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- 2026-05-20 02:00:24
- Policy
- Dongkook develops new triple-drug combo for hypertension
- by Lee, Tak-Sun May 11, 2021 06:00am
- Dongkook Pharmaceutical has started the development of a single-pill, triple-drug combination that contains S amlodipine. Although two-drug combinations are already available, no triple-drug combination with a substance added for high blood pressure currently exists in the market. On the 10th, the Ministry of Food and Drug Safety approved the Phase I clinical trial protocol for the hypertension treatment ‘DKF-361’ by Dongkook Pharmaceutical. DKF-361 contains 3 medications: S amlodipine, olmesartan, and hydrochlorothiazide. The original three-drug combination for hypertension that combined Amlodipine besylate-olmesartan medoxomil and hydrochlorothiazide is Daiichi Sankyo Korea’s ‘Sevikar HCT tablet.’ Sevikar HCT has gained popularity as the first three-in-one combination therapy introduced in Korea for the treatment of hypertension. The drug is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine, taken as dual-component formulation. Generic versions of Sevikar HCT that contain the same substances have also been sold in Korea since March 2019. So far, 18 generics have been released in Korea. However, Dongkook Pharmaceutical's DKF-361 is the first product developed to combine S amlodipine instead of amlodipine. S amlodipine is a substance separated from amlodipine that contains the actual effect of amlodipine. By removing R- amlodipine, which is more closely connected to side effects, the new substance is known to have the same effect of lowering blood pressure at half the dose of conventional amlodipine with reduced side effects. The domestic pharmaceutical industry developed S amlodipine as a means to avoid the patent on amlodipine and succeeded in its commercialization. The efficacy of Dongkook Pharmaceutical's product is similar to Sevikar HCT. It is for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled with the combination therapy of olmesartan medoxomil and S amlodipine. Dongkook Pharmaceutical has a two-drug combination therapy of S amlodipine besylate and olmesartan medoxomil, ‘Omevikar Tab.’ It also has a generic version of Sevikar HCT, ‘Amrovikar HCT tab.’ If the company succeeds in commercializing the three-in-one combination therapy, the drug may become an alternative to patients who failed to control their blood pressure with the Omevikar tab. Also, it may complement Amrovikar HCT, creating a synergistic effect between products. According to UBIST, the outpatient prescription sale of Omevikar was 2.1 billion won, and 0.5 billion won for Amrovikar HCT tab. The Phase I clinical trial for DKF-361 will be conducted at the Gil Medical Center, on 38 healthy adults.
- Opinion
- [FOCUS] Uncomfortable co-development regulation of medicines
- by Chon, Seung-Hyun May 11, 2021 05:59am
- There is a growing possibility that a bill will be implemented to regulate joint drug development by pharmaceutical companies. Recently, the National Assembly's Health and Welfare Committee held a bill subcommittee to pass a partial revision to the pharmaceutical practices law that limits the number of drugs that can be licensed through a single clinical trial. It allows up to four drugs that can be licensed with one biological equivalence test or clinical trial data. It does not apply to biopharmaceuticals or generic drugs. Biological equivalence testing is a kind of clinical trial for generic development, which effectively limits drug co-development by pharmaceutical companies. In fact, regulating the number of pharmaceutical companies participating in joint drug development by law is hard to find even in foreign countries. Sharing strategies for drug development through cooperation among pharmaceutical companies is an area of free business activities. The government does not directly intervene by law. If regulations on biological equivalence testing are applied, additional social costs may arise because the same drugs produced in the same manufacturer must be tested separately. This is why the Regulatory Reform Committee has opposed it. At a meeting of the Regulatory Reform Committee in October 2010, the restriction of biological equivalence tests was called a strange