The Medicines Patent Pool (MPP) signs licence agreement to increase access to nilotinib for the treatment of chronic myeloid leukaemia

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This is the first ever public health-oriented voluntary licence agreement on a cancer medicine

GENEVA, Oct. 20, 2022 /PRNewswire/ -- On the side lines of the World Cancer Congress, the Medicines Patent Pool (MPP) today announced the signing of a voluntary licensing agreement with Novartis AG to increase access to nilotinib, a twice daily oral medication used to treat chronic myeloid leukaemia (CML), part of the World Health Organization Model List of Essential Medicines (WHO EML) for treatment in adults and children of at least one year of age.

Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of nilotinib in the licensed territory, subject to local regulatory authorisation. In particular, the licence includes seven middle-income countries, namely Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines and Tunisia, where patents on the product are pending or in force.

This is the first licence that MPP has signed for a cancer treatment, and the first time a company is licensing a patented cancer medicine through a public health-oriented voluntary licensing mechanism.

While there has been tremendous progress in new technologies to treat cancer, major challenges persist in many low- and middle-income countries (LMICs) that face inequity in access to new-generation cancer medicines which could allow patients to live better and longer. Advances in treatment, such as nilotinib, have contributed to a greatly improved prognosis for people diagnosed with CML.

Charles Gore, MPP Executive Director, said, "Access to high-quality cancer medicines is a crucial component of the global health response to the cancer burden, therefore I am delighted to be signing our first licence agreement with Novartis for a much-needed cancer treatment in LMICs. Although the remaining patent life is relatively short, this voluntary licence in the non-communicable disease space sets a vital precedent that I hope other companies will follow."

Lutz Hegemann, President of Global Health and Sustainability, Novartis said, "We're proud to be pioneering this new licensing model with MPP in collaboration with the ATOM Coalition, but we know too that making a medicine available is only one part of the challenge to increase access to cancer treatments. For generic versions of this medicine to reach those who need it, wherever they live, the right diagnostics and quality of care will be critical. That's why we've helped to build the new Access to Oncology Medicines (ATOM) Coalition, and we will be relying on the support of our partners from research, non-profits and the private sector to help deliver on the promise of this initiative."

Zeba Aziz, Medical Oncologist at Hameed Latif Hospital, Lahore, Pakistan, and member of MPP's Expert Advisory Group said "Nilotinib is a second-generation tyrosine kinase inhibitor that offers a great alternative to people who are resistant or intolerant to imatinib, the first-line treatment, that is at least 20% of cases. I am glad more people in LMICs will have access to this essential cancer medicine."

Benedikt Huttner, Secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines, said "Cancer medicines constitute a large proportion of medicines recommended by WHO on the Model Lists of Essential Medicines. Nilotinib is an essential cancer medicine for adults and children with imatinib-resistant CML. We welcome this licence agreement, the first for cancer medicines. We hope this marks the start of a paradigm shift with more pharmaceutical companies following suit with licence agreements for essential patented cancer medicines to help ensure that patients globally can benefit."

In May 2022 Novartis and MPP^[1] joined the Access to Oncology Medicines (ATOM) Coalition . It is a new global initiative led by the Union for International Cancer Control (UICC) and its partners to improve access to essential cancer medicines in low- and lower-middle income countries, and to increase the capacity for diagnosing cancer and for the proper handling and supply monitoring of these medicines. Through MPP, the Coalition facilitates affordable access to cancer treatments through non-exclusive licences to generic manufacturers for selected products and countries.

Nilotinib was added to the WHO EML and EMLc respectively in 2017 and 2019 as second-line therapy for the treatment of chronic myeloid leukaemia that is resistant to imatinib.

MPP was founded by Unitaid, which continues to be MPP's main funder. MPP's work on access to NCDs is equally funded by Unitaid and the Swiss Agency for Development and Cooperation (SDC).

Access the licence agreement

The press release is also available in French and Spanish (translations by MPP).

MPP invites Expressions of Interest (EoI) from potential sublicensees for sublicences to manufacture and sell nilotinib in the licensed territory:

• Access the EoI portal
• More information about the EoI process

Deadline for applying: 18 December 2022, 11.59pm CET

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, and SDC. More information at https://medicinespatentpool.org/ and follow us on Twitter, LinkedIn and YouTube.

^[1] MPP participates in the ATOM Coalition as an observer

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