Jubilant Pharma develops novel oral formulation of Remdesivir, seeks DCGI nod for additional studies

Accordingly, Jubilant has sought authorization for additional studies for this novel oral formulation from the Drug Controller General of India (DCGI).

Remdesivir, a promising therapeutic candidate for Covid-19, is an adenosine analogue nucleotide prodrug administered intravenously, invented by Gilead, building on more than a decade of the company's antiviral research.

Remdesivir has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19. It acts by interacting with the viral RNA-dependent RNA polymerase and prevents viral replication by terminating RNA transcription prematurely. It has shown in vitro activity against the coronavirus 2 that causes extreme acute respiratory syndrome (SARS-CoV-2).

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. Seven Indian companies are producing Injection Remdesivir under a voluntary licensing agreement with Gilead Sciences, USA.

In May 2020, Jubilant signed a non-exclusive Licensing Agreement with Gilead Sciences, Inc. that gave 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.

Now, Jubilant Pharma Limited, a subsidiary of Jubilant Pharmova Limited has 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.

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.

According to the company, 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 company further said that 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.

Commenting on the same, Shyam S. Bhartia, Chairman and Hari S. Bhartia, Co-Chairman and Managing Director, Jubilant Pharmova Limited said, "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-toadminister formulation but also support an increasing demand of COVID-19 treatments."