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- 2025-12-18 08:33:14
- InterView
- ‘Reimbursing Revlimid as maintenance therapy beneficial’
- by Eo, Yun-Ho Mar 16, 2023 05:45am
- Professor Hyeon-Seok Eom The multiple myeloma treatment ‘Revlimid’ has finally been listed for reimbursement after 4 long years of await as maintenance therapy, starting from the new year of 2023. Reimbursement of Revlimid as maintenance therapy had undergone various twists and turns in Korea. Since 2019, BMS Korea had actively sought to list the drug for reimbursement, but was unable to make progress. The agenda has been deliberated by the Cancer Disease Drug Committee during meetings that were held in September 2019, June 2020, then again in September last year. The last meeting gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ but to no avail for Revlimid. After passing CDDC deliberations in June last year, Revlimid’s reimbursement was finally extended to cover its use as maintenance therapy after 4 years. That a drug can prevent or delay the recurrence of cancer is an extraordinary concept that all cancer survivors would opt for. Revlimid has presented such an option for the first time in the field of multiple myeloma, a type of blood cancer that has a recurrence rate of 70-80%. Dailpharm met with Hyeon-Seok Eom, Professor of Hemato-Oncology at the National Cancer Center to seek insight into the significance and value brought by Revlimid's reimbursement as maintenance therapy. -It took a long time for Revlimid to receive the reimbursement extensions. How do you believe the reimbursement extension will affect the field? When considering how research on Revlimid’s use as maintenance therapy started in the mid-2000s, quite some time had been taken for its reimbursement approval. After the 5-year, and 10-year study data were published, I remember demand started to rise for the reimbursement of the drug as maintenance therapy around 2015. Even patients recognized the need and filed petitions to the National Assembly. Despite such efforts, it took quite some time for Revlimid to receive reimbursement as maintenance therapy. Patients were unable to use the drug as maintenance therapy or had to pay the full non-insured price for such use. In fact, from the late 2000s to early 2010s, this difference in treatment options led to a difference in the 5-year survival rate of multiple myeloma patients in Korea and the U.S. This is an example of how access to drugs directly affected the survival rate of patients. In the same context, patients in Korea will enjoy an improvement in their survival rate with the reimbursement extension. Improvement in the patient's quality of life and survival rate is of the greatest significance in terms of treatment as well. -The reimbursement approval of RVd (lenalidomide+bortezomib+ dexamethasone) therapy last year has greatly changed the prescription pattern of HCPs in Korea. The reimbursement of the maintenance therapy will also bring much change in the prescription environment. I believe the reimbursement of Revlimid as maintenance therapy will change how HCPs progress with treatment in the first line as well as the second line for multiple myeloma. For example, a patient’s overall survival may improve further if he or she uses Revlimid as maintenance therapy after VRd (bortezomib+lenalidomide+dexamethasone) therapy. This is why many studies abroad investigated the use of Revlimid as maintenance therapy following VRd therapy. In this aspect, the reimbursement approval of Revlimid has great significance. -Ultimately, how well the disease can be cared for in the front line (as first-line therapy) seems to be key in managing multiple myeloma as well. That’s true. Despite the increasing diversity of treatment options available in the field, it is still most important to see a good prognosis in the earlier stages. Considering how about 30% of patients die while transitioning from first-line treatment to second-line treatment and the prognosis of patients generally worsens with later lines of treatment, it is very important to increase the time to recurrence and survival rate of patients by treating patients well in the earlier stages. Therefore, it is most important to improve the prevention of recurrence, PFS, and OS with first-line treatment after considering various treatment options. Many HCPs abroad use many drugs in the first line to prolong the treatment period as much as possible. -What improvements do you wish for in treating multiple myeloma? The reimbursement of Revlimid as maintenance therapy has improved the front-line treatment environment, therefore, we now need to focus on improving the second-line treatment environment. We need to use more diverse options to treat multiple myeloma in the second line as well. The survival period of the patients is greatly reduced when patients go through further lines of treatment. The PFS is only a few months, and even the OS does not exceed 1 year in later lines of treatment, so it is important to use drugs well in the earlier stages. Also, good drugs remain unreimbursed in Korea. It is a pity that these effective drugs cannot be used earlier due to environmental issues like lack of reimbursement and are therefore used in the later stages of treatment. As in the United States, we should allow the use of effective drugs in earlier lines of treatment, and discretion should be given to the doctors for the combined use of drugs with reimbursement. - Are there any drugs you are looking forward to in the field of multiple myeloma in the future? With treatments continuing to evolve, I expect new treatment methods like CAR-T therapies would also eventually be introduced to the field. Development of such treatments will significantly improve the OS and quality of life of patients in the earlier lines of treatment, in the first- or second-line. Currently, patients with multiple myeloma generally recieve chemotherapy and autologous hematopoietic stem cell transplantation. However, some patients may experience side effects such as hair loss due to strong drugs and the process itself is also cumbersome as it requires weekly hospitalization. I hope that positive changes would come to foster a better treatment environment for patients in the future.
