Boehringer Ingelheim issued a statement to report that it has decided to discontinue development of faldaprevir, the key drug of the company’s investigational hepatitis C pipeline, which was being studied in combinations both with and without interferon. The company will withdraw all pending marketing applications for faldaprevir worldwide as a result.  

In a statement, the company said: “Boehringer Ingelheim has re-evaluated its strategy in hepatitis C (HCV), and as a result the company has decided not to move forward in this therapeutic area. 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. This decision was taken as there is no longer an unmet medical need for the faldaprevir interferon-based regimen that was the subject of the application.”

In December 2013, the US Food and Drug Administration approved Gilead Sciences’ Sovaldi (sofosbuvir), an oral, once-a-day drug that is used with other antiviral medicines (in combination with ribavirin or in combination with pegylated interferon and ribavirin) to treat chronic hepatitis C infection in adults. Sovalid posted first quarter 2014 sales of $2.27 billion.

AbbVie recently received accelerated market review by European and US regulatory authorities for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus. The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir  with or without ribavirin. AbbVie received accelerated assessment, which is designated to new medicines of major public health interest, by the European Medicines Agency in May 2014. If approved, AbbVie’s regimen could be available for marketing in the European Union (EU) in the first quarter of 2015, according to the company.  On June 13, 2014, AbbVie announced that its new drug application for AbbVie’s regimen was accepted and granted priority review by the US Food and Drug Administration.

Earlier this month, Merck & Co. agreed to acquire Idenix Pharmaceuticals Inc. for approximately $3.85 billion; Idenix’s is primary focus is on the development of  oral antiviral therapeutics to treat HCV infection. Idenix Pharmaceuticals currently has three HCV drug candidates in clinical development: two nucleotide prodrugs (IDX21437 and IDX21459) and a NS5A inhibitor (samatasvir). These drug candidates are being evaluated for their potential inclusion in the development of all oral, pan-genotypic fixed-dose combination regimens.

Merck's R&D portfolio includes several HCV medicines in development, the leading of which is a combination of MK-5172, an investigational HCV NS3/4A protease inhibitor and MK-8742, an investigational HCV NS5A replication complex inhibitor. The combination of these two investigational candidates has received breakthrough therapy designation from FDA for the treatment of HCV. In April 2014, Merck announced the initiation of Phase III clinical trials for MK-5172/MK-8742 to evaluate the combination with and without ribavirin in various genotypes and across a broad range of patient populations with chronic HCV.

See related stories:
“AbbVie Moves Forward on US, EU Accelerated Review of Hepatitis C Drug” 

“Merck & Co to Acquire Idenix Pharmaceuticals”

“Pharmaceutical Industry First Quarter Scorecard”

Source: Boehringer Ingelheim