Following the news that Merck & Co. (Merck) has agreed to acquire Cidara Therapeutics (Cidara) for $9.2 billion;
Fiona Chisholm, Associate Director of Infectious Diseases at GlobalData, a leading data and analytics company, offers her view:
“The acquisition strengthens and diversifies Merck’s infectious disease portfolio, a strategic move that aligns with the company’s goals to offset huge revenue losses due to the impending patent expiry of its multi-blockbuster drug Keytruda and other products.
“Merck will pay $221.50 per share in cash for the US-based biotech, a premium of over 108% from its last closing price, which testifies to the company’s confidence in Cidara’s pipeline, particularly its lead asset, CD388. This potentially first-in-class, long-acting strain-agnostic antiviral is designed to prevent seasonal and pandemic influenza infection in individuals at higher risk of influenza complications and is expected to provide season-long protection. It consists of a small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody.
“Influenza remains a prominent global health threat, causing widespread morbidity and mortality each year. The number of influenza-related hospitalizations is expected to exceed 697,000 in 2025 across seven major markets (7MM*), according to projections by GlobalData epidemiologists. Older adults and immunocompromised individuals are particularly at risk of the most severe consequences of influenza including death.
“The large health burden of influenza reflects limitations in current prophylactics. Influenza vaccines are updated annually to provide the best protection against circulating strains. However, the extent to which the chosen vaccine composition matches circulating strains of influenza varies season to season, which can result in suboptimal efficacy. Vaccination rates are also often low and vary by country. Across the 7MM, vaccination rates typically range from around 16% in Germany to around 48% in the US, according to GlobalData.
“If successful, CD388 has potential to address key unmet needs within influenza prophylaxis. As CD388 is strain-agnostic it is expected to provide durable, universal coverage for all influenza A and B strains, eliminating the potential for mismatch that is often observed between vaccines and circulating strains. Additionally, CD388’s activity is not dependent on the immune response. This makes it a particularly desirable option for those who have a weakened immune response to vaccines, including immunocompromised individuals and the elderly, as well as those for whom vaccines are contraindicated.
“CD388 has been granted breakthrough therapy designation and fast-track designation by the FDA and is currently undergoing evaluation in the Phase III ANCHOR trial. Additionally, the Phase IIb NAVIGATE study met all primary and secondary endpoints associated with preventing symptomatic laboratory-confirmed influenza in healthy unvaccinated adults ages 18-64.
“With its robust efficacy profile, and potential to address unmet needs for key high-risk groups, CD388 could attain blockbuster status, if approved.
“The move by Merck to snap up CD388 also reflects a wider R&D trend towards investment in universal or strain-agnostic influenza prophylactics. Aside from CD388, other notable candidates within the pipeline include CR-9114, a monoclonal antibody currently in Phase II development by Leyden Laboratories, as well as universal influenza vaccines such as OVX-836, currently in Phase II development by Osivax, and FluMos-v2, currently in Phase I development by the National Institute of Allergy and Infectious Diseases.”
*7MM: the US, France, Germany, Italy, Spain, the UK, and Japan
