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Gilead Licenses Hepatitis C Drug To Cipla, Ranbaxy, 5 Others

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US drugmaker Gilead Sciences Inc has agreed to license its hepatitis C drug Sovaldi to seven India-based drugmakers to sell cheaper versions of the $1,000-a-pill medicine in 91 developing nations including India.

Gilead also plans to launch its own branded Sovaldi in India at a price of $300 per month. The drug is normally given for either three or six months and it costs $84,000 for a 12-week course in the United States. Gilead's next generation version its going to be even more expensive.

Sovaldi, chemically known as sofosbuvir, is hailed as a breakthrough in treating the liver-destroying disease, but the company has come under fire over its price tag in the United States.

Gilead's licensing agreement with firms including India's Cipla Ltd and Ranbaxy Laboratories Ltd clears the way for the launch of a cheap generic version of the drug in 91 developing countries that make up 54 percent of the total global hepatitis infected population.

Cadila Healthcare, Sequent Scientific Ltd, Strides Arcolab Ltd, Hetero Drugs Ltd and Mylan Laboratories Ltd, a unit of US-based Mylan Inc, are the others who will now be able to make and sell the Sovaldi generic, Gilead said in a statement on Monday.

All companies will be allowed to set their own prices for the generic drug, and will pay a royalty on their earned sales to Gilead, it said.

"We need to have enough companies to have a competitive marketplace," Gregg Alton, Gilead's executive vice president, corporate and medical affairs told a news conference in New Delhi.

Improve Access
Campaigners, however, were critical of the licensing deals, saying they would restrict access to several countries.

"There are no patents on sofosbuvir in India and several other countries that these generic companies could have sold to," said Tahir Amin, director of intellectual property at I-MAK.org, a group of lawyers and scientists that has opposed a patent on Sovaldi in India.

Bhavesh Shah, vice-president of international marketing at Hetero Drugs, said Gilead's price would serve as the "benchmark" for Sovaldi generic. The launch of the generic version is expected by the second or third quarter of 2015.

The World Health Organisation said earlier this year it wanted a "concerted effort" to drive down the cost of new hepatitis C drugs that offer a cure, but are unaffordable for most infected people worldwide, adding to pressure on Gilead to do more to improve access to Sovaldi.

In Egypt, Gilead offered in March to supply the medicine at a 99 percent discount to the US price. The country has the world's highest prevalence of the liver-destroying virus.

The pact with seven firms will also cover Gilead's next generation version of Sovaldi, which would combine sofosbuvir with the experimental therapy ledipasvir. US regulators are due to decide by Oct 10 whether to approve this new combination.

(Reuters)


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