Sofosbuvir, Gilead

The drug: Sofosbuvir
The disease: Hepatitis C
The developer: Gilead
Peak sales potential: Peak sales estimates for sofosbuvir are ranked in the billions--Barclays pegged it at close to $4 billion, though Evaluate Pharma recently assessed an average of $7.4 billion among analysts' estimates--making this likely the most promising drug in the late-stage pipeline/regulatory arena today. The FDA has a December deadline to decide on Gilead's NDA for sofosbuvir.

The scoop: Gilead ($GILD) is within a couple of months of hearing about an approval for what is shaping up as a new standard of care for hepatitis C. Longtime observers will recall that Gilead caused more than a few jaws to drop when it agreed to buy out Pharmasset for $11 billion, largely on the back of this new hepatitis C drug. Then they kept amazing the industry with stellar late-stage data that demonstrated the value of the drug.

The current gold standard treatment for hep C is Incivek from Vertex ($VRTX) and Merck's ($MRK) Victrelis (boceprevir). But both rely on interferon, a drug that typically places a heavy burden on patients--unless they can't tolerate it at all. Sofosbuvir will go a long way toward eliminating that particular element from the cocktail therapies now in use. Gilead has a follow-up combo program in play now (with GS-5885) that will take the company a step further.

Competitive? AbbVie ($ABBV; ABT-450/r + ABT-267 + ABT-333) says it can play with the leaders, while Bristol-Myers Squibb ($BMY) and other developers race ahead with their own separate approaches. Determined to get the biggest payday possible, Gilead ignored a challenge from Bristol-Myers (daclatasvir) to pair their therapies in a late-stage program, preferring to keep its leading combo program in-house.

We're about to see how well Gilead's aggressive strategy plays out on the marketing end. If both daclatasvir and sofosbuvir end up on the market, look for some off-label combo use in hard-to-treat patient groups.

For more:
Merck demand triggers expanding patent war over Gilead's sofosbuvir
Gilead's sofosbuvir cures some of the toughest hepatitis C cases
Gilead gains FDA's inside track for hep C drug sofosbuvir
Gilead steals a march for hepatitis C drug application
Gilead Sciences bags Pharmasset's hep C pipeline in $11B buyout

Sofosbuvir, Gilead

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