The International Diabetes Federation estimates that approximately 19 million people in these 7 EU countries are currently living with diabetes, and Alimera estimates that approximately 1 million people living there suffer from DME.
With respect to U.S. regulatory matters, Alimera has reported that it met with the FDA in an effort to gain a better understanding of the regulatory path for ILUVIEN for DME. Alimera further reported that based upon this meeting, it plans to submit a response to the FDA’s second complete response letter to include additional analysis of the benefits and risks of ILUVIEN based upon clinical data available from Alimera’s completed FAME™ Study. Approval in the U.S. would entitle pSivida to a $25 million milestone payment and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera.
“The investigator sponsored Phase I/II dose-escalation study of our bioerodible, injectable latanoprost micro-insert for glaucoma and occular hypertension is ongoing,” continued Dr. Ashton. pSivida granted Pfizer an exclusive option under various circumstances to license the development and commercialization worldwide of this micro-insert for human ophthalmic disease other than uveitis.
“We are encouraged by the progress of our pre-clinical programs. In July 2012, we announced the execution of our first funded technology evaluation agreement for our Tethadur™ protein/antibody delivery technology. The agreement, which is with a leading global biopharmaceutical company, covers the field of ophthalmology. Tethadur is an application of our BioSilicon™ technology platform designed to provide sustained delivery of large biologic molecules, including peptides, proteins and antibodies using an injectable, bioerodible, nanostructured, porous BioSilicon material for drug delivery. A sustained delivery system for these types of molecules which must currently be injected into the eye every one or two months would offer a significant clinical advance in the ophthalmic area."Revenues for the fiscal year ended June 30, 2012 totaled $3.5 million compared to $5.0 million for the prior fiscal year. Revenues in both years included royalty income from sales of Retisert® by Bausch & Lomb and revenue recognition from the June 2011 amendment and restatement of the Pfizer collaboration agreement. In addition, fiscal 2012 reflected revenue recognition from the July 2011 termination of the Intrinsiq license agreement. For the year ended June 30, 2012, pSivida reported a net loss of $24.8 million, or $1.19 per share, compared to a net loss of $8.6 million, or $0.44 per share, for the prior fiscal year. Fiscal year 2012 results included a $14.8 million impairment charge for pSivida’s finite-lived intangible assets arising from the November 2011 complete response letter for ILUVIEN for DME and the resulting significant decrease in pSivida’s share price.