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- 2026-04-04 16:37:41
- Opinion
- [Reporter's View] ‘Tyranny of Drug Committees persist'
- by Eo, Yun-Ho Sep 11, 2024 05:54am
- Even after a drug is approved by the Ministry of Food and Drug Safety and listed for reimbursement, the drug cannot be prescribed immediately by medical staff at general hospitals. A drug can only be prescribed at each hospital after a prescription code is generated upon review by their respective drug committees (DCs). The process, in itself, is quite systematic. Rather than allowing prescriptions of all drugs that are commercialized, an expert meeting is held internally to discuss the need to introduce the drug to each medical institution. DCs have long been regarded as powerful sales targets within the pharmaceutical industry. When it's time for each hospital's DC, a war ignites between pharma companies to land their products. Like all wars, there are winners and losers. The problem is that the winner is not necessarily the company that deserves to win, and the loser is not necessarily the company that deserves to lose. Landing a drug in some hospitals still often depends on the deals made, rather than good clinical results that prove the drug's efficacy and effect. Such cases are especially prominent when the patent of the original drug expires and generics are launched. The DC of a hospital is mostly composed of professors (doctors) in each medical department, except for the head of the pharmaceutical department (pharmacist). Naturally, they are the first targets in line if a company wishes to generate prescription codes for their newly launched drugs. Add to that the medical institution’s foundation’s influence and unexpected code-ins and code-outs do occur. A hospital with a strong DC still calls up the pharmaceutical companies of original drugs when the drug’s patent expires and requests so-called ‘code maintenance fees.’ In fact, over the past 2-3 years, the hospital has gone without some of the most popular original drugs for hypertension, hyperlipidemia, and antithrombotic medications that anyone in the industry would know. This is because the companies that own them refused to pay the code maintenance fees requested by the foundation. DC lobbying also occurs between original drugs when new drugs of the same generation, or same-class drugs, are introduced one after another. This means that pharmaceutical companies are at the mercy of foundations and professors alike to get a drug ‘coded in’ in these hospitals. However, with the recent trend of new drugs being released for cancer and rare diseases, the proportion of drugs that hold a unique position rather than having competitors is increasing, reducing the DC's power. However, industry representatives say ‘it still exists.’ The end consumer of the drugs is the patient, not the doctor or the foundation. It is now time to examine whether the introduction of drugs is being done properly. Isn't it time that drugs are prescribed in hospitals based on fair value assessments?
- Company
- Why SK Chemicals applied for EUA, not SK Biosicence
- by Kim, Jin-Gu Sep 11, 2024 05:54am
- SK Chemicals has applied for emergency use approval of the Novavax COVID-19 vaccine to the Ministry of Food and Drug Safety to introduce the vaccine to Korea. One interesting fact is that it was SK Chemicals, not SK Bioscience, that applied for the EUA. This is because the regulations for EUA require a prior record of vaccine imports. Since SK Bioscience does not have a record of vaccine imports, its parent company SK Chemicals applied for the EUA, and SK Bioscience will take charge of the domestic supply of the vaccine. According to the pharmaceutical industry on Tuesday, SK Chemicals applied for EUA of Novavax's COVID-19 vaccine, which protects against the new variant (JN.1). The EUA application is in line with the Korea Disease Control and Prevention Agency’s 2024-2025 COVID-19 inoculation plan. The KDCA announced on the 9th that it would introduce Pfizer, Moderna, and Novavax vaccines for COVID-19 vaccination. 5.23 million doses of the Pfizer vaccine will be introduced first. 4.19 million doses arrived in Korea on the 9th. 810,000 doses will be introduced this week, and the remaining 230,000 doses are set to be introduced in the future. The MFDS had approved the Pfizer vaccine on August 30. In the case of Moderna's new JN.1 variant targeting vaccine, its marketing authorization is underway in Korea. KCDA plans to introduce 2 million doses of the vaccine gradually in Korea step by step in line with the vaccination season. The Novavax vaccine will be introduced through the EUA process. It is interesting to note that it is SK Chemicals, not SK Bioscience, that has applied for EUA of the Novavax vaccine. SK Bioscience is a subsidiary of SK Chemicals, which had previously contract manufactured the production of Novavax's COVID-19 vaccine during the last COVID-19 outbreak. The industry explanation is that this is because SK Bioscience does not meet the regulatory requirements to apply for EUA. According to the current ‘Emergency Use Authorization and Management of Medicines Used for Public Health Crisis Response’ regulations, to apply for EUA, companies need to have a track record of manufacturing and importing drugs. In this regard, a company official explained that SK Bioscience does not own a track record of drug imports. SK Bioscience supplied the Novavax vaccine domestically during the 2021-2022 COVID-19 crisis, but it was a contract manufacturing organization (CMO) deal, not an import deal. In 2023, the company concluded its CDMO contract with Novavax, and the Omicron variant (XBB.1.5) vaccine was imported from Novavax instead of being manufactured domestically. Again, SK Chemicals, which had an import history, was in charge of applying for its EUA. In the future, SK Bioscience will supply Novavax vaccines domestically through the EUA process. This year, the amount of Novavax vaccine introduced to Korea had decreased compared to last year. Last year, the KCDA introduced 500,000 doses of Novavax's COVID-19 vaccine (XBB.1.5 strain). This year, it will introduce 320,000 doses, a decrease from last year.
