Luye Pharma Group announced today that the pivotal study for Rivastigamine Multi-Day Transdermal Patch (Rivastigamine MD), an innovative delivery system drug for the treatment of Alzheimer’s disease, has been completed in Germany. Developed on the transdermal drug delivery platform by Luye Pharma AG, the Group's subsidiary in Germany, Rivastigamine MD is a core product in Luye Pharma’s Central Nervous System (CNS) portfolio. Another product in this category is Rivasigamine Single-Day Transdermal Patch, which has to date been marketed in more than 20 countries around the world and will be brought to China in the second half of this year.
Innovation in drug delivery improves patient compliance
The pivotal study was designed as an open, randomized, 2-period, 2-sequence, cross-over study to assess the bioequivalence of Luye Pharma’s Rivastigmine MD compared to the reference Exelon® (once daily patch) in steady state at dosage strength 9.5mg/24h. Pharmacokinetic bioequivalence of Rivastigmine MD compared to Exelon® at steady state could be concluded for all primary parameters as per protocol by applying the typical bioequivalence acceptance range of 80.00%–125.00%. Moreover, Luye Pharma’s Rivastigmine MD achieved the skin adhesion endpoint as proposed per current EMA guideline, i.e. the 90% confidence interval of mean adherence at the end of dosing interval was above 90%.
Today, Alzheimer's disease has become the fourth biggest threat to the health of the elderly after cardiovascular diseases, malignancies, and stroke. According to the World Alzheimer Report 2018, there were 50 million people living with dementia worldwide in 2018, with the number of patients expected to reach 82 million in 2030 and 152 million by 2050. The total cost of dementia was estimated at US$1 trillion in 2018 and is expected to reach US$2 trillion by 2030. The large patient population has brought about many challenges. Symptoms such as memory impairment and cognitive abnormalities caused by the disease have seriously affected the quality of life and family relationships of a large number of elderly people. Meanwhile, Alzheimer's disease is considered one of the most difficult areas for medical breakthroughs, with pharmaceutical companies in various countries failing repeatedly in clinical trials despite huge investment. Rivastigamine is currently the first-line drug used for the treatment of mild to moderate Alzheimer's disease.
Rivastigamine MD, administered twice-weekly, is an innovative delivery system drug. It is absorbed by the body through the skin, providing convenience of use for patients who experience difficulty using multiple medications or with oral administration. It can also protect patients from gastrointestinal disorders caused by orally administered medications. Compared with daily-administered medications, the twice-weekly Rivastigamine MD can better improve patient compliance. Currently, the product and its formulation process are protected by multiple patents worldwide. In addition to Germany, Luye Pharma plans to register the product in other European countries, China, the United States, Japan and others.
“Rivasigamine patch is one of the core products in our CNS portfolio. We will accelerate the clinical development and registration process for this product in major developed and developing markets, as well as continue to bolster our CNS pipeline to further enhance our global competitiveness in this therapeutic field", said a senior spokesperson at Luye Pharma Group.
Accelerating the pace of global expansion in the CNS therapeutic field
Since last year, Luye Pharma has made significant progress with its CNS product pipeline development. On March 28th this year, the NDA for Rykindo®, a microsphere agent for the treatment of schizophrenia and bi-polar disorders, was submitted by Luye Pharma to the FDA in the United States, while Rykindo® is expected to become the first Chinese innovative drug to be approved for marketing in the United States. In addition to Rykindo®, Luye Pharma has a number of other late-stage pipeline candidates at home and abroad. These include Rotigotine Extended-Release Microspheres for Injection (LY03003) for the treatment of Parkinson's disease, which has entered Phase III studies in China and the U.S. and Phase I studies in Japan; Ansofaxine Hydrochloride Extended-Release Tablets (LY03005), a new compound for the treatment of depression, which has entered phase III clinical trials in China and a pivotal clinical phase in the United States; Rivasigamine Single-Day Transdermal Patch and Pramipexole Dihydrochloride Extended Release for the treatment of Parkinson’s disease, which have filed for registration application in China and Paliperidone Extended-Release Suspension Injection (LY03010) for the treatment of schizophrenia and schizoaffective disorders, which is being developed simultaneously in China and abroad.
Luye also boasts a number of established brands in the CNS field, such as Seroquel and Seroquel XR, Fentanyl Patch and Buprenorphine Patch, among others. These products, which are being sold in more than 80 countries and regions including China, the United States, Europe, Japan and other major pharmaceutical markets, as well as fast-growing international emerging markets, will form a competitive product portfolio together with the upcoming pipeline drugs, generating synergy which will help to accelerate the company’s pace of expansion into CNS therapy in the future.
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