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 September 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.
| pSivida Limited | ||
| |
|
|
| Date: September 27, 2006 | By: | /s/ Aaron Finlay |
|
Aaron Finlay
Company Secretary
|
||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Voluntary
Lock-up Period Expires On Acquisition Shares
|
|
EXHIBIT
99.2:
|
Appendix
3B - pSivida Completes Additional Funding
|
|
EXHIBIT
99.3:
|
pSivida
appoints non-executive Director to Audit
Committee
|
 |
|
| ASX/MEDIA RELEASE |
27
September
2006
|
Voluntary
Lock-up Period Expires On Acquisition Shares
Boston,
MA and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:
PSD,
NASDAQ: PSDV, Xetra: PSI) is pleased to announce, in accordance with Listing
Rule 3.10A, that 14,464,800 ordinary fully paid shares, issued in the form
of
American Depositary Shares will be released from a voluntary lock up period
on
30th
September 2006. These shares are held by Dr Paul Ashton a director of pSivida
Limited and the shares were issued by pSivida in part consideration for the
acquisition of the shares in Control Delivery Systems Inc during December
2005.
This
termination does not apply to certain employee-held, non-vested ADSs which
may
not be sold for additional periods.
This
release does not constitute an offer of any securities for sale.
-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
|
European
Public Relations
Accent
Marketing Limited
Eva
Reuter
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
|
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 (QQ.)
was instrumental in discovering BioSiliconTM
and
pSivida’s strong relationship with QinetiQ includes access to its cutting edge
research and development facilities.
This
document contains forward-looking statements that involve risks and
uncertainties. The statements reference potential products, applications and
regulatory approvals. 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 company to successfully close a new issue of
convertible notes; the failure of the Company to obtain the requisite
shareholder approval to issue the new convertible notes; failure to obtain
shareholder approval for the issue of shares underlying the ADS conversion
and
the warrant issues under the new convertible notes; our inability to raise
additional funds at favourable terms or any terms; our inability to repay the
amended notes and new convertible notes; issues relating to share registration
in the U.S. that may delay our registration; our inability to develop proposed
products, including without limitation, in the drug delivery, wound healing,
orthopaedics, and tissue engineering, diagnostics and food technology fields;
failure of our evaluation agreements to result in license agreements; failure
to
develop applications for BioSilicon™ due to regulatory, scientific or other
issues; failure to complete negotiations for new centers for the BrachySil™
phase IIb clinical trial for inoperable primary liver cancer; failure of
our discussions with the FDA for BrachySil™ to continue or to lead to FDA
approval; 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 of the BrachySil™ primary liver programme 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;
failure to commence phase IIa BrachySilTM trials for the treatment of
pancreatic cancer; 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 our two pancreatic cancer study centres; 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; failure of Medidur™ to release
fluocinolone acetonide at the same rate as Retisert™; our inability to recruit
patients for the phase III Medidur™ for DME trial. 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.
Rule
2.7, 3.10.3, 3.10.4, 3.10.5
Appendix
3B
New
issue announcement,
application
for quotation of additional securities
and
agreement
Information
or documents not available now must be given to ASX as soon as available.
Information and documents given to ASX become ASX’s property and may be made
public.
Introduced
1/7/96. Origin: Appendix 5. Amended 1/7/98, 1/9/99, 1/7/2000, 30/9/2001,
11/3/2002, 1/1/2003.
|
Name
of entity
|
|
PSIVIDA
LIMITED
|
|
ABN
|
|
78
009 232 026
|
We
(the
entity) give ASX the following information.
Part
1 - All issues
You
must complete the relevant sections (attach sheets if there is not enough
space).
|
1
|
+Class
of +securities
issued or to be issued
|
1. Unquoted
subordinated convertible notes (“Notes”)
2. Unquoted
options issued as warrants over American Depositary Shares (“Warrants”)
3. Unquoted
options issued as warrants over American Depositary Shares
(“Warrants”)
4. Unquoted
options issued as warrants over American Depositary Shares
(“Warrants”)
|
||
|
2
|
Number
of +securities
issued or to be issued (if known) or maximum number which may be
issued
|
1. US$6,500,000
2. 2,925,001
3. 5,700,000
4. 500,000
|
||
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 1
|
|
3
|
Principal
terms of the +securities
(eg, if options, exercise price and expiry date; if partly paid
+securities,
the amount outstanding and due dates for payment; if +convertible
securities, the conversion price and dates for conversion)
|
1. Unquoted
subordinated convertible note
· Each
Note will have a face value of US$1.00
· The
Notes may be converted by the holder into Shares (represented by
ADSs) at
any time prior to the third anniversary of the date of issue of
the Notes.
