FORM
6-K
REPORT
OF
FOREIGN ISSUER
Pursuant
to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
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)
(Translation of registrant’s name into English)
Level
12
BGC Centre
28 The Esplanade
Perth WA 6000
(Address of principal executive offices)
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: May 2, 2006 | By: | /s/ Aaron Finlay |
|
Aaron
Finlay
Chief
Financial Officer and Company Secretary
|
||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
Rights
Issue to fund late stage Macular Edema trials and commencement of
Pancreatic Cancer trials
|
|
EXHIBIT
99.2:
|
Appendix
3B Rights Issue
|
 |
|
| ASX/MEDIA RELEASE | |
|
2
May
2006
|
Rights
Issue to fund late stage Macular Edema trials and commencement of Pancreatic
Cancer trials
Boston,
MA and Perth, Australia - Global bio-nanotech company pSivida Limited
(NASDAQ:PSDV,
ASX:PSD, Xetra:PSI)
today
announced details of a Non-Renounceable
Rights
Issue offering one new ordinary share for every eight shares held at
22nd
May
(“the Record Date”) at an issue price of AU$0.60 per share.
The
issue
price represents an 18% discount to the 30 days volume weighted average closing
price (VWAP) on
the
ASX up
to
1st
May
being the last trading day and a 7% discount to the 5 day VWAP. Excluding the
effect of vested options which may be exercised prior to the Record Date, the
Rights offering could result in the issue of up to 48.25 million new ordinary
shares, raising gross proceeds of approximately AU$29 million
(US$22m).
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 being
registered in the U.S. under the U.S. Securities Act of 1933, as amended (the
"Act"), or any U.S. state securities laws, and Rights and Shares will not and
may not be issued, offered, sold or transferred in the U.S. or to any
U.S. persons
unless (i) they are registered under the Act or an exemption from the
registration requirements of the Act is available, or (ii) the offer, sale
or
transfer is performed in accordance with regulations under the Act.
The
Rights Issue is not underwritten but pSivida will seek to place any shortfall
with institutional and sophisticated investor
clients of our U.S. based Lead Manager, Janney Montgomery Scott LLC, and certain
co-managers appointed for this issue. Any
ordinary shares issued in the U.S. in connection with the Rights Issue as a
result of any shortfall will be issued in an unregistered action. These shares
will not be registered under the Act and may not be offered or sold in the
U.S.
absent registration or an applicable exemption from registration
requirements.
Capital
raised from this Rights Issue will primarily fund the phase III clinical trials
of MedidurTM
for the
treatment of Diabetic Macular Edema (DME), and phase IIa clinical trials of
our
lead BioSiliconTM
product,
BrachySilTM
which is
being developed for the treatment of inoperable pancreatic cancer. pSivida
expects to receive a significantly greater return by funding the
MedidurTM
trials
under the Co-Development Agreement to receive a profit share with Alimera
Sciences rather than a straight royalty which would be payable if we did not
co-fund the trials.
The
Record Date for the Rights Issue is 22nd
of May.
It is expected that New Shares issued under the Entitlement Offer to eligible
shareholders will be quoted on a deferred settlement basis on 8th
June
with normal trading for all New Shares issued under the Offer expected to
commence as soon as practicable after that date. Further details on the proposed
timetable for the Rights Issue will be set out in the prospectus. Any ordinary
shares issued in the U.S. in connection with the Rights Issue will be issued
in
an unregistered transaction. Applications are expected to close on the
7th
June.
A
prospectus for the Rights Issue will be made available when the New Shares
are
offered and applicants under the Rights Issue wishing to apply for New Shares
will need to complete the application form that will be in or will accompany
the
prospectus.
-ENDS-
Released
by:
|
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
|
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 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 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.
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.
