Boehringer and InterMune data on IPF drugs impress
pharmafile | May 19, 2014 | News story | Research and Development, Sales and Marketing | Boehringer Ingelheim, InterMune, idiopathic pulmonary fibrosis
Two new medicines for a generally fatal lung disease, known as idiopathic pulmonary fibrosis and made by Boehringer and InterMune, have enjoyed strong clinical trial results.
InterMune’s pirfenidone and Boehringer’s nintedanib (also known as Inpulsis) are the first medicines to show progress in slowing the disease’s ability of restricting patient breathing, according to new studies in the New England Journal of Medicine.
Both drugs do not, however, reverse damage from idiopathic pulmonary fibrosis (IPF), a lung-scarring disease whose cause is unknown.
The two studies were separate, and each was funded by the companies that developed the treatment.
InterMune announced last week that it would give its medicine to some US patients at no cost, a decision that may help kick-start sales of its product.
However, neither treatment is approved for sale yet in the US, although InterMune did receive European approval for the medicine, where it is known as Esbriet, in 2011 at a cost of around $21,000 per patient.
The FDA knocked it back in the same year due to the need for more clinical trial data – but the firm says it will now resubmit its latest data sets to the FDA in the hope of an approval. Analysts predict Esbriet can reach in excess of $1 billion in peaks sales.
The FDA has already awarded nintedanib orphan designation, which increases its patent life, and analysts are also predicting blockbuster sales for the drug.
BI is hoping to add several cancer licences to its indication in the coming years, which should shore up its earning potential.
Slowing disease progression
As well as being published in the NEJM, the data for Boehringer’s drug were also presented this week at the American Thoracic Society (ATS) 2014 annual meeting in San Diego, US.
Study investigator Professor Luca Richeldi spoke to Pharmafile in California – and asked if the results were expected or surprising, he said: “I was optimistically expecting these results. In all of the trials all the results go in the same direction. It means you feel confident providing the drug to patients.”
Questioned whether he expects to see a lot of calls for early access to the drug on compassionate grounds: “A huge amount. My expectation will be there. But I want to underscore the fact that we’re not preventing anything, rather slowing disease progression.”
Nintedanib is also being studied in non-small cell lung cancer (NSCLC) and impressed at the European Cancer Congress (ECC) in Amsterdam last year, when it showed it could extend overall survival by 2.3 months for advanced NSCLC patients when compared to placebo and docetaxel.
IPF has been diagnosed in about 128,000 Americans, with around 40,000 people dying from the disease each year according to the Coalition for Pulmonary Fibrosis, a US patient support group.
The disease causes tissue deep in the lungs to become increasingly thick and stiff, or scarred over time, according to the National Heart, Lung and Blood Institute. When that happens, it inhibits the ability of the lungs to move oxygen into the bloodstream, limiting the amount that gets to the brain and other organs.
Brett Wells
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