Sanofi and Shire Lead Pipeline News
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Sanofi and Shire.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, November 29, 2017 to Tuesday, December 5, 2017.
Sanofi Ends Development of Clostridium Difficile Vaccine
Sanofi has decided to discontinue clinical development of its experimental clostridium difficile vaccine to focus on six key vaccine projects currently in development.
Sanofi said that it concluded a Phase III clinical trial program showed that the probability of the vaccine meeting its primary objective is low. The trial was designed to test the efficacy and safety of a candidate toxoid vaccine in a subpopulation at risk of clostridium difficile infection.
Sanofi Pasteur, the vaccines business of Sanofi responsible for the program, is informing all investigators, regulatory authorities, and trial ethics committees. In addition, investigators are notifying study volunteers of the decision to stop the program. Data from all vaccinated volunteers in this trial will continue to be analyzed for more information and shared with the scientific community.
FDA Grants Shire’s Ulcerative Colitis Drug Orphan Drug Designation
The US Food and Drug Administration (FDA) has granted orphan drug designation to Shire’s investigational anti-MAdCAM-1 antibody, SHP647, for treating pediatric patients with moderately-to-severely active ulcerative colitis.
SHP647 is a fully human IgG2 monoclonal antibody targeting the mucosal addressin cell adhesion molecule-1 (MAdCAM-1).
Shire licensed SHP647 from Pfizer in June 2016, adding to Shire’s gastrointestinal (GI) portfolio. Shire says MAdCAM-1 plays a role in leukocyte trafficking in the GI tract and also appears to facilitate excessive lymphocyte infiltration under conditions of chronic GI inflammation.