BioGaia subsidiary Infant Bacterial Therapeutics gets Orphan Drug Designation in Europe

Infant Bacterial Therapeutics (IBT), subsidiary of BioGaia, is in the early
stages of developing a drug to prevent necrotizing enterocolitis (NEC) which is
a rare and fatal disease that affects premature infants. IBT has now obtained
the Orphan Drug Designation for the prevention of NEC in Europe, which
complements the corresponding designation in the US from FDA, granted in August
2013.
Orphan drugs are either drugs or biologics intended for the treatment, diagnosis
or prevention of rare diseases which are defined as life-threatening or
chronically debilitating conditions affecting less than five in 10,000 people in
the European Union per year. The Orphan Drug Designation allows IBT to obtain
assistance with development of the drug, fee reductions and marketing
incentives.

In 2013 BioGaia founded the subsidiary IBT to manage all business related to the
development of a pharmaceutical for the prevention of NEC, as this was not
within BioGaia’s normal business activities.

“We are pleased that the European Commission have granted the Orphan Drug
Designation. We are confident that our subsidiary IBT can significantly
contribute in the care of premature infants in the future”, says Peter
Rothschild, CEO, BioGaia.

“The US and European approvals of the Orphan Drug Designations are important
steps in our efforts to develop this preventive therapy to save the lives of
premature infants from one of the most deadly diseases occurring in the most
vulnerable human population”, says Staffan Strömberg, CEO, Infant Bacterial
Therapeutics.

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BioGaia has published this information in accordance with the Swedish Securities
Market Act. The information was issued for publication on 23 February 2015, 9:30
am CET.
For additional information please contact
Peter Rothschild, CEO, BioGaia: +46 8 555 293 00
Staffan Strömberg, CEO, IBT: +46 8 410 145 55

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