- Policy
- Price of Pristiq original and IMDs cut with generic release
- by Lee, Tak-Sun Sep 11, 2024 05:54am
- PfizerThe release of generic versions of Pfizer's antidepressant ‘Pristiq ER Tab,’ has hit not only the sales of the original drug but also the salt-modified version. Korea Pharma launched the first generic version of Pristiq in Korea last month, and the release has also affected the salt-modified drug that was released 4 years ago. According to industry sources on the 9th, the upper insurance price limit of the original Pristiq ER Tab and the salt-modified drug received ex officio adjustments upon the entry of the generic version. The insurance price of the items will remain at 70% of the maximum price for 1 year but then be reduced to 53.55% like the generic’s price. Desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI), which is characterized by its low risk of drug interactions and a low risk of side effects such as hypertension and sexual dysfunction. Due to such advantages, the drug has become a popular choice in the antidepressant market. According to IQVIA sales, the original Pristiq generated sales of KRW 7.2 billion last year. With the listing of the generic drug, its upper insurance price limit will be reduced to 70% from September. As a result, the price of Pristiq 50mg ER Tab will be reduced from KRW 1,002 to KRW 702, and Pristiq 100mg ER Tab will be adjusted to KRW 873. This was an ex officio adjustment of the upper limit upon the reimbursement listing of Korea Pharma’s generic drug. The upper limit of the original drug is adjusted to 53.55% of the initial price when a product with the same route of administration, ingredients, and dosage form is introduced for the first time, but then is set at 70% of the original price for one year. In addition to the ‘Pharma Desvenlafaxine ER Tab 100mg’ that Korea Pharma received reimbursement listing last month, the company has listed ‘Pharma Desvenlafaxine ER Tab 50mg’ with reimbursement this month. Both are generic drugs that contain the same active ingredient (desvenlafaxine succinate monohydrate) as Pristiq. The generic listing also affected the price of salt-modified versions of the drug that were released 4 years ago. The price of Whan In Pharm (desvenlafaxine), Myeongin Pharm, Hallim Pharmaceutical, and Nexpharm Korea (desvenlafaxine benzoate) was also reduced to 70% of the initial price. This is because when the price of the development target product (original Pristiq ER Tab) is adjusted, the price of the salt-modified drugs is also reduced together. No price adjustments had been made until now as only salt-modified versions with different ingredient names were listed, with no generic versions. The price of the salt-modified versions was set at 90% of the target product's price upon initial listing. However, generic products were introduced 4 years after the launch of the salt-modified drugs, rendering price adjustments of all the previously introduced drugs inevitable. The salt-modified drugs were developed to avoid patent infringement and introduced to the market in 2020. The patent for the original Pristiq ER Tab expired in October 2022. The price of the original and the salt-modified versions will be reduced to 53.55% after 1 year. An industry official said, “With the launch of the generic, the 4-year coexistence between the original and the salt-modified drug has come to an end. Due to the price cut, sales of the existing drugs will inevitably decline.”