- InterView
- SGLT-2 I is a great help in the treatment of heart failure
- by Kim, Jin-Gu Feb 06, 2023 05:51am
- SGLT-2 inhibitors developed for the purpose of treating diabetes are speeding up the expansion into the area due to heart failure. The use of SGLT-2 inhibitors targeting heart failure is expanding not only in university hospitals but also in the local area. This trend has been expanding since the revision of the domestic heart failure guidelines last year. Although benefits are still limited, expectations for the drug are said to be very high at the front-line prescription site. Jung Young-jin (37), head of the cardiovascular center at Yongin Myeongju Hospital, said, "SGLT-2 inhibitors are very helpful in treating heart failure. He said, "The effect of improving major symptoms of heart failure, including difficulty breathing, is visible," adding, "Personally, we are more actively prescribing SGLT-2 inhibitors to heart failure patients than in the past." ◆SGLT-2 Inhibitor, Improvement of Heart Failure Symptoms Visibly The Korean Heart Failure Association revised the guidelines for heart failure treatment in July last year. The revised guidelines recommended SGLT-2 inhibitors as the main treatment for heart failure treatment regardless of the presence or absence of diabetes. It was used limitedly only to reduce heart rate and mildness during heart failure, but the revision of the guidelines added an area to preserve heart rate. The pharmaceutical industry predicts that SGLT-2 inhibitors will become the basic treatment for heart failure. SGLT-2 inhibitors have previously been known to be diabetes treatments that benefit cardiovascular diseases. Still, their status has risen significantly as the results of solo clinical trials on heart failure patients were announced in 2019. Expectations for this drug are high even at the front-line prescription site. Jung Young-jin, head of the cardiovascular center at Yongin Myeongju Hospital, said, "It is prescribed a lot to patients with heart failure who do not have diabetes," adding, "Improvement of major heart failure symptoms, including difficulty breathing, is visible." Jung, head of the center, said, "It was often used in heart failure patients in the past, but I have been using it more actively since a paper was published last year that it is effective in heart failure patients whose heart function is preserved." He added, "We are seeking consent from patients and prescribing them because the salary has not yet been applied." The pharmaceutical industry also predicts that SGLT-2 inhibitors will be able to further expand their areas in the future. SGLT-2 inhibitors are mechanisms that selectively inhibit SGLT-2 transporters involved in the reabsorption of glucose. Through this, blood sugar is controlled by blocking the reabsorption of glucose discharged into the urine into the bloodstream. In this process, SGLT-2 inhibitors also inhibit the secretion of inflammatory cytokines, which has the effect of treating heart failure. Considering this mechanism alone, it is estimated to be effective not only for heart failure but also for cardiovascular disease as a whole. This means that SGLT-2 inhibitors can be used to treat heart failure and other cardiovascular diseases such as myocardial infarction. Already in the United States and Europe, a paper has been published on the effect of SGLT-2 inhibitors on the treatment of myocardial infarction. AstraZeneca and Beringer Ingelheim, which have major drugs, are undergoing phase 3 clinical trials for myocardial infarction. The two clinical results are scheduled to be released this year. He also agreed with the possibility. Since the most common cause of heart failure is ischemic heart failure, I think it will be effective in other cardiovascular areas, said he, head of the center. "There is a possibility in terms of the mechanism."
- InterView
- Takeda will lead industry with focus on Oncology
- by Eo, Yun-Ho Feb 02, 2023 05:47am
- A company has achieved evolution through aggressive investment in line with the current trend. Through such evolution, Takeda Pharmaceuticals has become renowned as a 'Big Pharma' rather than a 'Japanese company' from some point. The company had previously focused on OTCs and chronic diseases such as diabetes and hypertension. However, through various small and large M&As, the company quickly secured pipelines for anticancer drugs and rare diseases. Until now, the company conducted four M&As, starting with Millennium Pharmaceutical in 2008, Nycomed in 2012, ARIAD Pharmaceuticals in 2017, then Shire in 2018. As a result, the company has been actively releasing advanced anticancer drugs in the oncology market, including the PARP inhibitor ‘Zejula and the’ EGFR Exon 20 insertion mutation targeting ‘Exkivity.’ Also, the company has made constant progress in treating hematologic cancers with products such as ‘Ninlaro,’ and ‘Adcetris.’ Dailypharm met with Sun Jin Lee, Head of the Oncology Business Unit at Takeda Pharmaceuticals Korea to seek insight into the company’s vision and future. Sun Jin Lee, Head of Oncology BU at Takeda Pharmaceuticals Korea-Could you give us a brief introduction of yourself? I first started my career in the industry as a peritoneal dialysis Product Manager at Baxter. Since then, I also was in charge of high blood pressure treatment products for 3 years and then served as a marketing manager for the circulatory system division for 3 years at Boehringer Ingelheim. After joining Takeda Pharmaceuticals in 2017, I first worked for over 3 years in the hemophilia BU and was involved in the domestic launch of ‘Adynovate,’ etc. After that, I was assigned to Takeda’s Asia-Pacific office and worked in Singapore for 1 year. Last year, I returned to Korea after being appointed the head of Oncology BU at Takeda Pharmaceuticals Korea. In other words, I have worked in marketing throughout my entire career in the pharmaceutical industry. - Takeda has been known to have undergone many changes. In the Oncology BU, the role of its head would have increased significantly with the reimbursement listing and prescriptions of the company’s oncology products. What area did you focus most greatly on last year? I have been with the Oncology BU for about 7 months now. As the head of the BU, I feel the greatest responsibility in performance delivery. This is the basic goal for all business units. Takeda’s fiscal year begins in April, therefore