Necrotizing enterocolitis (NEC) is a rare and extremely severe disease that
affects premature infants. BioGaia is in a very early stage of investigating the
possibilities of developing a drug within this field and has submitted a request
for orphan drug designation in the USA. The FDA Office of Orphan Product
Development has now approved BioGaia’s request.
Orphan drugs are either drugs or biologics intended for the treatment, diagnosis
or prevention of rare diseases or disorders affecting less than 200 000 patients
in the USA per year. An orphan drug designation qualifies the company applying
for it to receive certain benefits from the US government, such as tax
reductions and marketing incentives, in exchange for developing the drug.
The approval does not change the standard regulatory requirements and processes
for obtaining marketing approval for a product. Consequently, all aspects of the
development must be investigated, including the clinical safety and efficacy
documentation required for a market authorisation.
As pharmaceuticals are not within BioGaia’s current business activities the
company is exploring how a possible development process should continue in order
not to deflect attention from the core business. For this purpose all business
related to this field is handled by the subsidiary Infant Bacterial Therapeutics
AB.
“We are pleased to see that the FDA has granted the product orphan drug
designation. NEC is a very serious disease that affects a vulnerable patient
group. We are now investigating if, and in such case how, we can contribute in
the care of these infants in the future without incurring unnecessary financial
risks”, says Peter Rothschild, Chief Executive Officer, BioGaia.
For additional information please contact
Peter Rothschild, Chief Executive Officer, telephone: +46 8 555 293 00
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BioGaia has published this information in accordance with the Swedish Securities
Market Act. The information was issued for publication on 6 August 2013, 02:00
pm CET.
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
