| ASX/Media RELEASE |
31
July
2006
|
pSivida
Quarterly Cashflow –
June 2006
Commentary
and Highlights
Focusing
business around late-stage product portfolio
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is pleased to release its quarterly cashflow statement
for the period ended June 30, 2006.
Cash
flow
The
net
operating cash outflow for the quarter was AU$7.4 million (US$5.5 million),
of
which AU$4.0 million (US$3.0 million) related directly to research and
development.
Novartis
Pharmaceutical Corporation (NVS - NYSX)
became a
co-marketing partner for Bausch & Lomb (BOL - NYSX) for RetisertTM
in the
US late in the first quarter of this calendar year. The Company believes that
RetisertTM
revenues
do not yet reflect the full impact of Novartis, as this co-marketing partnership
was only recently signed. Royalty revenue for the fiscal quarter ended June
30,
2006 is expected to total approximately AU$336,000 (US$250,000). However, this
amount is reduced by 50% in accordance with an advance royalty agreement the
Company entered into with Bausch & Lomb in June 2005.
In
the
quarter ending September 30, 2006, the Company will redeem US$2.5 million of
the
Convertible Notes issued to Castlerigg Master Investments as more fully
described in our ASX release dated July 17, 2006, in connection with an
Amendment to the Convertible Note held by that entity. In a separate
announcement today, the Company announced the new issue of new AU$8.5 million
(US$6.5 million) Convertible Notes.
Operational
Restructure
The
Company is making operational changes to bring about significant cost savings
to
make more efficient use of resources
by
directing resources away from its earlier stage, higher risk research activities
and reducing spending in these areas. To this end, the research operation
located in our facilities in Malvern, UK is being reduced. The Company will
move
to reduce corporate overhead and reliance on external consultants as it moves
its head office from Perth, Australia to Boston over the coming
months.
MedidurTM
MedidurTM
is in
pivotal phase III clinical trials for diabetic macular edema (DME) and continues
on schedule in the US, Canada, Europe and Asia. The Company has partnered with
Alimera Sciences to develop MedidurTM
for DME.
DME
is
the
leading cause of blindness among Americans under the age of 65 affecting some
500,000 people and is
characterized by a swelling of the retina and loss of vision. Currently, the
only FDA approved treatment is laser therapy in which holes are burned into
the
macula with a laser. This treatment is often ineffective or generally provides
only temporary benefit. There are no approved drug therapies for the treatment
of DME.
MedidurTM
is also
being evaluated in other programmes funded by two of the five largest pharmas,
one of the largest medical device companies and smaller biotech companies for
the delivery of their respective proprietary compounds. Two of these programmes
have entered key pre-clinical in
vivo
evaluation. The Company considers that the broader exploitation of this
technology through funded collaborations potentially represents a fast-to-market
solution for our pharma industry partners and a value-generating opportunity
for
the Company’s business.
Retisert™
Retisert™
is licensed to global eye care company, Bausch & Lomb, and co-marketed in
the US by Novartis as a 30-month treatment for uveitis, a sight threatening
condition that affects an estimated 175,000 Americans. We expect the
co-promotion agreement between B&L and Novartis announced in February 2006
will increase the number of sales representatives dedicated to the promotion
of
Retisert™ which is covered by Medicare and Medicaid in the US and is priced at
US$18,250. The Company receives royalties on all Retisert™ sales. Bausch &
Lomb recently launched a website, www.retisert.com outlining important
information about the product for both patients and providers.
BrachySilTM
Development
of the BioSiliconTM
delivery
platform will focus on the leading clinical product BrachySilTM
which is
in multicentre phase IIb trials for primary liver cancer. The trial is being
reset to optimise the protocol following valuable clinical experience and
feedback gained in the first planned patient cohort. The study has provided
essential clinical data to support determination of the optimum dose for the
product and its effective delivery to larger tumours. Regulatory filing is
expected in late 2009.
In
parallel, the Company reports the successful preparation and approvals for
the
initiation of the planned European phase IIa trial of BrachySilTM
in
pancreatic cancer, a disease of high unmet clinical need and a significant
potential market opportunity for this targeted oncology therapy.
The
Company is presently in negotiation with potential licensees to share the cost
of both the liver and pancreatic cancer trials now that these trials have
entered more advanced stages of the development process.
