
With operations in the US and Australia, NASDAQ-listed 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 month sor years. Dr. Paul Ashton, pSivida President and CEO, updates us onthe progress they've made over the past two years.
Dr. Ashton was named President and CEO in January 2009, having previously served as Managing Director and Executive Director of Strategy a tpSivida. He previously was the Presidentand Chief Executive Officer of Control Delivery Systems (CDS) from 1996 until its acquisition by pSivida in December2005. "At CDS we worked on theintravenous treatment of AIDS-relatedeye diseases," Dr. Ashton explains. "We developed the first back of the eye drugdelivery system and had it approved bythe FDA in 1996. We licensed that toChiron, and subsequently worked on another system which we also had FDA approved and which we licensed to Bausch & Lomb." It's this success i ngetting medical devices approved tha tprobably inspired pSivida to acquireCDS. "They had technologies themselves at the time but they were all early stage." Going public on the NASDAQ, in 2008, raised the funding for pSivida to accelerate their product development programme.
The most advanced result of thei refforts is lluvien, for the treatment of diabetic macular oedema (DME).pSivida's licensee, Alimera Sciences was notified in September of this year that the FDA has granted Priority Review status for the New Drug Application(NDA) filed for Iluvien. FDA Priority Review status is given to therapies that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This status reduces the review time goal from 10 months to six months. Dr. Ashton says that approval of Iluvien would trigger a USD 25 million milestone payment to pSivida fromAlimera. Under the license agreement pSivida is also to receive 20 percen tof net profits on sales by Alimera. Meanwhile lluvien is also filed for approval in Austria, France, Germany, Italy, Portugal, Spain, and Canada .pSivida has joint ownership and reference rights to these regulatory filings.
As pSivida continues to work to develop new products for the sustained release of drugs and proteins, Dr. Ashton is happy about the progress they're making. "Earlier this year our stock was added to the Russell Microcap(R) Index,which to me really underscores the evolution of the company. We have moved our third product toward commercialization with an NDA bein gfiled by our licensee Alimera, develope dadditional technologies and earlie rstage products and very importantly, improved our cash position. The company is in a good position to capitalize on the many opportunities that lie before us."

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