Nanoform Finland Plc announced the initiation of pivotal relative bioequivalence studies for Nanoenzalutamide, a nanocrystalline-enabled enzalutamide tablet formulation positioned as a potential alternative to XTANDI (enzalutamide), the leading prescribed androgen receptor inhibitor for prostate cancer treatment.
Study Design and Objectives
The bioequivalence studies are being conducted in both fed and fasted healthy volunteers across U.S. and European populations. The primary objective is to demonstrate bioequivalence between a single nanoformed 160 mg tablet dose and four XTANDI 40 mg film-coated tablets. The clinical results are intended to support product launch following the expiry of the enzalutamide substance patent in respective territories.
Addressing Patient Needs
The nanoenzalutamide tablet formulation was developed through a partnership with the ONConcept Consortium, comprising Bluepharma, Helm, and Welding. The development addresses well-documented challenges faced by prostate cancer patients, including tablet-burden and dysphagia. The nanoformed once-per-day regimen may offer advantages for patients requiring reduced daily pill burden.
"We commenced this bioequivalence study as planned and our commercialization partners are excited about our CESS technology, the IP advantages, the patient, sustainability & cost benefits and hence see significant commercial value in Nanoform's technologies," stated Prof. Edward Haeggström, CEO of Nanoform.
Commercial Strategy and Market Potential
Nanoform has secured its first license and supply agreement (LSA) for Germany, with additional LSAs anticipated for key markets including the United States, Japan, and France in the coming months. The total commercial value of the Nanoenzalutamide project is projected to exceed EUR 10 million in potential development milestones leading to launch, plus EUR 25 million in potential commercial milestones and significant profit sharing arrangements post-launch.
Technology Platform Advancement
The company continues to advance its broader pipeline of small and large molecule product kernels and customer projects toward clinical development. The Nanoenzalutamide program represents a key application of Nanoform's CESS technology platform in addressing formulation challenges for established oncology therapeutics.
