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- Policy
- Revival of omega-3 fatty acids...4g high-dose recommended
- by Choi, sun May 18, 2023 05:45am
- The Korean Society of Lipid and Atherosclerosis (KSoLA) disclosed the full version of its 5th edition of the Korean Guidelines for the Management of Dyslipidemia, in which the use of omega 3 was subdivided into the use of 'high dose and refined ingredients'. Although there has been controversy over its efficacy, the new guideline puts weight on the fact that the benefits of its use still outweigh its non-use. Annual Scientific Conference of the KSC with Affiliated Cardiac Societies On the 22nd, the Annual Scientific Conference of the KSC with Affiliated Cardiac Societies that was organized by 8 academic societies including the Korean Society of Cardiology, the Korean Heart Rhythm Society, the Korean Society of Heart Failure, and KSoLA, announced the ‘2023 KSoLA Guideline Update,’ ‘Evidence of Guidelines,’ and ‘Limitations in the Evidence’ were announced. A simplified version of the revised guidelines was announced last year, but this year, the full version was released to support its details and rationale. The new changes made in the 5th version were ▲the Method of diagnosis and standards, ▲Treatment standards. First, in the new diagnosis method and standard, the KSoLA showed the result that the non-fasting triglycerides level showed a high correlation with the risk of cardiovascular disease. In the standards, patients with coronary artery disease were recommended to lower their LDL cholesterol target level from less than 70 mg/dL to less than 55 mg/dL and lower it by more than 50% from baseline. In the case of patients with diabetes, the target goal is less than 70 mg/dL for patients with a disease duration of 10 years or more, one or more additional risk factors, or target organ damage, depending on the risk level. In addition, diabetic patients with 3 or more target organ damage or major cardiovascular disease risk factors can selectively consider reducing LDL cholesterol to less than 55 mg/dL. Furthermore, as exercise therapy, the recommendation grade for the use of wearables for fitness was newly presented as IIa, and additionally methods for using wearable equipment and a strategy for promoting physical activity were suggested. In the full version, society took a somewhat reserved position on the use of Omega 3, which was plagued by controversy over its cardiovascular protective effect. Professor Ye-Seul Yang (Endoctrioinology, SNUH), who presented on the 'New Changes on the KSoLA Guidelines,’ said, “The 5th edition of the revised guidelines segmented and reinforced the treatment criteria and treatment targets for dyslipidemia. The new guideline recommended different treatment standards by subdividing diabetes by risk group." Yang said, “Individualized guidelines were set according to specific groups such as those with stroke, chronic kidney disease, the elderly, adolescents, and familial hypercholesterolemia. In terms of drug therapy, the recommended grade was raised to emphasize that statins are a first-line treatment drug, and introduced icosapent ethyl(IPE) and the role of fibrate and omega-3 fatty acids in managing triglyceride.” As for whether omega 3 actually shows a protective effect against cardiovascular disease, large-scale studies have come to different conclusions. The most recent study that proved its efficacy observed an effect when only the IPE component was isolated from the omega-3 and used in high dosages. The KSoLA newly included the use of IPE in the recommendation for patients with atherosclerotic cardiovascular disease or diabetes who still have hypertriglyceridemia even after LDL cholesterol is controlled below the target level with statins. In the treatment of hypertriglyceridemia, "Use of fibric acid derivatives or omega-3 fatty acids that mainly lower triglycerides first are recommended as a priority (IIa, A), and even after achieving LDL cholesterol below the target level through therapeutic lifestyle improvement and statin drug treatment, if the triglyceride is 200 mg/dL or higher or the non-HDL cholesterol level is higher than the target value, drug treatments to lower the triglyceride can be considered (IIa, B)." KSoLA said, "In the recent REDUCE-IT study, 4g of IPE was administered per day in patients at high risk of atherosclerotic cardiovascular disease or diabetes, which reduced the incidence of cardiovascular disease by 26% compared to placebo. If hypertriglyceridemia persists in high-risk patients at a 200 mg/dL or higher level even after lifestyle improvement and statin administration, additional IPE (4g per day) can be administered to prevent cardiovascular disease (IIb, B)." However, KSoLA added a provision on account of the controversy in place. KSoLA added, “The effect of omega-3 fatty acids on reducing the risk of cardiovascular disease is still in controversy because of