Vertex investors barely noted yesterday evening that revenue from Incivek slipped in the second quarter. Their attention was on ALS-2200, a hepatitis C nucleotide analogue that has elbowed its way into the frenzied race for a near-term approval for an all-oral therapeutic regimen.
In a tiny, early-stage study the treatment produced promising human data, and investors rallied to the news, driving up Vertex ($VRTX) shares by 5%.
Carret & Co analysts Brean Murray and Brian Skorney and ISI Group analyst Mark Schoenebaum joined the cheering section when they heard the data. Schoenebaum told Reuters that the data puts Vertex firmly in the running with Gilead ($GILD) and Bristol-Myers Squibb ($BMY), which both paid billions to gain a contender in the race for a new hep C treatment that can do away with the troublesome need for interferon injections. Vertex licensed in ALS-2200 and another program from Alios with a $60 million upfront.
"It puts them back in the hep C race," Skorney told the news service about the data. "It makes them a real player again."
"There was a median 4.54 log reduction in hepatitis C virus RNA in people with genotype 1 chronic hepatitis C who were new to treatment after seven days of dosing with 200 mg of ALS-2200 once daily," Vertex reported. Next Vertex says it will study ALS-2200 in a combo trial with Incivek. And if everything continues as hoped Vertex says it can launch a pivotal Phase III next year.
Late last week Gilead laid out an ambitious schedule for its combination hep C program, promising to race into a late-stage study later this year after gaining proof-of-concept human data for its NS5a inhibitor. The biotech mapped out a two-year clinical game plan that matches GS-5885 with 7977.
- here's the press release
- read the Reuters story