- LOGIN
- MemberShip
- 2025-12-17 23:07:05
- InterView
- “Amgen knows how to do it right in Korea”
- by Eo, Yun-Ho Mar 25, 2021 05:59am
- Amgen knows the game in the industry. Besides the title of the ‘Number One Global Bio Company,’ Amgen Korea knows how to be versatile in South Korea. Since opening the South Korean office in 2015, Amgen listed all six products—antiarthritis Prolia (denosumab) and Evenity (romosozumab), skeletal-related events preventing drug Xgeva (denosumab), high cholesterol treatment Repatha (evolocumab), acute lymphoblastic leukemia (ALL) treatment Blincyto (blinatumomab) and multiple myeoloma treatment Kyprolis (carfilzomib)—for the National Health Insurance (NHI) reimbursement. Considering the NHI system, listing each product was not the easiest job. However, Amgen Korea’s determination and concentration drove the negotiation with the government to the conclusion. Currently, all six products are leading the respective markets. Surely their products are ‘good,’ but also Amgen Korea can play the game the right way. Daily Pharm interviewed General Manager Noh Sang-kyung, who has been overseeing the Korean office from the start to date, for his insight and know-how. -Seeking for coverage on every product could not have been easy. Each product developed by pharmaceutical companies has its own unique quality and strengths. And as listing a drug for coverage in South Korea requires to raise awareness of the unmet medical needs, it is crucial, for the reimbursement negotiation process, to provide data to prove how much of benefit the treatment can give to patients. The ‘Value Access’ division staffs in charge of drug pricing in the company analyze and compile a vast amount of data to survey the unmet medical needs in South Korean clinical scene, and support the company to convince the government to fully understand and relate with the said needs through the provided data. -Amgen’s global pipeline seems to be actively working on biosimilars. Do you plan to release the biosimilar products in South Korea as well? About two years ago, we had a relevant discussion, and Amgen Korea has decided to not launch any biosimilar for now. As a leading biotechnology company emphasizing the value of ‘science,’ Amgen’s has a goal to provide innovative treatment in the areas with unmet medical needs for patients. The further option could be considered in the future, but there is no immediate plan. -Amgen is expected to receive the U.S. Food and Drug Administration’s (FDA) approval on currently investigating KRAS treatment sotorasib. Do you think the approval process in South Korea would be swift? South Korea’s Ministry of Food and Drug Safety (MFDS) makes the decision according to their review, so I cannot give you detailed schedule. But as the health authority is well aware of the highly unmet medical needs in KRAS targeted therapy for patients with non-small cell lung cancer, the company aims to do its best to accelerate the process. -As mentioned above, all six products have been listed. Now seems to be the time to think of expanding the coverage. Chronic disease patients may not have immediate risk of urgent health issue, even if they do not get treated right now. But if they are left untreated, the condition could cause severe health issue. Unfortunately in South Korea, I personally think the introducing the new paradigm in managing osteoporosis, cardiovascular diseases and other chronic diseases is far over due. Only in this country, the patients with osteoporosis have to suspend treatment due to the one-year limit on the coverage. -While negotiating with the headquarters regarding the drug pricing, have you ever felt the chance of so-called ‘Korea Passing?’ I have not felt the threat, yet. But I do feel that the drug pricing discussion with the headquarters would get tougher in the future. Already China and Canada have officially stated they would include South Korea as one of pricing reference countries, and the U.S. also said it would refer to all OECD member countries including South Korea for the drug pricing. Calculating the drug pricing in South Korea against GDP, it is considered the lowest among the world. So if the pricing here eventually affects the pricing in the U.S., we may face some difficulties in the future. -In November last year, Amgen Korea also formed a labor union. How do you plan to handle negotiation with the labor union? When a labor union is created in a company, both parties need some time to build the relationship together. I think the union was formed due to the uncertainty in employment amid COVID-19, where the sales activities were restricted and the risk of infectious disease was wearing them down too long. Personally, the forming of the labor union ultimately means the employees want to talk to the management. The labor union mostly shares common objectives with the management. So the company is attentively listening to their opinions and frequently open conversations. -Recently, Amgen Global announced a downsizing plan. How is it affecting Amgen Korea? The U.S. headquarters announced a downsizing plan. But the company has only started the business in APAC region five to six years ago, and it still has strong determination to expand the investment in the region. Clearly, the current employees do not have to stress about the downsizing.
