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- 2026-03-10 05:38:13
- InterView
- “Why it took 20 years for new flu drug Xofluza to be out”
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- Since the 2009 flu pandemic, Tamiflu became a prescription drug with household name like Viagra. Tamiflu (oseltamivir) is a good drug. It shifted the world’s paradigm on influenza management and became the symbol of neuraminidase inhibitor drug. However, the unmet medical needs still exist in the market. Antiviral agent can always develop resistance, but for influenza treatment, no other agent than neuraminidase inhibitor is recommended. In Korea, the influenza vaccination rate boasts a top world class level, but 2.26 million patients have been infected with influenza in 2018. After two decades since Tamiflu was commercialized, Roche has showcased Xofluza (baloxavir). The new drug has a novel mechanism of action that inhibits polymerase acidic endonuclease and treats influenza with only a single dose (Tamiflu requires a five-day treatment). Daily Pharm met with Roche’s Principal Global Medical Director, Aeron Hurt, and spoke with him about the meaning and possibility created by developing Xofluza. He used to serve as a senior research scientist at the World Health Organization (WHO) Collaborating Centre for Reference and Research on Influenza. -What was your role at WHO? And what motivated you to be interested in influenza out of all infectious disease to study? At WHO, I led a team of researchers to analyze and monitor antiviral agents and vaccine for patients with influenza. Analyzing antiviral agents and vaccines’ effect at a research center in Melbourne, Australia, I came to realize the necessity and urgency to mange influenza better and more effectively. And naturally, I got interested in and passionate about advocating the importance of antiviral agent and vaccine to effectively manage influenza. -When it comes down to ‘influenza management,’ it is divided into ‘prevention’ and ‘treatment’ blocking the viral transmission. What is your idealistic management plan incorporating the two factors? First, the National Immunization Program (NIP) has to generate the maximum effect with limited resource. Accordingly, the government could consider conducting or expanding NIP focusing on patient group with high risk of inducing complications or with possibility of optimal vaccination effect. As WHO recommends, patient groups of the highest priority for vaccination—the elderly, children, individuals at high risk of medical complications and pregnant women—should be provided with quadriavalent vaccine than trivalent vaccine for better coverage of influenza vaccination. As far as treatment goes, it is crucial to use an exceptional antiviral treatment as promptly and widely as possible when it is released. Same goes for Xofluza and other antiviral treatment to be released in the future. Instead of saving the new and effective antiviral treatment as a last resort for a pandemic, patients’ symptoms should be alleviated by treating the patient with effective antiviral from the beginning, while social and financial burden of influenza should be lowered. -It sounds like you have Xofluza in mind. Could you elaborate on the major clinical outcomes of the treatment for the readers to fathom its efficacy? Xofluza demonstrated its positive efficacy in CAPSTONE-1 study treating a healthy patient group aged 12 to 64 diagnosed with acute influenza symptoms and CAPSTONE-2 study treating patient group aged over 12 at high risk of serious flu complications. Top-line findings of CAPTSONE-1 study evaluating the flu treatment on healthy adult and adolescent, Xofluza reduced the median time to alleviation of symptoms by approximately 26.5 hours compared to the placebo group. And it also demonstrated comparatively faster cessation of infectious viral shedding than the placebo. Xofluza’s median time of viral shedding marking 24.0 hours (about a day) was meaningful, as the placebo group took 96.0 hours (about four days) and oseltamivir group took 72.0 hours (about three days). Meanwhile, the CAPSTONE-2 study evaluated the treatment’s effect on elderly patient and who are at a high risk for influenza-related complications. The study also found exceptional effect of Xofluza as its median time to alleviation of symptoms in high-risk patient group took 73.2 hours (about three days), cutting down around 29 hours from the placebo group (102.3 hours). Moreover, Xofluza reduced the time to cessation of viral shedding in 48.0 hours, which was about more than 50 percent improvement than the placebo (96.0 hours) and oseltamivir groups (96.0 hours). -In the CAPSTONE-1 study, pediatric patients aged 12 to 19 years did not receive Tamiflu. What was the reason? The study was conducted in the U.S. and Japan from December 2016 to March 2017. The reason why adolescent patients from 12 to 19 were not in the Tamiflu group was because Tamiflu was not recommended to adolescent patients in Japan when the study initiated. Currently, the limitation has been lifted. For your reference, CAPSTONE-1 study had to apply equivalent condition to all participants in the U.S. and Japan, so the U.S. participants from age 12 to 19 only received Xofluza and placebo. -The outcomes of CAPSTONE-1 does not seem to show significant difference between Xofluza and placebo arms’ time to alleviation of symptoms The time to alleviation of symptoms between two groups may not have shown exceptional difference as the evaluation of ‘symptom’ could be subjective. The severity of symptoms could differ from each individual. And a patient infected with influenza virus show cytokine response, which is induced regardless of decreased virus titer. Therefore, it would be quite difficult to reduce the time to alleviation of symptoms by 24 hours more than the available antiviral agents, despite the new antiviral agent considerably shortens time of viral shedding. The most important differences between Xofluza and existing antiviral treatment are reduced time of viral shedding and lessened risk of complications. -With Tamiflu, there was an issue with neuropsychiatric events. Was there any similar event reported from Xofluxa study? The company is closely monitoring patients who have taken Xofluza, and there has not been any report of adverse neuropsychiatric event so far. Influenza itself could affect patients in neuropsychiatric