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- 2026-06-24 12:06:26
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- EUSA Pharma is entering the Korean market
- by Jul 15, 2022 05:57am
- EUSA Pharma, a British pharmaceutical company specializing in rare diseases, announced its full-fledged entry into the Korean market. EUSA Pharma plans to directly supply the existing domestic approved Castlemans disease treatment, Sylvant (Siltuximab), while also accelerating the introduction of new rare disease treatments. EUSA Pharma held a press conference at The Plaza in Seoul on the 13th and announced its ambition to improve its recognition of Castlemans danger and enter the Korean market. EUSA Pharma is a pharmaceutical company specializing in rare diseases established in the UK in 2015. It was established as EW Healthcare Partners Funding, an investment company specializing in life science. As of June last year, global sales were recorded at 130 million euros. The number of employees around the world is about 250. In the first half of last year, the Asia-Pacific regional headquarters was established in Korea and the Korean subsidiary EUSA Pharma was launched in the second half of last year. Korea is the first region outside Europe and the U.S. where EUSA Pharma has entered. The Korean corporation consists of a total of seven executives and employees. Lee Yeon-jae, CEO of EUSA Pharma CEO Lee Yeon-jae (46) was appointed as the integrated general manager of the EUSA Pharma Asia-Pacific headquarters and the Korean subsidiary. CEO Lee has worked as CEO of UCB Pharmaceutical Korea and executive director of Sanofi-Aventis Korea's rare blood disease business division through Novartis Korea and Daewoong Pharmaceutical. The representative item of EUSA Pharma is Silvant, a Castlemans disease treatment that was approved in Korea in 2015 and is being applied to benefits. EUSA Pharma acquired Sylvant from Jansen in 2020 and has global copyright. In Korea, Samoh is the right to import and sell, and EUSA Pharma will be in charge of supplying and marketing Sylvant. Regarding the background of EUSA Pharma's entry into Korea, CEO Lee said, "The Asia-Pacific region, especially Korea, is considered an important market for the company as multiple Castlemans disease diagnosis and treatment are actively conducted." He explained, "Korea is not a country with a large number of patients compared to the population, but thanks to the medical staff's efforts to find and diagnose patients, it is considered the best country to diagnose and treat multiple Castleman disease after the United States and Italy." EUSA Pharma's first activity is to create an environment where patients can be diagnosed faster by raising awareness of multiple Castleman disease. Multiple Castlemans disease is a rare blood disease that causes organs such as lymph nodes, liver with lymphatic tissue, and spleen to enlarge due to excessive proliferation of lymphocytes. According to Jeon Young-woo, a professor of blood medicine at Yeouido St. Mary's Hospital, it takes about 27.5 months for patients to be diagnosed with multiple Castlemans disease. Due to the low awareness of the disease and low specific symptoms, it is often diagnosed only after the disease has progressed considerably. There are about 150 annual patients in Korea, but it is speculated that there will be more hidden patients who have not yet been diagnosed. If you do not receive proper treatment early, there is a high risk of developing lymphoma. 27% of patients are diagnosed with cancer within 2 to 5 years after diagnosis of multiple Castlemans disease. In the case of idiopathic multiple Castlemans disease, 35% of patients died within 5 years. Professor Jeon said, "Even within the medical staff, the recognition of multiple Castlemans disease is not very high, so diagnosis is very difficult unless it is tested for a purpose." After the lymph nodes become enlarged, it can be said that the disease has already progressed to seriousness," he explained. Professor Jeon said, "As long as early diagnosis is done well, various drugs such as Sylvant can be used to treat it. In particular, if Sylvant is used for more than six months, symptoms improve dramatically, and permits and benefits are applied as the first treatment in Korea. We can suspect Castlemans disease as an early test, and we should try to raise the awareness of medical staff and patients," he said. EUSA Pharma plans to make efforts to introduce the treatment Dinutuximab beta, which targets another rare disease, high-risk neuroblastoma, in Korea. CEO Lee said, "We are currently preparing screening data for Dinutuximab beta permission." Meanwhile, as Global EUSA Pharma was acquired by Recordati at the end of last year, changes are expected in its Korean subsidiary. CEO Lee said, "We are discussing organizational charts and development strategies for each country, and major commercial organizations have been reorganized." CEO Lee added, "There is a possibility that the name of the company will be changed, and it is expected to be finalized at the end of this year."
