BNSO-3

ATHENS, Greece, May 30, 2023 /PRNewswire/ -- RAFARM, a Greek-based pharmaceutical company and established European manufacturer with expertise in Ophthalmics, and BioNanoSim (BNS), an Israeli-based nanotechnology drug discovery and development company co-founded by Prof. Simon Benita and Yissum, the Transfer Technology and IP company of The Hebrew University of Jerusalem, have entered into an agreement to create a new Ophthalmic company called BNS Ophthalmics (BNSO). BNSO will develop, manufacture and commercialize a range of innovative ophthalmic pharmaceutical products developed by BioNanoSim to address serious ophthalmic unmet needs for patients around the world. Over the past five years, BNS has developed the proprietary nano-technology platform (NTPO).The first product developed by BNSO according to this technology is BNSO-1, a Tacrolimus ocular emulsion for topical ocular administration. Tacrolimus is a potent non-steroidal drug with the potential to treat a wide range of serious ocular inflammatory conditions, but is highly unstable, insoluble in water, and does not permeate through the cornea. BNSO-1 demonstrates clear efficacy and safety in preclinical models. BNSO is on track to initiate a phase I/IIa clinical study before the end of 2023 in patients suffering from Chronic Anterior Uveitis. BNS has received FDA orphan designation for this indication and expects an accelerated 505b2 regulatory approval track assuming clinical results are positive. BNSO has two additional preclinical programs in its pipeline, both invented by Prof Benita and developed by BNS. The first is an innovative delivery technology enabling a prolonged release intravitreal injection of a steroid derivative drug (without any impact on the intra ocular pressure) for Macular Edema and Age-related Macular Degeneration [BNSO-2]. The second program is a novel topical drug for dry eye disease [BNSO-3]. Together, BNSO's programs target multibillion dollar global market opportunities. BNS will contribute its intellectual property and R&D expertise to BNSO while Rafarm will provide appropriate funding, together with infrastructure for development, commercial scale manufacturing, and distribution. Simon Benita, Professor Emeritus at The Hebrew University of Jerusalem, Founder, CEO and Chairman of ΒΝS, stated: "We are very pleased to partner with RAFARM and to leverage both organizations' expertise and infrastructure for promoting improved therapeutic options in the ocular area. At BNS, we synthesize new chemical entities and develop innovative delivery approaches to address some of healthcare's greatest challenges. BNSO will use our proprietary carrier technologies to improve the delivery, stability, and bioactivity of drugs in multiple ocular segments." Commenting on the partnership, Aris Mitsopoulos, Vice President of RAFARM, stated: "We are very proud of the establishment of BNS Ophthalmics, a company that enhances RAFARM's capabilities in innovation and contributes to cover unmet therapeutic needs in Ophthalmology. Our collaboration with BNS, whom we recognize as a leader in the field of nanotechnology, marks a significant milestone of RAFARM in innovative technologies. We join forces with BNS for the development and production of novel therapeutic products and to further expand our expertise in ophthalmics." About BioNanoSim (BNS) BioNanoSim is led by Prof. Simon Benita who has decades of scientific expertise as well as proven commercial success in bringing nanoparticle-based products to market. BioNanoSim is backed by strong leadership, the collective know-how of a talented cross-functional team, and affiliation with the Hebrew University. These enable us to target multiple areas of unmet needs simultaneously. Our inhouse GMP facility is the perfect platform for the manufacturing of independent nanocarrier-based drugs for clinical testing. About RAFARM RAFARM is an innovation-driven, dynamically growing pharmaceutical company and a well-established European manufacturer with an outward-looking orientation that invests 13% of net turnover in Research and Development. At RAFARM, we expand our exports worldwide and open new markets. We constantly enhance our expertise in complex pharmaceutical products and invest in high-tech platforms for the development and production of ophthalmics and injectables. We introduce high technology in our state-of-the-art sterile manufacturing plant and create new production lines with cutting-edge technology and robotic equipment. At RAFARM, we evolve beyond the obvious and make a positive impact on people's lives. Contacts: Alon Moran Tel: +972-2-5956171 [email protected] Christina Veiopoulou Tel: +30 211 176 1000 (1212) +30 6946 338234 [email protected] SOURCE RAFARM and BNS