The deal grants the pharma giant access to Idenix’s nucleoside/nucleotide chemistry and prodrug technologies, including its portfolio of hepatitis C candidates
“Idenix's investigational hepatitis C candidates complement our promising therapies in development and will help advance our work to develop a highly effective, once-daily, all oral, ribavirin-free, pan-genotypic regimen that has a duration of treatment as short as possible for millions of patients in need around the world,” said Roger Perlmutter, President of Merck Research Laboratories.
According to a report by Merck, chronic HCV affects 150 million people worldwide and is growing, making it a lucrative market for drugmakers to access.
Analyst Mark Schoenebaum from the ISI Group said in a note nucleoside/nucleotide drugs – described as ‘nucs’ – are “scarce and thus perhaps quite valuable. Idenix also has what they have always claimed is a vast patent estate covering the ‘nuc’ space,” and therefore almost certainly affected Merck’s purchase price.
Idenix’ lead candidate, the nucleotide prodrug IDX21437, is in Phase II clinical trials, as is its NS5A inhibitor Samatasvir. These will complement Merck’s current portfolio of HCV candidates which include a protease inhibitor (MK-5172) and an investigational replication complex inhibitor (HCV NS5A).
Competition with Gilead
Last December, Gilead’s drug Sovaldi (sofosbuvir) – a nucleotide analog inhibitor - became the first treatment for HCV without the need for co-administration of interferon to be approved by the US Food and Drug Administration (FDA), though the company has received criticism from the California Technology Assessment Forum in March over its price. According to Medicaid, a minimum 12 week course in the US costs $84,000, or $1,000 per pill.
Merck’s entry into HCV ‘nucs’ is, however, not bad news for Gilead, Schoenebaum noted. “Remember that Idenix could have just partnered with Merck (or any number of companies). Thus, the fact that Merck will now own IDIX outright doesn't change the competitive outlook much for Gilead.”
Bristol-Myers Squibb’s lead nucleotide polymerase inhibitor, BMS-986094 acquired from Inhibitex in January 2012 was suspended six months later in the interest of patient safety after a patient died of heart failure during phase II trials.
However, Schoenebaum said in speaking with Merck “it's clear they are acutely aware of BMS’s experience and feel that the extent of the data package here is very different from Inhibitex's.”