BioSiliconTM
The
application of BioSiliconTM
for drug
delivery applications will focus on partner-funded R&D programmes, where the
Company is negotiating additional evaluation agreements.
The
BioSiliconTM
platform
has been further enhanced by the demonstration of adjuvant properties as
described in an announcement during the quarter as well the demonstration of
key
imaging properties by our subsidiary, AION Diagnostics.
The
Company continues to seek partners for the development of non-core areas
particularly in the area of wound management.
pSiNutria
The
Company has been reducing to practice key technology to support potentially
promising products in the food and nutraceutical area following upon the review
conducted with Lux Research Inc. of New York.
AION
Diagnostics
The
Company is considering strategic alternatives with respect to its interest
in
AION, including a partial sale of its interest to raise additional cash.
Additionally, the Company stands to receive potential revenue from its license
to AION of BioSiliconTM
technology for use in diagnostic products.
SEC
Registration
The
Company is preparing registration statements related to resales of shares issued
or issuable pursuant to the August 2005 PIPE, the November 2005 Convertible
Note
and the December 2005 acquisition of Control Delivery Systems (CDS) and
progressing through the SEC comment process. The timing of this process has
been
affected by Australia’s migration from Australian equivalent Generally Accepted
Accounting Principles (A-GAAP) to the requirement that historical financial
statements be reported using Australian equivalents to International Financial
Reporting Standards (A-IFRS) and the SEC’s requirement that the Company’s
reports be reconciled to accounting principles generally accepted in the United
States (US GAAP). No shares may be offered or sold by selling shareholders
until
the registration statements are declared effective or pursuant to an exemption
from registration.
Share
Registry
The
share
ownership has become more concentrated in the June quarter with the Top 10
shareholders reaching 76.5% of total shares on issue. European and US based
shareholdings continue to grow and combined represent a majority of the share
register.
External
Consultants
The
Company has renewed a mandate with Bio IB in New York for assistance in
licensing agreements including advancing current material
evaluation agreements to the next stage as well as assisting in the
potential sale of certain intellectual property assets to maximize returns
on
our R&D platform.
Janney
Montgomery Scott LLC in the US have been mandated on up to a 9 month term to
assist in restructuring the Company as a US entity to remove the current dual
reporting structure in US GAAP and A-IFRS and its associated accounting overhead
as well as assisting with additional financing. Janney Montgomery Scott will
also collaborate with Bio IB.
The
Company has appointed London based Navigator Asset Management Ltd on a 10 month
term on a monthly retainer, payable in advance and a one-off issue of warrants
over ADSs to advise on strategies to manage the potential restructuring,
redemption and/or repayment of the Company’s Convertible Notes, if any, and to
advise on any capital market products the Company may be offered.
Shareholder
Extraordinary Meeting
The
Company intends to call an extraordinary meeting of shareholders in Perth,
Australia, in the first half of September to obtain shareholder approval of
the
issue of shares underlying the ADS conversion and Warrant issues under the
new
US$6.5 million Convertible Note separately announced today, and to ratifying
the
future issue of additional shares underlying the revised ADS conversion and
Warrant issue under the existing Convertible Notes. If the shareholders approve
both issues, the Company’s 15% pool of shares available for future issuance will
be restored.
Post
Quarter Highlights and Announcements
pSivida
amends subordinated convertible debentures
The
Company signed an agreement with Sandell Asset Management Corporation,
investment advisor to Castlerigg Master Investments (the Note Holder) to revise
the terms of the Note Holder’s US$15,000,000 subordinated convertible debentures
Subject to the completion of mutually satisfactory documentation
BioSilicon™
demonstrates Adjuvant properties for delivery of Vaccines
The
novel
drug delivery platform, BioSilicon™
has
demonstrated the capability to act as an adjuvant when delivered with an
antigen. BioSilicon™
alone
does not stimulate the immune system. The BioSilicon-antigen combinations
resulted in an enhanced immune response based on in
vivo
antibody
responses. This finding opens up the potential for exploiting
BioSilicon™
not only
for the delivery of vaccines, but also enhancing the immune response to those
vaccines. The global market for vaccines is estimated at $8
billion.
