Gilead licenses hepatitis C drug to Cipla, Ranbaxy, five others

By Aditya Kalra and Zeba Siddiqui

NEW DELHI/MUMBAI (Reuters) - U.S. drugmaker Gilead Sciences Inc (GILD.O) has licensed its hepatitis C drug Sovaldi to seven India-based drugmakers that will sell far cheaper versions of the $1,000-a-pill medicine in 91 developing nations.

Approximately 150 million people in the world live with chronic hepatitis C infection, most of them in low and middle-income countries, and the new licences are designed to give many of them access to an otherwise unaffordable drug.

As with AIDS 15 years ago, modern drugs are transforming the ability to fight hepatitis C, and Sovaldi has been hailed as a breakthrough in treating the liver-destroying virus.

Sovaldi, chemically known as sofosbuvir, is a far more effective and better-tolerated treatment than older injection regimens, but Gilead has come under fire over its U.S. price tag, with cost presenting a huge barrier in poor countries.

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

Gilead's licensing agreement with firms including India's Cipla (CIPL.NS) and Ranbaxy Laboratories (RANB.NS) clears the way for the launch of cheap generic versions of the drug in 91 developing countries, including India, which make up 54 percent of the total global hepatitis-infected population.

Cadila Healthcare (CADI.NS), Sequent Scientific (SEQU.BO), Strides Arcolab (STAR.NS), Hetero Drugs and Mylan Laboratories, owned by U.S.-based Mylan (MYL.O), 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 Gilead a royalty on their sales, 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 the Indian capital.

Sovaldi is already on track to be one of the world's biggest-selling drugs, with sales in 2014 - its first full year on the market - set to exceed $11 billion, according to consensus forecasts compiled by Thomson Reuters Cortellis.

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Campaigners, however, were critical of the licensing deals, saying they would not ensure access to several middle-income countries where health authorities would still struggle to provide treatment to patients.

“There are no plans to expand the list (of 91 countries) right now,” Alton said, noting that the drug would be sold at a price higher than $300 for a month's supply in better-off developing countries, such as China and Brazil.

Critics also argue that many poor countries do not have patent protection for Sovaldi, so the medicine could be sold in these places without the agreement of Gilead, at a lower price.

"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 the Sovaldi generic. The launch of the generic version is expected by the second or third quarter of 2015.

The World Health Organisation said this year that 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 U.S. price. The north Arfican country has the world's highest prevalence of hepatitis C.

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

(Editing by Sumeet Chatterjee and David Clarke)