BUSINESS WIRE
WATERTOWN, Mass.--(BUSINESS WIRE)--Drug delivery company pSivida Corp. (NASDAQ: PSDV) (ASX: PVA) today
announced the commencement of a Phase I/II clinical trial studying a new
bioerodible drug delivery implant for the treatment of glaucoma and
ocular hypertension. The implant is designed to provide long-term,
sustained release of latanoprost, the most commonly prescribed agent for
reduction of intraocular pressure in patients with ocular hypertension
and glaucoma worldwide.
The product candidate is a new, compact drug-delivery implant based on
the Company’s DurasertTM technology system. The implant is
designed to be administered by an eye care professional in a minimally
invasive, outpatient procedure; it is also designed to be injected into
the subconjunctival space of the eye and to be bioerodible.
The new study is a dose-escalating study designed to assess the safety
and efficacy of the implant in patients with elevated intraocular
pressure. If successful, pSivida plans to advance the product into a
multi-center Phase II trial.
Dr Paul Ashton, President and CEO of pSivida Corp., said, “We are
extremely pleased that this first application of our new bioerodible
drug-delivery technology has entered clinical trials. We look forward to
advancing this new delivery system both in glaucoma and potentially in
other applications as well.”
The insert is being developed under the recently amended Research and
Collaboration Agreement with Pfizer Inc. Under the revised agreement,
Pfizer will make an initial payment of $2.3 million. pSivida will, with
technical assistance from Pfizer, have the right to develop this
candidate for the reduction of intraocular pressure in patients with
ocular hypertension or glaucoma through Phase II clinical trials. At
that point, Pfizer has an option to take an exclusive, world-wide
license to develop and commercialize the product candidate in return for
a $20 million option exercise payment, double-digit royalty payments on
sales of the product and additional development, regulatory and any
sales performance milestone payments of up to $146.5 million. If Pfizer
does not exercise its option, pSivida will retain the right to develop
and commercialize the glaucoma product on its own or with a partner. As
part of the amended agreement, pSivida regains all rights to its
intellectual property in ophthalmic applications previously included in
the original Research and Collaboration Agreement, other than those
related to the latanoprost product.
About pSivida Corp.
pSivida is a world leader in the development of tiny drug delivery
products that are administered by implantation, injection or insertion
and provide sustained release of drugs on a controlled and level basis
for months or years. The Company uses these systems to develop
treatments for serious, unmet, medical needs. The Company’s most
advanced product candidate, ILUVIEN®, delivers fluocinolone
acetonide (FA) for the treatment of diabetic macular edema (DME). DME is
a leading cause of vision loss, affecting more than a million people in
the US alone, for which there is currently no FDA-approved drug therapy.
ILUVIEN is licensed to Alimera Sciences, Inc., which has completed Phase
III clinical trials and submitted a New Drug Application (NDA) with the
Food and Drug Administration (FDA) in June 2010 based on 24-month data.
In August 2010, the FDA granted Priority Review status for the NDA, and
in December 2010, the FDA issued a Complete Response Letter. In February
2011, Alimera reported 36-month top-line results from the completed
Phase III clinical trials and in May 2011, Alimera reported data which
analyzed the subgroup of patients who had been diagnosed with DME for
three or more years at entry of the study. Alimera resubmitted a New
Drug Application for ILUVIEN to the FDA on May 12, 2011 to address
questions raised in the Complete Response Letter (CRL) and reported that
data from the subgroup of patients with chronic DME was also provided
together with additional information regarding controls and
specifications on the manufacturing, packaging and sterilization of
ILUVIEN. pSivida has two products approved by the FDA for sustained
release delivery of drug to treat chronic back-of-the-eye diseases:
Retisert® for the treatment of posterior uveitis and Vitrasert®
for the treatment of AIDS-related cytomegalovirus (CMV) retinitis.
pSivida has licensed both of these products and the technologies
underlying them to Bausch & Lomb Incorporated. pSivida’s intellectual
property portfolio consists of over 50 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: ability of
pSivida, with Pfizer, another partner or alone, to successfully develop,
obtain regulatory approval for, finance, and commercialize a latanoprost
implant; ability to obtain additional capital uncertain; future losses;
impairment of intangibles; fluctuations in the fair values of certain
outstanding warrants; fluctuations in operating results; decline of
royalty income from Bausch & Lomb; Alimera's ability to obtain
regulatory approval of ILUVIEN; Alimera's ability to successfully
commercialize ILUVIEN if approved; risk/benefit profile of ILUVIEN;
timeliness of approval, if any, of ILUVIEN and any limitations on uses
thereof; ability to complete clinical trials and obtain regulatory
approval of other product candidates; ability to find partners to
develop and market products; termination of license agreements;
competition; market acceptance of products and product candidates;
reduction in use of products as a result of future publications; ability
to protect intellectual property or infringement of others' intellectual
property; 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 through exercise of outstanding warrants and
stock options or future stock issuances; possible influence by Pfizer;
ability to pay any registration penalties; absence of dividends; 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.