we are in our last quarter right now. Currently, we are focusing on achieving the performance target we set for the last year. My next area of focus was in strengthening the organization. After being assigned to the unit, I had a certain observation period, then focused on strengthening the internal capability of our unit. So I am focusing externally on performance, and internally on our human resources. In particular, only one manager had been assigned to manage all our oncology products despite our increasing portfolio. So we appointed additional managers and divided the work by disease area to increase efficiency. - What do you think is the most important competency required to be a marketer in the Oncology BU? Brand managers (BMs) in each unit have their own strengths and weaknesses as well as various abilities. Having experienced Primary Care and rare diseases firsthand, I believe anticancer drug brand managers should basically have an underlying respect for the patients and their life. In the Oncology BU, we consider various activities such as patient programs and directions to improve access to treatments. Many of these programs cannot be carried out if we are profit-focused or sales-focused. Therefore, I thought it would be difficult for our managers to understand how we carry out our activities if they do not have experience and patient-centricity at heart. Also, our managers need to have the ability to quickly acquire, examine widely, and draw out the essence of the flood of information. There is always a lot of up-to-date data on anticancer drugs. So you have to be able to read out the trend of the entire therapeutic area, including those about competing drugs. Otherwise, you will not be able to communicate with healthcare professionals. sb-The word all-comer is mentioned often during discussions on the reimbursement of anticancer drugs in Korea. Zejula was one representative example of such a drug last year, and more are expected to come this year. However, Korea has been conservative in reviewing these drugs for being less effective and having lower-level results. That is a very difficult issue. Our primary consideration is what will benefit the patient the most. This is also true on the doctors’ part. Pharmaceutical companies obtain permission based on clinical data and then promote drugs based on approved indications. And this will continue to be the same in the future. Doctors as clinicians will use the drug when they feel that the drug is beneficial and needed by the patient. The decision is entirely at the discretion of the doctor. - Exkivity was released this month and is receiving much attention from academic societies. The company would also have rising expectations for the product. Exkivity was approved in Korea last July and released on the 1st of this month. One significant aspect of the release is that we released the drug for the first time in Asia in Korea. Also, Korea is the 5th country in the world to obtain marketing authorization for Exkivity. Being the first oral anticancer drug that targets the EGFR exon 20 insertion mutation, we expect eligible patients to benefit greatly from our release.
- InterView
- “Novartis will lead the provision of innovative medicines”
- by Eo, Yun-Ho Jan 25, 2023 06:08am
- Byungjae Yoo, General Manager of Novartis Korea The Korean subsidiary of Novartis underwent a period of turmoil last year. The company integrated its Pharmaceuticals and Oncology business units in line with the reorganization policy set by its global headquarters. Before then, the company had been operating 2 separate business units independently under one name. The two units had separate support departments including marketing·sales departments as well as drug pricing·government relations·approval departments. Through the integration process, all of these departments were merged into single departments with one head. As a result, layoffs were made and the head of the integrated subsidiary was appointed for the first time since the company’s establishment. The fact that a Korean representative was appointed to head this first-ever integrated Novartis Korea was also a big change. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Galdsden in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015. Dailypharm met with Byungjae Yoo, General Manager of Novartis Korea, who first-handly lead the company through this momentous change. - You were appointed General Manager of Novartis Korea’s Pharmaceutical division in 2021, and then the General Manager of the integrated Novartis Korea last year. What have you been focusing on in the company amid the various changes that had been made last year? My prime focus was on finding the role and direction for Novartis Korea in the changing global pharmaceutical industry. For this, I reviewed much research and consulting reports on the global pharmaceutical industry over the past year. Also, I discussed Novartis’s strategic priorities and Korea's role with our global head office and region managers. Secondly, I tried to connect with our employees and find out what the employees wanted and how to satisfy such desires. After various discussions, I came to the conclusion that Novartis Korea as a company excelled in being ‘goal-oriented,’ but needed to make more effort in being ’purpose-driven.’ Ultimately, I want Novartis Korea to become a purpose-driven company rather than a goal-oriented company. -The Pharmaceuticals and Oncology business units were integrated last year. What was the purpose of the integration and what is your future direction? The biggest purpose of integrating the business units was to ‘do what we do best.’ As so many companies exist in the pharmaceutical industry, each company needs to find its areas of specialty, such as generic drugs or specialty drugs. Also, the needs of each society or patient are also different. Therefore, Novartis decided to integrate its business units to do what it does best – ‘ to overcome diseases’ – and focus on its 5 core therapeutic areas (cardiovascular, immunology, neuroscience, solid tumors, and hematology) to bring synergistic effects. -What is Novartis Korea’s business goal for this year? From 2018 to 2022, Novartis has had one of the most extensive and innovative pipelines among global pharmaceutical companies. Therefore, the company’s priority this year is to increase patient access to its innovative treatments. We plan to discuss how to increase patient access to such innovative treatments within the limited National Health Insurance budget with experts and reach a social consensus on the measures derived. Also, we plan to continue working with domestic companies and startups. We plan to actively support Korean companies that wish to enter the global market through discussions with our head office. -When setting the 1-year business plan, what products have you set as a priority? Among the newly launched products, therapies that are not yet sufficiently supplied to patients in need will likely be given priority. These include Entresto, Cosentyx, Kisqali, Scemblix, Zolgensma, and Kymriah. -The company received much attention, both good and bad, for successfully listing ultra-high-priced drugs such as Zolgensma, and Kymriah for reimbursement in Korea last year. I heard you have other formidable new drugs awaiting release in your pipeline. Could you share your plans for the future? Novartis is not afraid to take risks in developing new drugs for incurable diseases. This is why the company has a higher probability of developing new drugs as well as a high R&D cost. therefore, we will also need to make efforts to reduce such costs while developing new drugs. Patients talk of how a ray of hope shone through in their desperate situation with the introduction of a new drug. I think access to innovative treatments that address existing unmet needs has been strengthened in general in Korea. However, a lot of discussions are still needed on how to address the resulting increase in social cost. The issue cannot be resolved by just strengthening one part while sacrificing others. Therefore, I plan to continue discussions with relevant parties to devise measures that fit the situation. -Do you have plans in place to improve access to ultra-high-priced drugs in Korea? I think making dialogues will be the answer to finding ways to improve treatment access to such drugs. In the past, when Korea’s health expenditure amount of the total GDP had not been as high as other advanced countries and NHI finances were not in deficit, the patient's medical needs were a decisive factor in determining reimbursement. However, that time has passed, and much discussion is now required for any reimbursement. If experts provide opinions on how to finance the national health insurance and the pros and cons, including whether to finance the NHI through funds, private insurance, or bring in other sources of finances other than the NHI, we could provide opinions from the pharmaceutical company’s perspective and seek out solutions together.
- InterView
- Avodart, Real World Data
- by Dec 28, 2022 05:48am
- GSK's large-scale real-world clinical results of Avodart, a treatment for prostatic hypertrophy, which marks the 13th anniversary of its launch in Korea, have been released for the first time. Based on actual field data, the company expressed its ambition to further strengthen Avodart's position in early hair loss treatment.LEAD clinical trials are the first RealWorld study conducted to evaluate the long-term clinical usefulness of Avodart in Korean male hair loss patients. It was compared with Finasteride, the two major mountain ranges for oral hair loss treatment. 600 patients participated in five general hospitals in Korea, including Inha University Hospital and Gangdong Kyung Hee University Hospital, and the average analysis period reached 3.4 years. In particular, the Korean Hair Loss Type Classification Act (BASP) developed by the Hair Institute for data analysis with the domestic medical staff was applied. The accuracy of the evaluation was improved by using the Korean classification method, not the Western classification method, which is difficult to apply to Koreans. Dr. Gary Ong, general manager of GSK Global Dermatology Medical, who led the LEAD clinical trial, said, "This study confirmed that Avodart is more effective in treating male hair loss based on Korean classification," adding, "M-shaped hair loss is the part that patients care the most, and Avodart showed good results compared to Finasteride." LEAD clinical results showed that Avodart had a significantly higher cumulative number of patients with improved symptoms compared to Finasteride in most types of hair loss. In M-shaped hair loss, which is most common in Korean men, the proportion of patients with improved symptoms was 86.0% for Avodart and 45.5% for Finasteride, showing a difference of more than 40%p. The improvement rate of hair growth was also about twice as high in the Avodart group as in the Finasteride group. A common misconception about Avodart is that it has higher side effects than Finasteride, which inhibits only type 2 by inhibiting both type 1 and type 2 of 5-alpha reductase. As a result of the Real World study, Avodart showed only a similar level of adverse reactions to Finasteride. Dr. Gary Ong said, "As a result, Avodart was more effective, and safety was similar. "I think the results of this study not only help reduce misunderstandings and prejudices about Avodart but also help doctors make more appropriate decisions when prescribing it in real life," he explained. Based on the results of the first Real World, GSK set a goal of further enhancing Avodart's position as a primary treatment in the Korean hair loss market. This is because there is still a high perception that finasteride is used first in the early stages of hair loss and Avodart is used after further progress. Dr. Gary Ong said, "This study broadens the path to prescribing Avodart as a primary treatment. Male-type hair loss is a progressive disease, so you need to start treatment as soon as possible to get better results in the long term, he stressed. In order to achieve this goal, GSK Korea has recently increased its marketing staff. BM Kim Hwan-geun, who joined Avodart marketing two months ago, said, "Avodart has maintained the top prescription for oral male hair loss treatment from the fourth quarter of 2020 to the second quarter of 2022, and real-world data for 600 Koreans will have a positive impact on Avodart's prescription expansion." "Avodart started as a latecomer amid fierce competition and showed double-digit growth every year," said BM, in charge of Avodart. As it is expected to grow further in the future, two managers will join us in marketing, he said. "We will try to make Avodart the epitome of hair loss treatments next year."
