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- 2026-05-09 10:34:33
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- 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).
- Company
- NPS buys Samsung Biologics and SD Biosensor shares
- by Kim, Jin-Gu Jul 12, 2022 05:52am
- In the midst of the prolonged contraction observed in the Korean stock market, Korea’s largest institutional investor, the National Pension Service (NPS), was found to have expanded its investment in biotech/pharma companies by nearly ₩500 billion. NPS net purchased ₩140 billion worth of Samsung Biologics shares and increased investment in SD Biosensor, Celltrion, Hanmi Pharmaceutical, Celltrion Healthcare, and Daewoong Pharmacuetical by over ₩50 billion. Also, NPS net sold over ₩50 billion worth of Yuhan Corp’s shares and over ₩40 billion worth of SK Bioscience shares during the same period. ◆NPS increases investment in Samsung Biologics and SD Biosensor again this year… turns to net purchases from net selling According to the Korea Exchange on the 11th, NPS net sold ₩417.3 billion worth of shares in the domestic securities market and the KOSDAQ market in the first half of this year. However, no large-scale net sales like the ones made last year were observed. Last year, NPS had net sold shares worth ₩2.4 trillion after deciding to curtail local equity exposure to 16.8%. In the Pharma/Bio industry, NPS was found to have made more purchases than sales. It sold a total of ₩2.43 trillion and bought ₩2.89 trillion, resulting in net sales of ₩459.2 billion. In particular, NPS increased investment in Samsung Biologics, SD Biosensor, Celltrion, Hanmi Pharmaceutical, Celltrion Healthcare, and Daewoong Pharmacuetical by over ₩50 billion. NPS net purchased Samsung Biologics shares worth around ₩140.1 billion in only the first half of this year. This is analyzed to be NPS’s decision to continuously expand investment in Samsung Biologics this year. NPS had net bought ₩917.9 billion shares of Samsung Biologics’ stocks last year. NPS is also continuously increasing investment in SD Biosensor and had net purchased shares worth ₩95.3 billion in the first half of this year. NPS had net purchased ₩124.3 billion worth of SD Biosensor’s shares last year. In addition, NPS had net purchased over ₩70 billion worth of shares in Celltrion, Hanmi Pharmaceutical, and Celltrion Healthcare each in the first half of this year. The institution’s decision to purchase Celltrion’s shares again is a focus of interest as it had net sold ₩648.6 billion of Celltrion’s shares last year. NPS had net sold over ₩600 billion last year and then turned to net purchase over ₩70 billion in the first half of this year. NPS had also net purchased shares over ₩10 billion in 18 companies including Daewoong Pharmacuetical, ST Pharm, SK Biopharmaceuticals, Hanmi Science, Lutronic, Osten Implant, Daewoong, GC Pharma, Jeisys Medical, Dentium, Ray Pharma, PharmaResearch, and Pharmicell. ◆NPS net buys ₩280 billion of SK Bioscience shares last year but net sells ₩43 billion in 2022 1H On the other hand, NPS sold a large number of shares it owned in Yuhan Corp, SK Bioscience, Bukwang Pharmaceutical, Mezzion, Hugel, and GC Cell. In particular, SK Bioscience and GC Cell moved from the top net bought shares last year to the top net sold shares in the first half of this year. In the case of Yuhan Corp, NPS bought ₩86.2 billion and sold ₩140.3 billion in 1H this year, resulting in net sales worth ₩54.1 billion. Also, NPS net sold ₩43 billion worth of SK Bioscience’s shares in the first half of this year. This is in stark contrast to how the company net bought ₩280.3 billion last year. Also, NPS net purchased ₩112.2 billion last year, but net sold ₩11.9 billion of SK Bioscience’s shares in the first half of this year. NPS also net sold over ₩10 billion worth of shares from Bukwang Pharmaceutical (₩26.5 billion), Mezzion (₩19.8 billion), and Hugel (₩19.3 billion).
- Company
- Will Celltrion Pharmaceutical voluntarily cut down on Godex?
