02.08.2007 12:02:00
|
pSivida Managing Director Describes Recent Developments in Corporatefile.com.au Report
pSivida Limited (NASDAQ:PSDV)(ASX:PSD)(Xetra:PSI) today announced that
an interview with the company’s Managing
Director, Dr. Paul Ashton, has been posted at corporatefile.com.au. The
text of the interview follows:
corporatefile.com.au
pSivida Limited (ASX:PSD) announced in July 2007 the raising of A$24
million (US$21 million) in private placements through the sale of Nasdaq
traded ADSs (American Depositary Shares), ordinary Australian shares and
warrants. This raising is in addition to the A$11 million (US$9 million)
private placement in February, the A$11 million (US$9 million) private
placement in April and the A$6 million (US$5 million) share sale to
Pfizer also in April. How have these various raisings affected the risk
profile of pSivida?
MD Dr Paul Ashton
These financings have raised approximately A$49 million (US$40 million)
net of expenses and significantly improved our financial position.
Because of the cash we were able to raise in these private placements
including the sale of shares to Pfizer as part of our global
collaborative research and license agreement with Pfizer, we were able
to eliminate all of the Company’s debt –
some A$22 million (US$19 million), and had as at July 13, 2007,
approximately A$23 million (US$20 million) of cash.
Given that a large proportion of the fund raisings have been sales to US
buyers, most of the newly issued shares were issued in ADSs that are
traded on NASDAQ. Since the beginning of July, the Dollar volume of
trading on NASDAQ has been twice as large as the dollar volume traded on
ASX, where one ADS is equal to ten ordinary ASX shares. We believe that
this shift in relative trading volume toward the United States and the
strategic shifting of our core operations to the United States have made
the Company more attractive to US and European institutional investors.
Overall, through these capital raisings, we have simplified the Company’s
capital structure and as a result we believe we have significantly
reduced the amount of financial risk.
corporatefile.com.au
What is your current rate of cash burn? Do you expect this to vary much
into the foreseeable future?
MD Dr Paul Ashton
For the Quarter ended June 30, 2007, our burn rate, which we define as
our operating cash outflows net of operating cash inflows, was
approximately $A1.8 million ($US1.5 million),substantially less than the
burn rate for the quarter ended March 31, 2007. In the Quarter ended
March 31 we had a monthly burn rate of approximately A$2.2 million
(US$1.7 million).
We have reduced our burn rate primarily through more than a 30%
reduction of staff and we have rationalized projects to focus on
activities that we believe will generate commercial returns in the near
to medium term. With the cash we now have in the bank, we believe we are
fully funded for more than 12 months. We do not expect there to be any
further significant reduction in our burn rate during the next two years
partly because we expect to be funding two clinical trials. However, to
the extent that during that period we receive any milestone payments
from the Pfizer licensing agreement, or up front payments as part of
future collaborations our cash burn rate could be significantly reduced.
corporatefile.com.au
In the latest placement you raised A$7.5 million (US$6.5 million) from
Pfizer which is in addition to the A$6.1 million (US$5.0 million)
investment they made in April. How many shares will Pfizer hold in total
after this raising? What percentage of your shares on issue does this
represent? What are the strategic implications for pSivida of a large
pharmaceutical company taking such a stake?
MD Dr Paul Ashton
Pfizer’s participation in the latest capital
raising has lifted their shareholding to the equivalent of some 70
million ordinary shares, or approximately 10.2 percent of our issued
capital. Pfizer is now the largest single shareholder in the Company and
a strategic partner.
Having Pfizer take this stake is strategically very important for
pSivida as is the license agreement. On average it costs over US$800m to
develop a new drug. Under our license with Pfizer they are responsible
for the full development costs in addition to up to approximately US$155
development and sales related milestone cash payments to pSivida. We
believe this clearly demonstrates commercial interest for our drug
delivery technologies.
corporatefile.com.au
When do you expect to complete recruitment for your Phase III trials of
MedidurTM for Diabetic Macular Edema (DME), and
how long are the trials likely to take? What progress has there been for
MedidurTM in ophthalmic applications since you
announced the licensing deal with Pfizer in April?
