BioLineRx’s BL-5010 Submitted for CE Mark Registration
News Sep 11, 2015
BioLineRx Ltd. has announced that its partner, Omega Pharma, now part of Perrigo, has submitted an application for CE Mark designation for BL-5010, a novel treatment for the non-surgical removal of skin lesions.
BL-5010 is a novel product for the non-surgical removal of benign skin lesions. It offers an alternative to painful, invasive and expensive removal treatments including cryotherapy, laser treatment and surgery. Because the treatment is non-invasive, it poses minimal infection risk and eliminates the need for anesthesia or bandaging.
The product has completed clinical studies for the removal of seborrheic keratosis and other skin lesions with excellent efficacy and cosmetic results, and has received confirmation in Europe for the regulatory pathway classification as a medical device Class 2a.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated: "We are very pleased with the swift development by Omega Pharma of BL-5010 as an OTC solution for the non-surgical removal of benign skin lesions. BL-5010 offers a novel method for removing skin lesions without surgery, anesthesia or significant adverse effects, and we look forward to seeing this innovative product on the market. Assuming successful completion of the CE Mark registration process, we hope to see first sales in Europe of BL-5010 during 2016. We also look forward to the potential expansion of this product to other markets and to non-OTC indications."
In December 2014, BL-5010 was out-licensed to Omega Pharma for OTC indications in the territory of Europe, Australia and additional selected countries. BioLineRx retains the OTC rights to BL-5010 in the U.S. and the rest of the world, as well as the global rights to non-OTC indications.