Merck & Co., Inc. (MRK.US) accelerates: Subcutaneous injection Keytruda expected to be on the market by 2025, combating patent cliff with new strategies.

Merck & Co., Inc. (MRK.US) is preparing to launch a subcutaneous injection version of the cancer therapy pembrolizumab (Keytruda, aka K drug). The company's CEO, Robert Davis, said at the J.P. Morgan Healthcare Conference on Monday, "We are now expecting to submit, get approval and launch our subcutaneous version of Keytruda in 2025. This is actually new information and faster than we expected. So obviously, given the importance of the subcutaneous version of Keytruda, we are very excited about the continued progress we are seeing." It is reported that in November last year, Merck & Co., Inc. announced positive results from the pivotal Phase III MK-3475A-D77 study. The study evaluated the pharmacokinetics, efficacy, and safety of the subcutaneous injection MK-3475A of pembrolizumab compared to the intravenous injection Keytruda in combination with chemotherapy for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The results showed that subcutaneous administration can be completed quickly compared to intravenous injection, with similar efficacy and safety, potentially improving patient experience and drug accessibility. Marjorie Green, head of oncology clinical development at Merck & Co., Inc., said the subcutaneous version of Keytruda will take approximately 2-3 minutes to administer, "which could improve patients' experience and increase access for patients and healthcare providers compared to intravenous injection." Keytruda generates annual sales of up to $25 billion. However, with the expiration of patents in 2028, Merck & Co., Inc. faces significant market competition pressure. The introduction of the subcutaneous version of Keytruda is expected to be an important strategy after the patent expiration. The subcutaneous version of Keytruda contains the drug delivery compound berahyaluronidase alfa from the South Korean biotechnology company Alteogen, which is not expected to face competition in the short term, unlike the threat of generic versions for the intravenous version of Keytruda. In addition to the patent cliff, Merck & Co., Inc. is expected to face medical insurance price negotiations for the intravenous version of Keytruda in 2028. However, the subcutaneous version of Keytruda with new components may be exempt from the negotiation process, allowing the company to set pricing terms for a more convenient option.