the varying results shown depending on formulation or dosage. In the recent REDUCE-IT study that was conducted in patients at high risk of cardiovascular disease whose triglyceride levels were higher than 135-499 mg/dL, the use of IPE, a high-purity EPA, twice a day significantly reduced death from cardiovascular disease and the occurrence of ischemic disease." “In the European practice guidelines that were revised in 2019, control of triglyceride using IPE was recommended for patients at high risk of cardiovascular disease, however, IPE is not being sold in the market yet. Also, in another recent study, the STRENGTH study, the combination of EPA and DHA did not show any benefit in cardiovascular disease, but rather increased the risk of atrial fibrillation compared to the control group." Also, the guidelines emphasized the need to use a high-dose high-purity ingredient for the combined use of statin and Omega 3. KSoLA said, “Combination therapy can be used to reduce LDL cholesterol and triglyceride at the same time. "The combination of 4 g of Omega 3 per day with simvastatin significantly decreased triglyceride and slightly increased HDL cholesterol."
- Product
- Diabetes Association also paid attention to 'zero' drinks
- by Choi, sun May 18, 2023 05:45am
- Possible inhibition of glycemic response and increased risk of cardiovascular events This year, while the American Diabetes Association recognized intermittent fasting and time-restricted eating as part of a meal pattern based on research results that help reduce weight and improve blood sugar, the Korean Diabetes Association also reviewed low-carbohydrate diets and non-nutritive sweeteners. The Diabetes Association acknowledged the Mediterranean diet and the DASH diet, which have accumulated some evidence, while asking for a cautious approach in that non-nutritive sweeteners have mixed results. On the 12th, the Korean Diabetes Association held a spring academic conference at the Kimdaejung Convention Center in Gwangju, and disclosed the results of the review of evidence and revision work conducted by the Food and Nutrition Committee of the society. Professor Lim Jeong-hyeon, Seoul National University Hospital, Food and Nutrition Division (Cancer Committee, Korean Society of Clinical Nutrition) Numerous studies have already shown that healthy eating habits, including the Mediterranean, vegetarian, low-fat, low-carbohydrate, and DASH (salt-restricted diets designed to reduce blood pressure in people with hypertension), improve blood sugar, reduce weight, and reduce the risk of cardiovascular disease. being confirmed Because of this, the American Diabetes Association and other major treatment guidelines recommend individualizing various dietary patties and using them appropriately. In particular, according to the research results that time-restricted meals are helpful for weight loss and blood sugar improvement, in 2023 the American Diabetes Association included intermittent fasting and time-restricted meals as one type of meal pattern, and whether or not this was reflected in Korea has emerged as a matter of interest. This month, the Korean Society for Obesity published guidelines for low-carbohydrate diets that limit carbohydrate intake to 10-45% of total energy intake. situation you are doing. In the midst of this, the Korean Diabetes Association also presented an appropriate answer. The revised guidelines of the Korean Diabetes Association are largely divided into ▲ intake of carbohydrates in a form rich in dietary fiber ▲ refrain from sugar-sweetened beverages to minimize the intake of added sugars ▲ limited use of non-nutritive sweeteners for a short period of time. “The 2021 recommendation did not recommend an extreme diet method that did not prove long-term benefits,” said Lim Jeong-hyun, professor of nutrition at Seoul National University Hospital (Cancer Committee of the Korean Society of Clinical Nutrition). The method was observed and reflected in the 2023 recommendation.” "Mediterranean, vegetarian, low-fat, DASH, and low-carbohydrate eating patterns have demonstrated long-term benefits," he said. "Therefore, these eating patterns can be adapted according to goals and preferences (limited recommendations)." He said, “The American Diabetes Association revised the carbohydrate section of medical nutrition therapy in 2022 to emphasize the quality intake of carbohydrates. We presented the rationale for this and added an ultra-low-carbohydrate diet to the dietary pattern session.” In fact, as a result of analyzing 10 RCTs involving 1376 type 2 diabetes patients, it was found that glycated hemoglobin and body mass index decreased according to carbohydrate restriction. Professor Lim said, "In a 2022 meta-analysis study of 50 RCTs for patients with type 2 diabetes, reducing carbohydrate intake to less than 45% of total energy intake showed improvements in several indicators such as body weight, lipids, and glycated