While the biopharmaceutical industry is made up of big companies with global reach, many smaller enterprises are making their mark. Established in 2006, the company Medika Natura Sdn Bhd (Medika Natura) is a growing player in Malaysia’s agricultural biotechnology and biopharmaceutical markets.
As a clinical-stage company, Medika Natura focuses on botanical drugs and high-value herbal ingredients of Malaysian origin. Formerly known as Orchid Life Sdn Bhd, Medika Natura was founded by two university friends with a passion for horticulture and botany.
In 2015, the company was appointed as an “anchor company” by the Malaysian Ministry of Agriculture and Food Industry (MAFI) to conduct pre-clinical and clinical research on the Malaysian herb, Labisia pumila, a small, woody and leafy plant that grows widely in the shade of the tropical forest floor.
The Malays have used Labisia pumila, known locally as Kacip Fatimah, as a traditional medicine for over 400 years. Initial research and development, which demonstrated the benefits of the plant and highlighted its efficacy as an anti-obesity drug, was led by Prof. Zhari Ismail of the Universiti Sains Malaysia. Following its appointment by the MAFI, Medika Natura was able to commercialize their anti-obesity drug under the trademark, LABEESITY®.
As an extract of Labisia pumila, SKF7™, is a standardized, proprietary, bioactive botanical compound. The resulting product, LABEESITY® is put through a stringent quality control mechanism using PhytoProfile™, the company’s proprietary technology platform. This platform enables the company to implement phytochemical profiling and/or DNA fingerprinting to ensure the manufacturing process meets the industry’s highest quality and safety standards.
Pre-clinical research shows SKF7™ inhibits visceral fat accumulation in rodents on a high-fat diet, exhibiting anti-obesity effects. Case studies in humans reported the normalization of blood glucose levels and a reduction in total cholesterol, triglyceride levels, and waist circumferences.
After extensive pre-clinical trials, LABEESITY® was approved as a traditional medicine by the Malaysian National Pharmaceutical Regulatory Agency in 2017. The compound has also received approvals from regulatory bodies in Indonesia and Singapore, respectively. In 2020, SKF7™ became the first Malaysian-made bioactive compound to receive clearance from the United States Food and Drug Administration (FDA) as a dietary supplement.
The company is also the first Malaysian company to seek registration for a herbal medicine product in the European Union and the United Kingdom. Other countries for which the company is seeking clearance include Australia, Canada, China, New Zealand, the Republic of Korea, Saudi Arabia, the United Arab Emirates.
The importance of intellectual property (IP) protection has been relevant to Medika Natura from the outset. In fact, the company acquired its trademark and IP rights for LABEESITY® from the Universiti Sains Malaysia.
Medika Natura continues to expand its IP portfolio by filing additional trademark registrations for SKF7™ and Medika Natura™ with the Malaysian Intellectual Property Office (MyIPO). The company also plans to file for patent protection for its invention in Malaysia and the United States, to create an IP portfolio that will enable it to scale up its operations and to commercialize and license its products.