- Company
- Multinational companies leaving the Korean market
- by Jul 15, 2022 05:57am
- New drugs from multinational pharmaceutical companies such as Otezla, Cotellic, and Erievedge, which were not properly introduced in the domestic market, left the Korean market one after another this year. It is believed that it has made significant sales overseas but has decided to withdraw due to lack of marketability in Korea. According to the MFDS on the 7th, Roche voluntarily dropped two types of anticancer drugs, Cotellic and Erievedge, in the first half of the year. The licenses for Cotellic and Erievedge were revoked as of June 23 and April 7. Erivedge is a skin cancer treatment approved by the MFDS in 2013. It is used to treat metastatic basal cell cancer that cannot be operated or radiated. It is the first target anticancer drug for skin cancer and a rare drug that raised global annual sales of 380 billion won. Although Erivedge was a non-reimbursed drug in Korea, it was selected as the government's "disaster medical expenses support project" in 2015 as a treatment for rare diseases and provided medical expenses. However, as severe skin abnormalities were reported and it was pointed out that the drug price was higher than its clinical usefulness, In 2017, the UK removed Erivedge from the list of anti-cancer drug support funds. Even in Korea, Erivedge has not been imported since 2019. Cotellic is a melanoma treatment approved in Korea in 2015. Although it was conditionally approved as a new drug for MEK inhibitors, it was pointed out in the 2017 parliamentary audit because it was not supplied to Korea after approval. It seems that he did not enter the domestic market after that. Since it has never been supplied, no application for salary has been made. Due to the cancellation of the Cotellic, Roche's immuno-cancer drug Tecentriq and combination therapy are not expected to be used in Korea. Roche obtained an indication of progressive melanoma treatment in the United States with Tecentriq+Cotellic+Zelboraf 3 drug therapy in 2020. Amgen's psoriasis drug Otezla has left the market. Otezla is the first PDE-4 inhibitor that Amgen acquired from Celgene. In the global market, they performed so well that they were ranked as blockbusters. Otezla's annual sales reached 2.9 trillion won last year. Korea also showed high expectations for Otezla, which obtained permission in 2017. However, Otezla was not even released in Korea. It is believed that negotiations were not smooth because Celgene, the first permit holder, was merged with BMS, and Amgen changed one after another in the process of acquiring Otezla. In addition, as the expiration date of Otezla's patent approaches, Amgen seems to have decided that it has lost marketability in Korea. Amgen dropped Otezla's permission on June 9.
- Company
- Tabrecta can be prescribed at hospitals
- by Eo, Yun-Ho Jul 14, 2022 05:54am
- According to related industries, Tabrecta of Novartis Korea passed the D.C. of medical institutions such as the National Cancer Center, Pusan National University Hospital, Samsung Seoul Hospital, and Sinchon Severance Hospital. Tabrecta, which is currently undergoing the insurance benefit registration process, was approved in Korea in November last year. MET mutations are rare types that account for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Tabrecta targets c-Met and was first approved in the United States as a non-small cell Lung Cancer treatment in May 2020. The drug was validated by a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among patients who took Tabrecta, patients who had not previously been treated (DoR was 12.6 months and those who had been treated were 9.7 months. Tabrecta is also stepping up research for future combination therapy. In particular, it is expected to solve the resistance problem of EGFR TKI in lung cancer. Tabrecta is conducting clinical trials in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Specifically, combination therapy of Tabrecta and Tagrisso is compared with platinum-based chemotherapy for EGFR mutated non-small cell lung cancer patients with T790M negative and amplified MET genes during treatment with first and second generations EGFR TKI or Tagrisso. Han Ji-yeon, a professor of hematology and oncology at the National Cancer Center, said, "The prognosis of patients with MET amplification is also very poor. At a time when it is very important for MET inhibitors to enter the market quickly, it is significant that drugs such as Tabrecta, which proved a clear effect only on MET Exxon 14 deficit mutations, were approved."
