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Scandinavian Biopharma and PATH sign amendment to collaborative agreement to develop a vaccine against diarrhoeal disease

Enterotoxigenic Escherichia coli (ETEC) bacteria are responsible each year for around 400 million cases of diarrhoea and hundreds of thousands of deaths in low- and middle-income countries. Because of difficulties with diagnosis, mortality and morbidity estimates for ETEC are considered significant underestimates of the actual global public health burden. Children under the age of five years are most affected with frequent infections increasing the risk of death, as well as poor physical and cognitive development. ETEC bacteria also cause diarrhoea in nearly one in two travellers to these areas, and 10 to 14% of ill travellers may go on to develop functional bowel disorders during convalescence.

The international non-profit organization PATH and Scandinavian Biopharma recently signed an amendment to their collaborative development agreement and agreed to continue their collaboration to develop a novel ETEC vaccine candidate. PATH supports the project by providing technical expertise and financial resources.

The research project is a successful collaboration between the University of Gothenburg, PATH, and Scandinavian Biopharma. Scandinavian Biopharma holds global rights to commercialize the product and will support PATH in its goal to make the product affordable and available in low-resource countries.

This new amendment comprises an upcoming Phase I/II study and chemistry, manufacturing, and controls activities. The financial value of PATH’s support for this product is 3 million USD to Scandinavian Biopharma under the amendment, along with a comparable amount of funding directly to the study site and other organizations for clinical trial activities. The vaccine candidate will be tested for safety and immunogenicity in different age groups, including infants, in a Phase I/II clinical trial in Bangladesh beginning this year. Data from the trial will provide additional evidence of the vaccine candidate’s safety and immunogenicity in infants and establish the appropriate dose to be used in a follow-on clinical trial in infants. In parallel, the company is also preparing for a clinical efficacy study in travellers during 2016.

For more information, please contact:
Björn Sjöstrand, CEO: +46 727-125 120, bjorn.sjostrand@scandinavianbiopharma.se

About Scandinavian Biopharma

Scandinavian Biopharma is a Swedish, research-based biotech company. The company is also a leading distributor of vaccines and immunoglobulins to the Nordic market.

We are developing, together with PATH and researchers at the University of Gothenburg, a new oral travellers’ diarrhoea vaccine candidate against ETEC. In several clinical trials, the vaccine has been proven safe and has shown a strong ability to activate the immune system. We believe that PATH’s support of this work to develop a new vaccine for diarrhoeal disease confirms that we are on the right path, that our vaccine meets very high standards, and that it has the potential to save lives in the developing world.