system, saying that "unscientific and logical regulations should be abolished." As the government pushed for the regulation again, the Regulatory Reform Committee opposed last year, saying, "Restricting pharmaceutical companies to enter the market also has low direct improvement in drug quality and safety and minimal R&D promotion." IMD's joint development regulations are also seen as the government's involvement in pharmaceutical companies' R&D strategies. There have been many ways to jointly develop new improved drugs while sharing clinical costs with small and medium-sized pharmaceutical companies that do not have enough funds. If development costs are divided and paid, this is to reduce risks caused by failure of development or sluggish sales after commercialization. In other words, the government restricts voluntary R&D cooperation of pharmaceutical companies. The MFDS, which is in charge of the project, is also burdened with regulations on joint development. According to the minutes of the bill subcommittee, Kim Jin-seok, deputy director of the MFDS, said, "I think mentioning the same part as joint R&D in pharmaceutical law exceeds the legal scope." Like Rx drugs, OTC can be cloned indefinitely through consignment, but it is hard to understand that only specialized drugs are subject to regulation. The KPBMA, one of the leading interest groups in the pharmaceutical industry, is welcoming the bill immediately after it is passed by the subcommittee. It is somewhat unusual for the industry to express its support for tightening regulations. It is undeniable that the "limit on the number of joint drug developers" is a strange system in science or common sense. What is even more uncomfortable, however, is the deformed environment of the domestic pharmaceutical industry, which led to the introduction of a strange system. More than 100 pharmaceutical companies are entering the large generic market and are excessively competing. As of December last year, according to the HIRA. A total of 139 pharmaceutical companies released Atorvastatin products. It increased by 40 from 99 in 2015. It has increased from 118 in 2018 to 133 in 2019 and 139 companies in recent years. In 2015, there were 91 domestic pharmaceutical companies that released Clipidogrel, but five years later, it increased to 133 companies, increasing to 42 companies. There were 112 pharmaceutical companies that released Atorvastatin in 2018, and 21 more joined in two years. The number of companies that released Donepezil reached 134 in two years from 89 in 2018. The value of generic is also gradually decreasing. In foreign countries, when the patent of the original drug expires, cheap generic dominates the market. The situation in IMD is similar. The joint development of IMD is seen as trying to curb generics' entry into the market. The new generic drug price system, which took effect in July last year, includes a stair-type drug price system in which the upper limit is lowered as the benefit is registered late. If more than 20 generic items are listed in the specific ingredient market, the upper limit for newly registered items will be up to 85% of the existing lowest price. If a certain pharmaceutical company develops IMD through clinical trials and recruits more than 20 delegated generics, the generic price will drop significantly. Doubts have been raised that many pharmaceutical companies may be trying to reduce the motivation for entering generics through sharing IMD clinical data. As a result, it led to the introduction of a strange system that also limits IMD clinical data sharing companies. With the reorganization of the drug price system, IMD infinite cloning of delegated generics has emerged to preempt high drug prices, and side effects of "intentionally registering drugs at low prices to induce competitors to receive lower prices." It is hard for anyone to understand the recent unprecedented phenomenon of drug production. Whenever regulations are made to solve urgent problems such as the general crisis, it is likely to backfire in the market. Overseas, inexpensive generic drugs are encouraged, and at some point, generic drugs have been ignored in Korea. It is time to reflect on where it went wrong and what responsibilities the government and pharmaceutical companies have and gather wisdom.
