Gilead, the US biotech company, is poised to benefit from new World Health Organisation guidelines for HIV which call for earlier treatment using more up-to-date antiretroviral drugs for millions of extra patients around the world.
The company is expecting to receive hundreds of millions of dollars in additional revenues each year from the new approach, with significant extra sales for Bristol-Myers Squibb of the US, its partner on one drug combination treatment.
A number of low-cost generic drug manufacturers including several based in India will suffer falling sales, with the phasing out of the older antiretroviral medicine stavudine (also called d4T), which is now judged as too toxic to justify continued use.
The changes follow new international HIV treatment guidance issued this week by the World Health Organisation, mirrored by similar advice in other influential national bodies including the Office of Aids Research Advisory Council in the US and the European Aids Clinical Society.
The new recommendations to doctors and national medical bodies call for patients with HIV to be given drugs earlier in the development of their disease, with treatment beginning at the so-called CD4 count of their immune strength at or above 500 cells/mm3 compared with 350 currently. The WHO calls for treatment at 350 compared with 200 currently.
In the developing world, the guidelines also call for the first time for a switch away from older therapies, and for longer use of newer drugs in mothers with HIV breastfeeding their children in order to prevent them transmitting the infection.
In a research note, Maged Shenouda, senior pharmaceutical analyst for UBS in the US, estimated that the earlier start on treatment would increase Gilead’s $5.5bn annual sales of HIV medicines by 20 per cent, with more than 180,000 patients in Europe and the US given drugs. Currently more than 700,000 receive treatment in the developed world.
“This will have a significant upside with more patients coming onto therapy,” he said, while cautioning that it could take up to three years for doctors to switch to the new guidelines.
In the developing world, the World Health Organisation estimated that the new guidelines would add 3-5m patients to the 9.5m currently estimated to require HIV therapy.
However, only about 4m of these patients currently received medicines, with others unable because of lack of diagnosis and poorly funded health systems to gain access to treatment.
Yusuf Hamied, head of Cipla, the Indian generics company that is one of the largest providers of stavudine and other HIV treatments, dismissed the financial impact, pointing out that he could also sell Gilead’s principal drug in developing countries after overturning the US company’s patent on tenofovir in India.
He said his concern was still more recent and expensive third and fourth generation medicines, which are subject in India to tougher patent restrictions. “Even if I received permission for those today, it would take three to five years to bring them to market,” he said.
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