French price regulator authorizes reimbursement of InterMune's Esbriet

12 September 2012

USA-based InterMune (Nasdaq: ITMN) says that French regulator  the Comite Economique des Produits de Sante (CEPS) has granted reimbursement for Esbriet (pirfenidone), making it the first medicine for the treatment of idiopathic pulmonary fibrosis (IPF) to be reimbursed in France.

The drug was approved by the European Commission last year (The Pharma Letter March 4, 2011). The price of Esbriet is expected to be published in France's Journal Officiel in the fourth quarter of 2012, which is the final step in the reimbursement process for a new medicine in France. The French Transparency Commission (CT: Commission de Transparence) of the French National Health Authority (HAS: Haute Autorite de Sante) issued a favorable opinion for the reimbursement of Esbriet by French National Health Insurance earlier this year (TPL April 10).

European Union sales of Esbriet could top $700 million by 2015 and a US approval in 2014 would put the drug at more than $1 billion in sales, according to Leerink Swann analyst Howard Liang’s estimates. The drug was approved in Japan in October 2008, where it is sold under the name Pirespa by Shionogi.

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