Sun Pharmaceutical Industries Limited. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, 'Sun Pharma' and includes its subsidiaries and/or associate companies) has said that it is gearing up to introduce Merck Sharpe Dohme (MSD) and Ridgeback's molnupiravir under the brand name Molxvir® in India. The Drugs Controller General of India (DCGI) is currently reviewing clinical data of molnupiravir for the treatment of COVID-19 in adults in India. Earlier this year, Sun Pharma had signed a non-exclusive voluntary licensing agreement with MSD to manufacture and supply molnupiravir in India and to over 100 low and middle-income countries (LMICs).
Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID -19 in adults. It is under review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).
Kirti Ganorkar, CEO of India Business, Sun Pharma said, "The recent authorisation of molnupiravir, licensed from MSD and Ridgeback, by the UK regulator is a positive step. In line with our consistent efforts to accelerate access to new drugs for COVID-19 treatment, we are gearing up to make Molxvir® available to patients and healthcare providers across India at an economical price post approval by DCGI. Molxvir® will be manufactured at one of our plants in India and we have enough capacity to meet the demand."
In the Phase 3 trial by Merck, Molnupiravir significantly reduced the risk of hospitalization or death by approximately 50% in a planned interim analysis of the MOVe-OUT trial in at risk, nonhospitalized adult patients with mild-to-moderate COVID-19. Additionally, based on the participants with available viral sequencing data (approximately 40% of participants), molnupiravir demonstrated consistent efficacy across viral variants like Gamma, Delta, and Mu.
Molxvir® is a registered trade mark of Sun Pharma.
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