The search for a hepatitis-C cure is one of the most active areas within biotechnology research and development.
One of the company’s ushering in the next generation of hepatitis-C treatment is Gilead Sciences, Inc. (NASDAQ:GILD). The company acquired hepatitis-C drug sofosbuvir in its $11.2 billion acquisition of Pharmasset back in January 2012.
Sonosbuvir has a very good chance of beating rival drugs to the market. Those competing drugs are being developed by Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX), Merck & Co., Inc. (NYSE:MRK) and AbbVie, the drug manufacturing giant that split off from Abbott Labs last winter.
Gilead’s hopes for first-to-market approval
In April, Gilead Sciences, Inc. (NASDAQ:GILD) reported strong phase 3 trial data. Those positive results for sonosbuvir as a combination therapy with ribavirin for genotype 2 and 3 hepatitis-C patients prompted Gilead Sciences, Inc. (NASDAQ:GILD) to file for approval from the Food and Drug Administration. The filing also seeks approval for sonosbuvir combined with ribavirin and interferon for genotype 1 — the most common variant of the disease. The FDA granted Gilead Sciences, Inc. (NASDAQ:GILD)’s application priority review in June.
However, the holy grail of hepatitis-C treatment is an interferon-free oral treatment alternative.
Developing such a solution will likely grab significant share in the $20 billion hepatitis-C treatment market because interferon comes with significant side effects and current non-oral treatments require injections, which many patients dread.
As a result of the opportunity, Gilead Sciences, Inc. (NASDAQ:GILD) is studying 12- and 24-week dosing of oral sonosbuvir without interferon through its Ion 1 and Ion 2 trials.
If those trials work as hoped, doctors will likely make it a first line treatment, shifting use of current treatments from Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) and Merck & Co., Inc. (NYSE:MRK) to second tier status. Vertex’s Incivek — the fastest drug to reach $1 billion in sales after launching in May 2011 — and Merck’s Victrelis combined to generate $330 million in sales last quarter.
But that underestimates the true potential for an oral hepatitis-C treatment as many doctors are delaying treatment in hope of these new options. This suggests the first to market will see significant ramp in sales tied to pent-up demand.
Gilead’s competitors aren’t giving up
That’s not to say that Vertex and Merck are giving up on the market. Both are committing significant resources developing their own interferon-free choices.
Vertex hopes to follow up its highly successful Incivek with another all-oral option. However, the company’s VX-135 faced headwinds in late July when the FDA put a partial hold on a mid-stage trial of the drug due to toxicity concerns tied to the highest 400 mg dose. The trial is continuing for the lower 100 mg dose.