ViiV HIV drug boost
pharmafile | February 18, 2013 | News story | Sales and Marketing | Dolutegravir, GSK, HIV, ViiV
ViiV Healthcare has received a boost with the news that the FDA is to give a priority review to its HIV drug dolutegravir.
The product was submitted in December for the treatment of HIV in combination with other antiretrovirals in adults and adolescents.
The US regulator has set a target date of 17 August to decide on the drug’s future, with the speed of the process reflecting dolutegravir’s potential to offer significant improvement to existing products.
ViiV hopes the pill will rival the current triple-drug combination, Gilead’s Atripla, in treatment-naïve HIV patients.
A head-to-head study last year between the drugs showed dolutegravir had a small but measurable advantage over Atripla, helping more patients eradicate signs of the virus in their blood.
Atripla brings in about $3 billion a year, and analysts think dolutegravir’s more convenient dosing could help it earn $5 billion annually in peak sales.
ViiV was established in 2009 as a joint venture between GlaxoSmithKline and Pfizer, with GSK holding 85% and Pfizer 15%.
Last October, Japan’s Shionogi took a 10% share in ViiV (with GSK’s share dropping to 76.5% and Pfizer’s 13.5%) in exchange for handing over rights to integrase inhibitor dolutegravir and other early-stage drugs in the same class.
ViiV’s submission includes the results of four phase III trials treating more than 2,500 patients with HIV/AIDS across the treatment spectrum, from therapy-naïve to salvage patients.
The company also submitted the drug to the European Medicines Agency last December – and if it is approved in both the US and EU, GSK will be entitled to 1.8% additional equity.
For its investment, Shionogi receives royalties on net sales of the whole integrase inhibitor portfolio averaging in the high teens, gets representation on the ViiV board and will, for a defined period, have input into the development and commercialisation plans for those drugs.
The companies say the new deal will help them push forward the integrase inhibitor portfolio most effectively and efficiently, while maximising the potential long-term value of the assets.
ViiV says that acquiring full rights to the portfolio means it can streamline R&D and commercial operations in order to maximise sales growth and shareholder returns.
The idea of putting ViiV together in the first place was to get round the R&D and commercial problems of discovering new HIV treatments.
Pooling resources should help the companies make new advances in a field where much treatment is now genericised.
Adam Hill
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