Four manufacturers sign sublicence agreements with the Medicines Patent Pool to produce generic versions of nilotinib for the treatment of chronic myeloid leukaemia
22 June 2023
Geneva – The Medicines Patent Pool (MPP) announced today that it has signed sublicence agreements with three India-based companies, Eugia, Hetero and Dr. Reddy’s Laboratories, along with Indonesian-based company BrightGene to manufacture generic versions of Novartis’ cancer treatment nilotinib that is used for the treatment of chronic myeloid leukaemia (CML). These are the first sublicence agreements that MPP has signed for a cancer treatment and are the result of a licence agreement signed between MPP and Novartis Pharma AG in October 2022 for their patented cancer medicine.
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. The licence includes the opportunity to develop and supply generic version 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 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.
Charles Gore, Executive Director, MPP, 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.”
Lutz Hegemann, President of Global Health and Sustainability, Novartis, 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. 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.”
Dr Dan Milner, Executive Director, ATOM Coalition, said: “The surge in cancer-related mortality rates around the world, particularly in LMICs, fuels our determination to work collectively to strengthen access to affordable, high-quality cancer medicines in these regions. Today’s announcement underscores the critical role of joint efforts with generic manufacturers to broaden the reach of life-saving cancer medicines and to bring them into the hands of more people when they need them.”
Andrian Rakhmatsyah, Indonesian CML survivor and Civil Society representative, said: “Access to affordable medicine is not only a matter of economic fairness; it is also a fundamental right that guarantees the health and happiness of humanity. I welcome this announcement as reliable supply of quality-assured nilotinib is a part of the right to health. Let us unite our efforts to support and encourage the development of generic and original medicines; as long as their safety and efficacy have been made clear, everyone must have access to healthcare.”
Bahija Gouimi, President and founder of AMAL Association, CML Patient and Parent Group in Morocco, said: “For people in Morocco, this brings fresh hope for treatment of CML. With ever-increasing cancer diagnoses, access to affordable cancer treatment is more important than ever. Our countries need to have quality generic versions of treatments and we will advocate for this with government, so treatments are procured for the people who need them.”
About the Medicines Patent Pool
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 18 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, three oral antiviral treatments for COVID-19 and 12 COVID-19 technologies. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation and SDC. More information at https://medicinespatentpool.org/ and follow us on Twitter, LinkedIn and YouTube.
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