First established in 1920, ASKA Pharmaceutical has grown to become the leading company in female healthcare in Japan, and currently occupies the number one sales position domestically in the fields of obstetrics and gynecology.
One of the big criticisms of the Japanese medical sector is the slow regulatory processes, which are, on average, three to five years slower than those of Europe or US. We have seen some changes since 2012 with the introduction of the Sakigake system as well as the PMD Act. From your point of view, how would you rate Japan's regulatory framework? What are some of the improvements that you would like to see?
It is true that before the year 2010, there was a lag due to the time-consuming consideration process. However, since 2010, the situation has improved; the structure of the PMDA, the body to which applications are submitted before being submitted to the MHLW, has been strengthened. Currently, depending on the sector, the drug lag caused by prolonged examination periods has now been eliminated. Whereas the reality is that it sometimes takes a long time for clinical trials before you can submit the application, and there are many pharmaceuticals that are approved overseas but not yet approved in Japan. Additionally, some of the world's drugs currently under development are not being tested in Japan.
There are two reasons why clinical development in Japan takes time. First, additional clinical trials may be required for clinical trials in Japan even though clinical trial results are available in other countries such as Europe and the US. Second, the market attractiveness of Japan is becoming lower compared to other countries, so pharmaceutical companies are not prioritizing the Japanese market for development. The government and PMDA are taking this situation seriously and have introduced the Sakigake system. At the same time, there is a system where drugs of high medical necessity that are not approved in Japan but are approved overseas take priority screening. The government and companies are taking active steps, however, there are still some drugs that have not been developed in Japan, or drugs approved abroad that have not been approved in Japan.
The declining population in Japan and the government's efforts to lessen the burden on social security means that the State should implement annual reductions in NHI prices. As a result, the price of pharmaceuticals is relatively lower, making the market less attractive for companies. These factors combined have contributed to the current drug lag in Japan.
In recent years, the lines between medical remedies and treatments have begun to blur. As a result, many patients are opting for over-the-counter medications rather than physically seeing a doctor and the COVID-19 pandemic has further exacerbated this trend. In an era where many patients choose OTC and self-medication, what opportunities are there for ASKA Pharmaceutical?
Generally speaking, the Japanese people are becoming more health-conscious, not only in terms of treatment, but also in the entire life cycle, including prevention, examination/diagnosis and post-treatment. OTC options are gaining popularity, and we are aware of that. This situation actually presents an opportunity for us. Since 2021, ASKA Pharmaceutical has changed its management style to holdings, and the Group as a whole is now able to provide a holistic service from prevention, examination and diagnosis to treatment and post-treatment. ASKA Pharmaceutical Holdings Ltd. has several group companies, and one of them focuses on pharmaceutical drugs, while another company focuses on testing and equipment for early diagnosis and prevention. With this comprehensive approach, we can increase our business opportunities.
In the medical industry, as people become more health-conscious and their needs evolve, there is an increasing demand for specialized medications. For instance, in the fields of obstetrics, gynecology and thyroid disorder, there are numerous potential customers who could benefit from the pharmaceuticals we provide. With growing health awareness, individuals are more proactive in preventive measures and early diagnosis, as a result, patients who had not previously reached the point of treatment are now also being treated.. Thus, we believe there is still significant untapped potential for the pharmaceuticals we offer.
One of the core businesses of ASKA Pharmaceutical is the production of oral contraceptives (OCs), which suppress the penetration of sperm into the uterus, making impregnation difficult. However, it is important to note that there are other forms of contraception available in the market, such as intrauterine devices (IUDs), condoms, and surgical methods. So, what advantages do OCs have over these alternative forms of contraception?
OCs offer advantages. The failure rate of contraception is lower than with condoms. Moreover, they allow females to assert their preference for non-pregnancy, in contrast to condoms, which are primarily male-oriented. There are several contraceptive methods, including OCs, condoms, IUDs, and others. Each has its own distinct features and advantages. As a company, we provide one of the available options in the market.
There are several women who take these pills, but there are potential negative effects such as changes in blood pressure and mood swings due to hormonal changes. What steps is your company taking to minimize these secondary effects?
We are actively working on developing drugs to minimize them. Since the initial launch of our OCs, we have been engaged in research and development to reduce side effects. While there is no drug in the world yet that removes all side effects, we are currently in phase three of developing LF111, which utilizes only progesterone, thus eliminating the side effects associated with estrogen. We strive to provide multiple options so that patients can choose the medication that best suits them.
Why is it that a particular treatment may be suitable for one woman but not for another?
It is difficult to provide a definitive answer to your question. This is because all medicine can have some side effects, but how an individual reacts to a medicine is a complex combination of many factors. This applies not only to OCs but to medicine in general. People's reactions can vary based on their individual physiology, sensitivity to additives in the medicine, and even specific reactions to the active ingredients. Determining the exact reasons behind these variations is challenging, and it is important that patients have multiple treatment options available to them.
A significant number of women experience pain for one or two days during their menstrual cycles, with some cases being so severe that it hinders their daily activities for several days. In June 2022, ASKA launched the DroEthi combination tablets for the treatment of dysmenorrhea, which has been listed in the NHI drug price standard as well. What sets this pharmaceutical apart from the others, and how effective is it in treating severe dysmenorrhea?
