Gilead signs hepatitis C pact to cut drug cost for poor (updated)

Viyash Scientific

15/09/2014 14:04

* Generic Sovaldi to be available in 91 developing countries 
    * Companies allowed to set own prices for Sovaldi 
    * Gilead plans to sell Sovaldi in India for $300 a month 
 
 (Adds detail, background) 
    By Aditya Kalra and Zeba Siddiqui 
    NEW DELHI/MUMBAI, Sept 15 (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.  ID:nL1N0RD21N  
    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.     
     
    IMPROVE ACCESS 
    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.  ID:nL6N0MZ47K  
    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.  
 
 (Additional reporting by Ben Hirschler in London; Editing by 
Sumeet Chatterjee and David Goodman) 
 ((zeba.siddiqui@thomsonreuters.com;)(+91 22 6180 7503)(; 
Reuters Messaging: 
zeba.siddiqui.thomsonreuters.com@reuters.net)) 
 
Keywords: GILEAD SCIENCES INDIA/