Gilead passes two Phase III tests with key hep C pill

Three down, one to go. Gilead Sciences ($GILD) met the main goals of two Phase III studies with its blockbuster hopeful sofosbuvir in patients with hepatitis C virus. The biopharma giant aims to use the results from the late-stage studies as part of a larger data package, which will go to the FDA later this year in the company's bid to advance the first all-oral attack on the liver-damaging disease.

With the results Gilead keeps the huge hopes alive for sofosbuvir (formerly GS-7977), a once-daily nucleotide pill or "nuc" acquired in its $11 billion buyout of Pharmasset last year. Gilead has the most advanced program for an all-oral treatment against hep C in the U.S., with its prized nuc serving as the key ingredient to quickly attacking the virus without requiring patients to take injections of interferon, which causes flu-like side effects. And analysts predict new all-oral drugs could fuel the hep C market beyond $20 billion in future years.

Today Gilead revealed data from its late-stage "FISSION" and "Neutrino" studies, both of which met their primary endpoints. In the FISSION study, 67% type 2 and 3 hep C patients on sofosbuvir and standard ribavirin saw the virus wiped out to undetectable levels after 12 weeks of treatment, compared with a 67% sustained viralogic response (SVR) in patients on ribavirin and peg-interferon for 24 weeks or twice as long as those given Gilead's nuc.

The Neutrino was different, since all patients got Gilead's sofosbuvir in combination with ribavirin and peg-interferon and it included patients with four different genotypes of hep C, including types 1, 4, 5 and 6. The trial showed a viral knockdown in 90% of patients after 12 weeks of treatment, versus a historic rate of 60% on ribavirin and peg-interferon for about half a year to a year of treatment.

"With the success of FISSION removing the biggest near-term risk to sofosbuvir's development, we view the results as an incremental positive for [Gilead]," analysts at Cowen & Co. wrote in a note to investors this morning.

Late last year Gilead, the world's top HIV drugmaker, revealed successful results from the first of four Phase III studies geared toward gaining approval of its nuc for certain hep C patients. Results from the fourth study, called Fusion, are expected later this fiscal quarter.

"These data support the favorable clinical profile of sofosbuvir as the backbone of a potent, safe and well-tolerated treatment regimen that is effective across a broad range of HCV patient genotypes," said Norbert Bischofberger, Gilead's chief scientist, said in the company's release.

Gilead is gunning to cross the finish line in the U.S. before contenders such as Bristol-Myers Squibb ($BMY) and Vertex ($VRTX), and Gilead could manage to wipe out the virus in patients using fewer drugs than its rival AbbVie in the hep C race.

- here's the release
- see Reuters' article

Special Report: Hep C pill race report 2012: Gilead, others rush toward pharma gold