Gilead signs Sovaldi generics deal for 91 developing countries

Gilead has signed a deal with seven India-based generics firms which will see them manufacture hepatitis C drug Sovaldi for no fewer than 91 developing countries.

The deal is an extremely bold move by Gilead to meet demand for new, more effective hepatitis C treatment in the developing world, which accounts for 54% of the world's total infected population.

The deal will see the generics firms granted licences to produce generic Sovaldi (sofosbuvir) as well as an investigational single tablet regimen of ledipasvir/sofosbuvir (currently in phase 3) for treatment of chronic hepatitis C.

Launched in the US in December last year, Sovaldi has enjoyed the most lucrative ever launch uptake of all time, thanks to its effectiveness, ease of use – but also its high price.

The drug can the virus from most patients very quickly, and with fewer side-effects, and because of its breakthrough status, it carries a US high price; it costs $84,000 per patient for a 12 week treatment.

Sovaldi's high price means it has also generated huge controversy, with some US health insurance companies vowing to oppose the firm and its pricing policy wherever possible.

Thanks to its heritage in HIV drugs, Gilead is no stranger to anti-patent protests and patient access demands, and has decided to take pre-empt any moves to override or challenge its patent in developing countries.

India is home to an aggressive generics sector, which has been able to produce copies of new high price drugs by exploiting India's less strict patent system and opposition to pharma company prices and patents.

The seven Indian companies have been granted licences to manufacture their own version of sofosbuvir, as part of a 'technology transfer' agreement.

The deal means the generics firms can set their own prices, simply paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licences also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.

The seven companies are: Cadila Healthcare, Cipla, Hetero Labs, Mylan, Ranbaxy, Sequent Scientific and Strides Arcolab.

Covering a total of 91 developing countries, the cut price drugs will be available to more than 100 million people living with hepatitis C.

Controversy won't go away

Gilead has a treatment access strategy in developing countries which includes tiered pricing, voluntary generic licensing (often in advance of US/EU regulatory approval), negotiation with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organisations. The company says this approach has been successfully used in its humanitarian programme in HIV over the past ten years, with six million patients now receiving Gilead-based HIV medicines in developing countries.

Despite the company's bold move, there is a major question mark about how people with hepatitis C in the developing world can get access to the drug, mainly because of deficiencies in healthcare systems, including diagnosis of the disease, as well as lower generics prices still being too high for some patients to pay for themselves.

Gilead has already agreed tiered prices in other less wealthy countries – the drug costs $1,800 for a typical course of treatment in Egypt, for example. The drug will have to be much cheaper than this if it is to help patients in the poorest countries, but pricing will be in the hands of the generics companies.

The US company is likely to face criticism, nevertheless – including those in developed markets who point to its ability to lower its prices for poorer nations.

The company will also have to put in place safeguards which ensure the low-priced generic versions of its drugs do not find their way back into high priced markets, via so-called parallel imports.

Gilead's Sovaldi is just one of a wave of new oral hepatitis C drugs emerging on to the market, which hold out the promise of a cure for the disease. In response to the new drugs, the World Health Organisation has produced new guidelines on screening, care and treatment of people with hepatitis C.