After delivering data from multiple rounds of trials on all-oral combos against hepatitis C, pharma runners appear to be making progress with new therapies that could shorten treatment durations and wipe out the liver-damaging virus without infusions of interferon and the flulike side effects that go with them. However, nobody has managed to overtake Gilead Sciences ($GILD) as the frontrunner in the hep C race.
An industry watcher could get lost in all the data delivered today from the International Liver Congress 2013 in Amsterdam. So here are some of the key highlights from the pack of contenders, each of which wants its share of a market for HVC drugs that analysts believe is due to explode beyond $15 billion in annual sales within several years:
- After filing for approval of its lead oral "nuc" sofosbuvir on April 8, Gilead spotlighted data from four Phase III studies of the drug across a range of genotypes of HCV, drug combos and treatment durations. In the company's Neutrino study, for instance, 90% of patients' viruses were undetectable at 12 weeks after taking once-daily sofosbuvir in combination with standard ribavirin and peg-interferon. As Reuters noted, today's approved combos take at least twice as long (24 weeks to 48 weeks) to deliver cure rates as high as 80%.
- Bristol-Myers Squibb ($BMY) came out with promising Phase II data on a triple-combo oral attack on HCV that delivered cure rates of up to 94% in patients taking the combo for 12 or 24 weeks. The combo notably excluded ribavirin, which has nasty side effects, making it a potential threat to Gilead down the road. Yet as RBC Capital Markets analyst Michael Yee noted this morning, Bristol's midstage data show two cases of the virus coming back in treated patients, an issue that has not come up once in Gilead's some 1,000 patients treated with sofosbuvir. And Gilead has posted cure rates as high as 100% in certain patients. Later in 2013, Bristol aims to enter Phase III with the combo--which includes the NS5A inhibitor daclatasvir, the protease inhibitor asunaprevir and a non-nucleoside polymerase inhibitor called BMS-791325.
- There were no big surprises from the latest round of results from AbbVie's ($ABBV) Phase IIb trial "Aviator" to test the company's 5-oral-drug combo, which is undergoing late-state trialing. The combo offered cure rates of 96% in HCV patients who hadn't taken interferon before and 93% in patients who had failed prior treatment. Though these are promising data, analysts have called out the AbbVie combo for requiring patients to take 5 different drugs as opposed to the fewer pills in regimens from Gilead and others.
The European liver meeting attendees also saw results from Merck ($MRK), Achillion ($ACHN) and AbbVie's partner Enanta, among other hep C teams, as well. It's important to note that the estimated 170 million patients worldwide with chronic HCV are a very heterogeneous group, and different patients will respond better than others to various treatment combos. So the field remains open to biopharma competitors, even if they run behind Gilead, which could get an approval or two next year, in the race.
- here's the Gilead release
- see the Bristol-Myers release
- and Reuters' article on BMS's data
- check out the AbbVie release
- and Reuters' article
- find Achillion's release here
- and Merck's release
- plus one from Enanta
- and another from Medivir
Special Report: Hep C pill race report 2012: Gilead, others rush toward pharma gold