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- 2025-12-17 15:46:14
- InterView
- “Amgen addresses all unmet needs regardless of indication”
- by Eo, Yun-Ho Nov 17, 2022 05:54am
- Philip Tagari, VP of Research at Amgen Global Amgen owns a vast portfolio of treatments in many areas. Rather than focusing on a particular field, the company has been known to release new drugs in the right places at the right time In addition to actively developing drugs for chronic diseases such as the osteoporosis treatments 'Prolia (denosumab)’ and ‘Evenity (romosozumab),’ the osteoporosis complication prevention drug ‘Xgeva (denosumab),’ and the dyslipidemia treatment ‘Repatha (evolocumab),’ the company has also followed up with the recent trend and released oncology drugs such as the acute lymphoblastic leukemia drug ‘Blincyto (blinatumomab), multiple myeloma treatment 'Kyprolis (carfilzomib),' and the recent KRAS inhibitor ‘Lumakras (sotorasib).’ These achievements were of course made possible with the support of the company’s R&D department. Dailypharm met with Philip Tagari, Vice President of Research at Amgen Global, who recently visited Korea, to hear about the company’s R&D direction and open innovation strategy. -You served over 20 years in Amgen’s R&D department. Which treatment were you most deeply involved in developing? I would say Lumakras. Amgen won the 2022 Prix Galien Award for Best Pharmaceutical Agent with Lumakras. This was very meaningful for us as the Prix Galien Award is considered the industry’s equivalent of the Nobel prize and the highest accolade for pharmaceutical research and development. I have been involved in the research and development of Lumakras in Amgen's R&D department for more than a decade with many colleagues. In a way, the drug has been researched and developed in the shortest time not only in Amgen but throughout the whole industry. I still remember the joy I felt when our belief was confirmed in the clinical trial with groundbreaking data in non-small-cell lung cancer. Also, there is Repatha, our hypercholesterolemia treatment. We had great confidence in Repatha since the discovery of its candidate substance. I think Repatha will continue to have significance in the field and bring positive impact on public health for decades to come. -You said Repatha was commercialized in the shortest period yet. Is there a special know-how of Amgen's or any episode behind the rapid development of Lumakras you’d like to share? Amgen had long been thoroughly analyzing how to shorten the entire new drug development process, since several years before we discovered sotorasib, the active substance of Lumakras. After several years of analysis, we had gained some idea on how to conduct the R&D. It was around that time we discovered AMG 510, the candidate substance that later became Lumakras. So I would say our rapid development was a result of the company’s implementation of a delicate and carefully planned development plan rather than a special technology or ability. -Amgen is also known to be interested in open innovation. Were any of the products in your pipeline born through open innovation? Evenity is one representative result of our open innovation. The drug was developed through collaboration with a doctor in South Africa, a UK-based small biotechnology company British Biotech, and Amgen. At the time, a doctor in South Africa recognized how a specific disease continued to emerge in the local community and asked British Biotech to analyze the cause. Results showed that the disease was caused by a mutation of the sclerostin protein. So the company first needed sclerostin to develop a treatment, and Amgen was the only company that owned such technology. Amgen produced the protein, which led to the commercialization of Evenity. -Would you like to introduce any promising candidate substances that are in development? It is difficult to mention specifics before approvals, but one of the most promising items in our development pipeline is an obesity drug. Obesity is a serious global public health issue that is growing in importance. So you can expect various treatments for obesity and cardiovascular diseases from Amgen to come in the future.
- InterView
- “BMS makes the next leap with its solid pipeline”
- by Eo, Yun-Ho Oct 31, 2022 06:06am
- 이혜영 대표 Mergers have become one of the main survival strategies for global multinational pharmaceutical companies. In addition to buying new substances, companies are also making synergy, absorbing companies that own pipelines with high potential. BMS is one representative example of such successful mergers. When the power of its portfolio declining with the patent expiration of blockbuster drugs such as 'Baraclude Tab.', the company decided to acquired Celgene, the company that owns ‘Revlimid,’ the drug that recorded the highest sales among prescription drugs at the time. In addition to CAR-T therapy, Celgene owned various candidate substances in various areas including blood cancer. In addition, the company also signed an agreement to copromote ‘Opdivo’ with the Japanese pharmaceutical company ‘Opdivo,’ to build competitivity in the oncology sector. Its Korean subsidiary is also working to quickly conclude the merger process and make the next leap with the organizational restructuring. In this whirlwind of change, the company has newly welcomed a new leader. Hye-Young Lee, who has serves as the founding Country Manager of BMS, is dreaming of a new heyday at BMS with her appointment in July. Dailypharm met with the new Country Manager. -It hasn’t been long since you took office. Some might think it is too early to conduct an interview. Is there a reason why you decided to do the interview at this time? I wanted to publicize BMS as it is now. Since we have not conducted many external activities, including media activities, I thought that our business scale and the potential for growth has not been well known. Although there are still a lot of things that I would need to understand in terms of business, I thought it would be good to start by relaying the changed status of our company and its future direction. -You have been a Country Manager before, but this is a new company. What was your first impression about BMS?? As I had only known the company as a member in the same industry before, I was surprised in many aspects after joining the company. BMS's business scale, global presence, and pipelines were much stronger than I expected, and the company owns various industry-leading promising pipelines. -Could you introduce some of those strong pipelines? BMS’s main pipeline cover the 5 fields including Cardiology, Hematology, Oncology, Immunology, and Neuroscience. More than 50 new drug candidates for more than 40 diseases are being developed in these five areas. Based on those that received current domestic or FDA approval, we have Revlimid and Sprycel in Hematology, as well as Onurec, Inrevic, and Reblozyl that were additionally approved this year. In addition, two CAR-T treatments approved by the FDA are receiving much anticipation these days. Our cardiovascular pipeline has been further