For immediate release
BioLineRx’s Novel Treatment for Non-Surgical Removal
of Skin Lesions Receives CE Mark Approval
Tel Aviv, Israel, April 4, 2016 - BioLineRx Ltd. (NASDAQ/TASE: BLRX) announced today that its partner, Omega Pharma, now part of Perrigo, has received CE Mark approval for BL-5010 as a novel OTC treatment for the non-surgical removal of skin lesions. The product’s commercial launch by Omega Pharma is expected by mid-2016. Subject to the terms of the licensing agreement with Omega Pharma, BioLineRx plans to provide updates at a later stage regarding the commercial potential of the product and its contribution to the Company’s ongoing business.
BL-5010 is a novel product offering an alternative to painful, invasive and expensive skin lesion 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 Class 2a medical device. BL-5010 was licensed by BioLineRx from Innovative Pharmaceutical Concepts (IPC) Inc.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated: “We are very pleased with the CE mark approval for BL-5010, which is the final step necessary before the product’s launch as an OTC treatment in Europe, expected over the next few months. In particular, we would like to thank Omega Pharma for their efficient and professional development of this novel product, and hope this regulatory approval will also expedite the potential expansion of the product to other markets as well as to additional indications.”
“We in-licensed BL-5010 as a pre-clinical asset, completed all the necessary pre-clinical and clinical studies, successfully changed the development pathway in Europe from a drug to device, developed a new and unique applicator for the product, and extended the product’s patent life by many years. While our clinical and business focus remains on oncology and immunology, BL-5010 is an excellent example of our ability to create value from our non-core products as well, and to successfully bridge the gap between pre-clinical and advanced clinical development stages,” concluded Dr. Savitsky.