Luye Pharma Grants Zambon Exclusive Commercialization Rights to Its Innovative Alzheimer's Disease Treatment Rivastigmine Multi-Day Transdermal Patch in Switzerland

Luye Pharma Group (Luye Pharma) today announced that its subsidiary Luye Pharma Switzerland AG has entered into an agreement with Zambon Switzerland (Zambon), under which the company grants Zambon exclusive rights to commercialize Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) in Switzerland.

Rivastigmine MD is a twice-weekly innovative patch formulation of Rivastigmine for the treatment of mild to moderate dementia associated with Alzheimer's disease. The drug was developed by Luye Pharma on its proprietary transdermal patch platform and has received marketing authorization for several European countries. Luye Pharma will apply for marketing authorization for the drug in Switzerland.

Bruno Delie, General Manager of Luye Pharma (Switzerland), said: "Zambon has a comprehensive commercial platform and a wealth of knowledge and expertise in the central nervous system (CNS) therapeutic area in Europe. We look forward to working closely with Zambon to address the unmet needs of growing Alzheimer's patient communities in Switzerland, and to help them better manage the disease." Established in 1906, Zambon is a multinational pharmaceutical company with products currently sold in 87 countries around the world. The company has extensive experience in CNS diseases and robust business operations in Europe.

Luye Pharma is accelerating the development and commercialization of Rivastigmine MD in major global markets including Europe, Japan and China. Sales in European markets are covered by the company's local affiliates and partners Italfarmaco Group and Esteve Pharmaceuticals, S.A. Meanwhile, exclusive development and commercialization rights for Rivastigmine MD in Japan have been granted to Towa Pharmaceutical Co., Ltd. In China, the product has received approval from the Center for Drug Evaluation of China's National Medical Products Administration to commence clinical trials. Going forward, Luye Pharma has plans to accelerate the marketing of Rivastigmine MD in a number of developing countries and emerging markets around the world.

Alzheimer's disease is an irreversible neurodegenerative disease which causes progressive decline in memory and other cognitive aspects. Dementia associated with Alzheimer's disease is the most common form of dementia, accounting for 60-80% of all cases[i]. 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 2050[ii].

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.

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 daily administration tablets and patches.

Rivastigmine MD employs an innovative drug delivery system for Rivastigmine via twice-weekly transdermal administration. Rivastigmine MD has a lower application frequency than the once-daily Rivastigmine patches generally available in the market, enabling it to improve patients' medication adherence. 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 compared with the oral form.

About Luye Pharma Group

Luye Pharma Group (Luye Pharma) 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.

For further information, please visit www.luye.cn/lvye_en/

About Zambon

Zambon is a multinational pharmaceutical company committed to innovating cure & care to improve patients' lives. With ambitious plans for growth, its goal is to improve people's health through the development of innovative and quality medicines.

Zambon products are commercialized in 87 countries. The company has 23 subsidiaries in three different continents – Europe, America and Asia – and owns manufacturing facilities in Italy, Switzerland, China and Brazil.

The company has now taken a new role in the industry. In addition to pain and diseases of the respiratory system and urological system, Zambon is establishing a global pipeline and introducing important treatments for serious diseases such as Parkinson's Disease, Cystic Fibrosis, BOS and NCFB.

Zambon was established in 1906 in Italy and today counts around 2,400 employees all over the world.

[i] 2021 Alzheimer's Disease Facts and Figures Report. Alzheimer's Association. Accessed October 25, 2021. https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf

[ii] World Alzheimer Report 2019. Alzheimer's Disease International. Assessed October 25, 2021. https://www.alzint.org/u/WorldAlzheimerReport2019.pdf

Source: Luye Pharma Group