pSivida Corp. (PSDV) had received a draft guidance issued by the UK’s National Institute for Health and Care Excellence (NICE) in Jun 2013 recommending Iluvien for the treatment of pseudophakic patients with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
pSivida recently announced that the NICE has issued a final guidance recommending the same. Within three months of the final guidance publication (Nov 27, 2013), clinical commissioning groups, the National Health Service England and local public health authorities are required to comply with this recommendation.
We note that pSivida had collaborated with Alimera Sciences, Inc. (ALIM) to develop Iluvien for DME. The association between the two companies dates back to Feb 2005. Alimera Sciences is currently in conversation with retinal specialists, hospital pharmacists and commissioners throughout the UK to commercialize Iluvien.
pSivida’s Iluvien is approved in the UK, Austria, France, Germany, Portugal and Spain, while in Italy it has been recommended for approval. Alimera started the launch of Iluvien for DME in the U.K. and Germany in the second quarter of 2013 and will launch Iluvien in France in 2014.
Alimera experienced a setback in Oct 2013 when it received the third Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The FDA refused to approve the New Drug Application (NDA) for Iluvien in its present form. In the CRL, FDA indicated that results from a new study are 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.
pSivida carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Aeterna Zentaris Inc. (AEZS) and Jazz Pharmaceuticals plc (JAZZ) carrying a Zacks Rank #1 (Strong Buy).
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