pSivida announces resubmission of ILUVIEN NDA to FDA for chronic diabetic macular edema

Apr 2 2013

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN® for chronic diabetic macular edema (DME).

“To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”

Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.

"We are pleased to see the resubmission of the NDA to the FDA," said Dr. Paul Ashton, president and CEO of pSivida Corp. "To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera."

pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.