| Apr 8, 2013, 2:32pm PDT Updated: Apr 8, 2013, 2:51pm PDT |
John Martin is Gilead's chairman and CEO.
San Francisco Business Times
It could be the first company on the market with a once-a-day oral drug to combat chronic and potentially deadly hepatitis C.
The Foster City-based company (NASDAQ: GILD), long known for its portfolio of HIV/AIDS drugs, said Monday that it submitted a new drug application to the FDA to approve its experimental drug, called sofosbuvir.
Gilead, led by Chairman and CEO John Martin and President and COO John Milligan, got the drug in its $11 billion January 2011 acquisition of Pharmasset Inc. The company was criticized for the expensive move, but its subsequent clinical trials showed that sofosbuvir may eventually clear the body of the virus, vaulting Gilead into the lead in the race for a new, powerful, easy-to-take hepatitis C treatment.
"Current therapies are not suitable for large number of patients with (hepatitis C) infection and are challenging to take and tolerate," Martin said in a press release. "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."
Gilead's initial request is to sell the drug for patients who haven't been treated previously and have four specific types of hepatitis C, genotypes 1, 4, 5 and 6. At first, it would be used in combination with current treatments ribavirin and pegylated interferon, but Gilead officials have said that it eventually could be used in combination with other drugs that it is developing.
The drug, part of a new class of hepatitis C treatments, called "nucs," block a specific enzyme of the virus. It could be approved by the end of this year or early 2014.