31.07.2008 12:30:00
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pSivida Quarterly Highlights
pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PSI):
Reincorporation in the US Completed
Interim results from Medidur for DME Study
Commencement of new Medidur AMD Trial
Commencement of BrachySil Pancreatic Cancer Dose Ranging Clinical Trial
pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PSI), a leading drug delivery
company, headquartered in Watertown MA announced its Quarterly
highlights.
Cash Flow
The cash balance at June 30, 2008 was US$15.6m, a decrease of US$2.6m
from the balance at March 31, 2008. During the current quarter ended
June 30, 2008, cash flows used in operating activities was US$2.4m
compared to cash flows provided by operating activities of US$8.5m in
the previous quarter ended March 31, 2008. Cash flows from operating
activities in the current quarter included cash inflows from customers
of US$1.5m consisting primarily of US$1.0m of research and development
funding from Pfizer and US$437k in connection with the amended
collaboration agreement with Alimera Sciences. This compares to cash
inflows from customers of US$13.0m in the previous quarter, US$12.0m of
which was received from Alimera Sciences at the closing of the amended
collaboration agreement that provides total consideration up to US$78m
plus a 20% share of future profits. Cash flows used in operating
activities included US$3.9m of outflows for the current quarter compared
to US$4.6m for the previous quarter.
Subsequent to June 30, 2008, Bausch and Lomb will retain the next
US$2.8m of Retisert®
royalties otherwise payable to pSivida in accordance with an advance
royalty agreement the Company entered into in June 2005. Royalties
otherwise payable to pSivida for the quarter ended June 30, 2008 were
US$427k which represents a 15% increase from US$371k for the quarter
ended March 31, 2008 and a 24% decrease from US$559k for the quarter
ended June 30, 2007. Retisert®
is the only FDA-approved treatment for posterior uveitis, a chronic eye
disease.
Reincorporation in the US
In June, the Company completed reincorporation in the United States
following approval by shareholders. The reincorporation is designed to
make the Company a more attractive investment for shareholders by
increasing the potential scope and depth of the Company's shareholder
base and liquidity, reducing ongoing compliance costs and enabling the
Company to continue the engagement of its independent auditor, while
maintaining strong ties with the Australian investor base. This move to
the US was the next key step in the Company’s
long-standing strategy of building a global drug delivery company by
focusing growth and development in the US where the company has achieved
its recent significant business successes.
As a US company with common stock traded on NASDAQ, the Company files
quarterly unaudited financial statements on Form 10-Q and full year
financial statements on Form 10-K and will file these financial
statements with ASX after they are filed with the US Securities and
Exchange Commission.
Interim Results from the three-month Human PK Medidur™
FA Study
In June, the Company reported the interim three-month safety and
efficacy results from the first human pharmacokinetic (PK) study of
Medidur™ FA, in patients with Diabetic Macular
Edema (DME). This open-label Phase II study is designed to support the
ongoing pivotal Phase III clinical trial of Medidur in DME by assessing
systemic exposure to FA after administration of Medidur in the eye. The
study is secondarily designed to provide information on the safety and
efficacy of Medidur in a DME population.
A total of 37 subjects were enrolled in this trial, 20 patients on the
low dose (an approximate 0.23mcg per day dose) of Medidur and 17
patients on the high dose (an approximate 0.45mcg per day dose) with the
same inclusion/exclusion criteria as the ongoing Phase III study. The
three month interim readout from the PK study indicated 20 percent of
the low dose patients and 18 percent of the high dose patients showed an
improvement in best-corrected visual acuity (BCVA) of 15 letters or
greater from baseline on an eye chart. In addition, both the low dose
and the high dose of Medidur resulted in a significant reduction in
retinal thickness as compared to the baseline.
From a safety perspective, no adverse events related to intraocular, or
inner eye, pressure were seen in the low dose patients, while 12 percent
of the high dose patients experienced intraocular pressure increases of
greater than 30 mmHg. Additionally, the only adverse event related to
cataract formation was reported in a patient in the high dose group.
By comparison, the Retisert® intravitreal
implant (FDA approved for Uveitis), which releases FA at an initial rate
of 0.6 mcg per day, was also studied in a DME population. Retisert data
presented at the ARVO conference in 2004 and 2005 showed that at 6
months between 15% and 20% of DME patients receiving Retisert gained 15
letters from baseline on an eye chart and after 2 years this increased
to 27% but there were some steroid related side effects, particularly
cataract and elevation of IOP.
