Gilead Sciences to Allow 5 Indian Firms to Sell Hepatitis Generics in 90 Countries

The US drug maker Gilead Science was set to join hands with at least five Indian Generic Pharmaceutical Companies and permit them to manufacture and sell cheaper versions of its new hepatitis C medicines - sofosbuvir and ledipasvir - in 90 countries.

Among the Indian companies likely to sign pacts with Gilead are Cadila, Hetero, Strides Arcolab and Mylan, while Cipla is expected to earn active pharmaceutical ingredient (API) rights. The licensing agreements will allow the generic drug companies to make and sell copies of the expensive pill for low- and middle-income countries at lower prices.

According to sources, with this move, Gilead is responding to criticism from governments and advocacy groups about the high pricing of the drug that has put it beyond the reach of most patients, particularly those in developing nations.

The once-a-day pill used in combination with other antivirals is the most effective therapy to counter Hepatitis C, which kills about 350,000 people a year globally. The drug’s high price makes it nearly inaccessible to a majority of the patients diagnosed with the disease. Sources said that the low-cost version would probably be sold in India at $2,000 for a three-month therapy.

Gilead, which already holds the patent for this drug in the US and many other developed markets, has applied for a patent in India, too. However, the patent claim has been opposed by three parties—the Indian Pharmaceutical Alliance (IPA), global patient access group I-Mak, and an Indian generic company.

“We have opposed the Gilead patent for the new Hepatitis drug in India as it is violative of Section 3(d) of the country’s patent Act,” said IPA secretary general D.G. Shah.

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Source-Medindia