event. And also, the correlation between oseltamivir and neuropsychiatric event in treated patient has not been proven. So medical professionals should carefully consider treatment benefit and adverse reaction from antiviral treatment and prescribe Xofluza according to the patients’ individual conditions. The same applies to Tamiflu. Although there were reports of adverse reaction in Japan about a decade ago, but the Tamiflu prescription limitation has been lifted and the public’s perception has been changing as well. -The present indication for Xofluza is quite narrower than other available flu treatments. Are there any other ongoing clinical studies? A few studies have been completed, but the outcomes have not been officially announced, yet. They specifically were on post-exposure prophylaxis and pediatric patients. The prophylaxis study evaluated probability of a patient diagnosed with influenza transmitting the virus to their household members, who have been administered with Xofluza. The study result found the risk of influenza virus infection has gone down by 86 percent when administered with Xofluza. Another clinical study, MINISTONE evaluated virus titer and time to alleviation of symptoms in children aged one to less than 12. Also, there are three more clinical studies currently calling for participants. The first one is for infants younger than 12 months, whereas the second one named FLAGSTONE is evaluating the efficacy and safety of Xofluza in combination with the current standard of care, compared to the standard of care alone from hospitalised patients. The study would administer Xofluza not by single dose, but by total three times respectively on the first, fourth and seventh day of treatment. Lastly, the CENTERSTONE study is reviewing Xofluza’s effect on patient’s viral infectiousness. Unlike the previously mentioned post-exposure prophylaxis study, the treatment is administered not on the household members, but only on the patient. The study aims to not only confirm time to alleviation of symptoms, but also the infectiousness to household members. -Is there any other investigational drug in development at the moment? Xofluza blocks polymerase acidic endonuclease, an enzyme crucial for viral replication. Other candidate medicines inhibiting different enzymes are in R&D phase by other respective companies. If these investigational medicines have successful clinical trials, they would be commercialized as well. However, pharmaceutical companies, including Roche, have tried researching other mechanism of antivirus treatment like monoclonal antibody, but most of them have failed in clinical trial phase. Considering the challenges, release of Xofluza is particularly meaningful. The fact that Xofluza works in a novel mechanism of action, developed after twenty years, illustrates how the journey of developing an antiviral treatment is challenging and rough.
- InterView
- “Key to healthcare innovation is pharmaceutical industry"
- by Kim, Jung-Ju Jan 02, 2020 06:08am
- Korea’s Ministry of Health and Welfare (MOHW) has stated two core goals of the current administration are ‘creating an inclusive welfare state’ and ‘supporting innovative growth of emerging industry.’ The key is definitely the pharmaceutical industry. During a question and answer session with correspondents, Park Min-soo, a director of Health Insurance Policy Bureau under Office for Planning and Coordination at MOHW, said this year the ministry is committed to support all-around new drug development covering from basic science research to commercialization, and to strengthen industry competitiveness. Director Park, in charge of the ministry’s budget plan each year, allocated 12.9 trillion won on healthcare sector this year. The plan reflects the record-high National Health Insurance state funding of 1.86 trillion won, whereas 2.7 trillion won was allocated besides for healthcare. Director Park stressed the importance of pharmaceutical industry among the industries government is backing up. He elaborated, “Other than the goal of creating inclusive welfare state, the government is devoted to support innovative growth of emerging industry.” “The government is trying to find the hidden gem of the healthcare industry and create an environment to polish it. Among the emerging industries of IT, bio, pharmaceuticals, agriculture, and food the government is currently pushing on for innovation, the pharmaceutical industry is the most valuable key,” he continued. One of ongoing inter-ministerial programs supporting the key industry is the big data platform project. Director Park explained, “Big data utilization is expected to embody vast amount of data, but it needs the government to build a foundation to optimize utilization of the information, because it has a limitation of private information protection.” So apparently the director allocated budget to connect the dots between dispersed information. Government support for R&D is another highly expected project. He emphasized the investment value for R&D is high as Korea’s R&D investment rate against GDP is at worlds highest. “From basic science research to commercialization, we need to bridge the gaps to ultimately make a living out of the industry. To strengthen the industry competitiveness, the ministry would support new drug development in every step of the way and also train specialists to reinforce the industry strength,” Director Park said. He added, “Laying the groundwork for the R&D system would encourage more research activities and contribute on advancing technology further. The result may not be tangible immediately, but the government is committed to continue support it.” Moreover, Director Park explained about MOHW’s plan to open a tentatively named ‘Office for Health Policy’ that reinforces government’s preventive healthcare programs to reduce medical expense and solve the issue of increasing dependants in the aging society. Additionally, he emphasized the importance of preventive healthcare programs to get under way from this year. “The point of the policy in the end is to make people live their lives without dealing with serious health condition. Mobile Healthcare program providing high-risk chronic disease management would open 30 more centers this year, while the mental health sector would secure human resources and open Emergency Intervention Team with 39 percent increase in budget,” he said.
