WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ:PSDV
- News),
a leader in developing sustained release, drug delivery products for
treatment of back-of-the-eye diseases, announced today that the U.S.
Food and Drug Administration (FDA) acknowledged receipt of the
resubmission of the New Drug Application (NDA) for ILUVIEN®
for treatment of chronic diabetic macular edema (DME) and stated that
the resubmission was considered a complete, class 2 response to the
FDA's November 2011 complete response letter. The new Prescription Drug
User Fee Act (PDUFA) goal date is October 17, 2013.
pSivida's licensee Alimera Sciences reported that in the resubmission it
responded to the FDA's complete response letter and provided additional
analyses as well as new information to support that ILUVIEN is safe and
effective in the treatment of patients with chronic DME.
Using data from Alimera's two completed pivotal Phase 3 clinical trials
(collectively the FAME™ Study), the resubmission focused on the safety
aspects of ILUVIEN and the subgroup population of patients with chronic
DME, the same subgroup for which marketing approval for ILUVIEN has been
granted in six countries in the European Union. Additionally, Alimera
reported that data was submitted from the completed physician
utilization study for the ILUVIEN applicator and from a special reading
center assessment of photographs of the fundus, or interior surface of
the eye, which were collected during the FAME™ Study.
At month 36, the treatment effect for the chronic DME subgroup (i.e. the
difference in the proportion of 15 Early Treatment Diabetic Retinopathy
Study (ETDRS) eye chart letter responders between ILUVIEN and the sham
control) was more than twice that seen for the overall population. Given
that the risks associated with the chronic DME subgroup are similar to
the risks in the overall population, Alimera reported its belief that
the benefit to risk for this subgroup is optimized with ILUVIEN
treatment.
Alimera further reported its belief that the FDA resubmission package
includes important new information that demonstrates the safety and
efficacy of ILUVIEN for patients suffering from chronic DME and that a
clearer positioning now exists for ILUVIEN in the treatment of patients
with chronic DME since a first-line pharmacotherapy for DME was approved
by the FDA last year.
"We are very pleased with the FDA's acceptance of the resubmission of
the NDA and the new PDUFA date for ILUVIEN," said Dr. Paul Ashton,
President and CEO of pSivida Corp. "If the FDA approves ILUVIEN, we
would be entitled to an additional $25 million milestone payment from
Alimera as well as 20% of net profits, as defined, on any sales in the
U.S. by Alimera. We are entitled to the same net profit share on sales
of ILUVIEN for DME by Alimera in the EU, where Alimera has already
launched in the UK and reported plans to launch in Germany in 2013."
About ILUVIEN
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in
applicator) is a sustained release intravitreal micro-insert used to
treat vision impairment associated with chronic DME considered
insufficiently responsive to available therapies. Each ILUVIEN implant
provides a therapeutic effect of up to 36 months by delivering sustained
sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is
injected in the back of the patient's eye to a position that takes
advantage of the eye's natural fluid dynamics. The applicator employs a
25-gauge needle, which allows for a self-sealing wound. In the FAME™
Study, the most frequently reported adverse drug reactions included
cataract operation, cataract and increased ocular pressure.
In July 2010, Alimera submitted a Marketing Authorization Application
(MAA) to seven European countries via the Decentralized Procedure (DCP)
with the Medicines and Healthcare products Regulatory Agency of the U.K.
serving as the Reference Member State (RMS). The MAA included data from
the FAME Study, which involved 956 patients in sites across the United
States, Canada, Europe and India to assess the efficacy and safety of
ILUVIEN for the treatment of DME. At the end of the DCP, a consensus was
reached by the RMS and the other six countries that the MAA for ILUVIEN
was approvable. To date, six of the seven countries, Austria, the United
Kingdom, Portugal, France, Germany and Spain have granted national
licenses for ILUVIEN, which is now available in the United Kingdom for
private pay and privately insured patients. ILUVIEN has not been
approved by the FDA.
About pSivida Corp.
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, 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. ILUVIEN for DME has not been
approved in the U.S. 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 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: 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, successfully commercialize and achieve market
acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in
the EU; outcome of reimbursement for ILUVIEN in the U.K.; financing and
success of Phase III posterior uveitis trials including efficacy, side
effects and risk/benefit profile of the posterior uveitis micro-insert;
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
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The
President's Blog: http://www.thechairmansblog.com/paul-ashton
US Public Relations
Martin E. Janis & Company, Inc.
Beverly
Jedynak
President
Tel: +1 (312) 943 1123
bjedynak@janispr.com
or
pSivida
Corp.
Brian Leedman
Vice President, Investor Relations
Tel:
+61 (0) 41 228 1780
brianl@psivida.com
Source: pSivida Corp.
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