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Dr. Reddy's to Launch Sanofi's Beyfortus in India for RSV Prevention in Infants

• Dr. Reddy's Laboratories has secured exclusive rights to promote and distribute Sanofi's novel RSV drug Beyfortus (nirsevimab) in India, expanding their existing vaccine partnership.

• Beyfortus, a monoclonal antibody administered as a prefilled injection, prevents respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

• The drug, already approved in major markets including the EU, US, and China, received marketing authorization from India's CDSCO in June and is expected to launch in the second quarter of the current fiscal year.

Dr. Reddy's Laboratories is expanding its strategic partnership with Sanofi Healthcare India (SHIPL) to bring Beyfortus (nirsevimab), a novel preventive therapy for respiratory syncytial virus (RSV), to the Indian market. This development follows their existing exclusive distribution agreement for Sanofi's vaccine portfolio in India established last year.
Under the new agreement, Dr. Reddy's will receive exclusive rights to promote and distribute Beyfortus throughout India. The Hyderabad-based pharmaceutical company plans to launch the product in the second quarter of the current fiscal year.

About Beyfortus

Beyfortus is a prefilled injection containing nirsevimab, a long-acting monoclonal antibody specifically designed to prevent RSV lower respiratory tract disease (LRTD) in newborns and infants during or entering their first RSV season. The drug has already received regulatory approvals in major global markets including the European Union, United States, China, and Japan. In India, Beyfortus received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in June.

The RSV Disease Burden

RSV represents a significant health threat to infants globally. The highly contagious virus is the most common cause of lower respiratory tract diseases such as bronchiolitis and pneumonia in infants and leads to substantial hospitalization rates, even among otherwise healthy, full-term babies.
According to data shared by Dr. Reddy's, 2019 saw approximately 33 million cases of acute lower respiratory infections globally, resulting in more than 3 million hospitalizations. An estimated 26,300 in-hospital deaths occurred among children younger than 5 years due to these infections.

Strategic Importance

M.V. Ramana, CEO of Branded Markets (India and Emerging Markets) at Dr. Reddy's, emphasized that the addition of Beyfortus will significantly strengthen the company's immunization portfolio in India, where preventive healthcare solutions are increasingly important.
"This collaboration represents an important step in addressing a critical unmet need in infant health in India," Ramana stated.

Addressing a Critical Need

Nitya Padmanabhan, Head of Sanofi Vaccines (India), highlighted the significance of this partnership for public health in India: "In India, where the disease burden is significant and early protection is critical, this collaboration with Dr. Reddy's enables us to reach parents and healthcare providers with an innovative solution."
The introduction of Beyfortus comes at a crucial time, as awareness about RSV and its potential complications has increased globally. Unlike traditional vaccines, Beyfortus provides immediate protection through its monoclonal antibody mechanism, offering a new approach to preventing RSV disease in vulnerable infants.

Market Impact

Healthcare analysts suggest that the introduction of Beyfortus could significantly impact pediatric care protocols in India, potentially reducing hospitalization rates and associated healthcare costs related to RSV infections. The drug represents one of the first specific preventive options for RSV available in the country.
The partnership between Dr. Reddy's and Sanofi continues to strengthen both companies' positions in the Indian pharmaceutical and vaccine markets, combining Sanofi's innovative research capabilities with Dr. Reddy's established distribution network and market presence in India.
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