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- 2026-04-17 06:15:02
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- Lamisil distribution halted over 2 months inventory issue
- by Jung, Hye-Jin Mar 17, 2020 06:28am
- The distribution status of GlaxoSmithKline (GSK) Consumer Health’s anti-fungal treatment Lamisil has been unstable for a while. After the co-promotion deal with Dongwha Pharmaceutical has ended last year, GSK’s Lamisil has not been properly supplied for over two months. Although Zuellig Pharma Korea is negotiating with GSK on the Korean sales rights over Lamisil since last year, the contract signing has been long delayed. According to pharmaceutical industry and pharmacies on Mar. 13, stock of Lamisil has not been supplied since past January. Except for Lamisil, nine out of ten GSK items previously distributed by Dongwha Pharmaceutical are now taken over by Ildong Pharmaceutical from this year. Specifically Lamisil could not find its succeeding distributor for three months. Currently, Zuellig is a most likely candidate to take over the marketing license. The company has started the negotiation with GSK based on same conditions Ildong Pharmaceutical had. Although Ildong Pharmaceutical was capable of taking in all ten items to distribute, the Korean company’s Canesten Cream’s use and benefit overlapped with Lamisil. The industry initially predicted Zuellig would soon finalize the deal after Ildong Pharmaceutical inked theirs. But the companies have not announced any news, yet, regardless of the anti-fungal treatment’s top-selling season is approaching fast. Meanwhile, pharmaceutical industry experts point their fingers on the leftover stock of Lamisil from Dongwha Pharmaceutical. The former distributor has cleared out their GSK products to the regular vendors in last December. The distributor meant to minimize confusion in transaction with pharmacies in case their stocks had not been depleted before the new distributors start stocking up. But Ildong Pharmaceutical and Zuellig say plenty of stocks from Dongwha Pharmaceutical are still in the market. The global distributor would probably be burdened with return products, if Donghwa Pharmaceutical’s stock is not exhausted. The reasoning seems to be plausible as pharmacies’ inventory has been taken by Zuellig, recently. The distributor would likely to finalize the contract terms base on the inventory of Dongwha Pharmaceutical’s stock. (Source: Financial Supervisory Service, Unit: KRW 100 million) Another affecting factor seems to GSK’s low marketing margin. A multinational distributor, Zuellig has entered the Korean market with foreign capital, but its deficit has grown over the years due to aggressive sales tactics. In 2018, Zuellig’s sales have gone by 8.9 percent from the year before. Business profits and net profit have been in red for a few years now. What Zuellig needs at the moment are not just high sales made for the co-promotion deal, but also actual profit from high marketing margin. Apparently, the marketing margin of a co-promoted product by a multinational company generally tends to be lower than that from a Korean company. Predominantly, the industry experts are assuming that Zuellig trying to raise the margin rate and GSK trying to keep the original margin rate are clashing and delaying the deal signing. On Mar. 1, GSK insider on a phone call with Daily Pharm said the finalization of the deal is imminent and explained, “As soon as the deal is signed, the supply would resume normally. Right now, we are doing everything to minimize the impact on the market.” However, even after a month, the multinational company has not provided any other follow up. A distribution industry source commented, “Zuellig would not ink the deal only for the sales revenue. They are probably taking a long time fine-tuning various terms and conditions. As Lamisil stock at pharmacies is going down while summer is approaching, the companies would not take the negotiation longer.”
