Deals, Drug Development, Results

ViiV, GSK gamble a surprise $130M chip in a high-stakes HIV playoff with Gilead

GlaxoSmithKline $GSK hasn’t had much to boast about over the last couple of years when it comes to new drug development. But ViiV — the HIV specialist which it controls a majority stake in — has proven to be a notable exception to that rule.

Today, ViiV continued to live up to its star billing inside GSK circles, noting that it filed twin applications at the FDA and the EMA for a combination of dolutegravir (Tivicay) and rilpivirine (J&J’s Edurant), which it plans to market as the world’s first two-drug maintenance therapy for keeping a lid on the lethal virus.

In a surprise, ViiV says that GSK recently acquired a priority review voucher (PRV) for $130 million and will use it to shave four months off the FDA review process. That should give it a clear shot at beating Gilead to the market later this year.

A spokesperson for GSK declined to comment when I asked who they bought the voucher from. I have a query in to Marathon, which bagged a PRV in its controversial approval for an old steroid called deflazacort after gaining an approval specifically for Duchenne muscular dystrophy, but have yet to hear back.

Being first to market here can be a valuable advantage. The HIV market is worth billions of dollars, and new combinations like these offer prolonged hope for patients holding the virus at bay for years, with a growing risk for adverse events from the meds keeping them alive. For GSK, maintaining a leading role with ViiV is absolutely essential to retaining its investors loyalty.

Gilead $GILD recently declared that all four of its Phase III studies testing a combination therapy that adds bictegravir to its backbone HIV therapies proved non-inferior to dolutegravir and other antiretroviral therapies. But it didn’t prove superior, a prospect which had rattled GSK investors. GSK’s stock surged on Gilead’s readout, with ViiV seen warding off a major threat by Gilead, which has been a dominant rival for years.

Gilead recently acquired its own PRV from Sarepta for $125 million and is widely expected to use it in its race against GSK/ViiV. As Gilead’s blockbuster hep C franchise has begun to fade, the big biotech is increasingly reliant on its mainstay HIV work. And any added pressure by GSK is likely to increase analysts’ focus on a major deal to get Gilead’s numbers pointed back north.

“Traditionally, we have used a regimen of three or more drugs to maintain HIV viral suppression, but to best serve people living with HIV we must always question the status quo,” noted ViiV chief scientist John C. Pottage in a statement. “We believed that dolutegravir would have the right profile to be a core agent in a two-drug regimen. Data from the SWORD studies supported our hypothesis that a two-drug regimen of dolutegravir and rilpivirine could maintain viral suppression and these regulatory submissions mark what may be a step change in HIV treatment.  We are grateful to the study participants and clinicians who have contributed so much to making these submissions possible.”


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RAPS Regulatory Convergence 2017