Apraclonidine Hydrochloride

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.libproxy1.nus.edu.sg/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.

UK marketing authorisations forIOPIDINE® (apraclonidine) fully transferred to Essential Pharma as change in UK NICE guidelines for glaucoma treatment expected to lead to increase in patients’ need for product Recent change in NICE guidelinesindicating laser surgery as first line therapy for glaucoma is expected to increase need for IOPIDINE to control or prevent post-surgical elevations in intraocular pressure Continuation of global marketing authorisation transfer from Novartis for this important product Zug, Switzerland &Egham, UK – 15 December 2022 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically well-established pharmaceutical products across key therapeutic areas, announces that it has completed the transfer of the UK marketing authorisations for IOPIDINE® (apraclonidine) in both available concentrations, IOPIDINE® 0.5% and 1%, following its acquisition of the product from Novartis in December 2021. IOPIDINE® is a short-term adjunctive therapy for patients with chronic glaucoma to prevent or control intraocular pressure*,1 including after selective laser therapy, a form of laser eye surgery now recommended as the initial treatment for open angle glaucoma.2 A recent change in regulations by the UK’s National Institute for Health and Care Excellence (NICE), which placed laser surgery as first line therapy for glaucoma, means that IOPIDINE®, especially IOPIDINE® 1% which is indicated to control or prevent post-surgical elevations in intraocular pressure that occur in patients after selective laser therapy (SLT), will continue to be an important treatment for glaucoma patients that require additional intraocular pressure reduction.2 The acquisition of this long-established therapy sold across more than 20 global markets including several countries in the EU plus Canada, Australia and Japan, is in line with Essential Pharma’s commitment to ensure the sustainable supply of essential specialty medicines to patients. The acquisition also demonstrates Essential Pharma’s strong integration capabilities for newly acquired products and underlines the group’s strategy to be a trusted partner to regional and global pharma companies looking to streamline their portfolios across international markets. Steen Vangsgaard, CEO of Essential Pharma, commented: “We are delighted to have completed the MA transfer, enabling us to ensure the continued supply of IOPIDINE® and fulfilling a vital need for patients, as has been demonstrated by the change in recent NICE guidelines. We are also pleased that Novartis chose us as a trusted partner for its divestment, further underlining Essential Pharma’s expertise and commitment to ensuring long-term, structured supply of established medicines.” Gus Gazzard, Professor of Ophthalmology (Glaucoma Studies) UCL & Director of Surgery at Moorfields, commented: “Based on a 3-year scientific study, we compared the treatment of glaucoma using continuous daily eye drops with initial selective laser therapy. This study has shown that SLT has favourable cost-effectiveness versus treatment with daily eye drops.3 Followed by a public consultation finalised in 2021, NICE decided to change the guidelines to recommend SLT as a first line therapy for all open angle glaucoma, which is expected to contribute to meaningful savings to the NHS over the coming years.” 2 In the UK, chronic open angle glaucoma (COAG) affects around 2% of people aged over 40 and can rise to almost 10% in people aged over 75. Ocular hypertension (OHT) affects 3-5% of people in the UK over 40 years of age and occurs when pressure inside the eye is higher than normal, which can cause glaucoma. According to latest NICE guidelines which were updated in 2022, SLT is now recommended as a first line option to treat glaucoma and ocular hypertension allowing patients to quickly receive effective treatment to improve their quality of life.2 1. IOPIDINE® Summary of Product Characteristics. Available from . Accessed December 2022 2. NICE, Press Release 26 January 2022. Selective laser therapy recommended to treat glaucoma and ocular hypertension. Available from (Wednesday%2C%2026%20January). Accessed December 2022 3. Gazzard G, Konstantakopoulou E, Garway-Heath D, et al. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial, Lancet. 2019 Apr 13;393(10180):1505-1516. ( . Accessed December 2022) About Essential Pharma Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to well-established, "at risk" products essential to patients across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving patients access to medicines that otherwise may not be available. Essential Pharma operates globally, supplying a portfolio of over 150 essential medicines across multiple therapeutic areas. Essential Pharma's growth strategy is based around identifying and acquiring mature, at-risk products from larger pharmaceutical groups looking to streamline their product portfolios. Essential Pharma is a trusted partner to multiple pharma companies of all sizes with a proven history of integrating assets, managing complex technology and product transfers while ensuring continual and sustainable supply to patients. Essential Pharma maintains strong relationships with partners at multiple manufacturing sites across Europe and the US in order to ensure the continuing manufacture of its products to the highest regulatory standards. Essential Pharma's growth strategy is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long term sustainable growth, including healthcare. For more information, please visit essentialpharmagroup.com CONTACTS Essential Pharma Steen Vangsgaard, CEO Tel: +44(0)1784 477 167 Email: info@essentialpharmaceuticals.com Consilium Strategic Communications Mary-Jane Elliott / Tracy Cheung / Matthew Cole Tel: +44 (0) 20 3709 5700 Email: Essentialpharma@consilium-comms.com