Alteogen announced that MSD’s subcutaneous (SC) formulation of Keytruda, marketed in Japan under the name Keyject, has received approval for manufacturing and marketing in Japan. The formulation incorporates ALT-B4 (berahyaluronidase alfa), the key ingredient in Alteogen’s Hybrozyme platform.
Hybrozyme is Alteogen’s platform technology designed to convert biologic drugs administered intravenously (IV) into subcutaneous formulations. Its key ingredient, ALT-B4, is a recombinant human hyaluronidase that temporarily breaks down hyaluronic acid beneath the skin, helping drugs spread and be absorbed more efficiently within subcutaneous tissue.
The newly approved Keyject is a combination product containing MSD’s immuno-oncology drug Keytruda (pembrolizumab) and Alteogen’s berahyaluronidase alfa. It was developed to enable Keytruda, which has traditionally been administered intravenously, to be delivered through subcutaneous injection.
Keytruda has been available in Japan since 2017 and is used to treat a variety of cancers. While the existing intravenous formulation takes about 30 minutes to administer, the subcutaneous formulation can be administered in approximately one to two minutes, potentially reducing the treatment burden for both patients and healthcare professionals.
The Japanese approval is significant because it expands the global commercial markets for ALT-B4-enabled Keytruda SC following approvals in the United States, Europe, and Canada.
In August, Alteogen disclosed that it would receive a $25 million first sales milestone from MSD based on sales of subcutaneous Keytruda. This represents the first milestone achieved under the companies’ licensing agreement, which includes up to $1 billion in sales milestones tied to Keytruda SC.
An Alteogen representative said, “With the approval of the ALT-B4-enabled Keytruda SC formulation in Japan, we have established a foundation for further expansion of the global transition to SC formulations. As products incorporating ALT-B4 are commercialized in major markets, the technological capabilities and commercial value of the Hybrozyme platform continue to be demonstrated.”