- Company
- The export performance of biopharma is up
- by Kim, Jin-Gu Sep 10, 2024 05:48am
- The export performance of two out of three pharmaceutical and biotech companies is reported to have increased year-over-year (YoY). The total export sales of 24 companies increased from KRW 3.6869 trillion to KRW 4.8975 trillion over the year, up 33%. In particular, the export performance of Samsung Biologics, Celltrion, and SK Biopharmaceuticals has substantially improved. Samsung Biologics' export sales increased by over KRW 500 billion over the year, recording over KRW 2 trillion in export sales in the first half of the year. Export sales of Celltrion and SK Biopharmaceuticals increased by over 50% YoY. Export sales↑in 17 out of 24 listed pharmaceutical companies…Celltrion·SK Biopharm over 50% up According to the Financial Supervisory Service (FSS) on September 9th, the total export sales of twenty-four major pharmaceutical and biotech companies were KRW 4.8975 trillion in the first half 2024, up 33% YoY from KRW 3.6869 trillion last year. This is the result of summing twent-four KOSPI-and KOSDAQ-listed pharmaceutical and biotech companies that have generated over KRW 10 billion in export sales. The subsidiaries have been excluded from the calculation. Seventeen of the twenty-four companies investigated had increased export performance compared to the same period last year. The export performance of Celltrion, SK Biopharmaceuticals, Dong-wha, and Yungjin Pharmaceutical increased by over 50% over the year. Those of Samsung Biologics, Yuhan Corp, Jeil Pharm, Hugel, and PharmaResearch increased by over 20%. The export performance of Medytox, Hanmi Pharm, Kolon Life Science, Chong Kun Dang, Dongkook Pharmaceutical, Daewoong Pharmaceutical, and HK inno.N increased by over 10%. DONG-A ST remained the same as last year. In contrast, the export performance of Ilyang Pharmaceutical, ST Pharm, Korea United Pharm, GC Biopharma, Huons, SK Biosciences, and Kyongbo Pharmaceutical decreased from the same period last year. Samsung Biologics has increased export to Europe·U.S….will it surpass KRW 4 trillion by the end of the year? Samsung Biologics recorded over KRW 2 trillion in export sales in the first half of the year alone. It indicated a 33% increase from KRW 1.5399 trillion in the first half of last year to KRW 2.0298 trillion in the first half of this year. Samsung Biologics has made a breaking record in export sales every year. The company recorded KRW 1.2217 trillion in 2021, KRW 2.8466 in 2022, and KRW 3.5800 in 2023. This year, over KRW 4 trillion in export sales is expected till the end of the year. The total export sales Samsung Biologics generated since 2015 amount to US$13.055 billion (about KRW 17.36 trillion). The company has delivered US$6.901 billion worth of products and US$6.142 billion (KRW 8.13 trillion) remains a backlog of orders. If the company succeeds in product development, the backlog will increase to US$12.607 billion (about 16.84 trillion). Samsung Biologics export sales by countries (unit: KRW 100 million, source: FSS). The exports to all countries increased compared to the same period last year. European exports increased by 22%, from KRW 1.0637 trillion to KRW 1.3001 trillion. The U.S. exports increased by 50%, from KRW 384.9 billion to KRW 576.3 billion. Export to other countries increased by 32%, from KRW 91.3 billion to KRW 153.4 billion. Celltrion surpassed KRW 1 trillion in the first half of the year…SK Biopharm sales 72% UP following Xcopri sales increase Celltrion surpassed KRW 1 trillion in export sales in the first half of the year. It increased by 50% from KRW 947.1 billion in the first half of last year to KRW 1.4252 trillion in the first half of this year. Exports to European and North American markets substantially increased. Celltrion's exports to Europe increased from KRW 487.5 billion to KRW 689.3 billion. Based on Celltrion's analysis, its maximized direct sales have contributed to increased sales of all products. Remsima IV and SC formulations recorded positive sales in the U.K. and Netherlands. Furthermore, Yuflyma contributed to the sales increase after successfully entering the European countries. Exports to North America increased by 79%, from KRW 274.6 billion to KRW 490.3 billion. Inflectra generated sales in the North American market, and the sales of follow-up products are increasing. As the sales of Inflectra increased, Celltrion added the DP manufacturing plant. Celltrion expects the exports to North America to increase even more. The company expects simultaneous growth in Inflectra and Zymfentra sales in the U.S., similar to the increase in Remsima IV sales following the launch of the SC formulation in Europe. Celltrion export sales by countries (unit: KRW 100 million, source: FSS). SK Biopharmceuticals' export sales increased by 76% from KRW 137.8 billion to KRW 242 billion. The analysis suggests an increase in Xcopri's sales in the United States contributed to this. Xcopri generated KRW 105.2 billion in sales in the U.S. market in Q2, the first time Xcopri sales have exeeded KRW 100 billion in the U.S. market. SK Biopharmaceuticals launched Xcopri in the U.S. market in Q2 2020. Sales surpassed KRW 30 billion in Q1 2022, KRW 50 billion in Q1 2023, and KRW 100 billion this year. Earlier this year, SK Biopharmaceuticals set a sales goal for U.S. sales between US$ 300 million (about KRW 410 billion) and US$320 million (about KRW 440 billion). With this trend, the company expects to reach its goal soon.
