Strides Pharma (Cyprus) Ltd.

- Astellas contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium - TOKYO, Dec. 17, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel to treat one of the neglected tropical diseases, schistosomiasis, in preschool-aged children (3 months to 6 years of age) on December 15. EMA assessed arpraziquantel under the EU-Medicines for all (EU-M4all) *1 procedure for high-priority medicines intended for use in countries outside the European Union. For more details on arpraziquantel, please refer to the Consortium's press release. Continue Reading Astellas provided its innovative formulation technology to co-develop arpraziquantel as a member of the Consortium. The new pediatric formulation of arpraziquantel is palatable for very young children by reducing the bitter taste associated with the medication and administered via a 150 mg dispersible tablet that is dissolved in water. The prototype of the pediatric formulation has been developed by Astellas and further optimized by Merck (Germany) for global production using simple manufacturing processes yielding tablets that can remain shelf stable, even in hot and humid tropical climates. Farmanguinhos (Brazil) brings expertise in production and distribution and will be the manufacturing site for the future introduction of the new pediatric medication in endemic countries. The partnership with Universal Corporation Ltd. (Kenya) is also supporting the planned future large-scale local production to serve African countries. In parallel with this regulatory work, the Consortium's implementation research program (ADOPT)*2 is ongoing and preparing for the introduction of arpraziquantel in the first endemic countries in Africa. To ensure equitable and sustainable access, it is essential that new procurement and funding mechanisms are collaboratively explored and established. The intent is to make the product available at an at-cost basis in sub-Saharan African countries. Astellas has set a Strategic Goal to "deepen our engagement in sustainability" in the Astellas Corporate Strategic Plan 2021. To address the key sustainability issue of Access to Health (ATH), Astellas uses a comprehensive approach including, (1) Astellas' core business (Rx, Rx+), (2) Enhancing availability of Astellas products (Access to Medicines), and (3) Collaboration and support for the activities implemented by external partners. Initiatives in the Consortium apply to (3), and the positive CHMP scientific opinion by EMA of arpraziquantel represents a significant milestone in alignment with Astellas' Access to Health focus. Naoki Okamura, President and CEO, Astellas "We are so pleased that arpraziquantel received a positive scientific opinion by EMA, and also proud that Astellas could contribute to its development by providing our innovative formulation technologies. Access to Health is essential to the health of people around the world, and we recognize it as a material issue for Astellas. Through our VISION to be "On the forefront of healthcare change to turn innovative science into VALUE for patients", we are proactively taking a comprehensive approach to solving this issue." For more information on Astellas' contribution to the development of arpraziquantel, please see (). About schistosomiasis Schistosomiasis (also known as bilharzia) is one of the most prevalent parasitic diseases worldwide and a very important one in terms of public health burden and economic impact. It is a poverty-related disease that is widespread in tropical and subtropical regions where large sections of the population have no access to clean water. Flatworms transmit the disease and people become infected with the parasite through contact with freshwater, for example, while working, swimming, fishing, or washing their clothes. The minuscule larvae penetrate human skin, enter the blood vessels, and attack internal organs. The infection rate is particularly high among children. Schistosomiasis is a chronic condition and is classified by the World Health Organization (WHO) as one of 20 neglected tropical diseases (NTDs). About Arpraziquantel The current standard of care treatment for schistosomiasis is praziquantel. Praziquantel is safe, effective, and suitable for school-aged children and adults. Extending the range of options for the treatment of schistosomiasis, arpraziquantel is tailored for preschool-aged children against Schistosoma mansoni and Schistosoma haematobium. Tested in clinical development, under the responsibility of Merck, arpraziquantel contains the pharmacologically active enantiomer of praziquantel. In developing arpraziquantel, the Pediatric Praziquantel Consortium established a pediatric drug development program, divided into four major steps: preclinical development, clinical development, registration, and access. All details can be found on the Consortium website. About the Pediatric Praziquantel Consortium The Pediatric Praziquantel Consortium is an international public-private partnership that aims to reduce the global disease burden of schistosomiasis and improve child health by addressing the medical needs of infected preschool-aged children. Its mission is to develop, register, and provide access to a suitable pediatric drug for treating schistosomiasis in children 3 months to 6 years of age. For more information, and to see an overview of all Consortium partners, visit the Consortium website. Consortium Partners Merck (Germany) Astellas Pharma Inc. (Japan) The Swiss Tropical and Public Health Institute (Switzerland) Lygature (The Netherlands) Farmanguinhos (Brazil) Unlimit Health (United Kingdom) Kenya Medical Research Institute (Kenya) Université Félix Houphouët-Boigny (Côte d'Ivoire) Klinikum rechts der Isar der Technischen Universität München (Germany) Ministry of Health Côte d'Ivoire (Côte d'Ivoire) African Institute for Health and Development (Kenya) Other collaborators that contribute to the mission of the Pediatric Praziquantel Consortium: Makerere University School of Public Health (Uganda) Ministry of Health Kenya, Division of Vector Borne and NTDs (Kenya) Ministry of Health Uganda, Vector Borne and NTDs Control Division (Uganda) About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. SOURCE Astellas Pharma Inc.

