Baclofen/Naltrexone Hydrochloride/D-Sorbitol

Rochester, N.Y., Nov. 9, 2023 /PRNewswire/ -- Unither Manufacturing LLC celebrates this year its 10-year anniversary. Acquired in October 2013 to expand Unither Pharmaceuticals' group international presence, the Rochester (NY) site kept its previous activities while developing 2 core technologies: Blow-Fill-Seal (BFS) and Liquid Stick-pack technologies. Continue Reading Unither Manufacturing LLC in Rochester, NY "Our goal in Rochester is to continue building capacity to support the North American needs for BFS and Liquid Stick-Pack. Why BFS? Because at UNITHER, we envision a world where preservative free ophthalmic formulation is the norm, and patients don't have to compromise between safety and efficacy. We believe that everyone deserves access to safe, effective, and affordable treatments for their eye conditions, and are committed to making that vision a reality here in the US by supporting our partners regionally. Similarly, the Stick-Pack, as a unit dose format, offers a unique and safe way to dispense oral medication. While this technology helps improving the delivery of existing medication, the Liquid Stick-Pack also shows unique benefits for the delivery of Orphan drug, allowing dosage accuracy, as well as favorizing the treatment adherence by patients." says Julien SEID, Unither's North American General Manager. The site is involved in numerous development and technology transfer projects. For example, the CDMO is working on development projects such as PXT3003 for its customer PHARNEXT, an orphan drug for Charcot-Marie-Tooth disease type 1A (CMT1A), and but also supporting various companies specialized in Ophthalmic products in different stages, from the early stages through Phase III and commercial production of new and innovative sterile preservative-free products in BFS. The site also manufactures diagnostic reagents for Covid and Influenza tests, Cough & Cold Oral Suspension with extended release, controlled substances Oral solution and capsules. About Unither Manufacturing LLC Unither Manufacturing LLC was created by the French CDMO Unither Pharmaceuticals in October of 2013 with the acquisition of the pharmaceutical facility located at 755 Jefferson Rd. The Rochester site which is 430,500 square feet and have 320 employees is specialized in the development and manufacturing of pharmaceuticals products, generics, over-the-counter products, prescription drugs, in various dosage forms such as Sterile single dose units in Blow-Fill-Seal (BFS), Non-Sterile Liquid Stick-Packs and Non-Sterile Liquid Bottles, Controlled Substances and Extended releases capabilities. The facility is FDA approved and regularly inspected (General GMP and Sterile PAI in October of 2021, and Non-Sterile PAI in January 2020). Contact Unither Manufacturing LLC 755 Jefferson Road Rochester, NY 14623 Email: [email protected] Photo - Logo - SOURCE Unither Pharmaceuticals

PARIS, FRANCE / ACCESSWIRE / January 4, 2023 / Pharnext SA (FR001400BV89:ALPHA) (the "Company"), an advanced late-clinical stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases with high unmet medical need, today announces the appointment of Scott Johnson as VP, Head of Quality. This appointment further strengthens the Company's Senior Leadership Team (SLT) at the start of this important year, notably with the anticipated topline results of the pivotal Phase III clinical study of the drug candidate PXT3003, the PREMIER trial, in development for Charcot-Marie-Tooth disease type 1A (CMT1A). More than 15 years' experience in Quality and Compliance in Healthcare Scott has more than 15 years of experience in quality management and compliance within the healthcare sector. He joins from Oyster Point Pharma, where he was Head of Quality Assurance. There, he established and implemented a comprehensive quality management system and oversaw all quality-related functions during the submission of an NDA application and successful launch of Oyster Point's first commercial product. Prior to Oyster, Scott served as Director, Quality Assurance at Lupin Pharmaceuticals where he had overall responsibility for quality and compliance. He has also held roles at Johnson & Johnson and Warner Chilcott. Scott has a BA in Organizational Management from the Eastern University, St. David's, PA and previously served in the United States Navy. At Pharnext, Scott will continue to develop and maintain the Company's Quality strategy and ensure its operational