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Pioneering treatments: From ALS to plant-based COVID-19 vaccines

Interview - March 14, 2022

Mitsubishi Tanabe Pharma Corporation (MTPC), a wholly owned subsidiary of Mitsubishi Chemical Holdings Group, has proudly pursued medical breakthroughs for more than 300 years. In that time, the company has discovered several distinctive treatments for serious diseases including diabetes and multiple sclerosis. While these successes represent a strong part of its corporate identity, MTPC continues to build on its legacy by seeking new solutions to the pressing needs of patients worldwide. Today, MTPC is focused on driving scientific discovery in areas including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and – most recently – a novel vaccine for COVID-19.

 

DR. UENO HIROAKI, PRESIDENT & REPRESENTATIVE DIRECTOR OF MITSUBISHI TANABE PHARMA CORPORATION (MTPC)
DR. UENO HIROAKI | PRESIDENT & REPRESENTATIVE DIRECTOR OF MITSUBISHI TANABE PHARMA CORPORATION (MTPC)

Japan has the oldest population in the world with more than 28% of the population over 65 years old. However, Japan’s isn’t the only aging society as Italy, Germany and Sweden aren’t far behind with 20%. As the first aged society, what can Japan teach the world and what role are Japanese pharmaceutical companies playing in it?

If we could solve the issues around an aging population and come up with effective countermeasures to address its adverse effects, Japan could lead the world in this field as many other countries, as you mentioned, will be facing the same problem in the future.

There are two main issues involved. Firstly, the decreasing number of people in the Japanese workforce who can contribute to the local economy, and secondly the increasing number of aging people who may be more susceptible to disease and whose medical care needs and associated costs will be increasing. These two factors combined are a threat to economic growth.

To answer how Japanese pharmaceutical companies can respond, one possible approach for pharmaceutical companies is to try to prolong the working life of people by targeting diseases which effect older people. We would try to do that using highly targeted and efficient drugs which would lower the overall healthcare costs for older people. That would be the best contribution to society that pharmaceutical companies could make over the coming years.

 

You have had two key mergers, one with Mitsubishi Pharma in 2001 and one more recently with Tanabe Seiyaku in 2007. Can you tell us what have been the main benefits of these mergers and how did they strengthen your company when it became MTPC?

The main purpose of the 2007 merger between Mitsubishi Pharma and Tanabe Seiyaku was to expand the business globally. In fact, you could say that we are realizing the main goal of the merger right now having launched our RADICAVA® (cerebral neuro-protectant) in the US in 2017.

The strength of both companies lies in our very strong drug delivery capabilities. We were able to discover both a drug for hypertension and also more recently for Type 2 diabetes. Both companies have very strong discovery capability pipelines and complement each other in that way.

Another effect of the merger is that we could combine the discoveries of the two companies to create new drugs. Tanabe Seiyaku discovered SGLT2 inhibitor, the Type 2 diabetes drug Invokana, and Mitsubishi had discovered the DPP4 inhibitor also for the treatment of diabetes, so we created a combination of the Tanabe SGLT2 inhibitor and Mitsubishi DPP4 inhibitor to another diabetes agent. However, we were not able to develop the DPP4 inhibitor globally and therefore that combination drug is not available globally so if we could roll out the DPP4 inhibitor globally then our sales would dramatically improve.


RADICAVA®, a breakthrough treatment for ALS


Can you tell us more about the synergies that you've been able to establish between your parent company, Mitsubishi Chemical Holdings Corporation (MCHC), and your company?

One of the strengths of MTPC compared to other Japanese pharmaceutical companies is that since we are a 100% subsidiary company, the combination of our drugs with their materials increases the value of our drugs, especially in the field of drug delivery systems (DDS) technologies. We also have access to the facilities of other companies in the group where they are developing therapy drugs that we can support and contribute to. Therefore, our portfolio is well matched to the other companies in the group.

As of December 2021, MCHC has implemented a new management policy titled “Forging the future”, covering the period up to the end of FY 2025. The aim of the policy is to promote an integrated management structure which will leverage on MCHC’s key technologies. As part of this, MTPC is being positioned as one of several key assets that will form the foundation for the entire group’s growth as it looks to exit the petrochemical and coal business. This will, we believe, lead to a further synergistic effect which will allow us to innovate in the targeted areas of food and healthcare.

 

Your goal for the near future is to be a health care company that delivers optimal therapy for each individual based on ‘around the pill solutions’. Can you explain to our readers more about what ‘around the pill solutions’ means and what are the main goals of your vision?

We need to try to increase the value of our pills. Some diseases are similar in some ways but have different causes and doctors often find it very difficult to correctly diagnose an illness in a short timeframe.

If we have technology which could predict if a patient is at risk of a particular illness like ALS (amyotrophic lateral sclerosis) then their diagnosis could be conducted more quickly and effectively, and they could then be treated with our drugs in a timely way.

On the other hand, if the condition gets worse and worse over a period of years to the point where the patient needs help from a nurse or family members to take care of themselves, it is going to be more difficult for the “patient to get the right dose at the appropriate time.” We are therefore trying to provide solutions to help control dosing, and if such solutions are available for the patient, then the lives of patients will be improved, that's what we are thinking.

We need to find an appropriate partner who is strong in the field of such technologies, and work with them. This is a basic example of ‘around the pill solutions.’

 

You have a new medicine launched for ALS (Amyotrophic lateral sclerosis, or Lou Gehrig’s disease) called EXSERVAN™ which provides a new drug delivery method. The FDA has also accepted your application for MT-1186 (oral RADICAVA®). If the latter is approved, it will allow MTPC to offer three different drug treatments for ALS.  Why have you developed these three different types?

