American drugmaker Gilead Sciences Inc has expanded its Hepatitis C generic licensing agreements with Indian partners to include an investigational drug GS-5816.

The still-under-evaluation drug is a single tablet regimen that combines the compound (GS-5816) and sofosbuvir for the treatment of all six genotypes of Hepatitis C, Gilead said. It is at present being evaluated in late-stage or Phase III clinical trials.

“The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS- 5816, once approved, for distribution in 91 developing countries, which together account for 54 per cent of the total worldwide population of individuals infected with the Hepatitis C virus (HCV),” Gilead said.

The announcement from the California-headquartered company came even as US President Barack Obama was in India to participate in the Republic Day ceremonies, following which he interacted with Indian and American business leaders.

In fact, January has been a significant month for Gilead as it received regulatory approval to market the Hepatitis C drug sofosbuvir in India. And regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria, it added

However, this came even as the Indian Patent Office rejected a Gilead patent application that covered sofosbuvir. The company has since appealed the patent office decision, even as it maintained that the main patent application was still pending on the drug. Gilead’s patent applications in India have been opposed by pro-health groups and some industry representatives as well.

Last September, Gilead had inked generic licensing partnerships for its Hepatitis C drug allowing partners to produce sofosbuvir and the single tablet regimen of ledipasvir/ sofosbuvir. Eight India-based generic manufacturers now hold licences to manufacture Gilead’s HCV medicines — Biocon, Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific, and Strides Arcolab.

But Gilead’s sofosbuvir has also been globally criticised over the pricing of its breakthrough medicine, one of the first of several oral Hepatitis C drugs. It costs $84,000 for 12 weeks in the US and is expected to be pegged at less than $1,000 for the same period in India.

One pill

Outlining the benefit of this investigational drug, Gilead said the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.

It is an important milestone in Gilead’s effort to make effective Hepatitis C treatment accessible to as many patients, in as many places, as quickly as possible, says Gregg H Alton, Gilead’s Executive Vice-President, Corporate and Medical Affairs. “Developing countries are home to a diverse mix of Hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment,” he added.

The Gilead note further has Professor Abhijit Chowdhury, Head of Hepatology at Kolkata’s Institute of Post Graduate Medical Education and Research, explaining that a pan-genotypic Hepatitis C treatment has the potential to radically change the treatment landscape in developing countries, removing the need for patients to undergo burdensome laboratory tests. “Even if testing facilities are available, their cost is a barrier to treatment access, so a regimen that can be used for any genotype is going to be a real attribute in tackling this disease on a global level,” he added.

Giving more details on GS-5816, Gilead said the single tablet regimen of sofosbuvir/GS-5816 is an investigational agent and its safety and efficacy have not been established. Phase III studies evaluating the combination of GS-5816 and sofosbuvir are currently underway, with data anticipated in the second half of 2015, it added.

jyothi.datta@thehindu.co.in

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