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Marketing Authorization Application for Luye Pharma’s Rivastigmine Twice Weekly Transdermal Patch Accepted in China

2022 / 04 / 14 Publisher:Luye Life Sciences Group

Shanghai, China, April 12, 2022 — Luye Pharma Group announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the Marketing Authorization Application (MAA) for the company’s investigational Rivastigmine Twice Weekly Transdermal Patch indicated for treating Alzheimer's disease of mild to moderate symptoms. The product, which has already received marketing authorization in multiple European countries, adopts an innovative drug delivery system developed by Luye Pharma AG, the company’s German subsidiary, on its proprietary transdermal patch platform.

Alzheimer's disease is one of the biggest public health challenges in the world. Due to China’s rapidly aging population and growing risk factors for cardiovascular diseases, both the incidence of Alzheimer's disease and the total number of patients are growing in the country each year. According to the National Medical Journal of China, China had approximately 9 million patients with Alzheimer's disease in 2020, and this number is expected to reach 21 million by 20501. The growing number of patients exerts a heavy burden on their families and the society in terms of caring for the patients and the expenses involved. Besides, the options for treating this disease are very limited. Rivastigmine is a first-line drug for treating mild to moderate Alzheimer’s disease at present.

Rivastigmine Twice Weekly Transdermal Patch is a twice-weekly improved patch formulation of Rivastigmine. This product and its formulation methods are protected globally under a number of patents. Compared with the available once-daily Rivastigmine transdermal patch, the twice weekly patch is used less frequently, simplifies the application, and improves patient compliance. Compared with the oral formulation, the twice weekly patch is administered transdermally, which reduces adverse gastrointestinal reactions such as nausea and vomiting, allows patients to have a more stable concentration of the drug in their blood, and ensures a sufficient amount of the drug for a stable treatment. The twice weekly patch is also more convenient for use by patients who have difficulty in swallowing compared with the oral formulation.

To enable more Chinese patients to benefit from the twice weekly patch, Luye Pharma signed an agreement with Changchun GeneScience Pharmaceutical Co., Ltd. in December 2021 granting the latter the right to commercialize it and other products in the mainland of China. Milestones in the agreement include the acceptance and approval of the MAA for the product in China.

In addition to China, Luye Pharma is also collaborating with local partners in multiple European countries, Japan and Mexico regarding this product. Furthermore, the company plans to accelerate the launch of this product in other developing countries and emerging markets around the world.

[1] Guidelines for the primary prevention of Alzheimer's disease in China, National Medical Journal of China, September 22, 2020, Vol. 100, No. 35

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