2022-06-14| ChinaLicensing

Organon Licenses Biosimilars From Shanghai’s Henlius For $103 Million

by Joy Lin
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Organon, a global women’s health company, is in-licensing two biosimilars referencing  (pertuzumab, HLX11) and Prolia/Xgeva (denosumab HLX14) from Shanghai-based Henlius Biotech in a deal estimated to be worth $103 million. 

Pertuzumab is used in combination with trastuzumab and chemotherapy to treat HER2+ breast cancer, which constitutes 20% of breast cancer cases in the US. Denosumab is used in the treatment of osteoporosis and for the prevention of damage to the skeleton in patients with multiple myeloma and in patients with bone metastasis. Osteoporosis is prevalent, affecting over 20% of women over the age of 50 globally. 


Significance of Biosimilar Drugs


Biosimilars are medicines that are highly similar to an approved biologic medicine, and have no clinical meaningful differences in safety, purity and potency compared to the reference biologic. Unlike generics which reference fairly simple small molecules, biosimilars reference biologics that are far more complex. 

Touted to offer patients more treatment options and reduce biologics-related healthcare costs, biosimilars are estimated to save the healthcare system $104 billion from 2020 to 2024, and is a key focus of Organon.

“With our experience in biosimilars and women’s health, our goal is to help more patients gain access to treatments for breast cancer and osteoporosis, two areas that significantly impact the health of women,” said Kevin Ali, CEO of Organon. 

Related article: The Next SuperStar Drug? AbbVie Places its Hope on Skyrizi and Rinvoq 


Terms of the Deal 


Under the agreement, Organon will pay Henlius an upfront payment of $73 million, and around $30 million in milestones expected to be achieved in 2022. In exchange, Organon will acquire exclusive global commercialization rights to HLX11 and HLX14, excluding China, Hong Kong, Macau, and Taiwan. Henlius will be responsible for the development of the candidates as well as their supply to Organon if approved. 

Additionally, Organon could opt to obtain a global commercialization license for a third candidate referencing Yervoy (ipilimumab, HLX13). Ipilimumab is used to treat unresectable or metastatic melanoma, as adjuvant treatment in cutaneous melanoma, and certain cancers such as renal cell carcinoma and colorectal cancer. 


Merck Spinoff Focusing on Women’s Health and Biosimilars


Organon spun off from Merck in June 2021 to focus on women’s health and biosimilars. Based in Jersey City, New Jersey, the company has amassed a portfolio of more than 60 therapeutic products. 

Organon’s modus operandi involves partnering with R&D-focused entities to bring their products to the market. The company’s core business includes contraceptives and fertility products for women, as well as the biosimilars from Merck’s former portfolio. 

Biosimilars marketed by Organon include those referencing Renflexis (infliximab), Brenzys (etanercept), Aybintio (bevacizumab), Ontruzant (trastuzumab), and Hadlima (adalimumab) in collaboration with Korea’s Samsung Bioepis, another giant in the biosimilars business. 

Organon’s other products include dermatology, pain, respiratory, and cardiovascular treatments.

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