Cysticercosis

TOKYO, May 25, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has committed to supporting the 3rd phase of the Global Health Innovative Technology Fund (GHIT Fund), together with a cross-sector group of funding partners. The cross-sector group has committed over US$200 million to the GHIT Fund. Furthermore, we have contributed to the GHIT Fund for three consecutive terms since the inception of the GHIT Fund. The GHIT Fund launched in 2013 to leverage Japanese expertise and capability for life-saving health innovations, including drugs, vaccines and diagnostics, to combat infectious diseases including tuberculosis, malaria, neglected tropical diseases (NTDs)*1 prevalent in the world's poorest countries. A public interest corporation registered in Japan, the GHIT Fund is the first international public-private partnership fund (PPP) between the Japanese Government: Ministry of Foreign Affairs, Ministry of Health, Labor and Welfare, private sector, the Bill & Melinda Gates Foundation, the Wellcome and the United Nations Development Programme. The GHIT Fund has invested about 29.1 billion yen to support approximately 115 projects over the last ten years. The GHIT Fund engages in direct and effective activities, such as the establishment of a public-private partnership mechanism and launching R&D projects utilizing Japanese drug discovery technologies, innovations and investment in diagnostics development. "Astellas is working to solve issues of Access to Health (ATH) through the GHIT Fund which Astellas has been participating in since the 1st phase of the GHIT Fund and is participating in a GHIT-funded consortium*² that aims to develop a potential new pediatric treatment option for schistosomiasis in preschool-aged children." said Naoki Okamura, President and CEO of Astellas. "Astellas is contributing to this development by leveraging our formulation technologies and know-how. In addition, we have contributed to malaria research in collaboration with partners to solve issues of ATH since 2017." *1: About Neglected Tropical Diseases (NTDs) According to the World Health Organization (WHO), Neglected Tropical Diseases (NTDs) are a diverse group of communicable diseases that prevail in tropical and subtropical conditions and affect more than 1.6 billion people, costing developing economies billions of dollars every year. They mainly affect populations living in poverty, without adequate sanitation and in close contact with infectious vectors and domestic animals and livestock. NTDs are a group of 20 infectious diseases – Buruli ulcer, Chagas disease, Dengue/Chikungunya, Dracunculiasis (guinea-worm disease), Echinococcosis, Foodborne trematodiases, Human African trypanosomiasis (sleeping sickness), Leishmaniasis, Leprosy (Hansen's disease), Lymphatic filariasis, Mycetoma, Onchocerciasis (river blindness), Rabies, Scabies and other ectoparasitoses, Schistosomiasis, Soil-transmitted helminthiases, Snakebite envenoming, Taeniasis/Cysticercosis, Trachoma, Yaws (Endemic treponematoses) . *2: Schistosomiasis and consortium of pediatric formulation for praziquantel Schistosomiasis is one of the most prevalent parasitic diseases in tropical countries, mainly in sub-Saharan Africa. The disease has a particularly high incidence rate among children. The existing "gold standard" treatment for schistosomiasis is praziquantel. However, one challenge is that praziquantel tablets are difficult to administer to preschool-aged children, including infants and toddlers, mainly due to their large size and the drug's bitter taste. Together with a consortium of partners, Astellas has contributed to developing a potential new pediatric treatment option, arpraziquantel, for schistosomiasis in preschool-aged children. Derived from praziquantel, arpraziquantel is a small orally dispersible tablet, with reduction of bitterness. The new formulation was initially developed by Astellas. Arpraziquantel can be manufactured using simple production technology, while holding down production costs, and the tablets are stable even in the hot and humid environment of tropical areas. Astellas has transferred the technology and expertise needed to develop it to a consortium partner in Brazil, thereby helping to build local pharmaceutical manufacturing capabilities. In December 2022, EMA (European Medicines Agency) has validated the regulatory application for arpraziquantel and has started its review process. 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.

PISCATAWAY, N.J., April 23, 2021 /PRNewswire/ -- MSN Labs, based in Hyderabad, India, received FDA approval to market their generic versions of Albendazole 200mg tablets (AB rated to Albenza©), Droxidopa 100mg, 200mg, 300mg capsules (AB rated to Northera ©), Deferasirox Granules 180mg, 360mg sachets (AB rated to Jadenu Sprinkles©) and Pregabalin ER 82.5mg, 165mg, 330mg tablets, (AB rated to Lyrica CR©) under the Novadoz label. Novadoz is the U.S sales and marketing affiliate for MSN's portfolio of finished dosage forms. The company has commenced shipping of all the products which received approvals during Q1 2021. Albendazole 200mg is marketed in bottles of 2 tablets. It is indicated for the treatment of neurocysticercosis which is an infection caused by the pork tapeworm in the muscles, brain, and eyes that may cause seizures, brain swelling, and vision problems. The most recent 12 month published sales of the brand and generics total $26.9mil. Droxidopa 100mg, 200mg, & 300mg are available in bottles of 30 capsules. It is indicated for the symptomatic treatment of dizziness, lightheadedness, or fainting/black out sensation due to neurogenic orthostatic hypotension (a sudden fall in blood pressure). Novadoz participated in a Day 1 launch of the product, coinciding with the expiration of the brand exclusivity. Previous 12 month published sales for the brand totaled $366mil. Novadoz has also offered a patient e-voucher assistance plan for those qualified consumers needing aid to cover their out of pocket prescription co-pay costs for Droxidopa. Visit NovadozPharma.com to learn more information on the program. Among their recent FDA approvals include niche products, Deferasirox Granules 180mg, and 360mg that are available in a carton of 30 sachets. The product is used treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions. The other niche offering includes Pregabalin ER 82.5mg, 165mg, and 330mg tablets available in bottles of 30. The product is indicated for the treatment of pain caused by nerve damage due to diabetes or shingles (herpes zoster). Seshu Akula, Novadoz President North America Generics, states, "The first quarter of 2021 was a very active period for the MSN/Novadoz organization with four FDA approvals. We successfully introduced these products to the market, while keeping pace with the high demand for our existing product line created by the pandemic." He adds, "MSN's position as a global leader in APIs has provided Novadoz with the scale and leveraged strength comparable to some of the largest generic pharma companies in the U.S. We are well positioned in the generic industry with a deep pipeline of oral solids, injectable, and specialty products that we expect to launch over the next 10 years." MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates. MSN is a global leader in this category. Additionally, the company also manufactures oral solids, liquids, and specialty injectable products in sixty-five markets throughout the world, doing business in the U.S. as Novadoz Pharmaceuticals. For more information, visit the company's websites at NovadozPharma.com & MSNLabs.com. CONTACT: Tom DeStefano Novadoz Pharmaceuticals Vice President Sales and Marketing (848) 200-1909