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Boehringer pulls faldaprevir and exits hepatitis C market

Unable to challenge all-oral options from Gilead and others
Boehringer Ingelheim headquarters

Germany's Boehringer Ingelheim is bowing out of the race to develop oral hepatitis C virus (HCV) therapies and has discontinued development of lead candidate faldaprevir.

After a strategic review of its business, the company said it had elected to withdraw all regulatory filings for faldaprevir - a protease inhibitor - because the "HCV treatment environment has significantly and rapidly evolved" in the last couple of years.

"There are now several new treatment options available for patients and additional all-oral options are expected to be approved in 2014," said Boehringer in a statement released on Friday.

Faldaprevir was always likely to be at a disadvantage in the marketplace because it was submitted for approval alongside interferon-therapy, which is expected to fall out of favour dramatically now oral therapies are available.

Boehringer's main competition at the moment is Gilead Sciences, whose NS5B polymerase inhibitor Sovaldi (sofosbuvir) was approved in the US last December and in Europe earlier this year and has already become the biggest pharmaceutical product launch of all time, with sales of $2.3bn in the first quarter of 2014.

Gilead filed for approval of an all-oral HCV regimen based on Sovaldi and NS5A inhibitor ledipasvir in the US in February and could hear back from the FDA as early as October, while AbbVie is also hoping for approval of its rival combination therapy by the end of the year.

Other companies with oral treatment regimens in late-stage development include Bristol-Myers Squibb, Merck & Co (which recently paid $3.85bn for HCV specialist Idenix) and Johnson & Johnson.

Despite the massive market opportunity in HCV with over 150 million people worldwide infected with the virus, competition between the various treatment regimens is expected to be fierce.

Boehringer said it remains committed to developing new treatment options and will focus its efforts on the development of drugs for immunology, cardiovascular, respiratory and metabolic diseases, disorders of the central nervous system and cancer.

Aside from faldaprevir, the German drugmaker's late-stage pipeline includes diabetes therapy empagliflozin, nintedanib for lung cancer and a new version of insulin glargine that will compete with Sanofi's blockbuster Lantus brand.

Article by
Phil Taylor

23rd June 2014

From: Research



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