Luye Pharma enters into an agreement with ESTEVE to commercialize an Alzheimer's Disease Multi-Day Treatment Patch in Spain

BASEL, Switzerland, Sept. 16, 2021 /PRNewswire/ -- Luye Pharma Switzerland AG ("Luye Switzerland"), a fully owned subsidiary of Luye Pharma Group (Luye Pharma), and Esteve Pharmaceuticals, S.A. (ESTEVE) announced today that they have entered into an agreement under which ESTEVE receives exclusive rights to commercialize the Rivastigmine Multi-Day Transdermal Patch in Spain. Developed by Luye Pharma, this new drug is used to treat mild to moderate dementia associated with Alzheimer's disease and has recently been granted marketing authorization in Spain.¹ This product represents an important strategic addition to ESTEVE's central nervous system (CNS) portfolio, building on its depth of knowledge in this therapeutic area.

Xavier Valera, Managing Director Spain at ESTEVE commented: "This agreement allows ESTEVE to bring this innovative treatment to Spain and to complement our neurology-based portfolio in order to improve the quality of life of our patients."

"The collaboration with ESTEVE represents an important milestone in our commitment to addressing unmet needs for senior patients in Europe. By leveraging ESTEVE's extensive CNS experience and strong business operating system, we believe we will soon be able to bring this new therapy to patients in Europe," said Bruno Delie, General Manager of Luye Switzerland. "We aim to improve the quality of life for people suffering from dementia, as well as their families, friends and caregivers."

Alzheimer's disease remains a major global health issue, and the number of patients is constantly growing. As the development of new drugs in this therapeutic area is still a challenge, Rivastigmine, which is marketed worldwide, is a first-line medicine in the treatment of dementia associated with Alzheimer's disease.

About Rivastigmine MD

Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) is a twice-weekly innovative patch formulation for the treatment of mild to moderate dementia associated with Alzheimer's disease.¹ The product was developed by Luye Pharma group on its proprietary transdermal patch platform and is one of the company's core products in the central nervous system field.

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 never cells, which are less active in individuals with mild to moderate Alzheimer's disease. The drug is currently available in the form of daily administration tablets and patches.²

The product will be registered in major global markets, including Europe, Japan, and China. In May 2020, the Application for Marketing Authorization for this product in countries within the European Union was accepted for review by competent authorities of the European Union. In September 2020, the product was approved by the Center for Drug Evaluation of China's National Medical Products Administration to initiate clinical trials in that country. In February 2021, the exclusive rights to develop and commercialize the new drug in Japan were granted to Towa Pharmaceutical Co., Ltd. (''Towa''). This treatment is soon to start phase III clinical trials in Japan. Luye Pharma also plans to register this product in the U.S. and other countries.

About Luye Pharma Group

Luye Pharma Group (Luye Pharma), a member of Luye Life Sciences 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.

About ESTEVE

ESTEVE (www.esteve.com) is an international pharmaceutical company with headquarters in Barcelona. Its mission is to advance in innovation to improve the lives of people and, since it was founded in 1929, it has focused on providing solutions for medical needs that are not yet covered. ESTEVE has a significant presence in Europe and the USA. The company operates in the US through subsidiaries and its own production facilities dedicated to the development and manufacture of active pharmaceutical ingredients in Spain, Mexico and China, as well as a pharmaceutical plant in Germany.

References

1-  Ficha Técnica Alzerta dos por semana parches transdérmicos. Agosto 2021   https://cima.aemps.es/cima/dochtml/ft/86148/FT_86148.html

2-  Winblad B et al. Int J Geriatr Psychiatry 2007; 22: 456–467