Finafloxacin

SAB Strengthens GL CHEMTEC’s Mission of Being the Trusted North American CDMO for Small Molecule R&D, Scale-Up and Integrated Drug Delivery Solutions OAKVILLE, Ontario--(BUSINESS WIRE)-- GL CHEMTEC (“GLC”), a specialist in advanced chemistry R&D and scale-up services to support Active Pharmaceutical Ingredient (“API”) development, and the development of advanced materials for drug delivery, medical devices, and other life science applications, today announced the formation of its Scientific Advisory Board comprised of distinguished leaders in Small Molecule R&D (Chemistry/Biology), Process Development & Scale-Up, Green Chemistry, Medical Devices and Drug Delivery. Lisa Studnicki Hunt, Ph.D., COO and Co-Founder of GLC commented, “We are proud and honoured to introduce GL CHEMTEC’s inaugural SAB. This is a team of world leaders in their respective fields who bring a wealth of experience to our company during our next phase of growth. We can’t thank these outstanding individuals enough for committing their time and expertise to GL CHEMTEC’s success.” Gamil Alhakimi, Ph.D., MBA, CEO and Co-Founder of GLC commented, “It is a great privilege to welcome our distinguished Scientific Advisory Board members to the GL CHEMTEC family. Their vast experience and accomplishments in various scientific disciplines will be invaluable in supporting our dedication to innovation and growth within Small Molecule R&D, Scale-Up, and Integrated Drug Delivery Solutions. Their collaboration with our team will ensure we remain at the forefront of the industry, providing our clients with unparalleled expertise and cutting-edge solutions for years to come.” The founding members of the GL CHEMTEC Scientific Advisory Board are: Dr. John Warner is one of the cofounders of the field of green chemistry, coauthoring the defining text “Green Chemistry: Theory and Practice” and articulating the 12 principles of green chemistry with Paul Anastas. John has over 100 publications providing foundational work in the fields of noncovalent derivatization, polymer photochemistry, metal oxide semiconductors and synthetic organic chemistry. John received his BS in Chemistry from UMASS Boston, and his PhD in Chemistry from Princeton University. After working at the Polaroid Corporation for nearly a decade, he then served as tenured full professor at UMASS Boston and Lowell (Chemistry and Plastics Engineering). Dr. Mark Hellberg retired from Novartis where he built a Chemical Technologies group that developed an integrated model of chemical innovation as a key component of the discovery process spanning hit expansion through candidate advancement. Prior to joining Novartis, Mark was the Head of Research Chemistry at Alcon where he was responsible for medicinal chemistry, research, analytical and scale-up teams (initial synthesis through Phase 1 GMP material). He spent over 20 years at Alcon initially leading internal medicinal chemistry teams and ultimately serving as a member of both research and development governance boards representing all aspects of research chemistry. At Alcon he gained board experience in all aspects of ophthalmic drug discovery. Dr. Wolf-Ulrich Nickel has a PhD. In Organic Chemistry, which he earned at the University of Hamburg/Germany. After a Postdoc at ETH in Zürich/CH he entered the pharmaceutical industry in R&D area as his professional calling. From lab director in medicinal chemistry to research team leader, then project manager and later global program director, he contributed and was responsible for more than 40 drug development programs in ten therapeutic areas. He worked with increasing responsibilities and extended geographic foot print at companies Hoechst AG, HMR, Aventis, Kyowa-Kirin, Celgene and lately at Alcon and Novartis. Key areas were Ophthalmology/Otolaringology, Cardio-Metabolic-Renal, Neuroscience and Inflammatory diseases. Dr. Nickel contributed to more than forty patent applications and authored several academic and industrial publications with focus on chemistry and presented case studies at several project management and clinical association conferences. He retired recently from Novartis Pharmaceutical Corporation in US and continued to serve as consultant for program strategy reviews and scientific advisory boards. Dr. Rob Larsen is an organic chemist having received his BS degree in Chemistry from the University of Michigan-Dearborn and his PhD in Organic Chemistry with Professor Joseph P. Marino at the University of Michigan in Ann Arbor in 1982. He worked in the pharmaceutical industry for over 39 years in the area of Process Research & Development at Merck, Amgen, Alcon and Novartis having retired from Novartis in 2021. He rose through the ranks of Process R&D achieving the position of Executive Director. Over his career he was on the development teams that lead to the commercialization of rizatriptan, losartan, montelukast, etoricoxib, aprepitant, and finafloxacin. He is a co-author on 95 papers, 11 review articles and was the Book Editor for Topics in Organometallic Chemistry, Organometallics in Process Chemistry, Volume 6. His interests over his career covered heterocyclic chemistry, organometallics, in particular the application of palladium in processes, and biocatalysis. Dr. Kasey Minick has forty-one years of hands-on experience with Pharmaceutical (NDA & ANDA), OTC (Dry Eye, Ophthalmic Tears, Allergy, Vitamins, Oral liquids) and Medical Device (Contact Lenses and Contact Lens Care) Formulation Research and Development, Formulation Process Development and Engineering, Technical Transfer (R&D to Manufacturing), Product Registration and