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| ASX/Media
RELEASE |
28
April 2006
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pSivida
Quarterly Cashflow - March 2006
Commentary
and Highlights
RetisertTM
royalties rising, as sales increase
Cost
savings from acquisition
Global
bio-nanotech company pSivida Limited is pleased to release its quarterly
cashflow statement for the period ending the 31st
of
March, 2006.
Following
the acquisition of pSivida Inc. (formerly Control Delivery Systems Inc.) on
the
30th
of
December, 2005, the March quarter is the first whole quarter that includes
the
results of the recently acquired US business.
It
is
important to note that the net operating cash outflow for the quarter has been
limited to AU$4.8 million, an increase of AU$203,000 or 4.4% when compared
the
previous quarter. Despite this increase, cash outflows were mitigated as a
result of cost synergies being realised between the two companies, a review
of
costs being undertaken and implemented during the period and the receipt of
payments from collaborative partners and Retisert™
royalties. Cost synergies from the merger are continuing to be pursued with
greater use to be made of our Boston facilities.
Retisert™
royalties that would have otherwise been earned from launch in the United States
in the second half of 2005 to the 31st
of
March, 2006 totalled AU$1.25 million (US$894,144). It should be noted,
however that this amount is reduced by 50% in accordance with an advance royalty
agreement Control Delivery Systems entered into with Bausch & Lomb in June
2005 and we refer you to a detailed analysis of Retisert™
royalties within the Appendix 4C.
In
February, Bausch & Lomb appointed global pharmaceutical company, Novartis to
co-promote Retisert™ for uveitis in the United States, significantly increasing
the number of sales representatives dedicated to the promotion of
Retisert™.
Post
Quarter Highlights and Announcements
BrachySil™
clinical development programmes progress
The
clinical development of pSivida’s targeted oncology product has progressed with
further recruitment into the ongoing multicentre phase IIb trial in primary
liver cancer. The clinical programme for pancreatic cancer progressed with
the critical regulatory agency clinical trial applications filed with European
and Asian agencies as the prerequisite for treatment of the first patients
in
this second indication of high unmet medical need.
Positive
European trial results for Retisert™
for Uveitis
Two
year
results from Bausch & Lomb’s European clinical trial of Retisert™
for the
treatment of chronic non-infectious posterior
segment uveitis showed
the
recurrence rate for uveitis was significantly lower in
eyes
receiving Retisert™
than in
eyes receiving standard of care (systemic
corticosteroid or other immunosuppressive agents).
The
study involved 146 patients across ten countries in Europe and the Middle East.
These results were presented at the prestigious
6th
International Symposium on Ocular Pharmacology and Therapeutics in Berlin that
commenced on the 30th
of
March, 2006.
pSivida
signs new evaluation agreements for cardiovascular drug
delivery
pSivida
entered into an evaluation agreement with an undisclosed large medical device
company to evaluate cardiovascular
delivery of drugs using pSivida’s drug delivery technologies. The
agreement
demonstrated that pSivida’s drug delivery technologies are being evaluated in
areas beyond ophthalmology and oncology treatments
and
follows
recent announcements that pSivida had signed evaluation agreements with
various companies, including large global pharmaceutical companies, to evaluate
pSivida’s proprietary platform technology for their developmental compounds.
pSivida has licensing agreements with Bausch & Lomb, Alimera Sciences and
Beijing Med-Pharm and evaluation agreements with three of the five largest
pharmaceutical companies in the world.
In
non-core areas, pSivida has signed two new material evaluation agreements this
year for BioSilicon™
to be
incorporated into devices with larger US based companies.
Retisert™
slows progression of Diabetic Retinopathy in DME trials
Additional
two year trial results of Bausch & Lomb’s two randomized trials to evaluate
the safety and efficacy of the Retisert™
implant
in releasing fluocinolone acetonide in the management of Diabetic Macular Edema
(DME) demonstrated that 30% of eyes receiving standard of care (repeat laser
treatment) had a worsening of their Diabetic Retinopathy compared with only
10%
of eyes receiving a Retisert™
implant.
This was statistically significant. Retisert™
also
reduced retinal thickening involving the fovea (the centre most part of the
macula responsible for sharp, central vision) and led to a statistically
significant three line improvement in vision. The trial results were presented
at the prestigious 6th
International Symposium on Ocular Pharmacology and Therapeutics in Berlin that
commenced on the 30th
of
March, 2006.
