By Ben Hirschler
LONDON, April 29 (Reuters) - An antiseptic gel to stopumbilical cord infections in newborn babies was recommended assafe and effective by European regulators on Friday in a boostfor GlaxoSmithKline scientists who developed it from amouthwash.
The British drugmaker, which worked on the product with theSave the Children charity, won't make any money from thechlorhexidine antiseptic as it is designed exclusively fordeveloping countries and will be sold at a not-for-profit price.
But the green light from the European Medicines Agency (EMA)is a timely victory for GSK as it battles critics who arguethere are no benefits from combining pharmaceuticals withconsumer healthcare products, such as toothpaste and mouthwash.
GSK researchers developed the new product by reformulatingthe chlorhexidine solution found in its popular Corsodylmouthwash into a gel that can be applied to newly cut umbilicalcords.
The initiative was prompted by a United Nations commissionreport in 2012 that identified chlorhexidine as one of a numberof overlooked treatments that could save hundreds of thousandsof lives a year.
The stump of the umbilical cord can act as an entry pointfor bacteria, causing life-threatening infections, especially inpoorer countries with limited healthcare resources.
GSK said its single-use sachet product, to be known asUmbipro, had been assessed for quality, safety and efficacyunder a special procedure that allows the EMA to evaluate amedicine even if it will not be marketed in the European Union.
The company plans initially to manufacture about 6 millionsachets and will increase capacity according to global demand.It will also share its manufacturing know-how with othercompanies interested in making the gel. (Reporting by Ben Hirschler; editing by David Clarke)
Glaxosmithkline (GSK)
