- Source : Press Release
- Date : 2021-05-31
- Companies : BacThera AG, Chr. Hansen Holding A/S, Lonza Group Ltd.
Bacthera Receives Manufacturing Licenses in Switzerland and Denmark
Chr. Hansen’s joint venture with Lonza reaches a key milestone and is ready to start supplying Live Biotherapeutic Products
Following GMP inspections by Swissmedic at Bacthera’s drug product facility in Basel, Switzerland, and by the Danish Medicines Agency at Bacthera’s drug substance facility in Hoersholm, Denmark, both facilities have been granted manufacturing licenses by the respective national health authorities.
This milestone means that Bacthera, a specialist contract development and manufacturing organization (CDMO), is ready to supply customers with medicines from one of the world’s most advanced pharma manufacturing supply chains for live biotherapeutic products (LBP), a new therapeutic class based on live microbes.
“These licenses have been a key milestone to reach since the founding of Bacthera. It greatly excites me that we can now supply our customers with LBP medicines for clinical trials in humans and ultimately also commercial products. I am very proud of what our team has achieved,” states CEO Lukas Schüpbach, Bacthera.
“The manufacturing license is an important milestone for our microbiome lighthouse and a crucial enabler for the emerging LBP industry. We are very pleased that Bacthera can now truly start realizing its vision and business model to become a world-leading CDMO in this emerging field,” says CEO Mauricio Graber, Chr. Hansen.
“The addressable market for clinical and commercial supply long-term has the potential to exceed EUR 1 billion. With a growing pipeline of microbiome-targeting therapies, gaining the manufacturing license represents a significant milestone for Bacthera.The license will allow the company to fulfill the scope of bringing innovative live biotherapeutic products to patients with unmet medical needs,” adds Jean-Christophe Hyvert, President, Division Head Biologics, Cell and Gene, Lonza.
“Bacthera’s ambition is to enable our customers to bring life-changing treatments to patients by pioneering the LBP industry. We find it very rewarding to be treading on virgin territory together with our customers in the microbiome space,” concludes Schüpbach.
For further info, please contact:
Chr. Hansen: Seyer-Hansen Director, Head of Media Relations, tel 45 60 38 62 07, [email protected]
Lonza: Victoria Morgan Head of External Communications, Lonza Group Ltd, tel 41 61 316 2283, [email protected] and/or Dirk Oehlers, Investor Relations, Lonza Group Ltd, tel 41 61 316 8540, [email protected]
About Live Biotherapeutic Products
Live Biotherapeutic Products, LBPs for short or more popularly known as bugs as drugs, are a new therapeutic modality being developed by a range of biotech and pharma companies across the world. LBPs are unique because their active substance is a living organism, most commonly a bacterium, that has been identified as showing promise in treating one or sometimes several diseases. LBPs are diverse and can consist of e.g. a single organism, a genetically modified organism, or a consortium of organisms.
Bacthera was founded end of 2019 as a 50:50 Joint Venture of the two companies Chr. Hansen and Lonza AG to specifically serve the needs of the emerging Live Biotherapeutic Product industry. Overall, EUR 90 million will be invested, shared equally between Chr. Hansen and Lonza. Bacthera’s expertise and the capabilities of production of bacteria for pharmaceutical purposes were transferred by both parent companies to Bacthera right from the beginning. Bacthera offers a compelling set of services across the LBP life cycle and process chain, from technical R&D development right through to cGMP manufacture and QC testing of drug substance and drug product. Bacthera operates from its headquarters and Center of Excellence for drug product process development and manufacturing, and QC analytical testing in Basel, Switzerland, and its Center of Excellence for drug substance process development, analytical development, and manufacturing in Hoersholm, Denmark.
Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to prevent illness and enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. These enable our customers to commercialize their discoveries and innovations in the healthcare sector. Founded in 1897 in the Swiss Alps, today Lonza operates across five continents. With approximately 14,000 full-time employees, we are built from high-performing teams and of individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 4.5 billion in 2020 with a CORE EBITDA of CHF 1.4 billion. Find out more at www.lonza.com.
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX ST Listing Manual. Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.
Chr. Hansen is a global, differentiated bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. At Chr. Hansen we are uniquely positioned to drive positive change through microbial solutions. We have worked for over 145 years to enable sustainable agriculture, cleaner labels and healthier living for more people around the world. Our microbial and fermentation technology platforms, including our broad and relevant collection of around 40,000 microbial strains, have game-changing potential. Matching customer needs and global trends we continue to unlock the power of good bacteria to respond to global challenges such as food waste, global health and the overuse of antibiotics and pesticides. As the world’s most sustainable biotech company, we touch the lives of more than 1 billion people every day. Driven by our legacy of innovation and curiosity to pioneer science, our purpose – To grow a better world. Naturally. – is at the heart of everything we do.