pSivida CEO to Discuss Company's Sustained Release Delivery System for Biologics at Two Upcoming Conferences
"More than half of the top selling drugs today are biologics. Unfortunately to be effective these drugs must be injected frequently as there is currently no approved technology to deliver most biologics on a sustained basis," said Dr. Ashton. "We believe our Tethadur technology may provide a solution for sustained-release delivery of many of these molecules. We are pleased with our preclinical in vitro results to date and expect to report data from animal studies by the end of this summer."
Tethadur utilizes an injectable, bioerodible, nanostructured, porous BioSilicon™ material for drug delivery. The size of the pores in the material is manufactured using nanotechnology to accommodate specific biologic molecules. "Tethadur is not an implant," Dr. Ashton stated. "Rather, it is suspension of a powdery material and a solution of a biologic drug that is injected into the patient - either in the eye in ophthalmic indications or subcutaneously for other systemic indications—and is designed to deliver the biologic molecules on a sustained basis."
Dr. Ashton's presentation before the
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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: ability of Tethadur to successfully deliver proteins,
peptides and other large biologic molecules and the results of the
animal studies of Tethadur; 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, obtain adequate pricing and
reimbursement for, successfully commercialize and achieve market
acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in
the EU; the ability to finance, complete and achieve a successful
outcome for Phase III trials for, and file and achieve marketing
approvals for, Medidur for posterior uveitis, including achieving
acceptable risk-to-benefit and safety profiles in light of the CRL for
ILUVIEN; initiation, financing and success of Latanoprost Product Phase
II trials and any exercise by Pfizer of its option; ability to develop
product candidates and products and potential related collaborations;
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 income; 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; absence of dividends; and
other factors described in our filings with the
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