Luye Pharma Group announced today that one of its key central nervous system (CNS) products, Rivastigmine Transdermal Patch, has been approved by the National Medical Products Administration in China. It is the first transdermal patch product approved for marketing under China CDE’s quality and efficacy consistency evaluation. Luye Pharma is committed to the continual development of its CNS pipeline, further strengthening the company’s competitiveness in this therapeutic field.
Rivastigmine Transdermal Patch is indicated for the treatment of mild to moderate Alzheimer's disease. The product was developed by Luye Pharma AG, the company’s German subsidiary, on its proprietary transdermal patch platform. Luye Pharma has long been engaged in the research and development of advanced drug delivery technologies in the fields of transdermal drug delivery systems, microspheres and liposomes.
Today, Alzheimer's disease is one of the world's greatest public health challenges. The World Alzheimer Report 2018 noted that on average, every 3 seconds, a new case of dementia is diagnosed somewhere in the world. In 2018, an estimated 50 million people worldwide were living with dementia, and this number is expected to grow to 152 million by 2050. According to reports, China now has the single largest number of Alzheimer’s patients of any country, with the number expected to increase to 28 million by 2050. As of 2017, Alzheimer's disease has become the fifth leading cause of death in China.
The social burden caused by Alzheimer’s disease is very large. The complications caused by Alzheimer's disease, including memory impairments, cognitive anomalies, executive dysfunction, aphasia and other complications, adversely affect quality of life of patients and their family members. A major challenge for patients with Alzheimer’s disease is the serious shortage of therapies available. Achieving breakthroughs in the treatment of Alzheimer's disease, and the development of new drugs in this therapeutic area, are especially challenging.
Rivastigmine is currently a first-line therapy for mild to moderate Alzheimer's disease and is recommended by clinical practice guidelines in multiple countries. Rivastigmine Transdermal Patch works by delivering medication through the epidermis and dermis to the dermal layer, where it becomes available for systemic absorption to achieve effective plasma concentration. The efficacy of the patch is equivalent to that of the oral preparation.
Compared to the oral formulation, use of Rivastigmine Transdermal Patch is safer and results in better patient compliance. In terms of safety, the patch significantly lowers the peak-to-trough fluctuations in plasma concentrations of Rivastigmine, thus reducing incidence of the related side-effects and the risk of adverse gastrointestinal reactions. In comparison to oral formulations, Rivastigmine Transdermal Patch is used once a day and ensures both patient compliance and timely application. Due to these advantages, the patch provides physicians and caregivers with a preferable option over the use of oral Rivastigmine.
The product and the manufacturing process for Luye Pharma’s Rivastigmine Transdermal Patch are protected by multiple patents in various countries around the world. In addition to being approved in China, the product has already been launched in the United States, Israel, Thailand and 17 countries across Europe, among others. Luye Pharma AG is one of the largest independent transdermal patch developers and manufacturers in Europe, boasting a highly sophisticated process and high barrier technologies. The company’s facilities have passed FDA GMP inspections, EU GMP inspections, and Japanese GMP inspections. A series of transdermal patch products manufactured by Luye Pharma AG including Fentanyl Transdermal Patch and Buprenorphine Transdermal Patch have been successfully launched in Europe, the United States and other regions and countries.
Luye Pharma AG has long experience in transdermal drug delivery systems and has established its core strength in this field. In 2015, the company's Rivastigmine Transdermal Patch succeeded in challenging the originator’s patents in the United States, and was the first generic drug approved by the U.S. Food and Drug Administration. In addition, a Marketing Authorization Application for the multi-day Rivastigmine Transdermal Patch (Rivalif®), an innovative formulation developed by Luye Pharma AG, is under review at European Union Competent Authorities. In addition to its facility in Germany, Luye Pharma has also established a production base for transdermal patches in China, laying the foundations to achieve its long-term strategic goals in the field of CNS disease treatment.
A senior spokesperson for Luye Pharma Group said: "With a rapidly aging population, we expect to see growing demand for our Rivastigmine Transdermal Patch products, which provide additional beneficial treatment options for patients with Alzheimer’s. We will continue to expand our CNS portfolio and increase our global competitiveness in this field. "
CNS therapeutics is one of Luye Pharma’s key areas of focus. The company currently has a number of projects related to CNS therapeutics under development, targeting depression, Parkinson's disease, schizophrenia, bipolar disorder and Alzheimer's disease. The company is expediting the development and commercialization process for these new drugs, hoping to bring benefits to as many patients as possible, all around the world.
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