Dr. Reddy's Laboratories receives DCGI approval to launch Molnupiravir capsules 200mg (Molflu™) in India

 Dr. Reddy's Laboratories receives DCGI approval to launch Molnupiravir capsules 200mg (Molflu™) in India

 Hyderabad, India. December 28, 2021 - Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DR REDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced that it has received emergency-use authorisation from the Drugs Controller General of India (DCGI) to manufacture and market the oral anti-viral drug Molnupiravir capsules 200mg for the treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalisation or death.

Earlier this year, Dr. Reddy’s entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs). In a first-of-its-kind collaboration in the Indian pharmaceutical industry, a Dr. Reddy’s-led consortium of pharma companies collaborated to jointly sponsor, supervise and monitor the Phase III clinical trial in India, and presented its findings to the Subject Expert Committee (SEC).

Dr. Reddy’s will soon launch its molnupiravir capsules 200mg under the brand name Molflu™ across India. As a vertically integrated company, Dr. Reddy’s is able to manufacture the active pharmaceutical ingredient (API) as well as the formulation for molnupiravir, and has made adequate capacity preparations to ensure that it is able to help patients in India as well as in patient populations in need around the world.

Commenting on the development, G.V. Prasad, Co-Chairman and Managing Director, Dr. Reddy’s, said: “Molnupiravir is a continuation of our constant effort since the start of the pandemic to ensure access to every possible treatment option against COVID-19 from prevention to mild, moderate and severe disease for patients in India and around the world. The approval to launch molnupiravir is an important development not only as a treatment option, but also for the collaborative manner in which Indian pharma companies came together. Throughout the pandemic, we have sought to create diverse collaborations and partnerships to meet unmet medical needs of as many patients as possible globally.”

Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. It has been studied by Merck & Co., Inc., in collaboration with Ridgeback Biotherapeutics in a Phase III trial for the treatment of non-hospitalized patients with confirmed COVID-19 globally. It has received approvals from regulatory authorities in the U.K., U.S and Japan. 

CORBEVAXTM is India’s 1st indigenously developed protein sub-unit COVID-19 Vaccine

 CORBEVAXTM GETS DCGI APPROVAL*

CORBEVAXTM is India’s 1st indigenously developed protein sub-unit COVID-19 Vaccine

• CORBEVAXTM is a “recombinant protein sub-unit” vaccine, developed from a component of the spike protein on the virus’s surface, which helps the body build the immune response against the virus

• The vaccine has the Receptor Binding Domain (RBD) protein as an antigen, and also an optimum adjuvant consisting of Dynavax (DVAX) CpG 1018 and alum. 

Hyderabad, December 28, 2021: Biological E. Limited (BE), one of the world’s largest vaccine manufacturers, has today announced that its CORBEVAXTM, India’s first indigenously developed protein sub-unit vaccine against COVID-19, received the approval from the Drugs Controller General of India (DGCI). 

CORBEVAXTM is a “recombinant protein sub-unit” vaccine, developed from the receptor biding domain (RBD) of the spike protein on the virus’s surface combined with Dynavax’s CpG 1018 adjuvant with alum, which helps the body build the immune response against the virus. The vaccine has been developed by Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas. 

The vaccine will be effective both in scale and affordability, providing sustainable access to low-and middle-income countries.

Clinical Basis & Vaccine Characteristics

Biological E. Limited's CORBEVAXTM has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well tolerated and immunogenic. 

• In the pivotal Phase III study conducted with an endpoint of immunogenic superiority, CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELDTM vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAXTM vaccination also generated significant Th1 skewed cellular immune response. 

• CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies.

• CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies.

• While none of the subjects who took CORBEVAXTM or COVISHIELDTM had serious adverse events, CORBEVAXTM had 50 percent fewer adverse events than COVISHIELDTM.

In the continuous monitoring of phase II studies, CORBEVAXTM showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. 

The Government of India, Ministry of Health & Family Welfare said, “We are glad that India has produced yet another COVID-19 vaccine. We believe that this vaccine will address the needs of the world and help the global population fighting against the spread of COVID-19.

Vaccine Rollout Timeline

Biological E. Limited plans to complete production at a rate of 75 Million doses per month, anticipating 100+ million doses per month from February 2022. These capacities will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Government of India. Soon, the company plans to deliver more than one billion additional doses globally. 

“Our scientists at Texas Children’s Hospital and Baylor College of Medicine are thrilled to help in the development of this vaccine, possibly the first covid vaccine specifically designed for global health,” said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Centre for Vaccine Development.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. 

Ms. Mahima further said that ``The journey of CORBEVAXTM has been eventful and any words will fall short to appreciate and acknowledge the contribution of all our collaborators and their continued support in this endeavour. We would like to take the opportunity to especially thank our Prime Minister Shri. Narendra Modi ji for making vaccination a national mission. His vision and the advance commitments we received towards CORBEVAXTM were instrumental in our ability to scale up and manufacture at such huge capacities. While COVID Suraksha Program’s endeavour to accelerate vaccine development played a crucial role in the initial development, the mechanism that was set up with the support of the Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) allowed us to scale up to a capacity of about 1.2 billion doses per annum making the dream of accessibility – affordability and supply – a reality. 

We deeply appreciate CEPI, BCM, the Bill and Melinda Gates Foundation, DFC, Texas Children’s Hospital, and the Government of Telangana for their continuous support and cooperation during this journey. We also thank our volunteers and our funding institutions IFC and EXIM for the trust placed in us. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge.”