ASX/Media RELEASE 31 January 2008
pSivida Quarterly Cash Flow – December 31, 2007
Commentary and Highlights
- First R&D funding payments from Pfizer to commence
- BrachySil Pancreatic Cancer Study Results
- pSiNutria Business sold to Intrinsiq
Boston, MA. and Perth, Australia – pSivida Limited (ASX: PSD, NASDAQ:PSDV, Xetra:
PSI) announced the filing of its Quarterly Cash Flow Statement for the quarter ended
December 31, 2007 with the ASX.
Cash Flow
The cash balance at December 31, 2007 was $11.2m (US$9.8m), a decrease of
A$7.3m (US$6.7m) from the balance at September 30, 2007. During the quarter, net
cash used in operating activities was $A7.2m (US$6.4m). Medidur development costs
were A$910k higher in quarter ended December 31 2007 than the previous quarter.
Medidur development costs in the quarter ending March 2008 are expected to be
significantly lower than the most recent quarter. Cash royalties from Retisert were
A$307k lower than the previous quarter due to the royalty advance agreement with
Bausch and Lomb (further details below).
In January 2008 pSivida received A$562k (US$500k) as a first payment from the sale
of its pSiNutria business and pSivida expects to shortly receive the first R&D support
payment of A$562k (US$500k) from Pfizer as part of our ongoing R&D collaboration
(further details below). These and future scheduled payments will positively impact the
Company’s cash position going forward and the Company continues to pursue sources
of non-dilutive capital.
Retisert
Subsequent to December 31, 2007, Bausch and Lomb will retain 100% of the next
US$3.6m (A$4.1m) of Retisert® royalties otherwise payable to pSivida in accordance
with a royalty advance agreement the Company entered into in June 2005. Royalties
otherwise payable to pSivida for the quarter ended December 31, 2007 were US$541k
(A$608k), which represents a 6% increase from US$510k (A$601k) for the quarter
ended September 30, 2007 and a 33% increase from US$406 (A$527k) for the quarter
ended December 31, 2006. Retisert® is the only FDA-approved treatment for posterior
uveitis, a chronic eye disease.
pSivida to receive first R&D payments from Pfizer
The Company expects to shortly receive US$500k as the first quarterly research and
development payment from Pfizer under the terms of the exclusive worldwide
Collaborative Research and License Agreement signed in April 2007 for pSivida’s
controlled drug delivery technologies in ophthalmic applications. Under the terms of that
agreement, pSivida will receive up to US$153.5m in development and sales related
milestones. Pfizer has already invested US$11.5m in pSivida making Pfizer the largest
shareholder in Company holding approximately 10% of all outstanding shares.
BrachySil for Pancreatic Cancer Study Results
The results of the Phase IIa clinical trial of BrachySilTM for the treatment of advanced,
inoperable pancreatic cancer were presented at American Society of Clinical Oncolgy-
GI (ASCO-GI). Seventeen patients were treated with BrachySil (32P - radioactive
Phospherous combined with BioSilicon) directly into the tumor in combination with
standard chemotherapy at two major oncology hospitals in the UK and one in
Singapore. The trial, designed as a safety study, showed BrachySil was safe and easily
administered. Data also showed disease control in 82% of patients treated with
BrachySil and an overall median survival time of 309 days. A Phase IIb dose ranging
study is planned to commence this quarter.
Pancreatic cancer is the 4th highest cause of death by cancer in the US. Median
survival for people with inoperable primary pancreatic cancer (over 80% of pancreatic
cancer patients) is typically less than 6 months using standard chemotherapy.
pSiNutria business sold to Intrinsiq
The assets of pSiNutria Limited, a wholly owned subsidiary of pSivida, were sold to
Intrinsiq, a UK based company in January 2008. pSiNutria was established to develop
applications of the Company’s BioSiliconTM technology for the food industry and the
sale of this asset continues to sharpen the Company’s focus on our core business –
therapeutic delivery.
Terms of the agreements include:
• pSivida has sold and licensed intellectual property and other assets related to
nutraceuticals and food science applications of BioSiliconTM to Intrinsiq.
• Intrinsiq is obligated to make a series of payments totaling US$1.23m in the first year
following this closing of this transaction, $500k of which was received in January.
• Provided the license is in place, Intrinsiq is obligated to pay royalties with minimum
royalty payments of US$3.95m over approximately the next 6 years, $500k of which
would be payable 18 months after the closing.
• pSivida retains all rights outside the food science arena.
Enrolment competed for pivotal Phase III study of Medidur™ for DME
Enrolment was completed in October for the FAME™ (Fluocinolone Acetonide in
Diabetic Macular Edema) Study of Medidur FA™ for the treatment of Diabetic Macular
Edema (DME). FAME is a double masked, randomized, multi-center study that is
following more than 900 patients in the U.S, Canada, Europe, and India, for 36 months
with safety and efficacy assessed at two years. Alimera Sciences and pSivida are
jointly developing Medidur FA under a collaborative research and development
agreement.
More than 500,000 people in the United States have DME and this number is expected
to exceed 700,000 by the year 2010. Currently there are no FDA-approved drug
treatments for DME.
DSMB supports continuation of pivotal Phase III study of Medidur for DME
After completing its review of safety and efficacy data currently available, an
independent Data Safety Monitoring Board (DSMB) in October recommended that the
pivotal Phase III clinical trial FAME™ Study continue under the current protocol, without
change. The trial is studying the use of Medidur FA™ for the treatment of DME.
Annual General Meeting
The Company held its Annual General Meeting in Melbourne, Australia in November
2007 where all resolutions were passed.
-ENDSReleased
by:
pSivida Limited
Brian Leedman
Vice President, Investor Relations
pSivida Limited
Tel: +61 8 9226 5099
[email protected]
US Public Relations
Beverly Jedynak
President
Martin E. Janis & Company, Inc
Tel: +1 (312) 943 1100 ext. 12
[email protected]
European Public Relations
Eva Reuter
Accent Marketing Limited
Tel: +49 (254) 393 0740
[email protected]
NOTES TO EDITORS:
pSivida is a global 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™ 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 70 patent families, 103 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.
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: 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; issues relating to Australian incorporation; potential delisting from ASX or
NASDAQ; 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.
PSD
psivida limited