- Company
- SK Bioscience, "SKY Covione booster prevents Omicron”
- by Chon, Seung-Hyun Jul 14, 2022 05:54am
- SK Bioscience announced on the 13th that its ‘SKYCovione’ has shown to have an effect in preventing the Omicron variant as a booster shot. SK BioscienceThe company identified such results from an extension study on Phase I/II trial on SKYCovione that was conducted on 81 healthy adults who received a booster dose of SKYCovione around 7 months after primary vaccination. Study results showed that the neutralizing antibody titres against the Omicron variant BA.1 were 25 times the titres right after the second dose, and 72 times the titres 7 months after the second dose (immediately before receiving a booster shot) SKYCovione is a locally developed COVID-19 prevention vaccine that was approved in Korea last month. SKYCovione induces antibody response by administering antigenic proteins made by genetic recombination technology The vaccine had previously demonstrated its immunogenicity and safety through a global clinical trial. In a global Phase III trial conducted on 4,037 adults over 18 years of age, 98% of the participants seroconverted (with neutralizing titres after immunization greater than fourfold the titres at baseline). Neutralizing antibody responses also increased by 33 times the titres before SKYCovione injection and were 3 times the titres elicited by the control vaccine. In addition to the Phase I/II extension trial, the company is conducting an extension trial on the recent Phase III trial it had conducted, as well as a booster shot trial for those who have been vaccinated with other approved vaccines in Korea to further explore SKYCovione’s response to the Omicron variant. Jaeyong Ahn, CEO of SK Bioscience, said, “In addition to the various trials in progress for SKYCovione, we will make our most effort to accelerate the development of polyvalent vaccines and universal vaccines based on our platform in preparation of the endemic.”
- Company
- Indications of Jardiance have expanded
- by Jul 13, 2022 06:05am
- View of Jardiance press conferenceAs the SGLT-2 inhibitor Jardiance expanded its scope to a treatment for chronic heart failure unrelated to heart rate, expectations were also expressed in the clinical field. The medical staff said, "We changed the paradigm of heart failure treatment. There are also non-payment areas, but the burden of drug prices is low, so we are actively using Jardiance as a "non-reimbursement." Beringer Ingelheim Korea and Lilly Korea held a press conference on the 12th to commemorate the expansion of the adaptation of the SGLT-2 inhibitor Jardiance. Kang Seok-min, a professor of cardiology at Yonsei Severance Hospital, and Cho Hyun-jae, a professor of cardiology at Seoul National University Hospital and Yoon Jong-chan, a professor of cardiology at Catholic University, participated as speakers to share the value and significance of Jardiance, a new heart failure treatment option. Jardiance expanded its indication to HFpEF in May, becoming the first drug that can be used for all heart failure. Usually, the ejection rate is reduced by less than 40%, the boundary is 40 to 50%, and more than 50% is considered conservation. There have been no drugs that encompass both reduction and preservation of the ejection rate. This is because many new drugs have not proven their effectiveness in heart failure clinical trials. Jardiance succeeded in achieving a primary efficacy evaluation in EMPEROR-Preserved clinical trials in patients with ejection rate-preserving heart failure. According to clinical trials, the Jardiance group reduced the relative risk of hospitalization due to cardiovascular death or heart failure by 21%. Even in the secondary variable, the relative risk of first and repeated hospitalizations due to heart failure was reduced by 27%, and the reduction of eGFR, an indicator of renal dysfunction, was delayed. Medical staff believed that Jardiance's appearance was very meaningful in a situation where the number of patients with heart failure preserving the ejection rate increased, but there were no suitable drugs. Professor Cho said, "Although patients with heart failure, which accounts for about half of all heart failure patients, have relatively many comorbidities and the number is increasing, there are no treatments, so only symptomatic or comorbid diseases were available." "Jardiance proved its good effect in patients with heart failure exceeding 40% of ejection rate, making