Dive Brief:
- The vaccine division of French drugmaker Sanofi SA, Sanofi Pasteur Inc., announced it will invest €350 million (approximately $432.4 million) to build a new vaccine manufacturing facility at the Sanofi Pasteur Canadian headquarters in Toronto, Ontario.
- The site will address the increased demand for five-component acellular pertussis (5-acP) antigen, and by 2021, will be properly outfitted to make the antigens used for diptheria and tetanus vaccines.
- Sourcing of vaccine components has been constrained, but the hope is that a new injection of capital will help resolve these types of supply issues.
Dive Insight:
Billed as "one of the most important investments for the Sanofi global industrial network," by Philippe Luscan, Sanofi EVP of global industrial affairs, the new facility in Canada will focus on a five-component acellular version of the pertussis pathogen, which is believed to confer immunity in a safer way than whole-cell vaccines.
Sanofi Pasteur produces its pertussis combination vaccines in France, a company spokesperson wrote in an email to BioPharma Dive. "However, the Toronto site is the exclusive producer of the five-component pertussis ... in fact, this particular vaccine was researched, developed and [is] currently manufactured in Toronto."
There are two Tdap vaccines that are currently available in the U.S.: Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) from Sanofi Pasteur and Boostrix from GlaxoSmithKline Biologicals. Adacel and Boostrix were both approved by the Food and Drug Administration in 2005.
Adacel received an sBLA approval in September 2017 for a change to its prefilled tip cap on Adacel syringes, making them free of natural rubber latex.
Sanofi said during a fourth-quarter earnings call that issues with vaccines phasing and supply constraint may offset positive gains in the first half of 2018.
Fourth quarter sales in the adult booster category, including Adacel, were €137 million, up 13.2% at a constant exchange rate, but down 0.7% when adjusted for changes following the termination of the Sanofi Pasteur MSD joint venture with Merck & Co. in 2016.
The company also has Adacel+, a Tdap booster, listed in Phase 2 of its pipeline.