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 October 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:
October 27, 2005 |
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pSivida
Limited
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|
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By: |
/s/ Aaron
Finlay |
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Aaron
Finlay |
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Chief
Financial Officer and Company
Secretary |
EXHIBIT
INDEX
EXHIBIT
99.1:
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Beijing
Med-Pharm Licence
|
27
October 2005
Beijing
Med-Pharm Licence
Upfront
and milestone payments
BrachySilTM
entry
point for China
Global
bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that it has 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.
Under
the
terms of the Licence, pSivida will manufacture BrachySilTM
and
Beijing Med-Pharm will be responsible for clinical development, securing
regulatory approval, marketing and distribution in China. pSivida will retain
manufacturing rights for BrachySilTM
under
the Licence. It is a condition of the licence that a Manufacturing and Supply
Agreement for pSivida to supply BrachySilTM
to
Beijing Med-Pharm is concluded within 90 days.
The
Licence includes upfront and milestone payments in excess of US$2 million
and
royalties ranging up to 30%, depending upon level of sales, payable to pSivida
by Beijing Med-Pharm.
Beijing
Med-Pharm is a US-based company with Chinese subsidiaries that offers an
end-to-end solution to primarily Western pharmaceutical companies who wish
to
sell their products into the Chinese marketplace. In December 2004, Beijing
Med-Pharm initiated the first ever purchase of a Chinese
pharmaceutical distribution company by a foreign entity
after
it signed an agreement to purchase Beijing Wanwei Pharmaceutical
Ltd.,
a
pharmaceutical distributor covering the bulk of Beijing's
hospitals.
BrachySilTM
(32-P
BioSilicon™) will enter a Phase IIb dose-profiling study shortly as a potential
new treatment for primary liver cancer (also called hepatocellular carcinoma
or
HCC). China has the highest incidence of HCC in the world, with over 345,000
estimated new cases per annum (Globocan), representing 55% of total worldwide
cases. Given the clinical proof of principle already established for
BrachySilTM,
focused
programmes are being prepared to exploit its broader utility in other
significant cancer indications, including inoperable pancreatic and secondary
liver disease.
Gavin
Rezos, CEO of pSivida said, “China is the world’s fastest growing market for
pharmaceuticals with a large and steadily increasing incidence of the types
of
cancer that we believe BrachySilTM
can
effectively treat. Gaining entry into this market, through partners such
as
Beijing Med-Pharm, is an important part of pSivida’s global commercial strategy.
This
agreement clearly validates the commercial potential of the
BrachySilTM
product
and technology, and will serve as a robust platform for further licensing
agreements for BrachySilTM
in other
territories, including Europe and the United States”.
Martyn
Greenacre, Chairman of Beijing Med-Pharm said, “BrachySilTM
is a
highly innovative product addressing a significant patient population in
China
and thus an important addition to our portfolio of products to be
commercialized. The growing middle class in China allows for a growing and
significant population with the ability to pay for medicines of this
type”.
pSivida
Limited recently announced that it had entered into a definitive merger
agreement to acquire Control Delivery Systems, 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.
-ENDS-
Released
by:
pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
Beijing
Med-Pharm Corporation
Ben
Austin
Tel:
+1 (917)
686-3979
baustin@beijingmedpharm.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
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™. As a new and exciting
biocompatible material, BioSilicon™ offers multiple potential applications
across the high growth healthcare sector, including controlled release drug
delivery, targeted cancer therapies (including brachytherapy and localized
chemotherapy), tissue engineering and orthopedics. Potential diagnostics
applications are being developed through its subsidiary AION Diagnostics
Limited.
pSivida
owns the intellectual property rights 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 the QinetiQ group, the
largest science and technology company in Europe. QinetiQ is the former UK
government Defence Evaluation Research Agency and was instrumental in
discovering BioSilicon™. pSivida enjoys a strong relationship with QinetiQ
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
About
Beijing Med-Pharm Corporation
Beijing
Med-Pharm Corporation is a pharmaceutical marketing company that offers the
following services in China through its wholly-owned subsidiary, Beijing
Med-Pharm Market Calculating Co. Ltd.: pre-market entry analysis; clinical
trial
management; product registration; market research; and pharmaceutical marketing
to physicians, hospitals and other healthcare providers.
In
December 2004, Beijing
Med-Pharm signed an agreement to purchase Beijing Wanwei Pharmaceutical
Ltd.,
a
pharmaceutical distributor covering the bulk of Beijing's hospitals. This
is the
first-ever purchase of a Chinese pharmaceutical distribution company by a
foreign entity, permitted only after a December 2004 change in Chinese law.
By
adding this distributor to its existing sales and marketing services, upon
completion of the acquisition, Beijing Med-Pharm will offer an unparalleled
opportunity to reach China, the world's fastest-growing market.
For
more
information, visit www.beijingmedpharm.com
This
document contains forward-looking statements that involve risks and
uncertainties. 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. 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.