strengthened by acquiring a company called Myokardia, and there is a treatment for hypertrophic obstructive cardiomyopathy that was approved by the US FDA this year. This first-in-class treatment with a new mechanism of action has been receiving high expectations. We cannot disclose details as it has not been approved in Korea yet, but we are working hard to introduce it quickly to domestic patients. In terms of Immunology, there are treatments for plaque psoriasis and ulcerative colitis with a new mechanism of action that has been recently approved by the FDA. In addition, the treatments it acquired from Turning Point Therapeutics are also from a new class but is yet to be approved in Korea. -BMS two new CAR-T therapies, Breyanzi and Abecma. The two are also in the process of approval. When looking at existing cases, simply introducing CART-T therapies is not enough, and many other preparations are needed for their prescription. How are you preparing for this part? As CAR-T is an innovative therapy that is needed by many patients in Korea, we are continuously reviewing the preparations necessary for the patients in need of treatment in Korea. However, as mentioned, use of CAR-T therapies require various considerations and preparations, therefore, its introduction requires more time. One encouraging fact is that a clinical trial is planned for one of the CAR-T therapies in Korea. It is expected that the experience we are accumulating with clinical trials will be helpful when introducing CAR-T treatments in the future -If you look at BMs, the company is actively engaging in mergers, joint development, and promotion activities. Is there a possibility of expanding such partnerships with Korean companies? Open innovation is the DNA of BMS, to such an extent that 60% of the BMS pipeline has been secured through open innovation, and 40% of current sales were accrued from drugs developed through open innovation. We also plan to actively carry out open innovation in Korea, and a lot of clinical trials are already underway. There are 50 clinical trials in progress in about 20 pipelines in progress in Korea. Unlike the past, where many clinical trials for new drug development were traditionally conducted in the US and Europe, Korea is now in the spotlight in conducting early-phase clinical trials, and is also considered one of the most important countries in terms of expansion. One aspect I found impressive after joining the company was in the number of early clinical trials being conducted in Korea. 6 Phase I clinical trials are underway, and the company is also seeking ways to collaborate with one of the country's major hospitals for basic research related to oncology and hematology.
- InterView
- "Lilly rises in anticancer and autoimmune diseases"
- by Eo, Yun-Ho Oct 27, 2022 05:52am
- The pharmaceutical company Lilly is known for their strong diabetes treatment pipeline. As the world’s first developer of insulin, Lilly has solidified its position in the field, introducing DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 analogues into its pipeline. However, Lilly has transformed. It did not give up diabetes, the company just added more ‘weapons to its arsenal.’ From some point, the company began to exert its influence in the fields of cancer and autoimmune diseases. In the lung cancer drug market, where the company had made no significant impact other than with ‘Alimta,’ Lilly released the VEGFR-inhibitor 'Cyramza,’ and also introduced the first-in-class RET-targeted therapy ‘Retevmo.’ Also, its ‘Verzenio’ CDK4/6 inhibitor latecomer for breast cancer has successfully landed in the market with a successful insurance reimbursement strategy. The company is also showing marked growth in the autoimmune disease market. Its second JAK inhibitor ‘Olumiant’ has been targeting atopic dermatitis, and secured the first indication for alopecia areata among same-class drugs. Also, Interleukin-17A inhibitor ‘Talz’ is continuing to expand indications to psoriatic arthritis, ankylosing spondylitis, etc. In addition, the company’s new migraine drug ‘Emgality’ was recently listed for reimbursement. Dailypharm met with Mira Kwon (44), Lilly Korea’s Specialty Care BU Lead who oversees all of the products above. Mira Kwon, Sr. Brand Manager of Specialty Care BU, Lilly Korea-Please give us a brief introduction of yourself. I entered Lilly/s marketing team in 2006. Lilly runs an open talent development program that allows employees to experience various departments, through which I was able to experience various departments including the sales department, external affairs department, and also the oncology department at a time when the insurance drug pricing system was changing rapidly. I became the marketing lead of the Oncology department after working in Market Access, and since the company restructured the departments into Business Units, I have been in charge of the Specialty Care BU, which is the Oncology and Immunology Departments. -Lilly has undergone dynamic changes. It seems that your BU is in charge of the new growth engine of the company. Since Lilly acquired the anticancer drug company, Loxo Oncology in 2019, the company had been able to establish a strong pipeline in oncology as well, including Retevmo. The company is also developing and preparing launches of other candidate substances. In the field of autoimmune diseases, our main products are Olumiant and Talz. New indications were added in major areas in the past 2 years, and with new indications also set to be added next year, the pipeline is expanding quickly. At a recent global meeting, clinical data on the atopic dermatitis treatment that is currently undergoing clinical trials were also reviewed. - Autoimmune disease is one area that Lilly lacked experience in. It is also an area that has a high entry barrier in Korea, so it was surprising that Lilly jumped into this market. Despite the many companies that have already built a reputation in the field for more than 15 years, we have been receiving much feedback on how good and diverse Lilly’s portfolio is. We own both psoriasis and atopic dermatitis treatments with clinical trials being actively conducted on new indications. -The marketing points for anticancer drugs and autoimmune disease treatments may be different. What areas do you focus on for each in the promotion process? The oncology department, like the diabetes department, is Lilly Korea’s key area of focus, therefore, its sales division has experts with more than 13-15 years of experience and expertise. Due to the nature of anticancer treatments, we conduct various activities with various departments including Medical to produce domestic research data to meet the needs of patients and HCPs in Korea. The immunotherapy market is very competitive. With so many options available within the same class, we ponder ways to differentiate Lily's portfolio from others. In the case of the new indications that had been introduced during the COVID-19 period, our team has focused on activities that allow two-way communication via digital channels rather than traditional marketing activities