- InterView
- The key to drug development is not just safety and efficacy
- by Jung, Hye-Jin Dec 05, 2019 06:12am
- 박영준 대표“In short, it is an area that is easy to miss even though it is important enough to be the core of new drug development. Most of the domestic companies that have applied for a permit with the US FDA or the European EMA are asked to submit additional data. As more and more pharmaceutical companies are attempting to penetrate overseas, Korean companies are also beginning to recognize the importance of quality data”. The reporter met with Park Young-jun, Ph.D. (55, Seoul National University) who is a professor of Ajou University, to hear about CosmaxIMD, IMDpharm joins a venture founded by CosmaxPharma. However, Professor Park emphasized the importance of Chemistry, Manufacturing and Controls (CMC) in the new drug development process. Professor Park has been developing medicine at pharmaceutical companies since graduating from pharmacy. After 17 years as head of product development at Yuhan Research Institute, he worked as research director at Samil Pharmaceuticals and CJ Healthcare. Korea's No. 30 new drug 'K-Cap' is a product that he developed as a CJ research director.Professor Park then set up a new drug research institute. IMDfarm stands for 'Innovative Medicine & Drug Delivery'. ◆Overlooking the importance of CMC to ensure 'quality of material' IMDpharm is a company researching new innovative new drugs, ▲At the same time as developing new innovative medicine for intractable diseases, ▲Improving absorption of poorly soluble drug solubilization, a pharmaceutical formulation technology ▲Sustained Release Drugs ▲Persistent Injectable Technology ▲Disease Targeted Nanoparticle Technology ▲ It is a company that develops convergent new drugs by holding technologies in various formulations such as eye drops and external preparation technologies and applying them to new drugs. However, at present, IMDpharm's cash cow is quality management, or CMC, which is an essential element in the process of leading clinical trials. Venture companies that are engaged in new drug development are the main customers of IMD Pharm CMC service. According to Professor Park, there is no company in Korea that offers a full range of CMC services from nonclinical to clinical. Most of the nation's top pharmaceutical and venture companies, which spend ₩billions on new drug development, use CMC companies in China or India. This is the result of the CMC not receiving attention in the domestic pharmaceutical industry. But the mood has changed recently. This is because CMC, the quality control of the substance, is considered as important as the efficacy and safety of the drug. "The first thing to notice when developing a new drug is the effectiveness, because any substance has a 'pharmacological effect' to get started. The next thing to notice is safety. It is marketable as a drug, 'Quality Control' covers the whole process, from the beginning to the end, demonstrating that all experiments and tests are made of the same substance and keeping this process as records and data". A typical case is 'Rolontis' by Hanmi Pharmaceuticals, . In March, the US FDA requested additional data from Hanmi Pharmaceuticals for marketing approval, which is CMC data. Overseas, the quality control of substances has already been considered important, and more quality control data are required for companies attempting to obtain a marketing license. Professor Park said, "The reason we have to conduct CMC thoroughly from the beginning of new drug development is that we can't do the same clinical trial again." "Even if you already have finished the clinical trial and submitted the results, if you should prove that you have tested all the animals and humans with the same substances and without impurities, can companies that haven't left their data back in time?" "CMC is important for finished products as well as new drugs, increased impurity risk " "Controversial impurity management is also an important part of CMC. With the development of analytical techniques and tightening impurity regulations, this poses a greater risk for pharmaceutical companies. CMC will become even more important throughout the production and distribution of finished products, and Valsartan, Ranitidine, and Nizatidine are all about this. " In this atmosphere, IMDpharm has recently expanded its business. Established in 2016 and started full-fledged business from 2017, the company expanded non-clinical CMC to clinical CMC from August. In September, the company established a joint venture with CosmaxPharma. Cosmax Pharma, which has a finished mass production facility, produces the formulation developed by IMDpharm. “CosmaxPharma and IMDpharm have combined to provide full-service services for CMC, and this year, non-clinical and clinical CRO, Dt & CRO (DTI & CRO), will join us to ensure the safety of materials at all stages of drug development, from non-clinical and clinical. The ultimate goal is to increase the success rate of new drug development for domestic companies”. Professor Park would like to help create a new drug development foundation so that all the processes and technologies necessary for drug development can be solved in Korea".