- by Nho, Byung Chul Jul 12, 2022 05:52am
- Celltrion Pharmaceutical's Godex is on the verge of being expelled from insurance registration, and it is expected to cut voluntary drug prices at the level of comparative drugs as the last defense measure to maintain benefits. The reason why Celltrion Pharmaceutical's strategy is drawing attention is that if Godex, which looks like 60 billion won, is deleted, it is inevitable to lose about 20% of its total sales, which is expected to make every effort to maintain insurance drugs through clinical utility proof. Godex was not recognized for the appropriateness of the benefit at the 7th review of the Pharmaceutical Benefit Evaluation Committee held on the 7th, but the final results may change depending on the evaluation of the objection. This re-evaluation project is planned for five years from 2021 to 2025, and it is difficult to overcome obstacles in this way because it contains more than 20 billion won, or less than one country among A8 countries, or drugs pointed out by the committee due to insufficient policy, social needs and usefulness. It is insufficient to judge the HIRA's expression of its willingness to derive reasonable drug prices by comparing clinical usefulness and drug prices in excluded countries with domestic released drugs as simply proof of usefulness. The most effective means is the voluntary reduction of drug prices to the level of a single drug (or Pennel Cap ( 312 won ) with the same main ingredient). Godex capsules contain 25mg of Biphenyl Dimethyl Dicarboxylate, 500μg of Riboflavin, 125μg of Cyanoborate, 2.5mg of Adenine HCl, 25mg of Pyridoxynate, and 150mg of Carnitine Orotate. A comparative drug with the same main ingredient is Pharmaking's Nissel (144 won). Despite the expiration of Godex patents, many pharmaceutical bio companies failed to release generics because they could not successfully derive biological equivalence test data for other auxiliary substances except biphenyl dimethyl Dicharboxylate, the main ingredient. It is true that even though Godex is a composite agent, if the drug price is the same as the single drug Nissel by giving up the drug price value for the rest of the ingredient combination except for the main ingredient, the HIRA lacks the reasonable logic to prevent it. Sales of Godex could be halved due to a benefit cut of 371 won → 144 won, but it can actually prevent it from leaving the market and restore it to its original state according to its sales strategy, which is likely to reduce its weakness. It is logical that Celltrion Pharmaceutical's the HIRA limit is unfair to reduce the benefit of Godex capsules, a composite drug, at a time when insurance registration and benefits continue due to the clear effect of a single product. In addition, under the current regulations, drug prices fall only when generics enter, but there is a logic that it is unreasonable to target them for re-evaluation even though generics has not been released.
- Company
- 4th JAKi Cibinqo to be prescribed in general hospitals
- by Eo, Yun-Ho Jul 11, 2022 06:03am
- The fourth JAK inhibitor ‘Cibinqo ‘ has landed at general hospitals in Korea. According to industry sources, Pfizer Korea’s new Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ passed the drug committees (DCs) of various medical institutions in Korea, including the Seoul National University Hospital. The drug, which is approved for atopic dermatitis, is Pfizer’s follow-up of ‘Xeljanz (tofacitinib)’ that is set to compete with ‘’ Lilly Korea’s ‘Olumiant (baricitinib),’ ‘Abbvie’s ‘Rinvoq (upadacitinib)' for the same indication. Olumiant and Rinvoq were approved for reimbursement in May this year, and the reimbursement listing process for Cibinqo is also in progress. Cibinqo received marketing authorization in November last year when the reimbursement listing for Olumiant and Rinvoq was under review. As a JAK1 inhibitor, the drug modulates multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). It is indicated for the treatment of adults and adolescents over the age of 12 with moderate-to-severe atopic dermatitis. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at Week 12 and demonstrated an improvement in itch relief 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy in patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved an EASI-75 (improvement of at least 75% in lesion extent and severity) at Week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group and was higher than the 5% in the placebo group.
- Company
- ER contraceptive market battles over original & generics
- by Nho, Byung Chul Jul 11, 2022 06:03am
- Norevo (Levonorostrel 0.75mg) and Elaone (Ulipristal Acetate 30mg), which Hyundai Pharmaceutical received import licenses from HRA Pharma in 2001 and 2011, by a 10-year gap, are emerging as icons of changes in the emergency contraceptive market. Emergency contraceptives have been submitted to the Central Pharmaceutical Review Committee of the MFDS and classified and maintained as Rx drugs during the reclassification process of Rx drugs vs OTC. In 2014, seven years after Norevo, the first product of this series, was approved, the emergency contraceptive market showed box-office performance after forming about 8.7 billion won in appearance. In the past five years, the CAGR has been showing a gradual decline, with -2.6% based on market value and -4.9% based on prescription quantity. It is observed that the market of Levonorgestrel, where each brand's products were licensed and generic appeared less than a year after patents were not protected, has been bisected by the launch of Ulipristal in 2011. The share of Ulipristal products, which was 21% in 2013, the third year of its launch, has remained at 45% until last year since entering the 40% range in 2016. Ulipristal preparations have the advantage of extending the emergency contraceptive effect from 72 hours (3 days) to 120 hours (5 days) after the relationship. As mentioned above, the size of the oral emergency contraceptive market itself is stagnant, but new changes are also expected under the surface. Pharmaceutical companies that have oral hormone preparation facilities include Myungmoon Pharm, Dalim Biotech, and GL Pharma. GL Pharma, which entered the market last, is expanding its market share to 28% by manufacturing a total of six items, including its own product, Sexcon One. Hyundai Pharmaceutical's 5-year CAGR of Norevo one was -6.5%, and GI Medics' Phostino-1 sold by Bayer Korea had a CAGR of -20.4% during the same period, and its market share also decreased by more than half from 22% to 10%. Given this situation, the challenge of emergency contraception by Ulipristal's first generic, Ellaoil (authorized on June 13, 2022/GL Pharma), is drawing attention from the industry. Attention is being paid to THEU's move, which quickly rose to second place (23%) in market share from Levonorgestrel. The price change due to the shift in market flow from monopoly to oligopoly is also another point to watch. Four first generics companies, including GL Pharma, are competing with HRA Pharma, a French emergency contraceptive developer, to determine the scope of rights and to sue for patent infringement.