The number of Shares to be issued on conversion of the Notes is
to be
calculated by dividing the face value of the Notes to be converted
(and
any accrued but unpaid interest on those Notes) by the conversion
price of
the Shares (rounded up to the nearest 10 Shares)
· The
conversion price will initially be US$2.00 per ADS (or US$0.20
per Share)
and may be adjusted under certain circumstances
· The
Notes mature on 26 September 2009 and bear interest at the rate
of 8% per
annum
· Under
certain circumstances, the Company may make interest payments in
the form
of ADSs
2.
Unquoted Warrants constitute transferrable options to acquired
ADSs at any
time on or before 26 September 2011, exercisable at US$2.00 (representing
US$0.20 per Share)
3.
Unquoted Warrants constitute transferrable options to acquired
ADSs at any
time on or before 14 September 2011, exercisable at US$1.80 (representing
US$0.18 per Share)
4.
Unquoted Warrants constitute transferrable options to acquired
ADSs at any
time on or beforre 26 September 2011, exercisable at US$2.00 (representing
US$0.20 per Share)
|
|
4
|
Do
the +securities rank equally in all respects from the date of allotment
with an existing +class of quoted +securities?
If
the additional securities do not rank equally, please state:
· the
date from which they do
· the
extent to which they participate for the next dividend, (in the
case of a
trust, distribution) or interest payment
· the
extent to which they do not rank equally, other than in relation
to the
next dividend, distribution or interest payment
|
All
fully paid ordinary shares issued on the conversion of the Notes,
payment
of interest on the Notes and exercise of the Warrants will rank
equally in
all respects with the Company’s then issued fully paid ordinary
shares.
|
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 2
|
|
5
|
Issue
price or consideration
|
1. Total
consideration US$6,500,000. The conversion price will be
US$2.00 per ADSs
(or US$0.20 per Share) and may be adjusted under certain
circumstances
2. Nil
3. Nil
4. Nil
|
|
6
|
Purpose
of the issue
(If
issued as consideration for the acquisition of assets, clearly
identify
those assets)
|
1. The
funds raised by the Notes will be used by the Company to
provide necessary
working capital and funding for the further development and
clinical
trials being conducted by the Company.
2. Issued
in accordance with the Warrant to Purchase ADSs in connection
with the
Note
3. Issued
in accordance with the Warrant to Purchase ADSs in connection
with the
Note Amendment Agreement
4. Issued
in accordance with the Warrant to Purchase ADSs in connection
with a
Consulting Agreement
|
|
7
|
Dates
of entering +securities
into uncertificated holdings or despatch of certificates
|
26
September 2006
|
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 3
|
|
Number
|
+Class
|
||
|
8
|
Number
and +class
of all +securities
quoted on ASX (including
the securities in clause 2 if applicable)
|
397,564,507
|
Ordinary
Fully Paid Shares
6,650,000
Ordinary Fully Paid Shares subject to voluntary escrow ending on
the
effectiveness of a registration statement or prospectus.
1,211,180
Ordinary Fully Paid Shares subject to voluntary escrow ending on
the
effectiveness of a registration statement or prospectus.