MD Dr Paul Ashton
The MedidurTM for DME trials jointly funded by
our development partner Alimera Sciences, are now at an advanced stage
and we will share with Alimera in the profits on future product sales. We’ve
recruited well in excess of 500 patients in this 900 persons study. We
expect to complete recruitment for this trial by the end of this
calendar year.
As MedidurTM is a long-term drug delivery
system, we will be assessing safety and efficacy at two years and
continue to follow patients for three years. With this in mind, we
expect to file a New Drug Application, which begins the approval process
with the FDA in early 2010. We expect to have preliminary topline safety
and efficacy results available in late 2009. There are currently no FDA
approved drug treatments for diabetic eye disease that either stabilize
or effect improvement in the condition. The potential market size for
DME treatment is very large. Approximately one in ten people with
applications of our diabetes suffer from, or will develop this
sight-threatening eye disease and analysts estimate the market size in
the United States alone at 500,000 treatable cases.
We are very optimistic for our drug candidate MedidurTM
for diabetic macular edema. While our product is not yet approved, data
from a Bausch & Lomb three year follow-up study of 200 DME patients with
the Retisert® implant
produced very promising results and demonstrated a three line
improvement in vision on an eye chart. MedidurTM
for DME is designed to deliver the same steroid as Retisert®,
at a similar rate over a similar period of time.
Genentech and its licensing partner, Novartis are currently developing
Lucentis, their product for the ‘wet’
form of age-related macular edema, for the treatment of DME. While
Lucentis has been very successful in its sales for AMD, generating sales
of A$174 million (US$153 million) in its first quarter of sales, and
with predictions that sales could top US$1 billion in its first year on
the market, this AMD product requires injections as frequently as
monthly directly to the back of the eye for the duration of the
treatment for the disease. We understand that this will also be true for
their proposed DME application. By contrast, our product, MedidurTM,
releases a drug at a constant rate over a period of up to three years
from a single injection. This makes us optimistic that MedidurTM
may have a competitive advantage over Lucentis if both products are
available for the treatment of DME.
As for progress and developments on the Pfizer licensing deal announced
in April, other than their increased investment in the Company, there’s
little detail I can add at this stage.
corporatefile.com.au
How has enrollment progressed in your Phase IIa trials of BrachySilTM
for pancreatic cancer? When are you likely to be able to report on
meaningful trial data?
MD Dr Paul Ashton
Enrollment in the BrachySilTM trial for
pancreatic cancer which we are currently fully funding ourselves is
progressing well and we expect to complete recruitment of a 15 persons
study at hospitals in London, Birmingham and Singapore very shortly.
Pancreatic cancer is the fourth largest cause of cancer related deaths
in the United States and typically, the life expectancy of pancreatic
cancer patients is short. We hope to get three month follow-up data to
report on by the end of this calendar year.
corporatefile.com.au
You recently announced the renewal of an evaluation agreement for your
drug delivery technologies with a global medical device company. Are you
likely to announce any similar agreements in the near term?
MD Dr Paul Ashton
We believe that the renewed evaluation agreement demonstrates that there
is interest in controlled release drug delivery systems, particularly in
the treatment of cardiovascular disease. As this new agreement follows
the expiry of a previous evaluation agreement with the same large
medical device company, this is an exciting development. We expect
further evaluation agreements for our drug delivery technologies in
other applications this year.
corporatefile.com.au
What further milestones are you targeting in the 2007 calendar year?
MD Dr Paul Ashton
Over the last nine months, we have achieved significant milestones and
brought the Company to a sound financial position. The Company has
successfully transitioned from a bio-nano materials science company to a
drug delivery company with two FDA-approved products, a late stage
pipeline and several partnerships. We are focused on driving the
business forward and rebuilding value in our share price.
As mentioned, in the remainder of this calendar year we expect to
complete the recruitment of our MedidurTM for
DME Phase III trials, complete recruitment and release results from of
our BrachySilTM Phase IIa trials in pancreatic
cancer. We also expect to be in a position to announce further
evaluation agreements for our multiple drug delivery technologies. All
in all, we expect the second half of 2007 to be a pivotal period for
pSivida.
corporatefile.com.au
Thank you Paul.
