Development & Manufacturing of New APIs
Our Approach
Our Approach to API Development
What NOVARK BIO is taking on developing and manufacturing in-house is a macromolecular active pharmaceutical ingredient (API) for a new medicine. Building on the craftsmanship long cultivated in the manufacture and sale of OTC medicines, we are engaged in research and development to advance the technology of the active ingredient (API) itself.
Why We Do
Why We Take On API Development
The diseases medicine confronts are shifting from “infectious diseases” caused by external pathogens to “endogenous diseases” that arise from a complex interplay of multiple factors such as poor diet, lack of exercise, and chronic stress. To meet these unmet medical needs, it is essential to advance the very technology of the “API”—the foundation of any medicine. By fusing the formulation technology and quality-assurance know-how cultivated through OTC medicines with the wisdom of advanced science, NOVARK BIO aims to elevate this into the development and manufacture of APIs for prescription medicines, and to bring innovation to how medicine can overcome the age of endogenous disease.
Past
The Age of Infectious Disease
Infectious diseases caused by external pathogens. Single-target drugs, such as antibiotics, are effective.
Present
The Age of Endogenous Disease
Endogenous diseases whose causes lie within. Multiple factors are complexly intertwined.
A Crisis in Healthcare Economics
3-4 million yen
Annual drug cost
Annual drug cost per patient for certain immunological and biologic agents.
20 million yen
Ultra-high drug cost
With insurance coverage of cutting-edge drugs such as antibody therapeutics, there are cases where the annual cost per patient reaches a scale of 20 million yen.
When we keep making conventional single-target drugs for complex diseases that have multiple causes, cases are emerging in which drug costs reach roughly 3 to 4 million yen per patient per year. Some of the most advanced antibody drugs even reach a scale of 20 million yen per year, as the complexity of disease and a structural mismatch with treatment drive up the cost of drug discovery. These drug costs are borne by society as a whole through insurance coverage, and the structural strain on social security spending is creating a critical situation for healthcare economics.
Three Strengths Behind Our API Development
01.
Long-Cultivated Knowledge and Experience
Building on the OTC medicine formulation technology, high-quality mass-production know-how, and thorough quality-assurance systems we have long cultivated, we fuse in advanced processes.
02.
Fusion of Advanced Science and Pharmaceuticals
Combining advanced science with traditional formulation technology, and working with academia and research institutions in Japan and abroad, we advance API development grounded in the most cutting-edge scientific knowledge.
03.
An Integrated System from Development to Manufacturing
From drug-discovery research to process development and on to commercial production, we are working to connect the entire development process within an integrated framework and to build a controllable quality-management system.