pSivida Partners with Global Pharmaceuticals Company to Develop Sustained Release Formulations of Glaucoma Drugs
September 26 2017 - 7:00AM
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug products and technologies, has signed an
agreement with a major global pharmaceutical company to develop two
glaucoma drugs with pSivida's proprietary sustained release
technology. This agreement builds upon the positive results
seen in pre-clinical studies demonstrating extended release of drug
for up to six months utilizing pSivida’s proprietary technology.
The terms of the partnership includes upfront payments to pSivida
of $750,000 for initial development and potential additional
payments totaling $200,000 if all subsequent development activities
are conducted.
"A key focus for pSivida during 2017 is to
expand the number of development collaboration agreements with
other drug manufacturers and this is the second such agreement
during 2017,” said Nancy Lurker, President & CEO. ”This
agreement extends the strong working relationship between the two
organizations. Glaucoma is one of the major causes of
blindness and many patients are not compliant with administering
the commonly prescribed treatment of daily drops. Our proprietary
sustained release technology, combined with glaucoma drugs, has the
potential to provide new dosing options for patients.”
About pSivida Corp.
pSivida Corp. (www.psivida.com), headquartered
in Watertown, MA, is a leader in the development of sustained
release drug products for treating eye diseases. pSivida has
developed three of only four FDA-approved sustained-release
treatments for back-of-the-eye diseases. The most recent, ILUVIEN®,
a micro-insert for diabetic macular edema, licensed to Alimera
Sciences, is currently sold directly in the U.S. and three EU
countries. Retisert®, an implant for posterior uveitis, is licensed
to and sold by Bausch & Lomb. pSivida's lead product candidate,
Durasert™ micro-insert for posterior segment uveitis, is being
independently developed. Two pivotal Phase 3 studies with Durasert
achieved their primary efficacy endpoint of prevention of
recurrence of uveitis at six months of follow-up with statistical
significance, and the Company plans to file an NDA by late December
2017/early January 2018. pSivida's pre-clinical development program
is focused on using its core platform technology Durasert™ to
deliver drugs to treat wet age-related macular degeneration,
glaucoma, osteoarthritis and other diseases. To learn more about
pSivida, please visit www.psivida.com and connect on
Twitter, LinkedIn, Facebook and Google+.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made
in this release are forward-looking, and are inherently subject to
risks, uncertainties and potentially inaccurate assumptions. All
statements that address activities, events or developments that we
intend, expect or believe may occur in the future are
forward-looking statements. Some of the factors that could cause
actual results to differ materially from the anticipated results or
other expectations expressed, anticipated or implied in our
forward-looking statements include uncertainties with respect to:
our ability to achieve profitable operations and access to needed
capital; fluctuations in our operating results; successful
commercialization of, and receipt of revenues from, ILUVIEN® for
diabetic macular edema (“DME”), which depends on Alimera’s ability
to continue as a going concern and the effect of pricing and
reimbursement decisions on sales of ILUVIEN; the successful
development and, if approved, commercialization of Durasert (under
the ILUVIEN trademark) for posterior segment uveitis in Europe, the
Middle East and Africa (“EMEA”) by Alimera; the number of clinical
trials and data required for the Durasert three-year uveitis
marketing approval applications in the U.S. and EU; our ability to
file and the timing of filing and acceptance of the Durasert
three-year uveitis marketing approval applications in the U.S.; our
ability to use data in a U.S. NDA from clinical trials outside the
U.S.; our ability to successfully commercialize Durasert three-year
uveitis, if approved; potential off-label sales of ILUVIEN for
uveitis; consequences of fluocinolone acetonide side effects;
potential declines in Retisert® royalties; efficacy and our future
development of an implant to treat severe osteoarthritis; our
ability to successfully develop product candidates, initiate and
complete clinical trials and receive regulatory approvals; our
ability to market and sell products; the success of current and
future license agreements, including our agreement with Alimera;
termination or breach of current license agreements, including our
agreement with Alimera; our dependence on contract research
organizations, vendors and investigators; effects of competition
and other developments affecting sales of products; market
acceptance of products; effects of guidelines, recommendations and
studies; protection of intellectual property and avoiding
intellectual property infringement; retention of key personnel;
product liability; industry consolidation; compliance with
environmental laws; manufacturing risks; risks and costs of
international business operations; effects of the potential U.K.
exit from the EU; legislative or regulatory changes; volatility of
stock price; possible dilution; absence of dividends; and other
factors described in our filings with the Securities and Exchange
Commission. You should read and interpret any forward-looking
statements in light of these risks. Should known or unknown risks
materialize, or should underlying assumptions prove inaccurate,
actual results could differ materially from past results and those
anticipated, estimated or projected in the forward-looking
statements. You should bear this in mind as you consider any
forward-looking statements. Our forward-looking statements speak
only as of the dates on which they are made. We do not undertake
any obligation to publicly update or revise our forward-looking
statements even if experience or future changes makes it clear that
any projected results expressed or implied in such statements will
not be realized.
Contact:
EVC Group
Michael Polyviou/Doug Sherk –
Investorsmpolyviou@evcgroup.com; dsherk@evcgroup.com212.850.6020;
646-445-4800
Thomas Gibson –
Mediatom@tomgibsoncommunications.com201-476-0322
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