Merck buys hep C specialist Idenix

Merck is looking to gain long-term dominance in the hepatitis C field with the purchase of Idenix for $3.85 billion.

Cambridge, Massachusetts-based Idenix has a promising pipeline of novel hepatitis C drugs, and could help Merck gain the upper hand in the increasingly competitive therapy area.

The trailblazer in hepatitis C is Gilead’s Sovaldi, which has become an overnight blockbuster thanks to its clinical efficacy and its high price: it can cure most patients within 12 weeks in combination with existing drugs, and costs $84,000 for a course of treatment.

Sovaldi’s high price has brought howls of protest from US insurers, but so far its status as a leap forward for patients has helped it deflect this criticism.

Merck is one of a number of companies who are in pursuit of Gilead, and who are all hoping to advance treatment of HCV even further than Sovaldi.

AbbVie and Bristol-Myers Squibb are also getting ready to launch rival products, and all the products aim to raise cure rates to close to 100%, while also dispensing with the need for painful treatment with interferon.

Merck’s lead candidate is MK-5172, an investigational HCV NS3/4A protease inhibitor and MK-8742, an investigational HCV NS5A replication complex inhibitor. The combination of the two drugs has received FDA Breakthrough Therapy designation, but is unlikely to reach the market before late 2015.

By then AbbVie’s three-pronged treatment will have hit the market, but many analysts believe the efficacy of MK-5172, and its more convenient daily dose, will eventually make it the second-placed drug behind Sovaldi.

Idenix’s pipeline

Merck is looking to seize even more market share in the long-term, with the hoped for success of Idenix’s pipeline.

The company currently has three HCV drug candidates in clinical development: two nucleotide prodrugs (IDX21437 and IDX21459) and a NS5A inhibitor (samatasvir). These novel candidates are being studied for to be included in all oral, fixed-dose combination regimens for all genotypes of hepatitis C.

Genotype 1 HCV, is the most common strain of the disease, but one of the few weaknesses of Sovaldi is that it cannot currently be used without interferon in these patients.

Any company which can bring to market the first truly ‘pan-genotypic’ all oral HCV treatment will be guaranteed a dominant position in what will be a fiercely competitive market.

However there is no certainty that Idenix’s pipeline will pay off: it has been dogged by setbacks over the last 18 months. The FDA has demanded more data on its lead drug IDX20963, and last year it was forced to abandon two candidates, IDX184 and IDX19368, after safety concerns arose.

US health insurance companies such as Express Scripts are hoping that AbbVie and Merck’s competitors will spark a price war when they are launched. However this is would have a minimal impact compared to the overall increased cost caused by the availability of new drugs for the estimated 150-200 million HCV infected people worldwide, with around 4.4 million of these in the US.



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