- Company
- MS drug development poses a big challenge for pharma
- by Son, Hyung-Min Sep 10, 2024 05:48am
- Pharmaceutical companies based in South Korea and overseas are having difficulties developing new drugs for multiple sclerosis. Sanofi failed to demonstrate the drug's efficacy in some parts of clinical trials, and Merck's Phase 3 clinical trial did not meet primary endpoints. However, Sanofi announced that it will attempt to receive approval from the U.S. Food and Drug Administration (FDA) since the company acquired results confirming the efficacy in some parts of the clinical trial. In South Korea, D&D Pharmatech and AprilBIO jump into drug development. Sanofi fails to meet the primary endpoints in some of the Phase 3 clinical trials According to industry sources on September 7th, Sanofi recently completed clinical trials for 'tolebrutinib,' a new drug candidate for multiple sclerosis, and announced that the company will still plan to file for FDA approval. Tolebrutinib is an oral Bruton tyrosine kinase (BTK) inhibitor that works by selectively inhibiting immune responses in multiple sclerosis by regulating B lymphocytes and disease-related microglia. Sanofi acquired the U.S.-based biotechnology company Principia Biopharma for US$3.7 billion (about KRW 4.95 trillion) in 2021 and secured the development rights for Tolebrutinib. Multiple sclerosis is a chronic disease in which the myelin sheaths are damaged due to autoimmune inflammatory responses. Damages to the myelin sheaths cause muscle weakening, fatigue, and vision impairment, and the disease could lead to atraumatic disorders. As of 2022, there are approximately 2674 patients with multiple sclerosis in South Korea, and people aged 20-40 account for 62% of all patients. Until now, antibody medications such as Tysabri (natalizumab), Gilenya (fingolimod), and Mabthera (rituximab) have been used for treating multiple sclerosis. However, there are ongoing requests for new drugs. Sanofi confirmed the efficacy of tolebrutinib through the Phase 3 'HERCULES' study, which involved patients with nonrelapsing secondary progressive multiple sclerosis (nrSPMS). The results showed that tolebrutinib shortened the time to reach confirmed disability progression (CDP), which has been used as the primary endpoint, compared to the placebo group. However, GEMINI 1 and 2 of the Phase 3 trials, which involved patients with relapsing multiple sclerosis, failed to demonstrate the efficacy of tolebrutinib. In these clinical trials, tolebrutinib failed to reduce the annualized relapse rate (ARR) compared to Aubagio (teriflunomide). Notably, tolebrutinib delayed the time till relapse when the secondary primary endpoints were analyzed. Although GEMINI clinical trial results did not meet the primary endpoint, Sanofi plans to file for FDA approval since it secured positive results from the HERCULES study. In South Korea, D&D Pharmatech and AprilBio jump into the field D&D Pharmatech recently received the Investigational New Drug (IND) approval for the Phase 2 clinical trials of its 'NLY01,' a new drug candidate for multiple sclerosis. NLY01 is a GLP-1 (glucagon-like peptide 1) receptor agonist that works by inhibiting neuroinflammation, which is known as the major cause of degenerative brain diseases and protecting neurons. The NLY01 Phase 2 trial results for Parkinson's Disease were disclosed in 2020. However, 36 weeks of NLY01 administration, which was set as the primary endpoint, did not show statistically significant improvement in symptom alleviation compared to the placebo group. In detail, at 24 weeks of administration, a significant difference was found between the NLY01 treatment group and the placebo group. However, between 24 and 36 weeks, the placebo group’s symptoms showed more improvements than those of the NLY01 group. Then, D&D Pharmatech changed the clinical plan of NLY01 as a new drug for multiple sclerosis. As NLY01 showed effects in regulating neuroinflammation in patients aged 60 years and below in the Parkinson's Disease clinical trial, D&D Pharmatech plans to investigate the candidate's potential as a new drug for multiple sclerosis. The ongoing Phase 2 clinical trial evaluates whether NLY01 reduces neurodegeneration-related imaging indexes in patients with multiple sclerosis. The primary endpoints include changes to the normalization of cerebral volumes. AprilBio has expanded the clinical indication of 'APB-A1,' a new drug candidate for immune disease, to multiple sclerosis. During a conference call, AprilBio's U.S.-based partnering company, Lundbeck, announced that it would expand the APB-A1 development plan to include multiple sclerosis in addition to thyroid eye disease (TED). In 2021, AprilBio out-licensed APB-A1 to Danish pharmaceutical company Lundbeck for US$448 million (approximately KRW 540 billion). APB-A1 is a new drug candidate that inhibits CD40L. CD40L is commonly found in activated T cells following inflammation. Large quantities of cytokines are released when T Cells’ CD40L binds to CD40 of natural killer cells. APB-A1 works by targeting CD40, inhibiting the formation of cytokine-releasing antibodies through B cells and natural killer cells. Now, UCB’s dapirolizumab and the U.S. biotech company Horizon Therapeutics’ Dazodalibep are under development with mechanisms of action similar to APB-A1.