EXSERVAN™ is a different kind of drug for ALS. The mechanism of its action is very different as it is composed of a new formulation which is already approved for ALS in the United States. It is an oral drug, but it uses an oral film formulation that dissolves quickly on the tongue and so is very easy to administer and has improved dosing compliance when compared to alternative delivery methods. This formulation is beneficial to ALS patients because most ALS patients are suffering from dysphagia.

MT-1186 is an oral suspension formulation that contains the same active ingredient as RADICAVA® but avoids the need for intravenous infusion. Like EXSERVAN™, it reduces the burden on ALS patients by providing an alternative means of administration to injecting and is in sync with our goal of providing an ‘around the pill solution’ in outpatient settings. Through the development of these oral agents, we expect that the place of treatment will be changed from a hospital to home, and the quality of life (QOL) of ALS patients and their families will be greatly improved.

 

Your company was established in 1678. Now you're the oldest pharmaceutical company in Japan. Throughout those years of history, what would you say has been your main competitive advantages?

It is in our corporate DNA to be motivated to innovate and find new drugs for each new challenge. Our philosophy, or mission, is creating hope for all facing illness. Not only have we been producing drugs for a long time but in doing so we have been providing hope for patients and their families. That is our basic philosophy, and I would like to continue with this approach.


MTPC’s Historical Museum


Why do you choose to focus on diseases that are less prevalent and harder to treat rather than the more common and well known ‘blockbuster’ type of diseases?

9s of the number of patients involved, that’s what we are interested in. The second reason is that recently there has been more research and innovation in areas that can lead to the discovery of drugs for rare diseases, which was not available in the past.

 

You’ve also recently focused on a plant-based vaccine for Covid-19, Medicago. What is your plan for this vaccine in terms of expansion worldwide?

Yes, there was a coincidence in that last year we were already studying this plant-based vaccine when the Covid-19 pandemic started so we can hopefully produce a prototype of the vaccine quickly. At the present time it's not so easy to differentiate it from the currently available vaccines, but the technology it uses is very different and based upon a protein produced by plant-based technology.

We have now completed phase 3 clinical trials in Canada. The study involved 24,000 participants and the overall vaccine’s efficacy against all variants at the time of the trial was 71%. The vaccine efficacy was 75.3% against the then dominant Delta variant and 88.6% against the Gamma variant. The vaccine, named COVIFENZ®, was approved on February 24, 2022 and we plan to commercialize it as soon as possible. We have an agreement with the Canadian government to provide our vaccine there first, but after that we’ll try to bring the vaccine worldwide as well.

This is the world’s first plant-based vaccine for humans and as it can be stored in regular refrigeration temperatures, will be a real alternative in the fight against covid. Nobody knows the future of Covid-19, but I think it's very important to provide several types of vaccine because alternatives may be more effective for different variants of the virus.


Production of plant-based vaccines in Medicago


You have several operations in the US, Europe and Asia including China. Can you tell us more about your global strategy? What is the main goal of your operations worldwide?

We are a Japanese based pharmaceutical company with a very long history, so we feel the market in Japan is fairly saturated and we want to expand globally, and the US is our highest priority country or area, so that's why we have invested heavily in our US business. We’ve had a long history of subsidiary companies in Europe which have been developing drugs as well.

On the other hand, in Asia, and especially in China, there are more promising opportunities, and we are now seeking business engagement in the area. We’ve hired our first non-Japanese executive member to be in charge of our Chinese business operations. The population of China is huge and we feel we have the right drugs for that market so we should be able to expand our business there.

The basic business strategies in these regions are the same. We will advance the development of new drugs in collaboration with the drug discovery in the U.S. operational bases, obtain the approval in the U.S., and then develop products in Europe, Japan, and Asia, including China. We’d be looking at very high efficacy drugs especially for the central nervous system disease or the immune diseases. We’re not looking necessarily for high numbers of patients.

 

There is a growing trend from inpatient to outpatient treatment models in the US. Is this something that you're looking to leverage as an ‘around the pill’ solution provider?

That’s right. Our key strategy or initiative is to focus on outpatient treatment and prescriptions. If we can find the right patients with the conditions that we can cure, maybe we'll be able to obtain a high price for the drug. We will conduct “around the pill” solutions for outpatients, which will better suit the US business model.

 

Let's say, three years from now we have this interview all over again. What would you like to tell us then? What are your dreams for this company and what goals would you like to have accomplished by then?

We are working to expand our business in the U.S. and to strengthen our core technologies for future growth, and I believe that it will be achieved after three years from now.

In the U.S. business, RADICAVA®, EXSERVAN™, followed by oral RADICAVA® “MT-1186 ” will be launched in the field of neurology, catering to the field of ALS treatment as options for treatment expand beyond the hospital and into the home. In addition to drugs, we will continue to advance “around the pill solutions” such as early diagnosis and medication support using digital technology to provide comprehensive solutions for ALS patients. Besides ALS, the launch of “ND0612”, a drug for the treatment of Parkinson's disease, is expected to open up new markets and achieve dramatic growth in the neurological business. In addition, with the launch of MT-7117, a candidate for photo-sensitivities, we also enter into the new therapeutic area of immuno-inflammation in the U.S. Once the marketing capabilities are established then we will supply products to these markets one after another leading to future growth.

As core technologies for growth, we are developing and acquiring new modalities such as gene therapy, nucleic acid to realize “precision medicine” and early diagnosis and medication support using digital technology to realize “around the pill solutions”.

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