Regarding the European commercialization of ILUVIEN for DME, Alimera Sciences, pSivida’s licensee, has announced a planned direct commercial launch in three EU countries in 2013, with Germany expected in the first quarter, the United Kingdom in the second quarter and France in the third quarter. ILUVIEN has received marketing authorization in the United Kingdom, Austria, Portugal, France and Germany, and has been recommended for marketing authorization in Italy and Spain, for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Alimera completed a $40 million financing to proceed with the direct commercialization of ILUVIEN for DME in Germany, the U.K. and France. Alimera has estimated that there are approximately one million people suffering from DME in the seven EU countries where marketing authorization has either been received or recommended.
Alimera also announced that it intends to resubmit the NDA for ILUVIEN for DME to the FDA during the first quarter of 2013. Alimera further announced that using data from its two previously completed pivotal Phase III clinical trials, the resubmission will focus on the population of patients with chronic DME, the same group for which marketing approval for ILUVIEN has been granted in various EU countries. 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 pSivida’s bioerodible, injectable latanoprost micro-insert for glaucoma and ocular hypertension is ongoing. Pfizer has an exclusive option under various circumstances to license the development and commercialization worldwide of this micro-insert for human ophthalmic disease other than uveitis.
Revenues for the fiscal 2013 first quarter were $553,000 compared to $1.7 million for the first quarter a year earlier. The fiscal 2012 first quarter included $1.1 million of revenue recognition from the termination of a 2008 nutraceutical field of use license. pSivida reported a net loss of $2.6 million, or $0.11 per share, for the first quarter ended September 30, 2012, compared to a net loss of $2.4 million, or $0.12 per share, for the first quarter of the prior year.