GUILDFORD, England, Sept. 23, 2021 /PRNewswire/ -- Luye Pharma Group today announced that marketing approval for its innovative formulation Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) has been granted by the UK's Medicines and Healthcare Products Regulatory Agency, for the treatment of mild to moderate dementia associated with Alzheimer's disease. The drug has previously received marketing authorization for several EU countries.
As the marketing authorization holder of Rivastigmine MD, Luye Pharma Ltd., the affiliate of Luye Pharma in the UK, will take full ownership and responsibility for market supervision, marketing, distribution and supply chain management, among others. Rivastigmine MD is the latest of several products in the central nervous system therapeutic area to be offered by Luye Pharma Ltd. in the UK, representing another important milestone for the company in the continuation of its business development efforts and growing presence in Europe.
Alzheimer's disease is an irreversible neurodegenerative disease which causes progressive decline in memory and other cognitive aspects. Dementia associated with Alzheimer's disease is the most common form of dementia, accounting for 60-80% of all cases[i]. It is estimated that there are over 50 million people living with dementia globally, a figure which is set to more than triple, to 152 million by 2050[ii]. Rivastigmine is a first-line drug in the treatment of dementia associated with Alzheimer's disease.
Rivastigmine MD was developed by Luye Pharma on its proprietary transdermal patch platform. A number of international patents protecting the product have since been issued. Rivastigmine MD employs an innovative drug delivery system for Rivastigmine via twice-weekly transdermal administration, requiring a lower application frequency than the once-daily Rivastigmine patches generally available on the market and enabling improved medication adherence among patients. Due to its transdermal route of administration, Rivastigmine MD is convenient for patients who have difficulty swallowing, and may have the potential to lower the incidence of gastrointestinal adverse reactions such as nausea and vomiting when compared with the oral form of the drug.
"The number of patients with Alzheimer's disease is increasing, while existing treatment options are limited. Rivastigmine MD with its upgraded formulation optimizes the treatment regimen for Alzheimer's, which helps to alleviate some of the difficulties in medication management faced by patients and their caregivers," said Yang Rongbing, President of Luye Pharma Group. "The CNS therapeutic area, including Alzheimer's disease, is one of our strategic focal points. We are dedicated to addressing the unmet needs of patients and providing them with innovative treatment options to improve their quality of life and the lives of their caregivers."
To bring this new treatment option to patients as soon as possible, Luye Pharma is accelerating the development and commercialization of Rivastigmine Multi-Day Transdermal Patch in major global markets including Europe, Japan and China. In EU countries, the product will be commercialized by the company's partners Italfarmaco and Esteve, meanwhile exclusive development and commercialization rights for Rivastigmine MD in Japan has been granted to Towa Pharmaceutical Co., Ltd. In China, the product has received approval from the Centre for Drug Evaluation of China's National Medical Products Administration to commence clinical trials. Going forward, Luye Pharma has plans to accelerate the marketing of Rivastigmine MD in a number of developing countries and emerging markets around the world.
About Rivastigmine MD
Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) is a twice-weekly innovative patch formulation for the treatment of mild to moderate dementia associated with Alzheimer's disease. The product was developed by Luye Pharma Group on its proprietary transdermal patch platform and is one of the company's core products in the central nervous system field.
Rivastigmine is in a class of medicines called cholinesterase inhibitors. These medicines can improve cognitive functions such as memory and thinking by increasing the amount of a certain natural substance in the brain and amplifying the communication channels between never cells, which are less active in individuals with mild to moderate Alzheimer's disease. The drug is currently available in the form of daily administration tablets and patches.
About Luye Pharma Group
Luye Pharma Group (Luye Pharma) is an international pharmaceutical company dedicated to the R&D, manufacturing, and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Along with a number of new drugs and new formulations in the Central nervous system and oncology therapeutic areas under study in the U.S., Europe and Japan, Luye Pharma has reached high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems, as well as actively making strategic developments in the fields of biological antibodies, cell therapies and gene therapies, among others.
Luye Pharma is developing a global supply chain of 8 manufacturing sites with over 30 production lines in total, establishing GMP quality management and international standard control systems. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe, and Japan, as well as in fast-growing emerging markets.
[i] 2019 Alzheimer's Disease Facts and Figures Report. Alzheimer's Association. Accessed September 18, 2021. https://www.alz.org/media/Documents/alzheimers-facts-and-figures-2019-r.pdf |
[ii] World Alzheimer Report 2019. Alzheimer's Disease International. Assessed September 18, 2021. https://www.alzint.org/u/WorldAlzheimerReport2019.pdf |