- Company
- Pharmaceuticals, growth rate to be cut in half
- by Eo, Yun-Ho Mar 17, 2020 06:28am
- Major National Pharmacy Sales Trend [Source: IQVIA]It was analyzed that the domestic pharmaceutical industry would be suffered hard from the aftermath of COVID-19. Drug market research firm IQVIA predicted that the growth of the Korean pharmaceutical market this year will be only 4.4%, half of the previous year due to the spread of COVID-19. This analysis compared changes found in major institutions and organizations in healthcare, including pharmaceutical companies, hospitals, pharmacies, and drug wholesalers, before and after the outbreak of COVID-19. Initially, IQVIA estimated the growth rate of the pharmaceutical market to be similar to 8.6% in 2019, but the situation changed due to the spread of COVID-19. According to IQVIA, the number of outpatient prescriptions may decrease as the number of patients visiting the hospital decreases in the aftermath of COVID-19, which in turn may reduce drug production and sales. Since the spread of COVID-19, the number of patients visiting hospitals and pharmacies in Daegu and Gyeongbuk areas has decreased significantly. Looking at each region, Daegu and Gyeongbuk accounted for about 85% of all COVID-19 confirmed patients, and the proportion of deaths was more than 90%, so the short-term impact in the region was the largest. It is estimated that the impact of COVID-19 on Daegu and Gyeongbuk sales will be 1.25 times greater than that of other regions, and as a result, it is expected that the usage of medicines in Daegu and Gyeongbuk in the first half of this year will likely be less than last year's level. Changes in over-the-counter drug sales [Source: IQVIA]In addition, as a result of questioning 300 pharmacists, the number of patients visiting pharmacies decreased by 23% compared to before the COVID-19 spread. Sales of 11 major drug wholesalers also fell by an average of 13%. Drug wholesale sales fell 8% less and 30% more. However, with the spread of COVID-19, sales of various hygiene products such as masks and hand sanitizers increased. As a result of analyzing the sales of 540 domestic pharmacies, the sales volume and proportion of masks and hand sanitizers began to increase on January 20, when the first COVID-19 confirmed in Korea. The sales volume of hygiene products, which had been faltering for a moment due to the lack of masks and the increase in the number of confirmed patients, has jumped since February 18, when the 31st confirmed patient occurred. This trend was prominent in pharmacies in Daegu. Masks and hand sanitizers accounted for less than 1% of the total sales of pharmacies in Daegu, but increased to 30% at the end of last month. It was analyzed that sales portion was expanded since the 18th of last month when the first COVID-19 confirmed patient occurred in Sincheonji Daegu Church. IQVIA said that sales of over-the-counter drugs at pharmacies, except for outpatient prescriptions, have decreased significantly since the occurrence of COVID-19, and sales of all products across all over-the-counter drugs, not specific products, have been analyzed to be attributed to a decrease in overall patient visits.
- Company
- Supect by Il-Yang Pharm reduces COVID-19 by 70%
- by Jung, Hye-Jin Mar 17, 2020 06:27am
- Research has shown that Il-Yang Pharm's 'Supect' has the effect of reducing the COVID-19. Il-Yang Pharm announced on the 13th that as a result of experimenting with COVID-19 received from the KCDC, the virus in the group using Supect decreased by 70% within 48 hours. Supect (Radotinib) by Il-Yang Pharm is a leukemia treatment agent. This study was conducted in an in vitro test method in the Biosafety Level 3 Laboratory (BSL-3) at the Biosafety Center of Korea University College of Medicine. The experimental group that used Supect for the virus and the control group that did not, were compared. As a result, the firm explained that 70% of viruses were reduced in the Supect group compared to the control group, which is superior to that of the HIV treatment 'Kaletra' and the flu treatment 'Avigan'. Result of Supect experiment Experimental results of candidate drugs for MERS treatment In addition, Il-Yang Pharm also revealed that five candidate substances that are being developed as MERS treatments reduced COVID-19 by more than 99% within 24 hours in the same experiment. candidates for MERS are IY1209, IY1471, IY1472, IY1901, and IY1209 from substances discovered through the research project of the next-generation applied ohmic 'source technology development of new and variant virus (MERS) treatment' hosted by the Korea Research Foundation under the Ministry of Science and ICT. "Supect is a commercially proven drug that can shorten the development period quickly compared to other candidates. If COVID-19 is declared a pandemic and even considers seasonal infectious diseases that come every winter, therapeutic development will be the most powerful weapon to protect humanity from disease".
- Company
- Herceptin market recovers ￦100 billion in three years
- by An, Kyung-Jin Mar 16, 2020 06:31am
- (From the left) Herzuma, Herceptin, and Sampenet Domestically developed biosimilars enter the blockbuster anti-cancer drug 'Herceptin' market. The market share of the two products 'Herzuma' and 'Sampenet' exceeded 28%. The market size of Trastuzumab that Celltrion developed as 'Herjuma' shrank with the expansion of the biosimilar market has recovered to the level before drug price cuts. According to the drug research agency IQVIA on the 11th, the market size of Trastuzumab in the fourth quarter of last year was ￦27 billion, up 19.8% from the same period last year. Last year's cumulative sales were ￦104 billion. It surpassed the record of ￦103.4 billion in 2016 before the biosimilar was released. Trastuzumab market quarterly trend in 2015-2019 (Unit: ￦100 million, Source: IQVIA) Trastuzumab is generic for Roche's targeted anticancer drug 'Herceptin'. It is prescribed for metastatic breast cancer and gastric cancer that show positive human epithelial factor receptor 2 (HER2). In Korea, after the patent expiration of the original product Herceptin, two types of biosimilar products, such as Celltrion’s 'Herzuma' and Samsung Bioepis' Sampenet, began to be sold. The original product, 'Herceptin', sold