- Company
- CAR-T cell therapy Yescarta expected to enter the KOR market
- by Eo, Yun-Ho Sep 10, 2024 05:48am
- Product photo of Gilead Sciences Another new CAR-T cell therapy 'Yescarta' is anticipated to enter the Korean market. The Ministry of Food and Drug Safety (MFDS) recently posted that it has designated an orphan drug for Gilead Sciences' Yescarta (axicabtagene ciloleucel). The designated indication will include ▲Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL) who have undergone two or more systemic treatments ▲Adult patients with DLBCL who have relapsed or refractory within 12 months after the first-line chemoimmunotherapy. Yescartav is a CAR-T cell therapy that received the first approval from the U.S. Food and Drug Administration (FDA) as the third-line treatment in October 2017. After receiving approval from the European Commission (EC), the drug has expanded to the second-line treatment. In 2021, it became available for use in treating follicular lymphoma. The efficacy of Yescarta as the third-line treatment has been confirmed through the ZUM-1 clinical study. The study reported a 5-year survival rate, showing that 42.6% of all patients treated with Yescarta survived for five years, and 92% of those no longer needed additional cancer treatment. Then, the ZUMA-7 Phase 3 clinical trial confirmed the drug's efficacy for the second-line treatment. It was the first-in-class for a CART-T cell therapy, the largest in scale, and the longest follow-up trial. 359 patients world-wide were randomly assigned to receive one-time treatment of Yescarta or the existing standard-care second-line therapy. The analysis results presented at the American Society of Clinical Oncology conference (ASCO 2023) last year included a median follow-up at 47.2 months, at which the median value of overall survival (OS) with Yescarta was not reached. However, Yescarta's death rate was 27%, which was statistically lower than the control group's 31.1 months. The OS at 48 months was 54.6% for Yescarta and 46.0% for the control group. Yescarta treatment showed consistent survival benefits in pre-assigned subgroups, including age groups, refractory at the first-line therapy, early relapse, or high-grade B-cell lymphoma (HGBL). Additionally, excluding the impact of treatment shift using the pre-assigned method, Yescarta's risk of death was 39% lower than the control group. In South Korea, Novartis Korea's 'Kymriah (tisagenlecleucel)' was the first CAR-T cell therapy to receive approval. In March, Janssen Korea's 'Carvykti (ciltacabtagene autoleucel)' was approved. Kymriah is now listed for insurance reimbursement, and Carvykti is still a non-reimbursed drug.
- Company
- Is the heyday of domestic flu vaccines coming to an end?
- by Moon, sung-ho Sep 10, 2024 05:48am
- Competition among pharmaceutical and biotech companies with influenza (flu) vaccines is intensifying more than ever. As more and more companies, including global pharmaceutical companies, are seeking to supply vaccines on-site, and specialized vaccines are being launched for each age group, the competition is expected to be unprecedented this autumn. # In particular, the formation of a non-reimbursed market for both vaccines has become a hot topic in the field, especially in the context of the resurgence of COVID-19. However, industry insiders do not expect large-scale co-vaccination to be carried out among adults, except for high-risk patients who are eligible for the National Immunization Program (NIP). According to industry sources on the 7th, the vaccine contracted by the Korea Disease Control and Prevention Agency (KDCA) for the ‘2024-2025 Influenza NIP Project’ is 11.7 million doses worth KRW 12.9 billion. This is more than the previous year's contracted volume of 11.21 million doses. KDCA signed contracts with GC Biopharma, Sanofi, Boryung Biopharma, SK Bioscience, Korea Vaccine, and Il-Yang Pharmaceutical. This is similar to last year. However, the details are different. Last year, GC Biopharma supplied less than planned after making the highest bid through the NIP, but the company made a different choice this time. Last year, GC Biopharma bid to supply 4.3 million doses, but only 1.74 million doses were delivered through NIP due to its supply price being pushed back. In other words, the doses that the company was unable to supply through the NIP were released into the non-reimbursed adult vaccine market. But the situation was different this year. GC BIopharma bid the highest price for the