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. A senior management spokesperson at Luye Pharma commented: “Rivastigmine patches are one of Luye Pharma’s core products in the CNS field. We will continue to drive marketing and sales activities in China and in overseas markets for this drug, expediting its registration process in major developed and developing markets to help expand our business presence in the world’s major strategic markets."
CNS is considered one of the four core therapeutic areas for Luye Pharma’s long-term development. The company recently acquired the assets to AstraZeneca's signature products, Seroquel and Seroquel XR, in 51 countries and regions. In addition, a number of CNS drugs are being developed in parallel, both in Chinese and overseas markets. Several drugs have entered the late stages of clinical trials and will soon be launched in major markets around the world; examples include: Risperidone Extended-Release Microspheres (LY03004) for the treatment of schizophrenia and bipolar disorder, which have reached the final stage of the NDA process, with submissions planned for China and the United States. Rotigotine Extended-Release Microspheres (LY03003) for the treatment of Parkinson’s disease and Ansofaxine Hydrochloride Extended-Release Tablets (LY03005) for the treatment of depression, which have both entered Phase III clinical trials in China and the United States respectively. Meanwhile, Buprenorphine Patches, an analgesic drug, have entered the pre-clinical phase in China.
In addition to CNS, Luye Pharma has a wealth of pipeline products at home and abroad in the fields of oncology, metabolism, and cardiovascular diseases. Driven by a “global R&D” focused strategy, Luye Pharma has established a global R&D network, with R&D centers covering China, the United States and Europe. Currently, 30 drugs are being developed in China, with more than 10 drugs being developed in overseas markets. Luye Pharma has reached a high level international standard in advanced drug delivery technologies such as microspheres, liposomes and transdermal drug delivery systems, with the company making active efforts to develop innovative compounds and antibodies, cells and gene therapies, as well as smart formulations.
To enable patients to benefit the most from these excellent R&D results, Luye Pharma has established 7 manufacturing sites with more than 30 production lines around the world, also maintaining a GMP quality management and control system of the highest international standards. The company has more than 30 marketed products, with a business presence in more than 80 countries and regions around the world, including China, the United States, Europe, Japan and other major global pharmaceutical markets, as well as high-growth emerging markets. The high standard of the global quality management system coupled with resourceful global market operations capability helps Luye Pharma better provide patients worldwide with high quality, innovative drugs.
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