J&J is going to be late to the blockbuster, interferon-free hepatitis C party, but it appears determined to wrangle an invitation.
Rounding the bend on a likely approval for its hepatitis C drug simeprevir, J&J ($JNJ) has acquired an NS5A replication complex inhibitor from GlaxoSmithKline ($GSK) to add to its combination approach to the disease. J&J says it will waste no time in pushing ahead with new mid-stage studies of GSK2336805 in combination with simeprevir (TMC435) and TMC647055, Janssen's non-nucleoside polymerase inhibitor.
The pharma giants were both happy to stay mum on the financial details, but J&J has been devoting considerable resources to rival Gilead ($GILD) (sofosbuvir-plus) and AbbVie ($ABBV), among others, which are ramping up new interferon-free therapies expected to replace the current standards of care.
"We're excited to add GSK2336805 to our existing portfolio of direct-acting antivirals. This addition will broaden our clinical development program as we continue to look for new investigational interferon-free treatment combinations to combat the hepatitis C virus," said Gaston Picchio, the hepatitis disease area leader for Janssen.
Back in May the FDA agreed to give J&J's application for simeprevir--an NS3/4A protease inhibitor--in combination with interferon and ribavirin a priority review. An approval could come before the end of the year, though analysts give sofosbuvir the lead in the race for market share. The goal here is to knock down all signs of the virus in a large group of patients, without subjecting them to the onerous side effects linked to interferon. That means a better cocktail, and the multibillion-dollar market at stake is driving major investments in R&D programs.
Hepatitis C has proven to be a very risky field. While Gilead and J&J and AbbVie surged forward, some biotechs like Idenix ($IDIX), Vertex and Achillion ($ACHN) have struggled with key regulatory and clinical setbacks. Bristol-Myers Squibb experienced a blow-up in the clinic, but has had success with daclatasvir. Idenix shares were down 8% this morning on the news of J&J's deal.
- here's the press release