Novartis, the Swiss pharmaceutical group, plans to use likely US approval of its malaria medicine Coartem to ease the regulatory pain and boost the profits of another of its late-stage experimental medicines.
Daniel Vasella, chief executive, told the FT he hoped to parlay authorisation of Coartem, which was discussed by the US Food & Drug Administration this week, into accelerated scrutiny of a different Novartis product using a groundbreaking new mechanism designed to stimulate tropical disease research.
Coartem – a highly effective and rapid malaria treatment combining the drugs artemether and lumefantrine in a single pill – is already widely prescribed in many poor countries, but US approval would ease its use for travellers, military and US government purchases for anti-malaria programmes in the developing world.
Under a new programme being finalised, pharmaceutical companies that win approval for a drug to treat a tropical disease would earn a transferable “priority review voucher” allowing them to win faster review by the FDA of any other medicine.
While the voucher does not guarantee the approval of the second medicine, it could accelerate a decision by at least six months and, if granted, would permit earlier launch of a medicine – a decision that could be worth hundreds of millions of dollars in extra sales.
The FDA has yet to issue final guidance on how the priority review voucher would operate, but it is likely to be transferable, so it could potentially either be used for another drug under development by the maker of the qualifying medicine, or sold at auction to another company.
Mr Vasella said: “If well used, the voucher would allow the double gain of supporting patients in the developing world with a neglected disease, and for another medication of real additional benefit.”
He said he would most likely use the voucher to accelerate review of another drug currently under development by Novartis, but did not rule out selling it.
He said Coartem – on which the FDA is likely to decide by the end of this year – had been submitted in the US to help treat the estimated 1,500 annual reported cases of malaria, mainly travellers and soldiers.
Globally, Novartis has sold 200m treatments to date, saving an estimated 500,000 lives.