Reinforcing its oncology product range, Intas Pharmaceuticals recently introduced azacitidine molecule in Azadine in India to help fight Myelodysplastic Syndrome (MDS) and acute myelogenous leukaemia (AML). Azadine has been priced with an objective to make it accessible to a majority of the needy patients and is priced at 1/5th of the innovator brand.

MDS is a type of cancer in which the bone marrow does not make enough healthy blood cells and there are abnormal (blast) cells in the blood and or in the bone marrow and advanced stages of MDS may lead to AML. Currently, for combating this type of cancer in the country, oncologists have to rely on an imported version of azacitidine. The treatment cost of imported azacitidine can range between Rs.15 to 18 lakh. The cost of treatment with other options ranging from conventional agents to transplants may cost between Rs.2 lakh to 15 lakh.

Azacitidine approved by the US FDA since May, 2004, induces antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting into tumourous cell death.

It is estimated that 4 to 5 people per 1,00,000 suffer from MDS or AML, data extrapolated to Indian population from global epidemiologic studies suggest that the disease burden of MDS in India is likely to be sizeable. Also, cytogenetic studies suggest that MDS patients in India get affected by the disease at a younger age and also tend to have a higher risk.

Azacitidine is the only drug which has been shown to prolong overall survival duration, prolong time to transformation into AML, increase response rate, reduce transfusion burden and improve quality of life. Azacitidine will also offer better convenience and compliance and reduce hospital visits due to subcutaneous administration.

Azadine is manufactured in the state of the art, Intas SEZ facility in Ahmedabad, Gujarat which is spread over 35,565 square metres. The plant has dedicated manufacturing facilities for cytotoxic formulations (tablet, capsule, liquid injection, lyophilised injection, ointment) and other oral solids (tablets, capsules). This plant operates in compliance with global regulatory standards like US FDA, MHRA and ANVISA.