CML stands for Chronic Myeloid Leukaemia, a cancer of the blood and bone marrow. The condition is caused by a genetic mutation that leads to abnormal white blood cell growth. CML is a rare type of leukaemia, accounting for approximately 10% of all leukaemia cases. There is no cure for CML, and it is a cancer that requires ongoing management and support. It is important for patients with CML to work closely with their healthcare providers to develop a treatment plan that is tailored to their individual needs. Many people with CML can live long and healthy lives with the appropriate treatment and management.

Observed annually on 22 September, World Chronic Myeloid Leukemia (CML) Day raises awareness about this form of cancer and supports patients around the world.

Nilotinib

In October 2022, the Medicines Patent Pool signed the first-ever public health-oriented voluntary license agreement for a cancer medicine with Novartis. The licensed product, nilotinib, is a twice daily oral medication used to treat 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. The licence was signed under the auspices of the Access to Oncology Medicines (ATOM) Coalition, led by UICC and its partners. Seven months later, in June 2023, MPP signed sublicence agreements with four generic manufacturers. One of them is MPP’s long standing partner Hetero, who can, alongside the three other selected generic manufacturing partners, develop and produce generic versions of nilotinib in India and seven middle-income countries where it is still patented and supply it in the countries included in the licence, subject to local regulatory authorisation.

The MPP team visited Hetero’s facilities in Hyderabad, India and interviewed Bavesh Shah, Director of International Marketing and Director for Global Access at Hetero

Over the past decade, Hetero has demonstrated significant capital commitment towards advancements in oncology. Since 2010, we have proudly partnered with MPP, extending our reach to patients in over 130 nations and spanning a multitude of disease domains. A testament to our expertise in accessibility and robust infrastructure is Hetero’s pivotal role in facilitating access to nilotinib in low- and middle-income countries (LMICs). Our goal is to underscore our dedication to enhancing patient care in LMICs, encompassing not only HIV, tuberculosis, and hepatitis but also the critical field of oncology.

As we move forward, we recognise the unique set of challenges that licensing in cancer medicines presents, distinctly different from our licenses for treatments in hepatitis or HIV. Hetero remains unwavering in its commitment to disseminate these pioneering medicines to the most economically challenged nations. Our 36 sophisticated manufacturing facilities, producing APIs and finished dosage intermediates, are primed to cater to these intricate demands.

True access transcends mere medicinal availability to underserved communities. In the realm of  non-communicable diseases, access is an intricate tapestry woven from knowledge transfer, the establishment of apt health infrastructures, and beyond. The journey to render a single pill accessible to a patient in an LMIC involves multiple meticulous steps. To us, access represents a strategic investment as a generic partner. Our overarching aspiration is equitable access, and in this mission, the role of MPP has been transformative, enabling innovation to touch even the most impoverished. It’s an association we hold in the highest regard.