Alteogen (196170) said Sept. 23 that the European Patent Office (EPO) has granted a composition patent covering a subcutaneous formulation combining ALT-B4 (berahyaluronidase alfa), based on its Hybrozyme platform, with Keytruda (pembrolizumab).
Hybrozyme is Alteogen’s platform technology that enables biologic drugs administered intravenously (IV) to be converted into subcutaneous (SC) formulations. Its key component, ALT-B4, temporarily breaks down hyaluronic acid, helping high doses of drugs be absorbed through subcutaneous tissue.
The European composition patent is valid through 2040 and can be extended through a supplementary protection certificate (SPC). An SPC provides up to five additional years of patent protection to account for time spent obtaining regulatory approval for a drug.
Alteogen previously secured a composition patent in the U.S. related to the subcutaneous formulation of Keytruda. With the European patent, the company has expanded the intellectual property protection for its Keytruda SC™ product-related composition patents to both the U.S. and Europe.
Keytruda SC, which uses ALT-B4, has received regulatory approvals in the U.S., Europe, Canada, South Korea and Japan, among other markets, and continues to expand its approved markets. Alteogen recently received the first $25 million milestone payment out of a total $1 billion in sales milestones under its agreement with MSD, with additional milestones and royalties to be received based on future sales.
An Alteogen official said, “Following the U.S., we have now secured a composition patent combining ALT-B4 and pembrolizumab in Europe as well. As commercialization of the Hybrozyme platform technology progresses, we will continue securing related intellectual property to build a comprehensive portfolio and support stable commercialization.”