Gilead Sciences (GILD), a forerunner in hepatitis C virus drugs, said that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval of sofosbuvir, a once-a-day oral treatment from chronic HCV. Gilead had previously said that it intended to submit the NDA in the second quarter and delivered earlier than many expected as it looks to keep a leg up on competitors like Abbott Laboratories’ (ABT) spinout AbbVie Inc. (ABBV) and Bristol-Myers Squibb (BMY), companies that are also developing all-oral hep C regimens.
The NDA includes data for four successful Phase III clinical trials supporting a combination of sofosbuvir and prodrug ribavirin as an all-oral therapeutic for genotype 2 and 3 HCV patients as well as a cocktail of sofosbuvir, ribavirin and pegylated interferon for treatment-naïve genotype 1, 4, 5 and 6 HCV patients.
Foster City, California-based Gilead acquired sofosbuvir (GS-7977, formerly called PSI-7977) when it paid $11 billion to buy Pharmasset Inc. in November 2011, a move many criticized for the exorbitant price tag. At $137 per share, the offer was at an 89 percent premium to Pharmasset’s previous day’s closing price. Princeton, New Jersey-based Pharmasset had no commercial products, but was leading the race for an all-oral therapy for hep C that can replace approved treatments, such as that of Merck & Co.’s (MRK) Victrelis, that must be used with injectable interferon, which is known to have significant side effects.
If approved, Gilead will be the first company to garner FDA blessings for an all-oral regime…and the bet on buying Pharmasset will pay-off. Chronic HCV infection affects as many as four million Americans and is the leading cause of liver cancer in the U.S. Research firm Decision Resources estimate the worldwide hep C market will surge from $1.7 billion in 2010 to $16 billion in 2015.
"Current therapies are not suitable for large numbers of patients with HCV infection, and are challenging to take and tolerate," said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. "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."
Dr. Martin is referring to the fact that Gilead’s drug candidate shortens treatment time from today’s standard of 24 – 48 weeks to 12 – 16 weeks with less side effects.
Gilead also said that it intends to file for regulatory approval of sofosbuvir in other geographies, including the European Union, this quarter. The European Medicines Agency has accepted Gilead's request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest, which could shorten review time by two months.
Gilead already has a blockbuster franchise of drugs used to treat Human Immunodeficiency Virus, or HIV, the virus that leads to Acquired Immune Deficiency Syndrome, or AIDS.
Shares of Gilead closed lower by 17 cents at $47.20 on Monday, but are looking to move forward at the opening bell on Tuesday with pre-market trading taking the stock price up 2.5 percent on light volume. Over the past year, shares have more than doubled. Since announcing the deal to buy Pharmasset, shares of Gilead have risen about 150 percent.
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