Financial Times
August 13, 2013
GlaxoSmithKline stands to receive a substantial financial boost after US regulatory approval of a new HIV treatment produced by its subsidiary ViiV Healthcare.
ViiV, a specialist HIV drug developer 76.5 per cent owned by GSK, received authorisation by the Food and Drug Administration late on Monday to commercialise dolutegravir, one of a class of drugs called integrase inhibitors.
The medicine, to be known by the brand name Tivicay, has the potential to become a backbone for treatment for millions of HIV patients around the world as part of a “first line” drug cocktail.
Depending on the price, it could overhaul treatment and compete with existing HIV drugs, including Merck’s Isentress (known generically as raltegravir) and Atripla, a combination commercialised by Gilead.
Studies of Tivicay showed it to be effective in low doses of 50mg for adults and only required once a day, with or without food.
Approval marks the first successful new drug developed by ViiV, which was created in 2009 as a pioneering joint venture by GSK and Pfizer to develop and commercialise both companies’ existing and experimental medicines.
Dominique Limet, chief executive of ViiV, said: “I think this is a real achievement of ViiV as a single entity fully dedicated to HIV. We are able to deliver a very exceptional, effective product that is convenient to use. We feel extremely proud.”
Manica Balasegaram, executive director of Médecins Sans Frontières’ Access Campaign, said: “Based on studies to date, dolutegravir holds important advantages for use in developing countries, but as treatment providers, our biggest concern is what the price will be.”
Mr Limet said Tivicay would be priced in the US in line with equivalent products, with patient access subsidies. It would be offered at a discount in middle income markets, and licensed to generic producers in low income countries.
Research on the drug was originally conducted by Shionogi of Japan, and it was jointly developed with GSK after a partnership for a range of drugs agreed between the two companies more than a decade ago.
It was added to the portfolio of ViiV, and under the terms of a new agreement completed last year to reflect its pivotal role, Shionogi received 10 per cent of the equity in ViiV. The Japanese company is also set to receive separate royalties on sales.
GSK will gain still more from the launch of the new drug, because of an agreement stipulating that on the successful approval of Tivicay in the US and Europe, the UK pharmaceutical group will increase its stake in ViiV by 1.8 per cent at the expense of Pfizer, which currently holds the remaining 13.5 per cent in the joint venture.
Simon Collins from HIV i-base, an HIV treatment activist and advocacy organisation in the UK, said: “Early results with dolutegravir look very exciting as it has the potential to change the way HIV combinations therapy have been prescribed for the past 15 years – both in western and resource-limited settings.”
GlaxoSmithKline stands to receive a substantial financial boost after US regulatory approval of a new HIV treatment produced by its subsidiary ViiV Healthcare.
ViiV, a specialist HIV drug developer 76.5 per cent owned by GSK, received authorisation by the Food and Drug Administration late on Monday to commercialise dolutegravir, one of a class of drugs called integrase inhibitors.
The medicine, to be known by the brand name Tivicay, has the potential to become a backbone for treatment for millions of HIV patients around the world as part of a “first line” drug cocktail.
Depending on the price, it could overhaul treatment and compete with existing HIV drugs, including Merck’s Isentress (known generically as raltegravir) and Atripla, a combination commercialised by Gilead.
Studies of Tivicay showed it to be effective in low doses of 50mg for adults and only required once a day, with or without food.
Approval marks the first successful new drug developed by ViiV, which was created in 2009 as a pioneering joint venture by GSK and Pfizer to develop and commercialise both companies’ existing and experimental medicines.
Dominique Limet, chief executive of ViiV, said: “I think this is a real achievement of ViiV as a single entity fully dedicated to HIV. We are able to deliver a very exceptional, effective product that is convenient to use. We feel extremely proud.”
Manica Balasegaram, executive director of Médecins Sans Frontières’ Access Campaign, said: “Based on studies to date, dolutegravir holds important advantages for use in developing countries, but as treatment providers, our biggest concern is what the price will be.”
Mr Limet said Tivicay would be priced in the US in line with equivalent products, with patient access subsidies. It would be offered at a discount in middle income markets, and licensed to generic producers in low income countries.
Research on the drug was originally conducted by Shionogi of Japan, and it was jointly developed with GSK after a partnership for a range of drugs agreed between the two companies more than a decade ago.
It was added to the portfolio of ViiV, and under the terms of a new agreement completed last year to reflect its pivotal role, Shionogi received 10 per cent of the equity in ViiV. The Japanese company is also set to receive separate royalties on sales.
GSK will gain still more from the launch of the new drug, because of an agreement stipulating that on the successful approval of Tivicay in the US and Europe, the UK pharmaceutical group will increase its stake in ViiV by 1.8 per cent at the expense of Pfizer, which currently holds the remaining 13.5 per cent in the joint venture.
Simon Collins from HIV i-base, an HIV treatment activist and advocacy organisation in the UK, said: “Early results with dolutegravir look very exciting as it has the potential to change the way HIV combinations therapy have been prescribed for the past 15 years – both in western and resource-limited settings.”