or channels. -What do you consider most important in running your marketing department? This is no longer an era where a newborn first-in-class blockbuster dominates the market. That's how dynamic the market is. In particular, due to uncertainties in patient access in Korea, it is important to adapt quickly and modify our strategies in line with the ever-changing environment. Although the Oncology and Immunology departments are in charge of different diseases, both are facing the same situation in the pharmaceutical industry, especially in the current situation where so many new products and indications are being released. I think it is the role of our marketing department to think about in-depth strategies and prepare various scenarios in advance. -Your promotion strategies will also need to be changed with the end of the COVID-19 situation. So we plan to strengthen offline activities that have been restricted due to the COVID-19 pandemic. However, HCPs have also become familiar with digital channels for over two years in the COVID-19 pandemic, and as it also has advantages such as convenience, we are focusing on how to combine these well. We also have a digital marketing department within the company, and I know that they are actively discussing with the headquarters measures to find contact points with customers based on analyzed data. In the future, our marketing activities will evolve in the direction of delivering messages through effective channels by identifying areas with the greatest needs for HCPs based on data. -In the Korean pharmaceutical market, reimbursement became a determining factor that makes or breaks the success of drugs. Currently, Retevmo is undergoing reimbursement review, and marketing will also be conducting activities for reimbursement in addition to MA. The reimbursement listing process is always uncertain and requires discussion with authorities. Therefore, as a multinational pharmaceutical company, it is on us to facilitate smooth discussions between headquarters and regulatory authorities. Although the MA is responsible for communication with HQ, the marketing department provides opinions on how the drugs can be used for patients in Korea and to which extent the drugs can provide therapeutic benefits. -So how well do you communicate with global headquarters? Korea is one country where reimbursement is difficult, but with the environment in other countries rapidly changing as well, it seems that our global headquarters now understand Korea's situation. The company already saw through this reimbursement process with oncology drugs like Cyramza and Verzenio. However, it is true that Korea’s drug price differs greatly from other countries, and there are difficulties due to various related systems in Korea.
- InterView
- “AstraZeneca’s sincerity in oncology drives cont. growth"
- by Eo, Yun-Ho Oct 17, 2022 06:03am
- AstraZeneca is known for its ‘sincere attitude’ towards R&D. Not only is the company in the top ranks in terms of its investment amount, but it has also always been at the forefront in terms of R&D-to-Total-revenue ratio as well. In 2021, AstraZeneca’s R&D-to-Total-revenue ratio stood at 26%, the highest in the industry. Due to their invested interest, the company is rarely behind in recognizing new drug development trends. More often, AstraZeneca has led the trend, releasing first-in-class drugs. AstraZeneca developed the antidiabetic SGLT-2 inhibitor ‘Forxiga,’ a drug that has recently been receiving attention for demonstrating cardiovascular benefit, and the oral antiplatelet ‘Brilinta,’ the only contender of Plavix (clopidogrel). Also, 'Crestor (rosuvastatin)’ which had threatened the sales of ‘Lipitor (atorvastatin),’ and the ICS/LABA combination ‘Symbicort’ are also some of AstraZeneca’s well-known products. Building on this solid foundation, AstraZeneca is now busy reinforcing its Oncology pipeline. In addition to the third-generation epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) ‘Tagrisso (osimertinib),’ the company has added the PD-L1 inhibiting immuno-oncology drug ‘Imfinzi (durvalumab)’ to its portfolio. In other words, the company's oncology pipeline is no longer represented by its first-generation EGFR TKI “Iressa (gefitinib).” Dailypharm met with Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca to hear about the company’s oncology drug development. Trained as a clinical oncologist and Ph.D., EVP Galbraith has been leading Oncology R&D at the company for the past 12 years. -Which product were you most deeply involved in developing? I would have to say that I am most fond of Tagrisso. AstraZeneca aspires to become a leader in Oncology. When I joined the company, hormonal treatments such as Faslodex, as well as Iressa were already developed, and Tagrisso was in the development stage. My first work after joining AstraZeneca was to organize the company’s research portfolio. At the time, I suggested that we should focus on products with higher potential rather than products that have less chance of success. This was even before a project name had been coined for the development of Tagrisso, but I believed in the potential of the substance and made the decision to accelerate its development. Many patients who were treated with existing targeted therapies at the time had been developing resistance or intolerance to their treatments. They developed secondary mutations, and the drugs were not binding well in their targeted sites. I saw the potential of Tagrisso in addressing this unmet need. So Tagrisso was first administered to a patient in 2013. The Seoul National University Hospital in Korea also participated in our Phase I clinical trial, and tumor size was reduced in 2 of the 4 patients that were administered Tagrisso at the time. Resistance to existing treatment options -the T790M mutation - is found in around 50% of all EGFR-mutated lung cancer patients. Although we weren’t testing for the T790M mutation at the time, the tumor size reduction in 2 of the 4 patients raised hopes on how the drug targets the T790M mutation and brings therapeutic benefits. I still remember telling the chemist that developed the substance the good news about how promising the substance was. AstraZeneca was able to gain such insight based on solid collaboration with healthcare professionals in Asia. Our collaboration with healthcare professionals in Korea, Japan, and Taiwan greatly contributed to our discovery by helping us secure information on the resistance mechanism in advance. -As you mentioned, AstraZeneca’s oncology pipeline is rising in prominence. The pipeline, which had already existed for a while, seems to be getting stronger. You already own extensive product lines in Respiratory, Cardiovascular, and Endocrinology, does this mean you will be focusing on oncology drugs in the future? That’s not so. Rather than concentrating on either part, we are making efforts to build a balanced portfolio that can cover various treatment areas. Although 40-50% of our R&D budget is being invested in oncology drugs, we also have pipelines in various other treatment areas including Cardiovascular (CV), Renal, Respiratory, Immunology, Vaccines, etc. Oncology drugs do take up much of our interest, but it is not our sole area of interest. We have recently seen reports on how Forxiga, our antidiabetic drug, has significantly improved the risk of cardiovascular death. -It is also impressive that the company collaborated with Asian researchers from early phase trials for Tagrisso. Contrary to how Korea actively attracts Phase III trials, there has been criticism on how global pharmaceutical companies lack investment in early phase trials in Korea. I hope more opportunities will come in the future for Korea to collaborate with AstraZeneca. We are very interested in seeking opportunities in Korea. South Korea has been an innovation hub in developing new drugs for quite a long while and is leading in clinical trials. It is number three in contribution to global oncology clinical trials worldwide. In fact, involvement in the early phase clinical trials is something we have been doing with South Korea for many years and has built on year-on-year. -AstraZeneca’s competitivity has been further reinforced with the addition of the PARP inhibitor Lynparza to the pipeline. On the other hand, your immuno-oncology drug Imfinzi has been showing less impressive performance. Do you believe there is an opportunity for its comeback? We were excited to present data on the first improvement seen in biliary tract cancer for many years with Imfinzi. Biliary tract cancer is quite prevalent in Asia, and the addition of Imfinzi to first-line chemotherapy improved the treatment effect. The Imfinzi combination therapy was approved in the US based on this TOPAZ study, and we look forward to its approval in Japan as well. We also presented data earlier this year for the HIMALAYA study in liver cancer, in which the combination of Imfinzi with ‘Tremelimumab (anti-CTLA4 antibody)’ in a regimen where just one higher dose of Tremelimumab in order to improve the tolerability profile showed an improvement in the long-term survival benefit in liver cancer patients. I hope to hear from the US FDA on an indication based on the HIMALAYA study within the year. In addition, we have also submitted data in the first-line and non-small cell lunger cancer setting for the combination of Imfinzi with Tremelimumab added to chemotherapy.
- InterView
- “Sanofi’s flu vaccine is different...has 100-year legacy"
- by Oct 06, 2022 06:05am
- Sanofi has been making unexpected strides in Korea's flu (influenza) vaccine market this year. The company has not only made a bid for the National Immunization Program (NIP) for the first time this year, but it also started supplying its flu vaccines exceptionally quickly. Multinational pharmaceutical companies usually start the supply of their flu vaccines in October every year due to the longer time required for their release in Korea. However, Sanofi received the approval to release their vaccines at the same time as domestic vaccines and started distributing in mid-August. Its supply price is also not so different from domestic flu vaccines. Sanofi's unprecedented move is not unrelated to this year’s influenza outlook. This year, influenza, which had been on the low side due to COVID-19, is predicted to rise for the first time in 3 years this year. The Korea Disease Control and Prevention Agency issued a nationwide influenza warning last month. According to KDCA, the proportion of suspected flu patients per 1,000 people on the 39th week (September 18th-24th) was 4.9, exceeding the epidemic standards. In particular, Type A H3N2, which is expected to become the dominant strain this year is a successor of the ‘Hong Kong Flu,’ and is known as one of the most virulent strains. This is why the KDCA has been actively encouraging flu vaccinations. Although the 9 types of quadrivalent flu vaccines distributed in Korea are thought to have similar prevention effects, a closer look shows that there are differences. Some vaccines cannot be administered to infants or patients with cardiovascular diseases. Also, domestic vaccines can be administered to pregnant women, but their safety has not been demonstrated through clinical trials. Vaxigrip Tetra (Sanofi) and Fluarix Tetra (GSK) are the only flu vaccines that can be administered in all high-risk groups. This is why Sanofi, which is standing at the same level as domestic companies in terms of price, supply timing, and amount, is showing confidence this time. During an interview with Daily Pharm, Guan Lee Ang, Country Medical Lead at Sanofi Korea, said, “With over 100 years of history in developing vaccines, Sanofi owns a vaccine portfolio for over 20 types of infectious diseases. Our quadrivalent flu vaccine, ‘Vaxigrip Tetra,’ has verified safety and immunogenicity with robust clinical data. Vaxigrip Tetra’s differentiated strength lies in how it is the only vaccine to have verified efficacy and safety in the high-risk group.” Guan Lee Ang, Country Medical Lead at Sanofi Korea The high-risk group, infants over 6 years of age, pregnant women, cardiovascular patients, etc., are known to be at 10 times higher risk of acute myocardial infarction and at 8 times higher risk of strokes when infected with influenza. Infants and children are also at high risk of pneumonia as a related complication. Influenza infection can also lead to death, and an estimated 70-85% of those deaths were observed in patients over the age of 65. Clinical trial results showed that influenza infections from vaccine-like virus strain were reduced by 68%, and infection from all A&B types of influenza virus was reduced by 72% in infants aged between 6 months to 35 months when vaccinated with Vaxigrip Tetra. The risk of influenzas infection in pregnant women was also reduced by up to 72%. Also, the study showed vaccination was related to a reduction in the mortality rate in patients with myocardial infarction or high-risk coronary artery disease. The problem lies in the low public awareness of the need to receive influenza vaccines. Due to the prolonged COVID-19 crisis, people have been receiving vaccinations every 3 to 6 months, which led to increased fatigue over vaccinations and decreased reliability. Also, some are expecting influenza to not spread as much due to the small number of flu patients and the cultural specificity of how people are continuing to wear masks even after the mandatory outdoor mask regulation was lifted, In response, Sanofi's Vaccine Division is concentrating on reinforcing flu awareness. While carrying out a campaign to raise awareness of influenza among the general public, the company plans to hold a webinar for healthcare professionals on the preventive benefits of vaccinations based on clinical data. Ang said, “65% of employees in the vaccine division serve in departments related to quality testing, and most of the vaccine production period is devoted to quality testing. Also, we are working with distributors who have established thorough cold chains to stably supply our high-quality products. We will continue to strive to improve access to influenza vaccines for high-risk groups and improve public health in Korea.”
