BeiGene, Max Foundation team up to provide free Brukinsa to CLL patients in 29 low-income countries

It was only in January that BeiGene won an FDA approval for Brukinsa in the all-important chronic lymphocytic leukemia (CLL) indication, and the biotech has already struck a deal to make it available for free to patients in low-income countries.

Under a new deal signed with the health equity-focused Max Foundation, BeiGene and the foundation will provide Brukinsa free of charge to CLL patients in 29 low- and middle-income countries over the next three years, the partners said Wednesday.

The deal marks Max Foundation’s first with a biotech company and its first for a CLL treatment, Pat Garcia-Gonzalez, CEO of Max, said in an interview with Fierce Pharma. Before BeiGene, the Seattle-based foundation inked similar deals with Novartis, Bristol Myers Squibb, Pfizer, Takeda and Incyte on other cancer drugs. And Cepheid is a diagnostic partner to Max.

For its part, BeiGene prides itself as a global biotech company that’s developing oncology treatments that are “more accessible and affordable.”

“When I started BeiGene, my goal was to ensure more patients have access to critical medicines regardless of geography or socioeconomic status,” BeiGene CEO John Oyler said in a statement. “This collaboration with Max is a critical step in achieving this objective and emphasizes the necessity of high-impact partnerships to remove some of the obstacles that prevent patients’ access to treatment.”

In the next six months, the Max Foundation will focus on preparing treatment sites in its network and, over a longer period, educating and training doctors about CLL, Garcia-Gonzalez said.

“We always are saying that, in general, organizations and people in global health are doing things backwards,” Garcia-Gonzalez said. “If you want to strengthen health systems, first you need to make your drug available.”

Thanks to a lack of effective treatments, knowledge about CLL is limited in in many low-income countries. So the biggest hurdle to access is diagnosis, Garcia-Gonzalez said.

Based on the amount of time and effort needed to increase awareness and diagnosis, the foundation’s “educated estimate” is that it’ll find about 300 eligible patients over the next three years, Garcia-Gonzalez said.

To help fund Max’s operations, BeiGene will also offer a grant from the BeiGene Foundation. The company said it will explore potentially expanding the partnership beyond the initial three-year term. No matter what it eventually decides, patients who have received Brukinsa under this program will continue to receive the drug, a BeiGene spokesperson said.

“There are other companies in the CLL disease space,” Garcia-Gonzalez said. “Our hope is that other companies will join this humanitarian pact.”

Besides BeiGene’s Brukinsa, AbbVie and Johnson & Johnson market CLL drug Imbruvica, and AstraZeneca has Calquence. All three meds belong to the BTK inhibitor class.

As the first treatment option to reach the market, Imbruvica sales have lately started to decline—partly because of a less favorable safety profile compared with its two rivals.

Brukinsa won its first U.S. approval in 2019 as a treatment for mantle cell lymphoma and added CLL to its label in January. Analysts at SVB Securities have put the BeiGene drug’s peak sales estimate at $3.1 billion in CLL and $5.1 billion across all indications.

Founded in 1997, Max first teamed with Novartis to make the Swiss pharma’s chronic myeloid leukemia (CML) drug Gleevec available in poorer countries. In December, the parties expanded the partnership to include Novartis’ next-generation CML therapy Scemblix in 36 low- and middle-income countries. Takeda’s Iclusig, Pfizer’s Bosulif and Bristol Myers Squibb’s Sprycel are also part of Max's CML program.

Outside of that disease, the nonprofit group and Novartis recently launched a program for the latter’s breast cancer drug Kisqali. The foundation expects to treat the first patient with Kisqali in August.