Luye Pharma Group announced today that the company has received the approval from the Center for Drug Evaluation of China to begin clinical trials for the new drug product Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD, LY03013). The product was developed for the treatment of Alzheimer's disease by Luye Pharma AG, the company’s German subsidiary, on its proprietary transdermal patch platform. Marketing Authorization applications for Rivastigmine MD have been formally accepted and are under review by the relevant authorities in seven European countries: Germany, the United Kingdom, Spain, Italy, Portugal, Luxembourg and Greece.
With the pathogenesis of Alzheimer’s not yet fully understood by scientists, the development of new drugs to combat the disease is a constant challenge. Only a very limited number of drugs are available for most patients. Rivastigmine is currently a first-line therapy for mild to moderate Alzheimer's disease and is recommended by clinical practice guidelines in multiple countries.
LY03013 provides an innovative method of drug delivery. Requiring twice-weekly administration, the product further increases patient compliance and reduces the burden on caregivers, as well as the social and economic burden on patients. In addition, LY03013 delivers the drug to the human blood circulation system, achieving a systemic effect via a transdermal route of administration. This allows the patient to maintain a more stable blood plasma concentration of the drug, ensuring more reliable dosage levels when compared with oral medications. Being a patch product, LY03013 is also more convenient for use among patients who have difficulty swallowing, reducing the incidence of adverse gastrointestinal reactions such as nausea and vomiting.
LY03013 and its formulation methods are protected globally under a number of patents. In addition to Europe and China, Luye Pharma Group also plans to register the product in the United States, Japan and other countries. The company has long been focused on advanced drug delivery techniques such as transdermal patches, liposomes and microspheres, and has gradually made this field a core strength. Luye Pharma AG is one of the largest independent transdermal drug delivery system manufacturers in Europe, utilizing a highly sophisticated process with high barrier technologies, and has passed U.S. FDA GMP inspections, EU GMP inspections, and Japanese GMP inspections.
The Rivastigmine once-daily patch, also developed by Luye Pharma AG, has been marketed in more than 20 countries, and was the first transdermal patch product approved in accordance with the requirements of China’s Quality and Efficacy Consistency Evaluation. A series of transdermal patch products manufactured by Luye Pharma AG, including Fentanyl Transdermal Patch and Buprenorphine Transdermal Patch, have also been successfully launched in Europe, the United States and other countries and regions.
In addition to its facility in Germany, Luye Pharma has also established a production base for transdermal patches in China, producing high-quality transdermal patches with the highest international standards to better meet the needs of global patients.
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