During the J.P. Morgan Healthcare Conference last year, biotech insiders were abuzz about blockbuster buyouts involving all-oral drug combos against hepatitis C. As this year's meeting gets into full swing this morning, Gilead Sciences ($GILD) has provided hep C updates that suggest its huge wager on experimental drugs in this field is on track to start paying off.
Gilead offered more evidence that its lead 'nuc' drug, sofosbuvir, is anchoring what could become the first interferon-free regimen against the liver-damaging disease in the U.S. New data from the company's midstage "Electron" study showed all 9 patients in a study cohort who have the most common variant of HCV and failed interferon-based therapy were free of the virus four weeks after treatment with sofosbuvir, GS-5885 and standard ribavirin.
The Foster City, CA-based company remains on schedule to deliver an FDA app for approval of its experimental nuc in combination with ribavirin for patients with genotypes 2 and 3 in mid-2013. That's just months away, and the update comes about a year after Gilead gobbled up sofosbuvir in its $11 billion buyout of Pharmasset. The gamble was somewhat controversial at the time, with some industry watchers wondering whether Gilead grossly overpaid in the acquisition.
A year later Gilead has a leading position in advancing interferon-free therapies for HCV, with sofosbuvir (formerly GS-7997) expected to be a blockbuster if approved and a key piece of the company's planned combo pills against the chronic ailment. The company is now conducting numerous Phase III and midstage trials to advance its all-oral hep C therapies.
"We are on track to submit the initial regulatory filing for sofosbuvir by mid-2013 and to file for approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014," Gilead's R&D chief, Norbert Bischofberger, said in a statement.
Sofosbuvir appears to have eluded the safety concerns that have plagued rival meds such as Bristol-Myers Squibb's ($BMY) BMS-986094, a colossal flop that went down in flames over toxicity problems last year just months after BMS forked over $2.5 billion to acquire the asset in its Inhibitex buyout.
Bristol made big news with the Inhibitex deal during last year's J.P. Morgan Healthcare Conference. We've not seen anything as bold on the deals front so far this year. Big failures have a way tempering big deals, perhaps.
- here's Gilead's full update
- see the Reuters item
Special Report: Hep C pill race report 2012: Gilead, others rush toward pharma gold