(By Mani) Gilead Sciences, Inc.
) said the U.S. Food and Drug Administration (FDA) has approved Stribild, a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults, and it should improve margins for the biotech company due to its premium pricing.
The outcome was anticipated, following the FDA advisory committee's 13-1 vote recommending approval.
Stribild, referred to as "Quad" prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate.
Similar to Gilead's HIV drug Atripla, Stribild has a black box for lactic acidosis/hepatomegaly and warnings for renal impairment. Though, Stribild's label is slightly more restrictive than Atripla's, these restrictions are not expected to hinder adoption in the broader population.
"In our view, the drug's label does not contain any surprising restrictions," Oppenheimer analyst David Ferreiro wrote in a note to clients.
Meanwhile, Stribild would improve margins as it has been priced at $2,342/month, above Atripla ($1,757), Complera ($1,830), and Isentress-based regimens ($2,183), and slightly below protease inhibitor regimens (PI)-based regimens ($2,430).
Importantly, the wholly owned Stribild has better economics compared to Complera and Atripla, and is expected to generate peak sales in excess of $2 billion, given the drug's advantages in tolerability and bill burden relative to other front-line HIV regimens.
"We expect QUAD (Stribild) to take most share from PI regimens, which have the worst pill burden/side effects. We also expect QUAD to take share from integrase inhibitor Isentress, which is BID/uncoformulated. We model Atripla cannibalization, given QUAD's fewer CNS effects, but note QUAD's better economics," Ferreiro added.
Stribild is the third single tablet HIV regimen developed by Gilead. The first, Atripla, was approved in 2006 and is marketed by Gilead and Bristol-Myers Squibb (NYSE:BMY) in the United States. The second single tablet regimen, Complera, which combines Gilead's Truvada and Janssen R&D Ireland's rilpivirine, was approved in 2011.
Gilead Sciences said its antiviral product sales increased 14 percent to $2.01 billion for the second quarter of 2012, reflecting sales growth of 21 percent in the U.S. and 3 percent in Europe. In the U.S., antiviral product sales for the second quarter of 2012 reflect the benefit of purchases by certain state AIDS Drug Assistance Programs (ADAPs) in excess of demand.
Sales of the key drug Atripla increased 10 percent to $904.0 million, reflecting sales growth of 12 percent in the U.S. and 5 percent in Europe. Truvada sales rose 10 percent to $785.9 million, reflecting sales growth of 18 percent in the U.S. and 2 percent in Europe.