Launching Hepatitis C Product “Lesovir” in Vietnam

After Gilead Sciences, Inc. Ireland UC. (“Gilead”) has been licensed from U.S. FDA for selling product contains the API Sofosbuvir (Sovaldi on December 6, 2013) and its fixed dose combination of Sofosbuvir and Ledipasvir (Harvoni on October 10, 2014); In 2016, Hetero Labs Limited, India (the “Hetero”) , as API manufacturer, have licensed by Gilead for distribution in India and some countries in Asia, and STADA-VN J.V. Co., Ltd., Binh Duong Branch (the “Company”) currently known as Stellapharm J.V. Co., Ltd. – Branch 1 (“Stella”),  have worked together on the project of  producing Hepatitis C Products to bring its treatment to patients infected by Hepatitis C virus in Vietnam.

On 31st October 2018, the Company signed the agreement with Hetero to obtain a limited sub-license for the purpose of manufacturing, marketing, distribution of Hepatitis C Products in Vietnam. Whereas, Hetero shall supply the APIs such as Sofosbuvir and Ledipasvir to the Company in which they have licensed officially by Gilead. These Products have been still under the Patent of the Innovator and the Licensor, Gilead Sciences Ireland UC.

The Product is manufactured under the brand “Lesovir” by its EU-GMP facility in Binh Duong Province, marketed and distributed by exclusive distributor of the Company, Khuong Duy Pharma Co., Ltd.; Lesovir is available in pack of 28 film-coated tablets.

Lesovir (a fixed-combination preparation of Ledipasvir 90 mg and Sofosbuvir 400 mg) is an oral drug used for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection which are common types in Asia including Vietnam.

As an antiviral medicine, combination of Sofosbuvir and Ledipasvir, it can cure more than 95% of persons with hepatitis infection, thereby reducing the risk of death from liver cancer and cirrhosis.

This licensing association marks significant milestones that ensuring the treatment medicines are accessible to low- and mid- income patients widely that they can use medicines without financial influence during treatment to until completely cured.

About STELLA

STELLAPHARM is one of leading generics pharmaceutical companies and strong producer of anti-viral drugs in Vietnam. The company established in Vietnam in 2000; and focuses on both prescription drugs and non-prescription especially in cardiovascular diseases, anti-viral drugs, anti-diabetics drugs, etc. and our products are now used by millions of patients in more than 50 countries worldwide.

The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

Additional information for this article: Stellapharm J.V. Co., Ltd. – Branch 1
A: 40 Tu Do Avenue, Vietnam – Singapore Industrial Park, An Phu Ward, Thuan An Town, Binh Duong Province, Vietnam
T: +84 274 376 7470 | F: +84 274 376 7469 | E: info@stellapharm.com | W: www.stellapharm.com

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