India's hep C market sets a global pace on cost, access

Two Indian companies are set to roil the global market for hepatitis C drugs further, calling into question spending and approval paces by Japan, Australia and the United States among others, while China, the potential top market, slowly grinds through clinical and regulatory processes.

Hyderabad-based Natco Pharma said in late December that it will market generic daclatasvir in a fixed-dose combination with Gilead Sciences' ($GILD) sofosbuvir for the treatment of patients with genotype 3.

The product, according to the company website, will go under the brand name Natdac at INR6,000 ($90.46) for 28 tablets, according to a company release.

The cost places it light-years away from the $84,000 price tag for a 12-week full-scale treatment of Sovaldi in the U.S., though the treatments are not directly comparable.

The announcement by Natco came on the heels of a similar one from Hetero Drugs, also based in Hyderabad, of approval from the Drug Controller General of India to sell a fixed-dose combination of ledipasvir-sofosbuvir, a generic version of Gilead's Harvoni.

The company did not provide pricing.

The move to combination drug formulae was highlighted in October when Bloomberg noted that companies in India were taking a page out of a playbook used to make cheap HIV drugs in fixed-dose combinations and applying it to hep C.

In this particular case, both companies are among nearly a dozen licensed by Gilead to manufacture and/or market its existing hep C treatments at sharply lower prices in India and nearly 100 developing countries, but not China or Russia.

That's in sharp contrast to China, where hepatitis C patients must rely on imports in a country with 10% of the world's cases.

What's more, the standard treatment in China, interferon/ribavirin, is a poor second cousin to cutting-edge antivirals that can cure 95% of hep C cases.

Gilead is still in the approval process with China FDA on Sovaldi and told FiercePharmaAsia last year it was in price discussions with the Chinese government.

In the meantime, Hangzhou-based biotech Ascletis Pharmaceuticals is pushing along its hep C treatment candidate as the first Chinese company to seek a clinical trial in-country for an interferon-free treatment. Bristol-Myers Squibb ($BMY) has also made clinical progress in China for Daklinza.

Gilead too is at work on a drug combination in the U.S., but faces more stringent patent and regulatory approvals than the companies do in India.

But in India, according to the Sydney Morning Herald, the licensing deal with Gilead and ability to move quickly on new formulations have resulted in fierce price battles for sofosbuvir patients, and the same is expected for the fixed-dose versions.

The Sydney Morning Herald said this includes drug companies offering free test kits to hospitals and discounts based on numbers recruited for treatments.

The lower rates for drugs and services in India are also at sharp odds with Japan, where a pitched battle for market share is in progress following a spate of new approvals and reimbursement last year. Costs, though, are still considerably higher to the government than levels paid out of pocket by patients in India.

Additionally, in Australia, plans are approved to spend $1 billion over 5 years in reimbursement starting in March of this year to work to eliminate hep C in the country within a generation.

The wide gap in pricing is also already a key debate feature of the 2016 U.S. election.

- here's the story from the Sydney Morning Herald
- here's the release from Hetero
- and the release from Natco