pSivida Corp. Announces New ILUVIEN® PDUFA Date of October 17, 2013

  pSivida Corp. Announces New ILUVIEN® PDUFA Date of October 17, 2013

Business Wire

WATERTOWN, Mass. -- May 1, 2013

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
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

Contact:

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
 
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