NIP, at KRW 10,810 per vaccine, and the largest volume of 2.65 million doses. The company was followed by SK Bioscience, which bid KRW 10,470 per vaccine for 2.55 million doses. It is also worth noting that Sanofi, which bid the lowest price at KRW 10,340, will supply 2.15 million doses. In addition, Il-Yang Pharmaceutical and Korea Vaccine will supply 2 million doses and Boryung Biopharma will supply 1.25 million doses to NIP. In addition, GSK will supply the flu vaccine Fluarix Tetra for the pediatric NIP. As a result, most of the flu vaccines are included in the NIP. The difference this year is in the adult vaccine market for the elderly. This is because Sanofi is planning to launch ‘Efluelda,’ a high-dose influenza vaccine for people aged 65 and over in time for this year's flu season in addition to the existing Vaxigrip. It is worth noting that CSL Seqirus launched ‘Fluad Quad’ last year for the 65+ age group. Fluad Quad was the first vaccine to enter this market, but the subsequent entry of Efluelda has created competition in the non-reimbursement vaccine market for the 65+ age group. While the NIP includes people aged 65 and older, clinical sites say there is a clear market for non-reimbursed Fluad Quad given the vaccination experience last year. “Given the situation last year, 1 in 10 of the elderly sought the vaccine,” said an otolaryngologist who requested anonymity. “I brought in about 100 units, which I used with the 1,200 doses of the NIP vaccine. I think the point that it is particularly effective for those aged 65 and older has made them aware of the need.” “Last year, the price of the vaccine was KRW 40,000 to 50,000, but this year, we need to consider the entry of its competitor,” he said. “There may be differences by region, but the price of the general vaccine is likely to be between KRW 25,000 and 30,000, and the price of the vaccine for the elderly is likely to set KRW 10,000 higher.’ Another point of interest is how the reemergence of COVID-19 will affect the flu vaccination season later this year. According to KDCA, 837 hospitalized patients were reported in the COVID-19 sentinel surveillance report at Week 35, a 28.0% decrease from Week 34 (1,163). This is a 48.2% decrease compared to Week 33 (1,464), 2 weeks earlier. The pathogen detection rate has also been decreasing for 2 consecutive weeks, from Week 33 (43.4%) to Week 34 (39.0%) to Week 35 (34.0%). COVID-19 viral concentrations in the wastewater surveillance also decreased by 27% from 2 weeks ago. While it is believed that the peak of the pandemic has passed, the government plans to continue to support COVID-19 vaccinations for high-risk groups, including those aged 65 and older and those who are immunocompromised. The clinical field is interested in the volume of non-reimbursed COVID-19 vaccinations alongside the flu vaccinations. If interest continues to rise, the patients may inquire about COVID-19 vaccinations during the flu vaccination season. In this situation, Moderna Korea, a leading vaccine supplier, has ended its relationship with Kwangdong Pharmaceutical and entered into a strategic partnership with Boryung Biopharma for the supply of COVID-19 vaccines in Korea. Through the partnership, Boryung Biopharma will provide medical information on Moderna's updated COVID-19 vaccine, which will be used in the government's ‘2024-2025 Season Inoculation Program,’ to healthcare providers in Korea. However, it is unlikely that many adults will be vaccinated with the non-reimbursed COVID-19 vaccine as it is relatively expensive. Currently, there is a consensus that the vaccine price will be in the mid-KRW 100,000 range without reimbursement. “The government seems to want to support COVID-19 vaccines to high-risk groups such as the elderly over the age of 65. Some of the other COVID-19 vaccines are currently in supply and their purchase price is in the KRW 100,000 range,” said Kyung-Geun Kwak, Chair of Seoul Physician’s Association (Seoul Medical Clinic) ”Because of this, the price of the COVID-19 vaccination will be in the mid- KRW 100,000 range. The flu had spread in Korea from August to September along with COVID-19, so those who had suffered inconvenience due to the 2 may likely seek vaccination for either disease.” Kwak added, “I understand that there are global policies in place, but personally I believe the COVID-19 vaccine is too expensive. “I doubt that relatively younger patients, except for high-risk groups, would be willing to receive vaccination at the price.”
