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- 2025-12-23 22:51:29
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- nAMD drug Vabysmo will likely be listed for reimb in Oct
- by Eo, Yun-Ho Sep 18, 2023 05:26am
- The macular degeneration treatment ‘Vabysmo’ is expected to be listed for reimbursement in October this year. According to industry sources, Roche Korea has completed drug pricing negotiations for its bispecific antibody Vabysmo (faricimab) with the National Health Insurance Service. Once it passes the Health Insurance Policy Review Committee, reimbursement can immediately be applied to the drug. Vabysmo, which was approved in Korea in January this year, passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in July, then immediately entered into drug price negotiations and virtually completed the reimbursement process within 8 months of its approval. As a treatment approved for neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME), it has a differentiated mechanism of action that targets both the vascular endothelial growth factor (VEGF) inhibitor and angiopoietin-2 (Ang-2). In particular, Vabysmo is the first medicine given by injection into the eye and can be administered every 16 weeks (4 months), therefore, the less frequent injection interval can reduce the treatment burden for patients. The recommended dose of 6mg (0.05ml) of Vabysmo is administered by intravitreal injection every 4 weeks for the first 4 doses. nAMD patients who show no disease activity after the initial 4 doses receive additional doses every 4 months (16 weeks). In the case of DME patients, the administration interval can be increased every 4 weeks to a maximum of 4 months (16 weeks) at the doctor’s discretion. The drug’s efficacy was demonstrated through 4 Phase III trials, TENAYA and LUCERNE studies on nAMD, and YOSEMITE, and RHINE studies on DME. The TENAYA and LUCERNE studies were non-inferiority trials comparing Vabysmo with 'Eylea (aflibercept)' as a treatment for nAMD. Results showed that Vabysmo, which is administered at a maximum interval of 4 months (16 weeks), was non-inferior to Eylea, which is administered every 2 months (8 weeks), in terms of visual acuity improvement at Year 1. In particular, at 1 year, nearly 80% of people receiving Vabysmo maintained a treatment interval of 3 months or longer. The results of the second year of treatment that were recently announced showed that more than 60% of patients maintained a 4-month (16 weeks) administration interval, and was expected to provide continuous clinical benefits to patients. Meanwhile, nAMD and DME are major causes of vision loss that affects 40 million people worldwide. If blood vessel leakage occurs in patients with nAMD or DME and accumulates in the macula, edema may occur behind the eye, causing vision impairment.
- Company
- KRW 100 bil loxoprofen market suffers reimb cuts
- by Chon, Seung-Hyun Sep 18, 2023 05:26am
- Industry concerns are rising on the announcement of reimbursement cuts for the nonsteroidal anti-inflammatory drug ‘loxoprofen.’ The adequacy of its reimbursement as an antipyretic/analgesic for acute upper respiratory tract inflammation has not been recognized by the authorities in Korea, and its scope of prescriptions is set to be narrowed as a result. As reimbursement for this particular indication has rapidly increased since the COVID-19 pandemic, the losses felt by pharmaceutical companies are expected to be even greater. According to industry sources on the 13th, the Health Insurance Review and Assessment Service concluded that only 2 out of the 3 indications for loxoprofen are eligible for reimbursement after deliberating the reevaluation results submitted regarding the reimbursement adequacy of insured drugs in 2023. Until now, loxoprofen was reimbursed as ▲an anti-inflammatory and analgesic for chronic rheumatoid arthritis, osteoarthritis (degenerative arthritis), back pain, periarthritis, and glenohumeral syndrome; ▲an anti-inflammatory and analgesic used post-operative, trauma and tooth extraction’ and as ▲an antipyretic and analgesic for acute upper respiratory infection. Among the three, the authorities determined the drug inadequate for reimbursement as an ‘antipyretic and analgesic for acute upper respiratory tract infection,’ and preannounced its removal from the reimbursement list. From the company’s perspective, they will have to bear the loss of prescriptions that had been made for the specific indication. Quarterly outpatient prescriptions of Loxoprofen (Unit: KRW 100 million, Data: UBIST) According to the market research institution UBIST, the amount of outpatient prescriptions for loxoprofen last year amounted to KRW 103.5 billion. From the pharmaceutical company's perspective, the over-KRW 100 billion annual prescription markets will inevitably contract with the reimbursement removal. The losses felt by pharmaceutical companies are expected to be even greater given that sales of that particular indication for loxoprofen had risen rapidly during the COVID-19 pandemic. The prescription amount for loxoprofen preparations increased by 6.6% from