Three product approvals in one therapy area in less than 12 months would be cause for celebration for most companies in the industry.
For Boehringer Ingelheim its efforts in respiratory diseases come at an important time as the company prepares to weather the expiry of patents on Spiriva.
The asthma and COPD drug is a key medicine for the company – bringing in $4.7bn last year it’s Boehringer’s biggest-selling drug – so its newly-approved respiratory products are eagerly-awaited to help replace Spriva’s sales when its decline begins.
PMLiVE spoke to Allan Hillgrove, member of the board of managing directors and head of marketing and sales at Boehringer, about the company’s respiratory advances in 2015.
It’s a year that has seen the approval Spiriva successor combination Spiolto (tiotropium/olodaterol) for chronic obstructive pulmonary disease (COPD), OFEV (nintedanib) for the rare lung disease idiopathic pulmonary fibrosis (IPF) and Spiriva Respimat (tiotropium) in asthma.
“Spiriva is certainly our largest product and has been a major success with millions of patients taking it over the years but such a product is not easily replaced in the short term,” Hillgrove said.
“However we’re very confident in the quality of new products coming through. We are also looking at Spiriva Respimat in paediatric asthma patients because there is an unmet medical need there.”
Spiolto is positioned as offering greater benefits for patients and physicians than Spiriva and was approved in its first European markets for COPD in July.
Currently 40% of asthma patients still experience symptoms despite treatment, presenting Boehringer with ‘a very big opportunity’ in the area, Hillgrove said.
He added: “Boehringer has been in respiratory medicine for about 90 of our 130 years and so respiratory is in our blood, and to have such a significant year and so much data is exciting.”
Another of the company’s new drugs is OFEV, which was approved by the European Commission in January to treat IPF, in which lung tissue becomes scarred leading to a significant decline in lung function.
Hillgrove said: “OFEV has shown to cut reduction in lung function decline by 50%. This is very exciting news for Boehringer and for patients.”
Competition, however, will come from Roche’s Esbriet (pirfenidone), which has shown to boost survival in patients with IPF and was approved in the US at nearly the same time in late 2014.
Hillgrove commented: “The two products were approved in the US relatively close together but we believe we have an advantage in the methodology of the treatment with one capsule twice a day and additionally it’s quite well tolerated on the market. It’s a high potential product.”
Looking to Boehringer’s future focus in respiratory medicine, Hillgrove said the company currently has eight compounds in preclinical phase I/II stage, with compounds taking aim at, interstitial lung disease, cystic fibrosis and acute respiratory distress syndrome, along with early work on acute lung injury.
He concluded: “We can continue to be one of the significant leaders in respiratory disease – which is exciting for us commercially and its of course good news for patients as well.”