Boehringer abandons hep C
pharmafile | June 23, 2014 | News story | Research and Development, Sales and Marketing | AbbVie, Boehringer, HCV, faldaprevir, german, hep C
Boehringer Ingelheim has abandoned its hepatitis C (HCV) drug development programme as a dead loss after ‘re-evaluating’ its strategy.
The German firm said it has “decided not to move forward in this therapeutic area” – a significant move, in part because of what it says about the landscape for HCV treatments.
Late last year Boehringer was confident that its putative HCV treatment faldaprevir could be available in Europe in the second half of 2014, after the European regulator granted it an accelerated assessment.
The manufacturer was seeking a licence for it in combination with pegylated interferon and ribavirin (PegIFN/RBV) for patients with genotype-1 (GT-1) HCV.
The attraction for the authorities was that the drug had also been mooted as a treatment for difficult-to-cure populations, such as those with HIV co-infection or advanced liver disease.
However, the company now says it “will withdraw all pending marketing applications for faldaprevir worldwide and is discontinuing further development”.
This means it is turning its back on a market which analysts believe could rise to more than $100 billion over the next decade: around 170 million people worldwide have HCV, with nine million estimated to be living with the disease in the European Union.
In a statement the company explained: “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.”
Among the latter is AbbVie’s oral, interferon-free treatment for adults with chronic GT1 HCV, a fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin (RBV).
The manufacturer’s applications, submitted last month, have been validated and are under accelerated assessment by the European Medicines Agency (EMA). Last week, the US Food and Drug Administration gave the same applications priority review status.
AbbVie’s belief is that combining three different mechanisms of action interrupts the HCV replication process, which should in turn improve sustained virologic response rates across different patient populations.
Meanwhile Gilead’s Sovaldi (sofosbuvir) has been marked out as a clear frontrunner in HCV by analysts, with huge demand and a high price ($1,000 per day or $84,000 for a full course of treatment) the key factors.
Sovaldi enjoys the best cure rates on the market in a quicker time and with fewer side effects than its rivals, making its rise inevitable.
In short, Boehringer feels it has been overtaken by others and it is not worth fighting to make up the gap.
The company says it will focus instead on immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.
Adam Hill
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