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Rendering of Alteogen’s headquarters and research center. / Courtesy of Alteogen

Following the U.S., Alteogen has secured a composition-of-matter patent related to the subcutaneous (SC) formulation of Keytruda in Europe as well. By establishing a foundation for patent protection through 2040, the company is broadening the intellectual property defense network for its Hybrozyme platform across the global market.

Alteogen announced on the 23rd that it has registered a composition patent with the European Patent Office (EPO) for an SC formulation combining its Hybrozyme platform-based ALT-B4 with Keytruda (active ingredient: pembrolizumab).

The European composition patent will remain valid until 2040, and the protection period can be extended by up to five years under a Supplementary Protection Certificate (SPC). An SPC is a system that provides additional patent protection in consideration of the time required to obtain pharmaceutical regulatory approval.

Alteogen previously registered a co-formulation patent related to the subcutaneous formulation of Keytruda in the U.S. as well. With this European patent registration, the company has expanded its intellectual property protection coverage for Keytruda SC from the U.S. into Europe.

Keytruda SC, which incorporates ALT-B4, has been expanding its list of approved regions, obtaining regulatory clearance in countries including the U.S., Europe, Canada, South Korea, and Japan. Under its recent agreement with MSD, Alteogen received 25 million dollars (approximately 33.9 billion won), the first tranche of sales milestones totaling up to 1 billion dollars. The company is also set to receive additional milestones and royalties based on future sales performance.

An official from Alteogen said, "Following the U.S., we have now secured a composition patent combining ALT-B4 and pembrolizumab in Europe as well. In line with the commercialization of our Hybrozyme platform technology, we will continue to secure patents covering substances, compositions, manufacturing processes, and fixed-dose combinations, thereby bolstering our intellectual property portfolio to support stable commercialization."

                                                                                                           Kang Hye-won