ViiV Healthcare nabbed FDA approval for its HIV fighter Tivicay, a once-daily drug that could raise the company's fortunes by up to $5 billion. But first, the drug will have to make up ground gained by rivals already on the market--and submit to the usual questions about its price.
Tivicay is an add-on to two standard HIV drugs, Ziagen and Zeffix, both available as generics. Its wholesale price will be $1,175 per month, or $14,105 per year. "This is within the range of third agents used to treat HIV and reflects the benefits of Tivicay as part of combination antiretroviral therapy," ViiV spokesman Marc Meachem said in an emailed statement.
For comparison's sake, Complera, a three-drug combination pill sold by Gilead Sciences ($GILD), launched in 2011 at $1,704 per month. Stribild, Gilead's four-drug "quad" treatment, rolled out last summer at $28,500. (Both drugs have quickly grown, incidentally, with Stribild at $190 million so far this year.)
Both of those debuts drew fire from AIDS activists; Stribild had the additional distinction of criticism from Democratic members of Congress. So, it is no surprise that Médecins Sans Frontières (MSF) quickly jumped in with a cost critique on Tivicay, known generically as dolutegravir.
The group isn't worried so much about the drug's price in wealthy countries like the U.S.; in fact, MSF made something of a case for Tivicay storming the market. MSF says ViiV's access programs in the developing world won't be enough to get the drug into broad use there.
"We are deeply concerned that ViiV's business strategy will result in dolutegravir being priced out of reach in countries excluded from ViiV's licensing deals," MSF's Rohit Malpani said in a statement.
Meachem said ViiV has already wrapped up a deal allowing a generic company to make a low-cost version of Tivicay, subject to regulatory approvals. That version would be intended for the globe's poorest countries and countries in sub-Saharan Africa. "We are committed to helping patients receive access to effective HIV treatment in the U.S. and across the globe," Meachem said.
MSF's concerns are, in a way, a compliment to Tivicay; if it weren't a promising treatment, the organization wouldn't care so much. In its statement, the doctors' group called Tivicay "well-tolerated and extremely effective" at stopping the HIV virus, with a high barrier to drug resistance. Those advantages give Tivicay a shot at capturing market share. Encouraged by trial data, analysts figure the drug can grow to $900 million by 2017. Longer term, analysts are looking at anywhere from $2 billion to $5 billion in peak sales.
Tivicay is ViiV's first new product since it was born from the marriage of GlaxoSmithKline ($GSK) and Pfizer's ($PFE) HIV assets. Shionogi, which joined the ViiV joint venture last year, is the drug's original developer.