- InterView
- “High pressure and hopes in the policy affairs at KRPIA"
- by Eo, Yun-Ho Mar 11, 2021 06:07am
- Director Kim Minyoung Some say this is the era where policy comes first than an academy, and pricing is more important than an approval. The top priority for pharmaceutical companies in South Korea supplying new drug is the National Health Insurance (NHI) coverage. The era of highly expensive drug has emerged, while the government and pharmaceutical industry are struggling to see eye-to-eye on drug pricing. And now the reimbursement listing and its timing became the deciding factor for the success of a new drug. The Korean Research-based Pharmaceutical Industry Association (KRPIA), representing the multinational pharmaceutical companies in South Korea, has appointed Kim Minyoung as a new Market Access and Policy Director after the position was vacant for about six months since a former Senior Director Sean Kim left the organization last April. Kim was in charge of Market Access (MA) at Korean branch of Eli Lilly and Sanofi-Aventis, and until last year, he was leading the MA within JAPAC region at Amgen Asia. Now at KRPIA, the director is to oversee internal and external activities in regards to the ‘adequate value of new drug’ the industry tries to resolve for a long time. KRPIA’s MA committee and Policy Committee would be managed by Director Kim from now on. “Started off with marketing and sales job, I have worked in policy and drug pricing related work at pharmaceutical companies for 25 years. And I have finally joined KRPIA. When I was working at Amgen Korea, I vaguely thought of drawing up a bigger picture of it all when I go back to South Korea, regardless of my humble experience. And I feel now I have a grip on a good opportunity. It’s burdening, but I also have big hopes for it.” But the pressure on Director Kim is real. The pressure of increased drug price entails delay in listing. Although the government is also trying to versatile with risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption, their effort can hardly catch up with the speed of new drug development. And it casts a dark shadow on multinational pharmaceutical companies. Especially, at the movement KRPIA is considered to be missing personnel with former government affiliation. “I am aware of the raised concerns. But because we do not have staffs with previous government affiliation, it does not necessary mean the organization is incapable of operating policy related work. The organization does not operate only with the office staff, but with incorporated participation by 44 member companies at respective committees. Particularly, the Policy Committee consists of experts with various backgrounds from the National Assembly, government and media. The committee can assert the variety of opinions by the stakeholders.” Besides the MA and Policy Committees, he noted the importance of the Government Affairs staffs. Technically, the MA and GA within the industry have been ambiguously categorized, and the government affairs were limited to directly relevant institutes like the Ministry of Health and Welfare (MOHW), the Health Insurance Review and Assessment Service (HIRA), and the National Health Insurance Service (NHIS). Many companies have their MA staffs to also cover GA tasks. Director Kim said, “As the public’s interest is heightening not only in patients but also in new drugs, we are suddenly faced with more stakeholders to engage with like the National Assembly, civic groups and patient groups. To reflect the needs, the Policy Committee must be invigorated. This is one of our key agenda for the year.” If vitalizing the Policy Committee is the last piece of puzzle to achieve the goal, the policy recommendation would be outcome. KRPIA has to be nimble to improve the industry’s access to pipeline currently concentrated to rare disease area. Multinational pharmaceutical companies are taking steps to market targeted therapy, immunotherapy and gene therapy like CAR-T. Director Kim carefully mentioned of HIRA and NHIS regarding the core process in reimbursement listing. “As for HIRA, we could talk about the reimbursement standard expansion procedure. Previously, the Expert Committee used to deliberate clinical adequacy of reimbursement anticancer treatments, but now the agency demands for financial impact evidences besides clinical efficacy report. Financial impact can be reviewed once the clinical adequacy deliberation is completed. It would be wonderful if they could streamline the committee operation and deliberation process.” “And for NHIS, the fundamental predicament the industry faces regarding the negotiation procedure is largely the asymmetry in financial impact related information. NHIS has said the revised system would demand the negotiating company to confirm the financial impact evidences. As an industry representative, we welcome the agency’s decision and hope the system works as expected.”
- InterView
- There is still an unmet demand for antiviral drugs
- by Eo, Yun-Ho Mar 03, 2021 06:26am
- CEO Seung-Woo LeeCurrently, vaccines developed by AstraZeneca, Pfizer and others are a hot issue, but in the first half of last year, Remdesivir was ranked first as a keyword related to COVID-19. Gilead, the developer of Veklury (Remdesivir), is a pharmaceutical company specializing in antiviral drugs. It is leading and has pipelines in a variety of fields, from hepatitis B and C to HIV. Last year, the company is expanding its anticancer treatment portfolio by acquiring Forty Seven, an anticancer drug company, and Immunomedics, an ADC development company. This is the story of Lee Seung-woo ( 64 years old), CEO of Gilead, who has both'the original good and the latest trend' like killing two birds with one stone, celebrating the 10th anniversary of the foundation of the Korean subsidiary. -You've been very busy in 2020 with Remdesivir? Last year, as an antivirus company, I felt a great sense of responsibility and mission from the beginning of COVID-19. Upon receiving the news of the 'Wuhan virus' in January of last year, a clinical trial of Remdesivir in the headquarters' Asset Library began. At the same time, we developed and expanded production in a short time, taking all risks. Researchers have participated in various clinical studies in Korea, and many researchers around the world have contributed to the derivation of meaningful research results. Based on these results, we have obtained approvals in various countries such as the United States and Korea, and in Korea, we are grateful that the MFDS, the KCDA, and other related ministries and medical staff have worked together to ensure smooth