EMA assessed arpraziquantel under the EU-M4all procedure for high-priority medicines intended for use in countries outside the European Union Merck KGaA, Darmstadt, Germany, is committed to contribute to the elimination of schistosomiasis as a public health problem by 2030 Merck KGaA, Darmstadt, Germany, a leading science and technology company, and the Pediatric Praziquantel Consortium today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in children aged 3 months to 6 years. The application was submitted by Merck KGaA, Darmstadt, Germany, on behalf of the Consortium, under the EU-M4all procedure for high-priority medicines for human use intended for countries outside the European Union. “With this positive response by EMA, a critical milestone was achieved to broaden the range of options for the treatment of schistosomiasis so as to address the needs of millions of preschool-aged children”, said Peter Guenter, Member of the Executive Board and CEO of Healthcare at Merck KGaA, Darmstadt, Germany. “I thank all partners of the Pediatric Praziquantel Consortium for this achievement and for the continuous collaboration. Together, we strive to contribute to the elimination of schistosomiasis as a public health problem by 2030, as part of our commitment to drive health equity through our innovations and products.” Arpraziquantel is derived from praziquantel, the standard of care treatment of schistosomiasis developed in the 1970s. Extending the range of options for the treatment of schistosomiasis, arpraziquantel is tailored for use in preschool-aged children. The tablet is administered by dissolving it in water and has an improved taste to make it more palatable for very young children. In addition, the 150mg tablet has been specifically designed to withstand the hot and humid conditions presented by a tropical climate. The positive CHMP scientific opinion by EMA is the basis for a potential inclusion of arpraziquantel in the World Health Organization’s list of prequalified and essential medicinal products. Together with the positive scientific opinion, the planned prequalification will support the regulatory pathway in African countries. In Brazil, regulatory submission is under preparation by Consortium partner, Farmanguinhos. As the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, Farmanguinhos brings expertise in production and distribution, and will be the manufacturing site for the future introduction of the new pediatric medication in endemic countries. For planned future large-scale local production to serve African countries, Merck KGaA, Darmstadt, Germany, has also partnered with Universal Corporation Ltd., Nairobi, Kenya . In parallel, within the Consortium, the implementation research program (ADOPT) is currently ongoing, preparing for the introduction of arpraziquantel in the first endemic countries in Africa. To support equitable and sustainable access, it is essential that new procurement and funding mechanisms are collaboratively explored and established. The intent is to make the product available at an at-cost basis in sub-Saharan African countries. The collaborative program on arpraziquantel is part of the integrated approach of Merck KGaA, Darmstadt, Germany, to contribute to the elimination of schistosomiasis as a public health problem. Indeed, through its Schistosomiasis Elimination Program, Merck KGaA, Darmstadt, Germany, addresses the key requirements of the WHO’s 2021-2030 Roadmap for Neglected Tropical Diseases and contributes to the United Nations’ Sustainable Development Goals, especially Good Health and Well-Being (Goal 3) and Partnerships (Goal 17). The program also aligns with the Sustainability Strategy of Merck KGaA, Darmstadt, Germany, and the company’s commitment to expand sustainable and equitable access to medicines by bringing its existing products and innovative portfolio to patients in low- and middle-income countries recognizing the needs and the specificity of the health systems in each of the country. About EU-M4all Through the EU-M4all procedure , the European Medicines Agency (EMA), in cooperation with the World Health Organization (WHO), can provide scientific opinions on high-priority human medicines, including vaccines, that are intended for markets outside of the European Union (EU). The procedure was previously known as the Article 58 procedure, as the legal basis is Article 58 of Regulation (EC) No 726/2004. More information can be found here . About Arpraziquantel The current standard of care treatment for schistosomiasis is praziquantel, listed on WHO’s list of essential medicines , and suitable for school-aged children and adults. Extending the range of options for the treatment of schistosomiasis, arpraziquantel is tailored for preschool-aged children against Schistosoma mansoni and Schistosoma haematobium . Tested in clinical development under the responsibility of Merck KGaA, Darmstadt, Germany , arpraziquantel contains the pharmacologically active enantiomer of praziquantel. It is a 150mg dispersible tablet. The prototype of its pediatric formulation was developed by Astellas in Japan and further optimized by Merck KGaA, Darmstadt, Germany, in Germany. The manufacturing process served to produce clinical trial supplies from Merck KGaA, Darmstadt, Germany, and Farmanguinhos in Brazil. Future manufacturing is