Pressmeddelande - 23 December 2013 09:28

Scandinavian Biopharma and PATH sign collaborative development agreement after successful Phase I study of a novel vaccine candidate against diarrheal disease.

Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries. Enterotoxigenic Escherichia coli (ETEC) bacteria are the primary cause of this disease. ETEC is also a major cause of diarrheal disease among children living in endemic countries, leading to over 400 million diarrheal episodes and approximately 300,000 deaths each year. Today there is no ETEC vaccine available to address these unmet needs.

The international global health nonprofit organization PATH and Scandinavian Biopharma have agreed to continue their collaboration to develop a novel vaccine candidate against diarrhea caused by ETEC. Impressive results obtained in a recently conducted clinical Phase I study triggered this decision. PATH supports the project by providing expertise, know-how, and financial resources.

The clinical Phase I study showed very encouraging results. All primary endpoints were exceeded. The vaccine candidate was safe and well tolerated by the study participants. There was a high frequency of response, as 83 percent of the subjects responded to all five of the primary vaccine components; this result exceeds the primary immunological endpoint for the study (at least 50 percent of the subjects responding to at least four of the primary vaccine antigens).

Together, the partners will continue the development of this vaccine candidate in the effort to prevent and control ETEC-related illness and mortality among infants and young children living in ETEC-endemic areas, as well as to prevent ETEC-associated travelers’ diarrhea occurring among international travelers.

The development of this new ETEC vaccine candidate is a collaborative effort among Scandinavian Biopharma, the University of Gothenburg, and PATH.

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

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Scandinavian Biopharma:
Scandinavian Biopharma is a Swedish research-based biotech company engaged in marketing and sales of vaccines, rapid infectious disease tests, antidotes, and immunoglobulins to the Nordic market. Research and development is mainly focused on development of a new oral ETEC vaccine. Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries, and ETEC bacteria are the primary cause of this disease. About 80 million people travel from industrialized countries to high-risk areas in the developing world. Of these, 30 to 50 percent may experience at least one travelers’ diarrhea episode during their journey. ETEC is also a major cause of diarrheal disease among children living in endemic countries.

www.scandinavianbiopharma.com

Scandinavian Biopharma announces successful results in placebo-controlled Phase I study of an oral, inactivated vaccine against diarrhea for travelers and children in developing countries

Travelers’ diarrhea is the leading cause of illness among international travelers to developing countries. ETEC bacteria are the primary cause of this disease. ETEC is also a major cause of diarrheal disease among children living in endemic countries. A clinical Phase I study of a novel vaccine against diarrhea caused by ETEC has been successfully completed. All primary endpoints were achieved.

Scandinavian Biopharma announces first patient vaccinated in the age-descending study in Bangladesh

On October 20, we began enrollment of a placebo-controlled Phase I/II trial where our enterotoxigenic Escherichia coli (ETEC) vaccine candidate will be tested for safety and immunogenicity in different age groups, including infants as young as six months of age. The study is being conducted under a US Investigational New Drug Application and will enroll about 450 children.

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. 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.

Scandinavian Biopharma säkrar ytterligare finansiering genom ett tilläggsavtal med PATH för att utveckla ett vaccin mot diarrésjukdom

Enterotoxin-bildande Escherichia coli-bakterier, ETEC, orsakar varje år omkring 400 miljoner diarréfall och hundratusentals dödsfall i världens låg- och medelinkomstländer. ETEC-bakterier är också orsaken till att nästan varannan resenär som reser i dessa områden drabbas av diarré. PATH stödjer projektet genom att tillhandahålla teknisk expertis och mjuka pengar.

Vi är ett forskningsbaserat biotechföretag fast beslutna att ge människor i hela världen ett längre och bättre liv.

Vi utvecklar det första vaccinet i världen mot diarré orsakad av ETEC för att skydda både barn och vuxna i endemiska länder och resenärer till högriskdestinationer.

Vi distribuerar ett brett sortiment av biologiska specialistläkemedel med fokus på vacciner och immunglobuliner.

www.scandinavianbiopharma.se

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