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Sanofi Discontinues Clostridium Difficile Candidate in Blow to Vaccine Unit

Setback follows announcement of adverse patient outcomes with dengue vaccine

French drug-maker Sanofi will shut down further development of its Clostridium difficile vaccine following a review by an independent data-monitoring committee that found the study unlikely to meet its primary goal, according to a BioPharma Dive report. The trial, known as Cdiffense, tested Sanofi’s experimental toxoid vaccine in older patients who are at higher risk of infection from the bacteria.

In its short release announcing the setback, the company said it would focus resources on six “key vaccine projects.” Sanofi lists three other vaccines currently in phase 3 in its pipeline, including a quadrivalent flu vaccine and a conjugate meningococcal vaccine.

Sanofi’s announcement late on December 1 that it would shutter its C. difficile vaccine program closed a damaging week for the company. On November 29, the company disclosed that it would ask global health regulators to restrict use of its much-touted dengue vaccine to only people who have previously been infected by the virus. An analysis of long-term clinical data had revealed that, in individuals who had never contracted dengue, the vaccine could make subsequent infections more severe.

It was a damaging admission from the company, which had secured approval of the shot in 19 countries—several of which had run public immunization drives. One such country, the Philippines, announced it would launch an investigation into the purchase of Sanofi’s vaccine, and its Department of Health has put the vaccination program on hold. As a result of that investigation, the country announced on December 5 that it has asked Sanofi to stop sale, distribution, and marketing of the vaccine, effectively withdrawing it from the market.

Shuttering of the Cdiffense program marks a second setback for the company’s vaccines unit—albeit amid generally strong revenue growth, particularly in Europe.

According to the government website clinicaltrials.gov, Cdiffense targeted enrollment of more than 16,000 people and was scheduled to read out in October 2019.

Unlike some of its peers in the industries, Sanofi has been investing more resources into vaccine development. Last month, the company announced that it would spend $200 million to expand a manufacturing facility in France to better support production demand for flu vaccines. And earlier this year, Sanofi bought the Connecticut vaccine-maker Protein Sciences for $650 million upfront.

Source: BioPharma Dive; December 5, 2017.

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