The company says that the FDA has picked its antiviral combo--with and without ribavirin-- as a new breakthrough therapy worthy of a swift review and perhaps a shortened clinical trial process ahead of a regulatory decision.
Gilead Sciences was in a position to say, "I told you so," when its first quarter earnings fell a little short of Wall Street expectations Thursday. Profits were still up 63% even as sales of older HIV drugs came in shy of forecasts.
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.
AbbVie's rheumatoid arthritis drug Humira did exactly what the new company needed it to do in the first quarter. It returned significantly higher sales and allowed Abbvie to report better than expected earnings in its first earnings report as a stand-alone company.
The big biotech reported in its quarterly statement that the agency has provided the coveted "breakthrough" status for a combination of daclatasvir with two other direct-acting antivirals, asunaprevir, an NS3 protease inhibitor and BMS-791325, an NS5B non-nucleoside polymerase inhibitor.
After delivering data from multiple rounds of trials on all-oral combos against hepatitis C, pharma runners appear to be making progress with new therapies that could shorten treatment durations and wipe out the liver-damaging virus without infusions of interferon and the flulike side effects that go with them.
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.
Roche and the biotech startup Ascletis have joined forces to advance Roche's experimental drug danoprevir for hepatitis C virus in for the Chinese market.
Gilead Sciences moved up again in the hepatitis C race. With a bunch of companies hurrying along all-oral programs, Gilead has taken an application to the FDA for approval of its hep C pill sofosbuvir (GS-7977), positioning itself to become the first pharma group with a completely oral regimen on the U.S. market.
Vertex Pharmaceuticals has found another ally as the company plays catch up in the race to advance all-oral therapies against hepatitis C. Vertex and Bristol-Myers Squibb have agreed to combine experimental compounds to test in Phase II trials, the first of which will kick off during the current fiscal quarter.