- Policy
- Clinical results for Janssen Vaccine to be submitted
- by Lee, Tak-Sun May 11, 2021 05:59am
- If Janssen COVID-19 Vaccine, the third-largest licensed clinical trial in Korea, is completed by the end of this year, the permits will also be subject to change. Janssen COVID-19 Vaccine was approved on April 7 for the prevention of COVID-19 in adults aged 18 and older. However it has not been officially introduced in South Korea yet. According to the Central Pharmaceutical Affairs Review Committee minutes, a court expert advisory body that determines whether Janssen COVID-19 Vaccine is licensed, the company plans to complete two inoculation trials by the end of this year and submit the results to the MFDS. The Central Pharmaceutical Affairs Review Committee meeting was held at 10 a.m. on April 1 at Osong Food and Drug Administration headquarters. During the meeting, the commissioners connected with the company and asked about future plans. The company explained, "Phase 1 and Phase 2 clinical trials are scheduled to be followed for two years, and phase 3 clinical trials plan to further analyze immunogenicity by 18 months." "The immunogenicity subgroup is scheduled to be monitored for 24 months, and the fastest immunogenicity results in Phase III clinical trials are expected to be available in the third quarter of this year," it added. "Although it is difficult to give an accurate answer, it is expected to be possible by this year." Janssen COVID-19 Vaccine designed and conducted clinical trials with the first dose of inoculation, but since the end of last year, phase 3 clinical trials have been underway twice. The vaccination effect was 66% at one time, and it is expected that the effect will increase at the second time. At the meeting, an official from the MFDS replied, "According to the results of the clinical trial of two doses, we can consider changing the permits if necessary." Officials at the Central Pharmaceutical Affairs Review Committee said that it is reasonable to grant permission on the condition that the final results of clinical trials are submitted because the vaccination profit from Jansen vaccine is generally high. Product licensing also followed the Central Pharmaceutical Affairs Review Committee's opinion. There were some concerns about its effectiveness and safety. In terms of effectiveness, the lack of preventive effectiveness and safety in subjects aged 65 and older were about thrombotic risks, such as AstraZeneca vaccines. The Janssen vaccine has a preventive effect of 44% since the 28th for those aged 65 or older. In response, the MFDS said, "Foreign regulators also considered the fact that it was a subgroup analysis, it was difficult to confirm statistically meaningful effects due to the small number of cases in the subgroup, and 0.52% 8 days later." "If there was a risk factor, it was 67% effective in severe patients." "The prevention effect is less than 50% after 28 days in subjects with general risk factors such as high blood pressure," a member said. "The same hypothesis cannot be applied to subgroup analysis, but is the validity of the submitted data appropriate considering that most subjects are risk factors?" In response, the MFDS said it would give conditions to South Koreans after marketing them. He also mentioned the need to strengthen monitoring of thrombosis risks. "CVST (cerebral sinus thrombosis) is a rare disease, but it is a problem because the prevalence rate has increased in Germany, and the incidence rate is very low, so continuous monitoring is needed." Since its approval in Korea, the U.S. has temporarily suspended vaccinations against Janssen due to concerns over side effects such as CVST. However, the EMA and the CDC resumed vaccination, saying that the benefits of vaccination outweigh the risks. The MFDS plans to continue to monitor abnormal reactions such as CVST through a risk management plan after approval. Meanwhile, Janssen COVID-19 Vaccine is the third-largest licensed vaccine in Korea, a viral vector vaccine such as AstraZeneca. Janssen COVID-19 Vaccine is a recombinant viral vector vaccine that utilizes Ad26 as a vector (or carrier) of the genetic code for the SARS-CoV-2 antigen (called the spike protein) to create an immune response.
- Policy
- Hemlibra is likely to establish criteria for reimbursement
- by Nho, Byung Chul May 11, 2021 05:59am
- Hemlibra's reimbursement standard applied in February this year is ▲for patients who fail ITI, ▲ if there is a doctor's opinion that it meets the requirements for ITI but cannot be implemented, and ▲approved only if antibodies are regenerated after ITI success. These benefits criteria could be cut from the HIRA's screening after prescribing drugs depending on interpretation, resulting in discontinuation of administration for some pediatric patients, and patients' carers have sought solutions from various angles, including filing a national petition to the HIRA. The HIRA and the patient's group, led by the Anti-Correction and Civil Rights Commission, held a recent meeting and exchanged in-depth mutual opinions and positions on the validity of ITI prerequisites. According to the industry, the HIRA subcommittee is expected to proactively consider ITI when treating hemophiliacs under the age of 12, but discuss salary standards on a case-by-case basis based on prescriptions for communications and respect for medical rights. Treatment of Hemlibra subcutaneous injections in pediatric hemophiliacs, which are currently suspended, is likely to resume as early as this month or next month. In particular, the suspension of administration of pediatric antibody patients is expected to have a significant positive impact on the establishment of Hemlibra's standards for non-antibody patients. Analysis of Hemlibra clinical data shows that donor licensing is superior to factor VIII preparation and can help improve the quality of life of patients by improving the convenience of administration with subcutaneous injections. First-in-class Hemlibra, which has gained an advantage in economic evaluation due to its cheaper and easier to administer than conventional treatments, is currently expanding benefits to hemophilia A non-antibodies even among A7 countries. Patients exposed to factor XIII drugs inevitably produce antibodies at a certain rate, and factor XIII alone is likely to fail to control bleeding. Hemlibra is a dual antibody mechanism that replaces factor XIII, which is considered a new alternative to hemophilia treatment as it is free from intravenous pain in both pediatric and adult patients and avoids concerns about antibody production. According to the hemophilia patient group, the full treatment of Hemlibra in pediatric non-antibody patients must be paid by the patient, and the patient group is constantly asking the HIRA to set a benefit standard for this.
