InterMune’s IPF drug shines at ERS Congress
InterMune has posted positive data for its lung-scarring drug at this year’s European Respiratory Society Annual Congress 2014 (ERS).
Pharmafile was present to witness the findings which covered Phase III trial patients being treated with the biotech firm’s Esbriet (pirfenidone), the first drug to receive European approval to treat mild-to-moderate idiopathic pulmonary fibrosis (IPF).
Esbriet was found to significantly reduce decline in lung function and also improves patients’ mobility. “These results support the treatment’s effect of up to seventy two weeks with evidence of a sustained durable effect,” says Professor Paul Noble who hails from the Cedars-Sinai Medical Center in Los Angeles.
“The observations provide further support for a favourable benefit risk profile of Esbriet in patients with IPF.”
The percentage of patients abandoning treatment due to an adverse event during its ASCEND trial was 14.4 per cent. Overall, a total of 93.5% and 94.6% completed the study, died or had a lung transplant by study day 365 in both Esbriet and placebo groups.
Progression-free survival analysis showed the risk of disease progression was reduced by 38% persistence in the drugs group compared with placebo. But it was not all good news for InterMune as it failed to meet its secondary endpoint of dysphnea (shortness of breath) during the trials.
Although approved in Europe in 2011, the IPF drug has had a much more difficult time trying to gain a nod in the US when the FDA knocked back the drug in the same year – asking for more data.
Giacomo di Nepi, executive vice president and managing director, InterMune Europe says: “Our contribution to the disease has been to provide the first therapy, but also to add help to what has been done in getting a better knowledge of the disease and the way to approach it.”
Around 5,000 people are diagnosed with IPF every year in the UK according to the British Lung Foundation, and the disease makes up 305 of all lung disorders.
Also announcing results at the congress was Boehringer Ingelheim with its Inpulsis (nintedanib) offering, InterMune’s closest rival treatment. Although the drug is yet to gain approval in any market it has been accepted for a review from both the FDA and the EMA, and could potentially be available from 2015.
The German firm also presented data for its Phase III combination COPD treatment tiotropium + olodaterol Respimat, which is said to improve lung function better side-by-side than if the components were used individually.
Aside from Boehringer’s own positive results and Inpulsis’ future, according to a recent report in a German newspaper back in August the company itself has planned on trimming costs by 15% due to falling prescription sales.
InterMune’s finances on the other hand were boosted recently by the $8.3 billion takeover by Roche. Boehringer will be hoping its IPF drug is approved, whereas for InterMune it’s easier to rely on the success of Esbriet and the $8.3 billion Roche deal.
The California-based company will also be hoping that its lung-scarring drug, which made $67m in sales in the first half of the year, finally gets US approval.
Pharmafile’s attendance at this year’s ERS conference in Munich was sponsored by InterMune.
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