Boehringer's lung drug to hit EU markets

The prospects for patients in Europe with the rare debilitating and fatal lung disease idiopathic pulmonary fibrosis are looking up with the imminent market arrival of Boehringer Ingelheim's Ofev.

Ofev (nintedanib), which BI already sells as Vargatef for lung cancer, will now battle for IPF market share with Esbriet (pirfenidone) from InterMune (now owned by Roche), launched in Europe back in 2011. Speaking at a launch event in Brussels on Friday, Susanne Stowasser, global team leader of respiratory medical affairs at BI, confirmed that the tyrosine kinase inhibitor, taken as one capsule twice-daily, will go on sale in Germany this week.

The statistics surrounding IPF, which causes irreversible scarring of the lungs and affects some 85,000 people in Europe, make for grim reading. Characterised by a Velcro-like crackling sound, the disease, which primarily affects people between 60-80 years old (and mostly men) is more deadly than most cancers; half of the patients die within two-three years after diagnosis.

One huge problem is misdiagnosis, which occurs in about 50% of patients, as symptoms are similar to other respiratory diseases like COPD and asthma. However, Ofev has impressed in trials, reducing the annual decline in lung function by approximately 50 per cent.

No NICE verdict for many months
The drug was approved by the European Medicines Agency in January, and now BI has to enter into thorny reimbursement negotiations across the continent. Things look particularly complicated in the UK, where a launch is likely next month, but the National Institute for Health and Care Excellence (NICE) is not expected to deliver its verdict for several months, though a decision on the lung cancer indication for nintedanib is imminent.

Luca Richeldi, professor of respiratory medicine at Southampton University, told pharmaphorum that he hopes NICE will speed up its review given that time is very much of the essence for IPF patients. When asked what criteria doctors should adopt when deciding whether to prescribe Ofev or Esbriet, Prof Richeldi said that consultation with patients on issues such as side effect profile will be key, noting that there are no head-to-head trials that can be referred to.

However, after a decade of failed IPF trials, he said that having two approved drugs represents a historical turning-point and "new horizon" for treating the disease.

Pricewise, BI did not specify - but IPF drugs do not come cheap. In the USA, where Ofev and Esbriet were approved by the Food and Drug Administration on the same day in October last year, the former costs $96,000 and Roche charges $94,000.