- InterView
- “Number one in Asia is what we are shooting for”
- by Kim, Jin-Gu Nov 26, 2019 07:15am
- “As far as dermatological treatment business goes, I think we have a shot at becoming the number one in Asian market”, Cho Yong-joon, CEO at Dongkoo Bio & Pharma (“Dongkoo”) commented. The CEO said ‘entering global market’ is the next long-term goal for the company while it gets closer to its 50th anniversary next year. CEO Cho was confident that Dongkoo’s two most prominent business sectors, dermatological treatment and contract manufacturing, would both be competitive in the global market. He explained the recent aggressive investment and company expansion have been executed with the global market in mind. Visiting his office on Nov. 18 for an interview, it has not even been 24 hours since came back from his business trip to the U.S. Apparently, Cho was already making moves for the global market. -What business took you to the U.S.? “It was to dip our toes in the water of global contract manufacturing organization (CMO) market. I shared some positive talks with a U.S. company especially on our strength, the soft capsule manufacturing. When we ink the deal, we would fully disclose the story. Next year would be Dongkoo’s 50th anniversary. Accordingly we would put forth our global market vision”. - Would it be safe to assume the latest Hwaseong plant expansion was a part of the vision? “We have invested ten billion won. The plant started running from this month. Our production capacity would go up half as much again as before or even double. The company’s CMO sector made 21 percent more last year with 33.1 billion won, compared to 15.3 billion won in 2014. We are expecting to make about 40 billion won this year. To date, the manufacturing factory could not catch up with orders pouring in. “When the manufacturing facility stabilizes from next year, the overall sales and profit would rise. Not only did we enhance production capacity, but also we are focusing on developing new technology on soft capsule. We gained expertise in dermatological treatment through our experience”. -After the valsartan incident, many are concerned of CMO industry “Korean CMO industry is faced with crisis and opportunity all at the same time. As the regulator decided to abolish the joint bioequivalence test system, and revived the gradual drug pricing system, I expect the industry would get the blow soon or later. That is what Dongkoo is preparing for. Specialization and differentiation is the key. The government is also encouraging companies to focus on specialized manufacturing. So far, Dongkoo has been doing well with soft capsule and ointment items. “But the opportunity lies in the global market. Korean CMO industry would be competent enough in the global market. I confirmed that at the CPhI Worldwide 2019. From now on production cost would heat up the already competitive generic market. Now it’s a matter of who sources drug the best. Korean companies could also easily source drug from other countries. We all need to target the global market competition”. -What are your visions on Dongkoo’s specialized sector, dermatological and urological treatments? “Not too different from others, we’re aiming for the global market expansion. First, we would tackle the Asian market. The company is carefully preparing for the leap. To be specific, we are considering opening an office in China. In Korea, our dermatological treatment prescription is ranked at the top with, and urological treatment prescription is at eighth place. Why not then go for the top rank in Asia? This is our goal. We have constantly introduced dermatological treatment. Some are ready to be released next year. For the long-run, we are in process of developing new drug and incrementally modified new drug”. -You’ve shown some notable moves not only on facilities but also on venture investment. “We have signed deals with Novacell Technology, D&D Pharmatech and BioNote. D&D Pharmatech is a bio venture led by a group of professors from the Johns Hopkins University School of Medicine. They are developing treatments for Parkinson’s disease, Alzheimer’s disease and rare fibrosis conditions. Dr. Lee Seulki from Johns Hopkins University School of Medicine is leading the R&D and clinical trials. “We have invested 3.1 billion won on D&D Pharmatech. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the venture company’s rare fibrosis treatment. Recently, the company successfully attracted 140 billion won worth of series B funding. We expect the company to go public next year. “Novacell Technology obtained its U.S. patent on atopic dermatitis peptide this year. And BioNote was the first Korean company to develop African Swine Flu diagnosis kit”. -Investment expansion comes with business profit drop. Seems like Dongkoo’s revenue has been falling for last two years. “It was given that operating profit would go down. We have spent much of capital on facility expansion investment, recruitment, clinical investment and marketing. But the actual sales revenue has constantly gone up. It verifies that the business is growing steadily. The last two years of decreased revenue was about preparing for the future ‘quantum jump’. The return on the investment is expected to show even from next year and on". -Some other business expansion on other sectors like cosmetics and medical device has been noticeable as well. “We’ve jumped into cosmetic market. ‘Cell Bloom’ is a brand based on 3D stem cell media skin care products. We are expecting the brand to generate synergy effect with our expertise in dermatological treatment. And we are taking this for a long run. A few home shopping TV channels have offered us a slot, but we turned them down. We could’ve gotten some instant sales hike, but we are planning to build the brand image centering hospitals and duty free shops first. “Besides Cell Bloom, we also have an ongoing development of bio medical device called ‘Smart X’. We are challenging the chronic disease sector with bio technology. There are unmet needs that cannot be resolved with drugs. An example would be diabetic foot (chronic foot condition derived from diabetic mellitus). Not many drugs treat diabetic foot. “Smart X is a convenient stem cell extraction kit. We have observed meaningful effect from extracting stem cell and injecting back into the ulcer on a foot. Clinical trial is in process to receive approval on the new medical technology. It would get approval in first half of next year at earliest, and generate expected sales from the latter half of the year. The approval application reviews are well on their ways in the U.S., China and Russia as well. And it’s already on sale in Spain”. -Celebrating the last 50 years of the business, what’s next for Dongkoo? “Bio sector is where Dongkoo would be investing on for the next 50 years. Cell Bloom and Smart X are on the same track as well. We would not superficially imitate bio technology, but strive for sustainable business with genuine bio technology, as I would reiterate at the company foundation ceremony. "For the goal, Dongkoo aims to transform from pharmaceutical and bio company into a total healthcare company. Dongkoo would generate great synergy effect with dermatological and urological treatments, as well as stem cell-applied healthcare technology, and reborn as a total healthcare company to cover from head to toe with diagnostic, preventive, treatment and maintenance products”.
