InterMune says it will launch its idiopathic pulmonary fibrosis drug Esbriet in Germany, its first European market, on Thursday September 15.
The European Commission approved Esbriet (pirfenidone) back in March for the treatment of mild to moderate IPF, a devastating and often fatal lung disease which affects more than 100,000 patients in Europe. In trials, Esbriet reduced the decline in lung function and exercise capacity in IPF patients, and also cut disease progression by 30%.
There are currently no approved treatments in Europe for pulmonary fibrosis, and patients tend to be managed with corticosteroids or immune suppressants such as azathioprine, despite a lack of data to support their use. That lack has led to speculation that Esbriet could eventually achieve sales in excess of $1 billion.
Germany will be the second market for pirfenidone, which has been marketed in Japan since 2008 by Shionogi under the Pirespa brand name, and additional launches in Europe will take place over the coming months. The drug is scheduled to be launched in France, Italy and Spain during the first half of 2012, and in the UK during the third quarter of next year.
There are 13,000-17,000 IPF patients in Germany, and InterMune chief executive Dan Welch said on a conference call yesterday that the firm plans to sell its drug there at an ex-factory price of around €36,000 per patient per year. This is a little higher than previously indicated, because of Germany's mandatory 16% rebate on all drugs, he noted. The net price booked by InterMune will be a little over €30,000.
In Japan, pirfenidone has already captured a large chunk of the IPF market with sales of $35 million within two years of its launch, according to GlobalData, which is predicting that the global IPF market will go from a standing start in 2008 to almost $2 billion in 2018.
Esbriet's progress in the USA was stalled last year, however, when the Food and Drug Administration rejected approval and asked for additional clinical data, despite the fact that its Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval two months earlier.
InterMune has commenced enrolment for a new Phase III study called ASCEND which is expected to generate results in mid-2013, so Esbriet is not likely to reach the US market until 2014.