WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is
a leader in developing sustained release drugs for treatment of
back-of-the-eye diseases, today announced that the Transparency
Commission (Commission de la Transparence or CT) of the French National
Health Authority (Haute Autorite de Sante) has issued a favorable
opinion for the reimbursement and hospital listing by the French
National Health Insurance of ILUVIEN® for the treatment of
chronic diabetic macular edema (DME) considered insufficiently
responsive to available therapies and despite optimized management of
diabetes. ILUVIEN is licensed to and sold by Alimera Sciences.
In France, patients will be reimbursed for 100% of the cost of ILUVIEN
under Affection de Longue Duree, a program for severe chronic disease,
such as diabetes. Alimera has reported that it will now move forward
with the next step in the process, which is to determine the price and
any reimbursement conditions for ILUVIEN in France with the Comite
Economique des Produits de Sante or CEPS. Alimera further reported that
it believes the CT's positive opinion for reimbursement of ILUVIEN will
help it in its discussions with the CEPS pricing committee.
About pSivida
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained
release, drug delivery products designed to deliver drugs at a
controlled and steady rate for months or years. pSivida is currently
focused on treatment of chronic diseases of the back of the eye
utilizing its core technology systems, Durasert™ and BioSilicon™. The
injectable, sustained release micro-insert ILUVIEN® for the treatment of
chronic DME considered insufficiently responsive to available therapies,
licensed to Alimera Sciences, Inc., has received marketing authorization
in Austria, France, Germany, Portugal, Spain and the U.K. and is
awaiting authorization in Italy. Alimera has resubmitted the New Drug
Application for ILUVIEN for DME to the U.S. Food and Drug
Administration. pSivida plans to institute pivotal Phase III clinical
trials for the treatment of posterior uveitis, a chronic back-of-the-eye
disease, with the same micro-insert as ILUVIEN for DME. An
investigator-sponsored clinical trial is ongoing for an injectable,
bioerodible micro-insert to treat glaucoma and ocular hypertension.
pSivida's FDA-approved Retisert® licensed to Bausch & Lomb Incorporated
provides long-term, sustained drug delivery to treat posterior uveitis.
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: determination of the price and reimbursement conditions
for ILUVIEN in France; 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.; Alimera's ability to finance, achieve additional
marketing approvals, achieve appropriate pricing and reimbursement and
successfully commercialize and achieve market acceptance of, and
generate revenues to pSivida from, ILUVIEN for DME in the EU; the
success of Phase III posterior uveitis trials including efficacy, side
effects and risk/benefit profile of the posterior uveitis micro-insert
and pSivida's ability to finance and complete the trials and receive
marketing approvals; initiation, financing and success of Latanoprost
Product Phase II trials and exercise by Pfizer of its option;
development of products using Tethadur and BioSilicon; initiation and
completion of clinical trials and obtaining regulatory approval of
product candidates; adverse side effects; ability to attain
profitability; ability to obtain additional capital; further impairment
of intangible assets; fluctuations in operating results; decline in
royalty revenues; 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; possible influence by Pfizer; 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. 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
IN US:
Martin E. Janis & Company, Inc.
Beverly Jedynak,
President
312-943-1123; 773-350-5793 (cell)
bjedynak@janispr.com
or
IN
AUSTRALIA:
pSivida Corp.
Brian Leedman, Vice President,
Investor Relations
+61 (0) 41 228 1780
brianl@psivida.com
Source: pSivida Corp.
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