- InterView
- IL-23 Continued research on inflammatory pathways
- by Dec 23, 2022 06:05am
- Efforts to develop treatments through various studies such as combination therapy and receptor targets. Interleukin (IL) inhibitors used in autoimmune diseases such as psoriasis are evolving as several companies continue to develop them. With the emergence of more effective treatments, psoriasis can expect "PASI 100," which means complete improvement. Interleukin inhibitors are classified according to the mechanism. Stelara, which appeared first, targets IL-12 and IL-23 simultaneously. Cosentyx and Taltz are mechanisms that inhibit IL-17. Recently, drugs that are attracting attention are Tremfya and Skyrizi, which are exclusively targeting IL-23. It is known to have the most powerful effect. As IL-23 pathway research becomes more active, evidence is accumulating that IL-23 inhibitors are inevitably more effective than interleukin inhibitors of other mechanisms. In a recent interview with Dailypharm, Daniel Cua Janssen, vice president of the immune business department, said, "IL-23 inhibitors act on immune cells themselves that activate inflammatory pathways, preventing the underlying cause in the early stages. Recently, it was found that IL-23 reprogrammed a group of T cells that produce IL-17 and found that a fairly strong inhibitor was needed among IL-23 inhibitors, he explained. Daniel Cua is a world-renowned scholar who first discovered the IL-23 pathway 22 years ago. The IL-23 route he discovered was the beginning of the development of IL-23 inhibitors such as Trempier and Skyrich. Studies on the mechanism of how IL-23 causes inflammation are still ongoing. "It is clear that IL-23 is the strongest interleukin associated with autoimmune diseases. Based on this, he added, "In the future, challenges to develop treatments through various studies such as combination therapy and receptor targets will continue." The following is a question-and-answer session with Vice President Cua. -After studying immunology for a long time, we discovered the IL-23 pathway that is the target of autoimmune disease treatment. We are curious about the history. =22 years ago, I was researching a small biotech in Silicon Valley, USA. At that time, research was in full swing to discover substances that control inflammation. The goal was to find an inflammatory control substance, but the IL-23 pathway was found at that time. At that time, not many people believed it because it was an unexpected discovery. It was only a year or two later that the substance that academia wanted to find was IL-23 which we discovered in 2000. It began to be recognized as a very important discovery. Animal models that inhibited IL-23 showed all resistance to several autoimmune diseases. This also affected future research and treatment development. The discovery of the IL-23 pathway is considered to be the starting point of several subsequent studies. - Various interleukin inhibitors such as IL-12/23, IL-17 and IL-23 have been developed as treatments for autoimmune diseases. What differences do differences in mechanisms make? =One of the most frequently asked questions is why blocking only IL-23 works better than blocking IL-12 and 23 together. To put it simply, IL-23 is the standard target we have to hit. Cytokines sometimes cross-regulate each other. Controlling one means that the other rises. IL-12 and IL-23 are. Blocking the two together in a cross-regulation relationship results in a "push and pull" conflict effect of each other's actions at the same time, which reduces the effect. Only IL-23 should be blocked to show the most precise inhibitory effect we want. IL-17 is an interleukin present in a lower stage than IL-23 on the reaction path. It has higher specificity in intestinal epithelial cells and skin epidermal cells. On the other hand, IL-23 acts on immune cells themselves that activate inflammatory pathways. For this reason, IL-23 must be suppressed to prevent the underlying cause of the inflammatory system in a more early stage. In psoriasis, IL-23 shows a clinical improvement effect of 80-90% in more than 90% of patients. - Like immuno-cancer drug combination therapy in cancer, can autoimmune diseases be more effective by combining upper and lower series that suppresses interleukin? = combination therapy is the approach that many researchers and companies in this field are most interested in. The concern is the accumulation of adverse reactions caused by combination therapy. Therefore, research on port therapy is being conducted on the most reasonable and scientific basis. A combination of specific route drugs based on biomarkers is being sought. Although it is still in its early stages, many efforts are being made to find a combination that increases the effectiveness but does not increase the response. So far, it is known that blocking complementary paths may be more effective than targeting only specific paths. For detailed research, the understanding of various paths is improved based on biomarker analysis. -How far has the research on IL-23 progressed? =The level we know is that IL-23 induces the production of receptors called IL-17, IL-22, and GM-CSF. However, it was not clear exactly how IL-23 causes inflammation. It has recently been revealed that IL-23 reprogrammed a group of T cells that produce IL-17. Reprogramming is a fairly powerful action and cannot go back because it is semi-permanent in itself. To prevent this, considerably strong inhibitors among IL-23 inhibitors should be used. In the end, I realized that inhibiting IL-23 has a much stronger effect than inhibiting elsewhere and that it is also effective in preventing lower-level diseases when applying a mechanism that prevents reprogramming at the epigenetic level to new drug development. - What are the targets or pipelines to pay attention to in the subsequent development of interleukin formulations? = First, the receptor. Ligands such as IL-23 bind to receptors, a new drug that blocks the receptor itself to prevent binding. The number of receptors is smaller than that of ligands, so it is easier to block and has precise access, making them a good candidate. The second is the study of RORgamma-t. Many researchers are targeting it, but no one has succeeded yet. Treatments that produce the most accurate and precise effects in this route are expected to be developed in the future.
