ACE BioSciences & SynCo BioPartners collaborate in GMP manufacture of first commercial vaccine for severe Traveller's Diarrhoea - Press Releases

ACE BioSciences & SynCo BioPartners collaborate in GMP manufacture of first commercial vaccine for severe Traveller's Diarrhoea
March 16th, 2005
ACE BioSciences A/S
Vaccine Moves Into Development Following Strong Pre-Clinical Results
Odense, Denmark and Amsterdam, Holland, March 16th, 2005
ACE BioSciences A/S, the emerging biopharmaceutical company focused on infectious diseases and SynCo BioPartners, the leading vaccines and biopharmaceuticals manufacturer are to collaborate on the GMP production of ACE BioSciences? lead product, ACE 393, the world?s first commercial vaccine for Traveller's Diarrhoea caused by Campylobacter. The move follows very encouraging pre-clinical research.
Under the terms of the agreement, SynCo will work with ACE BioSciences to develop and implement a competitive and scalable process for the manufacture of the vaccine, which combats infection by Campylobacter jejuni, the bacterium responsible for severe Traveller's Diarrhoea. SynCo will deliver the initial well-characterized vaccine for ongoing pre-clinical testing during 2005 and it will provide clinical grade material by the end of quarter one 2006.
Ms Ingelise Saunders, ACE BioSciences' CEO commented, 'This is a landmark deal for ACE BioSciences as we move our focus onto drug development rather than research. SynCo BioPartners has a strong track record in process development, GMP manufacture and commercial vaccine production. As part of this collaboration we will share our pioneering proteomics technology with SynCo to further strengthen their protein-based vaccine production capabilities. This will enable ACE BioSciences and SynCo to deliver highly characterized and high purity vaccines, which should have more predictable efficacy and have superior side-effect profiles.'
Mr Pierre Warffemius, CEO of SynCo said 'We are delighted that ACE BioSciences has selected SynCo as its partner of choice to undertake both the process development and GMP production of ACE 393. We aim to establish a long-term relationship with ACE BioSciences to support the consistent, high quality production of their expanding vaccine portfolio and we look forward to working together with ACE BioSciences in implementing leading edge technologies in the development and characterization of new protein-based vaccines.'
Campylobacter is the greatest cause of bacterial diarrhoeal infections in the developed world and the leading cause of enteritis in the world, accounting for more cases, hospitalizations and deaths than E coli provoked food borne illness (Source: The World Health Organisation). ACE 393 is based on novel cell surface protein derived from Campylobacter jejuni, which is responsible for 99% of Campylobacter infections. The annual global market for a Campylobacter vaccine is estimated to be worth $300 million. ACE BioSciences is actively seeking a development partner for this project.
Notes for Editors
ACE BioSciences is an emerging pharmaceutical company focused on developing novel protein-based vaccines and antibodies to address infectious diseases. It has unique expertise in the extraction and analysis of the cell surface proteins used by pathogens (eg bacteria, viruses and fungi) to interact with and infect human host cells. Unlike many other companies, ACE BioSciences identifies real proteins (rather than those predicted from DNA or the genome) and has the skills to isolate novel proteins as potential new drug targets (as opposed to working on known pathogen proteins). Furthermore, the company?s pioneering proteomics capabilities fast track research to yield animal efficacy results in just one year, considerably faster than the industry average. These features give ACE BioSciences multiple product opportunities, a rapid route to the clinic and considerable competitive advantage.
ACE BioSciences aims to develop a portfolio of products independently and in collaboration with other companies up until Phase II trials. In addition to its work on severe Traveller's Diarrhoea, the company is also developing ACE 5033, an antibody directed against Aspergillus fumigatus, the fungus which causes Aspergillosis, usually in immunocompromised patients. This is a collaborative venture with the Danish antibody company Genmab A/S. The annual global market for an Aspergillosis therapeutic is estimated to be worth $500 million.
ACE BioSciences investors are BankInvest, V?kstfonden and Dansk Innovationsinvestering P/S which have contributed Euro 19 million since the company was established by Dr Ejvind Mortz, Christian Hodal and Dr Angus King in 2001. ACE BioSciences is based in Odense, Denmark, a noted proteomics centre of excellence and it currently employs 20 staff.
Synco BioPartners is focused on the manufacture and development of biopharmaceuticals and has a track record of expertise in the production of recombinant proteins and vaccines. SynCo BioPartners offers a fully integrated range of services in manufacturing and supports biopharmaceutical companies from the earliest stage in process development, through clinical trials to market supply. Established in 2000 and privately owned, SynCo collaborates with a number of leading biopharmaceutical companies, in Europe and the USA. Approximately 100 employees are based at the company?s headquarters and manufacturing facility in Amsterdam, NL. Here, SynCo?s activities include analytical and process development for new products, manufacture of Active Pharmaceutical Ingredients for licensed products and clinical trials, and sterile filling and lyophilization (for clinical trials and market supply).
For more information contact
Ingelise Saunders - ACE BioSciences + 45 6565 2032 or mob + 45 20 20 36 87
Dr Ejvind Mortz ? ACE BioSciences + 45 6565 2030
Nicki Brimicombe ? NB PR + 44 (0) 1883 732353
Andrew Lewin ? SynCo BioPartners + 31 61000 3675