supply. -Are there any problems with supply of Remdesivir? It is still supplying through consultation with the KCDA. The situation has improved a lot since last October, but treatment is still important because the vaccine supply is not smooth yet. Although there are difficulties due to the continuing pandemic, we will do our best to cooperate with the KCDA to provide a smooth supply. -Remdesivir also had price issues In the early days, it was supplied free of charge to many countries, including Korea. In the process of commercialization, fast supply was more important than anything else. Accordingly, advanced countries, including Korea, are supplying them at the most reasonable price. During the period designated by the WHO as a pandemic, it has been supplied to developing countries such as India and 129 low-income countries according to two price policies, which are provided at a low price without a license fee. -Gilead is recognized as an antiviral company. It has powerful pipelines such as Viread, Sovaldi, Harvoni, and Truvada. However, diseases such as hepatitis B, hepatitis C, and HIV are now well managed The company believes that there is still unmet demand for the diseases mentioned. Viread improved the quality of life of hepatitis B patients and improved prognosis, but has not yet reached a cure. Gilead is not satisfied with the current treatment options, and is still undergoing clinical trials aiming to cure hepatitis B in many countries, including Korea. There are good treatments for HIV as well, but they are investing more in research and thinking more about ways to cure them like hepatitis C. It is also preparing to build a new pipeline. In addition, in the anticancer field, it is carrying out various R&D through mergers and acquisitions of several specialized companies. In addition, they are continuously working on research and development in areas such as inflammatory drugs and NASH. -Is there an anticancer drug pipeline that is imminent for commercialization? Yescarta, which was introduced through the acquisition of Kite Pharma, is showing excellent treatment results based on good data. This treatment is also under consideration for introduction to Korea. Trodelvy, a breast cancer treatment acquired through the acquisition of Immunomedics, is also a breakthrough treatment, and Magrolimab, obtained through Forty Seven last year, is still in the clinical stage, but has high potential in the field of blood cancer. -It seems that Gilead's drugs have not been postponed in registration of insurance benefits in Korea. When communicating with the global headquarters, are there any cases of crisis such as Korea Passing? Any company has a global pricing policy, and I think it is important to create a balance for accessibility. So far, drugs for hepatitis B, hepatitis C, and HIV have been well listed according to the domestic price policy. And we will try to coordinate the products that will come in the future so that there is no disruption in the supply. There are many good things about the domestic medical system, but there are also some difficulties in setting prices for new drugs. I think the industry and the government should work together.
- InterView
- Genexine Licenses out immuno-cancer Drug Technology
- by Kim, Jin-Gu Feb 22, 2021 06:17am
- Genexine announced on the 18th that it has signed a technology transfer contract worth ₩1.2 trillion with KG BIO, a subsidiary of Indonesian pharmaceutical company Kalbe Farma, for GX-17, an immune anticancer drug candidate. KG BIO is a joint venture established in 2016 by Kalbe Farma, the largest pharmaceutical company in Southeast Asia, and Genexine. Under this contract, KG BIO took over the copyright of GX-17 to ASEAN countries, the Middle East, Australia, New Zealand, India and Africa. The down payment is $27 million (approximately ₩30 billion), and additional milestones that can be received according to phased schedules such as clinical progress, approval, and commercialization are $1,073 million. Separately, it was decided to receive 10% royalties when GX-17's sales were generated. KG BIO is said to be owned by Kalbe Farma (64%), Genexine (20%), and US investor General Atlantic (15%). GX-17 is a candidate substance for Genexine's anticancer drug. In phase 1b·2 clinical trials conducted in combination with Keytruda, another anticancer drug last year, the objective response rate (ORR) was 5 times higher than that of Keytruda.
- InterView
- Takeda's evolution continues
- by Eo, Yun-Ho Feb 16, 2021 06:08am
- Moon Hee-seok, CEO It is difficult to stop what is going well. Even more so if it is a company's business. Takeda sold its diabetes and over-the-counter (OTC) business to Celltrion, a domestic company, last year. Takeda's Actos is a TZD-family drug that persisted in the Avandia outbreak, while Whituben and Albothyl are famous OTCs that everyone knows, meaning they sold the products that symbolized the company. Takeda has carried out a total of four mergers and acquisitions: Millenium Pharmaceutical in 2008, Nycomed in 2012, ARIAD Pharmaceuticals in 2017, and Shire in 2018. Pipelines have been reinforced in the areas of anticancer drugs, rare diseases, and gastrointestinal diseases. The situation is rapidly keeping pace with the rapidly changing market environment. There were also difficulties. As a follow-up to the sale of the division, Takeda reduced the number of employees. Along with the labor-management conflict, items that used to be cash cows disappeared, resulting in a change in the sales structure. Dailypharm met Hee-Seok Moon (56 yrs old), CEO of Takeda Korea, who had been through an eventful year, and heard the story of the past and the future direction of the company. -There were many issues such as merger and sale. It feels like a completely different company over the years. Takeda was founded in 1781 and celebrated its 240th anniversary this year. It has been a traditional pharmaceutical company. However, since the early 2000s, we have tried to become a global company, and there have been many concerns. As a result of these concerns and efforts, the anticancer drug pipeline has been strengthened since the mid-2000s, and through the merger of Millenium Pharmaceutical and Shire, the company focused on specialty care. Takeda is trying to obtain approval for new products in the fields of anti-cancer, gastrointestinal diseases, rare diseases, nervous system diseases, and vaccines, which are key treatment fields. In the future, Takeda aims to achieve a sales volume of over ₩50 trillion by 2030, and has a pipeline that divides into products that are ready to be released within the next five years (Wave 1) and