Luye Pharma Group has announced that import registration procedures for one of the company’s core central nervous system (CNS) products, ‘Rivastigmine Transdermal Patches’, have been completed and approved by the China National Medical Products Administration, with the expectation that the drug will soon launch in China.
Outside of China, the drug is available in more than 20 countries worldwide, for years a strong sales performer. Luye Pharma hopes to continue to strengthen its product line in the field of CNS treatment, further enhancing its core competitiveness and global operational capabilities.
Developed on the transdermal drug delivery R&D platform at Luye Pharma AG, the German subsidiary of Luye Pharma, Rivastigmine patches are used for the treatment of mild to moderate Alzheimer’s disease. Luye Pharma has long been engaged in the research and development of advanced drug delivery technologies, such as transdermal drug delivery systems, microspheres and liposomes, reaching advanced international standards in these fields.
Today, Alzheimer’s disease is the fourth leading threat to the health of the elderly after cardiovascular diseases, malignancies, and stroke. According to the World Alzheimer’s Disease Report, there were 46.8 million patients worldwide suffering from dementia in 2015, with the overall cost of dementia in 2018 expected to reach USD 1 trillion. The average prevalence of Alzheimer’s disease in people over the age of 65 in China is 6.6%, meaning the number of patients living with Alzheimer’s disease in China is estimated to be over 6 million.
Alzheimer’s disease can cause memory impairments, cognitive abnormalities, executive function disorders, aphasia and other complications which seriously impact the quality of life and familial relations of the elderly. Moreover, Alzheimer’s disease is widely acknowledged to be one of the most difficult diseases to treat, with the number of new drugs approved by the FDA remaining very low. Rivastigmine is currently used as a first-line treatment for mild to moderate Alzheimer’s disease.
Luye Pharma’s Rivastigmine patch provides another delivery option for patients experiencing problems with drug compliance or swallowing (active ingredients are instead absorbed by the body through the skin), avoiding any gastrointestinal discomfort caused by oral medications and dysphagia in some patients. Compared to traditional tablets, they can effectively reduce the required frequency of administration and fluctuations in levels of medication in the blood, providing a smooth and sustained drug release. In addition, Luye Pharma’s Rivastigmine patches are designed for once-daily administration, thus improved ease of use and patient compliance can greatly alleviate caregiver burdens and effectively reduce allocation of public resources.
The company’s Rivastigmine patch product and its formulation methods are protected under multiple patents worldwide. The product is already available in more than 20 countries around the globe, including the United States, ten European countries comprising Germany, Portugal, France, Italy, the Netherlands, Denmark, Finland, Norway, Sweden and Switzerland, as well as Israel and Thailand, among others. Due to its clinical value and success at addressing patient needs, sales have been very strong in the global markets. According to IQVIA data, in 2017, total sales in the European and American markets for Luye Pharma’s Rivastigamine patches reached USD 520 million. In the U.S. market, the company’s Rivastigmine patches represent 44% of sales by volume of all transdermal patch products.
In addition to Rivastigmine single-day patches, multi-day patch products are also under clinical development by Luye Pharma AG.
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