- InterView
- From domestic sales to the global brand general
- by Dec 22, 2022 05:53am
- Considering healthcare systems around the world such as in Russia, the Middle East, Southeast Asia, and South America, the company will set up a strategy to launch a new anti-cancer drug. It is the main job of Kim Soo-yeon (48), executive director of the International Lung Cancer Brand, at AstraZeneca. Managing director Kim's role has also grown as the number of new anti-cancer drug pipelines from companies such as Tagrisso and Enhertu has increased. Having been working in Singapore for two years, he is neither a study abroad nor a pharmacist or doctor. Executive Director Kim is the only case in a multinational pharmaceutical company where a native Korean, not an expert or a study abroad, has stood as a global marketer. Kim, who met in Singapore, cited four things. "I think confidence, courage, responsibility, and people have grown me this much." It is also something that executive director Kim wants to emphasize the most to his juniors. In fact, she plucked up courage in certain areas. Kim, who set foot in the domestic pharmaceutical industry about 20 years ago with cardiovascular sales at Pfizer Korea, moved to Novartis with the aim of marketing anticancer drugs. At that time, multinational pharmaceutical companies were just starting to set up an anti-cancer drug division. "I had a clear goal. I thought the market for anticancer drugs, which is more grounded and directly affects patients' lives, would grow, and I thought I should be in charge of anticancer drugs. I went to Novartis and launched the first targeted anticancer drug, Glivec, and I did a lot of work to tell them what targeted anticancer drugs were. Another targeted anti-cancer drug, Tasigna, was launched." Based on the successful launch of anticancer drugs such as Glivec and Tasigna, AstraZeneca contributed to the rapid introduction of Tagrisso in Korea. Korea's approval of Tagrisso was the fifth in the world. Kim was not satisfied with her domestic success. It has jumped into unfamiliar markets such as the Middle East and South America. Executive Director Kim was in charge of Tagrisso marketing in all global markets except the United States, Europe, and Japan. The situation was not good because it was a time when COVID-19 was spreading. Even under difficult conditions, Executive Director Kim successfully launched Tagriso and was promoted to the general manager of lung cancer once again after a year and 10 months of promotion. "In fact, the domestic anticancer drug market knows the market to some extent, so I was able to work well. I think it's time to try something new. When I was in charge of global marketing, the Middle East and South America were really unfamiliar. She didn't know anything about culture, economic conditions, government policies, and healthcare systems. It is also greatly affected by the international situation such as COVID-19 and the Russia-Ukraine war. On the contrary, it was new and fun to understand the market. It was also fun to communicate with employees all over the world." She made it his first goal to be responsible and influential in a given role until the end. In countries where the early diagnosis of lung cancer is not well performed, cooperation continued to activate the early diagnosis system. It is not just about introducing products, but about increasing the size of the market. Executive Director Kim's marketing strategy is to lead early diagnosis as an important agenda and create an ecosystem where lung cancer treatments can be used for patients at an appropriate time. Executive Director Kim stressed that such success cannot be achieved alone. As a mother of two children, the support and support of the family became the driving force to focus on work. The good influence of the surrounding seniors and juniors became manure and grew Executive Director Kim. This is why executive director Kim values "people." "People are important in the family, in the company, and everywhere. I was able to come here because my family supported my children when they were young. The company should also help each other so that the seniors and juniors can grow together. I can't succeed alone just because I'm good. With confidence, courage, and responsibility, what matters is people."
- InterView
- The issue of SE of JAK inhibitors should be given authority
- by Kim, Jin-Gu Dec 02, 2022 06:08am
- Shim Seung-cheol, professor of rheumatology at Chungnam National University HospitalThe treatment results of rheumatoid arthritis have improved dramatically. This is because doctors can use it a lot. Following the advent of MTX in the late 1980s, TNF-alpha inhibitors changed the treatment paradigm of this disease. Recently, JAK inhibitors that improved the shortcomings of TNF-alpha inhibitors have emerged. JAK inhibitors, which have been attracting attention as next-generation treatments, have recently been at the center of controversy due to safety issues. This is because concerns have been raised that the drug may cause cardiovascular side effects. How do the prescription sites view the safety issue of JAK inhibitors? Shim Seung-chul, a professor of rheumatology at Chungnam National University Hospital, said, " We should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." He said, "If clinical data are added to confirm which patients are more likely to have drug side effects, detailed treatment guidelines for JAK inhibitors will be prepared." ◆ One in 10 patients is difficult to treat with MTX or TNF-alpha inhibitors Rheumatoid arthritis is an autoimmune disease. Treatment is also carried out in a way that suppresses autoimmune phenomena. The most traditional treatment is MTX. It is a drug that suppresses lymphocytes and was initially more commonly used as a treatment for leukemia. Since it was approved for the purpose of treating rheumatoid arthritis in 1988, it has been used for more than 30 years. Since it was originally developed as an anticancer drug, there were many patients whose drug did not work. In time, a better treatment was developed. It is a TNF-alpha inhibitor. It not only inhibits one target that causes autoimmune diseases but also inhibits several parts at the same time. Since the advent of this drug, the treatment results of rheumatoid arthritis have improved dramatically. The limitations of TNF-alpha inhibitors were also