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Zydus launches SoviHep – the breakthrough therapy for Hepatitis C in alliance with Gilead Sciences

– A Novel Oral Treatment Regimen for patients suffering from Hepatitis C –

Ahmedabad, March 17, 2015

The breakthrough oral therapy, ‘SoviHep’ which will provide succour to more than 10 mn patients who suffer from Hepatitis C in India has been launched by the Zydus group. The therapy will be marketed by the specialty division of the group, Zydus Heptiza. Zydus and Gilead Sciences, Inc. had 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.

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 sterilized 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 1% 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. The current Hepatitis Genotype prevalence landscape in India is Genotype 3: 64% ; Genotype 1 : 26% & Genotype 4 & 6 : 10%. SoviHep is an effective therapy for all the above Genotypes. 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.

Speaking on the development, Chairman and Managing Director of the Zydus group, Mr. Pankaj R. Patel said, "Innovations in healthcare have made it possible to deliver better therapy outcomes and improve quality of lives. 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. It also underlines our mission of providing access to new, affordable therapies and we stand committed to this."

Zydus Heptiza, a specialty division of the group has a complete basket of brands for Hepatitis B & C. The addition of SoviHep shall complete this critical care portfolio which offers the advantages of quality, globally accessed, preferred treatment options at affordable prices.

About Zydus Cadila

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group launched its own patented NCE — LipaglynTM, the world's first drug to be approved for the treatment of diabetic dyslipidemia. It also launched `Exemptia' the world's first biosimilar of adalimumab for the treatment of inflammatory arthritis, Ulcerative Colitis and Crohn's Disease in adult & paediatric patients. The group aspires to be a research-based pharmaceutical company by 2020. The group employs over 16,500 people worldwide and is dedicated to creating healthier communities globally.