for ￦19.4 billion in the fourth quarter of last year. Herceptin's upper limit of insurance fell by 20% from ￦517,628 to ￦414,103 based on 150mg two months after Celltrion listed 'Herzuma' on the health insurance benefits list in April 2017. Since the drug price cut, it have been maintaining quarterly sales of around ￦20 billion. In principle, in the domestic drug price system, biosimilars can receive up to 70% of the original drug price before the patent expires. Starting in October 2016, 'innovative pharmaceutical companies, equivalent companies, domestic pharmaceutical companies, and products developed by companies that have entered into a joint contract between foreign companies or products that are the country's first licensed country or those produced in Korea' are guaranteed up to 80%. When the biosimilar is released, the patented expiration of the original drug will automatically lower the insurance price to 70-80%. Quarterly sales of Trastuzumab products in 2015-2019 (Unit: ￦100 million, Source: IQVIA) Biosimilar products led the recent expansion of the Trastuzumab market. Celltrion Herzuma's sales in the fourth quarter of last year were ￦6.8 billion, up 115.4% from the same period last year. Herzuma began to generate sales in earnest in the third quarter of 2017, surpassing ￦5 billion in the second quarter of last year as sales continued to rise. Last year's cumulative sales amounted to ￦23 billion, a three-fold increase from a year ago. On the other hand, Samsung Bioepis' Sampenet does not show market presence. Sampenet sold ￦800 million in the fourth quarter of last year. Last year's cumulative sales were ￦2.2 billion. Daewoong Pharmaceutical is responsible for the sale of Sampenet. Biosimilar has greatly increased its share in the Trastuzumab market within two years of starting domestic sales. In the fourth quarter of last year, the share of the two biosimilars in the Trastuzumab ingredient market expanded to 28.2%. Herzuma's market share was 25.3% and Sampenet's 2.9%. In fact, Herzuma led the expansion of the biosimilar market. 'Herzuma 150mg' was added to the reimbursed list with an upper limit of ￦372,692, which is 72% of Herceptin before patent expiration in April 2017. In February 2018, Samsung Bioepis registered an insurance premium of 'Sampenet 150mg' at ￦291,942. This is 56.4% of the price of Herceptin. Since then, in March 2018, Celltrion's insurance price was reduced by 21.7% from ￦372,692 to ￦291,942, making it the same price as Sampenet. The market size of Trastuzumab is similar to that of three years ago, but the actual usage has increased significantly considering the launch of low-cost biosimilar products and the price cuts of original products. This means that the advent of biosimilar, which has the same effect as the original medicine and is inexpensive, has a positive effect on improving patient accessibility.
- Academic lectures & student education are available online
- by 박상준 Mar 16, 2020 06:31am
- Due to the impact of COVID-19 spread, it shows signs of spread of “UNTACT” trend that seeks contactless non-face-to-face in the medical and pharmaceutical industries. As an alternative to canceling academic conferences and training courses, conference, hospitals, and medical schools are preparing or conducting online services, and the pharmaceutical industry, which has a strong conservative tendency, is gradually preparing to expand online meetings. The COVID-19 crisis is changing the current situation. ▲Training courses, medical student education also emerged as non-face-to-face online classes In the aftermath of COVID-19, cancellations are continuing from the annual international medical fair to the international academic conference. The opening of medical school is also delayed. With the gloomy prospect that the spread of COVID-19 will last from May to June, the provision of online education contents is emerging as an alternative. The Korean Neurological Association recently opened an on-line education for program director(clinical doctors training specialists). For the first training, face-to-face training is required within 1 year after completing the basic training of the hospital association, but it can be replaced by online training from the retake. The Korean Ophthalmological Society also opened an on-line education system for program director. Prof. Young-Min Cho, Department of Endocrinology, Seoul National University Hospital, produced educational contents to provide to medical students through online system. #The Korean Diabetes Association replaced the 23rd training course on-line education on the 4th of next month. An official of the KDA said, “Because of concerns about the spread of COVID-19 in Korea, this training course was decided to be conducted as an on-line lecture considering the safety of attendees”. However, in order to promote mutual exchange with speakers, such as question and answer, education was planned as a live broadcast, not as a recording. In fact, the difference is that they don't take training in the field, but they decided to make use of the advantages of online and offline. In addition, many of the academic conferences hold non-face-to-face online courses and training courses, so this situation is expected to spread more and more. Professor A of Orthopedic Surgery at Kyunghee University Hospital said, “We have provided lecture materials recorded through the webistes or application, but there were not many readings, and the online service has already been completed, but it will be an opportunity to be activated through the COVID-19 incident”. Hospital meetings have also turned into video type. Seoul National University Hospital held a video conference between medical teams through a program called Zoom. Professor Young-min Cho of the Department of Endocrinology, Seoul National University Hospital said, "Technologies that have been delayed due to COVID-19 are on the rise. After using the online and video conferencing service, I felt that I didn't have to go to the society". Although there are positive aspects to increase the scope of human exchange and find mentors through offline conferences, the online method is also efficient without great inconvenience in terms of the transfer of knowledge. "I had a meeting at the last week with a video conferencing platform called