Agenus has signed $141m partnership agreements with Zydus Lifesciences and its subsidiaries to enhance clinical developments and advance manufacturing globally while expanding patient access to botensilimab and balstilimab (BOT/BAL).
The agreement includes an exchange of Agenus鈥� biologics chemistry, manufacturing and controls facilities in Emeryville and Berkeley in the US state of California for $75m upfront.
Agenus will receive up to an extra $50m in contingent payments obtained by production orders for BOT/BAL.
Zydus plans to launch a BioCDMO [contract development and manufacturing organisation] business using these facilities as its flagship US sites provide biologics contract manufacturing services to biopharmaceutical companies across the globe.
Agenus will be Zydus鈥� inaugural BioCDMO customer as a result of an exclusive manufacturing agreement for BOT/BAL. This ensures that the combination regimen鈥檚 biologics licence application (BLA) and launch readiness needs are met effectively.
Agenus will give Zydus an exclusive licence for the development and commercialisation of BOT and BAL in Sri Lanka and India.
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By GlobalDataThis move benefits Zydus鈥� established regional presence and infrastructure. In return, it will pay a 5% royalty to Agenus聽on net sales within those countries.
Zydus will also make an equity investment in Agenus through the purchase of 2.1 million common stock shares at $7.50 per share.
This $16m in gross proceeds will be used by Agenus for working capital purposes and for accelerating ongoing clinical development, registration and potential commercialisation related to BOT/BAL.
Agenus CEO Dr Garo Armen stated: 鈥淲ith a trade agreement between the US and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations.
鈥淭here is also a growing recognition by both countries of the need for the US to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the US.鈥�
By combining Agenus鈥� research capabilities with Zydus鈥� manufacturing strength globally, along with operational expertise, the partnership will help advancements in cancer immunotherapy in India and internationally.
