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Extracting nature’s best for the advancement of healthcare

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Interview - April 26, 2020

Established in 1947, Alps Pharmaceutical Ind. Co., Ltd. combines its expertise in traditional medicine and prowess in modern science and innovation to turn nature’s bounty into a vast range of pharmaceutical, food and cosmetic products and ingredients. The Worldfolio sits down with president, Mr. Osamu Ushimaru, to discuss some of the company’s latest developments, such as its work in Eubioflavonoids, which have the potential to have an enormous impact on healthcare. Mr. Ushimaru also discusses how Alps’ “power of assembling technology” sets it apart from its competitors, while also giving some insight into the company’s rich history of R&D and innovation.

 

MR. OSAMU USHIMARU PRESIDENT OF ALPS PHARMACEUTICAL CO., LTD.
MR. OSAMU USHIMARU | PRESIDENT OF ALPS PHARMACEUTICAL CO., LTD.

The global pharmaceutical sector is expected to reach US$1.5 trillion by 2023. The industry is booming and growing at a CAGR of around 4.5%. There are various noticeable trends. An aging population in need of more pharmaceutical products, and an increasing middle class in Asia spending more on products and shifting their consumption towards natural products. What is your global assessment of the pharmaceutical industry and what are your expectations for the future?

The global pharmaceutical market revolves around American and European companies with leading companies based in the US and the EU. Even Takeda, the largest pharma company in Japan which has mainly grown through M&A, is only the seventh largest in the world. While demand in Southeast Asian pharmaceutical markets remains steady, it represents a small share of the global market.

The approach of big companies is to concentrate on new and existing pharmaceutical projects with the greatest revenue potential. SMEs instead take over the projects developed by the bigger companies and supply these under generic drug names in the market. The sales volume of generic drugs is small in comparison to the sales of larger scale companies. But given these sales supply the middle class and in some cases low income earners, their underlying value is arguably equivalent to that of larger companies.

Our company's mission is to supply high-quality drug substances at a low cost to encourage widespread use of our products. Even though our sales volume is somewhat small when we factor in maintaining public health and addressing varying stages of health our value add is at par to larger companies.

 

Your company was founded in 1947, and you have a long and rich history. Can you share with us the key milestones of your company as well as the evolution of the corporate philosophy at Alps Pharmaceutical?

The first milestone was in 1970 when we stepped into India for dealing with a natural drug substance contained in a plant which grows in India. Our challenge was how to procure the high-end plant-derived drug substance. First, we secured an extraction facility in the local area. Second, we taught our extraction technology to the locals. Thirdly, we established the distribution system of the material to Japan, and, finally, we imported the crude material to Japan for the further purification. These are the four steps that took place in the 1970s when we entered India and they represented our first strong milestone.

The second milestone happened in 2013 when we began the cultivation of raw materials, the plant. We opened three sites, two of them in China, in [Shinjang], where we began the cultivation of licorice. The third plant was located in Myanmar where we cultivate Senna.

One of our strengths is that we are one of the few companies in the world who is taking a self-contained business from the cultivation of medical plants through the extraction and the purification of active components in the plants. It is known that Merck in Germany was taking this business model until the early 2000s. We intend to rebuild it.

 

Technology is at the core of your mission “to provide clients with the finest products using the best technology”. What unique technology makes Alps Pharmaceutical special and how important is R&D for the company?  

There is no special technology at Alps. The power of assembling technology is at the core. Companies have similar technologies and that is why our technology itself is not unique, but nobody has our assembly technological know-how.

Kampo medicine is based on traditional Chinese medicine that was imported and developed in Japan in the 5th and 6th century. It is considered a kind of pharmaceutical drug and it is regulated and the most important characteristic is that it has many active components. However, the Japanese government strictly regulates the ratio of the total components and it is very difficult to comply with the specifications.

To give an example, big pharma asked Alps to supply variety of Kampo extracts for many years. But several years ago, they decided to produce a couple of these extracts by themselves in China. But it was very difficult to get constant ratios within the specifications because the quality and the ratio of these active components in the medical plants depend on the weather, nature as well as other environmental influences. They spend many years attempting to establish production, but it proved very difficult even with access to the same protocols. Hence, this is Alps’ know-how and a special, great technology that differentiates Alps from other companies.

We should be harmonious in nature and operate as a sustainable business to nature. Wild species have many components, and therefore, the best way is to cultivate the medical products with a constant quality. That is the only way to continue the natural product business which is a very important, yet difficult business compared to the manufacture of synthetic products.

 

What is the goal that ALPS should move towards?

