Health Canada recently approved InterMune, Inc.’s Esbriet (pirfenidone) for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF) in adults. The company expects the product to be available in Canada, from January 2013 onwards.
We note that Esbriet was designated Priority Review status in Canada and the Canadian regulatory body completed its accelerated review process according to the target guidelines of 180 days. InterMune is looking to secure reimbursement for Esbriet from private insurance providers and the public (provincial) drug reimbursement plans in Canada.
Meanwhile, the pricing and reimbursement process for Esbriet continues in the EU. In September this year, the Comite Economique des Produits de Sante (CEPS), the pricing committee of France, granted reimbursement for InterMune’s Esbriet. InterMune expects to make Esbriet available to the French population by year end.
We note that Esbriet, which was approved in the EU in February 2011, is already available in Germany, Austria, Sweden, Norway, Denmark, Iceland and Luxembourg. InterMune expects to conclude its discussion regarding the product’s pricing and reimbursement in Italy, Spain, Belgium and the Netherlands by year end.
Similar discussions are expected to be concluded in the UK (first quarter of 2013), Ireland and Finland (first half of 2013). The product will be launched in those countries following pricing and reimbursement approvals by the relevant authorities.
We remind investors that Esbriet is the first and only approved treatment for IPF. In the US, Esbriet is currently in a phase III clinical trial.
We currently have a Neutral recommendation on InterMune. The stock carries a Zacks #3 Rank (short-term Hold rating). We expect investor focus to stay on the pricing and reimbursement process in Europe.