|Indication:||Benign skin lesions|
|Mode of action:||Mummification and preservation of the lesions|
|Stage of development:||CE Mark registration process|
|Patent status:||International Patent Application covers the BL-5010P applicator, 20-year expiration in 2033|
BL-5010 is a customized, proprietary pen-like applicator containing a novel, acidic, aqueous solution for the non-surgical removal of skin lesions. In December 2010, BioLineRx announced positive results from a Phase 1/2 clinical trial of BL-5010. BioLineRx have received European confirmation of the regulatory pathway classification of BL-5010 as a Class IIa medical device. In December 2014, BioLineRx entered into an exclusive out-licensing arrangement with Omega Pharma, a division of Perrigo Company plc, for the rights to BL-5010 for over-the-counter, or OTC, indications in the territory of Europe, Australia and additional selected countries. During 2015, Omega Pharma conducted a 30-patient, open-label clinical study to evaluate the advantages of BL-5010 in one of the intended OTC indications. Study results indicate that BL-5010 is safe and efficacious. In March 2016, Omega Pharma received CE Mark approval for BL-5010 as a novel OTC treatment for the non-surgical removal of warts. The commercial product launch of this first OTC indication (warts/verrucas) commenced in the second quarter of 2016 and it is already being sold in a number of countries in the EU.
BL-5010 was invented by Prof. Pinchas Burstein and is being developed by BioLineRx Ltd. under a worldwide exclusive license from Innovative Pharmaceutical Concepts, Ltd.