ZURICH (Reuters) – Roche has won U.S. breakthrough therapy status for Esbriet for unclassifiable interstitial lung disease (uILD), the company said on Tuesday, as it aims to lift disappointing revenue by expanding conditions for which it can be used.
Esbriet, approved in 2011 in Europe and 2014 in the United States, is now used to treat adults with lung-scarring idiopathic pulmonary fibrosis, which belongs to so-called interstitial lung disease (ILD). About 200 types of rare pulmonary diseases fall within ILD, marked by coughing and shortness of breath.
With breakthrough therapy status aimed at speeding up a U.S. Food and Drug Administration review, Roche aims to broaden Esbriet’s label to cover uILD, a form of ILD suffered by about 10% of patients who cannot be given a definitive diagnosis despite thorough examination.
Roche acquired Esbriet six years ago with its $8.3 billion Intermune acquisition, but the Basel-based drugmaker has since written down Intermune’s value by billions as Esbriet’s $1.1 billion in annual sales have fallen short of initial expectations.
With some Esbriet patent protections scheduled to expire as early as 2021, Roche is also seeking to protect the pulmonary drug through legal action.
It has an ongoing patent lawsuit against about a dozen generics companies including Novartis’ Sandoz unit and Teva Pharmaceutical Industries, aiming to block copycat versions of Esbriet, whose generic name is pirfenidone.
(This story corrects targeted disease in lead, adds disease definitions in second paragraph, new third paragraph)
(Reporting by John Miller; Editing by Barbara Lewis and David Goodman)