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

(Reuters) – 15, Sep 2014-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 and Ranbaxy Laboratories 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 , Strides Arcolab, Hetero Drugs and Mylan Laboratories, owned by U.S.-based Mylan, 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.

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Delhi Network of Positive People and Indian Drug User Forum held a silent protest at Gilead’s Press Conference

15 Sep 2014, New Delhi

Delhi Network of Positive People and Indian Drug User Forum held a silent protest at Gilead’s Press Conference on Announcement of Voluntary License with Indian generics. 

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Gilead Deal to Sell Sovaldi in Poor Countries Meets Criticism

Source: Wall Street Journal

By ED SILVERMAN

In a bid to forestall criticism over the price of its expensive Sovaldi hepatitis C treatment, Gilead Sciences GILD -2.58%has reached licensing deals with seven large generic drug makers based in India to sell lower-cost versions in 91 developing countries.

The goal is to provide greater access to the estimated 185 million people who live in low and middle-income countries, and avoid the reputational damage the pharmaceutical industry sustained more than a decade ago in South Africa over litigation surrounding access to costly AIDS medications.

The deal calls for the generic drug makers – including Cipla, Ranbaxy Laboratories and the Indian unit of Mylan Laboratories to pay royalties to Gilead for the right to make both Sovaldi and ledipasvir, which the biotech hopes to sell very soon along with Sovaldi as a fixed-dose combination in the U.S.

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Statement of Civil Society Organizations in Thailand

Voluntary License on Sofosbuvir and Ledipasvir between Gilead Sciences Limited and Generic-medicine Manufacturers in India

September 16, 2014

Civil society organizations working on access to HIV and HCV treatment in Thailand, as listed at the end of the statement, are appalled by the announcement of the voluntary license agreed between Gilead Sciences Limited and a number of generic-medicine manufacturers in India. We were hoping that Gilead’s new drug, sofobruvir, would be both a life-line to the almost one and half million people infected with the hepatitis C virus (HCV) in Thailand and a potential means of eradicating this disease worldwide. Instead we are now faced with corporate greed building yet another barrier to access to a new medicine needed by millions of people with HCV infection in middle-income countries, instead of a mechanism promoting access to this life saving treatment for ALL who need it.

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MSF Access Campaign response to Gilead’s deal with generic companies for sofosbuvir and ledipasvir

Source: MSF Access Campaign

16 Sep 2014

On 15 September, Gilead Sciences is expected to announce agreements with a handful of Indian pharmaceutical manufacturers to produce and sell generic versions of two new hepatitis C drugs – sofosbuvir and ledipasvir.  Approximately 180 million people live with hepatitis C today, with 350,000 people dying annually of the disease.

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Gilead licence/ Sofosbuvir : Myths & Facts – HepCoalition

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KEI welcomes the Gilead HCV licenses, as a step to expand access to treatments. Notes challenges that remain

Source: KEI

16 Sep 2014

Today Gilead announced it will provide seven generic drug manufacturers licenses to make and sell two drugs that are used in combination to treat the Hepatitis C Virus (HCV) in 91 developing countries.

The 91 countries in the licensed territory had a 2013 population of 3.26 billion persons, about 46 percent of the world population, and a per capita income of $1,879. According to Gilead, about 54 percent of persons infected with HCV live in the 91 countries. (Countries outside of the licenses had a population of 3.87 billion persons, and a per capita income of $17,876). Among countries not considered high income by the World Bank, the percentage of persons included in the covered territory was 56 percent. When both China and high income countries are excluded, the percentage is 73 percent. (Calculations here: http://goo.gl/3QgBS5)

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