Voluntary
Lock-up Period Expires On Acquisition Shares
The
voluntary lock up period applied to the American Depositary Shares (ADSs) issued
by the Company on the acquisition of CDS terminated on July, 1 2006. The
termination did not apply to certain employee-held, non-vested ADSs which may
not be sold for additional periods. The
Company filed a registration statement on Form F-3 to register the resale of
the
ADSs issued in relation to the CDS acquisition with the Securities Exchange
Commission and expects that the registration statement will be declared
effective in the near future. The ADSs issued in the acquisition may only be
sold pursuant to an effective registration statement or an exemption from
registration.
Highlights
and Announcements for the Quarter
pSivida
Rights Issue Closure
Proceeds
of AU$6,309,487 (US$4,795,209) before costs were raised through the issue of
10,515,811 new ordinary shares at an issue price of AU$0.60 per share. This
represents a subscription of 22% of the total shares available for subscription
under the Rights Issue,. A large number of shareholders reside outside Australia
and were therefore ineligible to participate. US holders who were ineligible
to
participate own approximately 45% of the Company. Eligible Directors of the
Company exercised their right to subscribe for ordinary shares. The Company
elected not to place the shortfall subscription shares due to current US market
conditions.
BioSilicon™
Breakthrough for pSivida's AION Diagnostics
Wholly
owned US subsidiary, AION Diagnostics Inc, discovered a novel new property
to
pSivida’s nanotechnology platform, BioSiliconTM.
The
biomaterial was shown to be effectively visualized on four key imaging
modalities; x-ray, ultrasound, CT and MRI. This discovery could eventually
lead
to AION Diagnostics being competitively positioned in the multi-billion dollar
imaging agent market.
Medidur™
DME Programme: Government Approvals for International Phase III
Trials
pSivida
Limited and Alimera Sciences jointly announced that regulatory agencies in
the
UK, Canada and India have approved the commencement of Phase III clinical trials
of the Medidur™ device for treatment of diabetic macular edema (DME). These
international clinical sites were opened in conjunction with the sites already
underway in the US. The Medidur development plan was already granted Fast Track
status in the US by the Food and Drug Administration (FDA).
BrachySil™
Pancreatic Program: Regulatory Approval for European Human
Trial
The
Regulatory Agency in the UK (The Medicines and Healthcare Products Regulatory
Agency or MHRA) granted approval to proceed with the first human study of
BrachySil™ in pancreatic cancer through a phase IIa clinical trial. The six
month clinical study in patients with inoperable pancreatic cancer will be
undertaken at two leading centres of cancer treatment, Guys & St Thomas’
Hospital in London (UK) and Singapore General Hospital. The trial represents
the
“first-in-Man” safety study for BrachySil™ in this indication and is designed to
enrol a total of 15 patients. The primary objective is to determine the safety
of the targeted imaged-guided implantation of pSivida’s BrachySil™ product.
Efficacy, as determined by CT scanning of the tumour size and overall survival,
will be secondary endpoints. The findings will provide a platform for further
multicentre efficacy and safety trials.
Boston
based CFO and General Counsel appointed
Mr
Michael J. Soja was appointed Vice President, Finance and Chief Financial
Officer, and Ms Lori H Freedman was appointed Vice President, Corporate Affairs,
General Counsel and Secretary. Both Mr Soja and Ms Freedman remain based at
pSivida’s Boston facility in the US. Mr Aaron Finlay, who has served as
pSivida’s Chief Financial Officer and Company Secretary remains in Australia to
continue as the Company Secretary while pSivida is still an Australian
company.
Positive
European trial results for RetisertTM
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 March 30, 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.
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 RetisertTM
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 RetisertTM
implant.
This was statistically significant. RetisertTM
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 March 30, 2006.
-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
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 Novartis co-marketing partnership to have a
positive effect on Retisert revenues; the failure of the Company to come to
agreement with its note holder on terms of an amendment; 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 Note; the failure to complete the SEC review process and or obtain
have its registration statements declared effective prior to the deadline for
effectiveness or at all; the failure of the operational changes or restructuring
changes to result in significant cost savings and efficiencies; the clinical
trials for Medidur do not produce anticipated results and the Company is unable
to secure funded collaborations for the product; the Company fails to reach
agreement in its negotiations with potential licensees to share the cost of
both
the liver and pancreatic cancer trials, the Company’s failure to develop
products in the food and nutraceutical areas and the Company’s inability to find
a buyer for part of its interest in AION to raise additional cash; our inability
to raise additional funds at favourable terms or any terms; our inability to
repay the amended debentures; 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 BrachySilTM 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.