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
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
the month of January 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.
Date:
January 3, 2006
| pSivida Limited | ||
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| By: | /s/ Aaron Finlay | |
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Aaron
Finlay
Chief
Financial Officer and Company
Secretary
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EXHIBIT
INDEX
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EXHIBIT
99.1:
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pSivida
completes acquisition of Control Delivery Systems Inc.
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 |
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| ASX/MEDIA RELEASE |
3
JANUARY 2006
|
pSivida
completes acquisition of
Control
Delivery Systems
Global
bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that on 30 December 2005 it completed the acquisition
of
Control Delivery Systems, Inc. (“CDS”), a private US drug delivery company
located in the Boston, Massachusetts area. CDS
has
been renamed pSivida Inc.
This
acquisition is an integral part of pSivida’s on-going US growth strategy. CDS’
portfolio of products and product candidates includes two approved and marketed
products, one Phase III product and other early-stage product candidates.
The
acquisition of CDS will bring additional product development and regulatory
expertise to pSivida’s management team and provide pSivida with an operating
base in the Boston biotech hub, enhancing its 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.
The
acquisition was overwhelmingly approved by pSivida shareholders at its Annual
General Meeting held in November, with 99.9% of proxies in favour. pSivida
is
now one of the world’s first bio-nanotech companies with product and licensing
revenues and has operations in the US, UK, Singapore and Australia. pSivida
shares are traded on the NASDAQ, Frankfurt and Australian
exchanges.
The
acquisition was funded through the issuance of approximately
16 million pSivida American Depositary Shares (“ADSs”) to CDS stockholders,
representing approximately 41.5% of the ownership of the combined
company. CDS
shareholders will be subject to lock-up periods ranging
from 6 to 9 months, while pSivida Executive Directors have agreed to a voluntary
6 month lock-up period.
pSivida
now owns the only two FDA approved sustained release drug delivery systems
for
the back of the eye, Vitrasert®and
RetisertTM.
pSivida
also now owns another sustained release drug delivery system in phase III
trials, MedidurTM
at
a time
when the Company believes that the ophthalmology market is growing strongly,
particularly in developing drugs for age related macular degeneration and
diabetic retinopathy.
RetisertTM,
marketed by global US ophthalmology company Bausch & Lomb, is a treatment
for chronic, non-infectious uveitis affecting the posterior segment of the
eye,
a debilitating eye disease that is the third largest cause of blindness in
the
US, affecting 175,000 people. RetisertTM was
approved in October, 2005 for full US CMS (Medicare) coverage at a rate of
US$19,345 which is 106% of the wholesale price of the device of US$18,250.
“Bausch
& Lomb in its last quarterly commentary said that the sales outlook for
RetisertTM
is
bright,” said Mr Gavin Rezos, MD and CEO of pSivida Limited. In addition to
uveitis, Bausch & Lomb has the right to use RetisertTM
as a
delivery system for compounds to treat other eye diseases.
Former
CEO of CDS, Dr Paul Ashton has accepted the position of Executive Director
of
Strategy of pSivida Limited and will be based at pSivida Inc. headquarters
near
Boston.
Combined
company’s marketed products and lead product candidates:
|
Marketed
|
RetisertTM for
Uveitis
|
An
intravitreal drug implant marketed by Bausch & Lomb,
approved by the FDA
for the treatment of chronic non-infectious
uveitis affecting the posterior segment of the eye,
a
sight threatening inflammatory disease that
is the third largest cause of blindness in the US.
Two long-term, multi-center clinical trials of Retisert™ for DME are also
ongoing.
|
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Marketed
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Vitrasert®
for CMV Retinitis
|
An
intravitreal
drug implant marketed
by Bausch & Lomb,
approved by the FDA for the treatment of AIDS-related
Cytomegalovirus (CMV) Retinitis,
a
blinding condition in immune compromised patients.
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Phase
III
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MedidurTM for
Diabetic Macular Edima (DME)
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An
injectable, non-erodible intravitreal device for DME, designed
to be
administered in an office procedure. DME is a major cause of vision
loss
in working age patients.
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Phase
IIb
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BrachySilTM
for
non-operable liver cancer
|
A
non-degradable, radioactive 32-phosphorus form of BioSiliconTM
for the treatment of non-operable liver cancer tumours.
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Phase
IIa (1st
half 2006)
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BrachySilTM
for
non-operable pancreatic cancer
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A
non-degradable, radioactive 32-phosphorus form of BioSiliconTM
for the treatment of non-operable pancreatic cancer
tumours.
|
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Preclinical
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BioSilicon
TM
platform
technology
|
A
new and unique material produced from elemental silicon for use
in
controlled-release drug delivery and other applications across
the
healthcare sector.
|
Vitrasert®
and Retisert™ are trademarks of Bausch & Lomb incorporated
-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 in particular in oncology and
ophthalmology.
pSivida
owns or has the exclusive rights to use the intellectual property pertaining
to
BrachySil™, Medidur™, Retisert™ and Vitrasert®.
The
company’s IP portfolio consists of 70 patent families, 74 granted patents and
over 290 patent applications.
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structrured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopaedics, and tissue
engineering. pSivida has granted an exclusive licence to its subsidiary,
AION
Diagnostics Limited to develop and commercialise diagnostic products using
BioSilicon™, and has also granted an exclusive licence to its subsidriary,
pSiNutria Limited to develop and commercialise food technology applications
using BioSilicon™.
pSivida
conducts its operations from offices and facilities near Boston in
Massachusetts, 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 July 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: our failure to develop
applications for BioSiliconTM
due to
regulatory, scientific or other issues, our inability to successfully integrate
CDS’s operations and employees; the failure of the CDS’s products to achieve
expected revenues and the combined entity’s inability to develop existing or
proposed products. 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.