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 22, 2006
| pSivida Limited | ||
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Open
Briefing: pSivida Update on Progress
|
Attention
ASX Company Announcements Platform
Lodgement
of Open Briefing®
 |
 |
pSivida
Limited
Level
12,
BGC Building
28
The
Esplanade
Perth,
Western Australia 6000
Date
of lodgement: 22-Mar-2006
Title:
Open
Briefing®.
pSivida. Update on Progress
Record
of interview:
corporatefile.com.au
pSivida
Limited (ASX: PSD) recently announced the publication of long-term trial results
from a Bausch & Lomb study of Retisert™ as a treatment for chronic
non-infectious posterior segment uveitis. The three-year study undertaken by
Bausch & Lomb involved 278 patients at 27 hospitals in the United States and
one in Singapore. A statistically significant number of eyes treated with
Retisert™ demonstrated a three-line improvement in vision on an eye chart as
well as significantly reduced recurrence rates. What impact will this study
have
on current sales?
MD
Gavin Rezos
A
three-line improvement in vision is a strong result and the study will be used
to brief doctors treating patients with uveitis. The effectiveness of the drug,
as demonstrated by this three-year trial data, can only add to the marketability
of the product in the United States and will be used to seek regulatory approval
in other regions.
In
addition, Bausch & Lomb recently appointed global pharmaceutical company,
Novartis, to co-promote Retisert™ for uveitis in the United States,
significantly increasing the number of sales representatives dedicated to the
promotion of Retisert™ in the United States. pSivida receives a significant
royalty on Retisert™ sales (current wholesale price is US$18,250) which is
covered by US Medicare. Uveitis is the third largest cause of blindness in
the
US with an estimated 175,000 treatable cases and an estimated 800,000
worldwide.
1
Further
reporting on the effectiveness of Retisert™ on uveitis will be presented at the
6th
International Symposium on Ocular Pharmacology and Therapeutics Conference
in
Berlin on 31 March 2006 and the Association for Research in Vision and
Ophthalmology, Inc. (ARVO) 2006 Annual Meeting on 1 May 2006.
corporatefile.com.au
Concurrent
to the release of the three-year results of Retisert™ as a treatment for
uveitis, Bausch & Lomb reported on a controlled clinical trial of Retisert™
for the treatment of Diabetic Macular Edema (DME). This study involved 197
patients at hospitals in the United States and results demonstrated a three
or
more line improvement on an eye chart at three years, which is defined by the
FDA as a Gold Standard level of improvement. How does this treatment compare
to
the current standard of care?
MD
Gavin Rezos
Diabetic
Macular Edema is the number one cause of blindness in the United States for
people under the age of 65 and afflicts about 10 percent of all diabetics with
an estimated 500,000 treatable cases in the US alone. The results of this study
have shown that at three years, in addition to improved vision, there was no
evidence of DME in 58 percent of the eyes receiving the implant versus 30
percent of eyes receiving the existing standard of care, repeated laser
surgery.
The
study
also demonstrated at three years, a two-grade improvement in the Diabetic
Retinopathy Severity score (a measure of the severity of the disease) in 13
percent of eyes treated with Retisert™ compared to 4 percent of eyes treated
with the standard of care. Diabetic Retinopathy is a measure of the underlying
disease rather than diminished vision, which is a symptom of the disease.
Diabetic Retinopathy occurs when diabetes damages the tiny blood vessels inside
the retina, the light-sensitive tissue at the back of the eye and usually
affects both eyes.
Further
reporting on the effectiveness of Retisert™ on DME will be presented at the
6th
International Symposium on Ocular Pharmacology and Therapeutics Conference
in
Berlin on 31 March 2006 and the ARVO 2006 Annual Meeting on 4 May 2006.
corporatefile.com.au
Will
you
seek FDA approval for Retisert™ in DME?