- InterView
- I know CRA grievances better than anyone else
- by Lee, Tak-Sun Nov 14, 2019 09:59am
- For CRA(Clinical Research Associate), it is very hard to communicate with many professional people. It's even harder if you don't have expertise. I wish my juniors would work with proud. I would like to have the pride of being an expert that communicates effectively with clinical expertise, monitors clinical practice, and leads clinical practice overall. Kyungsun Kong(52 years old), CEO of dreamCIS knows CRA grievances better than anyone else. The core of the CRO(Clinical Research Organization) is often called CRA. However, CRAs have a lot of work and are irregular, so they often move over. when working as a clinical monitoring agent, you may get hurt by professional experts, such as doctors and nurses. However, the power of the CRA may gaurantee clinical trial quality. It's no wonder that pharmaceutical companies are rushing to many CROs with competent CRAs. CEO Kong was also one of the most competent CRAs. In 1995, she began to work clinical trials as a clinical nurse (CRC) at SMC. The CRC is responsible for coordinating communication between subjects and researchers. In 2003, she conducted clinical trials for 25 years, including Wyeth, Parexel and YUHAN. She worked as a PM managing CRA at Parexel, and she took care of the clinical trial of Lasertinib, a lung cancer drug as a clinical development team leader at Yuhan. CEO Kong is probably the only one who started as a CRC and experienced various duties in the clinical field and became the head of the domestic CRO. This is because most domestic CROs maintain owner representative system. About the reason why she joined dreamCIS last April,“I wanted to try new experience and challenge, CEO Gong said. dreamCIS is an important global CRO since it was acquired by Tigermed in China in 2015. It was the first domestic CRO to undergo preliminary screening. By the end of this month, it will be decided. CEO Gong said, "The goal is to stably grow dreamCIS as a global CRO and It is very symbolic to have listed stocks as a leading company in the industry. It is expected in many ways.“ In recent years, dreamCIS has been gradually increasing global challenges in cooperation with Tigermed. 20-25% of current projects are global. Most of them carry out clinical tasks in China and Korea. CEO Gong said, “Chinese pharmaceutical companies are also growing so much that there is an increasing demand to conduct simultaneously clinical trials in Korea and Japan because the data is mutual recognition.” She said, "Since the merger of Taigermed, the progress of global tasks has been increasing considerably, and there are many opportunities for domestic companies to enter China." I want to contribute to the successful entry of Korean companies to China. ” CEO Gong plans to carry out his management philosophy with a focus on improving clinical quality. She said, “The important thing is clinical quality and I pay much attention to education and talent Recruitment.” Speaking as CRO, It is the key to have good talented CRA. Especially good CRAs control clinical quality. More than 50% of the 200 employees are CRAs in the company, and 80% of them are women. CEO Gong plans to devote herself to building a good company for women to work.“There are many benefits according to the number of women, and many of our employees are working from home and flexible, and I will continue to encourage them.” "I have experienced various companies as a female representative and also as a working mom, but I think that the diverse and flexible culture and system of dreamCIS provide more opportunities for competent working moms and young women focusing on their work creatively", she added. While working as a CRA, she had a lot of hard work, but much experience brought her here with pride. She advised, "To work with professionals such as nurses, pharmacists, doctors or nurses, you need expertise in the clinical field you are in charge of, and you need to communicate based on that knowledge. I wish our staff, as well as juniors working in the clinical industry, would be proud to work with them. ” “Global CROs are starting from the CRA and going up to the country head as they build up their careers, and I also have come to this position as I build up my career from the CRAs." I think it will be a good model for new emloyees and juniors to work” she said. CEO Gong concluded that she is planning a multi-faceted business after the IPO and plans to focus on a business based on the CRO.
