Generics to Novartis' leukemia drug Tasigna to reach poor countries under 4 MPP licenses

More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.

On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib).

The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories.

“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,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “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.”

It is the first sublicense agreement for a cancer drug under MPP, which made it name during the pandemic for similar deals around COVID drugs. It's also the first sublicence agreement to be executed after the Access to Oncology Medicines coalition was formed in May of last year, with Novartis joined by AstraZeneca, BeiGene, Bristol Myers Squibb, Gilead, Roche, Sanofi and Teva. Since then, major players such as Amgen, Eli Lilly, Merck, Pfizer and Thermo Fisher have signed on.

The effort is in response to the lack of cancer treatments in more remote and poverty-stricken nations. In 2020, the World Health Organization reported that 3.5 million new cancer cases were diagnosed in low- and middle-income countries annually, accounting for 2.3 million premature deaths. The toll is expected to escalate to 4 million deaths in the next 20 years.

“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 low- and middle-income countries,” Charles Gore, director of the MPP, said in the release.

Last year, Pfizer established its own initiative, dubbed "An Accord for a Healthier World," designed to get COVID-19 vaccines and oral antiviral treatment Paxlovid to poor countries. Early this year, the New York company expanded the program to provide drugs at cost to the world’s poorest countries from 23 patented medicines to its entire suite of approximately 500 products.  

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