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The worldwide leader in transdermal medication innovation

Interview - June 1, 2023

Since its foundation in 1848, Teikoku Seiyaku has continued to support medical innovation with the production of transdermal medication.

MISAKO FUJIOKA, PRESIDENT OF TEIKOKU SEIYAKU CO., LTD.
MISAKO FUJIOKA | PRESIDENT OF TEIKOKU SEIYAKU CO., LTD.

If we could start by having you give us a brief introduction to Teikoku Seiyaku and some of the key milestones in your very long history?

More than 170 years ago in 1848, Shozo Akazawa, the 5th head of the Akazawa family obtained a license to open a pharmacy. This was the start of Teikoku Seiyaku. In 1883 Chutaro Akazawa, the head of the 7th generation of the family graduated from medical school and inherited the family’s drug store business and began selling medicine nationwide. In May 1918 Teikoku Seiyaku Company Limited was established with a capital investment of JPY 1 million. In those days the focus of the pharmaceutical industry was on cure-all products claiming to relieve all sorts of symptoms. In contrast, Chutaro decided to concentrate on effective drugs that targeted specific symptoms. He would ask a patient about their symptoms and then sell them the appropriate medicine to treat them. In order to sell their drugs, pharmacists needed to be a bridge between medicine and patient. So, Teikoku Seiyaku organized a Pharmacist Association and started selling medicine nationwide. This was the antithesis of the pharmacy chain store equivalents in Japan at this time.

In 1938, the Horxis, a forerunner to the current medicated plaster, was launched. This product became the foundation for Teikoku Seiyaku’s current-day focus on pain relief. The Horxis had humble beginnings – at first it required both a medicated paste and cloth to be effective. As the product’s adherence and elasticity improved, it was modified into its current form as a medicated plaster. Teikoku Seiyaku’s medicated plasters received approval for prescription use, becoming the company’s main product line. Teikoku Seiyaku even became the first company to develop a hot-sensation poultice.

The hydrogel patch - our key product - has seen many developments through the years. We named our hydrogel patch technology Hydrohesive. Teikoku Seiyaku remains a world leader in the research and development of transdermal technology. Our continued growth comes from our drive to be the world’s number-one producer of hydrogel patches. We place a particular focus on transdermal systems and pain relief medicine.

The Teikoku Seiyaku philosophy is built upon two slogans: First, to release human beings from pain. We seek to alleviate pain not only by improving transdermal technology but also using all kinds of dosage forms. Second, we seek to apply transdermal patch technology to all therapeutic areas. We aim to be quiet innovators in the sense that we use technology that is unique to us in order to deliver drugs across the skin barrier. And we are not limited to the analgesic/anti-inflammatory field.

Depending on the drug, medication can sometimes be more effective with fewer adverse reactions when administered transdermally. As a world-class group of professionals in transdermal technology, Teikoku Seiyaku has been able to obtain many market authorizations for new drugs, and in the process gained the trust of many patients. We are active in joint research and development with other companies both in Japan and overseas.

In addition to the hydrogel patch, Teikoku Seiyaku has produced many more transdermal products such as tapes, plasters, ointments, creams, and more. Our plants produce products of the highest quality and meet strict Japanese Good Manufacturing Practice (GMP) standards. In fact, Teikoku Seiyaku operates one of the few pharmaceutical plants in Japan to have been inspected by the US Food and Drug Administration (FDA) as well as other government agencies from overseas.

 

Japan is lauded for its excellent universal health care and longer life expectancy, but one of the main criticisms of Japan’s medical sector has been its difficulty in translating that success to overseas markets. Do you agree with this statement? If so, why do you believe that to be the case?

Part of this issue arises from the excellent universal health care system that we have here in Japan. Thanks to this system, everyone can receive the highest levels of medical care at quite a low cost, regardless of their income. This has played a part in Japanese people having such a long life expectancy. However, this does have some unintended consequences, namely the aging population and associated medical costs keeping the population healthy. As a result of these costs, the health ministry puts pressure on the medical sector, and every year they change the guidelines for the recommended price of medicine. It used to be once every two years, but now they are revising those guidelines every year. In fact, they are setting medicine prices lower and lower every year, making it difficult for all companies in our sector to stay profitable. Less profit means less capital for investment in innovation. This is challenging industry-wide, and for that reason, many pharmaceutical businesses are moving their business outside of Japan.

In Japan, it can be difficult to obtain approval for new medicines considering both its limited market size and ever-increasing development costs. One of the key locations most pharma companies aim to be active in is the American market. Many pharma companies from the US and worldwide have approached us to develop new transdermal patches for the US market with them because they know about our success with transdermal technology. This has been one way we have secured a position in the American transdermal medicine market.

We just received approval on the 23rd of December 2022 in Japan for our Alzheimer's medicine, ALLYDONE®. In fact, we had applied for approval in the US in advance for this medicine. We received a complete response letter for this approval from the US. This was a case of the same thing happening in the approval process like we have seen in our efforts to develop transdermal patches for the US market.



Obviously, the aging population is having a tremendous strain on the Japanese medical sector. Some have stated that a preventative model and more over-the-counter (OTC) solutions could alleviate some of the pressure on the system. What is your thinking when posed with this challenge of unburdening the medical sector?

I think that the push for more OTC comes from OTC manufacturing companies. Given that the OTC manufacturers and prescription manufacturers have completely different ways of operating, we have different points of view – and even different logistics concerns and target markets. Unlike OTC, prescription drugs need a doctor to determine which is the right one based on the patient’s symptoms.

