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Gilead Seeks Regulatory Shortcut to Bring New HCV Drug to India

Posted 27 January 2015 | By Michael Mezher 

Gilead Seeks Regulatory Shortcut to Bring New HCV Drug to India

Gilead Sciences announced it is extending licensing agreements with eight Indian generic manufacturers to include rights to make a yet-to-be approved drug in combination with Sovaldi (sofosbuvir).

Background: A New Drug

In a press release on Gilead’s website, the company says the new combination, if approved, would be the first treatment that effectively treats all six genotypes of hepatitis C (HCV). Previous treatments for HCV tended to be effective in select subpopulations of the disease. For example, Vertex Pharmaceuticals’ Incivek was only approved for use in patients with HCV genotype 1.

If Gilead’s investigational compound, known as GS-5816, is able to effectively treat HCV regardless of genotype, the drug could be a major breakthrough for treating HCV in the developing world where it is often difficult and expensive to conduct genotype testing.

Getting to Market Faster

The investigational compound, referred to as GS-5816, is currently undergoing phase 3 clinical trials, which Gilead expects will be completed in the second half of 2015. However, in a bid to speed GS-5816 to market, Gilead will ask India to “waive clinical trials [requirements] and expedite approval for the compound,” Bloomberg reports.

Such a request is not without regulatory precedent in the country. In 2014, India’s Central Drugs Standard Control Organisation (CDSCO) issued an order allowing the country’s “clinical trial in Indian population” to be waived for drugs that are approved in other countries “in cases of national emergency, extreme urgency, and epidemic” as well as for orphan drugs or other areas of unmet need.

Setbacks for Market Access

However, Gilead's request comes just as its market access strategy in India has experienced major setbacks.

In September 2014, Gilead said it would license Sovaldi to multiple generic manufacturers in India. The licensing agreement would allow the generic manufacturers to market Sovaldi in India and 90 other low- and middle-income countries. Gilead has said it plans to sell Sovaldi for $900, and expects licensed generic versions to cost less.

On 13 January 2015, India’s Patent Office rejected a patent application for a compound produced by the body as it metabolizes Sovaldi. Gilead has said the patent rejection will not change its plans to sell the drug in India, and that its “main patent applications” are still being reviewed.

Gilead's licensing plans have also come under fire by some access-to-medicines groups such as Médecins Sans Frontières (MSF). The group has been critical of Gilead’s voluntary licensing agreements, arguing they "fall short of ensuring widespread access to [Gilead's] new drugs." Despite the inclusion of GS-5816, MSF says the terms of the expanded licensing agreement are limiting due to restrictions on where the drug can be sold.


Gilead Press Release

Categories: Regulatory News

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