hemoglobin." For each 10% reduction, A1C decreased by 0.2%, FPG by 0.34mmol/L, and body weight by 1.44kg, and all serum lipid indicators were improved.” He said, "Up to 6 months, the rest of the indicators showed a linear decrease in the 40% carbohydrate diet, but triglycerides and LDL cholesterol showed a U-shaped shape." Although they decreased, their weight showed a U-shaped pattern." "Because a meal is a combination of various foods, there can be many patterns in a weight control diet," he said. It is important to increase individual compliance, such as using a Mediterranean diet or Mediterranean diet, and to allow patients to choose individually according to their goals and preferences, and to provide evidence for that.” In view of the consistent increase in the risk of developing diabetes when consuming sugar-sweetened beverages, the society recommended refraining from sugar-sweetened beverages while urging caution against consuming beverages that have been replaced with non-nutritive sweeteners. Professor Lim said, “The risk of diabetes rises by 51% when you consume one or more sugary drinks a day, and a 10% reduction in sugar-sweetened beverage intake consistently reduces the risk of diabetes.” It should be recommended to replace it with coffee.” He said, “The problem is that the effect of replacing sugar-sweetened beverages or sugar-sweetened beverages with artificial sweeteners is inconsistent. "I haven't made a clear statement," he said. He said, “In a 2021 study, sucralose and saccharin inhibited the blood sugar response, and a study published in NATURE this year showed that erythritol increased the risk of major cardiovascular events.” For this purpose, the use of non-nutritive sweeteners for a short period of time can be considered on a limited basis.”
- Policy
- Initial appvl rate of drugs subject to prior review varies
- by Lee, Tak-Sun May 18, 2023 05:45am
- As a result of analyzing the approval rate of prior authorization drugs over the past 10 years, the approval rate varied greatly according to the type of drug. However, unlike during the initial review, the review for maintenance therapy showed a high approval rate of 90%. Yong-Kyun Won, Professor of Radiation Oncology at Soonchunhyang University Cheonan Hospital, announced so through a retrospective record analysis study on the prior authorization drugs over the past 10 years (2021-2022).' The study was presented at the 22nd Annual Conference of the Korean Society of Insurance Medicine which was held on the 14th. The prior authorization system was implemented in 2012 to establish clear standards for the use of high-priced drugs and to prevent drug abuse. Soliris, Spinraza, Ultomiris, Strensiq, and Zolgensma, which are rare disease drugs and ultra-high-priced drugs that cost more than KRW 300 million won per year, receive health insurance reimbursement through the system. Crysvita was recently added as a drug that requires prior authorization. According to the study, drugs that were expensive but are essential for the treatment of rare diseases have been able to receive reimbursement through the system, and this pre-deliberation system has been successful, such as in managing the quality of treatment through patient monitoring (maintenance therapy), etc. However, the approval rate was different for each drug. In particular, the prior authorization approval rate for initial administrations ranged from 20% to 100% by product or indication. In comparison, the review approval rate for maintenance therapy exceeded 90%. The varying initial approval rate of prior authorization drugs (retrospective record analysis study on prior authorization drugs (2012~2022)) For example, in the case of patients who seek to use Soliris for aHUS, the initial approval rate was only 21.6%. On the other hand, drugs such as Ultomiris (77.8%) and Strensiq (100%) showed high approval rates. On the other hand, the number of acceptations of objections on the disapproval was low. Only 1 out of 17 objections in 2022 were accepted, and therefore the analysis was that it was a difficult environment for disapproved drugs to receive deliberations again. Professor Won expressed concerns about how the low approval rate may limit access to reimbursement. In addition, for drugs in need of urgent deliberations due to the child's age or disease type, Won explained that the system where institutions need to wait for announcements until the end of the month to see why their application was disapproved and what needs to be supplemented, should be improved as well. Professor Won said, “The prior authorization system is settling as an essential system in securing access to treatment for high-priced drugs that are being continuously introduced to the field. Doctors may feel it is difficult to use a drug if the approval rate is too low. Therefore, it is necessary to review whether the reimbursement standards are too strict and whether it needs revisions.”