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 owns the trademarks Vitrasert®
and Retisert®.
pSivida has licensed the technologies underlying both of these products
to Bausch & Lomb. The technology underlying Medidur™
for diabetic macular edema is licensed to Alimera Sciences and is in
Phase III clinical trials. pSivida has a worldwide collaborative
research and license agreement with Pfizer Inc. for other ophthalmic
applications of the Medidur™
technology.
pSivida owns the rights to develop and commercialize a modified form of
silicon (porosified or nano-structured silicon) known as BioSilicon™,
which has applications in drug delivery, wound healing, orthopedics, and
tissue engineering. The most advanced BioSilicon™
product, BrachySil™ delivers a therapeutic,
P32 directly to solid tumors and is presently in Phase II clinical
trials for the treatment of pancreatic cancer.
pSivida’s intellectual property portfolio
consists of 71 patent families, 99 granted patents, including patents
accepted for issuance, and over 300 patent applications. pSivida
conducts its operations from facilities near Boston in the United
States, Malvern in the United Kingdom and Perth in Australia.
pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange
(PSD) and on the Frankfurt Stock Exchange on the XETRA system (PSI).
pSivida is a founding member of the NASDAQ Health Care Index and the
Merrill Lynch Nanotechnology Index.
This document contains forward-looking statements that involve risks and
uncertainties including with respect to products and potential products,
including the successful development, marketing and commercialization of
our products and potential products, applications, regulatory approvals,
the potential size of certain markets, our ability to raise funds and
potential partnerships. 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 risk that we may
not meet any of the milestones in the Pfizer agreement or may not
successfully develop or commercialize the products under development or
our proposed products; the risk that Pfizer terminates the license
agreement; the risk that we will not be able to exploit our drug
delivery technologies outside of the eye; the risk that our evaluation
agreements for our products may not produce favorable results and/or
result in license agreements or partnerships and the risk of our failure
to otherwise establish partnerships; the risk that other companies do
not have a commercial interest in pSivida; failure to enter into any
additional evaluation agreements for our technologies; the risk that we
will not be able to raise additional funds at favourable terms or at
all; the risk that the Company is not fully funded for more than 12
months; failure to have significantly reduced the amount of financial
risk; failure of the activities that the Company is currently focusing
on to generate commercial returns in the near to medium term; risks with
respect to the efficacy of pSivida's drug delivery technology; risks
with respect to the final results of the Medidur for DME clinical
trials; 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 or the phase II BrachySil trials for pancreatic cancer or
to complete recruitment for our Medidur for DME trial by the end of this
calendar year or the BrachySil trials for pancreatic cancer shortly; the
risk that we do not have preliminary top line safety and efficacy
results available in late 2009; failure to file an NDA with the FDA for
Retisert™ for DME in early 2010; failure of
our Medidur™ for DME product to have a
competitive advantage over our competitors; failure to have three month
follow up data for our BrachySil trials for pancreatic cancer by the end
of this calendar year; failure to develop applications for
BioSilicon(TM) due to regulatory, scientific or other issues; failure of
the pSivida Inc’s products to achieve
expected revenues; failure to achieve cost savings generally; our
inability to penetrate the Uveitis or other markets; our inability to
continue to develop products currently in our pipeline or to continue
to feed our product pipeline; our failure to achieve our stated 2007
milestones or to execute on our stated U.S. growth strategy. 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.
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
JETZT DEVISEN-CFDS MIT BIS ZU HEBEL 30 HANDELN
Handeln Sie Devisen-CFDs mit kleinen Spreads. Mit nur 100 € können Sie mit der Wirkung von 3.000 Euro Kapital handeln.
82% der Kleinanlegerkonten verlieren Geld beim CFD-Handel mit diesem Anbieter. Sie sollten überlegen, ob Sie es sich leisten können, das hohe Risiko einzugehen, Ihr Geld zu verlieren.
Nachrichten zu Puget Energy Inc.mehr Nachrichten
Keine Nachrichten verfügbar. |