FOSTER CITY, Calif. (
) --U.S. regulators turned back an approval application for a new HIV drug from
due to manufacturing issues, the company said Tuesday.
The "refuse to file" letter for Gilead's B-tripla means at least a two-month delay in the drug's approval. Gilead submitted B-tripla for approval on Nov. 23 and was hoping for approval by the end of May. Now, the company plans to resubmit the drug by the end of the first quarter, which suggests approval won't come until the end of September.
Gilead shares were down 3% to $37 in after-hours trading. The stock closed Tuesday at $38.16.
B-tripla combines Gilead's current HIV drug Truvada with
Johnson & Johnson's
HIV drug TMC278 into a single pill that HIV patients take once daily. B-tripla is one of two new HIV treatments that Gilead hopes to launch in the next two years to maintain its dominant market share in the HIV treatment market.
Analysts were expecting about $60 million in B-tripla sales in 2011, according to ISI Group biotech analyst Mark Schoenebaum. "We believe a quarter or two of missing sales will have limited impact on financials," he wrote in an email to clients following Gilead's disclosure.
Gilead's announcements Tuesday also included 2010 earnings and detailed guidance for 2011. Per the latter, Gilead forecast 2011 total product sales to be in the range of $7.9 billion to $8.1 billion, bracketed current consensus of $8 billion.
Expense guidance for 2011 was higher than the Street expected, however, suggesting the current consensus 2011 earnings estimate of $4.06 a share may be too high, Schoenebaum added.
For the fourth quarter, Gilead earned 95 cents a share, adjusted, on total revenue of $2 billion. Earnings beat consensus by a penny while revenue were in line.
--Written by Adam Feuerstein in Boston.
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