MD
Gavin Rezos
As
Bausch
& Lomb own the licensing rights to Retisert™ in all applications, they are
responsible for any regulatory filing strategy and product commercialisation.
corporatefile.com.au
How
does
the outcome of this trial data impact your assessment of Medidur™, which
commenced phase III trials for the treatment of DME in October 2005?
MD
Gavin Rezos
As
these
Retisert™ and Medidur™ products can deliver the same drug, at a similar rate
over a similar period of time, it is reasonable to expect the three year results
from the current phase III Medidur™ trial will be similar to the results from
the three year data on Retisert™. In our view, the data therefore reduces
significantly the approval risk of the Medidur™ product.
2
corporatefile.com.au
What
are
the differences between Retisert™ and Medidur™?
MD
Gavin Rezos
Both
products work in the same way, however, Medidur™ is smaller and injectable,
whereas Retisert™ has a larger drug reservoir and is inserted in a surgical
procedure.
corporatefile.com.au
pSivida
Limited acquired Control Delivery Systems (now pSivida Inc.) in December 2005.
What synergies have been experienced to date and what future synergies do you
expect to achieve?
MD
Gavin Rezos
The
bringing together of our existing platforms and expertise has the potential
to
create a leading global bio-nanotech company developing next generation products
and technologies in the areas of ophthalmology, oncology, and drug delivery
generally. The acquisition has significant benefits to our shareholders in
terms
of future value enhancing prospects. We are particularly excited about the
potential to integrate BioSiliconTM
with
our
drug delivery technology platform to create next generation treatments for
a
broad range of diseases and conditions.
The
acquisition has also brought additional product development and regulatory
expertise to pSivida’s management team and provided pSivida with an operating
base in the Boston biotech hub, enhancing our overall visibility as well as
access to the US scientific and investment communities. Australian publication
Bioshares recently announced pSivida’s acquisition of CDS as the ‘Biotech
M&A Deal of the Year’, citing pSivida’s increased presence in the US,
current revenue stream and synergies for combining the two companies’
technologies and expertise.
corporatefile.com.au
Given
the
recent progress made in ophthalmology, what new developments are there with
BioSilicon™?
MD
Gavin Rezos
The
ophthalmic area has had significant news of late that is reflected in our
announcements and the maturity of these products. Since the planned acquisition
of CDS was first announced, there have been a number of significant value-adding
announcements including; several new evaluation agreements with large pharmas
in
ophthalmology; Retisert™ was granted full Medicare cover in the US; Novartis
began co-promoting Retisert™ in the US with Bausch & Lomb; and Bausch &
Lomb released important three year trial data on Retisert™ for uveitis and
DME.
In
relation to BioSilicon™, there has been strong progress made in this important
part of our business. The clinical programmes advancing the BrachySil™ targeted
oncology product as well as programmes relating the drug delivery applications
of BioSilicon™ are progressing well and continue to meet expectations.
3
corporatefile.com.au
What
is
the status of your BioSiliconTM
collaboration with an undisclosed Top 5 global pharmaceutical company and have
you entered into any new evaluation agreements?
MD
Gavin Rezos
The
technical programme at the Top 5 global pharma was completed on schedule with
successful results and discussions are still continuing as to the form of the
next stage of our business relationship.
We
also
recently entered into another agreement with an undisclosed large pharmaceutical
company to evaluate the BioSiliconTM
technology for certain drug delivery applications. In addition, there are
ongoing discussions with other pharmaceutical and biotech companies with more
news expected this year.
corporatefile.com.au
A
phase
IIb clinical trial for determining the optimal dose of BrachySil™ in the
treatment of primary liver cancer commenced in October 2005. When will interim
results be made available?
MD
Gavin Rezos
There
have been a number of patients treated at key centres in Singapore with further
patients being recruited. Patients will soon be treated in Vietnam as
well.