Zoom, and the presentations were shared on the screen, so anyone could easily ask and answer questions," he said. He said, “there was a video conferencing system, but I didn't use it because of my preference for face-to-face. I'm also hoping that the world will change a little over this time”. Online education is also introduced in medical lectures, which have been delayed. Seoul National University has asked some professors to submit video recordings for online education. If they write with a smartpen on educational materials such as PPT, online courses will be opened next week in the form of recording and providing them. It is known that Seoul National University is currently building a server that can connect to 30,000 people simultaneously. ▲Pharmaceutical companies also use video services, telecommuting Currently, multinational pharmaceutical companies that have entered the country have converted most of their internal and sales positions to telecommuting to prevent further infection spread. In addition, direct communication activities between the head office and branch offices, overseas business trips, and meetings have also been extended indefinitely. In the pharmaceutical industry, video conferences using platforms such as Skype are in progress.#A representative from a European foreign company A said, “As COVID-19 affects the world, overseas business trips and large-scale meetings are very limited. In fact, the head office has already halted or postponed all overseas business trips and large-scale meetings, except inevitable". He also said, “there is a risk of COVID-19 infection through salespeople's visits to hospitals and commuting by public transportation in Korea. Since early February, employees have been working at home in advance to ensure their health and safety”. This aftermath changed the way of town hall meetings in the foreign-owned companies. Previously, the company gathered and held face-to-face meetings, but at this event, all of the employees except for some salespeople held an online live broadcast town hall meeting. An American foreign investigator said, "Currently, all internal conferences in the region are being broadcast live online, and all questions are left in the comments and receive comments. It is the first time that a live broadcast event involving all employees other than the officials participates". In addition, there is a view that concerns about work discomfort and confusion due to the implementation of telecommuting, but there is no difficulty in handling or communicating at the site. Since it has been introducing and using online collaboration tools such as Microsoft Teams and Skype from the past, there is no great confusion in the process. In addition, it is evaluated that there is no problem in maintaining the continuity of work because it can access the company's internal system through a VPN connection anytime, anywhere. An official from a European pharmaceutical company said, "For foreign companies, the working method has been operated flexibly with the core time, and the working environment of employees has changed to a flexible smart office environment depending on the situation, not a designated seat system. We are already familiar with using these online platforms, such as telecommuting". He said, “In fact, it doesn't matter where you go, so in the case of my office work, I just changed my working place to my home, and nothing changed. Instead, I actively utilize online collaboration tools such as Skype for voice or video calls”. ▲Will it be a way to introduce remote medical treatment? The old theme was also recalled due to COVID-19 crisis. That is the introduction of telemedicine. In foreign countries and conferences where remote medical treatment is possible, there are opinions urging the introduction of remote services due to the spread of COVID-19. NEJM, an international academic journal, agreed to the theory of telemedicine affirmation through an editorial on the 11th. Dr. Judd E. Hollander and Dr. Brendan G. Carr said, "We can't create a telemedicine program in one day, but US health systems that have already implemented telemedicine innovation can use it to respond to COVID-19". In fact, the United States is said to have more than 50 telemedicine programs. Since infection and transmission within a medical institution are possible, it means that diagnosis can be effective in an infectious disease crisis by minimizing exposure through remote medical treatment in a dedicated office space. The Korean Neurological Association recently opened an on-line education for program director#The Ministry of Health and Welfare also left a spark of conflict between departments, allowing phone consultations and phone in prescriptions from the 24th of last month. A Professor of Hospital S, who conducted video telephony counseling, said that every patient has a smartphone, so I could see face ot face". Also he added, “on the contrary, I thought what would happen if there was a system that could be used for auscultation in a smartphone?”. He said, "At least in a crisis situation, it is better to use a video platform to provide a certain level of medical service than to block the provision of the service". He pointed out that he know clinics are against the video platform, but the flow of times cannot be stopped. He said, "A variety of services and technologies are being tested through the COVID-19 incident, and confirming the possibility is an unexpected harvest. Opponents may dislike the situation, but it is difficult to take the same position in the future of infectious diseases". On the other hand, the medical community expresses a strong refusal to allow the government to temporarily allow remote medical treatment. The Korea Medical Association said, “There was no prior consultation and agreement with the Ministry of Welfare regarding phone consultations and phone in prescriptions. Counseling and prescription using wireline is a violation of the principle of face-to-face treatment between doctors and patients”. He stressed that in COVID-19 community outbreaks, telephone consultations and phone-in prescriptions with clear limits for doctors to check patient status are at risk of delaying the diagnosis of patients in need of testing or missing the opportunity for adequate initial treatment.