- InterView
- "The reason why BI is the ‘Crown Jewel’ among all MNCs"
- by Eo, Yun-Ho May 10, 2021 06:22pm
- Bom-Mai Park, Head of HR/HRBP at Boehringer Ingelheim Korea Multinational pharmaceutical companies are a dream job for many workers in the industry. With its high salary, good welfare, and smart business system, many multinational pharmaceutical companies have all the requirements that office workers desire. Even among these multinational pharmaceutical companies, Boehringer Ingelheim is considered to be top tier. Headquartered in Ingelheim, Germany, the company has maintained its ‘family-operated system' for over 100 years. Since its establishment in 1976, its Korean subsidiary, Boehringer Ingelheim Korea, has also been known as an ‘employee-oriented company that you can work for until retirement.’ Like other companies, Boehringer Ingelheim Korea had also implemented the Early Retirement Program (ERP) in 2014 and 2018 and made reductions in its workforce. However, its downsizing scale and frequency were much smaller and less than other subsidiaries in Korea. The company also showed an encouraging response to the current situation where COVID-19 had swept the world, changing everyone’s daily lives. Boehringer Ingelheim Korea took 'Our FOCUS' and 'Future of Work' as their key message to drive change to fit the new era with their employees. DailyPharm met with Bom-Mui Park (52), VP of Boehringer Ingelheim Korea who heads Human Resources (HR), to hear about the company’s vision and strengths. -What are Boehringer Ingelheim Korea’s strengths in HR? There are official strengths, and those I personally consider as strengths. Officially, the company considers the employee-company relationship in the long term. The policies HQ took during the COVID-19 crisis that broke out last year are a good example. The company made policies to preserve the level of income for employees in sales, such as MRs, who had suffered economic damage due to reduced incentives, etc. from COVID-19. Also, the company provided paid leave for employees who went to do volunteer activities related to COVId-19. I was moved by the immediate response to crisis and rewards provided for employees by the company. Personally, I believe the strength of Boehringer Ingelheim Korea lies in the provision of an ‘environment that allows learning from mistakes.’ Our company has a forgiving nature that allows employees to grow with feedback rather than being punished for a single mistake. Also, as Boehringer Ingelheim is a limited liability company that pursues long-term performance and value creation, it is relatively more stable than the other companies that I have previously worked for. -On the other hand, the company’s ‘forgiving’ culture could be abused and be considered an ‘easy company’ to work for, allowing employees to become lax in their work. I disagree. Those who make mistakes are those who made attempts. Employees who do nothing are the bigger threat to a company. Boehringer Ingelheim has a well-established organizational culture that silently pressures those who do nothing. In other words, our organizational culture is established so that everyone must do their part. The roles and responsibilities of each employee are clearly set, and the evaluation standards for assessing each employee’s performance are also set quite high. In these aspects, Boehringer Ingelheim is not an easy company to work for. Also, our system is constantly evolving to fit the changes, and our employees grow in line with the changes. -What is the ‘Future of Work’ that the company has newly implemented? The Future of Work was implemented in our headquarters to establish a flexible work culture and create a good environment for employees to work for which actively embraces the internal and external changes seen in the current era of change. We worked hard to change the role of the office, which was just a mandatory space for work, into a space for cooperation and innovation. In line with the efforts, Boehringer Ingelheim Korea also opened a smart office on April 5th. The newly transformed office was designed to maximize collaboration, work efficiency, creativity, and employee’s health and well-being based on the company’s vision of ‘creating value through innovation.’ The office is no longer a mandatory workspace, but rather a place of collaboration and innovation which may be selected according to an employee’s nature of work and personal preferences. Our new space has various kinds of meeting rooms and an Innovation Zone, as well as a Quite Zone where employees could focus on their work. We also offer telecommuting, so employees may work at the office or from home. The new office was designed so that all employees and executives may work efficiently and creatively without spatial constraints. - What kind of talents do Boehringer Ingelheim Korea seek for its employees? We have a very specific type of talent we desire in our employees. We want responsible individuals that are alert to change and have entrepreneurship, and not fear innovation or taking risks. This is not limited to Boehringer Ingelheim Korea; it is what Boehringer Ingelheim wants for all its employees and is what we strive to become. With work these days being conducted non-face-to-face and a leaner culture being set within the organization, the work culture in Korea as well has well moved away from the apprenticeship method. In other words, employees nowadays need to lead their own work independently as soon as they enter the company. Of course, feedback is provided; however, the learning curve has also become shorter than in the past, and employees must become on-set quickly. So, we need people who do not feel burdened by learning. We need learners with positive minds that say, ‘I will learn if I don’t know,’ that can strictly manage themselves. -What kind of organization does Boehringer Ingelheim Korea wish to become in the future? Much has changed with COVID-19. The biggest change that occurred is the non-face-to-face work through digital. At first, I had my concerns. But in fact, the flow now is better than expected. We had experienced changes every year, but after COVID-19, we started to consider how to engage and immerse employees in the non-face-to-face environment. In the past, I believed team-building was only possible face-to-face. But I changed my mind after working non-face-to-face. I now believe it is more about the vision set by the company. The vision itself should make the employee's heart beat faster, and a goal needs to be set so the employees can bond over and take pride in its achievement.
- Policy
- Korea United Pharm has started developing a combined IMD
- by Lee, Tak-Sun May 10, 2021 05:57am
- [ It is confirmed that Korea United Pharm has started developing a triglyceride treatment compound called "Pravastatin-Fenofibrate." The intention is to commercialize Fenofibric Acid, which can be taken with or without meals, as it is more convenient than conventional drugs. On the 28th of last month, the MFDS approved a Phase I clinical trial plan for UI061 for Korea United Pharm's treatment of complex dyslipidemia. This test is designed to identify the safety and pharmacokinetic properties of UI061 in healthy adult subjects. The event will be held at Chungnam National University Hospital for 10 people. The component of UI061 is Pravastatin-Fenofibrate. It also selected Yooyoung's "Pravastatin-Fenofibrate" as a control drug. Pravafenix is a drug introduced by Yooyoung from Belgian pharmaceutical company SMB in 2009 and is gaining popularity as a combination of triglyceride treatment. Based on UBIST, amount of out-of-pocket prescriptions last year was $21.6 billion, which is also playing a role of cash cow for companies. In particular, it is currently the only Pravastatin-Fenofibrate compound in Korea. United used Fenofibric Acid instead of Fenofibrate. Fenofibric Acid was first introduced as 'Fenocid' in 2012. In 2019, United were granted Fenorics EH (Fenofibric Acid). Fenofibric Acid can be taken independently of meals. Fenofibrate must be taken with food to increase absorption. So, Fenofibrate-based Pravafenix should be taken for dinner. If Fenofibric Acid is combined with Pravastatin and made into a compound, it can be taken independently of the meal. However, it is difficult to be sure of the possibility of commercialization at this time because United is still conducting clinical trials for the first time. In the meantime, United has new IMDs such as CilostanCR. Attention is focusing on whether there will be new drug development items that will make competitors nervous again this time.
