Azactidine has been approved by the USFDA and is manufactured in a Intas SEZ facility
Intas Pharmaceuticals has become the first Indian company to indigenously develop an Azacitidine molecule. Intas’s Azadine will benefit millions of Indians suffering from MDS (Myelodysplastic Syndrome) and AML (Acute Myelogenous Leukemia) types of cancer as the treatment cost has been drastically brought down to a fifth of its imported variant (which is currently in use).
“It is estimated that 4-5 people per 100,000 suffer from MDS/AML. Data 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. With the launch of Azadine, we further reinforce our commitment towards making quality healthcare affordable and accessible to maximum number of Indians,” said Dr Vijayesh Gupta, head, Marketing and Sales, Intas Pharmaceuticals, India.
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. Advanced stages of MDS may lead to AML. Azacitidine (effective molecule in Azadine) is the only drug which has been shown to prolong overall survival duration and time for the transformation into AML, increase response rate, reduce transfusion burden and improve quality of life. There is no need for the patient to get admitted to a hospital, due to subcutaneous administration of the drug, which is an OPD procedure. As there is little impact on lifestyle and fewer hospital visits, this drug ensures higher patient compliance. 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 15-18 lakhs. The cost of other treatment options which range from conventional agents to transplant, may cost anywhere between Rs 2-15 lakhs. With an objective to make it accessible to most of the needy patients, Azadine has been priced at 20 percent of the imported brand. Azacitidine molecule 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 in tumourous cell death.
Azacitidine has been approved by the US FDA since May 2004. Azadine is manufactured in the state of the art, Intas SEZ facility in Ahmadabad, Gujarat which is spread over 35,565 sq. mts. The plant has dedicated manufacturing facilities for cytotoxic formulations (Tablet, Capsule, Liquid Injection, Lyophilized Injection, and Ointment) and Other Oral Solids. This plant operates in compliance with global regulatory standards like USFDA, MHRA and ANVISA.