Aurobindo Pharma arm signs voluntary license with Medicines Patent Pool to develop generic version of Nilotinib Capsules for chronic myeloid leukemia treatment in 44 countries

Hyderabad: Pharma major, Aurobindo Pharma Limited, has announced that its wholly-owned subsidiary company, Eugia Pharma Specialities Limited, has entered voluntary sub-licensing agreement with Medicines Patent Pool (MPP), to develop and market Nilotinib Capsules, originally developed by Novartis, for the treatment of chronic myeloid leukemia (CML) in 44 Low and Middle-Income Countries (LMIC), including the seven countries where patents on the product are pending or in force.

The product will be produced at the Eugia Pharma Specialities Ltd. Unit-I, Medchal, Malkajgiri District, Telangana, India. The company has adequate capacities of world class standards, to meet the global demand for the product across the licensed territory.

Nilotinib is indicated for the treatment of:

- Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,

- Adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available,

- Paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Mr. K. Nithyananda Reddy, Vice Chairman & Managing Director, Aurobindo said, “We are excited that Eugia has been granted the voluntary license from MPP to develop, manufacture & distribute generic Nilotinib Capsules in select markets. These are the first sublicence agreements that MPP has signed for a cancer treatment that will be made available in the LMIC, through this license. This product will be a good addition to Aurobindo’s Oncology portfolio and will further strengthen our leadership in the generic Oncology medicine space. We are looking forward to start supplying the product at the earliest and to help reducing the risk chronic myeloid leukemia (CML) in certain patients.

Charles Gore, Executive Director of the Medicines Patent Pool said, "We are delighted to be working with these four generic manufacturers to develop generic nilotinib and bring an affordable treatment option to people diagnosed with CML in these countries. At MPP, we are determined to show that voluntary licensing is a truly impactful way of delivering affordable treatments to tackle the ever-rising burden of cancer in LMICs."

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