KRW 78.3 billion in 2018 to KRW 83.5 billion in 2019, but then decreased to KRW 74.9 billion and KRW 72.4 billion in 2020 and 2021, respectively. At the time, COVID-19 was pointed out as the direct cause of the declining loxoprofen prescription market. After the spread of COVID-19, the number of patients with infectious diseases such as flu and colds plummeted due to strengthened personal hygiene management such as washing hands and wearing masks, and the market for related treatments had also decreased significantly However, its prescriptions soared thereafter to KRW 103.5 billion, up 43% YoY. The rise of confirmed COVID-19 cases which amounted to hundreds of thousands of cases per day had significantly increased the demand for loxoprofen. In terms of quarterly prescriptions, loxoprofen showed rapid growth after recording KRW 17.6 billion in Q3 2021, increasing 12.1% YoY, surging to KRW 19.8 billion in Q4. In Q1 last year, prescriptions for loxoprofen amounted to KRW 24.9 billion, up 47.9% YoY,. Its sales from Q2 to Q4 last year, recording over 30% growth rate compared to the previous year. Its growth continued this year as well. In 1H last year, loxoprofen prescriptions amounted to KRW 56 billion, rising 14.2% YoY. Prescriptions in Q1 were KRW 26.9 billion, up 8.0% YoY, and in Q2, prescriptions increased 20.4% YoY to KRW 29.1 billion. The recent increase in loxoprofen prescriptions appears to also have been influenced by the increase in cold and flu patients after the end of the COVID-19 pandemic. If the indication for ‘antipyretic and analgesic for acute upper respiratory tract infection,’ which has been bringing the most growth, is removed from reimbursement, the losses felt by pharmaceutical companies will inevitably be significant. The restrictions made on loxoprofen’s reimbursement are expected to have an impact on the entire domestic pharmaceutical industry. According to HIRA, 125 pharmaceutical companies have loxoprofen drugs that are listed for reimbursement. Shing Poong Pharm, Hutecs Korea Pharmaceutical, Huons, Genuone Science, and Dongwha Pharm have recorded the highest prescriptions in Korea’s loxoprofen market. Hutecs Korea Pharmaceutica’s Lexofen Tab posted the highest prescriptions of KRW 5.5 billion last year. Huons' Hurophen and Shinpoong Pharmaceutical's Loxofen recorded prescriptions of KRW 4.3 billion and KRW 4.1 billion, respectively. Genuone Science’s Genuone Loxoprofen and Dongwha Pharm’s Loxonine Dongwha followed with prescription sales of KRW 3.7 billion each.
- Company
- nAMD tx Vabysmo can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 15, 2023 05:33am
- Vabysmo, a treatment for macular degeneration, can be prescribed at general hospitals. According to related industries, Vabysmo, Roche Korea's first bispecific antibody treatment for eye diseases, passed the drug committee of medical institutions such as Konyang University Hospital, Kim Eye Clinic, Nune Eye Clinic, Inje University Busan Paik Hospital, and Chung-Ang University Hospital. Roche is also conducting landing procedures at medical institutions across the country. As Vabysmo is currently negotiating drug prices with NHIS, it is expected to be linked to actual prescriptions if it is listed on the insurance benefit list. Vabysmo, approved for the treatment of neovascular or wet age-related macular degeneration and vision damage caused by diabetic macular edema, is a new drug with a differentiated mechanism that targets both VEGF-A and Ang-2, the main disease pathogenesis. It is the first intraocular injection that enables administration at 4-month (16-week) intervals through approved clinical research based on a new mechanism, which can reduce the treatment burden on patients by administering a small number of injections. Vabysmo is administered by intravitreal injection once a month (4 weeks) at the recommended dose of 6mg (0.05ml) for the first 4 doses. Afterward, nAMD patients without disease activity are administered once every 4 months (16 weeks). In patients with DME, the dosing interval can be increased in 4-week increments up to a maximum of 4 months (16 weeks) at the discretion of the medical staff. Meanwhile, Vabysmo has proven its effectiveness through a total of four phase 3 studies, including clinical studies of TENAYA and LUCERNE related to nAMD treatment and YOSEMITE and RHINE related to DME treatment. Among them, the TENAYA and LUCERNE studies are non-inferiority trials compared to Vabysmo and Eylea in the treatment of nAMD. As a result of the study, Vabysmo treatment at intervals of up to 4 months (16 weeks) in the first year of treatment showed a non-inferior level of visual acuity improvement compared to Eylea treatment at 2-month (8 weeks) intervals. In particular, in the first year of treatment, approximately 80% of the Vabysmo treatment group maintained a dosing interval of more than 3 months (12 weeks). The recently announced results of the second year of treatment showed that more than 60% of patients maintained a dosing interval of 4 months (16 weeks), raising expectations that it would provide continued clinical benefits to patients.
- Company
- Gilead Sciences Korea appoints Jae-Yeon Choi as new head
- by Eo, Yun-Ho Sep 15, 2023 05:33am
- Gilead Sciences Korea announced it has appointed Jae-Yeon Choi as its new General Manager as of October this year. The position had remained vacant for the past 6 months. At Gilead Sciences Korea, the new GM Choi will oversee Gilead's business operations in Korea, and promote businesses in the fields of HIV, viral hepatitis, COVID-19, antifungal, and oncology. After acquiring an MBA from Kellogg School of Management at Northwestern University, Choi accumulated over 20 years of experience in Eli Lilly and MSD, holding leadership roles in various functions including commercial, human resources, drug pricing, and policy, in various regions including the United States, China, and Taiwan. Before joining Gilead, Choi had served as the Managing Director of MSD Taiwan, where she achieved remarkable business growth for 2 consecutive years. She joined MSD Korea in 2017 as an Executive Director of External Affairs, where she achieved excellent results in the field of immune-oncology drugs. Before entering MSD, she had worked at Eli Lilly for 11 years, serving various positions including as a Marketing Director at the company. Choi said, “I am pleased to be able to join Gilead Sciences Korea and carry on the company’s mission of improving and saving the lives of patients in Asia. In addition to our team, I will work with Gilead executives and employees in Asia to provide better treatment solutions for patients suffering from HIV, viral hepatitis, fungal infections, and cancer.”
- Company
- Wellysis receives FDA approval for electrocardiograph
- by Nho, Byung Chul Sep 14, 2023 06:40am
- Access Bio (CEO Choi Young-ho), a global in vitro diagnostic company, announced on the 13th that Wellysis' patch-type electrocardiograph S-Patch Ex, with which it formed a strategic partnership last year, has received approval from the U.S. Food and Drug Administration (FDA). Access Bio previously made an investment by acquiring redeemable convertible preferred stock issued by Wellysis through Mason Healthcare New Technology Investment Association No. 2. The market expects that the solid global distribution network of Access Bio, headquartered in the United States, will play a significant role in Wellysis' entry into the United States through this approval. In the future, Access Bio plans to expand its business model to enable real-time monitoring, analysis, tracking, and remote patient management by combining Wellysis' platform technology with its diagnostic products. Through this, we plan to leap forward as a digital healthcare platform service company by maximizing IT convergence synergy in ‘field-centered diagnosis’. An Access Bio official said, “Many domestic healthcare startups are trying to enter the United States, the largest market, but in reality, it is not easy due to the high entry barrier,” adding, “On the other hand, Access Bio, headquartered in the United States, has advanced technology and global supply capabilities during the COVID-19 pandemic. “It has already been recognized through the pandemic,” he said confidently. Wellysis is a digital healthcare company that spun off from Samsung SDS in 2019 and currently provides S-Patch-EX to 14 countries. S-Patch, which weighs only 9g, is a small and lightweight cable-shaped patch design that collects accurate ECG waveforms while minimizing noise. Continuous measurement is possible for up to 100 hours without battery replacement, so the arrhythmia detection rate is high. Inside the device, Samsung Semiconductor's Bio-Processor, a chip specializing in biosignal collection, is installed, allowing the electrocardiogram to be collected and processed effectively. The global wearable electrocardiogram test market is estimated to be worth more than 1.5 trillion won by 2022, of which the US market accounts for about 55%. Access Bio has also recently invested in CuraPatient, a US digital healthcare company, and is looking forward to further accelerating its digital healthcare business with Access Bio's US FDA approval. Access Bio is a KOSDAQ-listed American company in which PharmGen Science acquired the majority stake and has been recognized for its high technology, including being recently selected as a research company for the development of next-generation diagnostic kits by the National Institutes of Health.
- Company
- Hanmi will focus on anti-obesity drugs... from GLP-1 to DTx
- by Kim, Jin-Gu Sep 14, 2023 06:37am
- Hanmi Pharm Hanmi Science has pointed to obesity management as a future growth engine for the Hanmi Group. Hanmi Science plans to select 5 types of pipelines, including a new GLP-1 obesity treatment, and operate the project under the name, 'H.O.P (Hanmi Obesity Pipeline)'. The H.O.P project includes 5 types of treatment that include ▲'efpeglenatide', which is being developed as an economical GLP-1 obesity treatment customized for Koreans, and ▲ a 'next-generation triple agonist (LA-GLP/GIP/GCG)' that simultaneously activates GLP-1, glucagon, and GIP. In particular, Hanmi’s LA-GLP/GIP/GCG is a candidate substance that uses the company’s next-generation independent platform technology rather than the existing biodrug platform ‘LAPSCOVERY,’ Hanmi Science explained that it is a different substance from the ‘efocipegtrutide (LAPSTripleagonist)’ that is currently undergoing global Phase IIB clinical trials as a treatment for NASH. Based on the effects confirmed through preclinical studies, Hanmi Science expects that its LA-GLP/GIP/GCG substance will be able to demonstrate strong efficacy comparable to the weight loss effect (about 25%) of surgical therapy. In addition, the company is also developing a new biodrug that can prevent the loss of muscle mass that may occur from the use of GLP-1 agents, improving the quality of weight loss, while helping to suppress the weight rebound. In addition, the company has also identified candidate substances that can improve eating disorders like binge eating. In addition, the company has started to develop oral peptide platform technology plans and saw its potential for commercialization and will start development of an oral GLP-1 agent as soon as possible. Hanmi Science also added that it plans to start working on developing digital therapeutics. Hanmi Science believes that digital therapeutics can further increase the weight loss effect of the treatments administered and taken by patients, strengthen the safety of drugs, and help correct the patients' lifestyles. Furthermore, the company plans to sequentially introduce a series of ‘personalized treatments' that can support the patient’s obesity treatment cycle that covers the whole range of treatments from obesity treatment to weight gain prevention and post-weight-loss management. Hanmi Science explained that a large number of researchers from Hanmi Pharmaceutical’s R&D Center, New Product Development Headquarters, Strategic Marketing Team, Pyeongtaek Bio Plant, Paltan Pharmaceutical Research Center, and Hanmi Fine Chemical (raw material company), are all participating in this H.O.P project. In particular, the company emphasized that company-wide efforts are underway to establish the H.O.P. project as Hanmi’s next-generation core growth engine based on the leadership of the recently appointed Director of Strategic Planning, Ju-Hyun Lim. An official from Hanmi Science said, “We expect the H.O.P project to become a new growth engine for Hanmi as it prepares to make another leap forward in celebration of its 50th anniversary.”
- Company
- SMA drugs Spinraza and Evrysdi complete pricing negotiations
- by Eo, Yun-Ho Sep 14, 2023 06:36am
- The spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ finally passed the final hurdle to its reimbursement in Korea According to industry sources, both SMA treatments, Biogen Korea’s ‘Spinraza (nusinersen)’ and Roche Korea’s treatment ‘Evrysdi (risdiplam),’ reached a final agreement with the National Health Insurance Service after drug pricing negotiation. The discussions were being made for Spinraza's reimbursement extension and the new listing of Evrysdi. As a result, the two drugs are expected to be listed for reimbursement starting next month (October) if no unexpected events arise. The current reimbursement standard for Spinraza is 5q which satisfies all of the following criteria: ▲genetic diagnosis of deletion or mutation of the 5q SMN-1 gene ▲appearance of SMA-related clinical symptoms and signs at age 3 or younger ▲case not using a permanent ventilator He is a patient with spinal muscular atrophy. Spinraza is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients that satisfy all of the following conditions: ▲received genetic diagnosis of 5q SMN-1 deficiency or mutation; ▲had onset of SMA-related clinical symptoms and signs at the age of 3 or less; and ▲ are not using permanent ventilators. In other words, only patients whose symptoms have been found before the age of 3 were allowed reimbursement until now. The reimbursement extensions discussed this time aimed to expand that age limit to ‘the age of 18 or less.’ In the case of the oral SMA drug Evrysdi, the drug will be also listed for reimbursement under the same reimbursement standards set for Spinraza. Discussions on the reimbursement and reimbursement extension of SMA treatments had seemingly started to make rapid progress due to rising demand for the abolition of Spinraza’s treatment discontinuation standards, however, the discussions became prolonged as the requested range of reimbursement was broader than what the government and pharmaceutical companies had expected. At the time, the government had planned to proceed with discussions on the reimbursement listing of Evrysdi after making an agreement on the scope of extended reimbursement for Spinraza, but both drugs have entered the final negotiations stage. The decision for the two drugs had been delayed once.
- Company
- Obesity is a chronic disease
- by Kim, Jin-Gu Sep 12, 2023 05:37am
- “Currently, only obesity metabolic surgery is covered. The scope needs to be expanded to include obesity treatments, etc.” “Obesity is a chronic disease like high blood pressure and diabetes. We need to apply health insurance benefits from a treatment perspective, not from a beauty perspective.” Gyeong-gon Kim, Vice President of the Korean Obesity Society (Department of Family Medicine, Gachon University College of Medicine) Kim Gyeong-gon, vice president of the Korean Society of Obesity (Department of Family Medicine, Gachon University School of Medicine), made this claim at the policy symposium of the Korean Society of Obesity academic conference held at the Conrad Hotel in Seoul on the 7th. Vice Chairman Kim said that the number of obese patients in Korea has been increasing at a very rapid rate recently. Vice Chairman Kim said, "Severe obesity, especially among young people, is increasing rapidly. Just 10 years ago, severe obesity with a body mass index (BMI) of 30 or more was less than 3%, but recently, especially among men in their 20s and 30s, it accounts for 3% of the total." “More than 10% of people are severely obese,” he warned. Vice Chairman Kim emphasized that obesity should be recognized as a chronic disease like high blood pressure or diabetes. For example, in the case of high blood pressure, a systolic blood pressure of 150 mmHg does not immediately cause serious problems, but because we know that it can cause various problems, such as cardiovascular disease, in the future, we are prescribing various medications through health insurance coverage, he explains. Obesity does not cause any symptoms right away, but it causes a variety of conditions such as high blood pressure, diabetes, cardiovascular disease, stroke, osteoarthritis, and obstructive sleep apnea, so it is argued that it should be managed in advance through compensation. Vice Chairman Kim said, “In Korea, there are quite a few patients with stage 2 and 3 obesity with serious complications,” and added, “They must be provided with appropriate treatment.” Vice Chairman Kim said, "Fortunately, we have recently secured many diverse and effective tools for obesity treatment, such as obesity metabolic surgery and next-generation obesity treatment drugs," and added, "Patient treatment, examination, education, and drug treatment are still non-reimbursed." “Policies are needed to improve access to effective treatments for weight loss and improving complications,” he emphasized. Vice Chairman Kim added, "A change in perception is necessary. Obesity should not be viewed only from the perspective of beauty. Obesity must be recognized as a major chronic disease."
- Company
- Celltrion’s Remsima celebrates 10th year of export
- by Chon, Seung-Hyun Sep 12, 2023 05:37am
- Celltrion’s first biosimilar, ‘Remsima’, has marked its 10th anniversary in entering the overseas market. Together with its subcutaneous injection formulation Remsima SC, Remsima successfully settled in the European market and recorded total exports that exceeded KRW 6 trillion over the past 10 years. Celltrion Healthcare announced on the 11th that it will launch various campaigns throughout the world to celebrate the 10th anniversary of Remsima's approval in Europe. Celltrion Healthcare is Celltrion's affilate that receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltrion Healthcare plans to hold global lecture tours and symposiums around the globe from year to the second half of next year, starting with the United European Gastroenterology Week. During the campaign, the company will reexamine Remsima's achievements over the past 10 years and identify how the biosimilar industry, which was born with Remsima's success, has been impacting the field. Celltrion received marketing authorization for Remsima in Europe in August 2013 and received the title, ‘the world’s first antibody biosimilar.’ Remsima is a biosimilar of Remicade. Annual exports of Remsima and Remsima SC (Unit: KRW 1 million, Data: FSS) According to Celltrion Healthcare, Remsima's export volume has gradually increased since it generated exports of KRW 145.3 billion in 2013. Remsima recorded exports of KRW 402.3 billion in 2014, then exceeded KRW 700 billion in 2016. The growth of Remsima's exports slowed somewhat thereafter, recording exports of KRW 506.9 billion and KRW 401.4 billion in 2017 and 2018, respectively. However, its exports rebounded and exceeded KRW 500 billion for the first time in 2 years in 2019, then continued to grow to exceed KRW 800 billion in 2021 and last year, setting a new record for two consecutive years. By the first half of this year, Remsima recorded exports of KRW 477.3 billion. Remsima's cumulative exports over the past 10 years amounted to KRW 5.6314 trillion. Remsima SC has also started to produce export results in 2020. Celltrion received approval for Remsima SC, a subcutaneous injection formulation of Remicade, in Europe in November 2019 and began targeting the market in earnest. Remsima SC first generated exports of KRW 34.8 billion in 2020, and then posted KRW 236.9 billion last year, exceeding KRW 1 trillion in exports together with Remsima. Remsima SC recorded exports of KRW 146.6 billion in the first half of this year, exceeding KRW 500 billion in cumulative exports. The cumulative exports of Remsima and Remsima SC together over the past 10 years were calculated to be KRW 6.1394 trillion. Remsima is recording the highest sales performance among finished products sold overseas by domestic pharmaceutical companies. Celltrion Healthcare explained, “Remsima has steadily maintained its top spot in infliximab prescriptions since surpassing the market share of its original in 2017.” According to the market research institute IQVIA, Remsima recorded a market share of 56% in Europe, including 83% in the UK and 61% in France, in Q1 this year. An official from Celltrion Healthcare said, “Remsima was able to succeed and maintain its lead in the market for a long time by preoccupying the market after implementing a customized strategy for each country based on proven data on treatment efficacy and safety in the highly competitive biosimilar industry.”
- Company
- Entresto’s 2nd patent suit ruling postponed to November
- by Kim, Jin-Gu Sep 12, 2023 05:37am
- The rulings for the 2nd trial surrounding the chronic heart failure treatment ‘Entresto (sacubitril/valsartan)’ have been postponed to November 9. The drug has been posting annual prescriptions of more than KRW 40 billion annually. According to industry sources on the 11th, the Patent Court of Korea 1st Division recently postponed the decision date for the 2nd trial on Entresto’s crystalline patent to November 9. With the argument now concluded, the court originally planned to pronounce judgment on the 14th of this month but decided to postpone the decision for two more months. The exact reason why the judgment was postponed remains unknown. As a result, the outline of the second trial of the Entresto patent dispute is expected to come out after the end of this year. Three Entresto patent disputes are currently being tried at the Patent Court. In addition to the crystalline patent (10-1432821), whose judgment has been postponed, disputes over the composition/use patent (10-0984939) and the salt/hydrate patent (10-1549318) have not yet been resolved. The ruling surrounding the crystalline patent is expected to come first, followed by the other 2 rulings. Entresto is protected by 6 patents: ▲salt and hydrate patent that expires in November 2026, ▲use patent that expires in July 2027, ▲crystalline patent set to expire in September 2027, ▲composition patent set to expire in November 2028 (10-1700062), ▲another composition patent set to expire in January 2029 (10-1589317), and ▲a use patent set to expire in 2033 (10-2159601). Among the 6 patents, generic companies have succeeded in nullifying or avoiding 2 patents. The results of the two were finalized after the generic companies won the first trial and Novartis did not file an appeal. In the case of the use patent that expires in 2033, the patent was listed after generic companies applied for marketing authorization of their generics. The generic companies have also succeeded in winning against Novartis in the first trial for the other 3 patents as well. However, Novartis chose to appeal and proceed to the Patent Court of Korea for all 3 cases. The generic companies that challenged the 3 patents plan to succeed in overcoming the remaining patents and qualify for early release. Entresto's PMS already expired in April, so the companies may release their generic versions early as long as they overcome the remaining patents. However, if generic companies lose or win the second trial but Novartis appeals to the Supreme Court, the release of their generic will be further delayed. There is the possibility that the Entresto patent dispute will be prolonged for more than four years. Since 2021, generic companies have been filing trials against Entresto's patents. Starting with Elyson Pharm, about 10 companies including Hanmi Pharm, Chong Kun Dang, and Daewoong Pharmaceutical jumped into the dispute. According to the market research institute UBIST, Entresto's outpatient prescriptions amounted to KRW 42.5 billion last year. Entresto has shown rapid growth in the market, increasing prescription sales by nearly KRW 10 billion every year. Its prescription performance, which recorded KRW 5.5 billion in 2018, increased to KRW 14.3 billion in 2019, KRW 22.4 billion in 2020, then to KRW 32.4 billion in 2021. By the first half of this year, its cumulative sales reached KRW 27.2 billion, heralding annual sales of KRW 50 billion this year. The sales have surged after its indication was extended from heart failure with reduced ejection fraction (HFrEF) to heart failure with preserved ejection fraction (HFpEF) Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril. The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction in combination with other heart failure treatments.