- InterView
- 50-year-old Pfizer Korea “For both patients and innovation"
- by Eo, Yun-Ho Nov 06, 2019 08:59am
- CEO Oh Dong-wook Half a century in Korean pharmaceutical industry, Pfizer Korea seems to have mastered ‘how to win’ in the Korean market. Pfizer took its first step into the Korean market as a joint corporation with Joongang Pharmaceutical in 1962 and founded Pfizer Korea in 1969. Except for a couple of times, Pfizer Korea’s sales have been the top among global pharmaceutical companies in Korea. Last year, the company had the highest sales so far of 734.4 billion won, a level no global company has ever reached. The key to its driving force is in ‘evolution’. The company has sought after ‘cash cow drugs’ by acquiring numerous companies like Warner-Lambert Company, Wyeth, Pharmacia, and Hospira, and also undergone various organizational reform like the recent split-up with Upjohn. Through series of changes, Pfizer and Pfizer Korea have achieved successful ‘survival’ and ‘development’ every single time. But, not all good drugs can make a success. If it were not for Pfizer’s solid foundation, its profitable drugs would not have made it. Celebrating the 50th anniversary of Pfizer Korea, CEO Oh Dong-wook (50) of Pfizer Korea spoke of the company’s history and the future. - Half a century in Korea, what have been the most important milestones for Pfizer Korea? I can say about three major achievements to note. First, Pfizer contribution on making patients live happier lives by providing outstanding new drugs. Second, Pfizer’s continuous effort to become a responsible corporate citizen of the community and to conduct long-running corporate social responsibility (CSR) activities. Many of CSR activities Pfizer Korea provide are over a decade old. Last but not least, the fact that Pfizer Korea has consistently contributed in creating a healthy pharmaceutical and bio environment along with various stakeholders to advance new drug development, health and society in Korea. Numerous clinical trials have been conducted in Korea so far, which we expect the gained experience and tips on developing innovative new drug with global company would come through eventually and immensely contribute to the future of new drug in Korea. -‘Drug’ has a unique quality as a commodity, which is why the sense of ethics is always under the limelight. But as a business, profit would have to be the main objective. What is Pfizer doing to balance out two polarizing values? Pfizer seeks for an ‘innovation that changes patient’s quality of life’. Not only Pfizer, but many of pharmaceutical companies used to maximize profit centering customer (healthcare provider) in the past. However, this day and age requires immensely high level and standard of ethics. And it makes a sense for stakeholders to have higher level of expectation on the industry than any other industry. In such strict environment, Pfizer would never seize to make every decision prioritizing and centering patients. -Reflecting patients’ voice is not that easy. A pharmaceutical company directly engaging with patients has its limitation, and a lot of times patients cannot have their way regardless. Despite availability of a great new drug, limited access (health insurance coverage) puts a gap between patient and the treatment. That is why patient advocacy groups usually voice out on drug approval review and National Health Insurance (NHI) listing policy-making processes. Medical industry has a quite unusual ecosystem, where a patient is an ultimate consumer, but an experienced and knowledgeable healthcare provider is making decisions on prescription. While a company supplies drug, consumer and National Health Insurance Service (NHIS) are paying for the drug. Even the ultimate consumer raises an issue, changes can only be made when experts’ judgment and reasonable decision making coincide. The decision making process has improved significantly compared to the past, but it still has a room to grow. As a leading company in pharmaceutical and bio sector, Pfizer plans to engage in various activities with various stakeholders in community, such as industry organization, healthcare providers’ group and patient advocacy group, to reflect patients’ voices on government policies. -As you mentioned, patients’ voices in Korean society is skewed on ‘NHI reimbursement’ and now their interest is growing on drug pricing for the same reason. The administration plans to reduce their expense on drug with expired patent and reuse the saved finance on introducing new drug to Korean market. After separating the organization into two and ‘Pfizer Upjohn’ solely dealing with expired patent, the said government’s plan could be a bad news. As a whole company, what do you think of the direction government policy is taking? Pfizer Korea has a say in making the best choice for patients, regarding what Pfizer Upjohn Korea and Pfizer Biopharmaceuticals Korea do in respective treatment sectors. My role is to represent general operation of the company when discussing with government body and other stakeholders, and respective branches are to make a reasonable decision for their own businesses. -Going