Vertex may be playing catch-up with the likes of Gilead ($GILD) and Abbott ($ABT) in the race to develop an all-oral hepatitis C combo, but the biotech is teaming with some major league players in this high-stakes game. Vertex ($VRTX) announced this morning that it will pair up with J&J ($JNJ) and GlaxoSmithKline ($GSK) on a pair of Phase II matchups.
First up: J&J, which will set up a drug-drug interaction study early next year to determine if they should push on quickly with a Phase II study that combines its simeprevir--or TMC435, a late-stage protease inhibitor in-licensed from Medivir--with VX-135, Vertex's nucleotide polymerase inhibitor. In a partnership of equals, the two companies plan to split the costs on a 12-week combo study with and without ribavirin.
There's no follow-up agreement. Each company will study the results of the 2013 Phase II study and see where they go from there. Vertex in-licensed VX-135 from Alios, along with a second program which was recently scrapped as ineffective. Vertex has a similar pay-as-you-go approach with its deal to combine VX-135 with GlaxoSmithKline's NS5A inhibitor GSK2336805 in a separate Phase II study.
"We are focused on the development of new all-oral treatments for hepatitis C that have the potential to provide a high cure rate with only 12 weeks of treatment, and we look forward to the start of this study with GSK," said Robert Kauffman, Vertex's chief medical officer.
To the winner of this race for an interferon-free oral cocktail therapy for hepatitis C will go a hefty market share potentially worth billions of dollars. Interferon injections are notorious for triggering a slate of nasty side effects which often prevent patients from continuing therapy. And physicians are already advising new patients to stay off of currently available medications--such as Vertex's Incivek--until a better approach comes along. At this rate, even with occasional crack-ups, such as Bristol-Myers Squibb's ($BMY) BMS-094 fiasco--they won't have long to wait.
In a note this morning ISI Group analyst Mark Schoenebaum told investors that the risks associated with the Vertex drug will remain high until more data comes in. But he gave the deal a thumb's up for demonstrating Vertex's willingness to try several recipes rather than limit itself to Incivek match-ups.
- here's Vertex's press release on the J&J deal
- read the release on the GlaxoSmithKline pact