The U.S. Food and Drug Administration (:FDA) accepted Alimera Sciences Inc.’s (ALIM) re-submitted new drug application (:NDA) for Iluvien. The FDA said that the resubmission is a complete, class 2 response to the complete response letter (CRL) issued by the agency in Oct 2013. Alimera is looking to get Iluvien approved for the treatment of diabetic macular edema (:DME) in the U.S.
The Prescription Drug User Fee Act (:PDUFA) date for Alimera and pSivida Corp.’s (PSDV) Iluvien is now set for Sep 26, 2014.
We note that Alimera had suffered a setback in Oct 2013 when it received the third CRL from the FDA. The FDA refused to approve the NDA for Iluvien in its present form. The FDA stated that the benefits of Iluvien did not outweigh its risks. In the CRL, the FDA had indicated that results from a new study were required to be submitted along with a minimum of 12 months of follow-up for all enrolled patients. The FDA also talked about deficiencies at the manufacturing facility for Iluvien.
Alimera resubmitted the NDA to the FDA in Mar 2014. Alimera responded to the questions raised in the CRL. Alimera also provided data from Iluvien patients in the U.K. and Germany.
Alimera in-licensed Iluvien from pSivida to develop it for DME. The association between the two companies dates back to Feb 2005. Iluvien is marketed in U.K. and Germany. Moreover, the drug is approved in Austria, France, Portugal and Spain. In Italy it has been recommended for approval for the treatment of vision impairment associated with chronic DME for patients considered insufficiently responsive to available therapies. Alimera is also seeking approval for the drug in 10 additional EU country approvals.
Once approved, pSivida will get a $25 million milestone payment from Alimera along with 20% of net profits on U.S. sales of Iluvien for DME.
pSivida currently carries a Zacks Rank #2 (Buy) while Alimera carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Amgen (AMGN) and Sucampo Pharmaceuticals, Inc. (SCMP). Both carry a Zacks Rank #1 (Strong Buy).