back to Pfizer’s principle of ‘centering patient’, would it be safe to say Pfizer Upjohn would not oppose against Korean government when it reduces pricing of drug with expired patent? That is correct. As I said before, Pfizer’s aim is to supply as many new drugs as possible to patients and to bring changes to their lives. Regardless of patent expiration, we believe changing the lives of patients has enough meaningful merit. -But as the age of high-cost drug approaches, the gap between the government and pharmaceutical industry’s views on drug pricing is getting wider. I assume Pfizer Korea would experience discrepancies when negotiating with Korean government and persuading the headquarter office. Some are concerned about global pharmaceutical companies giving up on Korean market as more countries are referencing drug prices in Korea. Many have contributed for patients to benefit from Pfizer’s innovative new drug, but our companies’ staffs had poured in vast amount of work into it as well. We do our best to promptly introduce new drug to Korean market. And in the process, the company tries to find the middle ground between negotiating with Korean government and convincing headquarter as soon as feasible. One could simply think, lowering drug price would be the answer for putting patients first. Or in an extreme sense, providing drugs for free would be the answer if we were to truly think of patients. But, in the end, we are a company, and a company has to be sustainable. We are always faced with discrepancy between insured drug pricing and headquarter-approved drug pricing. Obviously, we are working hard to make Korean patients to receive benefit as soon as possible, and that is that is the direction we taking. While Chinese market is growing rapidly, many markets around the globe, including Taiwan, Thailand, Saudi Arabia and China have started to reference drug price in Korea. The U.S. also announced it would reference price in Korea as well. As for the headquarter office, making deficit after investing astronomical amount in R&D for new drug and receiving inadequately low pricing would be a devastating result. It would ultimately hinder any company from investing in future pipeline. This is why we need an appropriate pricing. -Let us now focus more on Pfizer. Upjohn was split from the recent reorganization. What is it like to manage the company in the new state? To enhance efficiency of Global Pfizer’s organizational structure, Pfizer Korea separated itself into two; Pfizer Biopharmaceuticals Korea focusing on new drug development and innovative drug, and Pfizer Upjohn Korea providing drug with expired patent and generic. We expect the two corporate bodies to mutually strengthen potential growth in respective fields. Based on a variety of drug pipelines and treatments each business sector owns, Pfizer aims to improve patient’s quality of life by providing treatment timely to many more patients. The approaches we would take are still in talks, but staffs’ role and responsibilities would be unchanged. -When a drug owned by Pfizer Biopharmaceuticals has its patent expired, then is it transferred to Pfizer Upjohn? No, it wouldn’t be. Drugs are categorized by disease group. -It feels like in the future, Pfizer Biopharmaceuticals and Pfizer Upjohn would be completely split up and would become completely different two entities. For now, management direction or timing has not been specifically discussed, yet. Until everything is set, both bodies would be managed under the name of Pfizer Korea. -How is the current status of the consumer healthcare (OTC) sector joint venture with GSK? As far as Global Pfizer goes, it officially announced closing of joint venture with GSK, as of Aug. 1. And accordingly, Pfizer’s consumer health sector was transferred to the new joint venture. However, each region would have different timing as to when the joint venture would take over the management. In case of Korea, the closing is delayed as the company has to complete the necessary approval process and end some ongoing operations. When the deal is finally closed, Pfizer’s staffs would undergo some organizational changes and those would be notified after everything is set in stone. -How would you define the last 50 years and the next 50 years of Pfizer Korea? Looking back at past 50 years, the company went through absence of well-established healthcare and corporate environment when it was first founded in 1969. Back then, Separation of Prescription and Dispensing (SPD), or proper medical and pharmaceutical regulations were not stipulated. But now, we feel quite proud of how Pfizer Korea contributed in building the current healthcare environment alongside many stakeholders by placing a brick at a time. In the end, we think Pfizer contributed in bringing meaningful changes to local communities and patients suffering from disease. But it also means Pfizer Korea still has a long way to go, although it made proud achievements under the corporate objective and goal. As a responsible corporate citizen and leading pharmaceutical company, Pfizer Korea would continue to keep its leadership among patients and in local community.
