On the hepatitis C front, Gilead confirmed that sustained virologic response (SVR) or "cure rate" data from a phase II study of its GS-7977/GS-5885 plus ribavirin all-oral regimen in genotype 1 patients will be presented at the upcoming AASLD Liver Meeting in November.
Investors are keen to compare the results from this study to Abbott's (ABT) competing Hep C all-oral regimen that has demonstrated cure rates of between 96% and 99%.
Phase III studies of GS-7977 plus long-acting interferon and ribavirin are nearing completion, with the first data to be announced in December, Gilead said. The company expects to file GS-7977 for regulatory approval in the second quarter of next year.
Moving back to HIV, Gilead is developing a follow-on version of its core HIV drug Viread. A phase II study of this drug, known as GS-7340, is nearing completion with results to be announced in November.
GS-7340 is designed to cause less kidney toxicity than Viread. If developed successfully, GS-7340 could also help blunt the financial blow of looming generic versions of Viread. For the third quarter, net income was $675.5 millkon, or 85 cents per share, compared to $741.1 million, or 95 cents per share in the third quarter 2011. On a non-GAAP basis, which excludes acquisition-related charges and other expenses, net income for the quarter totaled $1 per share or 6 cents per share better than Street consensus. Total revenue in the third quarter increased 14% to $2.43 billion from $2.12 billion one year ago....
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-- Reported by Adam Feuerstein in Boston.
On Tuesday's conference call, Gilead, alluding to the Abbott data indirectly, acknowledged that the SVR rates from its all-oral combination "needs to be very high these days." But Gilead also stressed that other parameters besides high cure rates, including convenience and tolerability, will also play a role in which therapies become widely used.
Gilead has begun treatment-naive hepatitis C patients in a late-stage study of a single-pill combination of GS-7977 and GS-5885.
Moving back to HIV, Gilead is developing a follow-on version of its core HIV drug Viread. A phase II study of this drug, known as GS-7340, is nearing completion with results to be announced in November.
GS-7340 is designed to cause less kidney toxicity than Viread. If developed successfully, GS-7340 could also help blunt the financial blow of looming generic versions of Viread. For the third quarter, net income was $675.5 millkon, or 85 cents per share, compared to $741.1 million, or 95 cents per share in the third quarter 2011. On a non-GAAP basis, which excludes acquisition-related charges and other expenses, net income for the quarter totaled $1 per share or 6 cents per share better than Street consensus. Total revenue in the third quarter increased 14% to $2.43 billion from $2.12 billion one year ago....
Continue reading....
-- Reported by Adam Feuerstein in Boston.
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