Luye Pharma Group today held a press conference to announce the launch of its Rivastigmine Transdermal Patch (Brand Name: 金斯明®) in China. Administered once a day to the body through the skin, the drug is indicated for the treatment of mild to moderate Alzheimer's disease. The product was developed by Luye Pharma AG, the company's German subsidiary, on its proprietary transdermal patch platform. In addition to China, Luye Pharma AG’s Rivastigmine Transdermal Patch has been marketed in many other countries and regions including the United States, 11 countries across Europe, and Thailand.
China has a vast number of Alzheimer's disease patients, creating a heavy burden of care
Alzheimer's disease is one of the world's greatest public health challenges. Due to a rapidly aging population and growing risk factors for cardiovascular diseases in China, both the incidence of Alzheimer's disease and total number of patients are growing each year. According to the National Medical Journal of China, China currently has around 9 million patients with the disease, and this number is expected to grow to 21 million by 2050i.
The huge and growing patient community presents a challenge on multiple fronts. Symptoms including memory issues and cognitive anomalies, among others, caused by this disease present a serious threat to the life and health of elderly people, meanwhile, due to the reduced capacity for basic self-care, patients will need long-term 24-hour care as well as community health care services, placing a heavy burden on their families and society. A survey conducted in China shows that around 57 percent of caregivers for Alzheimer’s patients provide all-day companionship, and nearly 2/3 of them experience what they describe as a “mild” or more severe burden ii.
"Alzheimer's disease is the most common irreversible neurodegenerative disorder, and early intervention is vital in reducing the effects of the disease and slowing down its progression," says Xiao Shifu, Director of the Department of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine. "In clinical practice, however, due to the lack of awareness, stigma, disability and dementia associated with the disease, patients are often late to seek medical treatment. Patient treatment rate is low, the dropout rate is high, treatment compliance is poor, and often, best outcomes cannot be achieved. A therapy with better safety and efficacy can significantly reduce disease progression, lighten the burden on both patients and their caregivers, and improve the quality of life for both parties."
Rivastigmine Transdermal Patch treatment for Alzheimer's disease helps to increase safety and compliance.
Rivastigmine is currently a first-line therapy for mild to moderate Alzheimer's disease and is recommended by clinical practice guidelines in multiple countries. Rivastigmine Transdermal Patch works by delivering medication through the epidermis and dermis to the dermal layer, where it becomes available for systemic absorption to achieve effective plasma concentration. The patch has equivalent therapeutic effects with the Rivastigmine oral formulation.
Compared to the oral formulation, use of Rivastigmine Transdermal Patch is safer and results in better patient compliance. In terms of safety, medication from Rivastigmine Transdermal Patch is not metabolized by the liver's CYP450 enzyme, nor does it increase renal burden. It also reduces systemic adverse events, especially adverse reactions associated with the gastrointestinal tract. In terms of tolerance, Rivastigmine Transdermal Patch provides stable and continuous delivery as well as lasting therapeutic plasma drug concentration, which is easier to titrate to the targeted dosage. This enables patients to begin high-dose treatment as soon as possible, and helps to slow down disease progression. At the same time, the once-daily patch is more convenient, which can improve patient compliance and reduce the time spent by caregivers on administering the drug.
Peng Dantao, Director of the Neurology Department and Executive Director of the Geriatrics Center, China-Japan Friendship Hospital, says: "Rivastigmine Transdermal patch has higher drug loading capacity than the oral formulation, which brings greater benefits to patients by effectively delaying the progress and relieving the symptoms of Alzheimer's disease. The transdermal patch is easy to use and causes less gastrointestinal side effects, as well as offering better protection to the liver and kidneys. It can better help those patients with dysphagia, patients intolerant to oral drugs, those with renal or hepatic impairment and combined diseases, those with digestive system disease, those with psychiatric symptoms who are reluctant to take medication, and patients requiring larger dosages of the drug.”
Luye Pharma AG has been working on the development and production of transdermal patches for over 20 years, with subsequent product iteration updates
As the Marketing Authorization Holder for 金斯明®, Luye Pharma AG has been working on the development and production of transdermal patches for over 20 years. The company is also one of the largest independent manufacturers of transdermal systems in Europe. Leveraging its strengths in transdermal patches as well as its best-in-class manufacturing expertise, Luye Pharma AG has long been a one-stop platform for providing transdermal patches to customers around the world. Since 2013, the Rivastigmine Transdermal Patch developed by Luye Pharma AG has been marketed in many other countries and regions including the United States, 11 countries across Europe, and Thailand.
In addition to the once-daily Rivastigmine Transdermal Patch, Luye Pharma AG has also developed a multi-day Rivastigmine Transdermal Patch for use twice a week, for which the Marketing Authorization Application is currently under review by the relevant European Union authorities. In China, the drug has entered the clinical trial phase and is expected to provide more treatment options for patients with Alzheimer's disease.
Luye Pharma is building a strong pipeline of CNS drugs around the globe.
Central nervous system (CNS) therapeutics is one of Luye Pharma's key areas of focus. The company already has a number of innovative drugs and formulations under development in this area, both in China and overseas, covering multiple diseases including depression, Parkinson's disease, schizophrenia, bipolar disorder and Alzheimer's disease.
In January this year, the company’s innovative formulation for the treatment of schizophrenia, Rykindo®, received market approval in China. Rykindo® is also China's first independently developed innovative microsphere formulation to be registered globally with its own intellectual property rights. In addition, multiple other new CNS drugs are already in late stage clinical development and the new drug application phase in countries and regions including the United States and Europe.
"CNS diseases seriously threaten the physical and mental health of patients and place heavy burdens on their families and society," said Xie Wenmin, President of Luye Pharma China. "The CNS area is a key strategic focal point for us today, and will continue to be so in the future. Having been active in this area for many years, we hope to leverage our strengths, provide new high-quality treatment options for patients, and contribute to the improvement of people's health."
i,ii Guidelines for primary prevention of Alzheimer's disease in China, National Medical Journal of China, Published on September 22, 2020.