“Based on these newly announced Phase II data, we are preparing for a Phase III start before the end of this year.”

In context

“rkets as we grow our presence in the hemophilia market projected to reach nearly $10 billion by year 2030. Moving to our vaccine portfolio. We are enthusiastic about our potential to deliver the first approved vaccine for C. difficile infection. Our second-generation investigational vaccine candidate builds upon encouraging results from the prior Phase III CLOVER trial of our first-generation candidate. This trial demonstrated 100% efficacy against medically attended C. diff infection, despite not achieving the study's primary endpoint. With our second-generation C. diff vaccine formulation, we have the potential to simplify the dosing schedule from 3 to 2 weeks. This candidate now in Phase II increased the strength of the immune response fourfold compared to the first-generation vaccine. Based on these newly announced Phase II data, we are preparing for a Phase III start before the end of this year. We will incorporate learnings from the previous CLOVER study to develop new primary endpoints focused on the prevention of severe disease outcomes rather than primary infection. If approved, the vaccine could significantly reduce the health care burden of the nearly 500,000 annual C. diff infections and approximately 30,000 annual deaths in the U.S. alone. In another one of our phased programs, we finished dosing the last patient in our study of a vaccine candidate for Lyme disease. If successful, we expect to submit for approval next year. We also continue to strengthen our portfolio by harnessing external innovation through strategic business development. The recent closing of our global ex China in-licensing agreement with 3SBio grants has exclusive rights to develop, manufacture and c”