Zydus launches Hepatitis C drug in alliance with Gilead

Ahmedabad-based pharma major Cadila Healthcare (Zydus Cadila) today announced that it launched an oral therapy called 'SoviHep' to treat Hepatitis C that would be marketed by the specialty division of the group, Zydus Heptiza.

Zydus and Gilead Sciences Inc has signed a non-exclusive licensing agreement which  will allow the manufacture of sofosbuvir and the fixed-dose combination of ledipasvir/sofosbuvir for distribution in 91 countries including India. The company said that the oral therapy would be able to help  more than 10 million patients who suffer from Hepatitis C in India.

Hepatitis C is an infectious disease affecting primarily the liver, caused by the Hepatitis C Virus (HCV). It spreads primarily through blood-to-blood contact associated with poorly sterilised medical equipment, and transfusions. An estimated 150–200 million people worldwide are infected with hepatitis C. The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and cirrhosis. Some patients may also develop liver failure, liver cancer, or life-threatening complications. Those who develop cirrhosis or liver cancer may require a liver transplant. Hepatitis C is the leading reason for liver transplantation, though the virus usually recurs after transplantation.

For over a decade in India, the disease has been treated with PEG-IFN alongwith Ribavirin. However, the management of the disease has been a challenge with less than one per cent of 10 million Hepatitis C patients having access to treatment. The problem is further compounded by the fact that patients remain undiagnosed till the late stage and can ill afford the treatment.

“The launch of SoviHep is expected to improve the situation as it takes care of all current treatment needs of PAN-genotypic activity, with barrier to resistance, potent with convenience & compliance therapy. Additionally, SoviHep can also be used in combination with ribavirin (RibaHep) for treatment of chronic Hepatitis C patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation to prevent post-transplant HCV infection,” the company said in a statement here.

Speaking on the development, chairman and managing director of the Zydus group, Pankaj R Patel said, “We are happy to partner with Gilead Sciences to make this breakthrough therapy accessible to patients of Hepatitis C in India. It bridges a longstanding unmet healthcare need.” Zydus Heptiza, a specialty division of the group has a complete basket of brands for Hepatitis B & C.