- InterView
- “Will rise independently as Organon in the industry”
- by Eo, Yun-Ho Sep 08, 2022 05:59am
- So Eun Kim, Managing Director of Organon Korea Spin-offs, which are made for various reasons in various circumstances, bring out various positive and negative issues in the process. Organon’s course of the spin-off was also quite eventful. However, the company quickly straightened its affairs after completing the spin-off and being reborn as an independent organization in June last year. Organon was established in 1923 in Netherland and had become part of MSD. In 10 years since then, the company again was separated from MSD and reborn as Organon. Utilizing the power of its existing legacy brand, the company heralded its new leap into a pharmaceutical company specializing in biosimilar and women’s health. Dailpharm met with So Eun Kim (51), the founding Managing Director of Organon Korea, to hear about the company’s vision and value. -A year has already passed since the establishment of Organon Korea. Has the company undergone many changes? During the past year, the company had made efforts -small and large – to lay the foundation to realize our women's health vision. Above all, we were able to achieve organizational stability, and in terms of business, Global Organon has earned the trust of its investors by making a stable start from the first year. Organon Korea made a 4% YoY growth in the first year of the spin-off, expanding its product influence. -There must have been difficulties as well. One of the things our employees had the most trouble with was meeting with various healthcare professionals who were unfamiliar with our name, ‘Organon.’ The heightened COVID-19 situation had further rendered sales activities and external meetings with partners and stakeholders difficult. Therefore, we focused on utilizing digital channels in communicating with healthcare professionals. One main example of this is ‘Organon Connect,’ a portal site we prepared for HCPs. Korea was the first among all Organon subsidiaries globally to launch the portal and had launched it upon the establishment of the company. Through the system, we have continued to hold symposiums during the pandemic. -In addition to your existing items, what other products are you preparing for your goal to become a women’s health pharmaceutical company? Organon has signed agreements for 6 solutions in the field of women’s health where unmet needs remain. In the case of our solution for postpartum hemorrhage, the solution has been approved by the FDA and is being sold in the US. XACIATO, the bacterial vaginosis treatment, has been granted accelerated approval by the FDA. We are preparing to introduce these treatments to Korea as soon as possible, through market analysis in Korea. Clinical trials or preclinical trials on solutions for premature birth, endometriosis, breast cancer, contraception, etc. are also being completed. We are preparing to launch the products in development according to their development stage. Also, the contraception, infertility, childbirth, and postmenstrual treatments that we already own have much potential in the Korean market. Although the company was unable to pay sufficient attention to these products but based on Organon Korea’s vision, we plan to make the most of the opportunities owned by each and every product. -With so many of your women's health products in development, it seems like not many products are readily available for introduction to Korea. In this sense, the company would have to focus on its chronic disease area. What kind of efforts and attempts have you made to increase your influence in women’s health in Korea? Well, we expect that Korea will be able to participate in various stages of applicable clinical trials of the various products in development, and is preparing plans for such trials. Also, for the FDA-approved products, we are working to quickly introduce them to Korea. The chronic disease business accounts for over 90% of Organon Korea’s business. This field will be our main business for the few years to come, during which we will be making efforts to expand our portfolio and share in women’s health. -has the labor-management issues that you experienced in the course of your spin-off been resolved? Many of the concerns and anxiety held by our executives and employees with regard to the spin-off have been resolved. At the time of the spin-off, we focused on listening and communicating with our executives and employees about their various concerns and received consent from each through discussion with the union. After the spin-off, we worked to relay the direction of the company and build solidarity among our executives and employees. We are regularly communicating with the union every week, and are holding a labor-management council to listen to the opinions and answer questions held by the employees, facilitating smooth communication between the union, executives & employees, and the company. For your reference, only a very few employees left the company due to the spin-off. -What are your future ambitions? Based on Organon’s global ESG reporting standards, we believe we need to find areas where Organon can contribute to Korean society and increase our influence in Korea. Building on the vision and confidence we have today, we plan to grow together with our executives and staff and strive to lay the foundation for bigger dreams, toward our vision of women's health.