products scheduled to be released after that (Wave 2). -Although drastic change in business model is desirable and necessary to some extent, employment issues are a problem with this sale. Didn't the company actually suffer a lot from this? Currently, the sale and all circumstances resulting from it have ended. We considered what the best efforts would be for the employees who were inevitably forced to leave Takeda, and made efforts to provide maximum opportunities and support through continuous discussions with the headquarters. It looks like it's almost finished systematically, and as we have spent a difficult time together, we will continue to think about the future together. -Wave 1 and Wave 2 products were prepared. Do you have a keynote or strategy when introducing new drugs such as anticancer drugs or treatments for rare diseases? Product strategy is important from the early stages of development. Takeda Korea is also making efforts to include Korea in clinical research when developing new products. Takeda Development Center Asia, which oversees drug development in Asia, and TDC Asia are located in China, and recently hired a Korea Development Leader from TDC Asia. When a product included in Wave 1 is introduced in Korea, a staff member who is a doctor is working in Korea to know how to conduct clinical trials and to speed up the clinical process. It will be able to influence even more by belonging to TDC Asia. We are considering ways to help patients as quickly as possible before listed, such as the EAP (Early Access Program). -There seems to be a lot of worries about domestic insurance benefits. Is the government's conservative attitude toward Zejula's indication? In the case of anticancer drugs or rare diseases, the drug price is very expensive and accessibility is low, making it difficult. However, I think the accessibility of patients with anticancer drugs has improved a lot over the past two to three years through the registration. Nevertheless, it is unfortunate that the Cancer Disease Review Committee still seems to consider a lot of conservative and economic aspects. It would be better if looking at it in terms of more scientific evidence and patient accessibility. In the case of rare diseases, there is still a need for improvement in terms of patient accessibility compared to anticancer drugs. In many cases, it is difficult to compare with alternative drugs, and because the ICER value is also low, it is very difficult to prove by economic evaluation. The government is currently conservative on the drug exempt from economic evaluation track. -Do you have any experience in receiving orders for Korea Passing from the head office due to domestic drug prices? Takeda is fully aware that the domestic situation is not easy because it has a good understanding of the Korean market. We are operating so that we can set drug prices appropriate for the Korean situation. Due to the Chinese drug price reference system, it may be launched in China first, but the release has never been canceled.
- InterView
- “34 years in drug industry, but now as a law firm advisor"
- by Eo, Yun-Ho Jan 28, 2021 05:59am
- Advisor Kwon Jaehong A new advisor at Kang Han Law, Kwon Jaehong has 34 years of a long experience in the pharmaceutical industry. After joining JW Pharmaceutical sales department in 1998, Kwon moved to Bristol Myers Squibb (BMS) Korea in 1998 and was leading the Government Affairs and Market Access businesses until last August. But as he retired, he left the corporate boundary. And from this January, he wide opened the door to a law firm. While law firm recruiting a pharmaceutical industry specialist is becoming a latest trend, a global pharmaceutical company’s former government affair director joining a law firm holds a greater level of significance. Daily Pharm interviewed Advisor Kwon at Kang Han Law office in Seoul. “I do not think I would do ‘something groundbreaking.’ But I have been in the center of the communication among pharmaceutical company, government, patient group and healthcare providers for over two decades, which gave me a deeper insight on their perception gap and problem solving measures. Based on those experiences, I want to contemplate on what role I could play here.” Behind his humble words, there were prudence and aspiration. In fact, the law firm has a clear agenda in specifically recruiting him. It is quite different from recruiting a high-level government officer as an advisor from the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS). These days, South Korean law firms are concentrating on offering a ‘total consulting service for drug pricing,’ covering drug approval, reimbursement application, pharmacoeconomic evaluation (PE) designing, risk sharing agreement (RSA) and PE exemption. Advisor Kwon’s expertise surely meets the need. When he was at BMS, he participated in the National Health Insurance (NHI) listing procedure for blockbuster new drugs. He led the talks on the NHI reimbursement listing and expansion on a blockbuster hepatitis B virus treatment Baraclude, a “super-Gleevec” Sprycel, and a novel oral anticoagulant Eliquis. Also he handled a blockbuster antiplatelet drug Plavix, a first-in-class oral hepatitis C virus treatment Daklinza-Sunvepra, and an immunotherapy Opdivo. As a representative from Korean Research-based Pharmaceutical Industry Association (KRPIA), he also participated in talks for major regulatory reform changes in reimbursement listing and drug pricing, such as introduction of positive listing, selective listing, RSA, PE exemption and lump-sum pricing reduction. “I don’t want to limit myself to pharmaceutical reimbursement listing. The regulations are ever changing. Projecting and preparing for prospective changes takes a vast part of pharmaceutical business. I could provide a help in the process and each phase of adapting to the change, and also I could set up blueprints for now my colleagues and fellow advisers to better understand the industry.” Technically, Kang Han Law is not a major law firm like Kim & Chang and Lee & Co. Also the firm does not even have a team entirely dedicated for healthcare. But as a law firm specialized in healthcare, it has been handling administrative law suit related to the healthcare authority regarding drug pricing. “As I would be working alongside with expert attorneys and advisors, I’m positive we would be able to create a synergy effect. The healthcare sector is directly related to patients, but its regulations are tight and often it finds various variables, which makes it quite interesting. I would do my best to strive for positive outcomes along with my competent colleagues.”