it the first treatment to cover the entire spectrum of chronic heart failure left ventricular ejection rate," he said. In an EMPULSE study of patients with acute or non-compensatory CHF, Jardiance also confirmed treatment effects such as death from all causes, reduction of heart failure events, and improvement of heart failure symptoms compared to placebo group. In the sub-analysis, more than 65% of the patient groups showed poor efficacy, but this patient group is an object that needs more research even within heart failure. Professor Yoon said, "More than 65% of the ejection rate can be considered normal, but it is classified as a heart failure patient because it shows signs of heart failure. However, there is also a controversy over whether the group can be viewed as the same as existing heart failure patients, he said. "In-depth research on this group is needed." They agreed that SGLT-2 inhibitors, including Jardiance, changed the paradigm of heart failure treatment. Professor Kang said, "Just as SGLT-2 inhibitors are compared to '21st century Statins', SGLT-2 inhibitors in heart failure treatment are drugs that have changed the paradigm." In the future, there will be a perception that SGLT-2 inhibitors will be installed as basic as statins in the clinical field," he said. "We hope that a medical system will be established to diagnose and manage chronic heart failure early as drugs that can be used in patients preserving the ejection rate are created and the number of patients with chronic heart failure is increasing," he said.
- Company
- J&J will spin off its consumer health division next year
- by Eo, Yun-Ho Jul 13, 2022 06:05am
- Johnson & Johnson will officially spin off its Consumer Health division in the first half of next year. According to industry sources, Johnson & Johnson Korea’s Consumer Health division, which is in charge of cosmetics and the OTC drug business, will be spun off into a separate corporation in the first half of 2023. In line with the measures made by Johnson & Johnson’s global headquarters, the Korean subsidiary has also started the spin-off process. For Johnson & Johnson in Korea, the spin-off would mean that the company will be operated as two separate corporations – Janssen Korea, which is in charge of J&J’s pharmaceutical business, and Johnson & Johnson Medical Korea. The spin-off of the consumer health division is settling as a trend in multinational pharmaceutical companies. Many companies, such as Pfizer, MSD (Merch US), and GSK have already completed the spin-off of their consumer health divisions. While announcing the separation of its consumer health business in November, Johnson & Johnson explained that the new consumer health company will be in charge of iconic brands such as Neutrogena, Aveeno, Tylenol, Listerine, and Band-Aid, and would become a global consumer health company that would impact the lives of over 1 billion consumers globally. The name, board of directors, and executives of the new corporation will be decided upon in the spin-off process. The consumer health division had raised approximately $15 billion (₩17.7 trillion) in sales last year in more than 100 countries worldwide. J&J's consumer health portfolio consists of 4 megabrands that gross annual sales of over $1 billion and 20 brands with annual sales of over $150 million. Meanwhile, the medical device division of the global healthcare company Johnson & Johnson, headquartered in the US, changed its corporate name from Johnson & Johnson Medical Devices to Johnson & Johnson MedTech in March this year. However, the name of the Korean branch will be maintained as Johnson & Johnson Medical Korea.
- Company
- Pharmbio's Orafang was published in the JCC
- by Nho, Byung Chul Jul 13, 2022 06:05am
- Pharmbio (Chairman Nam Bong-gil) announced on the 12th that the comparative clinical results on the use of Orafang PO and 2L PEG drugs for IBD patients in Ccaid were introduced in the famous journal Journal of Cron's and Colitis. JCC is an SCIE-class medical journal in the field of inflammatory bowel disease published by Oxford University Press (OUP), and is a prestigious paper with an impact index of 9.485 over the past five years. In the paper, the comparative clinical results of the intestinal crystallinity (HCS) of the two preparations revealed that the intestinal tract of Orafang was significantly excellent in all compartments such as ascending colon (3.06
- Company
- Will Godex overcome its reimb crisis at half price?
