10 Apr 2014
Lonza and AMYRA Sign Comprehensive Development and Manufacturing Services Agreement for Enzyme-Based Treatment of Celiac Disease
  • AMYRA Biotech AG to develop a rational oral treatment for celiac disease using a cocktail of two proprietary enzymes
  • Contract covers the process development and production of AMYRA’s two enzymes for the treatment of celiac disease
  •  Lonza will develop and manufacture AMYRA’s enzymes in their Kourim, Czech Republic facility
  • Included in the contract is an XS™ Commercial License with access to Lonza’s XS™ Microbial Expression Technology Platform    

Basel and Zug, Switzerland, 10 April 2014 – Lonza, a global leader in biological manufacturing, and AMYRA Biotech AG (“AMYRA”), a biotech company developing novel enzyme-based treatments for celiac disease (gluten intolerance), announced today an agreement for the development and manufacture of AMYRA’s two proprietary enzymes targeting gluten. Under the agreement, Lonza will produce material at its microbial manufacturing facility in Kourim, Czech Republic. The XS™ Commercial License provides access to Lonza’s multi-host XS™ Microbial Expression Technology Platform.  

After a series of exploratory experiments, Lonza and AMYRA recently performed an extensive expression feasibility study using Lonza’s proprietary XS™ Microbial Expression Technology. Multiple strains, promoters and signal sequences were tested in a high-throughput system to determine the best process for the enzymes and to identify a production strain suitable for commercial product supply. The developed strains achieved high cell-density fermentations and high-titer production of AMYRA’s proprietary enzymes. The Lonza XS™ Microbial Expression System successfully produced multiple g/L quantities of enzymes, which are orders of magnitude greater than previously published. Based on this data, AMYRA will continue to work with Lonza to develop a commercial-scale production process.  

“The collaboration between AMYRA and Lonza, which began in the early stage of expression system development and is now moving into large scale process development, demonstrates the power of the Lonza XS™ System. Partnering with Lonza from the start enables emerging companies like AMYRA to access world-class expression platforms and development programs, as well as to secure manufacturing capabilities for the complete product lifecycle,” said Janet White, Head of Lonza’s Custom Development Services Organization.   

 “The scientific know-how and professional integrity of Lonza’s project team enabled us to achieve results beyond our expectations,” said Werner Tschollar, CEO and President of AMYRA. “We are greatly encouraged by the positive outcome of the expression optimization and scale-up work, as well as the continued support of our shareholders and board members. Looking ahead, we are excited by the prospective milestones for 2014 and the long-term collaboration with Lonza in view of resolving a very relevant public health issue, gluten intolerance.”    

About Celiac Disease  

Celiac disease is a lifelong condition caused by the inability of the gastrointestinal tract of affected individuals to properly digest gluten, a major protein component of wheat, rye and barley. Incomplete digestion of gluten results in the toxic peptides that cause chronic inflammation with pain, diarrhea and abdominal cramping. Without treatment, the small intestine becomes seriously damaged and in the mid-long term nutritional deficiencies and severe secondary diseases can occur.  

Celiac disease can be effectively and rapidly diagnosed by serological and genetic tests, as well as by biopsy. Currently, the only treatment for celiac disease is the lifelong adherence to a strictly gluten-free diet. Although the availability of gluten-free options has increased in recent years, they are expensive and the taste and consistency are not consumer friendly. In addition, the extraction process does not eliminate all traces of gluten, so that many affected individuals still suffer symptoms.   

AMYRA’s unique combination of two synergistically acting enzymes rapidly and completely destroys the toxic activity of the gluten peptides, thereby removing their immunogenic and inflammatory potential. AMYRA and its scientific advisors believe that AMYRA’s approach to the treatment of celiac disease is considerably superior to other products under development. The development of a safe and effective treatment for gluten intolerance has the potential to significantly improve the quality-of-life of patients with celiac disease and to avoid short and severe long-term medical complications.      

About XS™ Microbial Expression Technology Platform  

The proprietary XS™ Microbial Expression Technology platform is Lonza’s advanced and versatile biopharmaceutical production service offering for the product development lifecycle. The platform addresses the diversity of microbially derived proteins with a collection of complementary expression systems that have been shown to express recombinant proteins at levels in excess of 20 g/L. The diversity of systems enables the delivery of high expression levels for a variety of product types. The XS™ system has been used in more than 120 projects spanning preclinical development through commercial-scale manufacturing.     About AMYRA Biotech AG   AMYRA Biotech AG is a Swiss biotech company that is developing a novel enzyme-based treatment for celiac disease (gluten intolerance). The company owns the worldwide IP rights to highly active enzymes targeting immunogenic gluten metabolites. AMYRA’s proprietary enzymes are very similar in structure and function to naturally occurring enzymes in the gastrointestinal tract of healthy individuals and, therefore, offer a strong safety profile and a high probability of clinical and regulatory success. Due to the nature of the enzymes, AMYRA’s approach differs significantly from competition.