Planned Operations Funded into 2017
WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV, ASX:PVA), a leader in the development of
sustained release, drug delivery products for treating eye diseases,
today announced that it has received the $25 million milestone payment
under its out-license of ILUVIEN® for the treatment of diabetic macular
edema (DME). The milestone was earned on the approval of ILUVIEN by the
U.S. Food and Drug Administration (FDA).
"This milestone payment together with our cash on hand should fund our
planned product development and other operations into calendar 2017. In
addition, we will receive 20% of any net profits from sales of ILUVIEN
for DME on a country-by-country basis as well as royalties on sales of
Retisert," said Dr. Paul Ashton, Ph.D., President and CEO of pSivida
Corp.
"Our lead product candidate, Medidur™ for the treatment of chronic
posterior uveitis, uses the same micro-insert delivering the same drug
as ILUVIEN. Medidur is currently being studied in a pivotal Phase III
clinical trial. If the FDA concurs, we plan to file a New Drug
Application for Medidur based on data from this single trial, together
with supplementary data from a study of our proprietary inserter. Our
pre-clinical research is focused on use of our Tethadur™ and Durasert™
platform technologies to deliver biologics to the eye and systemically
and to treat wet and dry age-related macular degeneration, glaucoma and
other retinal diseases and osteoarthritis," continued Dr. Ashton.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, is a leader in the
development of sustained release, drug delivery products for treating
eye diseases. pSivida is currently focused on treatment of chronic
diseases of the back of the eye utilizing its core technology systems,
Durasert™ and Tethadur™. pSivida's lead product candidate, Medidur™ for
treatment of the chronic, back-of-the-eye disease posterior uveitis, is
in a pivotal Phase III clinical trial. Medidur uses the same injectable,
sustained release micro-insert as ILUVIEN® for the treatment of DME.
ILUVIEN, licensed to Alimera Sciences, is marketed in the U.K. and
Germany and has received or is pending marketing authorization in 15
other EU countries for the treatment of chronic DME considered
insufficiently responsive to available therapies. In the U.S., ILUVIEN
has been approved for the treatment of DME in patients who have been
previously treated with a course of corticosteroids and did not have a
clinically significant rise in intraocular pressure. pSivida's
FDA-approved Retisert®, an implant that provides long-term, sustained
drug delivery to treat posterior uveitis, is licensed to and sold by
Bausch & Lomb Incorporated. pSivida's pre-clinical research is focused
on ocular and systemic delivery of biologics and treatment of wet and
dry age-related macular degeneration, osteoarthritis and glaucoma.
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. The following are
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: changes in
actual capital requirements to 2017; Alimera's ability to finance,
achieve additional marketing approvals, obtain adequate pricing and
reimbursement for, successfully commercialize and achieve market
acceptance of, and generate revenues to pSivida from, ILUVIEN; FDA
requirements with respect to clinical trial data necessary to support an
NDA for Medidur; pSivida's ability to finance, complete and achieve a
successful clinical outcome, file and achieve marketing approvals for,
Medidur for posterior uveitis; ability of Tethadur to successfully
deliver large biologic molecules; ability to develop product candidates
and products and potential related collaborations; initiation and
completion of clinical trials and obtaining regulatory approval of
product candidates; level of continued sales of Retisert; adverse side
effects; ability to attain profitability; ability to obtain additional
capital; further impairment of intangible assets; fluctuations in
operating results; decline in royalty income; ability to, and to find
partners to, develop and market products; termination of license
agreements; competition and other developments affecting sales of
products; market acceptance; protection of intellectual property and
avoiding intellectual property infringement; retention of key personnel;
product liability; consolidation in the pharmaceutical and biotechnology
industries; compliance with environmental laws; manufacturing risks;
risks and costs of international business operations; credit and
financial market conditions; legislative or regulatory changes;
volatility of stock price; possible dilution; absence of dividends; and
other factors described in our filings with the SEC. Given these
uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements. 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. 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.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
Martin E. Janis & Company, Inc.
Beverly Jedynak, +1 312-943-1123
M:
+1 773-350-5793
President
bjedynak@janispr.com
Source: pSivida Corp.
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