- by Nho, Byung Chul Jul 13, 2022 06:05am
- Celltrion Pharm’s Godex cap, which was not recognized for its reimbursement adequacy and rejected reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 7th, is drawing attention due to the possibility of receiving a reimbursement cut rather than a reimbursement deletion decision. The reason why this speculation is gaining strength is that other drugs that contain the same main active ingredient as Godex - biphenyl dimethyl dicarboxylate (BDD)- such as Pharma King’s Nissel Tab and its 2-drug combo Pennel Cap (BDD+garlic oil) are still listed and recognized for reimbursement in Korea. Also, the current drug pricing regulations are based around a phased price reduction system that cuts the price of original drugs with the entry of generics, forcing reimbursement deletions or cuts after reevaluations with no other follow-ons in the market may be considered somewhat irrational. Therefore, the industry speculation is that Celltrion Pharm will overcome the current situation using a voluntary drug price cut, which would reduce the price of Godex to the level set for single and two-drug combo agents as its negotiation card during the objection period after demonstrating Godex’s efficacy and effect through literature and clinical data. Godex, a combination drug that contains BBD and 6 other ingredients, is currently listed at ₩371. The two-drug combo Pennel is listed at ₩312, and the single-agent drug Nissel at ₩144. Under the indication approved by the Ministry of Food and Drug Safety, Godex is used to treat liver disease with increased serum glutamic-pyruvic transaminase (SGPT), and Nissel and Pennel are used to treat chronic persisting hepatitis. Based on the indication, Godex may be considered to be different from Nissel or Pennel. However, the API used in all three drugs, BDD, is a standardized and synthesized derivative of schisandra chinensis (Omija) that rapidly lowers the liver inflammation GPT level with its antioxidant action and normalizes ALT with little rebound effect. In this broader sense, the three drugs can be considered to be in the same drug group. The sales performance of each drug last year amounted to ₩53.8 billion for Godex, ₩0.3 billion for Nissel, and ₩5.9 billion for Pennel. No latecomer of the combination drugs Godex and Pennel has been released yet due to difficulty securing subjects for bioequivalence tests, etc. Among single agent drugs, 23 products including Nissel are currently competing in the ₩4 billion market. HIRA aims to consolidate NHI finances using its reimbursement adequacy reevaluation standard to adjust items that cost ₩20 billion or more in claims (0.1% of the NHI claims amount). Using Nissel and Pennel as comparators for Godex also reflects HIRA's determination. Then, by how much would Celltrion Pharm need to lower Godex’s drug price to persuade HIRA? Celltrion Pharm would have two options. First, it could reduce the price of Godex to align with the price of the two-drug combination Pennel at ₩312. In this case, Godex’s price will fall 15.9% from its current price. The other option is to accept Nissel’s price, which is listed at ₩144, and attempt a blowout reduction in its price, lowering the price by 61%. When only considering the situation where Godex’s reimbursement adequacy was already rejected without regarding the current drug price regulation or rationality, using Nissel’s price for the voluntary price cut would be safer than using Pennel’s price to persuade the members of DREC. If Godex, which makes external sales of ₩60 billion, continues to sell the same after a 15.9% price cut, the drug can maintain its position as a blockbuster drug, bringing in ₩40 billion. However, with a 61% price cut, the drug’s sales will drop under the "claims of ₩20 billion or more" guideline that was set for reevalurationalehis time, and nullify any rational HIRA has to reject the proposition. Also, the fact that a new administrative notice has been issued for the "Rule for Standard of Medical Insurance Benefits of National Health Insurance" that stipulates the patent continuity as a factor for reimbursement reevaluations in addition to the existing standards such as clinical efficacy and drug pin overseas countries, may also act as a factor. If the continuity of a patent is applied as a new standard in the reevaluation, Celltrion Pharm would need to take into account the patent expired status of Godex even after demonstrating Godex’s efficacy and effect through literature and clinical data. In this case, it would be more advantageous to reduce the price of Godex to the price level of the single-agent drug rather than the two-drug combination. Regarding the overall situation, an industry official said, “If Celltrion Pharm and HIRA do not come to an agreement during the arbitration period, it can result in a lawsuit. And the court may accept the injunction to suspend the deletion of reimbursement, considering the current drug regulation and reevaluation conditions. However, rather than turning for the worst, the company may pursue a lesser evil method and work to increase sales after undergoing a reimbursement cut.”