- InterView
- [Reporter’s View] Era of drugs better known than diseases
- by Son, Hyung Min
- A notable shift has recently emerged in clinical practice where drug names are increasingly being known before the diseases they treat.For example, when discussing obesity treatment, many people now think first of ‘Wegovy (semaglutide)’ or ‘Mounjaro (tirzepatide)’ rather than the disease itself. A similar trend is emerging for major immune disorders like atopic dermatitis. This change is also evident in the field of cancer treatment. It is now commonplace to hear specific drug names mentioned before the broader category of immuno-oncology drugs.Whereas diseases were traditionally recognized first, followed by treatments, we now frequently see drugs becoming symbolic markers that define or represent the disease itself.This shift cannot be explained simply by increased brand recognition. As more new drugs actually shift treatment paradigms, these therapies have taken on the role of driving disease awareness.For certain conditions, the emergence of specific treatments has altered diagnostic and therapeutic strategies, leading the drug name to become synonymous with the disease's treatment.The role of pharmaceutical companies has also evolved. Whereas disease awareness preceded the introduction of treatments, it is now common for disease awareness activities to proceed alongside new drug development. With treatment development and disease education occurring simultaneously, the drug name naturally becomes central to shaping disease awareness.The shift does have positive aspects. When innovative treatments emerge for diseases with limited therapeutic options, they inherently attract patient and clinician attention, serving as catalysts for heightened disease awareness. Indeed, for some conditions, social awareness of diagnosis and treatment has increased significantly following the introduction of such drugs.However, there are also concerns. If the structure where drug names become known before the disease itself solidifies, there is a risk that awareness could center around specific treatments rather than fostering a deeper understanding of the disease itself. While medicine inherently evolves through diverse treatment strategies and multiple options, public perception can be simplified around a single brand name.The influence of new drugs continues to grow. At the same time, the role of the pharmaceutical industry is expanding beyond developing therapies to shaping disease awareness itself. This means companies are becoming entities that shape disease perception, going beyond just treatment developers.Consequently, the social responsibility that the pharmaceutical industry must shoulder is also growing. As the influence of new drugs expands, so does the need to examine how this power operates and what its implications mean for the healthcare environment and patients. Now that pharmaceutical innovation can reshape disease awareness itself, the industry must consider its public responsibility towards patients and society, alongside its private corporate interests.
- InterView
- [Desk’s View] On exempting innovative pharmas from price cuts
- by Lee, Tak-Sun
- Fostering the pharmaceutical and biotech industry while ensuring the soundness of the national health insurance budget is no easy task.The two are intertwined like a double-edged sword. Cutting drug prices indiscriminately to save money risks stifling the industry, yet allowing skyrocketing drug prices to go unchecked in the name of industry growth will quickly drain the health insurance coffers.That is why the government’s push to cut generic drug prices is undoubtedly a card played as the health insurance coffers are running dry. Yet, it is equally impossible to neglect the pharmaceutical and biotech industry, which is only now beginning to gain stature.The ‘Korea Innovative Pharmaceutical Company’ certification system emerged after long deliberation between fostering industry and maintaining fiscal soundness. The government aimed to identify and nurture the so-called ‘pharmaceutical companies capable of developing new drugs’ through this certification.However, 15 years have passed since the system's establishment in 2011, and one can't help but wonder if it has effectively achieved its original goal of fostering companies. The number of certified innovative pharmaceutical companies has now risen to 49, yet very few have developed drugs capable of competing on the global stage.The pharmaceutical industry claims the current certification doesn't offer ‘significant enough benefits to push promising companies forward.’ Rather, it's seen as merely ‘enough to keep them afloat within their group.’The most significant benefit pharmaceutical companies perceive from the Innovative Pharmaceutical Company certification is preferential drug pricing. Holding this title grants preferential treatment in pricing calculations for first generics or incrementally modified new drugs. For instance, while a standard company's first generic listing is priced at 59.5% of the highest price, an Innovative Pharmaceutical Company can set its price at 68%. Considering that drug prices directly translate to sales revenue, this means that certified companies can earn 7.5% more than non-innovative companies.However, this pricing preference is only a temporary benefit. After one year, the premium disappears, and “non-innovative” pharmaceutical companies end up with the same drug prices as the certified innovative ones.Even so, starting from the same line with even a slightly higher price is undeniably advantageous. This is why many pharmaceutical companies celebrate or despair over the results of the innovative pharmaceutical company review, which takes place every two years.If the innovative pharmaceutical company certification system is to better fulfill its purpose of ‘screening and fostering’ firms, the direction should be to tighten the review standards while expanding the benefits.In other words, the government should identify companies that truly have the capability to develop new global drugs while providing full support until they actually develop them.Some argue that innovative pharmaceutical companies should be exempt from unilateral price cuts made for listed drugs. From the perspective of fostering domestic pharmaceutical companies, this isn't entirely wrong. But would any company spend tens or hundreds of billions of won on new drug R&D while facing the risk of declining sales just to be saved from price cuts on existing drugs? Just for the title of being a certified innovative pharmaceutical company?However, even such benefits, if granted only to the 49 certified innovative pharmaceutical companies, would trigger backlash from non-innovative companies. There is already distrust in the field regarding the standards used to certify innovative pharmaceutical companies.But still, current discussions on drug price cuts for already-listed products and on reforming the innovative pharmaceutical company system need to be somewhat aligned. Rather than pushing through generic drug price cuts in a hasty manner despite strong opposition from the industry, perhaps it would be better to take a little more time and discuss them along with substantive benefits for innovative pharmaceutical companies. At the same time, the criteria for selecting innovative pharmaceutical companies should be reorganized so that they are truly centered on companies that genuinely engage in R&D.From a cautious standpoint, that may be the only way to both foster the industry and maintain health insurance sustainability.
