September 19, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
New York state health officials announced late Thursday that they will be prioritizing the administration of Gilead Sciences, Inc. ’s Sovaldi, a life-saving hepatitis C drug, to approximately 60 percent of the state’s 60,000 Medicaid patients diagnosed with the condition.
Patients who have advanced stages of the disease and those who have liver disease, HIV and other conditions as a result of hepatitis C will be given high priority. However, recommendations will still require approval from the New York state health commissioner.
Sovaldi is a once-a-day prescription medicine that is used with other antiviral medications to treat hepatitis C. The drug directly targets the hepatitis C virus to stop it from making copies of itself in the liver. Sovaldi attaches itself to RNA to block the multiplication.
Generic Versions of Sovaldi
On Sept. 15, Gilead Sciences announced that it had signed a non-exclusive licensing agreement with seven generic pharmaceutical manufacturers in India to expand access to hepatitis C drugs. Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. will now have permissions to manufacture sofosbuvir, which will be marketed as Sovaldi.
“Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible. In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries,” said Gregg Alton, executive vice president of corporate and medical affairs for Gilead Sciences.
Under the agreement, the companies will receive a complete technology transfer of the Gilead manufacturing process, which will help them scale up production as quickly as possible. The companies will also be able to set their own prices for generic products that they create, paying a royalty on sales to Gilead.
Hepatitis C is a contagious liver disease that may become life threatening if it is not addressed. The hepatitis C virus attacks the liver, and it is spread through contact with the blood of the infected individual. The Centers for Disease Control and Prevention estimates 3.2 million people in the U.S. have chronic hepatitis C infection.