Gilead Sciences, Inc. (NASDAQ:GILD) was planning to launch its blockbuster hepatitis C drug Sovaldi in India by June, the company announced before US markets opened. The biotech firm also said that it aims to further the reach of its licensing agreement with India-based drug-makers by giving them the right to research on a new investigational combination therapy drug involving the use of Sovaldi.
This new combination treatment therapy, as per Gilead, could be used to treat hepatitis C in as many as 91 low-income countries; the combined hepatitis C population of these countries makes up 54% of the total worldwide hepatitis C population. The disease is known to infect about 130 million people each year worldwide.
If granted regulatory approval, the new therapy, which involves the use of sofosbuvir along with an investigational compound in advanced testing stages, could be used to treat all six genotypes of the hepatitis C virus. This is especially a significant development for the developing countries, given that genotype testing for the virus in these countries in either unreliable or not easily available due to a lack of medical facilities and infrastructure.
Gilead plans to request India’s health ministry to “waive clinical trials and expedite the approval for the compound” which could be used to treat hepatitis C. The company has, by now, licensed eight Indian pharmaceutical companies to research on bringing newer versions of Sovaldi to 91 developing countries, with the exclusion of China. Clinical trials have shown that the newer version of Sovaldi eliminates the need to use hard-to-tolerate interferon, making it easier for individuals to complete their treatment plans.
Meanwhile, Gilead is due to sell the 12-week dosing plan for Sovaldi for $900 in India, roughly at about 10% the price it is being sold at in the US and other developed countries. The company’s decision to price the drug at the said level, however, has still attracted severe criticism from patient rights advocates, who believe that the subsidized cost is still too high for most of the middle-income population, where the incidence of hepatitis C is high. According to the World Health Organization, 12 million people in India are estimated to be affected by the life-threatening virus.
Furthermore, Gilead already lost a patent-related case in India earlier this month when the Indian patent office rejected one of the patents for Sovaldi based on an application filed against the company by Indian drug-maker Natco Pharma Ltd and New York-based NGO Initiative for Medicines, Access & Knowledge (I-MAK). The Patent Office ruled that the chemical composition for Sovaldi was not significantly different from the composition of an earlier drug, making it ineligible for patent protection. The office claimed that the “minor changes in the molecule” did not significantly improve the efficacy of Sovaldi.
Gilead clarified that the rejection by the Patent Office was only related to the patent application covering the metabolites of sofosbuvir and that “the main patent applications covering sofosbuvir are still pending before the Indian Patent Office.”
However, the patent rejection left the company exposed to generic competition for the drug in India, which is known as the hub of generic drugs production. Sovaldi could be reproduced without the necessary company approvals, in the absence of the said patent protection.