Luye Pharma's Innovative Alzheimer's Disease Therapy Rivastigmine Multi-Day Transdermal Patch Now Eligible for Marketing Authorization in Several EU Countries

Luye Pharma Group today announced the successful completion of the Decentralised Registration Procedures (DCPs) for its Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD). With the end of procedure achieved on 21 May 2021, the drug is now eligible for marketing authorization by individual member states of the European Union involved in the DCPs.

Rivastigmine MD utilizes an innovative drug delivery system developed by Luye Pharma AG, the company's German subsidiary, on its proprietary transdermal patch platform. The drug is used to treat mild to moderate dementia associated with Alzheimer's disease, and is a core product from the company's central nervous system (CNS) disease portfolio.

Alzheimer's disease remains a major global health issue, and the number of patients worldwide continues to grow. According to the World Alzheimer Report 2019, 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 2050i. Over 50% of caregivers for Alzheimer's patients indicated that their personal health had suffered as a result of caring responsibilities, with the annual cost of dementia treatment globally estimated at around US $1 trillioni.

Progression of new drug development in the field of Alzheimer's disease is relatively slow, and at present there are only a very limited number of therapeutic options available to patients. Rivastigmine is a first-line drug in the treatment of dementia associated with Alzheimer's disease and is currently marketed worldwide.

Rivastigmine MD employs an innovative drug delivery system for Rivastigmine via twice-weekly transdermal administration. Rivastigmine MD requires a lower application frequency than the once-daily Rivastigmine patches generally available on the market, 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. Luye Pharma has been issued a number of international patents for the product.

To bring this new treatment option to patients as soon as possible, Luye Pharma is accelerating the commercialization of Rivastigmine MD in global markets. The company recently granted Italfarmaco Group the rights to commercialize Rivastigmine MD in four European countries, as well as undisclosed partners for additional European markets. Furthermore, Rivastigmine MD will soon start phase III clinical trials in Japan,where the company has reached an agreement with Towa Pharmaceutical Co., Ltd. regarding the development and commercialization rights to Rivastigmine MD. In China, the development of the drug has entered the clinical stage. In addition, Luye Pharma also plans to register the product in other countries.

"The number of people living with Alzheimer's disease is growing worldwide, and available treatment options are currently limited. We wish to address these unmet needs and provide patients with innovative treatment options to improve their quality of life, and the lives of their caregivers," said Mr. Yang Rongbing, President of Luye Pharma Group. "The CNS therapeutic area, including Alzheimer's disease, is one of Luye Pharma's strategic focal points. We will continue to develop our expertise in this area, bringing treatment to more patients in need around the world."

Luye Pharma has a series of innovative CNS formulations and drugs under development in different global regions, covering Alzheimer's disease, severe depression, Parkinson's disease, schizophrenia and bipolar disorder. Among them, a number of new drugs have entered late clinical development and NDA stages.

About Rivastigmine Multi-Day Transdermal Patch

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 nerve cells, which are less active in individuals with mild to moderate Alzheimer's disease. The drug is currently available in the form of tablets and patches. Rivastigmine Multi-Day Transdermal Patch is a twice-weekly innovative patch formulation of Rivastigmine.

About Luye Pharma Group

Luye Pharma Group 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.