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PR016 - 31st May 2007


- Deal Involves Initial Payment, Milestone and Royalties -

Odense, Denmark and Cambridge, UK………. 31 May 2007 -- ACE BioSciences A/S, the infectious diseases company and Cambridge BioStability Ltd (CBL), the British biotechnology company have entered a strategic deal whereby ACE BioSciences in-licenses CBL’s ‘HolaVax’, (to be called ACE537) an oral Phase I Enterotoxigenic E Coli (ETEC) vaccine which has the potential to be the first to market in the US and EU and which combats the single biggest cause of travelers diarrhoea.

Under the terms of the agreement, CBL receives an initial up-front payment and rights to milestone and royalty payments dependent on the successful completion of clinical trials and undisclosed sales targets respectively.

The vaccine, which comprises three different strains of attenuated Enterotoxigenic E coli bacteria, is scheduled to complete proof of concept studies in 2009, with potentially the first market launch anticipated in 2013. It is differentiated from other, competitive ETEC vaccines in development because it has a dual preventative action: it combats bacterial adherence to and colonisation of the small intestine and neutralizes the activity of the LT toxin, a key cause of diarrhoea. Its oral delivery formulation is another differentiating factor.

ETEC is the single largest bacterial cause of travellers’ diarrhoea (TD) around the world, followed by Campylobacter, Salmonella and Shigella. ACE BioSciences is already developing a vaccine to address Campylobacter infection, ACE393, and this is in Phase II clinical trials. Market launch is scheduled for 2010 when ACE393 would be the first commercially available vaccine for TD.

Ms Ingelise Saunders, ACE BioSciences’ CEO commented “ACE537 is a perfect strategic fit for ACE BioSciences, since it complements our Campylobacter vaccine and would follow it closely to market. Its dual action sets it apart from competitive programmes and should enable it to provide greater disease protection. In the first instance we intend to develop it as a stand-alone vaccine, but in the longer term there is potential to develop an oral combination vaccine to address ETEC and Campylobacter. We believe this would be of tremendous appeal to travellers, since it would protect recipients from the two greatest causes of travellers’ diarrhoea.”

Quote from CBL “HolaVax is a very promising vaccine. However, CBL is focused on heat stable vaccine formulations rather than product development and in this context we believe it will reach the market faster in the hands of a company dedicated to vaccine development. ACE BioSciences is the ideal company to make this happen, given its focus on travellers’ diarrhoea and the impressive speed with which it has developed its Campylobacter vaccine to date. The synergy with ACE’s Campylobacter vaccine programme makes them an excellent partner to develop the ETEC vaccine in its own right and also as a combination product.”

ACE BioSciences estimates that by 2010, around 58 million travellers will visit areas where ETEC is endemic, with 3.9 – 9.8 million of these travellers likely to experience TD caused by ETEC. The global market for an ETEC vaccine is estimated to be worth €550 million per year. At present there is no vaccine that is widely approved for specific use against ETEC.



Notes for Editors
About ETEC

ACE BioSciences
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.

The company’s lead product, ACE393, is an injectable vaccine that is on track to become the world’s first commercial vaccine for Travellers’ Diarrhoea caused by Campylobacter infection, having successfully completed Phase I clinical trials in March 2007. Campylobacter is one of the greatest causes of gastroenteritis in the developed world as well as a significant contributor to travellers’ diarrhoea. The annual global commercial market for a Campylobacter vaccine is estimated to be worth € 350 million. ACE BioSciences aims to develop a portfolio of products independently and in collaboration with other companies and as part of that strategy the company signed a collaborative development agreement with the US Naval Medical Research Center (NMRC) to progress ACE393 through Phase II clinical trials. In addition to ACE393, the company is working on a vaccine for Streptococcus pneumoniae, the bacterium responsible for Pneumococcal disease. The market for a Streptococcus product would be multibillion and ACE BioSciences aims to partner the project in the coming year. In 2006 ACE BioSciences also initiated an in-house pre-clinical ETEC programme.

In December 2005, ACE BioSciences announced a collaborative agreement with the Aeras Global TB Vaccine Foundation whereby ACE BioSciences will support the characterization of second-generation BCG-based tuberculosis (TB) vaccines under development by Aeras. In November 2005, ACE BioSciences and the Dutch biotechnology company Crucell N.V. entered a research and licensing agreement to discover antibody therapies to combat serious hospital-acquired infections, including those caused by antibiotic-resistant bacteria. The company is also working with Nordic Vaccine A/S to develop patch and oral delivery technologies, to enhance patient acceptability and delivery convenience.

Cambridge BioStability Ltd

Based in Cambridge and founded in 1998, CBL has developed a revolutionary technology, which formulates vaccines into ready-to-inject stable liquid suspensions requiring no refrigeration or reconstitution. Stable liquid vaccines offer significant advantages over existing vaccines as they do not require refrigeration or reconstitution – thereby significantly reducing their cost of administration and increasing their shelf life and their effectiveness in the field. The Company has filed seven patent families worldwide and has a number of development programmes underway. CBL has entered into a partnership with Panacea Biotec, to bring to production a pentavalent childhood vaccine that can be stored without refrigeration, for use in child vaccination programmes in the developing world. CBL is also working with US Government agencies to develop a stable, multivalent vaccine against botulism and a stable anthrax vaccine.


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