- Opinion
- [Reporter's view] Are you ready to use
- by Lee, Hye-Kyung May 18, 2023 05:45am
- The 'Act on the Safety and Support of Advanced Recycles and Advanced Biomedicines' will be in effect for three years in August. The Advanced Recycled Bio Act prepares a system for securing the safety of advanced renewable medicine, provides a plan for technological innovation, and practical use, and stipulates the necessary matters to secure the quality, safety, and effectiveness of advanced biopharmaceuticals, and to support commercialization.The Advanced Recycled Bio Act has been implemented, and 36 cell treatment facilities and 32 human cell management institutions have been approved in Korea. Cell therapy is made in Korea to export technology to foreign countries, or the CMO/CDMO business of biopharmaceuticals is actively underway. As if proof of this, 'BioKorea 2023', which was held from May 10th to 12th, was presented by a high-tech renewable medical center for the first time, and various sessions were held on the theme of revitalizing clinical research on advanced renewable medicine and exploring the direction of the development of the high-tech biopharmaceutical industry. A speaker who attended the site at the time said that the regenerative medicine session was formed for the first time in Bio Korea, and that it was time to seek industrial development as well as domestic advanced regeneration bio research. However, it has only been three years since the High-Tech Recycled Bio Act was implemented, so it seems that there is still a long way to go. The Ministry of Health and Welfare has expressed its will to improve regulations to revitalize clinical research on cutting-edge bioregenerative medicine treatment technology. It is said that the clinical research application target will be expanded and the clinical research results can be linked with approval, but the position of the researchers conducting the actual research was a little different. It is said that it is urgent to prepare a legal basis for the activation of clinical research data based on the Temple of Heaven's Regenerative Bio Act. In fact, there have been various attempts to utilize the health care big data platform, but the linkage rate between each institution is low as it still hits the wall of personal information. Even if you use data from multiple platforms, you have no choice but to hit the limits of using it with your gender, name, and date of birth alone. In the end, this phenomenon seems to be bound to occur in the use of advanced regeneration bio clinical research data. There is a provision in the Advanced Recycled Bio Act that 'if you need a head of a safety management agency, you can request the provision of data such as unique identification information', but it is not enough to expand it to pharmaceutical companies and clinical research practitioners. In accordance with the Advanced Recycle Bio Act, the basic plan for advanced renewable medicine and advanced biopharmaceuticals is established every 5 years. Three years are coming, and the time is coming soon to come up with a second basic plan. When you try to take advantage of the accumulated endless health care big data, you have to remember the many hurdles. Data from high-tech regeneration and biopharmaceuticals that have just crossed 2/3 of the first basic plan is being collected one by one. In order to actively conduct clinical research with this data, it is necessary to come up with various strategies that can utilize individual unique identification information.
