- Swiss drug contractor Lonza will partner with the Danish bioscience company Chr. Hansen in a joint venture to develop and produce bacteria-based therapies for biotech and pharma companies investing in the emerging field of microbiome research.
- The 50-50 partnership will be based in Basel, Switzerland, with facilities in both Switzerland and Denmark, the companies said in an April 2 statement.
- To start, Lonza and Chr. Hansen will jointly invest 45 million euros ($50.5 million). Once the partners confirm there's sufficient demand for supplying late-stage studies and commercial marketing, another 45 million euros in investment is planned.
Lonza and Chr. Hansen are making a bet on a field of research with broad potential, but a to-date limited track record in the clinic and in front of regulators.
Fecal transplants — a branch of microbiome research that's received the most attention — has shown success in patients with the bacterial infection Clostridium difficile. Variations of the treatment are under study for other conditions, and microbiome companies like Seres Therapeutics, Rebiotix and Vedanta Biosciences are working to develop drugs.
Just last month, AstraZeneca inked a deal with Seres to study the use of bacteria-based therapies in cancer patients.
But the Food and Drug Administration is still working out how such treatments should be regulated, and the issue has sparked some debate, The New York Times reported in March. Some doctors and patient advocates argue regulating microbiome therapies as drugs could limit experimentation in the field and hurt access. Treating fecal transplant and other microbiome-based therapeutics as drug products, on the other hand, would impose standards of safety and efficacy, and could lead to insurer coverage of any approved treatment.
Lonza and Chr. Hansen expect the market for supplying live biotherapeutic products for use in clinical trials to reach between 150 million and 200 million euros by 2025, based on ongoing studies. Ten years later, the companies predict, that market may top 1 billion euros through expanded clinical and commercial demand.
"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," said Lonza CEO Marc Funk in a statement.
The first phase of the venture will focus on upgrading existing facilities in Demark and equipping new facilities in Switzerland to produce live biotherapeutic products in stages from pre-clinical to Phase 2, the companies said. The joint venture will invest more in manufacturing facilities as products move further through the pipeline.
After the initial production facility expenses, the venture should be largely self-funding, they said.