pSivida
Quarterly Cash Flow - 30 September 2006
Commentary
and Highlights
Retisert™
royalty
income doubles
Registration
statements declared effective by the SEC
Convertible
Note reduced and restrictions eased
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is pleased to release its quarterly cash flow statement
for the period ended 30 September 2006.
Retisert™
Royalties
Royalty
revenue recorded in the quarter totalled A$328,000 (US$248,000), approximately
a
100% increase from the previous quarter. The reported amount is 50% of the
actual revenues earned in this fiscal quarter in accordance with a royalty
advance agreement the Company entered into with Bausch & Lomb in June 2005.
The Company believes this doubling of royalty revenues is related to increased
promotional activity by Bausch & Lomb and demonstrates growing acceptance by
the ophthalmic medical community in the United States to treat patients with
this novel, controlled delivery, back of the eye product.
Cash
Flow
Cash
at
the end of the quarter was A$7.9 million (US$5.9 million) following significant
one off expenditure relating to the Sandell convertible note, previously
announced.
The
Company expects to close a financing transaction in the quarter ending December
31, 2006.
SEC
Registration
Registration
statements related to resale 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) have been declared effective by the Securities
and Exchange Commission (SEC). As of October 31, 2006 the Company has filed
its
audited financial statements for the fiscal year ended 30 June 2006 including
reconciliation to financial results under US GAAP. Therefore, the resales
of ADSs which are registered by these three registration statements are now
able
to take place under the applicable prospectuses.
Further
amendment to Subordinated Convertible Debentures
In
a
significant post-balance date event, the Company has
amended terms with Sandell
Asset Management Corporation, investment advisor to Castlerigg Master
Investments
with
respect to the Subordinated Convertible Note dated 16 November 2005. The “Net
Cash Balance Test” was amended to reduce the required minimum cash balance that
the Company must retain from 30% of the aggregate remaining unamortized or
unconverted principal amount of the Notes then outstanding (presently A$16.7m
or
US$12.5m) to A$2.0m (US$1.5m) effective until 30 March 2007 at which time the
30% requirement will apply again. As a registration statement delay payment
to
the Note Holder, the Company will make a one time payment of A$1.1m (US$800k)
on
28 December 2006. The Company will make further payments of A$200k (US$150k)
on
each of 31 January 2007, 28 February 2007 and 30 March 2007.
Operational
Restructure
The
Company has made operational changes to bring about cost savings and make more
efficient use of resources
by
directing resources away from its earlier stage, higher risk research and
development activities and reducing spending in these areas. To this end, the
research operations located in our facilities in Malvern, UK and Singapore
have
been reduced. The Company is moving to reduce corporate overhead as it continues
to move its head office from Perth, Australia to Boston, Massachusetts over
the
coming months.
Medidur™
Medidur™
is our
lead programme utilising our Durasert™ Technology, an advanced delivery platform
which is being advanced through a series of product development opportunities.
The MedidurTM
product
delivers fluocinolone acetonide to treat diabetic macular edema (DME) which
we
consider to be a major ophthalmic market opportunity. This product is in the
final stage of the development programme, a global Phase III clinical trial,
with clinical centres in the US, Canada, Europe and Asia. The Company has
partnered with Alimera Sciences to develop Medidur™
for DME,
a
leading
cause of blindness for people under the age of 65, with some 500,000 persons
in
the United States affected. The disease 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. That treatment is often ineffective or generally provides only temporary
benefit. There are currently no approved drug therapies for the treatment of
DME.
The
Durasert™ Technology underlying Medidur™
is also
being evaluated in other programmes funded by large 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 believes that the broader exploitation of this
technology through such funded collaborations potentially represents a
fast-to-market solution for our pharma industry partners and a value-generating
opportunity for the Company.
Mifepristone™
Eye Drops
The
Company’s proprietary approach to the treatment of steroid-associated elevated
intraocular pressure, has entered Phase IIb clinical trials in the United States
under an investigator sponsored IND and is expected to involve up to 45
patients.
BrachySil™
Development
of the BioSilicon™
delivery
platform is focussed on the leading clinical product BrachySil™
which is
in multicentre Phase IIb trials for primary liver cancer. This phase of the
clinical development programme was 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 delivery to larger
tumours.
The
Company also reports the first BrachySil™
treatments in patients with pancreatic cancer, a disease of high unmet clinical
need and a significant potential market opportunity for this targeted oncology
therapy. The Phase IIa trial commenced at Guys & St Thomas’ Hospital in
London and is expected to commence in Singapore following the necessary
approvals.
The
Company is presently in negotiation with a potential licensee 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.
BioSilicon™
The
application of BioSilicon™
for drug
delivery to enhance bioavailability and/or control drug release will focus
on
partner-funded R&D programmes. The Company is conducting and negotiating
additional evaluation agreements.
The
BioSilicon™
platform
has been further enhanced by the demonstration of adjuvant properties as well
as
the demonstration of key imaging properties by our wholly owned subsidiary,
AION
Diagnostics.
Non-Core
Activities
The
Company is considering strategic alternatives with respect to its non-core
activities, including raising additional cash, reducing its cash burn and
focusing on core activities. Further to this strategy, the Company stands to
receive potential revenue from its license to AION of BioSilicon™
technology for use in diagnostic products.
