pSivida Announces Tech Evaluation Agreement With Leading Global Pharmaceutical Company
WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NAS: 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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