Gilead quickly asks FDA for blockbuster hep C approval

Gilead Sciences ($GILD) 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.

The Foster City, CA-based biopharma powerhouse's NDA for sofosbuvir comes on the early side of the expected timeline for filing in the second quarter, keeping the program ahead of late-stage rivals from AbbVie ($ABBV) and Bristol-Myers Squibb ($BMY). Yet the rapid filing speaks volumes about the fast pace of the hep C race, in which every week counts as companies seek entrance into a market expected to grow quickly beyond $20 billion after all-oral regimens hit the market.

Gilead, which is the top provider of branded HIV meds, bet its future on sofosbuvir when the company acquired the lead hep C candidate in a buyout of Pharmasset last year worth $11 billion. With data from four successful Phase III studies, the company has asked the FDA to approve the drug in combination with oral ribavirin for patients with genotypes 2 and 3 hepatitis C. If approved, the combo would be the first sanctioned all-oral hep C regimen in the U.S. Also, the company is requesting approval to treat genotypes 1, 4, 5 and 6 with a combination of sofosbuvir, ribavirin and injections of pegylated interferon.

"Current therapies are not suitable for large numbers of patients with HCV infection, and are challenging to take and tolerate," Gilead Chairman and CEO John Martin said in a statement. "Sofosbuvir's antiviral potency, safety profile and once-daily administration have the potential to improve cure rates by simplifying and shortening therapy for patients with this disease."

Vertex Pharmaceuticals ($VRTX) and Merck ($MRK) already offer treatments that provide cures in a high majority of hep C patients who take them, but both Incivek from Vertex and Victrelis from Merck are approved for use with interferon, which causes flu-like side effects. As a result of the side effects, many patients have been on the sidelines until interferon-free options such as Gilead's sofosbuvir-based therapy become available. Hepatitis C affects about 4 million Americans and is the leading cause of liver cancers and transplants.

With sofosbuvir-based treatments, Gilead also plans to offer a therapy with high cure rates in 12-16 weeks as opposed to 24-48 weeks on interferon.

Gilead expects to file a similar application for approval in the European Union later in the second quarter, according to the company. Regulators on both sides of the Atlantic could approve the hep C treatment in late 2013 or early 2014, setting the stage for sofosbuvir to become a blockbuster contender in 2014.

Based on high expectations for 7977, RBC Capital Markets analysts said today that the consensus estimate of $1.2 billion in 2014 sales of the drug was too low. The firm anticipates U.S. and EU approvals to happen early, making way for an extraordinary launch of the drug and sales next year of $2 billion.

- here's the release

Special Report: Hep C pill race report 2012: Gilead, others rush toward pharma gold

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