| ASX/Media RELEASE |
13
September
2006
|
RetisertTM
Wins International Award
Boston,
MA. and Perth, Australia — Global
bio-nanotech company pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) is
pleased to announce that a paper describing the initial clinical work on its
lead ophthalmology product RetisertTM,
has
been awarded first prize in the field of Clinical Uveitis by the DUAG (Deutsche
Uveitis-Arbeitsgemeinschaft), the umbrella organisation of all German uveitis
patient interest groups.
The
awards are to honour the three best publications in peer-reviewed journals
from
the previous year that have made a significant contribution to the area of
clinical or basic science in uveitis research, as judged by an international
committee of some of the world’s leading uveitis specialists.
‘Long-term
follow-up results of a pilot trial of a fluocinolone acetonide implant to treat
posterior uveitis’ published in Ophthalmology 2005
and
co-authored by pSivida’s Director of Strategy, Dr Paul Ashton, was awarded first
prize in the field of ‘Clinical Uveitis’.
|
|
Uveitis
is a leading cause of blindness
affecting an estimated ^175,000 people in the US, *200,000 persons
in the
EU and ^800,000 people worldwide.
Uveitis is a chronic auto-immune disease in which the body’s own defences
attack the inner lining of the eye (the uvea). Retisert™
is
the only FDA approved drug for this disease. Surgically implanted
into the
eye, Retisert™ is approved to release a constant amount of the drug,
fluocinolone
acetonide,
over a treatment period of 30
months.
|
pSivida
receives royalties from sales of Retisert™ which sells for US$18,250 and covered
in the United States by Medicare and Medicaid. Retisert™ was approved by the FDA
in late 2005 and licensed to Bausch
& Lomb (B&L). A dedicated Retisert™
website
was recently launched by B&L www.retisert.com.
*Source:
European Medicines Agency
^Source:
Bausch & Lomb
-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
|
|
European
Public Relations
Eva
Reuter
Accent
Marketing Limited
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.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 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 BioSiliconTM
and
pSivida’s strong relationship with QinetiQ includes access to its cutting edge
research and development facilities.
This
document contains forward-looking statements that involve risks and
uncertainties. The statements reference potential products, applications
and regulatory approvals. 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 company to successfully close a new issue of
convertible notes; the failure of the Company to obtain the requisite
shareholder approval to issue the new convertible notes; failure to obtain
shareholder approval for the issue of shares underlying the ADS conversion
and
the warrant issues under the new convertible notes; our inability to raise
additional funds at favourable terms or any terms; our inability to repay the
amended notes and new convertible notes; issues relating to share registration
in the U.S. that may delay our registration; our inability to develop proposed
products, including without limitation, in the drug delivery, wound healing,
orthopaedics, and tissue engineering, diagnostics and food technology fields;
failure of our evaluation agreements to result in license agreements; failure
to
develop applications for BioSilicon™ due to regulatory, scientific or other
issues; failure to complete negotiations for new centers for the BrachySil™
phase IIb clinical trial for inoperable primary liver cancer; failure of
our discussions with the FDA for BrachySil™ to continue or to lead to FDA
approval; 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 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;
failure to commence phase IIa BrachySil™ trials for the treatment of
pancreatic cancer; 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 our two pancreatic cancer study centres; 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; failure of Medidur™ to release
fluocinolone acetonide at the same rate as Retisert™; our inability to recruit
patients for the phase III Medidur™ for DME trial. 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.