New Delhi, NFAPost: MSN Labs (MSN) announced that they have entered into a royalty-free, non-exclusive, voluntary license agreement with Eli Lilly and Company of USA for manufacturing and marketing of baricitinib for Covid-19 in India.
The drug baricitinib has been granted a restricted emergency use approval in India by the Central Drugs Standard Control Organisation for emergency use in combination with remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalised adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
MSN Group CMD Dr. MSN Reddy said this Collaboration with Eli Lilly and Company is a landmark milestone in India’s fight against COVID-19 and will thus help in increasing the availability and affordability of baricitinib.
Pharmaceutical ingredient
The company will be launching the product under the brand name BARIDOZ in two strengths 2 mg & 4mg. “MSN has developed the active pharmaceutical ingredient and the formulation of baricitinib in its in-house R&D and manufacturing units,” said Dr. MSN Reddy.
As part of the COVID treatment range, MSN has already launched FAVILOW (Favipiravir) in the strengths of 200mg, 400mg & 800mg and OSELOW (Oseltamivir) as 75 mg capsules.
MSN Group is the fastest growing research based pharmaceutical company headquartered in India. Founded in 2003 with a mission to make health care affordable, MSN has nine API and five finished dosage facilities in Hyderabad and the US.
API and formulation
The Group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals. With its core focus on speed and consistency in delivery, MSN has achieved more than 650 national and international patents, over 100 ANDAs, is world no. 1 in active U.S. DMF filings, has a product portfolio featuring over 380 APIs and over 250 formulations covering over 35 major therapies and has won the trust of more than 40,000,000 customers across 65 countries worldwide.
Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes that transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function.
Baricitinib (Olumiant) is approved by FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.
Emergency use
FDA issued an emergency use authorization (EUA) for the drug Baricitinib, in combination with Remdesivir, for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In India, CDSCO has given emergency use approval for the same.
In a clinical trial of hospitalized patients with Covid-19, Baricitinib, in combination with Remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with Remdesivir.
The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continue to be evaluated. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
