pSivida Announces Tech Evaluation Agreement With Leading Global Pharmaceutical Company
May 29 2013 - 8:00AM
Business Wire
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a specialty
pharmaceutical company that is a leader in the development of
sustained release ophthalmic drug treatments, today announced that
it has signed a funded technology evaluation agreement with a
leading global pharmaceutical company. The agreement will evaluate
pSivida's proprietary Durasert™ technology for this pharmaceutical
company's select products in ophthalmology. The Durasert technology
system delivers specific quantities of drugs directly to a target
site in the body at controlled rates for predetermined periods of
time ranging from weeks to months.
"I am very pleased to be entering into a technology assessment
agreement in ophthalmology with another Global Pharmaceutical
company," said Dr. Paul Ashton, President and CEO of pSivida Corp.
"We are transitioning into a Specialty Pharma company developing
our own products, while continually looking for ways to use our
technology platforms to develop new products. Technology agreements
such as this enable us work with major companies further expanding
our reach and increasing our shots on goal."
pSivida has developed three of the four sustained release
devices for retinal diseases that have been approved in either the
US or Europe, the most recent being ILUVIEN®, partnered with
Alimera and approved in multiple EU countries. Independently,
pSivida is developing an injectable, sustained release product to
treat uveitis affecting the back of the eye (posterior uveitis) and
an injectable, bioerodible product to treat glaucoma and ocular
hypertension in collaboration with Pfizer.
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 Diabetic Macula Edema (DME),
licensed to Alimera Sciences, Inc., has received marketing
authorization in Austria, France, Germany, Portugal, the U.K. and
Spain and is awaiting authorization in Italy. ILUVIEN for DME has
not been approved in the US. pSivida plans to institute pivotal
Phase III clinical trials for the treatment of posterior uveitis
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 product, Retisert® for the treatment of
posterior uveitis, is licensed to Bausch & Lomb.
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 finance, achieve additional marketing
approvals, successfully complete pricing and reimbursement
discussions for, 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.; financing and success of planned 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 and potential collaborations
for those products; 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 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.
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