The treatment of dysmenorrhea typically involves a combination of two elements - estrogen and progesterone - with varying percentages depending on the specific medication. Our recently launched DroEthi combination tablets belong to the fourth generation of progesterone, and it is a generic version of a well-established original product in the market. We have received positive feedback from patients who found our generic alternative to be effective in reducing medical costs. We also have a line-up of Japan-specific therapeutic OCs (for dysmenorrhea). One of our strengths lies in providing a range of products for dysmenorrhea treatment, and we hold a 50% market share in this field. We offer different combinations of estrogen and progesterone compounds, allowing us to provide diverse options tailored to individual patient's preferences and responses. Some patients react better to particular pharmaceuticals, some have bigger side effects with other pharmaceuticals, so it’s important to give the most appropriate pharmaceuticals to patients.
Are you considering exporting these products to developing nations to ensure broader access to these pharmaceuticals for women?
Currently, we do not have ongoing projects specifically focused on delivering our products to developing nations overseas. However, as part of our plans for international expansion, there is potential to bring much-needed pharmaceuticals to developing countries, particularly products related to OCs and dysmenorrhoea treatments.
Speaking of your product pipeline, one drug in development is AKP-022, a Relugolix combination tablet that is set to go to clinical trials. What are your expectations for the upcoming clinical trial of this medication?
A Relugolix combination tablet called AKP-022, for instance, is set to go to clinical trials in July 2023. Focusing on uterine fibroids in females, the product is positioned as the successor to RELUMINA (relugolix) for the treatment of uterine fibroids, which is currently on the market; it is expected to enable longer durations of administration, which was not possible with RELUMINA, and is expected to improve patient convenience.
In 2005, Teikoku Hormone Mfg. Co., Ltd. merged with Grelan Pharmaceutical Co. and changed the name to ASKA Pharmaceutical Co., Ltd. What was the reason behind this merger, and what synergistic benefits did it bring?
The reason behind the merger of Teikoku Hormone Mfg. Co. Ltd with Grelan Pharmaceutical Co. in 2005 was to improve our drug development and sales capabilities. Drug development requires significant investment and resources. By merging these two companies, we were able to enhance our pipeline capabilities. This increased our business efficiency as well.
Can you tell us a little bit more about your R&D strategy, and is there anything new that you are currently working on that you would like to showcase?
The three main pillars of our business are internal medicine, obstetrics and gynecology, and urology. We conduct active R&D in these fields, both in-house and through partnerships with other companies for licensed products. In the field of obstetrics and gynecology, as of the second half of FY2022, we hold the number one sales position in the Japanese market. We aim to not only provide pharmaceuticals but also medical equipment and related services, offering comprehensive health services for females.
Could you tell us a little bit more about these partnerships that you have forged, and are you looking to forge partnerships in overseas markets?
We are actively seeking collaborations overseas. We have two approaches to partnerships. First, we introduce unique drugs developed by overseas companies to the Japanese market through licensing and business agreements, and develop, obtain approval, and market the product for Japan. Secondly, we develop drugs ourselves and offer licensing partnerships to overseas companies. Since drug discovery is costly, partnerships are the main way of conducting business in the medical industry, and we value the strengths of our partnering companies, and the synergies that can be created through these collaborations to speed up the launch of new products.
In addition, in terms of our expansion in Asian countries, in 2021 we invested in a partnership with Ha Tay Pharmaceutical Joint Stock Company in Vietnam and are currently supporting plant construction.. Vietnam has a growing economy and medical market, experiencing an annual 10% increase. Through our partnership with Ha Tay Pharmaceutical Joint Stock Company, we aim to establish a strong presence in Vietnam and expand further into other Asian countries from there.
ASKA Pharmaceutical’s mid-term plan for 2025 targets four key areas: expanding business groups centered on pharmaceutical products, improving business operations by promoting open innovation, continuing to be a company that holds society’s trust, and most interestingly, becoming the top domestic company regarding your specialty areas for pharmaceutical products. You have already reached number one when it comes to obstetrics and gynecology, but you still have internal medicine as well as urology to achieve. How are you planning on achieving this goal?
The goal is to continue to be the country's leader in our specialty areas of obstetrics and gynecology. Now that we are number one in terms of sales, we will continue to meet unmet medical needs through continuous investment, risk-taking and the provision of comprehensive services. We want to remain the leader in the field of obstetrics and gynecology, both in name and in reality. In the field of thyroid diseases in the area of internal medicine, we already hold more than a 90% market share. Our aim is to maintain this dominance. The thyroid disease area has many potential patients who are unaware of their symptoms or are confused with other diseases. As well as our approach to healthcare professionals, we work closely with them to raise awareness of these hidden and potential patients and improve overall health awareness.
We are aware that there are two types of thyroid: hyperthyroidism and hypothyroidism. These disorders require constant treatment and management, as neglecting them can lead to various adverse effects on the body. What actions are you taking to contribute to society in terms of addressing thyroid disorders?
Currently, we provide approximately 90% of the pharmaceuticals used in the treatment of thyroid disorders, so it is our mission and social responsibility to provide a stable supply to our patients. Given the long-term nature of thyroid disorder treatment, it is crucial for us to maintain a reliable pharmaceutical supply. Along with stable supply, ASKA is actively engaged in R&D in the field of thyroid disorders drugs that minimize the side effects of existing drugs, or drugs that treat thyroid disease with a different approach. Through this, we will respond to unmet medical needs.
Imagine two years from now, we have this interview again: what aspirations would you have achieved for your company?
By the time we reach our 105th anniversary in 2025, which marks the final year of our mid-term plan, I hope to report that we have successfully achieved our targets. I anticipate the emergence of new businesses that will shape the next 10 to 20 years, reflecting our commitment to continuous progress. We are actively taking measures for global expansion, and I anticipate tangible advancements in that area as well. Ultimately, we aim to become a total health company and a global company, aligning with our corporate philosophy.
Interview conducted by Karune Walker & Sasha Lauture