Boehringer Ingelheim exits hepatitis C arena

INGELHEIM, Germany—June 20 saw Boehringer Ingelheim announce that it has re-evaluated its hepatitis C (HCV) strategy in and “decided not to move forward in this therapeutic area.”

As the company notes, “the HCV treatment environment has significantly and rapidly evolved since the submission of the faldaprevir marketing applications to regulatory bodies around the world. There are now several new treatment options available for patients and additional all-oral options are expected to be approved in 2014.”

From Boehringer Ingelheim’s perspective, there is no longer an unmet medical need for the faldaprevir interferon-based regimen that was the subject of the application and therefore pursuing it was not longer a useful endeavor.

Boehringer Ingelheim noted that it would withdraw all pending marketing applications for faldaprevir worldwide and discontinuing further development.

However, Boehringer Ingelheim emphasizes that it is committed to developing new treatments that provide high therapeutic value in areas where medical need exists, and it is focusing its efforts on numerous development projects in immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.

One of the biggest reasons for this decision to abandon faldaprevir has to be the HCV treatment success of Gilead Sciences, which offers the NS5B polymerase inhibitor sofosbuvir under the brand name Sovaldi. That HCV therapy was approved in the United States in December 2013 and in Europe earlier this year, making a splash as the biggest pharmaceutical product launch of all time. Sales were around $2.3 billion in just the first quarter of this year.

In February, Gilead filed for U.S. approval of an all-oral HCV regimen based on Sovaldi and the NS5A inhibitor ledipasvir and might get a decision from the U.S. Food and Drug Administration on that by fall. AbbVie is seeking approval for its own combination therapy this year as well, and other players with late-stage HCV prospects include Bristol-Myers Squibb, Merck & Co. and Johnson & Johnson, making for a crowded field—and putting an interferon-based regimen like Boehringer Ingelheim’s at a serious disadvantage.