- Company
- Chong Kun Dang has the domestic license for the 110 billion
- by Chon, Seung-Hyun May 18, 2023 05:44am
- Chong Kun Dang bought the domestic license for MSD’s blockbuster diabetes treatment ‘Januvia series’. It is equipped with a stable cash cow that raises more than 100 billion won a year. Chong Kun Dang signed a license agreement with MSD headquarters in Switzerland to introduce all domestic rights for three diabetes treatments, Januvia, Janumet, and Janumet XR. Chong Kun Dang acquires not only domestic sales and distribution rights for the three Januvia series, but also all rights such as licenses, trademarks, and manufacturing. The contract period is from July 15th to August 31st, 2038. The total contract amount is 45.5 billion won. Chong Kun Dang paid MSD headquarters a down payment of 23 billion won, and the milestone scale according to sales is 17 million dollars (approximately 22.5 billion won). But Since 2016, Chong Kun Dang has jointly sold the Januvia series with MSD Korea. Through this contract, it exclusively secured domestic rights for the Januvia series for the next 15 years. Chong Kun Dang receives the Januvia series from MSD headquarters and sells them exclusively in Korea. Januvia is a DPP-4 inhibitory antidiabetic drug containing Sitagliptin. Janumet is a combination drug combining Januvia and metformin. According to UBIST, a pharmaceutical research institute, the Januvia series jointly invested a total of 109.4 billion won in outpatient prescriptions last year. Januvia and Janumet raised 40.5 billion won and 68.9 billion won, respectively. Outpatient prescription amount of Januvia series by year (unit: KRW 100 million, source: UBIST) The amount of prescriptions for the Januvia series last year decreased from 130.7 billion won in 2020 and 124.6 billion won in 2021, which is the aftermath of drug price cuts. In March of last year, through a 'trade-off' agreement with the government, MSD lowered the insurance cap for the Januvia series by an average of 6.0%. The drug price of the Januvia series was voluntarily lowered as a condition of expanding reimbursement for Keytruda, an immuno-oncology drug. Considering the drug price reduction rate of the Januvia series, it means that it still has a great influence in the market. As Chong Kun Dang has secured all licenses for the Januvia series, profitability from future sales is expected to increase. An official from Chong Kun Dang said, “We were leading the market with a diverse portfolio of diabetes treatments, including Duvie,” and “We stably expanded the treatment options for patients by securing the Januvia series.”
- Company
- Benefit extended DM Drug
- by Moon, sung-ho May 17, 2023 05:38am
- Clinical sites are busy finding the optimal prescription combination while the expansion of diabetes treatment reimbursement standards for each class and the release of generics following the patent expiration of original items coincided. It is an effort to find the optimal combination for each treatment category that can be covered by health insurance to minimize patient burden. According to the pharmaceutical industry on the 26th, the Ministry of Health and Welfare significantly eased the criteria for the accreditation of diabetes medications this month. The key is that various drug combinations are possible without specifying the SGLT-2 inhibitor component. With this revision, SGLT-2 inhibitors such as Ipragliflozin, Empagliflozin, and Ertugliflozin can be reimbursed when used together. Combinations of Metformin + SGLT-2 inhibitor + DPP-4 inhibitor and Metformin + SGLT-2 inhibitor + TDZ combination are also acceptable if the HbA1C is 7% or higher even if the two-drug regimen is administered for more than 2 to 4 months. Insurance cannot be provided if only SGLT-2 inhibitor + DPP-4 inhibitor or TZD is used without Metformin. In the clinical field, following the release of Forxiga's generic products in April, guidance is being given to prescribing DPP-4 inhibitors or TZD with reimbursement instead of prescribing inexpensive SGLT-2 inhibitors through the full cost of the patient's expenses. This is because the 2nd union is excluded from the benefit target. A professor of endocrinology at A University Hospital, an executive officer of the Korean Diabetes Association, said, "Three-drug therapy was applied as reimbursement, but SGLT-2 inhibitor + DPP-4 inhibitor or TZD two-drug therapy is not reimbursed, so it can be a prescription form." It is still in the early stages of expanding the salary standard, so there are various opinions coming and going.” In addition, there is an opinion that there may be a situation where there is no choice but to recommend the patient to take without 'metformin' instead of prescribing the three-drug therapy as the two-drug regimen is not covered. In the case of patients who cannot take metformin due to side effects, SGLT-2 inhibitor + DPP-4 inhibitor or TZD two-drug therapy is a prescription pattern that can occur in clinical settings because reimbursement is not possible. As the two-drug regimen is not possible, instead of prescribing SGLT-2 inhibitors as non-covered drugs, it is possible to recommend taking metformin out of the three-drug regimen that can be covered. In the pharmaceutical industry, it is a phenomenon that can occur in clinical settings, but it is evaluated that it will be only a small part. An executive of a domestic company A, who used to be a doctor, said, “It is a prescription pattern that can happen at the moment, but it is a concern raised because of changes in the clinical field due to the expansion of the reimbursement standard have not yet taken place.” The Ministry of Health and Welfare plans to list SGLT-2 inhibitors and DPP-4 inhibitor complexes of major pharmaceutical companies in May, following the expansion of the reimbursement standard and the Forshiga generic this month. Specifically, ▲AstraZeneca Qtern, ▲Boehringer Ingelheim's Esgliteo, ▲MSD Stegluzan, and ▲LG Chem's Zemidapa are included. In addition, Daewoong Pharmaceutical's Envlo, a new diabetes drug in the domestic SGLT-2 inhibitor class, will enter the prescription market in earnest with reimbursement.
