While AbbVie is widely expected to be the second entrant to the soon-to-explode market for hepatitis C cocktail drugs after standard-bearer Gilead Sciences, promising data from latecomer Merck have analysts relegating the Illinois company to third place despite some excellent late-stage results.
Three days after Bristol-Myers Squibb filed for FDA approval of the NS5A drug daclatasvir combined with asunaprevir, an NS3 protease inhibitor, the biotech company has turned over some of the Phase III cards it will be playing for an approval in markets around the world.
Merck may be late to the blockbuster party with its new hepatitis C drugs, but the pharma giant is moving fast with a top contender boasting high cure rates.
Express Scripts released more stunning numbers on what could happen with spending on drugs to treat hepatitis C as it builds a case against the price Gilead Sciences has put on a drug that can cure the disease.
Even after out-licensing a pair of hepatitis C therapeutic candidates to Vertex, which was bidding on finding a contender as a new wave of transformational drugs approached the market, South San Francisco-based Alios BioPharma stubbornly maintained a very low profile.
Express Scripts and Gilead Sciences are playing a high-priced game of chicken. At stake is the fate of Sovaldi (sofosbuvir), Gilead's high-priced hepatitis C pill, and the future of hep C treatment in the U.S. Not to mention the future of Sovaldi rivals from AbbVie, Bristol-Myers Squibb, and more.
Hepatitis C wonder-drug Sovaldi is still selling at breakneck pace. And at this rate, it could break some insurers. At $84,000 per 12-week treatment course, Sovaldi's quick uptake is threatening payers' earnings, analysts say--and the drug's stellar efficacy profile leaves them with few options.
In a matter of weeks Merck plans to move a closely-watched combination treatment for hepatitis C into a Phase III trial. The move will boost Merck's late-stage pipeline to 13 programs, giving new R&D chief Roger Perlmutter some additional evidence to back up a case that the leviathan outfit has finally shaken off the lethargy that led to a years-long drought of significant approvals, focusing on pioneering therapies that can carve out badly needed revenue.
Rep. Henry Waxman and several Democratic colleagues in Congress wrote Gilead CEO John Martin an excoriating letter on Friday, demanding to know why Gilead Sciences' hepatitis C wonder drug Sovaldi costs $84,000--and whether Gilead is doing anything to make sure that poor patients get access to it.
Gilead won the race to be the first to market with an interferon-free oral therapy that can essentially wipe out all traces of the virus for a large group of patients. Now it's angling to follow up that big score with a single combo pill that can do the job for just about everyone in the megablockbuster market.