Panacea Biotec inks tripartite agreement for Azacitidine injection in US market

Panacea Biotec Ltd. announced that it has entered into a tripartite agreement with Natco Pharma Ltd. and Breckenridge Pharmaceutical Inc. for the manufacture and supply of Azacitidine injection for the US market under Breckenridge's already-Approved New Drugs Application (ANDA).

Azacitidine is a generic equivalent of Vidaza. It is a chemotherapy drug used to treat conditions that affect the blood and the bone marrow, called myelodysplastic syndromes (MDS). It is used when treatment with a stem cell transplant is not suitable. The annual sales of the drug is about US$140 million, as reported by IMS, MAT, Dec 2017.

Natco has provided the technology for Azacitidine to Panacea Biotec, which will manufacture and supply the product to Breckenridge in the US to market, sell and distribute.

The technology has been provided to Panacea Biotec's facility located at Baddi, Himachal Pradesh, India. The application (prior approval supplement) for qualifying Panacea Biotec's site has been filed with the US FDA and approval is expected in due course of time.

This collaboration will enable the company to grow its revenues and will also ensure increased capacity utilization of its oncology plant at Baddi.