Alteogen(196170) will receive the first milestone tied to sales of Merck (MSD)'s immuno-oncology drug "Keytruda" in a subcutaneous (SC) formulation.
Alteogen disclosed on the 31st that it is set to receive a $25 million milestone (about 34.4 billion won) from MSD tied to sales of Keytruda SC (brand name Keytruda Qlex) (Keytruda Qlex).
This milestone is the first achieved among the $1 billion in sales milestones included in the license agreement between Alteogen and MSD.
Sales of Keytruda SC are growing rapidly. According to MSD, since its launch in Oct. last year, Keytruda SC posted $40 million in revenue in the fourth quarter last year. Quarterly sales surged to $128 million in the first quarter this year and $463 million in the second quarter. First-half sales this year reached $590 million (about 812.1 billion won).
Keytruda is an immuno-oncology therapy targeting PD-1 and is used alone or with other treatments across more than 40 cancer indications. MSD is expanding efforts to convert the existing intravenous (IV) formulation to a subcutaneous injection by applying Alteogen's hyaluronidase-based SC reformulation technology "Hybrozyme (Hybrozyme)."
The expansion of the Keytruda SC market also appears to be influenced by streamlined insurance billing procedures in the United States. In the United States, a permanent J-code for Keytruda SC took effect in Apr.
For Alteogen, this milestone is meaningful in that it signals the start of securing revenue linked to actual product sales, beyond royalties incurred during development stages such as clinical trials and approvals.
It is also positive that Keytruda's applications are widening. MSD is expanding Keytruda's use beyond monotherapy to combination regimens with other treatments such as oral anticancer drugs and Antibody-Drug Conjugate (ADC), as well as perioperative therapy before and after surgery.
Alteogen currently has partnerships with nine global pharmaceutical companies, including MSD, Sanofi, AstraZeneca, GSK, Biogen, Daiichi Sankyo, Sandoz, and Intas, based on the Hybrozyme platform. It signed three new technology out-licensing deals this year alone.
Alteogen plans to support clinical development and commercialization by existing partners while pursuing additional technology out-licensing.