14,464,800
Ordinary Fully Paid Shares subject to voluntary escrow ending 30
September
2006.
|
|
Number
|
+Class
|
||
|
9
|
Number
and +class
of all +securities
not quoted on ASX (including
the securities in clause 2 if applicable)
|
4,375,000
|
Options
expiring 31 December 2007 exercisable at $0.61 each
(ESOP).
|
|
2,050,000
|
Options
expiring 5 August 2008 exercisable at $1.09 each.
|
||
|
8,934,672
|
Options
expiring 5 August 2009 exercisable at $1.18 each
(ESOP).
|
||
|
115,000
|
Options
expiring 31 December 2008 exercisable at $0.80 each.
|
||
|
200,000
|
Options
expiring 22 April 2010 exercisable at $1.02 each.
|
||
|
3,852,000
|
Options
expiring 31 March 2010 exercisable at $0.80 each
(ESOP).
|
||
|
1,330,000
|
Options
expiring 5 August 2008 exercisable at US$1.25 each, over ordinary
fully
paid shares (represented by 133,000 warrants over ADSs, exercisable
at
US$12.50 per ADS) subject to voluntary escrow ending on the effectiveness
of a registration statement or prospectus.
|
||
|
2,250,000
|
Options
expiring 30 September 2010 exercisable at $0.92 each
(ESOP).
|
||
|
12,500,000
|
US$1.00
8% subordinated convertible notes maturing 15 November
2008
|
||
|
6,338,030
|
Options
expiring 15 November 2011 exercisable at US$0.72 each, over ordinary
fully
paid shares (represented by 633,803 warrants over ADSs, exercisable
at
US$7.20 per ADS)
|
||
|
38,720
|
Options
expiring 19 April 2007, exercisable at US$2.99148 each, over ordinary
fully paid shares (represented by 3,872 options over ADSs, exercisable
at
US$29.9148 per ADS)
|
||
|
704,000
|
Options
expiring 18 September 2007, exercisable at US$0.17756 each, over
ordinary
fully paid shares (represented by 70,400 options over ADSs, exercisable
at
US$1.7756 per ADS)
|
||
|
70,400
|
Options
expiring 31 October 2007, exercisable at US$2.99148 each, over ordinary
fully paid shares (represented by 7,040 options over ADSs, exercisable
at
US$29.9148 per ADS)
|
||
|
58,080
|
Options
expiring 15 April 2008, exercisable at US$2.99148 each, over ordinary
fully paid shares (represented by 5,808 options over ADSs, exercisable
at
US$29.9148 per ADS)
|
||
|
352,000
|
Options
expiring 25 August 2009, exercisable at US$0.22727 each, over ordinary
fully paid shares (represented by 35,200 options over ADSs, exercisable
at
US$2.2727 per ADS)
|
||
|
352,000
|
Options
expiring 12 November 2009, exercisable at US$0.34091 each, over ordinary
fully paid shares (represented by 35,200 options over ADSs, exercisable
at
US$3.4091 per ADS)
|
||
|
6,500,000
|
US$1.00
8% subordinated convertible notes maturing 26 September
2009
|
||
|
29,250,010
|
Options
expiring 26 September 2011 exercisable at US$0.20 each, over ordinary
fully paid shares (represented by 2,925,000 warrants over ADSs,
exercisable at US$2.00 per ADS)
|
||
|
57,000,000
|
Options
expiring 14 September 2011 exercisable at US$0.18 each, over ordinary
fully paid shares (represented by 5,700,000 warrants over ADSs,
exercisable at US$1.80 per ADS)
|
||
|
5,000,000
|
Options
expiring 26 September 2011 exercisable at US$0.20 each, over ordinary
fully paid shares (represented by 500,000 warrants over ADSs, exercisable
at US$2.00 per ADS)
|
||
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 4
|
|
10
|
Dividend
policy (in the case of a trust, distribution policy) on the increased
capital (interests)
|
N/A
|
|
Part
2 - Bonus issue or pro rata issue
|
11
|
Is
security holder approval required?
|
N/A
|
|
12
|
Is
the issue renounceable or non-renounceable?
|
N/A
|
|
13
|
Ratio
in which the +securities
will be offered
|
N/A
|
|
14
|
+Class
of +securities
to which the offer relates
|
N/A
|
|
15
|
+Record
date to determine entitlements
|
N/A
|
|
16
|
Will
holdings on different registers (or subregisters) be aggregated for
calculating entitlements?
|
N/A
|
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 5
|
|
17
|
Policy
for deciding entitlements in relation to fractions
|
N/A
|
|
18
|
Names
of countries in which the entity has +security
holders who will not be sent new issue documents
Note:
Security holders must be told how their entitlements are to be dealt
with.