- InterView
- “PARP inhibitor as backbone in ovarian cancer treatment”
- by Eo, Yun-Ho Dec 09, 2020 10:54am
- Dr. Kim Byoung Gie (left) and Dr. Kim Jae Won Disease with limited treatment options tends to simplify the treatment pattern itself. But an emergence of a new treatment mechanism can open doors to various treatment strategies. A poly ADP-ribose polymerase (PARP) inhibitor is the new mechanism opening the new doors to the ovarian cancer treatment scene. PARP inhibitors that target BRCA gene like Lynparza (olaparib) and Zejula (niraparib) are indicated as a monotherapy for the maintenance treatment in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first and second -line platinum-based chemotherapy, and also as a fourth-line monotherapy in patients, who have been treated with third and later-line chemotherapy. Beyond treating the BRCA mutation-positive patients, the medicine has expanded to a new biomarker like homologous repair deficiency (HRD). Especially, Zejula won an all-comer indication after proving its efficacy at all lines of treatments regardless of the gene mutation. Recently, a number of studies are confirming the effects of chemotherapy, Avastin (bevacizumab) and immunotherapy in combination with PARP inhibitor as a backbone. Daily Pharm interviewed Dr. Kim Byoung Gie, an obstetrics and gynecology professor at Samsung Medical Center and Dr. Kim Jae Won, an obstetrics and gynecology professor at Seoul National University Hospital about the current status of PARP inhibitor use and their future strategies in ovarian cancer treatment. -What does a PARP inhibitor mean in regards to the ovarian cancer treatment scene? Dr. Kim Byoung Gie Dr. Kim Byoung Gie (“KB:”): The search for a new treatment option in ovarian cancer has continued since two decades ago, but there was no noteworthy progress. But finding the PARP inhibitor for treating an ovarian cancer was the biggest breakthrough in last decade. While the existing standard of care Avastin for ovarian cancer is also effective in treating other types of cancer, PARP inhibitor has been actively conducting biomarker researches and entered the ovarian cancer treatment market as a result. Dr. Kim Jae Won (“KJ”): At a global gynecologic oncology society seminar a few years ago, we had a discussion on the “game changer” in ovarian cancer. I personally think the PARP inhibitor would be the game changer for ovarian cancer patients. Unlike before, the overall survival for the patients has been extended. -Other than BRCA gene mutation, PARP inhibitor also targets HRD as another biomarker. Please elaborate on the efficacy and value of HRD as a biomarker? KB: Based on the clinical findings so far, PARP inhibitor monotherapy demonstrates the best treatment effect in BRCA mutation-positive patients. The next in line is HRD group, where the medicine confirmed its effect through clinical studies. However, the problem was ‘how to define HRD?’ The BRCA mutation could be dichotomously divided into positive or negative mutation, but HRD is rather scaled by the level of severity. Therefore, the cut-off line for diagnosing the patients became crucial. No clear standard was set to determine score the severity of HRD that categorizes the patients. And as the standard could change depending on the PARP inhibitor and the line of treatment, more studies should follow in the future. KJ: I agree. It is great news that PARP inhibitor prescription can now cover both BRCA and HRD groups. But HRD diagnosis has to be developed further as it is not a clear dichotomy, but a spectrum. Then, does that mean there is no consensus on the clear cut-off line to define the HRD group at the moment? KB: There is a consensus agreed upon each drug. The PRIMA study on Zejula as a first-line treatment was conducted by dividing the patient group by the HRD cut-off score set at 42 points. Zejula’s efficacy was confirmed in all patients, regardless of biomarker, but the study divided the HRD group, because the prognosis has to be observed in different patient groups. Another PARP inhibitor candidate ‘veliparib’ by AbbVie has conducted a trial based on cut-off score of 33 points. Dr. Kim Jae Won -As mentioned just now, Zejula has an all-comer indication. But the South Korean government is conservative on granting the insurance benefit on BRCA or HRD-negative patients. Do you think the coverage should be provided for all types of ovarian cancer patients? KJ: With the launch of Zejula, a patient group who are homologous recombination proficient (HRp) can use a maintenance therapy, which can significantly raise the survival rate. And a first-line maintenance therapy and a second or later-line therapy showed a vast difference. Obviously, using the drug earlier boosts the survival rate. Personally, the first-line maintenance therapy should be covered with insurance for all patients, if possible.” JB: But the fairness among other types of cancer is important, and it would also require concrete evidence related to efficacy and survival rate. Currently listed for reimbursement in first-line therapy, Avastin’s overall survival (OS) evidence played a big role in the listing process. Zejula would also be able to receive the reimbursement, when the survival rate data is accumulated enough for all-comers. -In South Korea, Lynparza and Zejula can be prescribed as a first-line maintenance treatment. When there is a patient group with overlapping indications, how do you choose a drug? KJ: Zejula’s PRIMA study included more patients with advanced ovarian cancer. So I lean towards using Zejula more, when treating a patient in an advanced stage. And depending on the patients, I also take administration convenience into account. -The treatment scene has changed through the emergence of PARP inhibitor, and it would continue to evolve in the future. When there are more options to treat a disease, then naturally you would have to consider sequential treatment. KJ: While Avastin has evidence of the efficacy in a second-line treatment when relapsing after a first-line treatment, PARP inhibitors do not have such evidence, yet. It would be advisable to use PARP inhibitor in first-line maintenance treatment, and prescribing Avastin when relapsed. -It seems like PARP inhibitor would become a backbone substance in treating ovarian cancer. Is there a promising option with PARP inhibitor backbone in the future? KB: Currently, there are about four clinical trials in process to confirm combination therapies using PARP inhibitor as a backbone. Based on beyond biomarker testing, the clinical trials are seeking for mechanisms to treat patients without BRCA mutation more effectively, which would be integral studies for the prospective ovarian cancer treatment scene.
