Germany's IQWIG negative on InterMune's Esbriet

US biotech firm InterMune (Nasdaq: ITMN) says that Germany’s private Institute for Quality and Efficiency in Health Care (IQWiG) has issued a negative report on the benefit assessment of Esbriet (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

Pirfenidone is the first Orphan Drug to be reviewed by IQWiG since new health care legislation known as AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) was enacted in January of 2011. Last week, AstraZeneca’s blood thinner was the first drug to gain approval under the new regimen (The Pharma Letter December 16).

Despite its approval by the European Union regulatory authorities, IQWiG concluded that no additional benefit could be found for pirfenidone. InterMune launched Esbriet - which has been forecast as having an annual sales potential in Europe of $700 million by 2015 - in Germany in the fall (TPL September 13). However, by German law Orphan Drugs are deemed as having an additional benefit, leading the IQWiG to assess the Esbriet additional benefit as given but not quantifiable, notes InterMune.