Iluvien on the march in Europe
Friday, 20 July, 2012
pSivida (ASX:PVA) has had two wins this week for Iluvien, its treatment for vision impairment associated with chronic diabetic macular edema (DME).
Not only has it been given the go ahead for sale in France by the National Security Agency of Medicines and Health Products (L'Agence Nationale de Sécurité du Médicament et des Produits de Santé), but pSivida’s partner company, Alimera, is set to undertake a capital raising to continue the development and commercialisation of the treatment.
Alimera is seeking to raise $US40 million in equity financing which will go towards launching and marketing Iluvien in Europe.
The French marketing approval comes as a result of the European Union’s integrated approach to drug approvals, the Decentralized Regulatory Procedure (DCP).
In this case, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for Iluvien along with six Concerned Members States (CMS), Austria, France, Germany, Italy, Portugal and Spain.
The French authorisation is the fourth national approval in the EU, preceded by Austria, Portugal and the UK.
Alimera’s $US40m raising has already received the approval of institutional investors holding over 56 per cent of Alimera’s stock.
pSivida (ASX:PVA) was trading level at $2.10 as of 1.45pm on Friday.
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