There are many extracts that can contribute to maintaining human health and curing diseases. However, we cannot produce all of these. Our basic idea is to concentrate only on the flavonoid field in order to have a healthier world. Flavonoids are equal to natural manufacture and while there are many types it is difficult for them to be absorbed by the human body. However, when we have access to more advanced technology regarding absorption of natural manufacture it will have a greater impact on human health. Therefore, the goal is to develop more advanced technology in terms of the ratio of absorption of natural manufacture and to be able to apply it to each type.

This company must aim a top global niche business. Germany currently holds that position and the difference is that Germany has a B2C business model, but Japan has B2B businesses. In these business environments, two essential factors should be important. One is a self-contained business model I mentioned above. The other is a self-run business through our own new brand product even if this is not to consumers.

For this goal, we are focusing on ALPS strengths, flavonoids, abundant in nature, with various biological activities. Recently, natural flavonoids have attracted much attention across a variety of areas including the pharmaceutical, cosmetic, and nutraceutical industries. However, these flavonoids have a significant problem: low water solubility, which typically exhibits as poor oral absorption and insufficient therapeutic effects.

The market badly wants the high solubility flavonoid. Therefore, the first immediate project was to develop a new practical method for producing compositions of flavonoids with improved water solubility and it took us three years during which solubility was enhanced by 2,000 times and confirmed a significant improvement of the oral absorption in a human clinical study. In this way we have developed a revolutionary product, named EubioFlavonoidsTM as the first ALPS brand product.

 

How are you communicating the effects of this developmentEubioFlavonoidsTMto other companies and potential customers?

It can be adapted to the pharmaceutical sector but also the food sector because this new composition only consists of food materials and food additives which is why it must be safe. These materials mixed together under specific conditions and made soluble is unbelievable technology. However, to comply with Japanese regulations we have to add some toxicity data in order to deem it safe.

Moreover, Japanese regulation is too complicated and severe. We should progress step by step in order to meet regulatory standards. We rely on both institutional partners to conduct experiments and in-house testing. But at this pace perhaps overseas customers will be able to adapt their technology faster than the Japanese.

There is a privately held pharmaceutical company in Switzerland that collaborated with us for many years. This company asked Harvard University (Boston USA) to check the antithrombotic activity of flavonoids in 2012 and they found a flavonoid showing a strong activity against thrombosis which led the company to start a clinical trial of this molecule in the US.

We are supplying the clinical substance produced under GMP since 2014. They have successfully completed phase 2 and will move to phase 3 soon. As I mentioned, flavonoids have a disadvantage of poor oral absorption. This clinical flavonoid is also no exception. We learned that the effective dose is 1g a day for the first clinical trial.  The dosage of 1g seemed to be too high in terms of patient quality of life. The company CEO is very interested in our oral-absorption-improved EubioIoquercitrin because it can reduce the dose significantly and it will be possible to materialize a more appropriate dose. We are expecting that our new product can contribute to the next generation of flavonoid pharma drugs in the future. In addition it allows for the globalization of companies. Again this is one example but it shows the reasons why we have developed it.

 

You have mentioned India in the 70s, China, Myanmar and similar initiatives to yours in Switzerland. Where are you concentrating your expansion in terms of your international strategy and are you considering any local partners to achieve that?

Our technology is made in Japan and by the Japanese. In order to collaborate with international partners, it is very important not only to teach our technology but accept their local culture and way of thinking. This takes time. However, in order to maintain our technology and preserve the Japanese tradition in the world an attitude of acceptance of local realities is of utmost importance. That is a basic tenet of a future internationalization. More specifically, we are only further engaging with companies in the world that meet two conditions. One is that they should have a keen interest in naturally occurring active materials and, second, they should understand our business model.

We have had a poor track record in the past in establishing a plant overseas. The main reason was a lack of a proper attitude from us to understand the local reality or culture. Only teaching our technology to locals is not enough. In order to improve our track record we should understand their local culture and reality and then teach them kaizen and our ways.

 

How would you explain the importance of the Alps brand worldwide to someone reading your interview? What would you like stress about what the Alps brand stands for?

Two things: One is the ability to assemble our existing and accumulated technology. The other is the ability to understand the market and to retrieve the necessary information from customers and having the two abilities would enable us to have developed our brand, EubioflavonoidsTM.

 

You are developing many new products. If we were to interview you again in 10 years what would you like to tell us. What are your dreams as the president of the company?

My goal is for more and more people steadily accessing pharmas, regardless if they are lower income individuals by providing low cost, safe and powerful medicines

 

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