- Merck & Co. has discontinued the development of two investigational combination regimens that were in testing for the treatment of chronic hepatitis C, citing its review of Phase 2 efficacy data and the current status of the marketplace.
- The two regimens being dropped are MK-3682B and MK-3682C, both of which contained the experimental uprifosbuvir. Merck said it will maintain its already-marketed hepatitis C offering Zepatier, a fixed dose combination of elbasvir and grazoprevir.
- This move doesn't come as entirely unexpected. In February, Merck wrote down the value of hepatitis C drug uprifosbuvir by $2.9 billion, recognizing the drugs' reduced commercial potential given the competitive nature of the market.
Faced with the success of Gilead's near curative products Harvoni (ledipasvir and sofosbuvir), Sovaldi (sofosbuvir) and Epclusa (sofosbuvir and velpatasvir) — which brought in sales of $2.9 billion in the second quarter of 2017 —and the resulting decline in demand in the market, Merck & Co. has decided to step back from an active R&D role in this disease area.
"Remarkable progress has been made in the fight against hepatitis C infection, and Merck is enormously proud of the role we have had in that fight over the past 30 years," said Eliav Barr, SVP of global clinical development in infectious diseases and vaccines at Merck Research Laboratories. "We will continue to study Zepatier to understand even more about its role in treating chronic hepatitis C infection and will continue to work with others to help bring Zepatier to appropriate patients with chronic hepatitis C genotype 1 or 4 infection, the genotypes which make up the majority of patients with chronic hepatitis C infection."
Once a hot therapeutic area, hepatitis C is no longer considered an urgent unmet medical need. There are still millions who have the chronic disease, but currently available treatments can cure the condition in as little as eight weeks. This ability to effectively cure hepatitis C patients has meant that there are fewer and fewer patients who need treatment, thus shrinking the commercial opportunity. Many of the drugmakers that once worked in this field are now shifting focus to hepatitis B, a similar liver disease still lacking good treatment options.
Last month, Janssen Pharmaceuticals Inc., the drug development arm of Johnson & Johnson, announced that it was terminating the development of JNJ-4178, a regimen that combines three different hepatitis C medications. Janssen is shifting its focus to chronic hepatitis B.
Streamlining portfolios has been an ongoing trend throughout big pharma over the last couple of years. AstraZeneca has been selling off all non-core assets it can in an effort to raise cash, while new GlaxoSmithKline CEO Emma Walmsley recently announced the British pharma will cut more than 30 pipeline programs.
As drug development becomes more costly, and more of the easier to address needs — the "low hanging fruit" — are met, companies are culling their pipelines in an effort to devote resources to the programs most likely to be commercially successful.