Cross
reference: rule 7.7.
|
N/A
|
|
19
|
Closing
date for receipt of acceptances or renunciations
|
N/A
|
|
20
|
Names
of any underwriters
|
N/A
|
|
21
|
Amount
of any underwriting fee or commission
|
N/A
|
|
22
|
Names
of any brokers to the issue
|
N/A
|
|
23
|
Fee
or commission payable to the broker to the issue
|
N/A
|
|
24
|
Amount
of any handling fee payable to brokers who lodge acceptances or
renunciations on behalf of +security
holders
|
N/A
|
|
25
|
If
the issue is contingent on +security
holders’ approval, the date of the meeting
|
N/A
|
|
26
|
Date
entitlement and acceptance form and prospectus or Product Disclosure
Statement will be sent to persons entitled
|
N/A
|
|
27
|
If
the entity has issued options, and the terms entitle option holders
to
participate on exercise, the date on which notices will be sent to
option
holders
|
N/A
|
|
28
|
Date
rights trading will begin (if applicable)
|
N/A
|
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 6
|
|
29
|
Date
rights trading will end (if applicable)
|
N/A
|
|
30
|
How
do +security
holders sell their entitlements in
full
through a broker?
|
N/A
|
|
31
|
How
do +security
holders sell part
of
their entitlements through a broker and accept for the
balance?
|
N/A
|
|
32
|
How
do +security
holders dispose of their entitlements (except by sale through a
broker)?
|
N/A
|
|
33
|
+Despatch
date
|
N/A
|
Part
3 - Quotation of securities
You
need only complete this section if you are applying for quotation of
securities
|
34
|
Type
of securities
(tick
one)
|
|
|
(a)
|
o |
Securities
described in Part 1
|
|
(b)
|
x |
All
other securities
Example:
restricted securities at the end of the escrowed period, partly paid
securities that become fully paid, employee incentive share securities
when restriction ends, securities issued on expiry or conversion
of
convertible securities
|
Entities
that have ticked box 34(a)
Additional
securities forming a new class of securities
|
Tick
to indicate you are providing the information or
documents
|
|
35
|
o |
If
the +securities
are +equity
securities, the names of the 20 largest holders of the additional
+securities,
and the number and percentage of additional +securities
held by those holders
|
|
36
|
o |
If
the +securities
are +equity
securities, a distribution schedule of the additional +securities
setting out the number of holders in the categories
1
-
1,000
1,001
- 5,000
5,001
- 10,000
10,001
- 100,000
100,001
and over
|
|
37
|
o |
A
copy of any trust deed for the additional +securities
|
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 7
|
Entities
that have ticked box 34(b)
|
38
|
Number
of securities for which +quotation
is sought
|
N/A
|
||
|
39
|
Class
of +securities
for which quotation is sought
|
N/A
|
||
|
40
|
Do
the +securities
rank equally in all respects from the date of allotment with an existing
+class
of quoted +securities?
If
the additional securities do not rank equally, please state:
· the
date from which they do
· the
extent to which they participate for the next dividend, (in the case
of a
trust, distribution) or interest payment
· the
extent to which they do not rank equally, other than in relation
to the
next dividend, distribution or interest payment
|
N/A
|
||
|
41
|
Reason
for request for quotation now
Example:
In the case of restricted securities, end of restriction
period
(if
issued upon conversion of another security, clearly identify that
other
security)
|
N/A
|
||
|
Number
|
+Class
|
|||
|
42
|
Number
and +class
of all +securities
quoted on ASX (including
the securities in clause 38)
|
|||
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 8
|
Quotation
agreement
| 1 |
+Quotation
of our additional +securities
is in ASX’s absolute discretion. ASX may quote the +securities
on any conditions it decides.
|
| 2 |
We
warrant the following to ASX.
|
|
·
|
The
issue of the +securities
to be quoted complies with the law and is not for an illegal
purpose.
|
|
·
|
There
is no reason why those +securities
should not be granted +quotation.
|
|
·
|
An
offer of the +securities
for sale within 12 months after their issue will not require disclosure
under section 707(3) or section 1012C(6)
of
the Corporations Act.
