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 31,
2006 |
|
|
|
pSivida
Limited |
|
|
|
|
By: |
/s/ Aaron
Finlay |
|
Aaron
Finlay |
|
Company
Secretary |
EXHIBIT
INDEX
EXHIBIT
99.1:
|
pSivida
Directors to take up Entitlements under the Rights
Issue
|
EXHIBIT
99.1:
|
|
ASX/MEDIA
RELEASE
|
30
May
2006
|
pSivida
Directors to take up Entitlements under
the
Rights Issue
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited
(ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that the Directors of the Company have confirmed that they
will be taking up rights to subscribe for pSivida shares under their respective
individual eligible entitlements.
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.
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, and 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, the U.S. based Lead Manager for this issue, to
institutional and sophisticated investors. Any ordinary shares issued in the
U.S. in connection with the Rights Issue as a result of any shortfall 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 form 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. The period for placement of the shortfall is expected to be between 7
and
13 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:
Any
ordinary shares issued in the U.S. in connection with the Rights Issue as a
result of any shortfall 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 form registration
requirements.
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 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
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. 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.