In a move that would improve access and affordability, the Medicines Patent Pool (MPP) has signed sublicence agreements with four companies, including three from India, to manufacture generic versions of Novartis’ cancer treatment nilotinib, used to treat chronic myeloid leukaemia (CML).

The companies are Eugia, Hetero and Dr Reddy’s Laboratories, besides Indonesia-based BrightGene.

These are the first sublicence agreements that MPP has signed for a cancer treatment and are the result of a licence agreement between MPP and Novartis Pharma AG in October 2022 for their patented cancer medicine.

Generic versions

The selected generic manufacturers can manufacture generic versions of nilotinib in India and seven middle-income countries and supply it in 44 territories included in the licence through a non-exclusive licence agreement, subject to local regulatory authorisation, an MPP note said.

The licence includes the opportunity to develop and supply generic version of nilotinib in Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines and Tunisia, where patents on the product are pending or in force.

In 2020, the World Health Organization reported that more than 3.5 million new cancer cases were diagnosed in low- middle-income countries (LMICs), and premature deaths from cancer in these countries will rise from 2.3 million to 4 million in the next twenty years.

Expanding access

Charles Gore, MPP Executive Director said that working  working with four generic manufacturers to develop generic nilotinib, would help bring an affordable treatment option to people diagnosed with CML in these countries.

Lutz Hegemann, Novartis President of Global Health and Sustainability, said, “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone, leaving a risk of cancer becoming a disease that disproportionately kills the poor. Through ‘public-private partnerships’, we aim to address barriers to healthcare and expand access to innovative treatment solutions for the long-term for as many people as possible—regardless of location or socio-economic situation.”

The latest announcement is an important step in its commitment to the Access to Oncology Medicines (ATOM) Coalition, the official added.

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