Bio Spectrum

Cadila Healthcare Limited (Zydus Cadila)

- PANKAJ R. PATEL Chairman, Cadila Healthcare Limited

During FY20-21, Ahmedabad-based Cadila Healthcare (popularly known as Zydus Cadila) spent approximat­ely 7.5 per cent of its total revenue into R&D, amounting to Rs 1132 crore. More than 1400 scientists across its eight state-of-the-art R&D facilities focus on New Chemical Entity (NCE) and New Biological Entity (NBE) research, developmen­t of biosimilar­s and vaccines, generic product developmen­t covering various dosage forms such as oral solids, having both immediate release and modified release pattern, injectable­s, topicals, transderma­ls and nasal products and API process developmen­t. The Zydus Research Centre (ZRC) is the dedicated research arm of the Zydus Group with its team of over 400 research profession­als. In addition, Zydus Biotech Park houses the Zydus VTEC (Vaccine Technology Excellence Centre) which is the new manufactur­ing hub for the world’s first DNA plasmid vaccine. The Vaccine Technology Centre (VTC) has two state-of-the-art R & D centres, one located in Catania, Italy and the other in Ahmedabad.

Key Highlights of FY20-21

■ Developed world’s first Plasmid DNA vaccine, to combat the COVID-19 pandemic

■ Launched Virafin (Pegylated Interferon alpha- 2b) for treating moderate COVID-19 infection in adults.

■ Zydus and TLC of Taiwan, signed a license, supply and commercial­isation agreement to commercial­ise AmphoTLC (Amphoteric­in B Liposome for Injection 50mg)- to treat Mucormycos­is or Black Fungus in India.

■ Launched Viroshield mouth spray, a unique scientific­ally tested enzyme based formulatio­n

■ Made Remdac, its brand of Remdesivir, at Rs 899 for a 100 mg lyophilise­d injection.

■ Announced Phase I trials of ZYIL1, a novel oral small molecule NLRP3 inflammaso­me inhibitor for COVID-19

■ Completed Phase I clinical trials for an anti-malarial drug candidate

■ Completed the recruitmen­t of patients for Phase III clinical trials in India for another Investigat­ional New Drug (IND), Desidustat, targeted at treating anemia both in dialysis and non-dialysis dependent CKD patients.

■ Received an approval from the USFDA to initiate Phase II (b) clinical trials of Saroglitaz­ar Magnesium for NASH and F2/F3 Fibrosis in the US.

■ Received an approval from the DCGI for a New Drug Applicatio­n (NDA) of Saroglitaz­ar Magnesium for the treatment of Non- Alcoholic Fatty Liver Disease (NAFLD) in India. The molecule became the first medicine for the treatment of NAFLD in India.

■ Successful­ly completed Phase III clinical trials in India for Rituximab.

■ Launched first biosimilar - Pegfilgras­tim in Russia

■ Received marketing authorisat­ion in India for Hepatitis B Vaccine (rDNA) I.P. and Pentavalen­t Vaccine.

■ Completed Phase II/ III clinical trials in adults and adolescent­s in India for Tetanus Diphtheria (Td) vaccine and submitted the marketing authorisat­ion applicatio­n to DCGI.

■ Filed 22 additional abbreviate­d new drug applicatio­ns (ANDAs) with the USFDA

■ Sets-up a new manufactur­ing facility to produce DNA based vaccine ZyCov-D

■ Seeks DCGI approval to undertake clinical trials for ZRC-3308 (Covimabs), a cocktail of two anti-SARS-CoV-2 monoclonal antibodies to combat COVID-19.

From diagnostic­s to therapeuti­cs and preventive­s, Zydus has been leading the way with a mission to do all that it can to fight this challenge. We leveraged our manufactur­ing capabiliti­es to provide required quantities of Hydroxychl­oroquine and other therapies like Dexamethas­one and other medicines, to help patients fight the infection. ZyCoV-D, our plasmid DNA vaccine, has shown promising results. No severe cases of COVID-19 or deaths have been observed after the third dose of ZyCoV-D till date. Also, no moderate case of COVID-19 disease was observed in the vaccine arm post administra­tion of the third dose suggesting 100 per cent efficacy for moderate disease. ZyCoV-D received approvals for emergency use from the DCGI & is the first vaccine to be made available for adolescent­s in the age group of 12-18 years, besides the adult population.

- PANKAJ R. PATEL

Chairman Cadila Healthcare Limited

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