pSivida Corp. Reports ILUVIEN® for Chronic Diabetic Macular Edema Receives Marketing Authorization in Denmark, 9th EU Approval
July 31 2014 - 4:05PM
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 the Danish Health and
Medicines Authority granted marketing authorization to ILUVIEN® for
the treatment of vision impairment associated with chronic diabetic
macular edema (DME) considered insufficiently responsive to
available therapies. ILUVIEN has now been approved in nine EU
countries (Austria, Denmark, France, Germany, Italy, Norway,
Portugal, Spain and the United Kingdom), and is commercially
available in the United Kingdom and Germany. ILUVIEN is in the
national phase, pending approval, in eight more EU countries
(Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the
Netherlands, Poland and Sweden) following the successful completion
of the Mutual Recognition Procedure (MRP) for subsequent marketing
authorizations.
ILUVIEN is currently under review by the U.S. Food and Drug
Administration with a Prescription Drug User Fee Act (PDUFA) goal
date of September 26, 2014.
“We are pleased to see the continued expansion of marketing
authorizations for ILUVIEN across Europe,” said Paul Ashton, PhD,
president and chief executive officer of pSivida. “We look forward
to the FDA’s action on ILUVIEN. We are entitled to a $25 million
milestone payment from our licensee Alimera Sciences upon FDA
approval of ILUVIEN. We are also entitled to share in the net
profits from Alimera’s sales of ILUVIEN on a country-by-country
basis including in the EU and the U.S.”
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 BioSilicon™, including Tethadur™.
The injectable, sustained release micro-insert ILUVIEN® for the
treatment of chronic DME considered insufficiently responsive to
available therapies, licensed to Alimera Sciences, Inc., is
marketed in the U.K. and Germany, has also received marketing
authorization in nine EU countries and is pending approval in eight
more EU countries approvals under the Mutual Recognition Procedure.
ILUVIEN is currently under review by the FDA with a PDUFA goal date
of September 26, 2014. pSivida has instituted a Phase III clinical
trial of Medidur™ for treatment of the chronic, back-of-the-eye
disease posterior uveitis using the same injectable micro-insert
delivering the same drug as ILUVIEN. An investigator-sponsored
clinical trial is ongoing for an injectable, bioerodible
micro-insert to treat glaucoma and ocular hypertension, a product
candidate on which Pfizer Inc. has an option. pSivida's
FDA-approved Retisert®, which provides long-term, sustained drug
delivery to treat posterior uveitis, is licensed to and sold by
Bausch & Lomb Incorporated. .
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: uncertainties with respect to: the
number of clinical trials necessary to support an NDA for Medidur;
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 for DME in the EU;
Alimera’s ability to obtain regulatory approval for, and if
approved, to finance, successfully commercialize and achieve market
acceptance of, and generate revenues to pSivida from, ILUVIEN for
DME in the U.S.; the ability to finance, complete and achieve a
successful outcome for Phase III trials for, and file and achieve
marketing approvals for, Medidur for posterior uveitis, including
achieving acceptable risk-to-benefit and safety profiles in light
of the CRL for ILUVIEN; initiation, financing and success of
Latanoprost Product Phase II trials and any exercise by Pfizer of
its option; ability of Tethadur to successfully deliver proteins,
peptides and other 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; 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.
In US:Martin E. Janis & Company, Inc.Beverly
JedynakPresident+1 312 943 1123M: +1 773 350
5793bjedynak@janispr.com
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