The Food and Drug Administration said it cleared Roche’s Esbriet, known chemically as pirfenidone, and Boehringer’s Ofev, known as nintedanib, for use in the lung-scarring disease that kills 60 percent to 80 percent of patients within five years and, until now, had no approved drugs in the U.S. Roche acquired Esbriet from InterMune Inc. in a deal that closed last month.
“This disease state has been so dreadful but fairly well investigated for over a decade and it’s been really noted for the multitude of failures over time,” said Jonathan Leff, executive vice president of research and development at InterMune in a telephone interview. “It feels like we’re turning a corner in this field.”
Around 48,000 Americans a year are diagnosed with the disease. Esbriet’s market potential attracted an $8.3 billion buyout from Basel, Switzerland-based Roche, at a time when Brisbane, California-based InterMune was unprofitable. The two companies agreed on the acquisition in August.
Roche will charge about $94,000 a year for the therapy, which patients will be on for the rest of their lives because of the chronic nature of the illness. Boehringer, based in Ingelheim, Germany, declined to comment on the price of Ofev.
Both drugs were approved faster than typical new therapies as part of the FDA’s breakthrough treatment program, the agency said yesterday in separate statements. Esbriet may generate $1.6 billion of sales in 2020 for patients with idiopathic pulmonary fibrosis and as much as $2 billion by 2030, Leerink analysts said in a research note on Aug. 24.
Leff said it’s difficult to compare the two drugs because there haven’t been head-to-head trials between them. Sixty percent of the patients on Boehringer’s treatment experienced diarrhea as a side effect, a rate that could prove high enough to “relegate the drug to de facto second-line use,” Ritu Baral, an analyst at Cowen & Co., said in a research note.
Tunde Otulana, Boehringer’s senior vice president of clinical development and medical affairs, said the bouts of diarrhea were mild to moderate and typically occurred within the first three months of treatment. The U.S. will be Boehringer’s first market for Ofev. The company has started the process for approval in Japan and Europe.
Roche’s Esbriet was approved in 2011 the European Union and also is cleared for sale in countries including Canada, China, India, Mexico and South Korea for idiopathic pulmonary fibrosis.
Roche’s deal for InterMune was one of several this year involving a handful of areas where the medical need is great, treatment options are few and prices may be high. Research released in May showed Esbriet cut a patient’s risk in half of dying from the lung disease after the first year of treatment.
Esbriet will add to existing respiratory medicines sold by Roche, including Pulmozyme for cystic fibrosis and Xolair for asthma, both approved more than a decade ago. Roche has struggled to expand outside of oncology, halting development of diabetes and heart disease drugs in recent years.
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