Alteogen's 'ALT-B4' Manufacturing Method, US Patent Registration Approved

Alteogen announced on the 20th that a U.S. patent for the manufacturing method of hyaluronidase ALT-B4 has been granted.

Alteogen exterior view [Photo by Alteogen]

Alteogen's ALT-B4 is a hyaluronidase technology developed using proprietary Hybrozyme technology. Hyaluronidase is mainly used not only as a standalone agent but also to convert existing antibody therapeutics administered intravenously into subcutaneous injection formulations. Alteogen has already signed technology licensing agreements with three global companies aiming to develop subcutaneous injection formulation therapeutics using ALT-B4. In particular, MSD's Keytruda, which was changed to an exclusive contract last February, is currently undergoing global Phase 3 clinical trials for approval of the subcutaneous injection formulation. Additionally, for the standalone use market, Alteogen developed Tergase and received approval from the Ministry of Food and Drug Safety this year.

The patent granted this time pertains to the invention of a culturing method for hyaluronidase and is a special manufacturing method patent aimed at increasing the productivity of ALT-B4. With this patent registration, recognition from the U.S. Patent and Trademark Office has been obtained, allowing protection of intellectual property rights. It is also expected to greatly aid the future market entry of Tergase, which uses ALT-B4 produced under this patent, as a standalone product.

An Alteogen representative stated, “ALT-B4 has superior manufacturing yield compared to existing recombinant hyaluronidase, making it economical and stable,” adding, “The patent registration for the production method of this substance will serve as an effective intellectual property right, enabling various therapeutics using ALT-B4 to enter and be protected in the United States, the world's largest pharmaceutical market.”