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 November 2005
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:
November 02, 2005
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron Finlay |
||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
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EXHIBIT
99.1:
|
pSivida
September Quarter Cashflow Report - Commentary &
Highlights
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|
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EXHIBIT
99.2:
|
Appendix
4C - September 2005
|
-2-
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ASX/Media
RELEASE
|
31
October 2005
|
pSivida
Quarterly Cashflow - September 2005
Commentary
and Highlights
Global
bio-nanotech company pSivida Limited, is pleased to release its quarterly
cashflow statement for the period ending 30th
September 2005.
Post
Quarter Highlights and Announcements
First
Licence agreement for BrachySilTM
pSivida
signed a Licence with Beijing Med-Pharm Corporation (BJGP:PK)
for the
clinical development, marketing and distribution of pSivida’s lead product,
BrachySilTM,
in
China. The Licence includes upfront and milestone payments in excess of US$2m
and royalties ranging up to 30%, depending upon level of sales, payable to
pSivida by Beijing Med-Pharm. China has the highest incidence of primary
liver
cancer in the world with over 345,000 estimated new cases per annum (Globocan),
representing 55% of total worldwide cases. Beijing Med Pharm is the only
non-Chinese company with pharmaceutical distribution rights in China via
its
purchase in December 2004 of Beijing
Wanwei Pharmaceutical Ltd,
a
pharmaceutical distributor covering the bulk of Beijing's hospitals. In an
historic event, this purchase was approved by the Ministry of Commerce of
the
People's Republic of China on October 18, 2005.
Planned
acquisition of Control Delivery Systems
pSivida
entered into a definitive merger agreement to acquire Control Delivery Systems
(CDS), a US based drug delivery company, with the potential to create a global
bio-nanotech company specializing in drug delivery, with revenues from existing
products and generating long-term value through its diversified late-stage
product portfolio. The
planned acquisition, an integral part of pSivida’s on-going US growth strategy,
will bring additional development and regulatory expertise to pSivida’s
management team. This combination also provides 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.
CDS
recorded revenues in FY2005 of AU$11m, with revenues expected in the current
financial year from the sale of RetisertTM,
an
intravitreal
drug implant for the treatment of Uveitis that threatens the eyesight of
an
estimated 175,000 people in the US and an estimated 800,000 people worldwide.
RetisertTM
is
marketed by Bausch & Lomb and was recently given approval for full Medicare
rebate in the US.
Commencement
of Phase IIb liver cancer trials for BrachySil™
Phase
IIb
clinical trials commenced with BrachySil™ (32-P BioSilicon™) as a potential new
brachytherapy treatment for inoperable primary liver cancer (hepatocellular
carcinoma, HCC). The first patient has successfully received treatment at
Singapore General Hospital using a new fine-gauge needle multi-injection
device
which will enable for the first time, larger and also multiple tumors to
be
treated. A total of 50 patients will be entered into this multi-centre trial
which will be conducted in Singapore, Malaysia and Vietnam. BrachySil™ trials
for pancreatic cancer will commence in the first quarter of
2006.
pSivida
rings Closing Bell at NASDAQ
pSivida
CEO, Mr Gavin Rezos, presided over the NASDAQ Closing Bell Ceremony at the
Times
Square NASDAQ Market site in New York city. pSivida listed on a Level 2 American
Depositary Receipt (ADR) programme on the NASDAQ National Market in January
2005
in which Citigroup was selected as the Depositary Bank to administer the
ADR
programme. The number of ADR’s on issue has more than quadrupled over this
period reflecting the greater visibility the Company has achieved in the
US, the
world’s largest healthcare and investment markets.
pSivida
secured additional US$15m funding
Castlerigg
Master Investments, a New York based institutional investor, signed an agreement
with pSivida to purchase US$15m (AU$20m) of Subordinated Convertible Debentures
convertible into PSDV ADR’s at an initial conversion price of US$7.10 (AU$0.95)
per ordinary share. The proceeds of the issuance are expected to be used
for the
expanded development of pSivida’s platform technology, BioSiliconTM.
Highlights
and Announcements for the Quarter
pSivida
completes manufacturing infrastructure for BrachySil™ Cancer
Therapy
pSivida’s
manufacturing partner QSA, has completed the construction and validation
of a
state-of-the-art cleanroom facility, dedicated to the supply of pSivida’s lead
cancer therapy BrachySil™, at QSA’s Auriga Medical™ facility in Braunschweig,
Germany. This GMP facility will fulfil the final process in the manufacture
of
BrachySil™ for future clinical and commercial use, and represents the crucial
final stage in establishing the manufacturing and supply infrastructure to
support BrachySil™ as it advances through clinical trials towards the
market.
Collaboration
with Cirrus Pharmaceuticals
pSivida
signed a contract with US based Cirrus Pharmaceuticals, Inc. to accelerate
and expand development of a number of specific drug candidates formulated
in
BioSiliconTM
to
expand
a BioSiliconTM
product
pipeline of reformulated drugs. The development contract has an initial
extendable term of one year and provides a dedicated team of scientists from
Cirrus
Pharmaceuticals.