The early results of this study support our hypothesis that lower doses
of FA delivered via the Medidur system will provide visual acuity
improvements while reducing the risk of ocular side effects commonly
associated with the use of corticosteroids.
The technology underlying Medidur FA for DME is licensed to Alimera
Sciences, a privately funded biopharmaceutical company that specializes
in the research, development and commercialization of prescription
ophthalmic pharmaceuticals, in an agreement that provides total
consideration of up to US$78m plus a 20% share of future profits.
Medidur FA for DME is in fully recruited Phase III clinical trials. If
approved, it is anticipated that Medidur will be marketed under the name
IluvienTM.
Clinical trial to assess safety and efficacy of Medidur FA in
patients with AMD treated with Lucentis®
In May, the Company announced that enrollment has begun for a clinical
trial under an investigator sponsored IND to assess the safety and
efficacy of Medidur™ FA in conjunction
with Lucentis® (ranibizumab injection,
Genentech) in patients with exudative age-related macular degeneration
(wet AMD). The study is designed to provide preliminary information on
the potential of Medidur FA to maintain the efficacy established with
Lucentis while reducing the overall number of Lucentis treatments.
Commencement of BrachySil Pancreatic Cancer dose ranging clinical
trial
In July, the Company announced that a device dose ranging clinical trial
commenced using BrachySil™ (P32 BioSilicon™)
as a potential new brachytherapy treatment for inoperable pancreatic
cancer. The first patient received treatment at Guy’s
and St Thomas’ NHS Foundation Trust in
London. A total of six patients will be entered into this trial at two
centers in the UK (Guy’s and St Thomas’
NHS Foundation Trust, and University Hospital, Birmingham). The study
will determine the safety of escalating radiation doses of the BrachySil™
device, with tumor response as a secondary end point.
Opes Prime overhang cleared
In April, the Company announced that all the Company’s
shares subject to Opes Prime margin lending facilities were sold in an
orderly fashion after Opes Prime was placed in the hands of a receiver.
New Board Appointments
In July, the Company announced the appointment to the Board of Directors
of Peter G. Savas and Paul A. Hopper as non-executive Directors. Both
have demonstrated track records of success in building successful
biotech companies and the pSivida Board will benefit from their skills
and experience.
About pSivida Corp.
pSivida is a leading drug delivery 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™ FA for
diabetic macular edema is licensed to Alimera Sciences under an
agreement with total consideration of up to US$78m plus a 20% share of
future profits and is in fully recruited Phase III clinical trials. If
approved, it is anticipated that Medidur will be marketed under the name
Iluvien. pSivida has a worldwide collaborative research and license
agreement with previous and future payments of up US$165m with Pfizer
Inc. for certain 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 dose ranging clinical
trials as a device for the treatment of pancreatic cancer.
pSivida’s intellectual property portfolio
consists of over 65 patent families, over 115 granted patents, including
patents accepted for issuance and over 270 patent applications. pSivida
conducts its operations from Boston in the United States, Malvern in the
United Kingdom and Perth in Australia.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995: Various statements made in this release are forward-looking
and involve a number of risks and uncertainties. All statements that
address activities, events or developments that we intend, expect or
believe may occur in the future are forward-looking statements. The
following are some of the factors that could cause actual results to
differ materially from the forward-looking statements: achievement of
milestones and other contingent contractual payment events; failure to
prove efficacy for BrachySil; inability to raise capital; continued
losses and lack of profitability; inability to develop or obtain
regulatory approval for new products; inability to protect intellectual
property or infringement of others’
intellectual property; inability to obtain partners to develop and
market products; termination of license agreements; competition;
inability to pay any registration penalties; costs of international
business operations; manufacturing problems; insufficient third-party
reimbursement for products; failure to retain key personnel; product
liability; inability to manage change; failure to comply with laws;
failure to achieve and maintain effective internal control over
financial reporting; amortization or impairment of intangibles; possible
dilution through exercise of outstanding warrants and stock options or
future stock issuances; potential restrictions from capital raises;
possible influence by Pfizer; and other factors that may be described in
our filings with the Securities and Exchange Commission. Given these
uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements. We do not undertake to publicly update or
revise our forward-looking statements even if experience or future
changes make it clear that any projected results expressed or implied in
such statements will not be realized.
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