- GlaxoSmithKline and its subsidiary ViiV Healthcare have submitted to U.S. and European regulators a two-drug regimen for patients with HIV, and plan to use an accelerated approval tool worth millions to speed up the potential path to market stateside.
- The Food and Drug Administration grants priority review vouchers (PRVs) to pharmaceutical companies that bring treatments for rare conditions affecting children or for tropical diseases to market. Those drugmakers can then either use the voucher on another product — in which case the agency will finish evaluating the candidate on an accelerated timeline — or sell it off, often for a lucrative pricetag.
- There aren't many unused PRVs floating around, and only two have been given out this year. Nonetheless, GSK snagged one for $130 million, according to a June 1 statement, but is being tight-lipped about from whom. The company declined BioPharma Dive's request for comment on that front.
PRVs have become a hot commodity across the industry as competing drugmakers elbow each other for first-to-market status and the perks that come with that title, such as quicker access to physicians and patients, and a means of locking down market share. Those advantages can mean millions, sometimes billions, in return on investment, so it's no surprise pharmaceutical developers are willing to shell out big bucks for a potential fast pass toward them.
Right now, there aren't too many available either for use or for sale. Alexion has a couple. BioMarin and Biogen each recently snagged one as well for their respective rare disease drugs Brineura (cerliponase alfa) and Spinraza (nusinersen).
None of those companies immediately returned BioPharma Dive requests for comment.
Gilead, meanwhile, has been gobbling up PRVs. The big vaccines maker bought one from Sarepta earlier this year for $125 million, another from PaxVax in 2016 for $200 million and a third from Knight Therapeutics in 2014, also for $125 million. Johnson & Johnson also recently announced its decision to use a PRV on Tremfya (guselkumab).
GSK said its newest PRV purchase would appear as a R&D expense in the company's second quarter financial results.
While speculation swirls over where that PRV came from, it's important to note that many public companies report when they buy one, at least if it materially affects bottom lines. Marathon, a private company, has held onto its PRV despite selling off its Duchenne muscular dystrophy drug to PTC. Marathon did not respond to request for comment.
As for the two-dose regimen itself, which consists of GSK's Tivicay (dolutegravir) and Janssen's Edurant (rilpivirine), the New Drug Application comes at a time when competition in the HIV space is getting increasingly tight. Just earlier this week, for example, Gilead reported positive results from four late-stage trials of its triple-combo therapy and plans to submit the treatment by the end of June.
GSK has benefitted from its own triple-combo therapy of abacavir, dolutegravir, and lamivudine, sales for which ramped up drastically last year, helping the HIV business grow 53%.
"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. We believed that dolutegravir would have the right profile to be a core agent in a two-drug regimen," ViiV Healthcare's Chief Scientific and Medical Officer John Pottage said in the June 1 statement.