Haloperidol Decanoate

Agreement drives continued patient access to four important therapies in Japan and Korea Strengthens Essential Pharma and Clinigen’s combined market presence in the JAPAC region 6th February 2025 – Essential Pharma (“Essential” or “the Company”), an international specialty pharma group focused on ensuring that patients have access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, and Clinigen, the global specialty pharmaceutical services group, today announced an expansion of their JAPAC collaboration, aimed at driving continued patient access to four therapies in Japan and Korea, and strengthening their combined market presence in the region. This expanded collaboration encompasses several new market authorisation transfer and exclusive distribution agreements. Building on their 2024 agreement for IOPIDINE® (apraclonidine) in Korea, Essential Pharma and Clinigen now extend this to Japan. New agreements establish market authorisation transfer and exclusive distribution for HALDOL® (haloperidol) and REMINYL® (galantamine) oral capsules in Korea, and for HALOMONTH® (haloperidol decanoate) in Japan. IOPIDINE 5mg/ml is a short-term adjunctive therapy for patients with chronic glaucoma on maximally tolerated medical therapy to prevent or control intraocular pressure. HALDOL and HALOMONTH are antipsychotic drugs that contain haloperidol and are used in the treatment of schizophrenia and other psychiatric conditions including schizoaffective disorder. Haloperidol is included in the 2023 World Health Organization’s List of Essential Medicines1. REMINYL, a cholinesterase inhibitor, is a central nervous system (CNS) drug used to treat symptomatic mild to moderately severe dementia of the Alzheimer type. Essential Pharma CEO Emma Johnson and Clinigen CEO Jerome Charton held a ceremonial signing event yesterday. While initially focused on ensuring continuity of patient access in the JAPAC region, both organisations envision further strategic partnering, supporting Essential Pharma's goal to build on its diversified portfolio and late-stage pipeline focused on central nervous system, gastroenterology, ophthalmology, and rare disease, and leveraging Clinigen's rare disease and orphan drug expertise, to improve access to innovative medicines for patients globally. Emma Johnson, CEO of Essential Pharma, says: “Essential Pharma is delighted to expand our relationship with Clinigen as we continue to execute our strategy to become a leading, global specialty pharma group with a growing rare disease presence. Clinigen’s expertise in providing access to established brands as well as their expertise in the rare disease and orphan drug space makes them the ideal partner as we broaden access to our therapies and reinforce our strategic foothold in JAPAC. Guided by our shared patient-centric values, this collaboration represents a significant step forward in our commitment to serving patients in the JAPAC region and beyond.” Jerome Charton, CEO of Clinigen, says: “Our biggest achievements are marked by expanding patient access to much-needed medicines. While we are seeing the expansion of life sciences, R&D and clinical trials, population health is also becoming increasingly complex, and it is pertinent that patients do not feel the impact. With our trusted and equally motivated partner, Essential Pharma, Clinigen will further our mission to accelerate access to innovative medicines for patients worldwide.” Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to clinically differentiated, niche, branded medicines across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving underserved patient populations access to medicines that otherwise might not be available, and addressing clinical unmet needs. Essential Pharma operates globally in more than 70 countries, supplying a portfolio of products with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare disease. The group’s growth strategy is centred on portfolio optimisation and a targeted M&A approach to acquire commercial and late-clinical stage assets in the four therapeutic areas of focus. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous supply to patients. Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa, and the Asia Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year. 1 https://iris.who.int/bitstream/handle/10665/371090/WHO-MHP-HPS-EML-2023.02-eng.pdf The content above comes from the network. if any infringement, please contact us to modify.

MIAMI--(BUSINESS WIRE)-- Terran Biosciences Inc. ("Terran"), a biotech platform company developing therapeutics and technologies for patients with neuropsychiatric illnesses, has announced the development of TerXT, a combination of novel prodrugs of xanomeline and trospium designed to be long-acting treatments for schizophrenia. Terran has received notice of patent claims found to be allowable from the United States Patent and Trademark Office (USPTO) for the composition of matter for the world’s first prodrugs of xanomeline. To develop TerXT, Terran sought to overcome inherent pharmacokinetic and physical property limitations of the compounds xanomeline and trospium, such as poor colonic absorption and high aqueous solubility, by utilizing a novel prodrug strategy. These prodrugs were designed to enable fixed-dose combinations for once-daily oral administration (“TerXT”) and long-acting intramuscular injection with multi-month duration (“TerXT LAI”). These new forms could potentially allow Terran to pursue accelerated development and regulatory strategies such as the FDA 505(b)(2) approval pathway. Recent clinical trials of an oral, twice-daily, fixed-dose combination of xanomeline, a compound invented in the 1990s, and trospium, invented in the 1960s, have demonstrated safety and efficacy in treating schizophrenia. This combination has been submitted to the FDA for approval on the 505(b)(1) path and is currently undergoing FDA review, with a decision expected by September this year. If the FDA approves the xanomeline/trospium combination, Terran plans to pursue the rapid 505(b)(2) approval pathway for TerXT and TerXT LAI. This regulatory pathway could potentially enable Terran to use pharmacokinetic bridging studies and leverage existing safety and efficacy data from completed trials to bring Terran’s next-generation therapeutics to market approximately five years after the first xanomeline/trospium approval, helping to broaden access for patients, improve the use profile, and increase affordability. In order to successfully overcome the pharmacokinetic limitations of xanomeline and trospium, Terran assembled a team of the world’s experts in medicinal chemistry, resulting in over 10,000 new prodrugs designs. Terran’s PK modeling team developed a predictive model of both xanomeline and trospium across a vast spectrum of different formulation designs and release profiles to determine the optimal pharmacokinetic parameters and ratios. Terran utilized a team of 200 chemists to synthesize over 500 prodrugs, which then underwent preclinical testing, including 285 in vitro and 365 in vivo studies. “We’ve seen the prodrug approach significantly improve long-acting formulations of some of the most effective antipsychotics to date, including Aristada®, Haldol® Decanoate, and Invega Hafyera®, to the great benefit of patients,” said Sam Clark, MD, PhD, Terran’s founder and CEO, and inventor on the patent. “However, these improved forms were not developed until many years after the original compounds were first approved; in some cases, decades later. At Terran, we believe patients shouldn’t have to wait for the latest technology and we believe that our prodrugs of xanomeline and trospium will enable improvements in ease of use and quality of life on a much more rapid timescale than has historically been achieved.” ABOUT TERRAN BIOSCIENCES Terran Biosciences is a biotech platform company developing a portfolio of therapeutics and technologies for patients with neurological and psychiatric diseases. Terran has built a CNS-focused, tech-enabled drug development platform and is rapidly advancing a number of assets that include late-stage therapeutics for schizophrenia, an FDA-cleared neuroimaging software platform, and a drug design engine that has generated first-in-class and best-in-class psychedelic-based therapeutics and novel prodrugs optimized for patient use. Follow us on LinkedIn and X. For more information on TerXT visit