- Company
- Livtencity's introduction raises expectations in the field
- by Hwang, Byung-woo Sep 10, 2024 05:47am
- The introduction of Livtencity (maribavir), a drug that can be prescribed to manage infections in transplant patients following the use of existing treatments, has been met with positive reviews in the field due to a lack of treatment options. Although the actual number of patients who will be prescribed the drug is limited, the drug is expected to play a role in the management of infections in patients who value their transplant opportunity. Sung-Han Kim, Department of Infectious Diseases, Seoul Asan Medical Center Sung-Han Kim, Professor of Infectious Diseases at Seoul Asan Medical Center, attended a media session organized by Takeda Pharmaceuticals Korea to discuss the paradigm shift in the treatment of patients with cytomegalovirus (CMV) infection. CMV is a double-stranded DNA virus that is a member of the herpesvirus family and is mainly transmitted through body fluids, white blood cells, and tissues such as transplanted organs. In Korea, about 94% of adults are known to be seropositive for CMV. For this reason, allogeneic hematopoietic stem cell transplantation or solid organ transplantation patients, whose immune function is temporarily reduced to control the body's rejection during the transplantation process, may develop latent CMV, rendering it an essential condition to manage. In Korea, up to 88% of patients after allogeneic stem cell transplantation and up to 55% of patients after solid organ transplantation experience CMV infection. CMV infection may be initially asymptomatic, but if not successfully treated, it can progress to CMV disease. CMV infection is also considered a major threat that increases the risk of graft rejection, opportunistic infections, and death. “People can be infected with CMV during adolescence to about 25 years of age and remain latent,” said Professor Kim, “and it can cause a number of diseases when the immune system is suppressed following transplantation. CMV infection in transplant patients is an indication of a poorer immune status, so it needs to be managed appropriately.” Currently, CMV treatment is divided into three phases: prophylaxis for those who do not have the virus, preemptive therapy for those who do have the virus but have not developed a disease, and treatment for those who have advanced to a disease. For solid organ transplant and allogeneic stem cell transplant patients, who are at high risk for CMV, ganciclovir (intravenous) and valganciclovir (oral) are used as first-line treatments. In the case of patients who show resistance or are refractory to antivirals and require second-line treatment, solid organ transplant patients are treated with ganciclovir or valganciclovir in combination with an adjusted dose of immunosuppressive agents. Foscarnet and cidofovir may also be considered, but their use is limited due to their non-reimbursed status. ”Livtencity is expected to serve as a promising new weapon for treatment of CMV...changing the guideline protocols remains a challenge” Livtencity has emerged in this situation. The drug was launched last year and has been granted reimbursement as a second-line treatment since April. Although the number of transplant patients is limited in Korea, the significance of its arrival is that it brings additional options to the field. Although several drugs are already used for CMV, there are patients who are refractory to the existing options, so Livtencity is expected to play a role as a later-line option. Kim said, “Organ transplants and bone marrow transplants are expensive, and there are cases where CMV can ruin the transplant. In an area where options are limited, Livtencity’s introduction is significant because it has a better effect and fewer side effects.” ‘As Livtencity is an oral pill, it can be taken as an outpatient treatment, which makes it more convenient for the patients,” added Kim. However, Kim believes that guidelines for post-transplant infection control need to be contemplated. While the growing options have improved patient access, it also comes with the risk of cuts. For allogeneic hematopoietic stem cell transplantation, the current treatment sequence is to use conventional first-line treatments such as ganciclovir and valganciclovir followed by Livtencity as a second-line treatment. MSD's Prevymis (letermovir) has also emerged as a prophylaxis for CMV infection, but it can only be used for up to 100 days after transplantation. “Prophylaxis after allogeneic stem cell transplantation is done most of the time, but due to the high cost of the drug and concerns about reimbursement cuts, the treatment is sometimes terminated at the wrong time or the right dose not used,” said Kim. “There is also a need for the hematology and infectious disease departments to discuss the treatment protocols to manage CMV after allogeneic stem cell transplantation.” “Various discussions need to be made to address these protocol issues, which is not easy in the current environment. We would need to sort out these protocols after the overall healthcare situation improves in Korea.”