- InterView
- “30-year-old Novarsc is our pride”
- by Eo, Yun-Ho Nov 17, 2020 06:26am
- Norvasc (amlodipine) is not the world’s first calcium channel blocker (CCB). However, it is undisputedly the most famous CCB. Launched in 1990s, Norvasc was not the first-in-class but it instigated a notable change in the market with the first once-daily administration. Some say the drug marked the early beginning of the present convenient administration marketing. A key hypertension drug market presence Novarsc is now celebrating its 30 year anniversary of marketing approval in South Korea. Surely it is an old drug, but it still has its high reputation firmly built around ceaseless evolution. In 2017, Norvasc T was released to the market for the patients, who need amlodipine and telmisartan simultaneously. The company also introduced an improved bottle packaging to enhance the convenience of patients and healthcare providers storing and managing Norvasc T and to absorb the moisture of telmisartan. And besides the existing line of 5 mg and 10 mg tablets, the brand also launched 2.5 mg tablet for children from age six to 17, which was the first among all CCB original drugs for hypertension. From then on, Novarsc has been offering necessary dosage options to effectively bring down blood pressure in patients ranging from six years of age to elderly. Prior to next week’s launch of Viatris, Daily Pharm interviewed Pfizer Upjohn Regional Sales Manager Lim Hye-sook and a rookie Sales Executive Lee Chang-hwan, who have been in charge of Novarsc sales. Regional Sales Manager Lim Hye-sook-Please, give us a short instruction Lim Hye-sook (Lim): I started from the Clinic Team when I joined Pfizer in 2005, and the first product was Novarsc. Although I’m the youngest out of all regional sales managers, I was still the last one Pfizer Upjohn Korea appointed before we spilt as Viatris. It has been 15 years since I joined the company, and I still manage Novarsc sales. The drug is basically an old pal now, keeping me company for all these years. Lee Chang-hwan (Lee): Ever since I was young, I had an admiration for the company Pfizer. I had to apply for the job for seven times to get it. Because my father was a doctor, I was familiar with the name from early on. After learning that the company is the biggest pharmaceutical company in the world, I dreamed of joining the company since then. -Managing the Novarsc brand for 15 years, you must be particularly attached to the brand? Lim: Of course. I’m not sure about the rookies these days, but when I was managing private clinics, I was frequently recognized as the ‘Novarsc Account Executive.’ I still remember the days when I had to take quizzes every three months on the product. The entire sales department had to retake the quiz on their own products when they failed. Because Novarsc had a vast amount of clinical data, I had to cram in quite a bit of information. -I assume there were also bad days on the job Lim: When managing the hospitals, defending the Novarsc code was very difficult. At a hospital-level healthcare institute, your role as a salesperson is significantly narrowed when you lose the code. It is a challenge for any salesperson. Then again, there is nothing more exhilarating to see your product’s code getting registered. While I became a regional sales manager and celebrating the 30 years of Novarsc, a new 2.5 mg tablet was released. I was grateful to see the 2.5-mg tablet registered at multiple general hospitals. Three decades could be a long time for some, but it could be a new beginning for some. When we introduced the 2.5-mg tablet, the healthcare providers commented that Novarsc is still trying new things. Sales Account Executive Lee Chang-hwan -Let’s hear from the rookie now. When did you actually felt that Novarsc has the worthy fame? Lee: A new account, any hospital or clinic, or even a doctor who has never heard of the drug was still prescribing at least a case of Novarsc. At the moment I’m managing seven products, and the Novarsc brand gives me a leverage to introduce other products’ code to a hospital. That’s the time I can see that everyone knows, uses and prescribes Novarsc. -What are some hardships you face amid COVID-19? Lee: Due to COVID-19, the sales had to work from home for about three months. When we came back to in-person work, I initially though it is not easy coming back. But it seems like everything I have done so far is coming through in this time of darkness. As in-person meeting became risky, the sales who did not get to build rapport with existing clients face limitations. But for those who have been earnestly doing their job, the work seems to be easier amid COVID-19. It almost seems like we have less competitors. As for the regional sales manager, what would like to say as a word of encouragement to your fellow colleagues? Lim: I’ve mention of my 15-year experience here, but there are employees who have been with the company for 30 years. Just like Novarsc has been with us for three decades, I wish we can together see the 40 and 50 year anniversary of the brand. -What would you like to do next as a second-year account executive? Lee: I came to the company, because I desperately wanted to try the pharmaceutical sales. I’m managing clinic accounts at the moment, but I also want to move on and experience other general hospital channels as well. And if I get a chance, I also want to make decisions in marketing strategy at the marketing team. -Soon, Novarsc would start a new beginning under Viatris. How do you feel about the new beginning? Lim: We have prepared for it for a long time. I was a part of taskforce team last year and I’ve been anticipating it. Knowing that it’s just next week, I can’t wait any longer. I have big expectations for the changes I would experience in Viatris. As I handled other changes so far, I’m hoping the upcoming changes would be positive. Lee: As I said before, I came to the company with my admiration for Pfizer. So I didn’t know how to react to the news of splitting off as Viatris. But starting off as a new company and joining the first starting member of a new business model intrigued me. So far, Pfizer has been topping the ETC industry. I do not fear anything about joining Viatris, as I would still be with the colleagues, products and amazing culture that enabled Pfizer to maintain the reputation. Now I’m just looking forward to it. I just want to say, “Thank you, Pfizer. Let’s go, Viatris!”
