Alteogen Registers European Composition Patent for KEYTRUDA SC

[Financial News] Alteogen, a biotech platform company, has secured a composition patent related to the KEYTRUDA subcutaneous (SC) formulation in Europe, following the United States.
Alteogen said on the 23rd that the European Patent Office (EPO) had registered a composition patent for a subcutaneous formulation combining ALT-B4, based on its Hybrozyme platform, with KEYTRUDA. ALT-B4's active ingredient is vera-hyaluronidase alpha, while KEYTRUDA's active ingredient is pembrolizumab.
The European patent will remain in force until 2040. A supplementary protection certificate (SPC) may also be applied for, allowing the patent term to be extended by up to five years in consideration of the time required for drug approval.
Alteogen previously registered a composition patent related to the KEYTRUDA subcutaneous formulation in the United States. With the European registration, the company has expanded the foundation for composition patent protection for the KEYTRUDA SC product to both the United States and Europe.
KEYTRUDA SC containing ALT-B4 has been approved in the United States and Europe, as well as Canada, South Korea and Japan, with the number of approved markets continuing to grow.
Under a recent agreement with Merck Sharp & Dohme (MSD), Alteogen received $25 million, the first sales milestone payment out of a total of $1 billion. The company is expected to receive additional milestone payments and royalties based on future KEYTRUDA SC sales.
An Alteogen representative said, "Following the United States, we have secured a composition patent combining ALT-B4 and pembrolizumab in Europe as well. As commercialization of the Hybrozyme platform moves forward, we will continue securing relevant intellectual property rights, including substance, composition, manufacturing and fixed-dose combination patents, to support stable commercialization."

[email protected] Sang-hee Jeong Reporter