- Company
- Eliquis generics to enter and reshape DOAC mkt in SEP
- by Moon, Sung-ho Sep 10, 2024 05:47am
- From this month (September), numerous generic drugs will be released in the direct-acting oral anticoagulant (DOAC) market. Following Bayer's Xarelto (rivaroxaban), Pfizer and BMS's Eliquis (apixaban) is also facing its patent expiry. According to industry sources on the 26th, the Ministry of Health and Welfare recently prepared a notice on the reimbursement listing of 18 pharmaceutical companies' products containing apixaban and began collecting opinions. When looking at the DOACs that are prescribed in internal medicine hospitals and clinics, Bayer’s Xarelto (rivaroxaban), followed by Boehringer Ingelheim’s Pradaxa (dabigatran), Pfizer and BMS’s Eliquis (apixaban), and Daiichi Sankyo’s Lixiana (edoxaban) are currently the major players in Korea’s market. Among these, Xarelto’s patent expired in the second half of 2022, and its decline in the prescription market has become more pronounced recently as domestic drugmakers have launched a slew of Xarelto generics. According to the drug research institution UBIST, Xarelto’s prescriptions plummeted 37% from KRW 49.4 billion in 2022 to KRW 31 billion in 2023. The downward trend has continued in the first half of this year, with sales around KRW 15.3 billion. Moreover, as another blockbuster, Eliquis, is scheduled to expire on September 10, the MOHW has announced that 18 Eliquis generics from pharmaceutical companies will be listed for health insurance reimbursement benefits. For reference, Eliquis continues to dominate the clinical scene with prescriptions worth KRW 77.3 billion last year. In the first half of this year, it recorded KRW 38.8 billion, but this sales flow is expected to change after the launch of generics. Upon the entry of generics, Daiichi Sankyo's Lixiana, which has recently been strengthening its market dominance, is expected to take the sole lead in the field. Lixiana, which is copromoted and sold by Daiichi Sankyo and Daewoong Pharmaceutical, recently surpassed Eliquis’s sales and rose to monopoly. Last year, Lixiana's domestic sales reached KRW 105.3 billion, and in the first half of this year, it recorded KRW 55.8 billion, maintaining an upward trend. A professor of cardiology at A University Hospital said, “Nothing would notably change in the field aDOACs are well used in clinical practice. If generics are released, prescriptions will naturally be dispersed between them as they may differ in terms of drug price.” A director of a frontline internal medicine clinic also said, “Following Xarelto, the patent expiry of major original drugs in the DOAC market has followed. I think Eliquis’s market will show a similar result to Xarelto’s. We have already been approached by sales representatives from various pharmaceutical companies requesting prescriptions from September following the launch of their respective generics.” “I can feel the pressure put on the sales representatives by pharmaceutical companies that have launched generics. Everybody rep had been asking us to just prescribe one case,” added the director.
- Company
- Hugel hosts Train-The-Trainer seminar for global medical aes
- by Kwon Sung-Yong Sep 09, 2024 09:45am
- Hugel Inc., a leading global medical aesthetics company, said on Monday it hosted the Train-The-Trainer program at the end of August with medical experts from overseas to improve their knowledge and practices of skin rejuvenation. Some 20 medical practitioners from nine countries, including the US, Australia, Canada, China, Taiwan, Japan, Indonesia, Kazakhstan and Colombia, attended the two-day seminar in Seoul with lectures and cadaveric demonstrations. The company hosted a cadaveric workshop at the Catholic Institute for Applied Anatomy of the Catholic University of Korea on the first day. The injection of botulinum toxin and hyaluronic acid fillers, which helps facial rejuvenation and a youthful gaze, and theory courses were led by Dr. Kyuho Yi, the director at Maylin Clinic Apgujeong, Soo-Bin Kim, professor at the Department of Anatomy of Yonsei University College of Dentistry and Hyun Jin Park, professor at Department of Anatomy of Daegu Catholic University School of Medicine. On the second day, the seminar was focused on advanced aesthetic injection techniques. Lectures and live demonstrations for skin rejuvenation were performed by Dr. Ho Sung Choi, the medical director of Piena Aesthetic Clinic, and Dr. Jong Jin Lee, the medical director of DayBeau Clinic. “The trainees were highly satisfied with the seminar which facilitated sharing injection techniques of Korean medical experts, by using Hugel products, deep knowledge and emerging trends in the medical aesthetics field via a well-structured curriculum. The training course helps experts from different markets grow as global medical aesthetic industry leaders. Hugel will continue to actively organize academic events in each market to improve medical practices for skin rejuvenation,” a Hugel official said. Hugel hosted Train-The-Trainer for the second time after the first one held in April in Seoul. The course in August was part of Hugel Expert Leader’s Forum (H.E.L.F.), the global academic forum for medical aesthetic professionals that the company has held every year since 2013. About Hugel Established in 2001, Hugel is a leading global medical aesthetics company that manufactures injectables for skin rejuvenation such as botulinum toxin, hyaluronic acid fillers and skin boosters as well as tissue-lifting threads and cosmetics products. The company is the only South Korean supplier to the world’s three largest botulinum toxin markets, the US, China and Europe. It exports medical aesthetic products to around 70 countries and operates eight global subsidiaries in the US, Australia, Canada, Taiwan, China, Hong Kong and Singapore.