- InterView
- Pfizer in the center of autoimmune disease treatment scene
- by Eo, Yun-Ho Oct 08, 2020 06:24am
- I&I Business Unit Lead Kim Hee-yeon Shifting the paradigm in autoimmune disease, tumor necrosis factor (TNF)-α inhibitors have taken root as major treatment option not only for rheumatoid arthritis, but also for other various areas including ankylsoing spondylitis, psoriasis, and psoriatic arthritis. Regardless, there are still patients struggling with unmet needs as they fail to control the diseases with TNF-α inhibitors. As a result of many pharmaceutical companies jumping into developing alternatives of TNF-α inhibitors, other options like Janus kinase (JAK) inhibitor and interleukin (IL) inhibitors have emerged. Considering the change in treatment scene, Pfizer is a key player in the autoimmune disease area. The company owns a conventional TNF-α inhibitor Enbrel (etanercept), but also it launched a first-in-class JAK inhibitor Xeljanz (tofacitinib). The company is also in process of seeking approval on the Xeljanz follow-up drug ‘abrocitinib.’ Daily Pharm interviewed Pfizer Korea’s Inflammation & Immunology (I&I) Business Unit Lead Kim Hee-yeon on the trend in autoimmune disease drug and marketing strategies. -Please tell us about your experience in the industry. Currently, I am leading the I&I unit in Pfizer Korea. From 2001 when I joined Pfizer Korea, I have acquired a wide variety of drug marketing and sales experiences in internal medicine, pain, respiratory and I&I areas. While managing numerous drugs’ commercial strategies, I was in charge of launching Caduet (amlodipine), Eliquis (apixaban) and Viviant (bazedoxifene) in South Korea, and also leading the off-patent marketing strategy for Lyrica (pregabalin) in seven countries as a regional marketing director in Pfizer Asia. -The I&I unit consists of two key products. What are the respective strengths of those products? Enbrel, launched in South Korea in 2003, has over 16 years of a long history. As a first TNF-α inhibitor in the treatment area, it has been evaluated to have changed the paradigm of rheumatoid arthritis treatment. More than anything, the drug was able to maintain the market leadership with even a specific patient group dedicated to it as it is a TNF-α inhibitor without anti-drug antibodies (ADAs). And its trustworthy safety profile is its one of best strengths. Xeljanz has also proposed a new treatment paradigm in rheumatoid arthritis. A first JAK inhibitor used in rheumatoid arthritis, Xeljanz was listed for reimbursement in 2017 as a first-line therapy after it was released in South Korea in 2014. -The two drugs have an overlapping indication, which could put them in competition. As a business unit, what are the marketing strategies like? Rather than competitors, the two drugs are actually in mutually beneficial relationship. Except for the rheumatoid arthritis, Enbrel and Xeljanz do not share other common indications. Enbrel is indicated to treat patients with ankylsoing spondylitis, and it has been concentrating on the juvenile idiopathic arthritis (juvenile polyarthritis, extended oligoarthritis, psoriatic arthritis, and enthesitis) with healthcare reimbursement expanded last year. Especially, the patients and healthcare providers were exhilarated about the access to the treatment as the juvenile idiopathic arthritis market had highly unmet medical needs. On the contrary, Xeljanz is focused on rheumatoid arthritis and ulcerative colitis treatment area. Xeljanz may have more overlapping indications with Enbrel in the future as the drug is also constantly expanding its indication, but currently they are not competing against each other. -In terms of South Korean healthcare provider, there seems to be a barrier to prescribe JAK inhibitor. Because of that, it seems questionable if the drug would be able to expand its share in rheumatoid arthritis market. I agree. South Korea still tends to prefer conventional therapy. Despite the accumulating evidences highly recommending early treatment, the country’s healthcare providers seem to linger on using the conventional treatment. There could be many factors, but the patients’ stress on getting injections could be one of them. However, an oral JAK inhibitor like Xeljanz would be able to play a positive role in creating a new rheumatoid arthritis treatment environment. And it would also play a significant role in creating an encouraging environment for healthcare providers to assertively proceed with the treatment. -JAK inhibitor market competition is getting heated up. More competitors are emerging and generics are getting closer to challenge the original as it is a small molecule drug. Within the rheumatoid and digestive system disease treatment areas, Xeljanz would continue to expand its indication to provide as much medical benefit as possible to patients with inflammation and immune diseases. In fact, Xeljanz has the most number of indications for a JAK inhibitor, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis. Xeljanz is a top drug leading the JAK development program Pfizer is heavily engaged with. The company has already accumulated a vast amount of data on efficacy and safety of the drug tested with various groups of patients. The real world data (RWD) based on a wide array of patient groups is consolidating the healthcare providers’ trust in Xeljanz. As different JAK inhibitors have unique molecule structure, collecting such long-term safety data would also be very unique to Xeljanz. -What is the value of administration convenience in terms of autoimmune disease? Because autoimmune disease require a life-long management, consistent use of the needed drug is essential. Particularly, the company has been seeking for means to provide convenient treatment option to the patients as South Korean patients tend to shun injection and get