BioGaia

Regulatory Filings • Jul 22, 2010

Press Release 22nd of July 2010

New study published: Lactobacillus reuteri Protectis effective in infants with chronic constipation FKURQLFIXQFWLRQDOFRQVWLSDWLRQDQGVXSSOHPHQWHGZLWK /DFWREDFLOOXVUHXWHUL3URWHFWLV

Constipated infants supplemented with L. reuteri Protectis had a significantly higher frequency of bowel movements compared to the placebo group. Stool consistency improved significantly in the L. reuteri Protectis group, although no significant difference was seen compared to placebo. – This is the first study to show that L. reuteri has positive effects on infants suffering from chronic constipation, says Professor Annamaria Staiano, Department of Pediatrics, University Federico II, Naples, Italy. ,QWKLVGRXEOHEOLQGSODFHERFRQWUROOHGVWXG\LQIDQWVZLWKDPHDQDJHRIHLJKWPRQWKVDQGZLWK FRQÀUPHGFKURQLFIXQFWLRQDOFRQVWLSDWLRQZHUHUDQGRPO\DVVLJQHGWRWUHDWPHQWZLWKHLWKHU/UHXWHUL 3URWHFWLVGURSV'60 &)8GD\RUSODFHERGURSVIRUHLJKWZHHNV\$OOLQIDQWVKDGVWDUWHG ZHDQLQJDQGFRQVXPHGDGRVHRIJNJGD\RIGLHWDU\ÀEHURIWKHLQIDQWVZHUHUDQGRPL]HG WRWKH/UHXWHUL3URWHFWLVJURXSDQGWRWKHSODFHERJURXS1RDGYHUVHHIIHFWVZHUHUHSRUWHGDQGDOO LQIDQWVFRPSOHWHGWKHVWXG\3ULPDU\RXWFRPHPHDVXUHVZHUHIUHTXHQF\RIERZHOPRYHPHQWVSHU ZHHNVWRROFRQVLVWHQF\DQGSUHVHQFHRILQFRQVRODEOHFU\LQJHSLVRGHV

In the double-blind, placebo-controlled study 44 infants with confirmed chronic functional constipation were randomly assigned to treatment with either L. reuteri Protectis drops (DSM 17938, 10⁸ CFU/day) or placebo for eight weeks. Outcome measures included frequency of bowel movements per week, stool consistency and presence of inconsolable crying episodes. WZRWKHVXFFHVVUDWHZDVLQWKH/UHXWHUL3URWHFWLVJURXSFRPSDUHGWRLQWKHSODFHERJURXS \$WZHHNIRXULWZDVDQGUHVSHFWLYHO\DQGDWZHHNHLJKWFRPSDUHGWR

Treatment success was defined as equal to or more than three bowel movements per week. At week two the success rate was 91 % in the L. reuteri Protectis group compared to 59 % in the placebo group. At week four the figures were 100 % and 68 % respectively and at week eight 100 % in the probiotic group and 73 % in the placebo group.

Stool consistency improved significantly in the L. reuteri Protectis group during the treatment, from 86 % reported as hard at baseline to 50 % at week two and 18 % at weeks four and eight. However, there were no significant differences in stool consistency between the L. reuteri Protectis and placebo groups at any of the measuring points. No differences were observed in crying behaviour between the groups at any time point, which was expected since this population was too old to display colic.

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– The results of the study again show the positive effect of L. reuteri Protectis on infant gut function and further strengthens BioGaia's position in the infant segment, says Eamonn Connolly, Senior Vice President Research at BioGaia. ERZHOPRYHPHQWVWKDQSODFHERDWZHHNWZRS ZHHNIRXUS  DQGZHHNHLJKWS RIVXSSOHPHQWDWLRQ

The study was published online on the 14th of June 2010 in the Journal of Pediatrics: http://www.jpeds.com/article/S0022-3476(10)00385-9/abstract

For additional information contact:

Annamaria Staiano, MD, Department of Pediatrics, University Federico II: staiano@unina.it Eamonn Connolly, Senior Vice President Research, BioGaia: +46 8-555 293 00 or ec@biogaia.se

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BioGaia is a biotechnology company that develops, markets and sells probiotic products with documented health benefits. The products are primarily based on the lactic acid bacterium Lactobacillus reuteri (Reuteri), which has probiotic, health-enhancing effects. The class B share of the Parent Company BioGaia AB is quoted on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm. www.biogaia.com