The regulatory green light builds on the deal announced back in April, in which the two multinationals share a funding pot of €90m over three years to produce LBP products for gastrointestinal and cardiovascular conditions.
Headquartered in Basel, Switzerland, the funding is also for upgrading existing facilities in Hørsholm, Denmark and equip new facilities in Basel to serve pre-clinical to phase II projects.
As BacThera’s product pipeline matures, further facilities for phase III and commercial manufacturing will be developed as the collaboration expect BacThera to be largely self-funding.
“The joint venture is a quantum leap for Chr. Hansen’s human microbiome lighthouse,” said CEO of Chr. Hansen, Mauricio Graber back in April.
“It’s a great opportunity to utilise our microbial capabilities in the highly attractive LBP industry whilst sticking to our strategy of not becoming a fully-fledged pharma company.
‘End-to-end biotherapeutic solutions’
“Chr. Hansen has more than 145 years of experience in strain development and manufacturing and we are thrilled to join forces with a leading global company in the pharma CDMO market to become the partner of choice for end-to-end biotherapeutic solutions.
“The clinical trial supply industry is a rapidly emerging field, not to speak of the very large potential when the first bacteria-based medical products enter the commercial market.”
With the anti-trust approval in place, the company adds that it is now “engaging with its first customers,” as the pact looks to leverage Chr. Hansen’s know-how in developing, upscaling and manufacturing bacteria strains.
The collaboration taps into current efforts by the nutrition and pharma industry to combine resources and knowledge about the gut microbiome’s role in disease onset and progression.
LBP largely involves the application of living gut microbes that perform important metabolic roles encouraging growth and resilience in the gastrointestinal region as well as the human body.
The pharma side effectively deals with current challenges including trial cost, complexity and the sheer difficulty of upscaling gut microbe cultivation to form a LBP.
Furthermore, some anaerobe organisms require unknown complex, nutrient demands that also bring an unknown, poor or variable growth factor.
Pharma participation also covers manufacturing standards, particularly good manufacturing practice (GMP) facilities that include expensive large batch fermenting vessels and anaerobic chambers.
Lonza CEO thoughts
In a recent conference call briefing, Lonza’s CEO Marc Funk highlighted an estimated 80-90% of non-communicable diseases linked to gut dysbiosis.
“These disease areas include that of the Central Nervous System (CNS) and specifically the role of the gut-brain axis,” he said.
“This is something that will come as an alternative therapeutic route knowing that these conditions need a response. It is something that Lonza can address.”
“We need to think differently about how we develop solutions for manufacturing in the microbiome space as we see the potential of this therapeutic area develop.
“By teaming up with Chr. Hansen, one of the world’s largest producers of bacteria, we are combining expertise that perfectly fits the very specific needs of aspirational companies in the microbiome space.”