Organon inks $103M deal for pertuzumab and denosumab biosimilars
Organon is looking to boost its biosimilar portfolio with two well-known brand copies in development by Shanghai-based Henlius Biotech.
The women’s health pharma is paying $73 million upfront, plus up to $30 million in 2022 milestone payments, for the pertuzumab biosimilar to Roche’s Genentech’s breast cancer drug Perjeta and the denosumab biosimilar to Amgen’s Prolia for osteoporosis and Xgeva for bone problem prevention in cancer.
The deal also includes an option to negotiate for exclusive Yervoy biosimilar rights. Yervoy, or ipilimumab, is Bristol Myers Squibb’s CTLA-4 targeted cancer med which it most often markets as an adjuvant in combination with its PD-1 inhibitor Opdivo and chemotherapy. The Opdivo plus Yervoy combination is approved in several different therapy areas including certain types of non-small cell lung and colorectal cancers.
Organon CEO Kevin Ali said in a statement, “Biosimilars are a key growth pillar for Organon, and this collaboration represents the successful execution of our strategy to expand our biosimilars portfolio leveraging our strong global footprint and deep commercial expertise.”
Still, it may be some time away before that happens — both Henlius biosimilars are still in early-stage development. Pertuzumab is further along with Phase I successful endpoints and recently begun Phase III and the first subject was dosed in April, according to Henlius’ press release. Henlius is testing denosumab with a clinical trial listed, which began in April with results expected in 2024.
Organon said in an email to Endpoints News that the plan is aiming for approval in seven markets — US, Canada, UK, Germany, France, Italy and Spain — with “mid-2020s” market launches expected for both biosimilars.
A 2022 Cardinal Health report on biosimilars estimates a first Prolia/Xgeva biosimilar on the market in 2025 the same year its patent exclusivity ends in the US. Several others including Samsung Bioepis are pursuing the potentially lucrative bone treatment. Amgen reported $873 million in global sales for Prolia and $545 million for Xgeva in 2021.
Perjeta is set to lose market exclusivity in the US in 2024. Roche reported sales of 4 billion francs ($4 billion) for 2021.
Organon, which spun out of Merck last year, repeated its first-quarter change in regards to the Henlius deal that it “will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements.” This means the potential $103 million deal is not included in its 2022 guidance.