- Company
- Why Ezetimibe combination drug for dyslipidemia?
- by Eo, Yun-Ho Mar 16, 2020 06:30am
- Professor Chae In-ho For some diseases, combination drugs are vastly preferred than the other. Dipeptidyl peptidase-4 inhibitor plus metformin combination for patients with diabetes, and angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) plus alpha combination for patients with hypertension haven taken over significant part of respective overall prescription volumes. And combination drug is also on the rise for dyslipidemia treatment sector for last few years. The combination of statin and ezetimibe is the case. Despite many of specialists’ skepticism on ezetimibe, the drug has proven its catchphrase ‘the lower the LDL-C the better the benefit for cardiovascular system’ in the IMPROVE-IT trial that unveiled in 2015. Since then, the combination drug has gained popularity fast. Basically, ezetimibe-based combination drugs with either rosuvastatin or atorvastatin have shifted the market previously dominated by statin. Daily Pharm interviewed Executive Officer Chae In-ho of Korean Society of Interventional Cardiology (KSIC) (Director of Cardiology Center at Seoul National University Bundang Hospital) about the benefits of combination drugs and ezetimibe. -Do you prefer to prescribe ezetimibe-based combination drug? It would be safe to say the combination drugs have taken deep root as effective dyslipidemia treatment. For a long while, hyperlipidemia treatment was solely relying on statin and used high dosage. But nowadays, non-statin combination therapies previously marginalized have stolen the limelight again. Compared to same dose of statin, ezetimibe combination therapy has similar incidents of side effects but shows even more benefit in reducing LDL-C. When higher dose of statin is used, a patient’s LCL-C level at 100 mg/ dL would fall to 90 mg/ DL, but using ezetimibe combination the numbers fall even lower to 70 mg/ dL. -Is there any other reason why you would prefer the combination drug over the single drug? First of all, it would the convenience for sure. Administration convenience is far superior and drug compliance is also very high. Patients tend to ask a lot more questions than before when they get additional number of pills and they come prepared with basic online research. The patients are happy to hear my explanation about the combination drug not increasing the number of pills but resulting in better effect. Besides, the price of combination drugs in Korea are inexpensive than in other countries. Patients with chronic disease get sensitive about the cost, so the health insurance system is a plus factor for preferring a combination drug. -For the combination drug, there is a choice between rosuvastatin and atorvastatin. Is there a deciding factor when prescribing the combination drug? I don’t personally see a big difference. But I prefer prescribing rosuvastatin plus ezetimibe for a stronger effect. Using 20 mg of rosuvastatin and 40 mg of atorvastatin show similar level of effect, but I feel rosuvastatin lowers LDL-C better in combination. Of course, pharmaceutical companies could say otherwise. Anyway, now atorvastatin has more options with 80 mg dose added to combination option. -Is it possible to use ezetimibe combination on dyslipidemia patient as first-line therapy? Yes. For patients with high risk in acute coronary syndrome (ACS), myocardial infarction (MI) and unstable angina, a combination drug is used for an initial treatment. But for a relatively young patient with risk of arteriosclerosis, high-dose combination drug is used. As diabetic patient tend to have accelerated absorption of cholesterol, ezetimibe could demonstrate more dramatic effect. Because statin causes diabetes more frequently than ezetimibe, it would be more effective to specific patient group with high blood sugar level. Diabetes is treated not only with medication, but also with lifestyle. Cholesterol, relatively more controllable with medicine, should be managed with pharmaceutical push as much as it can. -Regardless, the 2018 dyslipidemia treatment guideline recommended ezetimibe therapy as a second-line therapy. And when the U.S. and Europe recommended LDL-C level of the mentioned groups with very high risk to be lowered to 55 mg/ dL and 40 mg/ dL, respectively, Korea recommended the level to be lowered to 70 mg/ dL. Basically, I agree with the phrase, “The lower the better.” But a guideline is merely a guideline in the end. Using the combination drug for first-line treatment means it’s targeting even more effective LDL-C reduction benefit, which coincides with the mechanism of ‘the lower the better.’ But if you’re asking whether to target 70 mg/ dL or 55 mg/ dL, it would be different case by case. I would be skeptical to prescribe higher dose or stronger drug to lower LDL-C of 80 mg/ dL in a patient with high risk, but who works out regularly and manages body weight. Probably 70 percent of clinicians in Korea and 25 percent in the U.S. would consider the guideline’s recommendation. Ultimately, it is a matter for a physician to judge and decide from their experience and expertise. Ezetimibe combination drug has diversified the choices, and it would be more frequently used as it accumulates prescription history.
