InterMune Inc. (ITMN) France's Economic Committee (CEPS) Authorizes Reimbursement of Esbriet Conference Call September 11, 2012, 08:00 am ET Executives Jim Goff - VP, Corporate Communications & IR Dan Welch - Chairman, CEO and President Giacomo Di Nepi - SVP and Managing Director, Europe Analysts Brian Abrahams - Wells Fargo Securities Ritu Baral - Canaccord Katherine Xu - William Blair Michael Yee - RBC Capital Markets Geoff Meacham - JPMorgan Terence Flynn - Goldman Sachs Matthew Harrison - UBS Liisa Bayko - JMP Securities Presentation Operator
These documents identify important factors that could cause our actual results to differ materially from our projections and other forward looking statements. These risk factors include regulatory revenue, pricing and reimbursement, intellectual property, clinical development and capital resourcing and other risks relating to our business. On the call today is Dan Welch InterMune's Chairman and Chief Executive Officer and President. Joining us for questions and answers will be Giacomo Di Nepi our Senior Vice President and Managing Director for Europe.During today's call we'll discuss the pricing and reimbursement conditions for Esbriet in France, we will share with you additional details of our commercial organization in France and are ready just to make Esbriet available to the estimated 8000 patients with mild to moderate IPF in that country. We also will review our progress in preparing to launch Esbriet in France and in other countries in the European Union, I will now turn the call over to Dan Welch. Dan Welch Thank you, Jim and good morning all. We are very pleased to announce today that we have reached agreement on pricing and reimbursement conditions for Esbriet in France with the French Pricing Committee or CEPS and we are very pleased to announce that Esbriet will be available to patients in France in the fourth quarter of this year consistent with the timetable that we have previously shared with you. In early April of this year we announced that the French Transparency Commission had granted SMR and ASMR ratings that allowed InterMune to proceed to the next step in the process which was the negotiation of price and reimbursement conditions with the economic committee or CEPS. During the past several months we've been involved in discussions with CEPS and are very pleased to report today that the committee has authorized an ex-factory reimbursed price of €25000 per patients per year. This is approximately $32000 at current exchange rates. The French healthcare system requires no mandatory discounts or rebases at the national or regional level, so the gross ex-factory price is also the net price to InterMune.
We are very pleased with this price. In particular for comparison with what we view as relevant analogs in France, the Esbriet price is similar to the current price of Tracleer, an oral drug for pulmonary arterial hypertension and that is priced at €25750 and the prices for the treatments of lung cancer such as Tarceva or Iressa are in the same -- very much in the same range at the price granted for Esbriet in France.In addition the Esbriet price is above those of the multiple sclerosis drugs Tysabri and Gilenya which are priced in France at €23500 and €22700 respectively. So within this context we are very, very pleased with the Esbriet price. Esbriet will be reimbursable after it is published in the French Journal Officiel year which we expect to happen in the fourth quarter of this year. We are planning to launch Esbriet as soon as possible after this publication of the Esbriet price in French Journal Officiel. And when our commercial team is fully recruited and trained to promote Esbriet. We therefore currently expect the launch to be in December of this year. Esbriet will be reimbursed by the French National Health Insurance System for the treatment of mild to moderate forms of IPF in adults. Esbriet will be reimbursed as a [medicamom dexepsion] which means that it will be reimbursed for the labeled indication defined previously by the Transparency Commission or CT as IPF patients with forced vital capacity greater than or equal to 50% and DLCO greater than or equal to 35%. You may recall that these metrics correspond to the lung function entry criteria, the bottom end of those criteria for our capacity Phase III program. In terms of post marketing commitments we have committed to conduct a patient registry to capture information regarding the use of Esbriet in everyday clinical practice. Read the rest of this transcript for free on seekingalpha.com