planned to be done by Farmanguinhos and Universal Corporation Ltd., in Kenya, which is preparing for extensive local production capacities in and for Africa. About Schistosomiasis Schistosomiasis (also known as bilharzia) is one of the most prevalent parasitic diseases worldwide and a very important one in terms of public health burden and economic impact. It is a poverty-related disease that is widespread in tropical and subtropical regions where large sections of the population have no access to clean water. Flatworms transmit the disease and people become infected with the parasite through contact with freshwater, for example, while working, swimming, fishing, or washing their clothes. The minuscule larvae penetrate human skin, enter the blood vessels and attack internal organs. The infection rate is particularly high among children. Schistosomiasis is a chronic condition and is classified by the World Health Organization (WHO) as one of 20 neglected tropical diseases (NTDs). About the Schistosomiasis Elimination Program of Merck KGaA, Darmstadt, Germany, Merck KGaA, Darmstadt, Germany, initiated its Schistosomiasis Elimination Program in cooperation with WHO back in 2007. Since then, more than 1.9 billion tablets have been donated, enabling the treatment of over 760 million people, mainly school-aged children in 47 endemic countries. Merck KGaA, Darmstadt, Germany, has committed itself to maintaining its efforts in the fight against the tropical disease until schistosomiasis is eliminated as a public health burden. To this end, each year Merck KGaA, Darmstadt, Germany, provides up to 250 million tablets to WHO. In addition, Merck KGaA, Darmstadt, Germany, has adopted an integrated schistosomiasis strategy that is implemented in close collaboration with partners worldwide and focuses on: treatment, research & development, WASH (Water, Sanitation & Hygiene), advocacy & partnerships. More information about the Schistosomiasis Elimination Program of Merck KGaA, Darmstadt, Germany, is available at www.makingschistory.com . About the Pediatric Praziquantel Consortium The Pediatric Praziquantel Consortium is an international not-for-profit partnership that aims to help improving child’s health by addressing the medical needs of preschool-age children with schistosomiasis for potentially reducing the global burden caused by this disease. Its mission is to develop, register and provide access to a suitable pediatric drug for treating schistosomiasis in children three-months to six years of age. For more information, and to see an overview of all Consortium partners, visit the Consortium website: www.pediatricpraziquantelconsortium.org The Consortium is financially supported by Merck KGaA, Darmstadt, Germany; in-kind contributions from the Consortium’s partners; and grants from the Bill and Melinda Gates Foundation (2012), the Global Health Innovative Technology Fund (GHIT) (2014, 2015, 2016, 2019 & 2020), and the European & Developing Countries Clinical Trials Partnership (EDCTP), under its second program supported by the European Union (2018 & 2021). All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.emdgroup.com/subscribe to register for your online, change your selection or discontinue this service. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Global malaria cases have been on the rise in recent years, according to the World Health Organization. Universal Corporation Limited, a unit of Strides Pharma Science, became the first African drug manufacturer to snare a World Health Organization (WHO) pre-qualification (PDF) to produce the anti-malarial drug sulfadoxine-pyrimethamine and amodiaquine (SPAQ). The treatment is a combination regimen used to prevent malaria in children living in areas with seasonal malaria transmission. The WHO's pre-qualification program is designed to set standards of quality, safety and efficacy in manufacturing medicines. With the designation, Kenya-based UCL will look to boost regional production and access to essential medicines on the African continent, where about 95% of all malaria cases and 96% of deaths from malaria occur, the company said in a Nov. 6 press release. “Universal Corporation is committed to advancing the fight against malaria and improving the health and well-being of communities across Africa,” Perviz Dhanani, founder and managing director of UCL, said in the release. “The WHO prequalification of our SPAQ production is a significant step forward in achieving these goals.” In 2022, WHO began to recommend SPAQ for any child at high risk of severe malaria in areas with seasonal malaria transmission. This recommendation resulted in more than 48 million children being protected from malaria, significantly reducing the burden of this deadly disease, the organization said. According to WHO, the reported cases of malaria hit 247 million in 2021, compared with 245 million in 2020 and 232 million in 2019. In an unrelated but recent move, Strides in September said it planned to spin off its CDMO and soft gelatin businesses into a single entity that will be known as OneSource. The goal of the spinoff, which is expected to happen in the next year, is to establish a specialty pharmaceutical CDMO company that offers services for biologics, oral softgels, complex injectables, sterile injectables and other complex drug delivery systems.