Highlights
and Announcements for the Quarter
DSMB
recommends continuation of Medidur™
Phase III clinical trial
Following
a planned interim review, a Data Safety Monitoring Board (DSMB) recommended
the
continuation of its Phase III clinical trial of Medidur™ following a meeting on
March 16, 2006 to review the Medidur™ Phase III clinical trial data. Medidur™, a
tiny injectable device, is being studied as a way to deliver fluocinolone
acetonide, a corticosteroid, to the retina for up to three years as a treatment
for diabetic macular edema (DME). After reviewing the preliminary safety data
from the initial US patients enrolled in the Medidur™ trial, the DSMB agreed
that enrolment should accelerate in the Phase III trial under the current
protocol. The DSMB provides independent evaluation of study data to identify
potential safety issues that might warrant modification or early termination
of
ongoing studies.
Medidur™ manufacture
certified to be GMP equivalent to EU standards
Following
an independent audit of its Boston, Massachusetts facility by a European
Qualified Person (QP), the QP issued a certificate that Medidur™
is
manufactured to a standard of Good Manufacturing Practice (GMP) equivalent
to
that in the European Union, as set out in directive 2003/94/EC and the EC Guide
to GMP.
pSivida
added to new Nanotechnology Index
pSivida
has been included in a new nanotechnology index established by The Nanotech
Company, LLC, of San Diego, California. The Nanotechnology.com ‘Small
Technology’ Index is composed of 30 of the leading, international,
publicly-traded companies and is designed to mimic the portfolio of a
sophisticated fund manager with US$30 million to place in the area of small
tech
and nanotechnology. The index is diversified by geography, industry sector,
type
of small tech, market capitalization and other criteria and does not include
Fortune 500 companies with relatively insignificant small tech product revenue.
Rather, the index focuses on companies that are primarily involved in the
nanotech space, such as pSivida.
Diabetic
Macular Edema trial with Retisert™
Preliminary
three year follow-up data from Bausch
& Lomb’s
multi-center, randomized, controlled clinical trial of Retisert™
for the
treatment of diabetic macular edema (DME)
showed
that significantly more patients receiving a Retisert™
implant
had improved visual acuity (of three or more lines on an eye chart) than those
receiving standard of care.
Uveitis
long term trial results positive for pSivida
Preliminary
three year follow-up data from Bausch
& Lomb’s
multi-center, randomized, dose-masked clinical trial of Retisert™
for the
treatment of chronic non-infectious posterior
segment uveitis showed
that the recurrence rate was significantly lower in
eyes
receiving Retisert™
than in
non-implanted eyes. This study involved 278 patients from 27 hospitals in the
United States and one in Singapore.
Novartis
to co-promote Retisert™
with Bausch & Lomb
Retisert™,
developed by pSivida, is the world’s first intravitreal drug implant for the
treatment of chronic noninfectious posterior segment uveitis, a sight
threatening condition that affects an estimated 175,000 people in the United
States and an estimated 800,000 people worldwide. Licensed to Bausch & Lomb,
pSivida receives royalties on Retisert™
sales
with the collaboration with Novartis expanding the dedicated sales force of
Retisert™
in the
United States.
Several
new Pharma agreements for pSivida Inc.
Wholly
owned subsidiary pSivida Inc. entered
into a number of new evaluation agreements with various companies, including
large global pharmaceutical companies, to evaluate pSivida’s proprietary
platform technology for their developmental compounds. The
terms
of the new evaluation agreements vary,
but
are typically 12 months in duration with the costs being borne by the
counterparty.
Acquisition
of Control Delivery Systems
pSivida
completed the acquisition of Boston based private drug delivery company
Control
Delivery Systems (CDS), following overwhelming approval by pSivida shareholders
at the AGM held in November 2005. The
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.
Australian publication Bioshares 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.
CDS was
renamed pSivida Inc. and former CEO, Dr. Paul Ashton has been appointed to
the
pSivida Board and is now the Director of Strategy, based in Boston.
Non-executive
Director appointed
Ms.
Heather Zampatti has been appointed as a Non-executive Director of the Company,
based in Perth, Australia. Ms.
Zampatti is the National Head of Wealth Management, Australia for Bell Potter
Securities, an Australian-owned private investment adviser and Top 10 broker
by
trading volume on the Australian Stock Exchange. Ms. Zampatti has over 20 years
experience in investment advising and her expertise in stockbroking and
financial investment planning is widely acknowledged in the Australian
investment community. The appointment of Ms. Zampatti to the pSivida Board
replaces Ms. Alison Ledger who has stepped down after 18 months of service
to
focus on new career initiatives. We thank Alison for her valuable contribution
and wish her well in her future endeavours.
-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 / 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. 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 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 2001 from
the
UK Government's Defence Evaluation & Research Agency (DERA). QinetiQ
was instrumental in discovering BioSilicon™
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: 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 BioSilicon™
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.
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.