pointed out. The number of patients who do not respond to this drug has gradually increased. The disadvantage of injection was also pointed out. Patients with mobility difficulties due to arthritis wanted to treat the disease more comfortably by reducing hospital visits. JAK inhibitors have emerged. The method of suppressing inflammation has also improved. If existing drugs were a method of blocking inflammatory substances outside the cell, JAK inhibitors are a method of accurately targeting and suppressing substances within the cell. Professor Shim said, "The use of MTX is effective in 70% of patients. If there is no reaction here, using TNF-alpha inhibitors improves 70% of them. He said, "10% of all patients were difficult to treat. Unlike TNF-alpha inhibitors, the development of JAK inhibitors that block inflammatory signals in cells has made it possible to treat such patients. ◆MTX also experienced side effects of TNF inhibitors…JAK inhibitors can also be overcome Safety issues have recently emerged in JAK inhibitors, which have emerged with high expectations. In 2021, the U.S. Food and Drug Administration (FDA) warned of risks such as heart disease and cancer against JAK inhibitors, and the MFDS in Korea also distributed safety letters. Eventually, the FDA decided to include risk information such as major cardiovascular events, thrombosis, and death in the box warning in the JAK inhibitor. Professor Shim Seung-chul said, "The existing drugs have undergone a similar process," adding, "What is important is how well you manage side effects and treat diseases." "I think we can overcome the problems that are currently being raised," he said. According to him, MTX has had side effects such as an increase in liver levels since its appearance. Accordingly, drugs were used at the prescription site while simultaneously performing a liver biopsy. As the experience of use accumulated, the drug has been set up to be prescribed in low doses when used for rheumatoid arthritis rather than anticancer drugs. The same is true of TNF-alpha inhibitors. Concerns have been raised that it causes tuberculosis in the early stages of its appearance. These concerns were addressed by the use of anti-tuberculosis drugs. In the case of JAK inhibitors, concerns about herpes zoster were raised at the beginning. Professor Shim explains that the newly emerged cardiovascular risk can also be seen as an extension of this. Professor Shim said, "We need to pay attention to the extent to which side effects occur frequently in certain patients, not in the side effects themselves," adding, "We expect that detailed treatment guidelines for JAK inhibitors will be prepared when more domestic clinical data are accumulated and drug side effects occur. JAK inhibitors are limitedly used only when other drugs do not work. If drugs are used sequentially, there will be no big problem. I think we should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." There are three representative JAK inhibitors released in Korea. In the case of Xeljanz, it is a general-purpose JAK inhibitor that inhibits all three inflammatory substances. Olumiant inhibits two substances and Rinvoq SR inhibits one substance. Professor Shim said, "There are currently various JAK inhibitors released, and further research is needed to find out the difference between general-purpose JAK inhibitors that suppress all inflammatory substances in cells and selective JAK inhibitors that suppress only certain substances."
- InterView
- The key to treating stroke tx is preventing the recurrence
- by Kim, Jin-Gu Nov 23, 2022 06:04am
- Stroke is a battle against time. Whether the blood vessels in the brain are blocked (brain infarction) or burst (brain hemorrhage), blood should be supplied to the brain normally within a short period of time. The medical community explains that the golden time of stroke is 4.5 hours. This means that the problem can be solved only when the symptoms occur and arrive at the hospital within 4 hours and 30 minutes. The importance of preventive treatment has been increasing. As the results of stroke treatment have improved compared to the past, drug treatment to prevent the recurrence of patients with stroke once has become more important. Park Jong-kyu, a professor of neurology at Cheonan Hospital affiliated with Soonchunhyang University, said, "The key to treating stroke drugs is to prevent a recurrence," adding, "Various drugs are used differently depending on the cause. Since the brain is a drug used in special areas, it should be used carefully in consideration of the side effects of bleeding, he said. ◆ Antiplatelet agents for vascular stroke and anticoagulants for embolic stroke There have been changes in the treatment of stroke over the past decade. In the past, even if a stroke occurred, it often came late. Many patients fell down holding the back of their necks and visited the emergency room. As such, the treatment period has been delayed. Major surgery was needed and the prognosis was not so good. As public awareness of stroke has been aroused, treatment performance has improved significantly recently. Unlike in the past, more and more patients visit the hospital due to initial symptoms, such as poor speech, narrow vision, and poor finger grip. Treatment methods are also changing. The importance of drug treatment is increasing as a secondary preventive treatment to prevent recurrence after treating an initial stroke. Professor Park Jong-kyu said, "Depending on the cause of stroke, drugs are used differently," adding, "In the doctor's opinion, if it is a vascular stroke caused by blood clots accumulating in the cerebral blood vessels, an anticoagulant is used." Professor Park emphasized, "In the case of anticoagulants, it may look better to prevent the recurrence of stroke in that it prevents blood itself from coagulating, but it should be used carefully because there is a high risk of side effects of bleeding." ◆"Anticoagulants have a high risk of bleeding side effects, so they should be used carefully for stroke" According to Professor Park, anticoagulants are mainly used for patients suffering from arrhythmia or heart valve disease at the same time. The problem is when heart disease is not clearly diagnosed. In this case, the doctor's judgment is involved. Professor Park explains, "Clinically, it seems that an embolized blood clot came from under