Merck is advancing the launch of a subcutaneous formulation of its blockbuster cancer drug, Keytruda (pembrolizumab), with expectations of approval and market availability in 2025. This strategic move aims to extend patent protection for Keytruda as the U.S. patent exclusivity for the intravenous form is set to expire in 2028.
Keytruda's Significance to Merck
Keytruda remains a pivotal asset in Merck's portfolio, generating $21.6 billion in revenue during the first nine months of 2024. This figure accounts for roughly 45% of Merck's total income. CEO Robert Davis emphasized the accelerated timeline for the subcutaneous formulation at the JPMorgan Healthcare Conference, highlighting its importance to the company's future.
Positive Phase 3 Trial Results
In November, Merck announced positive results from a Phase 3 trial comparing the subcutaneous Keytruda formulation to the intravenous version. The trial demonstrated that the subcutaneous formulation was effective, supporting its potential as an alternative administration route. The company plans to engage with global regulatory authorities to secure approvals for multiple cancer indications.
Strategic Implications
The introduction of a subcutaneous Keytruda formulation provides patients and healthcare providers with a potentially more convenient administration option. This formulation could help maintain Merck's market position as the intravenous patent nears expiration. The company is actively preparing for regulatory submissions and subsequent launches across various global markets.