- Policy
- The MFDS encourages production of KF80 masks
- by Lee, Tak-Sun Mar 16, 2020 06:29am
- In order to encourage the KF80 standard health mask to be produced, the MFDS decided to temporarily grant permission to change items that are currently approved under the KF94 standard to KF80. It is judged that the KF80 has less filter requirements than the KF94, which can lead to an increase in mask production. However, there is criticism that the MFDS recommended KF94 to block the virus in the early days of the COVID-19 epidemic, but as the demand for masks increased, KF80 and cotton masks could also be used, causing confusion in the mask supply and demand policy. The Ministry of Food and Drug Safety prepared a rapid approval plan for health masks according to the COVID-19 pandemic, and informed the first-line manufacturers (importers) on the 9th . The main contents of the rapid approval plan are ▲ temporary permission to change the new filter ▲ temporary permission to change the final mask for health ▲ rapid approval of the imported health mask. First, it is possible to change the filter standard of the health mask. Currently, the filter is a core ingredient of the health mask, and as a rule, it is permitted as a new item when the filter is changed. However, However, filters for air conditioners and air purifiers can be used for health masks temporarily. KF94 standard health masks are also permitted to change permission to KF80 temporarily. Currently, it is classified as KF80, KF94, and KF99 and is permitted as a separate item. Changing the KF94 mask that has already been approved to KF80 will have different efficacy effects, standards and test methods. The efficacy and effectiveness of KF94 is 'protecting the respiratory tract from particulate harmful substances such as yellow dust and fine dust and infectious agents', but if it is changed to KF80, there is no 'effectiveness and effectiveness' of 'protecting the respiratory system from infectious sources'. In addition, dust collection efficiency is changed from 94% to 80%. An industry insider said, "Change from KF94 to KF80 can reduce the filter requirement by 30%". Imported health masks are also quickly approved. It is a policy that permits prompt approval if imported mask raw materials and all product standards are equal to or higher than the Ministry of Food and Drug Safety's notice or guidelines. In the case of test reports, foreign test reports were also accepted. It is said that the US N95, the European FFP2, and the KN95 in China are more than the equivalent of the health mask standards in Korea. This measure will be temporarily operated until the effective date of emergency supplies and demands for masks and hand sanitizers. In the situation where the supply and demand of health masks is not smooth, it is interpreted as a way to increase production. When President Moon visited the mask maker on the 6th, Choi Kyu-bok, CEO of Yuhan-Kimberly, suggested that “the filter requirement for KF94 is 20-30% higher than that of KF80. If it is mainly produced in KF80, it will reduce the amount of filter shortage”. President Moon also said it was a "very good plan". However, there is a criticism that the countermeasure against this was that the Ministry of Food and Drug Safety recommended a health mask of KF94 or higher in the early days of the Corona 19 epidemic to prevent viruses, and recently changed to KF80 and cotton mask. The Ministry of Food and Drug Safety recommended in the end of January that "KF94" and "KF99" masks are recommended to prevent infections such as new coronavirus". However, on the 12th, if there were respiratory symptoms such as coughing, or if a healthy person cares for a suspicious person, a visitor to a medical institution and a worker in the occupational group at high risk of infection and transmission recommended a health mask of KF80 or higher. On the 3rd of this month, the use of cotton masks is also helpful when there is no high risk of infection or there is no health mask. According to the initial recommendations from the MFDS, manufacturers were more immersed in the production of KF94 masks in high demand, leading to a shortage of KF80 masks. Recently, it has been reported that a reversal phenomenon in which the price of the KF80 mask is more expensive than the KF94 mask is also occurring. Meanwhile, the KF80 mask can block more than 80% of fine particles with an average size of 0.6 μm, and the KF94 and KF99 masks can block more than 94% and 99% of particles with an average size of 0.4 μm, respectively. KF stands for Korea Filter, and the number after it means particle blocking performance.
