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pSivida Corp (PSDV) Announces Iluvien® Receives Marketing Authorization In Norway And Approval For Reimbursement In Portugal


7/29/2014 8:30:06 AM

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WATERTOWN, MA – pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that ILUVIEN® has been has granted marketing authorization in Norway for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and has been approved for reimbursement in Portugal for the same indication.

The Norway marketing authorization is the first following the successful completion last month of the Mutual Recognition Procedure for Norway and nine other EU countries. Marketing authorization is pending in the remaining nine countries (the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Belgium, Poland and Sweden).

ILUVIEN has been approved for reimbursement in Portugal by INFARMED, the marketing authorization body of the Portuguese Ministry of Health. Alimera has reported it plans to move forward with commercialization in Portugal in late 2014.

ILUVIEN is commercially available in the U.K. and Germany and has marketing authorization in Austria, Portugal, France, Spain and Italy. ILUVIEN is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014.

“We are very pleased at the steady progress ILUVIEN is making in Europe and look forward to the PDUFA date,” said Dr. Paul Ashton, President and CEO of pSivida. "Should ILUVIEN be approved by the FDA, we are entitled to a $25 million milestone payment from Alimera in addition to net profit payments on Alimera’s sales of ILUVIEN.”

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™, including Tethadur™. pSivida has instituted the first of two planned pivotal Phase III clinical trials for its lead development product, Medidur™, an injectable, sustained release micro-insert for the treatment of posterior uveitis, a chronic back-of-the-eye disease. ILUVIEN® for the treatment of chronic DME considered insufficiently responsive to available therapies, which uses the same micro-insert as Medidur and is licensed to Alimera Sciences, Inc., is marketed in the U.K. and Germany and has also received marketing authorization in Austria, France, Portugal, Spain, Italy and Norway and is awaiting authorization in nine additional EU countries. Alimera is seeking approval of ILUVIEN in the U.S. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible microinsert to treat glaucoma and ocular hypertension, a product candidate on which Pfizer Inc. has an option. pSivida's FDA-approved Retisert®, licensed to Bausch & Lomb Incorporated, provides long-term, sustained drug delivery to treat posterior uveitis.

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