- Company
- SK Bioscience & MSD signed a consignment production contract
- by Jung, Sae-Im May 17, 2023 05:38am
- At the contract signing ceremony held in Jongno-gu, Seoul, government officials such as Second Vice Minister of Health and Welfare Park Min-soo, MSD Vice President Sanat Chattopadhyay, Hilleman Research Center CEO Raman Rao, SK Discovery Vice Chairman Choi Chang-won, SK Bioscience President Ahn Jae-yong, Hoon Kim, CEO of Global R&BD, etc. attended. MSD is developing a next-generation Zaire Ebola vaccine candidate with improved process efficiency and stability of the currently approved and used Zaire Ebola vaccine Ervebo with the Hillemann Institute, an international non-profit research institute. In the future, if the candidate substance is successfully developed and approved by regulatory authorities, it is expected to contribute to increasing the global supply and improving accessibility of the Zaire Ebola virus vaccine. The candidate material will be produced at Andong L House after SK Bioscience has transferred related development and technology, and will be supplied to international organizations after obtaining approval from relevant health authorities to be used in the management of Ebola virus disease. Ebola virus disease is a serious hemorrhagic fever disease caused by infection with the Ebola virus. The main cause of outbreaks in the past 20 years has been the Zaire Ebola virus. Since the Ebola virus was first discovered in 1976, several outbreaks have caused serious human and economic damage. Starting with this contract, SK Bioscience plans to expand its CMO and CDMO business in earnest. Based on R&D technology proven with various self-developed vaccines and state-of-the-art vaccine production facilities, it is a strategy to expand the C(D)MO business for various infectious diseases to respond quickly to new pandemics and take the lead in promoting public health. In addition to the existing vaccine platform, C(D)MO business for new platforms such as mRNA and CGT will also be promoted. A pilot plant that will enhance competitiveness in the C(D)MO market will be built in the ‘Global R&PD Center’ established in Songdo, Incheon through the largest facility investment by SK Bioscience after its launch. The pilot plant, which is a small-scale test facility built before introducing new methods or products, will be equipped with facilities that can carry out research tasks such as CGT, mRNA, and viral vectors. Vice Chairman Choi Chang-won of SK Discovery said, "This collaboration is the result of SK bioscience's production capacity and global network recognized through COVID-19, and it will be an important milestone in our efforts to contribute to the promotion of human health." We hope that the cooperation between SK, MSD, and Hilleman Laboratories will be further expanded with the government, such as the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention, based on the common belief that it will solve the problem of imbalance in the country's vaccine supply and expand access to vaccines."