- Opinion
- [Reporter’s View] Support domestic COVID-19 vaccine first
- by May 10, 2021 05:56am
- The U.S had expressed support for waiving intellectual property (IP) protections for COVID-19 vaccines. Such support can induce the production of copies of Pfizer and Moderna’s COVID-19 vaccine, ultimately increasing vaccine supply. The U.S administration’s support was received with expectations, concerns, support as well as opposition. It is not an exaggeration to say that the key to mRNA vaccines -such as Pfizer’s and Moderna’s vaccines – lie in its patent. A sophisticated lipid nanoparticle (LNP) technology is required to deliver mRNA, which is vulnerable to the surrounding environment, well into the body. This technology has been preemptively patented by many companies. Moderna has also been paying another company for the LNP technology used in its COVID-19 vaccine. Therefore, if the production of mRNA-based COVID-19 vaccines is possible without employing patent avoidance strategies, many more companies may make the attempt to produce COVID-19 vaccines. However still, the prominent opinion among experts is that this is not the right solution for addressing the current vaccine crisis. According to foreign media, Scott Gottlieb, a former F.D.A. chief had said, “The production of COVID-19 vaccines requires a complex process and difficult materials. Allowing other manufacturers to use the patented technology will not increase supply immediately.” Chad Landmon, the chair of Axinn, Veltrop & Harkrider’s Intellectual Property and FDA practice groups, pointed out, “IP has not been the barrier to the production — it’s really been the technology and how complicated” it is to manufacture COVID-19 vaccines. He continued, “Also, the issues in the supply chain, such as shortage of raw materials will also be a challenge.” Without the cooperation of big drug companies, patent waivers are unlikely to expand the global supply of coronavirus vaccines, said “Vaccines are difficult to make because they use biological systems which are much more difficult than small molecules. Patents are only codified information. To make it work, the multinational pharmaceutical companies would need to share their actual technological know-how, quality control, manufacturing process. It is like a 3-Michelin Star restaurant. Even if the restaurant shares its recipe, it cannot be simply replicated. “ Rather than follow the false demand for IP waiver, experts advise that the government should listen to the voices of people with abundant drug development experience and implement practical support measures to increase vaccine supply. For example, Gottlieb suggested cooperating with vaccine developers rather than confronting them by increasing manufacturing capacity by assisting in the production of raw materials and purchasing special equipment. So how would this apply to Korea? Even if the controversial IP waiver passes through, the overall opinion stays that it will be difficult for the Korean industry to develop a generic mRNA vaccine. Rather, the focus should be on supporting the development of domestic COVID-19 vaccines that are already in progress. 5 domestic companies - SK Bioscience and Celid, Genexin, Eu Biologics, Cellid – have started clinical trials for their vaccines. It would be more effective for Korea if the government set specific guidelines for their Phase III trial and support the smooth operation of their clinical research.
- Company
- The cobas SARS-CoV-2 & Influenza A/B Test was approved
- by May 10, 2021 05:56am
- Roche Diagnostics Korea announced on the 6th that it has obtained permission from the MFDS to "cobas SARS-CoV-2 & Fluenza A/B," which can diagnose COVID-19 and flu at the same time. The cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider. It is based on automated molecular diagnostic equipment 'covas 6800' and 'covas 8800', and can proceed from nucleic acid extraction to gene amplification, test, result analysis, and report through one-stop automation method. The cobas 6800 provides 384 tests per eight hours and the cobas 8800 provides 960 tests. The intervention of personnel to replace reagents and consumables reduced the cobas 6800 to once every eight hours and the cobas 8800 to once every four hours, respectively, improving the convenience of the medical staff's COVID-19 test. This automated test prevents errors caused by manual work through an all-in-one solution that is inspected in a single equipment from extracting nucleic acids to producing test results, and also reduces the risk of contamination caused by external substances. The cobas SARS-CoV-2 & Influenza A/B confirmed over 97% sensitivity and specificity through clinical studies. For COVID-19, the sensitivity associated with the false (fake-positive) risk was 100.00%, and the specificity associated with the false (fake-positive) risk was 99.82%. For influenza A, sensitivity and specificity were 97.14% and 99.04% respectively, and for influenza B, sensitivity and specificity were 100.00%. The cobas SARS-CoV-2 & Influenza A/B was approved for EMA by the FDA in September 2020 and obtained European Medical Device Certification (CE) in the same month. Johnny Tse Roche, CEO of Diagnostics Korea, said, "We expect high-capacity fully automatic cobas SARS-CoV-2 & Fluenza A/B not only improves the speed and convenience of testing, but also helps prevent the spread of infections and provide appropriate treatment for patients."