the heart and blocked the cerebral blood vessels, but if there is not enough evidence." It is right to use antiplatelet drugs, but he explains that he uses anticoagulants on a limited basis because there is often a high risk of stroke recurrence. Multiple cerebral infarctions, in which several blood vessels in the brain are blocked at the same time, are a typical example. If the left blood vessel of the brain is observed to be blocked when the blood vessel of the brain is photographed, the cerebral infarction area should also be on the left side of the brain. However, there are patients who often have cerebral infarction on the right side of the brain. At this time, the location where the blood clot occurred is presumed to be below the heart, not the brain. At this time, if the patient has no history of heart disease, the anticoagulant is used under the judgment of a doctor that the patient lacks the basis for anticoagulant treatment, but the risk of recurrence is high. If multiple cerebral infarctions are not the first time, or if cerebral infarction occurs during recurrence prevention treatment with antiplatelet drugs, anticoagulants are used. Professor Park said, "Most of the patient's risk factors and mechanisms for cerebral infarction are identified and drug treatment is carried out accordingly to prevent a recurrence." ◆ Stroke is the fourth leading cause of death in Korea, and the number of young patients is increasing recently Severe or acute stroke is still treated surgically. Patients with blocked large blood vessels in the brain or blocked heavy blood vessels and poor symptoms are the targets. The key is to treat it as soon as possible. Generally, patients should visit the hospital within 4.5 hours. Professor Park said, "Finding and operating blood vessels is only possible when large blood vessels are blocked. In the case of heavy blood vessels and small blood vessels, surgery is attempted only when the symptoms are severe. He said, "Because there is a risk to the treatment itself, we solve it with thrombolysis through veins instead of surgery." Professor Park explained, "It can be rather harmful to perform surgery after golden time." He added, "This is because the bleeding occurs in weak areas in the process of penetrating blood vessels and supplying blood again, which can be dangerous for patients." Stroke is the fourth most fatal disease in Korea. According to the HIRA, 590,000 patients were diagnosed with stroke as of 2020. The perception of stroke has changed and the number of patients is increasing faster as the population ages rapidly. This is due to the increase in patients with hypertension and hyperlipidemia, which are the underlying diseases of stroke. The medical community estimates that the incidence rate doubles every 10 years after the age of 55. Professor Park explained, "As you get older, the risk factors you have are more likely to cause problems, so it will affect the increase in stroke." He said, "Recently, the number of young stroke patients under the age of 45 is increasing rapidly increasing. "There are concerns as risk factors for stroke, such as sleep apnea, are diversifying," he said.
- InterView
- “Korea is fully capable of developing new microbiome drugs"
- by Nho, Byung Chul Nov 18, 2022 06:04am
- Eung-Bin Kim, Professor of Systems Biology at Yonsei University “The development of metagenomics technology that extracts DNA directly from samples without culturing in 1998 enabled the field of human microbiome research to make a giant leap forward. The success and failure of innovative new microbiome-based therapeutics depend on identifying, standardizing, and materializing the keystone species in the human gut microbiome.“ The development direction for new, innovative next-generation human microbiome-based therapeutics sought by Professor Eung-Bin Kim, Department of Systems Biology at Yonsei University, is focused on the understanding of the material cycle in the ecological structure. More than 10,000 microorganisms inhabit our body (mouth, gut, nose, genital, skin, etc) along with 37 trillion bacteria. Regarding this, Professor Kim said, “What’s important is not the microorganisms themselves but the microbial genes and proteins. For example, microorganisms that digest fat are always present in a healthy intestine. However, the task is not always performed by the same microorganism. Just like how players replace each other’s role in sports games.” Among Professor Kim’s microbial studies, one that caught the reporter’s attention was his identification of the existence of probiotics in jeotgal (Korean traditional pickled fish made with croaker or hairtail, etc). In the early stages of the salt-aging period, jeotgal contains a lot of bacteria, but 99% of the bacteria are killed after 2 years of aging. In the end, only 2 or 3 types of basophilic lactic acid bacteria such as Tetragenococcus remain. The study received much interest from the academia and media. Professor Kim, who is considered an authority in microbiology, has his eyes on the potential held by Akkermansia muciniphila and Faecalibacterium prausnitzii in gut microbiota that is considered next-generation probiotic candidates.” Kim said, “The key to probiotics is in the time of residence in the intestine, and ‘Akkermansia’ and ‘Faecalibacterium’ were found to have a long survival time in the intestinal mucosal barrier. Also, the fact that these species were successfully cultured with domestic technology is also rated highly. We are looking forward to the development of innovative new drugs based on these species, which are the keystone species in the human gut microbiome.” On how to confidently compete against strong R&D players in developing new and innovative microbiome-based therapeutics in the global market, Kim said that the focus should be on treating various disease groups rather than simply developing and releasing intestinal microbiota products. In particular, open collaboration between the industry-academica-research and policy and systemic support should also be promptly prepared. Meanwhile, Professor Kim had served as the Dean of Admissions, and Dean of the College of Systems Biotechnology at Yonsei University, and authored ‘Alcohol, Disease, War: A History of Microorganisms', 'The Whole World is Full of Microorganisms', 'Biotechnology gives wings to Life Sciences’ and 'I Live with Microorganisms'.
