Development StoriesLUNABELL® LD NOBELZIN®
Story of R&D
Contribute to society by providing critical but neglected pharmaceuticals and medical devices.
Two new drugs give shape to this corporate mission
Vice President & COO, Head of Research & Development
Creating strongly desired drugs that other pharmaceutical companies do not
We might say that the medicines for unmet medical needs that Nobelpharma provides are “pharmaceuticals that are overlooked by other companies.” NOBELZIN® and LUNABELL® (LUNABELL® LD) were the first two products for which we obtained marketing approval. Our experiences in the process of commercializing these two products and managing their lifecycles after they were released further clarified our mission: “Contribute to society by providing necessary but neglected pharmaceuticals and medical devices.”
Nobelpharma's first drug for rare disease (orphan drug)
NOBELZIN® is a curative drug for Wilson’s disease and hypozincemia. It was initially developed as a curative drug for Wilson’s disease in capsule form. There are approximately 3,000 people with Wilson’s disease in Japan. A curative drug for Wilson’s disease did already exist at the time, but it was a chelating agent (a pharmaceutical that binds to copper ions in the blood and controls the absorption of copper) with strong side effects, and could not be prescribed to pregnant women. Wilson’s disease is genetic, and if patients stop taking medication their symptoms worsen. On top of this, there were concerns that taking medication when pregnant could affect the fetus. Meanwhile, in America, a curative drug that had few side effects and could be prescribed to pregnant women had been approved. “We really want to introduce this drug to Japan,” we thought, and so, with strong demand from patients and physicians, we started development.
As there are few patients, it was very difficult to recruit test subjects who could participate in a clinical trial, but we received cooperation from patient organizations, and were able to gain marketing approval and release the pharmaceutical. NOBELZIN® was the product that determined our attitude: there are no curative drugs, “so we will make a pharmaceutical for the patients that really need it.”
Creating drugs to be used by large number of patients in risk-taking attitude
LUNABELL® was originally developed overseas as an oral contraceptive, and is a combination pharmaceutical with the same components as one already being sold in Japan. Overseas, it was also being applied to dysmenorrhea due to it having a secondary effect on this. However, at this time it could not be used for anything but contraception in Japan.
The reason that other pharmaceutical companies had not developed this as a curative drug for dysmenorrhea was economic performance. Oral contraceptives are not covered by National Health Insurance, and so are not listed under pharmaceutical price standards, but were being traded at comparatively low prices. As a result, there was an expectation that, after paying research and development costs, if a National Health Insurance pharmaceutical price were to be listed for this as a curative drug for dysmenorrhea, the price would be low, and so companies were concerned that it would not pay for itself as a project.
However, Nobelpharma thought differently. Many of our founding members had a wealth of experience in development and obtaining approval from working in existing pharmaceutical companies; they were very familiar with the potential scale of the market for curative drugs for dysmenorrhea and with ways to advance clinical testing that would reduce development costs, and, believing that this pharmaceutical could be commercialized, they made the decision to develop it. It goes without saying that they had the support of expert doctors and people from patient organizations.
Creating drugs by indication expansion to be safely used by more patients
NOBELZIN® and LUNABELL® grew to be products that contribute to Nobelpharma’s income. However, the happiest thing for us is that by expanding the indication, we have been able to relieve more patients of their suffering. These two products gave us the confidence that the scale of our company—a pharmaceuticals venture—meant that we could develop and sell new pharmaceuticals even if they have been overlooked by large pharmaceutical companies, and the market for them is small.