- Product
- Will Kypris become dominant in multiple myeloma markets?
- by Whang, byung-woo May 10, 2021 05:56am
- "New treatments will also emerge in the treatment of myeloma. However, its importance is still expected to continue when Kypris compares combined therapy features with a single formulation and other formulations." As multiple myeloma is difficult to completely heal and many recurrences occur, recurrence and non-responsive polymyeloma is considered the key to treatment. In the domestic treatment situation, Kyprolis-focused KRd therapy (Carfilzomib, Lenalidomide, and Dexamethasone) became the main treatment strategy, as third-generation proteasome inhibitors (PI drugs) became the standard of treatment. However, since March, IRd therapy (Ixazomib+Lenalidomide+Dexamethasone), which is centered on the oral PI drug Ninlaro, has become convenient, and the market for prescribing recurrent and non-responsive multiple myeloma has begun to become active. Accordingly, let's listen to the strategies and perspectives of treating multiple myeloma through Joseph Mikhael, a professor of applied genomics at the Korean Society of Hematology International Conference. First of all, what he emphasized in his presentation at the Korean Society of Hematology conference is the importance of early treatment strategies for patients with recurrent and unresponsive multiple myeloma. As recurrence and non-responsive multiple myeloma have various options not only in the U.S. but also in Korea, optimal measures that take into account the characteristics of patients should be considered first. Professor Joseph Mikhael said, "It is very encouraging that there are more treatment options to choose from now on compared to the past. We expect more options for treating recurrent and unresponsive multiple myeloma in the future." Professor Joseph Mikhael pays attention to the fact that Kyprolis has achieved a 12-month extension of the PFS (Present Progressive Survival Period) compared to conventional treatments in treatment of recurrent and non-responsive multiple myeloma. "The improvements in the duration of the existing treatment are significant, compared to four to six months and eight months at the most," he said. "It's a great achievement in that about six months is a common improvement in other treatments." Professor Mikhael emphasized that Kypris clearly has an advantage in terms of efficacy compared to other PI agents, Velcade (Bortezomib) and Ninlaro (Ixazomib). "Kyprolis still has the greatest effectiveness of PI drugs used to treat multiple myeloma," he said. "A study directly compared to Velcade concluded that Kyprolis is the most effective treatment needed by medical staff and patients." Treatment options for increased myeloma. What's the situation in the U.S.? In Korea, as IRd therapy has recently been reimbursed, options for clinical doctors have also increased. In the United States, where both KRd and IRd therapy were available, how would the choice of prescription between the two treatments appear? Professor Mikhael said that KRd therapy is preferred, assuming that there are many options. "If a patient has an autologous hematopoietic stem cell transplant, there is a maintenance therapy based on Levlimide, and Kyprolis and Ninlaro are available options," He said. "KRd therapy is mainly chosen because Kyprolis is more effective." IRd therapy can be selected if patients want to avoid Kyprolis because they are concerned about abnormal reactions related to the heart, but IRd therapy is less used in the United States than KRd therapy. However, as Professor Mikhael mentioned earlier, Kyprolis' biggest concern is that patients with heart-related comorbidities require attention. Considering that multiple myeloma comes from older people aged 65 or older, concerns about heart failure and hypertension abnormalities of Kyprolis cannot be ruled out. Professor Mikhael acknowledged the abnormal response that could appear as Kypris, but evaluated it as manageable. "After more than 10 years of use of Kyprolis, experience in abnormal reactions can be accumulated and reduced to 2%," he said. "2% of patients should stop taking medication, but this situation is very small in the actual field."
