on track,” said pSivida CEO, Mr. Gavin Rezos. “Our
target is to generate value for our lead oncology product in all key markets,
particularly the US for which the active dialogue with the FDA is a key
component.”
-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:
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™, 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 the United
States, Malvern in the United Kingdom, Perth in Australia and Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and 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 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: failure to complete negotiations for new
centers for the BrachySil™ phase IIb clinical trial for inoperable primary liver
cancer; the failure of our discussions with the FDA for BrachySil™ to continue
or to lead to FDA approval; the failure of the BrachySil™ phase IIb clinical
trial for inoperable primary liver cancer to determine the optimal dose, provide
key safety data or support future pivotal efficacy trials or product
registration or approval; failure to commence Phase IIa BrachySilTM
trials
for the treatment of pancreatic cancer; 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
pSivida Inc’s operations and employees; the failure of the pSivida Inc’s
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™; failure of our evaluation agreements to result in license agreements;
failure of Medidur™ to release the same drug as Retisert™ at the same rate;
failure of the
Medidur™
trials
in DME to show a very similar stabilization or improvement diabetic retinopathy
as Retisert™
for
DME;
failure
to achieve cost savings; failure to execute on US growth strategy.
Other
reasons are 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.
ASX/MEDIA
RELEASE
|
|
24
May 2006
|
Despatch
of Rights Issue Prospectus
Boston,
MA. and Perth, Australia – Global
bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to confirm that the despatch to eligible shareholders of the Rights
Issue prospectus and entitlement and acceptance forms was completed
today.
As
announced on 2 May 2006, the Rights Issue is on a non-renounceable 1 for 8
basis
to raise approximately A$29 million at A$0.60 per ordinary share. The Rights
Issue has an incorporated top up facility whereby eligible shareholders may
apply for additional new ordinary shares in excess of their entitlement at
the
same price.
The
Rights Issue is not underwritten. To the extent there is any shortfall under
the
Rights Issue, pSivida has agreed to place such shortfall through Janney
Montgomery Scott LLC, its US based Lead Manager for this issue, to institutional
and sophisticated investors.
Any
ordinary shares issued in the U.S. will be issued in a private placement. These
shares will not be registered under the U.S. Securities Act of 1933, as amended,
or any U.S. state securities laws and may not be offered, sold or transferred
in
the U.S. absent registration or an applicable exemption from registration
requirements.
The
Record Date for the Rights Issue was 22 May 2006. The ordinary shares to be
issued in connection with the Rights Issue are expected to commence trading
on
the Australian Stock Exchange on 8 June 2006. Applications will close on 7
June
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:
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™, 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 the United
States, Malvern in the United Kingdom, Perth in Western Australia and Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and 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 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
pSivida Inc’s operations and employees; the failure of the pSivida Inc’s
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; failure of our evaluation agreements to result in license agreements;
failure of Medidur™ to release the same drug as Retisert™ at the same rate;
failure of the
Medidur™
trials
in DME to show a very similar stabilization or improvement diabetic retinopathy
as Retisert™
for
DME;
failure
to achieve cost savings; failure
to execute on US growth strategy.
Other
reasons are 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.