BioGaia subsidiary IBT starts trial already this year

Regulatory News:

Infant Bacterial Therapeutics’ (IBT) efforts to develop a drug to prevent the fatal disease necrotizing enterocolitis (NEC) has proceeded faster than planned and the company will already in 2015 prepare a study on the safety and tolerance of the product. According to the original plan, the study was scheduled to start in 2016. To allow for the earlier study start, BioGaia will supply IBT with an additional 520 000 US dollars.

In November 2013 the Board of BioGaia decided to invest up to SEK 42 million in a first phase of a long-term project aimed at developing a drug with very high requirements on hygiene, analysis and documentation, to prevent the fatal disease necrotizing enterocolitis (NEC), that affects premature infants. The project is run by BioGaia's subsidiary Infant Bacterial Therapeutics (IBT).

IBT has been granted Orphan Drug Designation for the prevention of NEC in Europe and the USA, has had consultations with the FDA and the EMA and has progressed far in the development of the production process of the product.

Before any clinical studies will be conducted the financial requirements of IBT needs to be met through external financing. Efforts to find a suitable cooperation partner have been initiated with a bank in London.

"With this additional limited funding from BioGaia we gain valuable time and thereby increasing the value of the project," says Peter Rothschild, President, BioGaia.

Latest press releases from BioGaia 2015-03-23 BioGaia signs exclusive agreement for oral health products in Mexico 2015-03-09 BioGaia’s oral health probiotic effective in patients with dental implants 2015-02-23 BioGaia subsidiary Infant Bacterial Therapeutics get Orphan Drug Designation in Europe

BioGaia has published this information in accordance with the Swedish Securities Market Act. The information was issued for publication on 26 March 2015, 08:30 am CET.

BioGaia (STO:BIOGB) 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

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