Bengaluru: Jubilant Pharma Limited, a subsidiary of Jubilant Pharma Limited announced the 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.
In a statement issued here on Tuesday, the 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 antiviral 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,” Mr Shyam S Bhartia, Chairman and Mr Hari S Bhartia, Co-Chairman and Managing Director, Jubilant Pharma Limited.