Project Management of full-scale Pharmaceutical and/or Medical Device projects from NCE/pre-clinical research to POC (proof of concept) through clinical studies to commercial transfer and commercial registration and product launch. Dr. Minick is a Pharm.D. and has worked for Alcon, CIBA Vision, Cardinal Health and Novartis. Dr. David Mangelsdorf is Professor and Chair of the Department of Pharmacology at UT Southwestern Medical Center and Investigator of the Howard Hughes Medical Institute. He holds the Alfred G. Gilman Distinguished Chair in Pharmacology and Raymond and Ellen Willie Distinguished Chair in Molecular Neuropharmacology. He is also an elected member of the U.S. National Academy of Sciences. Dr. Mangelsdorf is a molecular biologist and world leader in nuclear receptor and endocrine FGF signaling. Together with his scientific partner Steven Kliewer, he has discovered several of the orphan nuclear receptors, identified their hormonal ligands, and demonstrated their importance as therapeutic targets. About GL CHEMTEC: For almost 20 years, GL CHEMTEC (“GLC”) has been a leading chemistry-based CRO supporting the pharmaceutical industry and broader Life Sciences sector. GLC specializes in advanced multi-step organic synthesis, process R&D, and scale-up services to support API development, as well as advanced materials for medical devices, drug delivery, and other Life Science applications. GLC has a particular focus on the development of new bio-based materials inspired by the 12 Principles of Green Chemistry. Operating from two modern, North American-based facilities, GLC has the experience and capabilities to deliver materials ranging from milligrams to hundreds of kilos. GLC is the partner of choice from small emerging Biotechs to Big Pharma and other Life Science organizations, and is recognized for its speed and client-centric business model. Visit us at .

- Proceeds will be used to facilitate MerLion`s production and market launch of XtoroTM Berlin, (18/05/2021) - MerLion Pharmaceuticals GmbH (MerLion), a biopharmaceutical company focused on research and development of novel antibiotics for the treatment of serious bacterial infections, today announced the successful completion of a growth financing round raised via a private placement to European strategic investors. The funds raised will primarily be used to finance the production and market launch of MerLion’s US FDA and Health Canada approved drug XtoroTM, an otic suspension containing finafloxacin for treatment of ear infections. In addition to existing investors such as HeidelbergCapital and Vl Partners, new strategic investors such as Denk Pharma GmbH & Co. KG have taken part in the round. Further details were not disclosed. “This is a significant milestone in our mission to successfully launch Xtoro, an otic formulation of our antibiotic finafloxacin, in the US and Canada,” said Dr. Andreas Vente, Managing Director of MerLion. “This financing is proof of the high potential of our lead drug and the confidence of our investors in our strategy.” “We invest in projects and technologies that contribute significantly to patients’ healing,” said Stephan Huber, Managing Director at Denk Pharma. “Xtoro is an FDA-approved product for the treatment of Acute Otitis Externa in children and adults. Its superior, fast acting properties will aid patients considerably in their recovery.” ### About MerLion Pharmaceuticals MerLion Pharmaceuticals GmbH is a is a privately held company biopharmaceutical company headquartered in Berlin, Germany. The company  focuses on the advanced clinical development of its antibacterial lead program, finafloxacin. MerLion is supported by a group of leading global investors. For more information, please visit   POELLATH, Munich, Dr. Michael Inhester and Adalbert Makos advised MerLion on the investment and capital raise. About Finafloxacin Finafloxacin is a novel fluoroquinolone antibiotic with best-in-class features. Finafloxacin combines well-known, significant efficacy and resistance-breaking capabilities with an outstanding safety profile. In clinical and pre-clinical settings, the compound has shown a substantially improved therapeutic profile as compared to the existing gold standard and a broad utility in treating many severe infections, including those caused by resistant Gram-negative pathogens. Finafloxacin is available as intravenous, oral, and topical formulation. Finafloxacin’s superior profile arises from the compound’s unique mode of action, being equally active at physiological pH conditions and in the acidic environments which occur at most bacterial infection sites. Most other antibiotics, including other fluoroquinolones, show decreased activity under acidic tissue conditions, which results in a significant reduction of their overall efficacy. In addition to the FDA-approved liquid suspension formulation of XTORO™, MerLion has also developed intravenous and oral formulations of finafloxacin with equivalent bioavailability, which may offer physicians various options for in-hospital and out-patient treatment regimens. The impact of finafloxacin for the treatment of infections caused by the biological intracellular threat agents Burkholderia pseudomallei, Francisella tularensis, Yersinia pestis and other multi-drug resistant (MDR) pathogens of clinical significance are currently being investigated in a joint project with the Defense Science and Technology Laboratory, UK (Dstl). Dr. Andreas Vente        Managing DirectorMerLion Pharmaceuticals Gmbh Robert-Roessle-Str. 1013125 Berlin, Germany Phone: +49 (0) 30 9489-4050 Fax: +49 (0) 30 9489-4051enquiry@merlionpharma.de