On December 1 2017, Sanofi Pasteur announced its intention to discontinue the Phase III development program for its Clostridium difficile vaccine. The vaccine was on track to become the first option available globally for the prevention of C. difficile, which GlobalData, a leading data and analytics company, estimated could reach peak annual sales of around $400M.
Sanofi’s decision to cancel the vaccines development program will be interesting news to Pfizer and Valneva, who both have their own vaccines in late-stage clinical development.
C. difficile infections (CDIs) affect the gastrointestinal tract, resulting in diarrhea and pseudomembranous colitis and in severe cases can even lead to death.
Sanofi’s C. difficile vaccine was set to be the first prophylactic option to be approved for the prevention of CDIs. But with the cancellation of Sanofi’s vaccine program, Pfizer’s C. difficile vaccine, PF-06425090, is now set to be the first prophylactic option for CDIs. PF-06425090 is currently being investigated in a 16,000 participant Phase III trial, which has a primary completion date of September 2020.
Thomas Moore, Healthcare Analyst at GlobalData, comments: “The majority of major global healthcare markets have seen a gradual increase in the incidence of CDIs over the last 20 years, increasing the burden of the disease, and driving a high need for prophylactic options to reduce the risk of infection in vulnerable patients. If the Phase III efficacy endpoints for PF-06425090 are met, GlobalData expects strong uptake for this product, driven by Pfizer’s previous experience manufacturing and distributing vaccines.”
The France-based firm Valneva also has a vaccine in clinical stage development for CDIs, known as VLA84. From a developmental standpoint, VLA84 sits behind Pfizer’s vaccine, but its contrasting MOA could give it an advantage when it comes to successfully meeting Phase III trial endpoints. Moore continues: “The size and experience of Valneva make it unlikely that the company could effectively market this product on its own, making its success heavily reliant on securing a licensing deal with big pharma.”
Key opinion leaders interviewed by GlobalData believed that a vaccine for CDIs would be well received by physicians due to the high levels of unmet need for products to lower the incidence of this infection. However, they did have some concerns over how easy it would be to identify appropriate patient groups to receive vaccination, and they did not envision a blanket vaccination program for all patients above a certain age. Moore adds: “Should they successfully complete Phase III trials this will be an important consideration for Pfizer or Valneva when it comes to positioning their vaccines and could be key to influencing how successful these products will be from a commercial standpoint.”