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1 November 2022Generics

Pharma firm voluntarily licences cancer drug in novel deal

Agreement is 'first ever' public health focused voluntary licensing deal on a cancer medicine| Opportunities for selected generic manufacturers

N ovartis has signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) to increase access to its cancer drug nilotinib, a twice daily oral medication used to treat chronic myeloid leukaemia (CML).

This marks the first ever public health-focused voluntary licence agreement on a cancer medicine and is also the first licence that MPP has signed for a cancer treatment, according to the  statement released by the MPP on October 20.

As a result of this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply 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.

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, the MPP said.

In May 2022 Novartis and MPP joined the Access to Oncology Medicines (ATOM) Coalition, a global initiative led by the Union for International Cancer Control (UICC) 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.

Advances in treatment, such as nilotinib, have contributed to a greatly improved prognosis for people diagnosed with CML.

Lutz Hegemann, president of global health and sustainability at 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, nonprofits and the private sector to help deliver on the promise of this initiative.”

Charles Gore, MPP executive director, said that the deal set a vital precedent.

“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,” he said.

“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.”

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