Health Canada recently approved InterMune, Inc.
's ( ITMN ) 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
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
INTERMUNE INC (ITMN): Free Stock Analysis
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