Reformulated GSK mouthwash endorsed as umbilical cord antiseptic

By Ben Hirschler

LONDON, April 29 (Reuters) - An antiseptic gel to stop umbilical cord infections in newborn babies was recommended as safe and effective by European regulators on Friday in a boost for GlaxoSmithKline (Other OTC: GLAXF - news) scientists who developed it from a mouthwash.

The British drugmaker, which worked on the product with the Save (LSE: 0O98.L - news) the Children charity, won't make any money from the chlorhexidine antiseptic as it is designed exclusively for developing 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 argue there are no benefits from combining pharmaceuticals with consumer healthcare products, such as toothpaste and mouthwash.

GSK researchers developed the new product by reformulating the chlorhexidine solution found in its popular Corsodyl mouthwash into a gel that can be applied to newly cut umbilical cords.

The initiative was prompted by a United Nations commission report in 2012 that identified chlorhexidine as one of a number of overlooked treatments that could save hundreds of thousands of lives a year.

The stump of the umbilical cord can act as an entry point for bacteria, causing life-threatening infections, especially in poorer countries with limited healthcare resources.

GSK said its single-use sachet product, to be known as Umbipro, had been assessed for quality, safety and efficacy under a special procedure that allows the EMA to evaluate a medicine even if it will not be marketed in the European Union.

The company plans initially to manufacture about 6 million sachets and will increase capacity according to global demand. It (Other OTC: ITGL - news) will also share its manufacturing know-how with other companies interested in making the gel. (Reporting by Ben Hirschler; editing by David Clarke)