Owing to various setbacks and adverse market dynamics, Merck & Co.’s newest direct-acting antiviral (DAA) for hepatitis C, uprifosbuvir, will represent only a minor player in the hepatitis C market by 2025, according to research and consulting firm GlobalData.
In a recent Form 8-K filing submitted to the US Securities and Exchange Commission, Merck announced the revaluation of its newest NS5B inhibitor uprifosbuvir (formerly MK-3682) at $240 million, resulting in a pre-tax impairment charge of $2.9 billion. Merck originally acquired the drug through its 2014 purchase of Idenix for $3.85 billion.
As explored in GlobalData’s most recent hepatitis C report, the market is set to see a decline from $21.7 billion in 2015 to $17.5 billion by 2025 because of recent advances in hepatitis C treatment.
Indeed, the remarkably high cure rate of DAAs results in a fast and substantial reduction in the number of diagnosed patients requiring treatment. This fact, combined with uprifosbuvir’s mixed performance in a crucial 8-week therapy regimen for treatment-naïve hepatitis C virus (HCV)-infected patients, means the drug will face limitations on entering the market.
Mirco Junker, PhD, Healthcare Analyst for GlobalData, explains: “Currently, HCV treatment access is limited, owing to its high cost. If prices drop below a country specific level, insurance companies – and in particular governmental programmes – will have a significant incentive to treat as many patients as quickly as possible, consequently eliminating the need for DAAs even prior to major drug patent expirations.”
“It is not yet clear whether DAA combinations with uprifosbuvir will enter Phase III studies. Should the market dynamics develop as expected by GlobalData, the development of uprifosbuvir would still be profitable, despite only covering a small portion of the market share.”
“However, in the event of DAA prices declining further and governments initiating aggressive treatment coverage, the overall market size could shrink quickly below the profitability level for uprifosbuvir.”