- Policy
- Korea takes further actions for now-pandemic COVID-19
- by Kim, Jung-Ju Mar 16, 2020 06:28am
- As the outbreak of 2019 novel coronavirus (COVID-19) is spreading worldwide, the Korean government has decided to reinforce prevention of transmission from external source and to take related steps. Besides, the government plans to promptly update ‘Mask App,’ a Smartphone app used for government-issued mask sold at pharmacies. Led by the Head Chung Sye-kyun (Prime Minister), the Central Disaster and Safety Countermeasures Headquarters (CDSCH) for COVID-19 gave a briefing on newest updates and talked about new steps for the outbreak with representatives from central government and 17 city and provincial leaders at Central Government Complex, Seoul. As the World Health Organization (WHO) has officially designated the outbreak as ‘pandemic’ on Mar. 11, Head Chung Sye-kyun urged the government to prevent overseas travelers infecting the local community by taking preemptive actions. He also stressed about paying more attention on preventing further community transmission. Moreover, he ordered CDSCH to improve the Mask App, started working from Mar. 10, to minimize the people’s inconvenience. According to pharmacy sources, the Mask App crashed shortly after it started working, and customers were complaining about how the mask stock status indicated on the app differed from actual stock. And CDSCH is tightening inbound traveler control to block out the virus coming into Korea as the outbreak has been spreading rapidly in other countries. To this date, the Korean government has been applying special immigration procedure for travelers from countries with vastly growing number of infected cases or with extensive community transmission. Subjects applicable for special immigration procedure would have their body temperature checked and fill in a special quarantine declaration with address in Korea and contact information. The government is also requiring the travelers to install government-developed ‘Self-diagnostic App’ on their mobile phones for them to submit self-diagnosis everyday for 14 days. In case the app user reports suspected symptoms for two days straight, the app would relay the information to public health center to decide if the use has to be tested.
- Policy
- COVID-19 impacts MOHW pharmaceutical divisions’ personnel
- by Kim, Jung-Ju Mar 16, 2020 06:27am
- Korea’s Ministry of Health and Welfare (MOHW) fighting against COVID-19 outbreak at the forefront, is suffering from manpower vacuum as their directors and senior deputy directors in pharmaceutical affairs have been temporarily transferred. The Pharmaceutical Benefits Division, in charge of pharmaceutical benefit listing, reimbursement standard and policies regarding pharmaceutical benefit enhancement initiatives, is experiencing difficulties in processing their work as the director position is vacant and newly appointed senior deputy director has been transferred to COVID-19 response team. Also the Pharmaceutical Policy Division handling policies on pharmacy and pharmaceutical distribution is missing a director as the former director has been dispatched to overseas. According to MOHW on Mar. 11, the human resource issues in both Pharmaceutical Benefits Division and Pharmaceutical Policy Division would last at least until end of this month. Former Director of Pharmaceutical Benefits Division, Kwak Myeong-Seop (left) and Senior Deputy Director Lee Seon-joo The Pharmaceutical Benefits Division is a key part of the ministry enhancing pharmaceutical coverage, accessibility, and pharmaceutical review, such as new drug and generic reimbursement listing, revising generic pricing system, and reducing price based on actual transaction price. Including pharmaceutical coverage enhancement and expenditure structure reform (pricing reduction) based on the National Health Insurance Comprehensive Plan, all crucial parts related to pharmaceutical and bio industry are concentrated in the division. As the Former Director of Pharmaceutical Benefits Division, Kwak Myeong-Seop has been dispatched to South Korea Consulate in Guangzhou, China, on Mar. 11, Director General Lee Ki-il of Health Insurance Policy has taken over the division’s work at the moment. Moreover, the division is missing both director and senior director, as Senior Deputy Director Lee Seon-joo, has been temporarily transferred to COVID-19 response team immediately after the new appointment to the division was announced. When the outbreak subsides, Senior Deputy Director Lee Seon-joo would come back to the division and take over the role of leading reimbursed drug pricing system revision and reforming generic listing, which would affect the industry significantly. The Pharmaceutical Policy Division is also missing some key persons. The division generally covers all pharmaceutical affairs directly affecting pharmacy industry, such as pharmaceutical and medical device company expenditure report, pharmaceutical distribution, pharmacy on-site inspection, credit card fee at pharmacies and OTC drugs. The controversial issues about adding CSO as one of mandated subjects for filing expenditure report is also dealt by the division. Director Yoon Byung-chul of Pharmaceutical Policy Division Director Yoon Byung-chul of Pharmaceutical Policy Division has been dispatched to Central Disaster and Safety Countermeasure Headquarters (CDSCH) for COVID-19 in Osong as soon as the outbreaks started in Korea. Director Yoon is an expert in pharmaceutical affairs with three years of experience in the division. Technically he was supposed to be appointed to other division in past January, as he has served as the director of the division for the longest time in MOHW. Similar to the former Director Kwak, Director Yoon was initially decided to be assigned to an overseas position, but his personnel change has been postponed for the government to better confront the infectious disease issue. And the division is lacking sufficient manpower to tend practical affairs, because some assistant director positions are left open. Regarding the issue, MOHW official explained the ministry has been doing its best to prevent further spread of COVID-19 by borrowing specialists from all divisions, so the manpower shortage is unavoidable. However, the government plans to fill up the vacuum during the regular personnel season. The official commented, “All positions would be filled when the regular personnel changes are executed. The appointments would be unveiled from late March.”
