Four manufacturers sign sub-licence agreements with MPP to produce generic versions of Nilotinib for the treatment of chronic myeloid leukaemia

In a move that would make certain cancer drugs more accessible and cheaper for patients, the Medicines Patent Pool (MPP) signed sub-licence agreements with three India-based companies, Eugia, Hetero and Dr. Reddy’s Laboratories, along with Indonesian firm BrightGene to manufacture generic versions of Novartis’ cancer treatment drug Nilotinib. The drug is used for the treatment of chronic myeloid leukaemia (CML), a type of blood-cell cancer. 

These are the first sub-licence agreements that MPP has signed for a cancer treatment drug and are the result of a licence agreement signed between MPP and Novartis Pharma AG in October 2022 for their patented cancer medicine. Nilotinib is sold under the brand name Tasigna and marketed worldwide by Novartis. 

According to information released by MPP, a United Nations-backed group working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries (LMICs), the selected 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. 

The licence includes the opportunity to develop and supply generic versions of Nilotinib in seven middle-income countries, namely 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 LMICs and premature deaths from cancer in these countries will rise from 2.3 million to 4 million in the next 20 years.

Charles Gore, executive director, MPP, said that they have worked with the four generic manufacturers to develop generic Nilotinib and bring an affordable treatment option to people diagnosed with CML in the selected countries. “Voluntary licensing is a truly impactful way of delivering affordable treatments to tackle the ever-rising burden of cancer in LMICs,” he said.

Lutz Hegemann, president of Global Health and Sustainability, Novartis, added that great gains have been seen 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. Today’s announcement marks the next important step we are taking with our partner MPP as part of our commitment to the Access to Oncology Medicines (ATOM) Coalition,” he said.

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