- Company
- The trend to advertise vaccines is diversity and young men
- by May 07, 2021 06:02am
- GSK Rotarix model Jo Jeong-seok, MSD Gardasil9 model Jeong Gyeong-ho, Yoo Byeong-jae, Jo Se-ho, and Pfizer Pharmaceutical PREVENAR13 model Choi Gwi-hwaVaccine advertisements by pharmaceutical companies are diversifying. Instead of the flu vaccine, it has diversified into vaccines for rota virus, pneumococcus, cervical cancer, and whooping cough. This is to raise awareness of vaccinations for vaccines that have not been well-known until now as interest in preventing infectious diseases has increased due to COVID-19. The main model was a young male entertainer. According to the pharmaceutical industry on the 7th, MSD Korea is the most active. MSD selected singers Mommy Son, comedian Jo Se-ho and Yoo Byung-jae as models for the advertisement of the HPV virus (cervical cancer) vaccine Gardasil9 only last year. Also recently, actor Jung Kyung-ho was selected as the new Gardasil 9 model. The reason MSD has introduced a variety of male models is to emphasize the importance of vaccination against the HPV virus in men. Until now, the HPV virus vaccine was widely known as a cervical cancer vaccine, so there was a strong recognition that it was only suitable for young women. However, although this virus is rare, it can also cause anal cancer and genital warts in men. As a result, MSD, which focused on women's marketing with comedian Park Na-rae as a model, began to use a large number of young male models to improve awareness. Mami Son's rap and Jo Seho and Yoo Byungjae's parody competition aroused the interest of young men. In April, it emphasized a clean concept with actor Jung Kyung-ho as a model. GSK also introduced actor Jo Jung-seok, who is considered the best advertising star since August of last year, as a model of the rotavirus vaccine Rotarix. His credible image and comfortable voice are favored by young people, regardless of gender. In particular, Rotavirus vaccine is suitable for newborns, and at the time of selection, Jo Jung-seok also became a parent with the child. This is Rotarix first public TV commercial. GSK said, "To inform the necessity of vaccination against Rotavirus that does not apply to NIP, and to raise brand awareness, we will conduct a public advertisement with Jo Jung-seok." GSK also launched a public TV commercial for the whooping cough vaccine Boostrix this year. Since the main target of Boostrix is adults over 50, we decided to be the main model as actor Seong Dong-il. GSK emphasized the importance of vaccination by arousing the attention of silver generations to whooping cough with Boostrix advertisements. GSK introduced various versions of Boostrix advertisements, and raised consensus with the camping entertainment program" the Wheeled House Camping Edition' starring Sung Dong-il. Pfizer Pharmaceuticals selected actor Choi Gwi-hwa as a new model for the pneumococcal vaccine PREVENAR13 in November of last year. As interest in pneumococcal vaccine increased amid the COVID-19 crisis, a public TV advertisement was held in two years. Choi Ki-hwa, with his wife, child, and grandparents going to receive PREVENAR13, appealed to the point that it is a vaccine that is suitable for the whole family. The number of vaccine advertisements, which had not been in public marketing until now, has increased, but the widely-known flu vaccine advertisement has somewhat slowed down. In 2019, GSK, GC Pharma, and SK Bioscience showed active public advertisements, led by actors Cha In-pyo and Yoon Se-ah, but last year the frequency of advertisements decreased significantly. Sanofi Pasteur was the only one to run an advertisement with singer Song Ga-in as a model for Vaxigrip. It is analyzed that this was affected by the widening of NIP targets due to COVID-19.
