Alteogen has announced on Thursday that it has secured a U.S. patent for a subcutaneous injection formulation combining ALT-B4 (verahyaluronidase alpha) and Keytruda (pembrolizumab), based on its Hybrozyme platform.
This patent will protect the subcutaneous Keytruda formulation using ALT-B4 in the U.S. until early 2043, granting approximately 17 years of exclusivity.
Keytruda Curex, approved by the U.S. Food and Drug Administration (FDA) last September, is now available in the U.S. market. Alteogen stands to earn up to 1 billion USD in sales milestones based on annual and cumulative revenue figures, followed by royalties on sales after reaching these milestones.
Alteogen views this patent as a reaffirmation of ALT-B4’s novelty and independent invention by the U.S. Patent Office, despite previous intellectual property challenges.
This latest patent is part of Alteogen’s strategic efforts to build a comprehensive portfolio protecting its Hybrozyme platform.
The company stated that, alongside the ALT-B4 substance patent registered in the U.S. last year, it continues to expand its patent portfolio. This expansion aims to provide partners and potential collaborators with a robust patent foundation for developing competitive therapies.
Alteogen’s Chief Executive Officer (CEO), Jeon Tae-yeon, emphasized the significance of securing intellectual property protection for the combination of their proprietary hyaluronidase ALT-B4 with pembrolizumab. He added that this patent would reinforce the market exclusivity of Keytruda Curex, the first product leveraging the Hybrozyme technology.