BUSINESS WIRE
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of
sustained release back of the eye drug delivery systems for
difficult-to-treat conditions, today announced that its licensee,
Alimera Sciences (NASDAQ:ALIM) has submitted a Marketing Authorization
Application (MAA) to the Medicines and Healthcare Products Regulatory
Agency (MHRA) in the United Kingdom (UK) for Iluvien®. Iluvien,
developed by pSivida and licensed to Alimera Sciences in 2005, is a
sustained release drug delivery system releasing the steroid
flucocinolone acetonide for the treatment of diabetic macular edema
(DME). The MAA is being submitted through the Decentralized Procedure
with the UK MHRA as the Reference Member State (RMS). Applications have
also been submitted to the following other Concerned Member States (CMS)
in the European Union: Austria, France, Germany, Italy, Portugal and
Spain.
This submission closely follows the submission last week of the NDA to
the U.S. Food and Drug Administration for approval for Iluvien to treat
DME. The MAA submission includes the 24 month low dose data from the
FAME study. Alimera has indicated it plans to follow this MAA submission
with a registration filing in Canada in the near future. pSivida has
joint ownership and reference rights to the MAA and NDA.
pSivida continues to work to develop new products for the sustained
release of drugs and proteins based on its existing and new
technologies. Additionally, Pfizer and pSivida are collaborating to
develop ophthalmic products based on pSivida technology. While the
Company remains primarily focused in ophthalmology, pSivida is exploring
other therapeutic areas.
About pSivida Corp.
pSivida Corp. is a world leader in the development of tiny, sustained
release, drug delivery products and technologies that are administered
by implantation, insertion or injection. The Company uses these systems
to develop treatments for serious, unmet, medical needs. pSivida’s
intellectual property portfolio consists of 59 patent families, more
than 100 granted patents, including patents accepted for issuance, and
more than 150 patent applications. pSivida conducts its operations from
Boston in the United States and Malvern in the United Kingdom.
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: maintaining
collaboration agreements with Alimera and Pfizer; modifications of
existing terms of collaboration agreements with Alimera and Pfizer;
achievement of milestones and other contingent contractual events;
ability to prove safety and efficacy of, and achieve regulatory
approvals for, and successfully commercialize Iluvien, BrachySil and
other products;; ability to raise capital; ability to achieve
profitability; ability to derive revenues from Retisert; ability to
develop new products; impairment of intangibles; fluctuations in the
fair values of certain outstanding warrants; fluctuations in operating
results; termination of license agreements; ability to obtain partners
to develop and market products; competition; extent of third-party
reimbursement for products; product liability; ability to protect
intellectual property or infringement of others’ intellectual property;
retention of key personnel; consolidation in the pharmaceutical and
biotechnology industries; compliance with laws; maintaining effective
internal control over financial reporting; manufacturing risks; risks
and costs of international business operations; volatility of stock
price; possible dilution through exercise of outstanding warrants and
stock options or future stock issuances; possible influence by Pfizer;
ability to pay any registration penalties; and other factors described
in our filings with the Securities and Exchange Commission. 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.