scared of injections easier than patients in other countries. While Xeljanz has been embodying administration convenience itself, Enbrel—initially launched with pre-filled syringe—introduced a pen type called “MyClic” for patients to conveniently self-inject the treatment. The company also distributes an ambient package to store the injection at a room temperature and a E-base tool to keep 90-degree angle when self-injecting with minimum pain free of charge. -As a Business Unit Lead, what were the difficulties experienced when communicating with stakeholders like healthcare providers or government officials? Pfizer is putting much effort into developing and providing innovative pharmaceuticals in areas with highly unmet medical needs for the patients. Pfizer Korea is also endeavoring to introduce these innovative drugs to the Korean market, and to provide treatment benefits to the patients. However, new drugs like first-in-class drugs are facing a number of limitations when pursuing approval and reimbursement. It is gratifying when cooperating with various stakeholders like healthcare providers and government officials to resolve these limitations, but I also contemplate a lot on how to enhance access to innovative pharmaceuticals even faster for those patients fighting against their diseases in pain.
- InterView
- The corporation separation is started from Employee rights
- by Sep 07, 2020 06:12am
- Kyungrak Kim, CEO of Daesang Labor CorporationBusiness divisions of large foreign pharmaceutical companies such as Pfizer and MSD are actively in progress. Pfizer separated the patent-expired drug business unit into Pfizer Upjohn last year, and MSD is working to spin off the women's health, patent-expired drug, and biosimilar business divisions into a new corporation called Organon & Co. with the aim of the first half of next year. The division of the division itself has a good purpose. By becoming an independent incorporation, it can be specialized in specialized fields, and the management efficiency of the company is increased. Regardless of the will of some employees, their company name changes. The affiliation will change from one of the world's leading companies to an unknown company overnight. The change of affiliation also affects credit loans and visa issuance. The biggest reason why employees are more anxious about moving to a divided corporation is that there is a high concern that they will take steps to sell the so-called 'non-profitable business' to another company altogether. The 'carve-out deal', which sells off non-core businesses after physically splitting them, is an active M&A method. In fact, Pfizer announced the news of the merger with Mylan two months after Pfizer Upjohn was separated. It has been changed to Viatris, which is named after the existing one. Although Mylan and Pfizer are jointly controlled, Pfizer Upjohn employees think it is actually Pfizer's ‘Exit’. There are concerns that MSD's Organon & Co. will eventually follow the same procedure. Employees say that they move personnel such as sales and marketing, but do not move related R&D personnel, and that an organon office is set up in WeWork, a shared office that does not require long-term contracts. Kyungrak Kim, CEO of Daesang Labor Corporation, a former MSD salesman who specializes in the pharmaceutical industry in a meeting with Dailypharm, said, "In the case of the past, employees are more sensitive because there is a high possibility of the company’s sale." He said, "Pfizer and MSD are among the leading companies in the pharmaceutical industry, so depending on what kind of examples they set, they can have a big impact on other pharmaceutical companies in the future." Unlike Europe, where social security system is strong, and the United States, where horizontal movement is flexible, general administrative and sales positions are not easy to move in Korea, except for specialized fields such as research. He said that there is a large supply of manpower for the sales and marketing jobs, which account for the largest portion of pharmaceutical companies, but the current demand for those jobs that can be absorbed by the pharmaceutical industry is limited. Even if they move to a domestic company, they often come out without adapting to a completely different culture. Also he added they have no choice but to actively respond to issues such as division of a corporation. Currently, Pfizer's management and the union are negotiating over the issue of compensation due to the division and merger of corporations, and MSD is expected to proceed with negotiations in earnest when executives and staff members to move to Organon & Co. are announced in October. In relation to Hyundai Green Food in 2013, the Supreme Court did not recognize the 'opt out right', which allowed workers to choose or refuse a place of work when a company was divided. In other words, in the current situation, it is a favorable situation for companies only when it comes to case law. However, he expressed the opinion that It can be developed in a new way now. "In this case, following the decision of the National Labor Relations Commission, both the first and second trials acknowledged workers' right to veto to transfer companies, and in the current situation that advocates a labor-respecting society, so another judgment could come out." Hyundai Green Food’s case is too far to be compared with the current corporate division of foreign companies, so it is judged that there is a high probability of a fight in the future.” He continued, "In the issue of division and sale of a corporation, the management of the Korean branch only repeats the position that it is the decision of the global headquarters. If the division and sale is an unavoidable procedure according to the company's policy, employees should also actively respond to seek rights."
