ORMP: Advancing Development Efforts in China
By M. Marin
NASDAQ:ORMP
READ THE FULL ORMP RESEARCH REPORT
Licensing deal – potential royalty payments if product is commercialized in China …
Earlier this month, Oramed Pharmaceuticals’ (NASDAQ:ORMP) partner in China, Hefei Tianhui Biotechnology Co. (HTIT), completed a Phase 3 oral insulin clinical trial in China and, based on the results, submitted a marketing authorization application to China’s regulatory body, the National Medical Products Administration. The company believes the completion of the Phase 3 trials of oral insulin in type 2 diabetes (T2D) in China, which were conducted under a differentiated study protocol, and application submission furthers the partners’ ability to commercialize ORMD-0801 in China.
The company’s licensing agreement with HTIT included milestone payments to ORMP and potential royalty revenue when / if ORMD-0801 is commercialized in China, where ORMP believes there is significant opportunities for an oral insulin treatment. More than 10% of the adult population in China has diabetes, according to the World Health Organization (WHO), which noted in 2016 that:
“In 1980, less than 5% of Chinese men had diabetes. Now, more than 10% do. This increase has been largely driven by unhealthy lifestyles – diets that are too high in sugar and fat, and people not getting enough physical activity… Even more startling is the fact that almost half of all adults in China – close to 500 million people – have prediabetes. Not only does this pose a risk factor for developing Type 2 diabetes, but also for other conditions such as cardiovascular disease.”
Company encouraged by analysis of U.S. ORA-D-013-1 data …
Moreover, a recently completed analysis of the data from the U.S.-based Phase 3 trial for the treatment of T2D found statistically significant lowering of A1C levels seen in patient subgroups. Analysis of the data found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin. Certain population subsets displayed a greater than 1% placebo adjusted, reduction in HbA1c that the company has characterized as statistically significant. “Higher A1C levels are linked to diabetes complications,” according to the CDC (Centers for Disease Control). Based on the analysis, the company believes that patients over age 54 with BMI of less than 31 tend to have the largest reduction in A1c p-value lower than 0.002, as illustrated below where the bright yellowish colors represent large reduction in A1C for the treatment patients versus placebo, according to company.
… with multiple program / development efforts underway …
Oramed has multiple clinical development programs underway. ORMD-0801 is being studied for the treatment of T2D and in NASH. ORMP is also leveraging its technology for an orally ingestible glucagon-like peptide-1 (GLP-1) capsule. ORMD-0901 is an orally ingestible exenatide (GLP-1 analog) capsule designed to aid in the balance of blood-sugar levels and also to decrease appetite. ORMD-0901 is designed for the treatment of obesity in patients with diabetes. Obesity is a growing problem worldwide. In addition, through a JV, the company is developing an orally administered vaccine for the COVID-19 virus. We believe Oramed’s multiple clinical development programs underscore the potential versatility of the company's oral protein delivery platform technology.
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