Prescription drug manufacturers' profit is heavily impacted by the set prices that are determined by the Ministry of Health here in Japan. The target markets of the OTC manufacturers and prescription manufacturers are different, one targets the consumers directly and the other target is the patient – through doctors and hospitals. For OTC manufacturers their strategy is to build brand recognition so that more consumers come to buy their products. Furthermore, OTC drugs need to be cost effective and widely available. There are outlying cases, however, and those are usually prescription drugs that over time switch to OTC because of their proven safety and effectiveness. On the other hand, prescription medicine manufacturers like Teikoku Seiyaku need to place more importance on research and development to continue delivering our trusted medicine to patients in the future.

 

Your company has been responsible for a lot of “world’s firsts”, yet you are still continuing to innovate after 170 years. Your product, ALLYDONE, a medicated patch to treat early onset dementia associated with Alzheimer’s disease is a great example. Could you tell us more about the development history of this product and how you’ve managed to create a transdermal administration method for the treatment of such a complex illness?

This medicine was initially launched as oral medicine, but before we go into detail I think it might help if I tell you a little about our business model so that you have a better understanding.

We have fantastic technology in the field of medicated plasters. Obviously, big pharma companies are trying to develop new medicines and have the ability to produce a whole range of different and new active pharmaceutical ingredients (API). As I mentioned, ALLYDONE® came out as an oral medicine in the beginning. We thought that if we were able to change the delivery method to a transdermal type you could put on your skin, the body would continue to absorb the medicine for many hours, thus improving the effectiveness of the drug itself. Also, should there be any adverse side effect, all you would need to do is take off the patch. A pharmaceutical manufacturer contacted us and asked if it was possible to take their API and include it in a patch. In many cases, this is how we start our development process. As you can see, it is not like we are coming up with the API from scratch, rather we are able to adapt, alter, and shape existing APIs to create entirely new delivery methods. Essentially, we are seeking ways to incorporate an API into a plaster or patch using our long-established techniques and technology.

Medicine administered orally can give users an upset stomach, but transdermal products can lower the risk of such side effects. The API can be absorbed through the skin over a long period of time rather than being introduced into the system orally. And the stable and effective concentration of suitable APIs in the bloodstream can be achieved through transdermal delivery.

 

How does transdermal administration affect the efficacy of this drug? Have the results for patients been the same in terms of their treatment?

In the clinical trials, it was proven that there is no difference in efficacy between the oral drug and the patch.

 

You’ve alluded to this being a long process of getting this product to market, and you’ve also mentioned being a quiet innovator with the technology you have. What is next in your sights? Is there a current focus of your R&D or a new type of drug that you are trying to adapt that you would like to share with us?

As I mentioned earlier, pharmaceutical companies have access to many active ingredients and we have the technology and the expertise to make new patches a reality. When we start developing patches in collaboration with other companies, the U.S. may be the first candidate market to which we would like to submit an application for our transdermal products.

 

You said several times now that collaboration is an important part of R&D. You also mentioned that you are actively engaged in co-creation both domestically and overseas. Could you share with us your experiences co-creating with foreign companies? Are you currently pursuing new partners?

A key step for us is to secure access to APIs. We have extensive experience with research and development in adapting APIs from Japan and overseas. We have become known around the world as a transdermal specialist, so many pharma companies have contacted us directly to invite us to collaborate with them. And after our transdermal products are approved, the products we have worked on together can be sold by the same partner in their target territory.

 

How do your recent developments in the US connect with your overall vision for your international development? Can you tell us more about your bigger strategy? Are there any specific areas or regions that you currently have your eye on for future expansion?

What we have learned is that each country has different approval processes. Obviously, Europe and the US are totally different, so the best approach is to set goals first and build the strategy around that. The goal is to obtain approval and the strategy needs to outline each step to achieve that goal.

In addition, for the past 10 years, I have wanted to increase the number of users of our products in Asia. The current roadblock is the wealth gap in some countries in Asia. Our patches contain a lot of ingredients and can be more costly to produce compared to other dosage forms. We want to make it easier for all people, regardless of social status, to have access to effective medicines like our products. We see many people coming to Japan from other countries in Asia for medical reasons. They are learning about our products and other Japanese medicines. They may go home and recommend our excellent transdermal patches to friends and family, so for that reason, I think there is potential there.

The other area I have considered is Australia and New Zealand. They are promising markets, but unfortunately, their populations are not that big. The other downside is that plasters and poultices are not well known in that part of the world as a delivery method for medicine.

 

What does the US market represent for Teikoku Seiyaku and what would you like to see in the market in the future?

One of our greatest success stories is introducing Lidoderm® to the US market. It is not just the large population and number of potential customers which is appealing, but the frequency with which new products arrive and the changing landscape of the market too. We are striving to maintain and develop our position in the US.

Even though the population is so much bigger, China presents many challenges when compared to the United States. It has proven difficult for us to get approval there. In fact, sometimes in China the generic drugs come out first and then the branded drugs come afterwards; it is the opposite of the processes we are used to.

 

Imagine that we come back in five years and have this interview all over again. What are your goals and dreams for that timeframe?

My mind right now is aimed at our 200th anniversary which is in 25 years' time. I want to continue to ensure that Teikoku Seiyaku is a sustainable company for those 25 years. In order to do that we need to focus on growth and establishing the younger generation of Teikoku Seiyaku. They will be the ones that will lead the company in the not-so-distant future, so they need to be ready to take on that responsibility.

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