Jubilant Pharma Limited, a subsidiary of Jubilant Pharmova Limited, announces successful completion of safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of remdesivir against the commercially available injectable formulation of remdesivir.
Jubilant has sought authorization for additional studies for this novel oral formulation from the Drug Controller General of India (DCGI). Jubilant is hoping to provide an affordable, more convenient, easy-to-administer and potentially effective treatment option for COVID-19 patients. The proposed oral treatment is expected to be for 5 days, a duration similar to the injectable dosage form. Remdesivir is the first and the only anti-viral drug fully approved by the US FDA for the treatment of patients with COVID-19 requiring hospitalization.
This innovative formulation is likely to ease the capacity constraint that injectable formulation faces and ensure wider and timely availability for the patients of COVID-19. It is specifically designed to avoid hepatic metabolism which results in almost complete first-pass clearance/elimination of remdesivir when it is administered by the traditional oral route. The findings from both preclinical and human studies indicate that the drug is able to undergo absorption when administered using the novel oral formulation. The novel formulation was well tolerated by all the study subjects with no additional safety/ tolerability profile as compared to the injectable product.
In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that granted it the right to register, manufacture and sell Gilead’s remdesivir in 127 countries including India. On July 20, 2020, Jubilant received approval from the Drug Controller General of India (DCGI) to manufacture and market the antiviral drug remdesivir (“JUBI-R”) for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19.
“We are pleased to announce the ongoing development of a novel formulation of Remdesivir to address the pandemic at this critical juncture. Once approved, this will not only provide a more convenient and easy-to-administer formulation but also support an increasing demand of COVID-19 treatments.” stated Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman and Managing Director, Jubilant Pharmova Limited.
About Jubilant Pharma Limited
Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals, Allergy Therapy Products, Contract Manufacturing of Sterile Injectables and Non Sterile products, APIs, and Generics, through six US FDA approved manufacturing facilities in the US, Canada and India and a network of 49 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe. It is well recognized as a ‘Partner of Choice’ by leading pharmaceutical companies globally.
For further information: Visit our website @ www.jubilantpharma.com
About Jubilant Pharmova Limited
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company engaged in pharmaceuticals, contract research and development services and proprietary novel drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 49 radio-pharmacies in the US, Allergy Therapy Products, Contract Manufacturing of Sterile Injectibles and Non-sterile products, APIs and generics through six USFDA approved manufacturing facilities in the US, Canada and India. Jubilant Biosys Limited provides Contract Research and Development Services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of around 5,800 multicultural people across the globe. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals companies globally.