- InterView
- "Leclaza’s mOS data of 38.9 months is remarkable"
- by Kim, Jin-Gu Jul 04, 2022 05:55am
- “The fact that Leclaza (lasertinib) achieved an OS (overall survival) of over 3 years is remarkable.” New OS data on the homegrown novel lung cancer drug Leclaza that was presented at the AOS 2022 & KCA Annual Meeting 2022 that was held recently in Seoul drew the pharmaceutical industry's attention. The results were from a trial that evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI that was conducted in 17 centers in Korea. Analysis results on the 76 EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months This updated data is being received with significance in the field. The OS data is comparable to the results of the 3rd-generation EGFR mutation-positive NSCLC treatment ‘osimertinib (product name: Tagrisso),’ while owning the potential for its use as monotherapy. Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “The most important index used to assess the efficacy of anticancer drugs in clinical trials ultimately comes down to the patients' OS improvement. Long-term follow-up results of LASER201 trial showed that mOS of patients that received Leclaza reached 38.9 months. This is remarkable performance.” ◆"Cannot make direct comparisons…but results are as good as Tagrisso’s” Han highly rated the fact that Leclaza showed comparable performance to existing targeted therapies, although a direct comparison cannot be made to its competitor, osimertinib. Although various clinical trials are in progress for the first 3rd-generation EGFR targeted therapy. osimertinib, due to varying clinical trial designs and characteristics of registered patients, it is difficult to individually compare each trial's results with Leclaza’s. Also, Leclaza's trials are in their Phase I/II stage, but osimertinib's trials have progressed to Phase III. However, according to the Phase III AURA trial, osimertinib’s representative trial, the mOS was around 26 to 28 months in general, with some differences between countries. “Compared to osimertinib, which is used as the global standard of care, Leclaza is only available for use in Korea. However, data shows that Leclaza’s results are as good as the standard of care. Leclaza’s clinical data as demonstrated through LASER201 is being received without disagreement globally.” ◆" Leclaza has a low incidence of interstitial pneumonia·thrombocytopenia" Han also emphasized Leclaza’s safety. Leclaza has a lower incidence of adverse events than even its competitor osimertinib as well as 1st- and 2nd-generation EGFR targeted therapies. 1st and 2nd generation EGFR targeted therapies had higher skin toxicity. The drugs, although effective against lung cancer cells, also targeted normal skin cells, resulting in patients suffering from skin troubles such as rashes or itching. On the other hand, 3rd generation-targeted therapies selectively target mutations and therefore is less toxic and more efficient. This comes as a significant difference to the patients in terms of quality of life. In particular, Han explained that the two 3rd generation targeted therapies – osimertinib and Leclaza -differ in the adverse events aspect. With her experience prescribing Leclaza over the past year, Han explained that “long-term use of osimertinib may cause interstitial pneumonia or thrombocytopenia in the patients. One aspect I found interesting while monitoring the long-term safety profile of Leclaza demonstrated through the Phase I/II trial was that it had a very low incidence of interstitial pneumonia or thrombocytopenia. “ Han added, “From the patient’s perspective, Leclaza’s lower incidence of adverse events during the 3 years of intake may come as a great advantage. Grade I or II level numbness has been found with the use of Leclaza, but was infrequent.”
- InterView
- Tremfya to bring generation shift in the IL inhibitor market
- by Jun 23, 2022 05:50am
- The competition among latecomers is intensifying in the interleukin inhibitor market with the scope of their indications expanding to psoriatic arthritis. The leader in this market is Janssen’s IL-12/23 inhibitor, ‘Stelara (Ustekinumab).’ Although 10 years have passed since its approval, the drug still boasts a growth rate in the 30% range. Based on IQVIA, sales of Stelara recorded ₩36.1 billion last year. Janssen’s new goal in the market is to successfully make a generation change and replace Stelara with its follow-up drug, ‘Tremfya (guselkumab),' the first-in-class IL-23 inhibitor that was released in Korea in 2018. However, Tremfya is being challenged in the market by the second IL-23 inhibitor ‘Skyrizi (risankizumab)’ that entered the market. Therefore, making the successful generational shift from Stelara to Tremfya without losing any market share to other companies’ competitors is an important task at hand for Janssen. ▲ JungHyun Lee, Tremfya Marketing Manager at Janssen Korea Janssen Korea’s Tremfya Marketing Team has been working quickly to achieve this goal. The three members of the Tremfya Team at Janssen Korea have been focusing on conducting marketing activities for the psoriatic arthritis indication that was granted insurance benefits last month. In an interview with Dailypharm, Product Manager Jung-Hyun Lee, who had been in charge of Tremfya since it started preparations for marketing authorization at the end of 2016, said, “There are many treatments including Tremfya available for plaque psoriasis, and awareness on the availability of theses drugs have now increased significantly among psoriasis patients. Just as we have concentrated on marketing Tremfya in plaque psoriasis last year, we plan to concentrate on carrying out activities to make known the importance of early diagnosis and treatment in psoriatic arthritis this year.” Lee pointed to the low disease awareness of psoriatic arthritis as the reason for this year’s specific focus of interest. PM Hye-Ji Kang who newly joined the Tremfya Marketing Team this year, said, “It is important for patients with psoriasis to manage comorbidities such as psoriatic arthritis. Therefore, we need to raise awareness of psoriatic arthritis so that doctors and patients can suspect and allow for early diagnosis and treatment of their condition when joint pain occurs while maintaining skin symptom improvement in their course of treatment.” In addition to Tremfya, the IL-17 inhibitors Cosentyx (secukinumab) and Taltz (ixekizumab) are also approved for use in psoriatic arthritis. Also, Skyrizi added a psoriatic arthritis indication in January this year. Although Skyrizi is yet to be approved for reimbursement, Janssen may not rest assured as Abbvie is speeding up its reimbursement expansion process for Skyrizi. Ultimately, it is in the hands of Tremfya’s Marketing Team to highlight the characteristics of Tremfya that differentiate the drug from other IL-17 inhibitors, while appealing to the strengths of Tremfya compared to the other same class IL-23 inhibitor. Lee said, “Inhibiting radiographic progression of joint damage is considered the most important indicator in treating psoriatic arthritis because there is no way to reverse damage in the joints. Tremfya administered every 4 weeks has demonstrated