One of the few bright spots in GlaxoSmithKline’s late-stage pipeline has come through in a pair of Phase III studies. The pharma giant says investigators scored positive data from both Phase III studies designed to determine if patients could safely switch from multidrug cocktails to a combination of dolutegravir from ViiV Healthcare and J&J’s rilpivirine.
The outcome sets up regulatory filings for ViiV in a looming 2017, says the pharma giant, which is allied with Pfizer and Shionogi on the joint venture. And it also poses a new threat for Gilead, which has long relied on its blockbuster HIV revenue from its multi-drug cocktail regimens to finance the company.
The idea behind ViiV’s combo — to be offered as a single pill — is to provide a less threatening alternative to patients livings with HIV, many of whom have been on therapy for years now to keep the virus at bay. As they grow older, the threat of adverse reactions grows as well, making this a top prospect once it hits the market.
“The key debate remains whether Gilead will gain the upper hand again or whether a disruptive two-drug regimen becomes standard of care, favoring GSK,” UBS analyst Michael Leuchten told Reuters.
That’s some of the best news that GSK has heard in years, as its primary drug pipeline remains one of the least exciting in the industry. And it poses a problem for Gilead just as it faces off against a long string of clinical setbacks as well as a recent order to pay Merck $2.54 billion for violating its hep C patents.
Dominique Limet, CEO ViiV Healthcare, said: “These are important results for the HIV scientific community and represent an important milestone in our understanding of how HIV can be treated. The results support our strategy of investigating two-drug regimens as innovative treatment options for people living with HIV and we are planning regulatory submissions for this two-drug regimen as a single tablet in 2017.”
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