|
Note:
An
entity may need to obtain appropriate warranties from subscribers for the
securities in order to be able to give this warranty
|
·
|
Section
724 or section 1016E of the Corporations Act does not apply to any
applications received by us in relation to any +securities
to be quoted and that no-one has any right to return any +securities
to be quoted under sections 737, 738 or 1016F of the Corporations
Act at
the time that we request that the +securities
be quoted.
|
|
·
|
We
warrant that if confirmation is required under section 1017F of the
Corporations Act in relation to the +securities
to be quoted, it has been provided
at
the time that we request that the +securities
be quoted.
|
|
·
|
If
we are a trust, we warrant that no person has the right to return
the
+securities
to be quoted under section 1019B of the Corporations Act
at
the time that we request that the +securities
be quoted.
|
| 3 |
We
will indemnify ASX to the fullest extent permitted by law in respect
of
any claim, action or expense arising from or connected with any breach
of
the warranties in this agreement.
|
| 4 |
We
give ASX the information and documents required by this form. If
any
information or document not available now, will give it to ASX before
+quotation
of the +securities
begins. We acknowledge that ASX is relying on the information and
documents. We warrant that they are (will be) true and
complete.
|
Sign
here: ................................................. Date:
27
September 2006
(Company
secretary)
Print
name: Aaron
Finlay
| + See chapter 19 for defined terms. | |
| 1/1/2003 |
Appendix
3B
Page 9
|
|
|
|
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ASX/MEDIA RELEASE
|
26
September
2006
|
pSivida
appoints non-executive Director to Audit Committee
Boston,
MA and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:
PSD,
NASDAQ: PSDV, Xetra: PSI) is pleased to announce
the appointment of Stephen Lake to the Company’s audit committee effective
as of September
20,
2006.
Mr. Lake
has been a member of the Company’s board of directors since July 30,
2004.
This
appointment was
made
on the same day as and prior to the Company’s receipt of a Nasdaq Staff
Deficiency Letter indicating that, as a result of the recent resignation of
Heather Zampatti from the Company’s board of directors and audit committee, the
Company was not in compliance with the requirements of Marketplace
Rule 4350. That rule mandates, among other things, that the Company
maintain an audit committee comprised of not fewer than three independent
directors.
As
a
result of Mr. Lake’s appointment to the audit committee, the company
is
in
compliance with
Marketplace
Rule 4350, and the Company has received a compliance letter from Nasdaq
acknowledging that fact.
-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
|
European
Public Relations
Accent
Marketing Limited
Eva
Reuter
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
|
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 (QQ.)
was instrumental in discovering BioSiliconTM
and
pSivida’s strong relationship with QinetiQ includes access to its cutting edge
research and development facilities.
This
document contains forward-looking statements that involve risks and
uncertainties. The statements reference potential products, applications and
regulatory approvals. 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 company to successfully close a new issue of
convertible notes; the failure of the Company to obtain the requisite
shareholder approval to issue the new convertible notes; failure to obtain
shareholder approval for the issue of shares underlying the ADS conversion
and
the warrant issues under the new convertible notes; our inability to raise
additional funds at favourable terms or any terms; our inability to repay the
amended notes and new convertible notes; issues relating to share registration
in the U.S. that may delay our registration; our inability to develop proposed
products, including without limitation, in the drug delivery, wound healing,
orthopaedics, and tissue engineering, diagnostics and food technology fields;
failure of our evaluation agreements to result in license agreements; failure
to
develop applications for BioSilicon™ due to regulatory, scientific or other
issues; failure to complete negotiations for new centers for the BrachySil™
phase IIb clinical trial for inoperable primary liver cancer; failure of
our discussions with the FDA for BrachySil™ to continue or to lead to FDA
approval; 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 of the BrachySil™ primary liver programme 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;
failure to commence phase IIa BrachySilTM trials for the treatment of
pancreatic cancer; 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 our two pancreatic cancer study centres; 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; failure of Medidur™ to release
fluocinolone acetonide at the same rate as Retisert™; our inability to recruit
patients for the phase III Medidur™ for DME trial. 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.