statistically significant inhibition of radiographic progression of joint structural damage compared to placebo.” Lee added, “In over 70% of the cases, psoriasis skin symptoms appear before psoriatic arthritis, and as treatment effect in the main disease of psoriasis is most important until arthritis progresses, Tremfya’s long-term effect in maintaining skin clearance indicates how our drug brings greater treatment benefit than its competitors.” The lasting long-term effect of Tremfya that was mentioned by Lee was demonstrated through a 5-year long-term clinical trial and a 5-year real-world data on domestic patients, evidencing the differentiated benefit of Tremfya over the latecomers. Another positive aspect of Tremfya is that a survey on patients with severe psoriasis in the Asia-Pacific region including Korea showed that patients consider lasting, long-term effects as most important. ▲ Hye-JeeKang, Tremfya Marketing PM at Janssen KoreaAlso, the company had demonstrated the superiority of Tremfya through a head-to-head trial. Janssen’s ECLIPSE study that directly compared the efficacy between the first-in-class IL-23 inhibitor Tremfya and the IL-17 inhibitor Cosentyx showed that Tremfya’s mechanism of action allows for psoriasis lesions to not recur and provides long-lasting improvement of skin symptoms. Kang said, “Only Tremfya was found to maintain regulatory T cells that are involved in lesion recurrence and reduce the rise of resident memory T-cells. The trial was informative in understanding the different mechanisms of action between classes. Through such data, the IL-17 and IL-23 inhibitors are being differentiated in the field, and IL-23 inhibitors, as a higher level mechanism than IL-17 inhibitors, have provided convenience to the patients with their longer dosing interval.” Of course, opposing data also exists. Novartis’ ARROW trial is one example. However, no statistically significant difference was found in the proportion of patients that achieved a “clear” or “almost clear” status of the target plaques at Week 16, which was the primary outcome measure of the trial. Kang explained, “Results from the ARROW trial show no statistical difference between the two drugs, therefore, it is difficult to say there is a difference between the two drugs based on that data. Also, the study was conducted on only 40 patients in the short term of 16 weeks, different from the large-scale ECLIPSE trial that was conducted for one year on 1,048 patients.” On how the drug is different from Skyrizi, a same-class drug, the marketing team pointed out that Tremfya is the only ‘fully human monoclonal antibody.’ In antibody drugs, reducing immunogenicity by minimizing the sequence of other species such as mice is important as it can cause side effects and reduce the efficacy of a drug. If the humanized monoclonal antibody Skyrizi has nearly a 90% human-generated nucleotide sequence, Tremfya has a 100% human-generated nucleotide sequence. Lee also added that the team will continue to strengthen Tremfya’s status in the market through the provision of various customized data. Lee said, “With most drugs now being able to provide clear skin, the needs of the patients and medical are becoming more specific and subdivided. Some wish for the occasional lesions or itching to go away after skin clearance, others wish to get rid of the pigmentation left after treatment. We will work to provide customized data to fit the needs of these patients.”
- InterView
- “Roche reborn through customer-centric reorganization”
- by Eo, Yun-Ho Jun 21, 2022 05:54am
- Nic Horridge, General Manager of Roche Korea Multinational pharmaceutical companies are known to endlessly pursue change. In addition to active acquisitions, mergers, and spin-offs, the companies boldly reduce and expand their many originations in line with the new drug development trend, and show no hesitation in consolidating or reorganizing departments. Their endless evolution for efficiency and survival continues on even now. The same goes for Roche. Roche, which used to hold a strong image as a company specializing in anticancer drugs, have continued to maintain its strength in that area while expanding its interest to other diseases. The company released ‘Xofluza,’ a follow-up of its antiviral ‘Tamiflu,’ and is also spurring up the development of its new Alzheimer's treatment in CNS. The company had also undergone great change in the organization as well. The company had promoted ‘"agile transformation" at the global level to improve flexibility and responsibility as an organization. Unlike conventional organizations where employees are assigned specific products, at Roche, employees are assigned to each disease-specific indication. Roche Korea also joined in this transformative journey in 2018. In the process, quite a few issues in personnel adjustments and departures arose. General Manager Nic Horridge, who has been running Roche Korea for 4 years since being appointed GM in October 2018, has led this transformation in Roche Korea. Dailypharm met with Nic Horridge to hear about the transformations made and those to come for Roche Korea in the future. -Two years have passed since the company decided to undergo an agile transformation. What are the advantages of agile transformation? Agile transformation is an innovation that is being pursued at the global level to transform our organizational culture. In line with the rapidly changing healthcare technology, medical environment, and the exponential increase in information, Roche’s portfolio has continuously evolved and entered new treatment areas. The company had determined it would be difficult for Roche to achieve its goal of bringing the best results faster to our patients with the existing ways of business and operation model and decided to pursue agile transformation. We now have teams organized according to the treatment area or patient group to identify the practical needs necessary for each patient’s treatment journey and make optimal decisions. In the past, we had unmet needs in rapidly identifying how diagnoses and treatments were being made in areas unfamiliar to Roche, such as Alzheimer’s and Ophthalmology, but this organizational evolution now allows each team to rapidly identify, understand and strategize what’s needed. -The transformation process would not have been easy. How did the employees and executives at Roche Korea receive the change? We have now passed the adaptation period, and our efforts are now coming to fruition. The autonomous decision-making system was one thing that many employees and executives had first found difficult, as each employee, as his/her own leader, was required to contemplate and find an answer on 'what role he/she should play to bring value to the domestic medical ecosystem?’ Some employees have decided to part ways with the company in the process. I consider this positive as these former Roche employees continue to contribute to the development of the healthcare industry in their respective positions. At the time, we had candid discussions with the employees who believed the new business model was not right for them, and some had decided to seek new opportunities. In the process, younger employees were given the opportunity to take on a leadership role in the company, and this gave rise to fresh and new perspectives that could help achieve Roche's vision. The ideas were successfully incorporated into the organization. --Roche is developing ‘gantenerumab’ as a treatment for Alzheimer’s disease. Many other companies that have jumped into the scene are struggling, such as in the case of Aduhelm. What is your opinion on this? Roche’s gantenerumab is an anti-amyloid-beta monoclonal antibody that reduces brain amyloid plaques, which are known to induce brain cell death, to improve symptoms of Alzheimer’s disease. Its Phase III trial results are expected to come up in the second half of the year, and we are confident that we would be able to see good results. Also, in treating Alzheimer’s, Roche believes early detection of the disease is as important as new drug development. If a patient is prescribed treatment after his or her symptoms have progressed to a certain extent, the brain damage that has already occurred will most likely not be regenerated. Assuming that gantenerumab's clinical findings are successful, we believe that Roche’s approach of early detection and treatment will provide patients with an invaluable solution. -You served 4 years as the head of Roche Korea. What is your impression of the Korean healthcare ecosystem? I am pleased to have been awarded this opportunity to promote various changes in Roche Korea for the past 4 years. Due to the unprecedented crisis brought on by the pandemic, we have undergone many changes in our daily life and work, but I believe the Korean government showed excellent leadership in the containing COVID-19, and that Korea has received less damage than neighboring countries. This was very impressive. Statistics show that Korea’s accessibility to new drugs is 35%, which is significantly lower than other countries such as the US (87%), the UK (59%), and Japan (51%). Also, it takes an average of 601 days to reimburse listing, and new drugs account for only around 20% of the pharmaceutical expenditures spent in NHI finances. This is far below average in other OECD countries. I believe there would be a way to increase access to innovative drugs without significantly increasing the overall drug expenditure without affecting national finances. Roche will do its best to support the government in fulfilling its pledge on relevant tasks.
- InterView
- Otrivin package made user-friendly for pharmacist & patient
- by Eo, Yun-Ho Jun 13, 2022 05:55am
- Yewon Moon, Brand Manager, GSK Consumer Healthcare One strong perception of allergic rhinitis is that its symptoms worsen during the change of seasons and then decrease in summer. However, the large temperature difference between indoors and outdoors in summer due to excessive operation of air conditioners can dry out the mucous membranes and further weaken the immune system. Topical decongestant nasal sprays are one of the most popular products sought by customers due to rapid symptom relief. The spray constricts the blood vessels in the nasal mucosa to relieve symptoms of nasal obstruction to offer faster symptom relief than oral formulations and is effective in those who experience severe nasal congestion. However, people are reluctant to use the spray formulation due to the risk of side effects that can occur if users do not follow the correct method of its use. One well known side effect is rhinitis medicamentosa, or rebound congestion, which worsens the dryness in the nose and rhinitis. For its proper use, topical decongestant nasal sprays should not be used more than 3 times a day (up to 2 times a day for oxymetazoline products) and should not be used for more than a week at a time in adult patients. Also, a recovery period is required after its use for one week in a row. GSK Consumer Healthcare Korea announced a package renewal plan for its leading nasal decongestant ‘Otrivin.’ Dailpharm met with Yewon Moon, Brand Manager at GSK Consumer Healthcare who has been working to deliver the correct method of use of nasal decongestants. -Otrivin’s logo and the package have been renewed after 3 years. Its strong visual consistency seems to be one of its leading features. Could you introduce the changes? We used intuitive icons and vivid colors in the design. Consumers can easily locate Otrivin thanks to the ‘BlueRing’ design, and the package is structured to provide easier and quicker understanding of the product's efficacy and effect. Consumers would want to quickly find and purchase the product they need to relieve their nasal congestion. Therefore, we focused foremost on how to improve the convenience of purchase for our consumers in our package renewal. -What design element did you focus most on?? Of course, we considered each and every element in the process of renewing the package with a particular focus on the front design. The BlueRing design in the front allows consumers and pharmacists to quickly locate the Otrivin brand. The key focus of the renewal had been on clearly conveying the effects of each product. -What did consumers respond best to in the consumer testing process? Global test results showed that the consumers’ purchase intent increased because the new package provided a clearer understanding of each product’s effect. Brand search rate has also increased, and the modern design of the package contributed to increasing the positive image of the product. -I believe the new package will be useful not only for the consumers who purchase the product but on the pharmacy’s part as well. How will pharmacies and pharmacists benefit from the renewed package? As the design change allows for clearer delivery of the effect of each product, I believe this would help pharmacists conduct easier medication counseling on which Otrivin should be used according to each patient’s age and symptom. -When will it be released in Korea? Where can we find the renewed version? The period of each product’s release may differ somewhat, but we are preparing so that the renewed Otrivin 0.05% Pediatric, Otrivin Menthol 0.1%, Otrivin Baby Natural, and our newest product ‘Otrivin S’ can be found at pharmacies in Korea within the second quarter of this year. For your reference, the package design renewal is being made as a global project, but the period of renewal in each country will be conducted sequentially, subject to each country’s situation. -Do you have any other plans on providing support for pharmacies other than changing the package, with posters, etc.? We plan to improve access to Otrivin within pharmacies with the new package design during the change of seasons when an increasing number of consumers seek nasal decongestants. With the colors more easily discernable than in the past, the new Otrivin package will aid consumers in selecting the product they need and stand out from other products on display at pharmacies. Even when it is behind counters, pharmacists will be able to save the time that they had previously wasted looking for Otrivin due to the easily identifiable package. Also, we are preparing communication with pharmacies to facilitate smoother medication counseling on Otrivin for consumers at pharmacies.