- Company
- Duloxetine shows strength in ₩30B antidepressant mkt
- by Nho, Byung Chul May 17, 2023 05:38am
- Last year, top-line sales of the antidepressant duloxetine recorded KRW 17.7 billion, taking a big lead ahead of venlafaxine, which achieved KRW 12.7 billion in sales, and is solidifying its position in the relevant prescription market. According to drug distribution data, sales of duloxetine drugs grew from KRW 15.5 billion to KRW 17.7 billion from 2019 to 2022, whereas sales of venlafaxine drugs showed a declining trend from KRW 13.1 billion to KRW 12.7 billion. The contrasting performance of the top two major antidepressant substances in the market is interpreted to be attributed to the difference in their indications. The duloxetine original, Lilly’s Korea’s Cymbalta Cap can be prescribed in a broader scope as its indications include the treatment of generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and musculoskeletal pain that does not respond appropriately to non-steroidal anti-inflammatory drugs (NSAIDs). On the other hand, the venlafaxine leader, the indication of Viatris Korea’s Efexor Xr Cap. Is limited to depression, such as social phobia and panic disorder, which fall under the category of generalized anxiety disorder. The unwavering lead in the duloxetine antidepressant market is Cymbalta, which has raised sales of KRW 8.6 billion in 2018, KRW 9.1 billion in 2019, KRW 9.3 billion in 2020, KRW 9.7 billion in 2021, then KRW 9.7 billion in 2022. The second duloxetine in line is Hanlim Pharm’s Duxela Cap., which raised sales of KRW 1.7 billion last year. Myung-In Pharm’s Droctin Cap ranked third has shown aa over twofold growth from KRW 0.74 billion in 2018 to KRW 1.35 billion last year. Top-line sales of the duloxetine drugs that followed are HR Inno. N’s Culocta, ‘Hwan-In Pharm’s Duloxeptol, Korea Celltrion Pharm’s Julotine, then Korea Pharm’s Duroprex. The respective drugs raised sales of KRW 0.85 billion, 0.77 billion, 0.53 billion, and 0.38 billion, respectively. The combined sales of the 18 other minor products in 2022 were in the KRW 1.4 billion range. The lead product among venlafaxine drugs is Efexor XR, which recorded KRW 4.4 billion last year. The rapid growth of generic versions of venlafaxine is noteworthy in the market. Korea Pharma’s Pharma Venlafaxine arose to become the second-most sold the drug in the venlafaxine market, making a 1800% growth from KRW 0.15 billion in 2018 to KRW 2.89 billion in 2022. The third was Hanlim Pharm’s Venexor XR, which recorded sales of KRW 2.1 billion last year. Sales of Myung-In Pharm’s Cofexor, which had been in the KRW 3 billion range until 2019, were reduced to sales of KRW 1.7 billion last year. Daewoong Bio’s Verakan and Sam Chung Dang Pharm’s Venlafect, Youngjin Pharm’s Venfaxine raised sales of KRW 0.26 billion, 0.53 billion, and KRW 6.8 billion last year. Meanwhile, observations show that Alvogen Korea’s Ivenxine withdrew from the prescription market after raising KRW 12 million in sales in 2019.
- Opinion
- [Reporter’s View] Bitter ERPs following spin-offs and sales
- by Eo, Yun-Ho May 17, 2023 05:38am
- The operation of Early Retirement Program (ERP) schemes following sales of business units has been frequenting as an issue in the pharmaceutical industry. Although the spin-off and sales by multinational pharmaceutical companies aim at ‘separation of innovation and legacy, ‘this premise of ‘selecting and focusing’ on its strengths inevitably entails the negative situation of ‘layoffs.’ Also, the layoffs that occur from sales of businesses are different from general ERPs. Despite the notion of ERPs being a ‘voluntary retirement,’ ERPs that occurs during such situations are much less ‘voluntary.’ This is why such ERPs bring about labor-management conflict. Of course, multinational pharmaceutical companies provide immense compensation for their ERPs. In particular, the ERPs offered after spin-offs or sales offer industry-leading compensation. For employees that were considering whether to change jobs, ERPs can even be a fortune. However, there is no guarantee that there will be new jobs for everyone. Also, for some, a company is more than a place to earn a living but is also a place of value and pride. If layoffs are unavoidable, the company should focus on providing maximum compensation and ensuring succession of employment. The coercions being made under the word ‘voluntary ERP’ must be addressed, and the size of the layoffs should not be determined by a rule of thumb. There is no such thing as good layoffs. Only a few leave satisfied. Some will feel a sense of loss and separation just by the fact that they were being laid off as 'legacy'. As the companies that were the pride and hope of their employees, the companies should work to live up to their employee's expectations, whether those are being laid off as ‘legacy’ or not, and actively work to persuade its head office and take responsibility for the future course of the employees, if there is even the smallest room for improvement.
- Company
- Hemophilia drug Hemlibra coverage expansion
- by Chon, Seung-Hyun May 17, 2023 05:37am
- Hemlibra JW Pharmaceutical has laid the foundation for developing Hemlibra, a treatment for hemophilia, into a large-scale product. With the expansion of benefits, treatment benefits are provided to more patients, and expectations for sales growth are rising due to increased prescriptions. According to the Ministry of Health and Welfare on the 16th, Hemlibra will be covered for hemophilia A patients over the age of 1 who do not possess factor VIII antibodies from this month. Hemlibra is a routine prophylaxis for hemophilia A, which is caused by a deficiency of coagulation factor VIII. It is a product that applies bispecific antibody technology that simultaneously binds to blood coagulation factor 9 and factor 10. Unlike existing coagulation factor 8 preparations, it is the first non-coagulation factor preparation and can be administered subcutaneously once every 4 weeks at most. Hemlibra was developed by Chugai Pharmaceutical, a subsidiary of the global pharmaceutical company Roche. JW Pharmaceutical secured domestic development and sales rights for Hemlibra in 2017 and received permission from the Ministry of Food and Drug Safety in 2019. Chugai Pharmaceutical applied health insurance benefits to severe hemophilia A antibody patients in May 2020, and from this month, benefits were extended to non-antibody patients. According to JW Pharmaceutical, there are 1,746 patients with hemophilia A in Korea. Among them, severe hemophilia A patients were 1259, or 72%. Among patients with severe hemophilia A, 27 patients had antibodies and 1171 patients had non-antibodies. JW Pharmaceutical explained, “More than 60% of hemophilia A patients in Korea are covered by Chugai Pharmaceutical’s benefits.” JW Pharmaceutical expects that Hemlibra will provide great treatment benefits to patients based on the efficacy and safety proven by large-scale clinical trials. In the HAVEN1 clinical trial for antibody patients, it was confirmed that Hemlibra prophylaxis compared to the existing bypass therapy prophylaxis therapy reduced the annual bleeding rate (ABR) by 3.3 times by about 79%. In the HAVEN3 clinical trial for non-antibody patients, it proved an effect of reducing approximately 68% of the ABR (Annual Bleeding Rate) 1.5 times compared to prophylactic factor 8 therapy. The company explains that Hemlibra has also proven safety through clinical results. HAVEN 1~4 Clinical Results Among patients who received Hemlibra, most side effects were mild injection site manifestations. Quarterly Hemlibra sales (unit: million won, source: IQVIA) The company said, "Hemlibra has a long half-life of 28 days, so it increases patient convenience by reducing the number of administrations once every 4 weeks, compared to 2-3 times a week for conventional prophylaxis." In contrast to having to do intravenous injection, subcutaneous injection is possible, so it can help patients who have difficulty in intravenous injection or pediatric patients.” According to IQVIA, a pharmaceutical research institute, Hemlibra recorded sales of 7.6 billion won last year. In the first year of application in 2020, it raised 2.1 billion won, followed by 7.2 billion won in 2021, and showed an upward trend last year. Looking at quarterly sales, it recorded 2.2 billion won in the fourth quarter of last year, surpassing 2 billion won in sales for the first time. The cumulative sales of Hemlibra over the past three years were 17 billion won. The company expects that the amount of use will increase sharply as the target of benefit coverage expands significantly in the future. Last year, Hemlibra's global sales increased by 27% to CHF 3.823 billion. Currently, more than 20,000 patients in 144 countries around the world are using Hemlibra. “Hemlibra is an innovative new drug that can dramatically improve the quality of life of hemophilia patients with ease of administration and excellent efficacy,” said an official from JW Pharmaceutical. He said, "We expect that this new standard will expand the treatment accessibility of patients suffering from hemophilia and the choice of medicines for medical staff."