Annual
General Meeting
The
Company has provided Notice of an Annual General Meeting to be held in Perth,
Australia at 10:00am WST on 15 November 2006. Members of the Board of Directors
will be in attendance and shareholders are encouraged to attend to be advised
on
further completion of milestones and future developments that the Board believes
will result in considerable growth of the Company over the coming
year.
Highlights
and Announcements for the Quarter and Post-Quarter
First
patients implanted in European Pancreatic Cancer Study
The
first
patients have been implanted with BrachySil™
for the
treatment of inoperable pancreatic cancer at Guys & St Thomas’ Hospital in
London, a major centre for cancer therapy in the United Kingdom. The treatment
delivers BrachySil™
directly
to a tumour in the pancreas via endoscopic ultrasound (used to assist in
locating the delivery point). BrachySil™
is a
novel oncology product which comprises a combination of BioSilicon™
and the
isotope 32Phosphorus, a proven anti-cancer therapeutic. The targeted and
localized nature of the product could potentially provide oncologists with
an
effective and user-friendly treatment for this disease which has a high unmet
clinical need.
Initiation
of Phase II clinical study of novel ophthalmic product
The
Company initiated a Phase II clinical trial of Mifepristone (otherwise known
as
RU486) as an eye drop treatment for steroid associated elevated intraocular
pressure (IOP). The investigator sponsored trial is expected to involve up
to 45
patients in the United States. The Company will be supplying clinical trial
material for this study and has filed a patent application on this product
class. Elevated IOP may occur in patients receiving steroidal treatment for
chronic eye diseases. This study represents a potential new use of an existing
drug, made possible by a new delivery system.
Terms
renegotiated with
existing convertible note holder
The
definitive documentation related to the previously announced, renegotiated
terms
of the Convertible Note, dated 16 November 2005, between the Company and
Castlerigg Master Investments Ltd. was completed on 14 September 2006. The
renegotiated terms provided for the lifting of restrictions on future sales
of
securities and also provided for an extension to the registration deadline
under
the Company’s registration rights agreement with the note holder. The Company
signed a further amendment with the note holder on 17 October 2006 to revise
the
terms of the convertible note to provide temporary relief from the minimum
cash
balance requirement. The Company is required to make certain penalty payments
to
Castlerigg from December 2006 through March 2007.
Retisert™
Wins
International Award
A
paper
co-authored by pSivida’s Director of Strategy, Dr Paul Ashton, describing the
initial clinical work on the Company’s lead ophthalmology product
Retisert™,
had
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.
Additional
funding secured
The
Company signed an agreement with the Absolute Europe Catalyst Fund, Absolute
Octane Fund and Australian IT Investments Ltd, to purchase US$6.5m (A$8.5m)
of
Subordinated Convertible Debentures convertible into ADSs at an initial
conversion price of US$2.00 per ADS (A$0.27 per ordinary share). The agreement
was completed and announced on 27 September 2006 and raised cash, net of
expenses of A$6.7m (US$5.0m).
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.
This
release does not constitute an offer of any securities for sale or solicitations
of offers to buy any securities of the Company.
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Investor
Relations Director
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
Accent
Marketing limited
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 76 patent families, 95 granted
patents including patents accepted for issuance and over 250 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 BioSilicon™
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: our inability to raise additional funds at favorable terms or any
terms in the quarter ending 31 December 2006 or otherwise; the failure of our
current discussions regarding a financing transaction; our inability to complete
any other capital raising initiatives that we are considering, including sale
of
equity securities, spin offs, strategic collaborations and monetisation of
assets, with third parties; Bausch & Lomb’s failure to maintain or increase
its promotional activity related to Retisert™; the failure of the ophthalmic
medical community in the United States to continue to accept Retisert™ to treat
patients with uveitis; issues preventing or delaying the filing of the Company’s
audited financial statements for the fiscal year ended June 30, 2006, including
a reconciliation of the results under US GAAP or other events preventing selling
shareholders named in the Company’s registration statements to be permitted to
utilize those registration statements to sell the securities; the Company’s
failure to reduce corporate overhead; the Company’s failure to successfully move
its head office from Perth, Australia to Boston, Massachusetts over the coming
months or at all; the failure of Medidur™ for DME to represent a large
ophthalmic market opportunity; the failure of any funded development
collaborations to result in a fast-to-market solution for our pharma industry
partners or a value-generating opportunity for the Company; the failure of
our
clinical trials for the treatment of steroid-associated elevated intraocular
pressure; our failure to obtain required approvals to expand our the Phase
IIa
trial commenced at Guys & St Thomas’ Hospital in London to Singapore;
failure of our negotiations with potential licensee parties to share the cost
of
both the liver and pancreatic cancer trials; our failure to find partners to
participate in and fund BioSilicon™ drug delivery R&D programmes; AION’s
failure to achieve revenues from the BioSilicon™ technology for use in
diagnostic products resulting in royalty payments; our inability to achieve
milestones and future developments expected to lead to growth of the Company
over the coming year; failure of BrachySil™ to represent an effective and
user-friendly treatment for pancreatic cancer; our inability to repay the
amended convertible notes and new convertible notes; our inability to develop
proposed products, including without limitation, in the drug delivery, wound
healing, orthopedics, 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 program that is in
Phase IIb clinical trials to provide a valuable platform for the
development and commercialization 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 multicenter
efficacy and safety trials; failure of there to be optimization and
standardization between our two pancreatic cancer study centers;
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.