The
key
objectives of the phase IIb clinical trial is initially to determine the optimal
radioactivity dose implanted per cubic centimetre of tumour, as well as the
maximum radioactivity level implanted per patient. Three dose levels will be
evaluated and the data from the cohort of patients receiving the optimum dose
will lead directly into the generation of pivotal clinical efficacy and safety
data. Information about the progress made through the phases of this key trial
will be provided during 2006.
The
phase
IIa clinical trials of BrachySil™ for the treatment of eight patients with
advanced, inoperable primary liver cancer was concluded in early 2005.
BrachySil™ was found to be both safe and tolerable and all eight patients had
significant reductions in the size of their tumours.
corporatefile.com.au
When
do
you expect to commence human clinical trials using BrachySil™ to target
pancreatic tumours. Could you outline the progress you’ve made so far?
MD
Gavin Rezos
Pancreatic
cancer represents a further important clinical indication with a high unmet
clinical need. Plans are well advanced in finalising the details of the clinical
protocol and the clinical centres of excellence have been selected and have
agreed to conduct the work. Furthermore, interaction with regulatory agencies
and submission of clinical trial protocols are well progressed. An announcement
regarding the commencement of the clinical programme will be made in the second
quarter of this year.
4
corporatefile.com.au
In
October 2005, pSivida Limited signed a licensing agreement with Beijing
Med-Pharm. The licence included upfront and milestone payments in excess of
US$2
million. What progress has been made to date?
MD
Gavin Rezos
We
have
been receiving these payments to schedule. Currently, we are negotiating the
terms of the Manufacturing Supply Agreement to finalise local manufacture in
China.
corporatefile.com.au
In
May
2005, you announced successful completion of the first stage of a proof of
concept study in collaboration with Clinuvel Pharmaceuticals Limited, (formerly
known as Epitan Limited). How are you progressing in the evaluation of
BioSilicon™ as a delivery platform for Clinuvel’s lead drug CUV1647 (formerly
known as Melanotan™)?
MD
Gavin Rezos
Clinuvel
has extended the work programme and the next stage of technical collaboration
has been initiated. New technical work is focused on loading a hydrophilic
peptide into BioSilicon
TM
particles for injection.
corporatefile.com.au
How
has
the ADR programme on NASDAQ performed since the listing in January last year?
MD
Gavin Rezos
There
are
a total of 768,000 ADRs that are outstanding and tradeable as at the end of
February 2006, representing 7,680,000 ordinary shares that have moved to the
United States from the Australian market. There are also 16.5 million ADRs
issued to former CDS shareholders in the United States currently held in escrow
for periods of between six or nine months from the date of the closure of the
acquisition. Accordingly, the total number of ADRs outstanding represents 44.6
percent of the issued capital of the company as at the end of February 2006.
The
completion of the CDS acquisition has resulted in a significant shift in the
proportion of shareholders domiciled outside of Australia. There is also an
ever-increasing shareholder presence in the UK and Europe.
corporatefile.com.au
Thank
you
Gavin.
5
For
previous Open Briefings by pSivida, or to receive future Open Briefings by
email, visit www.corporatefile.com.au.
For
more
information about pSivida, visit www.psivida.com.au or call Brian Leedman,
Investor Relations Manager on +(61-8) 9327 8920.
PSIVIDA
DISCLAIMER:
This
announcement does not constitute an offer of any securities for sale or the
solicitation of an offer to buy any securities. Any securities offered may
not
be or have not been registered under the US Securities Act of 1933, as amended,
and may not be offered or sold in the United States absent registration or
an
applicable exemption from registration requirements."
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.
CORPORATE
FILE DISCLAIMER:
Corporate File Pty Ltd has taken reasonable care in publishing the information
contained in this Open Briefing®. It is information given in a summary form and
does not purport to be complete. The information contained is not intended
to be
used as the basis for making any investment decision and you are solely
responsible for any use you choose to make of the information. We strongly
advise that you seek independent professional advice before making any
investment decisions. Corporate File Pty Ltd is not responsible for any
consequences of the use you make of the information, including any loss or
damage you or a third party might suffer as a result of that use.
6