Merck's not the only big player in the hepatitis C competition to face losing bragging rights to the FDA's "breakthrough" drug designation for a late-stage program. It turns out that Bristol-Myers Squibb, another laggard in the race to hatch new therapies for the virus, also finds its daclatasvir on the FDA's chopping block.
Bristol-Myers Squibb has become the first drugmaker to win regulatory approval for a combination hepatitis C treatment that doesn't require painful injections, picking up a Japanese nod for its all-oral cocktail.
European regulators are recommending approval for Bristol-Myers Squibb's daclatasvir, an hepatitis C-fighting antiviral that plays a key role in the company's planned combo treatment.
No matter how hard Bristol-Myers Squibb tried to shame Gilead into pursuing studies for a combination of its hep C drug daclatasvir and the newly approved Sovaldi (sofosbuvir), Gilead wouldn't budge.
Rival drug combination works to perfection for toughest hep C patient group, and some patients and doctors appear willing to consider taking matters into their own hands.
Like most of its new drug programs in recent years, Merck's work on new hepatitis C drugs has never quite paid off as hoped. Now it's taken its lead clinical-stage program for MK-5172 and tied up with Bristol-Myers Squibb to test a combo approach with daclatasvir.
Bristol-Myers Squibb watched its coveted hepatitis C drug 094 go down the drain last year after discovering safety hazards in a midstage study. Yet the pharma giant ($BMY) managed to ease some of its financial pain from the failed program with a tax benefit that ended up lifting its fourth-quarter profits 8.6%, the Wall Street Journal 's Peter Loftus reported.
It looks as if Gilead can't be shamed into a late-stage hepatitis C collaboration with Bristol-Myers Squibb after all.
Bristol-Myers Squibb isn't giving up on pushing Gilead Sciences to move ahead with further study of the two companies' oral drugs as a combo treatment for the hepatitis C virus.
Jefferies analyst Thomas Wei posted some positive results from an all-oral combo of Gilead's 7977 and Bristol-Myers Squibb's daclatasvir (BMS-52).