Updated with new information throughout.
) -- Finally, highly anticipated data from studies of all-oral hepatitis C therapies under development by
(GILD - Get Report)
(BMY - Get Report)
have been released this morning at the European Association for the Study of Liver Disease (EASL) annual meeting.
Here are the headline EASL data most important to investors:
Gilead's "Electron" study of GS-7977 plus ribavirin which enrolled 25 treatment naive, genotype 1 patients: SVR4 (early cure) rate of 88%
Bristol's phase II study of daclatasvir plus Gilead's GS-7977 in patients with genotypes 1, 2, and 3: SVR4 (early cure) rate in the genotype 1 patients: 100%. In genotype 2/3 patients, the SVR4 rate was 91%.
Snap judgments: Strong data, particularly from the Bristol daclatasvir study. Anytime you cure 100% of patients, that's very good. Gilead's Electron study results appear to meet Wall Street's expectations for what's considered a strong cure rate.
contributor and healthcare investor Nathan Sadeghi-Nejad is in Barcelona at the EASL conference and reports back that the says the hedge fund crowd around the Gilead poster broke into high fives when the data were announced.
tweet from EASL
, Sadeghi writes, "Consensus here is 'thrilled.' Buysiders and sellsiders alike. I don't see any big flaws. $GILD management glowing."
Gilead also announced results from a second mid-stage study, dubbed "Quantum", using the same GS-7977 and ribavirin combination. The SVR4, or early, cure rate of 59% was not as robust as the Electron result.
Why the disparity between the strong Electron results and weaker Quantum results using the same treatment regimen? Electron enrolled easier to treat patients -- 44% had the IL28B "CC" genetic variant of the hepatitis C virus which is known to respond better to treatment. By comparison, only 16% of the patients in the Quantum study carried the "CC" genetic variant.
Wall Street reactions are starting to come in:
ISI Group biotech analyst Mark Schoenebaum says Bristol's daclatasvir plus GS-7977 study is the "best case" with an SVR4 rate of 100%, "it obviously doesn't get any better than this," he writes in an email to clients.
Schoenebaum also says Gilead's Electron results were "better than expected."
J.P. Morgan biotech analyst Geoff Meacham, with a nod to his time in Barcelona, calls the Gilead data "Muy Robusto."
More details and updates from the EASL conference on the way.
--Written by Adam Feuerstein in Boston.
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