The
relationship has been established to generate new products based on
reformulating existing specific generic and proprietary drugs and their delivery
utilizing BioSiliconTM.
To the
extent that such new reformulations or delivery demonstrate improved efficacy,
safety and/or compliance as compared to the original product, then pSivida
will
be able to claim patent protection on its new products. All intellectual
property developed through this collaboration relating to BioSiliconTM
will be
wholly owned by pSivida.
5th
US Patent granted - monodispersed porous silicon particles
pSivida
has been granted a 5th patent in the important US market. US Patent Number
6,929,950 provides for the classification of porous silicon into monodispersed
particles with a tight size distribution. The classification into defined
size
distributions is a key attribute of many micro-engineered particle products.
This patent provides an important manufacturing aspect to the pSivida portfolio
as it covers additional dimensions in the formulation of drug delivery products.
The successful manufacture of ‘monodisperse’ systems not only enables improved
control and flexibility in drug delivery to patients but it also makes the
regulatory registration process simpler as the product offers better definition
and less variability.
pSivida
becomes the founding member of the NASDAQ Health Care
Index
pSivida’s
inclusion on the Health Care Index is recognition of pSivida’s increased
visibility in the US, the world’s largest health care and financial market, and
follows its recent listing on the Merrill Lynch Nanotechnology Index. The
NASDAQ
Health Care Index is a market value weighted index that contains NASDAQ-listed
companies classified, according to the FTSE Global Classification System,
as
"Health", "Pharmaceutical" or "Biotechnology". These classifications include
health maintenance organisations, hospital management and long-term care,
medical equipment and supplies, other health care, biotechnology, and
pharmaceutical companies.
pSivida
appoints two US based Non-executive Directors
Dr
David
J Mazzo was appointed as a Non-executive Director of the company, based in
New
Jersey, USA. He is President and CEO of Chugai Pharma USA, part of the Roche
group of companies, and is a subsidiary of Chugai Pharmaceutical Company
Limited
(Japan), a global research-based pharmaceutical company with sales in 2001
of
US$1.7 billion. Dr Mazzo brings his significant business development experience
and pharmaceutical network to the Board and is recognized
for his strong scientific and regulatory expertise with broad technical and
managerial experience gained from working in a variety of multi-cultural
and
multi-lingual environments in the US, Europe and Asia.
Mr
Michael W Rogers was appointed as a Non-executive Director of the company,
based
in Massachusetts,
USA. He
is the Executive Vice-President, Chief Financial Officer and Treasurer of
Indevus Pharmaceuticals Incorporated, a biopharmaceutical company based in
Lexington, MA. which is engaged in the acquisition, development and
commercialisation of products targeting certain medical specialty areas
including urology and infectious diseases. Mr Rogers brings his significant
financing, acquisition, investment banking and partnering experience relating
to
pharma and biotech companies to the pSivida Board and will Chair the Audit
Committee.
pSivida
closes ADR PIPE after raising US$4.3m
pSivida
raised US$4.3m (AU$5.7m) before costs via the private placement of 665,000
ADR’s
to predominantly US investors at US$6.50 (AU$8.61) each, with each ADR
representing 10 ordinary shares. New York based Securities Dealers, Hunting
Party Securities Ltd placed the ADR’s which was structured as a PIPE (Private
Investment in Public Equity) and limited to the aforementioned amount given
the
recent announcement of a potential acquisition. The ADR’s have an attached 1 for
10, 3 year warrant exercisable for US$12.50 per ADR. The ADR’s will become
tradable on NASDAQ upon filing of a registration statement by pSivida with
the
Securities and Exchange Commission which is expected to take up to 120 days
in
view of the potential acquisition.
-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
|
UK
& Europe Public Relations
Mark
Swallow, PhD / Helena Podd
Citigate
Dewe Rogerson
Tel:
+44 (0)20 7282 2948 / 2867
mark.swallow@citigatedr.co.uk
|
NOTES
TO EDITORS:
pSivida
Limited
pSivida
is a global bio-nanotech company committed to the biomedical sector and the
development of products in healthcare. The company’s focus is the development
and commercialisation of a modified form of silicon (porosified or
nano-structured silicon) known as BioSilicon™.
pSivida
owns the intellectual property pertaining to BioSilicon™ for use in or on humans
and animals. The IP portfolio consists of 29 patent families, 34 granted
patents
and over 80 patent applications. The core patent, which recognises BioSilicon™
as a biomaterial was granted in the UK in 2000 and in the US in 2001.
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’s shares also trade in the United Kingdom on the OFEX International
Market Service (IMS) under the ticker symbol PSD.
pSivida
is a founding member of the NASDAQ Health Care Index and the Merrill Lynch
Nanotechnology Index.
The
Company's strategic partner and largest shareholder 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 on QinetiQ visit www.QinetiQ.com
For
more
information visit www.psivida.com