- Company
- Handok tops KRW 30 bln PAH treatment market
- by Nho, Byung Chul Mar 16, 2020 06:27am
- (From left) PAH treatment Uptravi, Traclear and Opsumit by Handok Korean pharmaceutical industry is closely paying attention to Handok’s market share constantly growing in pulmonary arterial hypertension (PAH) treatment sector. In 2019, Korean PAH treatment market volume was recorded at 30.7 billion won with 20 percent bump from the previous year. In the market, Handok’s PAH line up—Traclear (6.2 billion won), Opsumit (11 billion won), Uptravi (1.6 billion won)—has taken up 61 percent of the market share generating overall 18.8 billion won together. Opsumit and Traclear are dominating 80 percent of the endothelin receptor antagonists (ERA) PAH treatment market share. And among prostacyclins, Uptravi owns 35 percent of the market share. Products in the general prostacyclin class have soared in the PAH market share. The specific class has grown 56 percent in 2019 from the previous year, where Uptravi’s volume skyrocketed by 128 percent (700 million won to 1.6 billion won). After releasing Traclear in 2006, Handok has launched follow-on drugs, Opsumit and Uptravi in 2016 and 2017, respectively, that are now successfully competing in the PAH treatment market. The company’s effort to raise awareness of PAH since 2010 by organizing a forum and various academic conferences has soundly propelled the business. PAH is a rare disease causing high blood pressure in pulmonary artery, which comes with symptoms of dyspnoea, fainting, anasarca and even the motor nerve could be seriously affected. According to overseas studies, average time of survival after diagnosis has been reported to be around two to three years, and it takes about average of 1.5 years to get diagnosed. PAH treatments are divided into three types—oral, inhalant, and injection. The oral medications are again divided into three types. Traclear (bosentan), Opsumit (macitentan), and Volibris (ambrisentan) are categorized as ERA. Pahtension (sildenafil) and Cialis (tadalafil) are phosphodiesterase type 5 inhibitor (PDE5i). And lastly Uptravi (selexipag) is prostacyclin. Most popularly prescribed PAH treatment, Opsumit has conducted two-year-long trial SERAPHIN, unprecedentedly long for oral PAH medication, and clinically confirmed the lowered risk of mortality and morbidity and reduced hospitalization rate in patients with PAH. According to the study with 742 patients with PAH, an arm administered with 10 mg of Opsumit demonstrated mortality and morbidity 45 percent lower than the placebo arm, and the arm’s death and hospitalization by PAH was reduced by 50 percent. The incidents of side effects, such as increase in hepatoxicity and peripheral edema, were on par with the placebo group, confirming outstanding safety profiled. Unlike other PAH treatment in ERA class, Opsumit has advantages of not requiring monthly hepatoxicity test, and convenience with once-daily administration. And with special case reimbursement for rare disease treatment, the treatment can be provided with various medical aid benefits. Most recently launched Uptravi is the first oral prostacyclin. Unlike other existing options, the medication works selectively on IP receptor that induces vasolidation, and it has been consolidating its position in the PAH treatment market as a combination therapy option since its release. PAH treatment trend in 2008 to 2016 analyzed by Health Insurance Review and Assessment Service (HIRA) found three-year survival in Korea is at 54 percent, which is lower than the U.S. (2006-2007) at 68 percent. As combination therapy rate in Korea is at 18 percent, far lower than 52 percent in the U.S., the figure implies promoted use of combination therapy is needed. In GRPIHON study, extended up to three years with 1,156 patients with PAH, Uptravi has confirmed reduction in mortality and morbidity. Against placebo group (80 percent already administered with ERA or PDE5i), patient group treated with Uptravi combination therapy had 40 percent lower relative risk of mortality and morbidity, showing clinical efficacy in patients who are already in treatment with other options. In Korea, insurance reimbursement is granted on both sequential double and triple combination of PAH treatments. Patients, who used to take either ERA or PDE5i monotherapy or ERA plus PDE5i double combination therapy, could receive reimbursement when combining with Uptravi. As stipulated by PAH treatment’s general reimbursement standard for early combination therapy taken in effect from last June, patients who have been administered with ERA plus PDE5i combination for over three months may receive reimbursement for taking Uptravi as third combination.