execution. He will oversee the Quality activities in the areas of Manufacturing (Good Manufacturing Practices), Laboratory (Good Laboratory Practices) and Clinical (Good Clinical Practices) to ensure compliance with regulatory requirements. Scott will also be responsible for promoting a quality mindset across the Company and working with cross-departmental leadership to ensure the delivery of high-quality products and services. A renewed and enriched SLT With this new appointment, Pharnext strategically completes its SLT, which is now composed of experts in their field, namely: Hugo Brugière, MSc, Chairman and Chief Executive Officer since December 2022, is a serial entrepreneur with more than twenty companies to his credit, he has specialized in stock market and restructuring/turnarounds of listed companies. Burkhard Blank, MD, Chief Medical Officer since January 2022, has over 25 years of experience in global drug development, medical and regulatory affairs, and pharmacovigilance. Rob Quinn, PhD, Chief Financial Officer since September 2022, has raised more than €200 million in financing to date in his career. Xavier Paoli, MSc, Chief Operating Officer since April 2014, has almost 20 years of experience in drug commercialization, notably for diseases with high unmet medical need without acceptable therapeutic solutions. Antoine Gravelle, General Counsel since July 2022, has over 15 years of legal experience in the pharmaceutical and biotech sector, notably at Sanofi, Cellectis and OSE Immunotherapeutics. Raj Thota, MSc, Chief Manufacturing Officer and Head of CMC since August 2021, has over 28 years of experience. Throughout his career, Raj has successfully led the development, optimization and launch of Xtampza® ER Capsules, Vimovo® Tablets, Osmolex® CR Tablets and Entocort® ER Capsules, and many more complex and patentable clinical stage molecules. Melissa Israel, BSc, VP, Clinical Operations since December 2020, has over 30 years of clinical research experience as a results-driven clinical operations leader at Gan & Lee Pharmaceuticals, Johnson & Johnson Consumer, Pfizer Consumer Healthcare, Pfizer, Inc. and Rhône-Poulenc Rorer (now Sanofi). Abhijit Pangu, MPharm, Head of Regulatory Affairs since October 2021, has over 20 years of pharmaceutical industry experience in navigating drug development with global regulatory authorities. Hugo Brugière, Chairman and Chief Executive Officer of Pharnext, commented: "I look forward to working with Scott and am delighted to welcome him to the Pharnext Senior Leadership Team. His experience in quality assurance through the supply chain will be invaluable to Pharnextas we continue to progress our lead candidate PXT3003 in the pivotal Phase III PREMIER trial to treat Charcot-Marie-Tooth disease type 1A." On his appointment as VP, Head of Quality, Scott Johnson commented: "I am thrilled to join Pharnext at such an important time. Pharnext is moving closer to its goal of bringing a much-needed treatment option to patients with CMT1A and I am excited to be part of this important journey." About Pharnext Pharnext is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases that currently lack curative and/or disease-modifying treatments. Pharnext has two lead products in clinical development. PXT3003 completed an international Phase III trial with positive topline results for the treatment of Charcot-Marie-Tooth disease type 1A (‘CMT1A') and benefits from orphan drug status in Europe and the United States. An international pivotal Phase III study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing. PXT864 has generated encouraging Phase II results in Alzheimer's disease and will be advanced through partnerships. Both of Pharnext's lead assets originated from the Pleotherapy™ R&D approach. Pharnext draws the attention of investors to the financial and other risk factors detailed in its financial reports. More information can be found at . Pharnext is listed on the Euronext Growth Stock Exchange in Paris (ISIN code: FR001400BV89). Contacts Media Relations (International) Consilium Strategic Communications Mary-Jane Elliott Sukaina Virji Alexandra Harrison pharnext@consilium-comms.com Financial Communication (Europe) ACTUS finance & communication Jérôme Fabreguettes Leib pharnext@actus.fr +33 (0)1 53 67 36 78 Media Relations (France) Ulysse Communication Bruno Arabian barabian@ulysse-communication.com +33 (0)6 87 88 47 26 +33 (0)1 81 70 96 30 SOURCE: Pharnext View source version on accesswire.com: