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- 2026-05-06 13:34:04
- Policy
- Peramiflu shortages may require gov. intervention
- by Lee, Tak-Sun Dec 29, 2023 05:39am
- The government is poised to implement supply control of Peramiflu inj., an injection for transfusion, following the management of oral influenza treatment, Tamiflu. Peramiflu inj. is experiencing out-of-stock in medical services due to a recent increase in demand. Health Insurance Review and Assessment Service (HIRA)’s Korea Pharmaceutical Information Service (KPIS) designated two types of Green Cross’s Peramiflu Inj. (peramivir), after receiving reports through the information channel, as drug shortages, and plans to provide inventory information on these drugs. The information service has been operating a channel for receiving reports on drug shortages since July. Reporting on drug supply shortages is open to anyone, including associations, groups, doctors and pharmacist, and the public. HIRA discloses information on the inventory of drugs that are experiencing supply shortages by analyzing distribution status and identifying drugs currently facing supply issues. Until now, Peramiflu Inj. has not been registered on the drug shortages list. However, remaining stocks of three oseltamivir products, including Tamiflu, have been distributed following the drug shortages designation. Regarding Tamiflu, the government released Tamiflu from the national drug reserve into the market. Starting last week, pharmacists have been gradually releasing the stock for 180,000 people. Green Cross’s Peramiflu is an original drug that contains peramivir as active ingredient. Although it is a non-reimbursed drug, there are 15 generics available in the market. Generic drugs have not been reported to the drug shortages information channel. “HIRA is currently assessing management strategy to address the drug shortages; for example, sharing information about the drugs that have been reported through the information channel with a public-private consultative body,” stated a representative from the HIRA. The issue of Peramiflu abuse was discussed during the second meeting of the 'respiratory diseases joint-departments taskforce' on the 27th. Medical experts, including those from Korean Society of Pediatric Infectious Diseases and The Korean Pediatric Society, have expressed concerns that healthcare providers prioritize the prescription of injections over oral pills, despite both being equally effective. Peramivir ingredient is designated as a national essential medicine. Therefore, whether the government will actively pursue drug supply management for peramivir ingredient is of interest.
- Company
- Integrated Celltrion launches with goal of 40T market cap
- by Kim, Jin-Gu Dec 29, 2023 05:39am
- Celltrion and Celltrion Healthcare are set to launch an integrated corporation. The market capitalization of the integrated Celltrion is expected to reach around 40 trillion won. The launch of the integrated Celltrion is anticipated to unify the previously dispersed biosimilar production and distribution processes. This merger may address longstanding controversies such as allegations of unfair business partnership and inflation of sales figures. The newly merged entity aims to expand its business focus from primarily biosimilars to a new drug development. Seo Jung-jin, the chairman of Celltrion, announced company’s initiative to increase the sales to 12 trillion won by 2030 through this integration. Celltrion and Celltrion Healthcare set to launch integrated corp…Next merger with Celltrion Pharm within six months. According to the pharmaceutical industry on the 28th, Celltrion and Celltrion Healthcare are launching their integrated corporation. Celltrion will acuire Celltrion Healthcare through absorption-type merger. The merger will be carried out by issuing new shares of Celltrion to the shareholders of Celltrion Healthcare. The listing of the new shares of Celltrion is scheduled for Jan. 12, 2024. Once the listing is completed, all merger procedures will be finalized. After the merger, there will be a minor change in the ownership structure of the Celltrion Group. Currently, Celltrion Holdings holds 20.1% stake of Celltrion and 24.3% stake of Celltrion Healthcare shares. Celltrion is still holding 54.8% stake of Celltrion Pharm. 합병 후 예상 지배구조(자료 셀트리온) After the merger, Celltrion Holdings will acquire 21.5% stake in integrated Celltrion. Integrated Celltrion will continue to have 54.8% stake in Celltrion Pharm. The next merger plan of Integrated Celltrion is to merge with Celltrion Pharm within the next six months. Celltrion Group initially considered a three-company merger but decided to proceed with two-phase merger because of potentially conflicting shareholder interests. Merger would help dispel accusations of ‘unfair business partnership’ · ‘inflation of sales figures’, and they will reinforce transparency The launch of the integrated Celltrion is expected to unify the previously dispersed biosimilar production and distribution operations that were divided between the two companies. This move is also anticipated to address persistent controversies such as 'unfair business partnership ' or ‘inflation of sales figures.' Until now, Celltrion Group's biosimilar business operated in a structure where Celltrion developed and manufactured products, and these products were subsequently purchased by Celltrion Healthcare for distribution and sales in international markets. Since Celltrion Healthcare had an exclusive deal to sell Celltrion's biosimilar products, there were consistent allegations in the industry of a single business partnership. Additionally, when Celltrion Healthcare purchased products from Celltrion for international markets, sales were recorded for both companies, leading to criticisms of inflated sales figures. According to the Fair Trade Commission, Celltrion Group had the highest proportion of internal transactions last year among large corporations (those with assets over 5 trillion won) required to disclose their business operations. For six consecutive years since 2017, Celltrion Group ranked first, with 62.5% of their total sales originating from transactions within the group. In comparison, the average proportion of internal transactions for large corporations was 33.4%. The launch of the integrated Celltrion would effectively address these controversies. This is attributed to the fact that drug development, manufacturing, and distribution will all be consolidated within a single entity, simplifying the transaction process, reducing costs, and enhancing transparency. The market cap of the integrated Celltrion will reach 40 trillion won… Blueprint of “becoming a global big pharma developing biosimilars & new drugs” The pharmaceutical industry anticipates that the integrated Celltrion's market capitalization will reach 40 trillion won. This would place the company as the 8th largest company on the stock market, comparable to Hyundai (41.8621 trillion won) and POSCO Holdings (21.7782 trillion won) and higher than Kia (38.7571 trillion won) and Naver (36.0547 trillion won), in terms of market value based on the closing price on the 27th. After completing the merger with Celltrion Pharm next year, the total market capitalization of the group is expected to expand to 42 trillion won, leaping from the 13th to the 6th largest company on the stock market. 셀트리온 통합법인의 2030년 매출 12조원 목표(자료 셀트리온) The newly launched integrated Celltrion is aimed at becoming a global big pharmaceutical company, expanding business from biosimilars to new drug development. The chairman, Seo, has set a goal of achieving 12 trillion won in sales by 2030. The company’s initiative for its biosimilars business is aimed at commercializing 22 products by 2030. In line with this, the company is considering the construction of a fourth plant. Additionally, in the new drug business, the focus will be on Zymfentra, which recently received approval from the U.S. Food and Drug Administration (FDA) in October. Starting next year, the company will also initiate new drug development projects using ADC and mRNA platforms with the goal of making the new drug division contribute 40% of the total sales by 2030.
- Company
- Medytox submits BLA to FDA for its next-gen botulinum
- by Chon, Seung-Hyun Dec 29, 2023 05:39am
- Medytox is working to enter the U.S. market with its next-generation botulinum toxin product, which technology has been reverted to the company after being transferred to a foreign company. Pic of Medytox headquartersOn the 27th, Medytox announced that it has filed a biological license application (BLA) to the U.S. Food and Drug Administration (FDA) for its next-generation non-animal liquid botulinum toxin, MT10109L. Medytox has submitted a Biologics License Application (BLA) to the FDA for MT10109L for the treatment of moderate-to-severe frown lines and crow's feet. MT10109L is characterized by the lack of use of animal-derived ingredients throughout the entire manufacturing process, including strain culture and solution preparation, and by not using human serum albumin (HSA) as an excipient, eliminating the possibility of animal-derived virus infection. The company explained that it had minimized the number of chemical processing steps, reducing the potential for denaturation of the active neurotoxin protein. In February, Medytox completed five large global Phase 3 clinical trials of MT10109L, totaling 1,300 patients at medical centers in the U.S., Canada, and Europe. The trials demonstrated significant results in improving the rate of frown lines and crow's feet compared to placebo, as well as long-term safety results with repeated dosing. "Having successfully developed the world's first liquid formulation of botulinum toxin, Medytox will target the world's largest market, the United States with MT10109, its next-generation liquid toxin formulation. To date, there is no liquid formulation of botulinum toxin available in the United States. MT10109L is a product for which Medytox transferred technology to Allergan but was reverted the rights. In 2013, Medytox signed a license-out agreement with Allergan worth up to $362 million for botulinum toxin product MT10109L. However, AbbVie, which acquired Allergan, returned the rights in 2021. After receiving the returned rights for MT10109L, Medytox analyzed clinical results and applied for FDA approval in two years. Hyun-ho Jung, CEO of Medytox said, “We have been focusing on preparing for due diligence and improving our internal capabilities for a long time to enter the U.S., the world's largest market. We will make sure that our next-generation liquid toxin formulation, MT10109L, successfully enters the U.S. market.”
- Company
- Hugel Resolves to Retire 371,563 shares of its own stock
- by Nho, Byung Chul Dec 28, 2023 01:14pm
- Hugel, a global total medical aesthetics company, announced that it has held a board of directors meeting on the 22nd and passed a resolution to retire 371,563 shares of its own stock to enhance the shareholder’ value. This is equivalent to around 3% of the total outstanding shares (12,385,455 shares), and the expected value of the retired stocks amounts to 54,587,063,456 KRW based on the average acquired unit price. The total number of outstanding shares will decrease, but there will be no decrease in capital. The scheduled retirement date is the 29th of this month.
- Policy
- True Set, a triple hypertension therapy, to face generics
- by Lee, Tak-Sun Dec 28, 2023 06:02am
- Generics of Yuhan’s True Set Tab., a triple-combination drug for hypertension with rapid sales growth, are already gearing up for competition. True Set, a triple-combination drug that contains telmisartan, amlodipine besylate, and chlorthalidone, received approval in August 2019. Subsequently, True Set was released to the market in November following reimbursement approval. True Set’s re-examination period is set to expire in August 22, 2025, which is a year and 8 months from now. Given these circumstances, generic companies are actively pursuing opportunities for generic entry. The MFDS approved Jeil Pharm’s bioequivalence trial protocol for JLP-2202 on 21st. A comparative drug contains Telmisartan 80mg, Amlodipine Besylate 6.935mg, and Chlorthalidone 25mg as active ingredients. A currently authorized drug for the market is True Set Tab. 80/5/25mg. Released in November 2019, True Set Tab. recorded an annual outpatient prescription sales of 10 billion won, in just two years. According to the data from UBIST, True Set Tab.’s outpatient prescription sales recorded 16.8 billion won, with a cumulative outpatient prescription sales in Q3 reaching 13.4 billion won, breaking last year’s record and showing potential for rapid growth. Currently, Daiichi Sankyo Korea’s Sevikar HCT (Olmesartan Medoxomil/Amlodipine Besylate/Hydrochlorothiazide), Amosartan Plus (Amlodipine Camsylate/Losartan potassium/Amlodipine Camsylate), and True Set (Telmisartan/Amlodipine Besylate/Chlorthalidone) are dominating the triple-combination drug market. Among these, generics for Sevikar HCT has already been released in the market. Amosartan Plus and True Set remain exclusive in the market. However, drug product patent for Amosartan Plus is expiring in November 2036. Additionally, Amosartan Plus contains Amlodipine Camsylate, which is exclusively produced by Hanmi Pharm, making it difficult for generic companies to approach immediately. Since True Set does not have a relevant patent, and its re-examination is set to be completed three years from now, generic companies have been eyeing the drug. Korean pharmaceutical companies are facing limited opportunities for generic development due to the scarcity of original drugs with expiring patents. Therefore, many companies, including Jeil Pharm, are awaiting to seize the opportunity to manufacture True Set generics.
- Company
- Tezspire lands in Korea…joins 6-way race
- by Dec 28, 2023 06:02am
- The new drug for severe asthma that emerged joined the competition with the five existing biologics that were being used in Korea. AstraZeneca, which recently received domestic approval for its new drug, plans to differentiate itself from existing treatment options with new mechanisms of action and formulations. According to industry sources on the 26th, AstraZeneca Korea's severe asthma drug Tezspire (tezepelumab) was recently approved in Korea. This brings the total number of biologics approved for the treatment of severe asthma in Korea to six, following Novartis Xolair (omalizumab) and GSK Nucala (mepolizumab) in 2016, Teva-Handok's Cinquar (reslizumab) in 2017, AstraZeneca’s Fasenra (benralizumab) in 2019, and Sanofi Dupixent (dupilumab) in 2021. Xolair is an anti-IGE antibody that targets allergic asthma. Anti-IL-5 drugs such as Cinquar, Nucala, and Fasenra, are used to treat eosinophilic asthma. Dupixent is an anti-IL-4/IL-13 agent used for type 2 inflammatory asthma. Tezspire, which was jointly developed by AstraZeneca and Amgen, is approved in Korea as a maintenance treatment for patients with severe asthma. Tezspire is an anti-TSLP monoclonal antibody therapy that binds to thymic stromal lymphopoietin (TSLP), which causes airway inflammation, whereas other biologics inhibit IL-5 lgE. Tezspire is the first drug that targets this mechanism to tackle asthma. Two Phase 3 studies, PATHWAY and NAVIGATOR, demonstrated the efficacy of Tezfir compared to placebo. The primary endpoint in both studies was the rate of clinically significant asthma exacerbations measured over 52 weeks. In the PATHWAY study, which followed a total of 550 patients with severe asthma aged 18 years and older for 52 weeks, Tezspire had a 52-week asthma exacerbation rate of 0.20 compared with 0.72 in the placebo group, which is a significant difference. In the NAVIGATOR study, which followed a total of 1061 patients with uncontrolled severe asthma aged 12 years and older for 52 weeks, Tezspire demonstrated a 52-week asthma exacerbation rate of 0.93, an improvement over the 2.10 found in the placebo group. The secondary endpoints in both trials - percent change in forced expiratory volume in one second (FEV1) from baseline - improved with the use of Tezspire compared with placebo. In terms of safety, the most common adverse events with Tezspire were pharyngitis, rash, arthralgia, and injection site reactions. Dupixent remains non-reimbursed…whether reimbursement will be granted remains key The race between biologics is expected to come down to reimbursement. Currently, only Xolair, CInquair, and Nucala are reimbursed for severe asthma. Although the various treatment options target different asthma conditions, reimbursement for them is currently limited. #Cupixent has a novel mechanism of action that targets type 2 inflammatory asthma by inhibiting IL-4 and IL-17. However, to date, it has not been reimbursed for severe asthma. Biologics, even when effective, are too expensive for patients to pay out-of-pocket. In the case of Dupixent, its price varies from hospital to hospital, but it costs around KRW 700,000 for a single dose. Therefore, the industry eyes whether Tezspire, which entered the market as a late entrant, may quickly achieve reimbursement. Unlike other biologics that inhibit interleukins, Tezspire’s mechanism targets thymic stromal lymphopoietin, a key cytokine-like protein that triggers inflammation, differentiating gits mechanism of action from other biologics. In addition, Tezspire has the advantage of offering different formulations. The currently approved formulations of Tezspire are both subcutaneous injections, including Tezspire AutoInjector and Tezspire Prefilled Syringe Injection. In January and February of this year, AstraZeneca and Amgen received approval from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), respectively, for the pen formulation of Tezspire. The company's strategy is to differentiate itself from other biologics that are injected subcutaneously with its pen formulation that can be self-administered. Therefore, if the pen formulation enters the domestic market, the new mechanism of action and formulation is likely to help support the drug’s reimbursement.
- Company
- Acetaminophen syrup receives price hikes to meet demand
- by Chon, Seung-Hyun Dec 28, 2023 06:02am
- Starting next month, the maximum reimbursement prices for two acetaminophen suspension formulations will be increased by over 50%. The price hike follows the government’s decision to implement measures aimed at encouraging pharmaceutical companies to expand volume of acetaminophen production. Currently, there is a continuous demand for the drugs due to a high number of patients with influenza and the common cold. Following the drug price increase for pill-type acetaminophen monotherapy last year, suspension formulations have now joined the list of drug receiving pricing increases within a year. The drug pricing increase in acetaminophen suspension formulations is expected to lead to an annual increase by approximately 1 billion won in prescription sales. According to the Ministry of Health and Welfare (MOHW) on 27th, starting next month, the prices of the two acetaminophen suspension formulations will be increased by up to 55.6%. The price of Janssen Korea’s Children's Tylenol Suspension will be increased by 55.6%, adjusted from 18 won to 28 won, and Sama Pharm’s Setopen Suspension will be increased by 52.9%, adjusted from 17 won to 26 won. During the COVID-19 pandemic and endemic, the demand for acetaminophen, an antipyretic drug, has significantly increased. However, the low drug price has made it difficult to expand the production. In response, the government has decided to bring an increase in drug pricing to encourage drug companies to expand their volume of production. According to the data from UBIST, a drug market research agency, cumulative outpatient prescription sales in Q3 this year was1.9 billion won, a significant increase of 94.9% compared to the same period last year. When compared to the cumulative prescription sales of 4 billion won in Q3 2021, this is a five-fold expansion in just two years. An analysis of pharmaceutical industry suggests that the prescription market for suspension formulations has expanded because COVID19-positive patients continued to increase despite the declared end of pandemic, as well as an increase in patients with influenza and the common cold following the end of mask mandate rule. The cumulative prescription sales of Setopen Suspension in Q3 were 1.6 billion won, a five times increase in just two years. While the cumulative prescription sales of Children's Tylenol Suspension in Q3 of 2021 were below 100 million won, they have now reached 300 million won, showing more than three times increase. The quarterly prescription sales of acetaminophen suspension formulations have increased by three times, in particular, prescription sales of Setopen Suspension in Q3 of 2021 was merely 100 million won, but, this year’s YoY sales was 300 million won. In the same line, the prescription sales of last year’s Q2 was nearly 500 million won, which is three-fold expansion compared to two years ago. The prescription sales of Children's Tylenol Suspension in Q1 recorded below 100 million won, but, in Q2, it surpassed 100 million won. The prescription sales of Children's Tylenol Suspension in Q3 were only 70,000,000 won, but compared to two years ago, it has increased by more than two-fold. The market size of suspension formulations is larger than the entire market for acetaminophen monotherapy. The cumulative prescription sales of acetaminophen monotherapy in Q3 of 2021 reached 39.5 billion won, a 148.5% hike from the same period of last year. The margin of increase in prescription sales for suspension formulations was even greater, approximately two times higher. The drug pricing increase of acetaminophen suspension formulations follows that of tablets at the end of last year. The MOHW raised the upper limit for 18 items by up to 76.5%, starting in December 2022. The maximum reimbursement price of acetaminophen 650mg was only 43-51 won, but it has been adjusted to 90 won. The government decided to collectively set the price hike considering that many pharmaceutical companies were reluctant to expand the volume of production due to the poor cost structure. The pharmaceutical companies have agreed to expand production along with the increased drug pricing of acetaminophen. The price of Janssen Korea’s Tylenol 8 hours was adjusted from 51 won to 90 won, recording the highest increase rate of 76.5%. Both Bukwang Pharm’s Tacenol 8hours and Chong Kun Dang Pharmaceutical’s PENZAL were adjusted from 51 won to 88 won, a 72.5% hike. Hanmi Pharm’s Suspen 8 hours adjusted from 50 won to 85 won, a 70% hike. Kolon Pharmaceutical’s Tramol 8 hours is set to increase from 51 won to 85 won, a 66.7% hike. Genu Pharma’s Anisphen 8 hours and Hana Pharm’s Tylicol 8 hours will both be adjusted to 83 won, a 62.7% hike. Sama Pharm’s Setopen and Young Poong Pharmaceutical’s Tifen 8 hours are set to increase from 51 won to 80 won, a 56.9% hike. The adjusted prices of eight items, including Boryung Biopharma’s Cetaphen 8hr, will be raised to approximately 70 won. Initially, the price of acetaminophen 650g was schedule to be collectively adjusted to 70 won starting in December, but the price adjustment will be delayed until March of next year. The recent prescription sales for a year (Q4 of 2022 to Q3 of 2023) of Setopen Suspension and Children's Tylenol Suspension were reported to be 1.3 billion won and 300 million won, respectively. Applying the price increase rates for Setophen Suspension and Children's Tylenol Syrup, the annual prescription sales hike is expected to be 2 billion won and 400 million won, respectively. As a result of the price increase for these two acetaminophen syrup formulations, an expansion of the prescription market by 800 million won annually is anticipated.
- Company
- Genexine completes trial on its long-acting anemia drug
- by Son, Hyung-Min Dec 28, 2023 06:02am
- Genexine’s new drug candidate for chronic kidney disease-induced anemia, Efesa, has confirmed its efficacy through clinical trials. Genexine plans to confirm the drug’s competitiveness in the oversaturated anemia treatment market with its long-acting formulation. According to the Financial Supervisory Service, Genexin recently announced that its CKD-induced anemia drug candidate Efesa (candidate name GX-E4) met its primary endpoint in a Phase 3 clinical trial. Efesa comes in a long-acting formulation that utilizes Genexin's platform technology hyFc to extend the half-life of erythropoietin (EPO) in the body. Anemia is caused by decreased EPO production due to decreased kidney function, which in turn leads to decreased red blood cell production. Therefore, most anemia treatments activate the EPO. Genexine is developing a third-generation long-acting product that can be administered once every two to four weeks, compared to first-generation anemia treatments that require injections every two to three days. The company is looking at the cost reduction and dosing convenience effect. In clinical trials, Efesa has demonstrated non-inferiority to Roche’s Mircera, a third-generation anemia treatment. Genexin conducted a Phase 3 clinical trial in 391 patients with non-dialysis chronic kidney disease anemia in 7 countries, including South Korea, Indonesia, Taiwan, Australia, Malaysia, the Philippines, and Thailand. Results showed that Efesa achieved a hemoglobin response rate of 78.6%, compared to 69.3% for Mircera. Genexine concluded that Efesa demonstrated non-inferiority to Mircera. Based on the clinical results, Genexine plans to prepare for domestic approval of its drug as a treatment for non-dialysis chronic kidney disease-induced anemia. Long-acting ESA injection, if approved, has sufficient market potential If Efesa is approved domestically, analysts believe it will compete with existing first- to third-generation ESA injections. According to market research firm IQVIA, the total market size of ESA injectables is KRW 90 billion, with first-, second-, and third-generation injectables showing an even distribution in sales. ESA injectables are categorized into first-generation epoetin alfa, second-generation darbepoetin alfa, and third-generation methoxy polyethylene glycol-epoetin beta, 3rd gen treatment, Roche Among first-generation ESA injectables, LG Chem's Espogen has recorded the highest sales. Espogen generated sales of KRW 14 billion last year. The second-generation Kyowa Kirin’s Nesp generated KRW 21.4 billion, and the third-generation Roche Mircera generated KRW 19.7 billion in sales last year. Sales of each generation's flagship products alone totaled to KRW 55 billion. In particular, ESA injections are likely to play an important role in the near future as major oral anemia treatment drugs have not yet entered the reimbursement system. In this regard, long-acting injectable Efesa is said to have competition potential as it has secured dosing convenience. An industry official said, "Oral products that have secured dosing convenience compared to existing ESA injectables have emerged, but have not been reimbursed yet. In this sense, the ESA injectables are expected to continue to show strong sales in the existing market. In other diseases, long-acting injectables that have emerged later have cannibalized sales of existing therapies, so ESA injectables are likely to continue to play a major role in the existing market for some time. If approved, Efesa has the potential to drive sales in the ESA injectable market."
- Company
- KRW 250 bil market shakes from reimb reevaluations
- by Chon, Seung-Hyun Dec 28, 2023 06:02am
- The pharmaceutical industry has expressed great disappointment regarding the results of the government’s drug reimbursement reevaluations. The reimbursement scope of three ingredients - loxoprofen, limaprost alpha dex, and epinastine hydrochloride - will be reduced. This is a loss worth KRW 250 billion in the prescription market. The losses felt by pharmaceutical companies are expected to be even greater due to the reimbursement reductions made for products that have seen a surge in their respective prescription markets due to the COVID-19 pandemic and endemic. This year's reimbursement reevaluations resulted in the indication reduction of 3 substances including loxoprofen... KRW 250 billion market impact According to industry sources on the 28th, the Ministry of Health and Welfare recently held a Health Insurance policy review committee and announced the results of this year's salary reassessment. Reimbursement for the 2 substances, rebamipide, and levosulpiride, which demonstrated their clinical utility, was decided to be maintained as is. Three substances including loxoprofen sodium, limaprost alpha dex, and epinastine hydrochloride, will have their coverage reduced. Evaluation of 2 substances, oxiracetam, and acetyl-L-carnitine hydrochloride, whose reimbursement has already been discontinued and efficacy/effect indications removed due to lack of evidence of efficacy during MFDS clinical reevaluations, were excluded from reimbursement reevaluations. Pharmaceutical companies are now facing the reality of prescription market losses due to reimbursement reductions made on three drugs - loxoprofen, rimaprost alpadex, and epinastine - in addition to the two drugs that have been removed from the market due to failed clinical reassessments. The list includes a number of products that have seen a surge in prescription volume in the wake of the recent COVID-19 pandemic and epidemic. According to the market research institution UBIST, the total outpatient prescription market size of the three benefit reductions - loxoprofen, rimaprost alpadex, and epinastine - was KRW 251.4 billion last year. This is a large market worth 250 billion won a year, a market where a decline in prescriptions is expected with the reimbursement reduction. Loxoprofen’s reimb as a pain and reliever indication deleted from specifications…lights can serve as a loss of a KRW 100 million. Loxoprofen has been reimbursed in three areas: ▲as analgesia for chronic rheumatoid arthritis, osteoarthritis (degenerative arthritis), low back pain, periarthritis of the shoulder, and cervical spondylosis; ▲ analgesia for postoperative, post-traumatic, and post-extraction pain, ▲ and as antipyretic analgesia for acute upper respiratory tract infections. Of these, the ‘antipyretic analgesia for acute upper respiratory tract infection' indication will be removed as after the government found its reimbursement justification inadequate. For pharmaceutical companies, the removal of one indication for loxoprofen will result in lost prescriptions. Last year, the outpatient prescription market for loxoprofen was estimated at 103.5 billion won. Given the rapid growth of loxoprofen’s reimbursement-deleted indication during the COVID-19 pandemic, the losses felt by the pharmaceutical companies are expected to be even greater. Prescriptions for loxoprofen increased by 6.6% from KRW 78.3 billion in 2018 to KRW 83.5 billion in 2019, but then declined to KRW 74.9 billion and KRW 72.4 billion in 2020 and 2021, respectively. However, the prescription market for loxoprofen surged 43.0% year-on-year to KRW 103.5 billion last year. Since late 2021, the demand for loxoprofen has increased dramatically when the number of COVID-19 cases increased by hundreds of thousands per day. Loxoprofen continued to show growth in sales this year. the growth trend has continued. In the third quarter, prescriptions for loxoprofen totaled KRW 26.9 billion, up 52.4% from two years ago. Cumulative prescriptions in the third quarter of this year showed that the amount totaled KRW 82.9 billion, up 57.5% in 2 years from the KRW 52.6 billion it had raised in December 2021. of 2021. The recent increase in prescriptions for loxoprofen is likely due to the increase in cold and flu patients since the end of the COVID-19 pandemic. KRW 150 bil market may contract due to reduced reimbursement of limaprost alpha dex and epinastine limaprost alpha dex is used to ▲improve ischemic symptoms such as ulcers, arthralgia, and coldness caused by occlusive thromboangiitis, and to ▲improve self-symptoms and walking ability caused by acquired lumbar spinal stenosis. Dong-A ST’s Dong-A Opalmon is the original drug. limaprost alpha dex’s reimbursement for one of the two of its indications, ‘Improvement of ischemic symptoms such as ulcers, arterial pain, and coldness caused by occlusive thromboangiitis’ will be excluded from reimbursement. Prescription sales of limaprost alpha dex had recorded over KRW 25.6 billion in Q3. This is a 12.9% three-year increase from the KRW 22.7 billion in Q3 2020. While growth in the prescription market for limaprost may not have been significant, the removal of one of the two indications is likely to contract the prescription market. Last year, prescriptions for limaprost alpha dex amounted to KRW 98.9 billion. Among the reimbursement-cut drugs, epinastine has also recorded high growth recently. Epinastine is indicated for ▲ bronchial asthma ▲ allergic rhinitis ▲ urticaria, eczema-dermatitis, itchy skin, itchy rash, moderate psoriasis with itching ▲ prevention and relief of itching in allergic conjunctivitis. This indication, "Prevention and relief of itching in allergic conjunctivitis," is applicable only to epinastine ophthalmic solutions. Epinastine’s outpatient prescription sales in Q3 were KRW 15.1 billion. This is a 12.5% increase from the same period last year and a 27.9% increase from KRW 11.8 billion in Q3 2021. The increase in prescriptions for epinastine can be attributed to its increased use for bronchial asthma since the COVID-19 outbreak. With the removal of epinastine’s bronchial asthma indication reimbursement, prescription sales are expected to decline.
- Company
- Generic companies win 3 out 4 patent disputes
- by Kim, Jin-Gu Dec 27, 2023 11:39am
- This year, out of 29 trial decision and verdict cases that arose as patent disputes, companies that filed a trial or lawsuit have won in 21 cases. This translates to a win rate of approximately 76% for companies challenging patents. Especially, excluding cases where the lawsuit or suit qualification was deemed ineligible, the dispute hadn’t commenced, or was dismissed, generic companies have won all the other disputes, except for the Dukarb dispute. This year, patent challenging companies have won 22 out of 29 trial decision and verdict cases According to the pharmaceutical industry on the 26th, 29 cases of trial decisions and verdicts were made on patent disputes, excluding those cases with voluntary withdrawal of trial decisions or lawsuits. The 21 patent dispute cases included trial decisions from the first trial at the Intellectual Property Trial and Appeal Board (IPTAB), 5 verdicts from the second trial at the Patent Court of Korea, 3 verdicts from the third trial at the Supreme Court of Korea. Out of the 29 cases, 22 were won by companies that filed for the trial decisions or lawsuit. In terms of pharmaceutical patents, of the 4 cases that reached final decisions or lawsuits, 3 of which (76%) ended in victory. Excluding instances where cases were dismissed because the requirements for a patent trial claim were not met, or cases where the patent-holder deleted the related claim phrase after the trial has begun, generic companies have scored a major victory in all disputes, except for the Dukarb dispute. When generic companies challenge a patent, they typically approach it with a fully developed abdication or invalidating plan; therefore, this approach is known to contribute to a high success rate in the first trial. In other words, it’s relatively rare for companies challenging patents to lose in the first trial. For these reasons, pharmaceutical companies are closely watching the first trial decision in the Dukarb’ dispute. In Jaunary 2023, the IPTAB ruled in favor of the original-drug developer, dismissing the trial decision regarding Arlico pharm and others who filed a patent invalidation trial against Boryung Pharmaceutical’s combination drug patent related to Dukarb. Boryung also secured a victory in the second trial. In November, the patent court of Korea ruled against the plaintiffs in two cases of Dukarb patent disputes, favoring Boryung. These cases are awaiting a final ruling by the Supreme Court, following an appeal by generic companies who lost in the second trials. Boryung, having won both first and second trials, has been able to maintain the patent for Dukarb key dosages (30/5mg). As a result, generic companies are unable to release generics of these key dosages onto the market. Disputes involving Forxiga and Pazeo Eye Drops have finally concluded, with generic companies securing victory The two disputes involving SGLT-2 class diabetes treatments, Forxiga and Pazeo Eye Drops, have finally concluded with the Supreme Court ultimately ruling in favor of the generic companies that challenged patents. In February 2023, the Supreme Court issued a final ruling on the patent dispute regarding Forxiga, concluding a patent dispute that spanned eight years. The dispute comes after Kukje Pharma and other Korean companies filed a patent invalidation trial of the 2nd substance patent. The generic companies won both the first and second trials. AstraZeneca then appealed to the Supreme Court. However, in February, the Supreme Court ultimately ruled in favor of the generic companies. Following their victory in the lawsuit, generic companies could advance their plans by 9 months. After the 1st substance patent voided on April 7th 2023, generics released their drugs onto the market. In August, the Supreme Court delivered a final ruling on the patent dispute concerning Pazeo Eye Drops. The generic companies secured an ultimate victory after a six-year-long patent dispute. The dispute started on June 2017, when SamChunDang Pharm filed a patent invalidation trial against an active ingredient patent. Then in the following year, Hanmi Pharm filed a patent invalidation trial in another active ingredient patent. Having lost in the first trial, generic companies won all cases of the lawsuits. Novartis then appealed to the court, but the generic companies ultimately won the cases. Generic companies win patent disputes of Jublia, Recomid, and Monterizine The patent disputes concerning Jublia Topical Solution, Recomid SR Tab., Monterizine Cap., Ibrance Cap., Lenvima Cap., and Opsumit Tab. reached decisions in the first trials. In the patent dispute involving Jublia, seven companies, including Daewoong Therapeutics, gained victories in the first trial in November. In a similar lawsuit, ten pharmaceutical companies, including, Jeil Pharm, are still awaiting a decision. Yet, pharmaceutical companies anticipate that generic companies will likely win the cases, in line with previous trial decisions. Companies like Mother’s Pharmaceutical have won patent dispute in the first trial related to Yuhan’s Recomid SR Tab. in October. Last year, when generic companies filed for patent lawsuits, the reimbursement status of Rebamipide ingredient, which includes Recomid SR Tab., was uncertain because those were included as candidates in the 2023 reimbursement re-evaluation review. This year, however, Rebamipide successfully passed the reimbursement re-evaluation review. Additionally, the companies that challenged patents have also won in related trials, thus increasing the likelihood of early releases of generics. Companies like Han Wha Pharma achieved victory in trial decisions on four cases related to passive trials to confirm the scope of a right involving Hanmi Pharm’s Monterizine Cap. active ingredient patent. Although Hanmi Pharm, the original-drug developer, appealed to the patent court of Korea for two out of these four cases, the disputes ended with its withdrawal. Companies like Shin Poong Pharmaceutical, Boryung Pharmaceutical, and Samjin Pharmaceutical have achieved victories in passive trial to confirm the scope of a right. Shin Poong Pharmaceutical won against Pfizer's Ibrance active ingredient patent in October, Boryung Pharmaceutical Eisai's Lenvima active ingredient patent and salt and crystalline form patent in August, and Samjin Pharmaceutical won Actelion's Opsumit active ingredient patent in April. Novartis faced defeat in passive trial to confirm the scope of a right involving Gabes ingredient patent filed against Kyongbo Pharmaceutical. The Patent Court of Korea ruled against Novartis in April of this year. Despite Novartis previously initiating patent litigation against generic companies, these efforts did not achieve the desired outcomes. In January of the previous year, Novartis had filed a passive trial to confirm the scope of a right with the Patent Court of Korea to ascertain whether Kyongbo Pharmaceutical had infringed on the Gabes ingredient patent.