- Company
- Vyzulta reimbursed and prescribed at general hospitals
- by Eo, Yun-Ho Jul 12, 2022 05:53am
- The glaucoma treatment ‘Vyzulta’ has received approval for insurance benefits and is landing at general hospitals in Korea. According to industry sources, Baush + Lomb Korea’s ophthalmic solution Vyzulta (latanoprostene bunod) has passed the drug committees of various medical institutions including the Seoul National University Hospital and Gangnam Severance Hospital. Vyzulta, which was approved in Korea in February last year, passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) deliberations in the August of the same year and was listed for reimbursement starting February this year. Vyzulta is an ophthalmic solution that reduces intraocular pressure (IOP), which is a risk factor of glaucoma, and is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Drug treatment to reduce IOP is currently considered the most effective treatment for glaucoma. Vyzulta has two separate MOAs for drainage and is metabolized into two moieties1 – its API Latanoprost acid and nitric oxide –to reduce IOP through by increasing the outflow of aqueous humor through both uveoscleral and trabecular meshwork channels Also, Vyzulta demonstrated a superior mean IOP reduction effect over latanoprost 0.005%, a common glaucoma treatment, and demonstrated statistically significantly greater mean IOP reduction over Timolol 0.5% in clinical trials. Meanwhile, Vyzulta’s had costed around ₩110,000 per year without reimbursement, but the patient’s out-of-pocket cost was reduced to around ₩30,000 per year with reimbursement, being applied a 30% coinsurance rate.
- Company
- Johnson & Johnson Medical Devices changed its name
- by Eo, Yun-Ho Jul 12, 2022 05:53am
- Director Oh Jin-yong Johnson & Johnson Medical of Korea announced a new start with a change of name. The company held a press conference explaining the "J&J MedTech" rebranding at The Plaza Hotel in Jung-gu, Seoul on the 11th and announced its vision to lead innovation in the future medical market combined with digital as a global leading company. Johnson & Johnson's medical device division, a U.S.-based global healthcare company, changed its name from Johnson & Johnson Medical Devices to Johnson & Johnson MedTech in March. The name of the Korean branch will be maintained by the existing Johnson & Johnson Medical Center. The event was announced by Oh Jin-yong, president of North Asia, and introduced a new corporate vision and business direction focusing on digital transformation. President Oh pointed out the recent rapid development of digital transformation throughout the industry, and in line with this, Johnson & Johnson Medical Korea will make a new leap forward as a medtech company that encompasses not only medical devices but also digital solutions such as robotic surgery and medical software. As a specific strategy, it plans to develop new models of future healthcare in the digital era, contribute to improving human health through state-of-the-art technology and innovation, and present integrated solutions for optimal treatment away from existing products to focus on overall health. "The transition to &J MedTech is part of efforts to provide innovative treatment solutions to meet the rapidly digitizing medical environment and patient demand. "Our vision is to provide smarter, less invasive, and more customized treatment for patients by utilizing advanced technologies such as AI, machine learning, data science, and virtual reality," he said. To this end, three future directions were presented, leading the healthcare innovation, developing digital healthcare solutions that encompass the entire process of patient treatment, and optimal treatment using data science. It will also continue to cooperate closely with medical personnel to reflect the demand of clinical sites and to create a better medical environment. President Oh Jin-yong said, "The Korean medical device market is emerging as a center of Meditec innovation in the Asia-Pacific region thanks to continuous growth and the emergence of ventures with innovative technologies and global competitiveness." Johnson & Johnson Medical Korea is a global company that has provided medical devices and digital solutions for 34 years since its establishment in 1988, and consists of major business units such as ETHICON, which provides surgical medical devices and digital solutions, DePuy Syntes, and CSS (Cardiovascular & Specialty Solutions).
