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- 2026-04-07 01:06:40
- Policy
- Reimb for Paxlovid still pending amid COVID-19 resurgence
- by Lee, Tak-Sun Aug 12, 2024 05:55am
- Product photo of Paxlovid. As the COVID-19 treatment supply becomes an ongoing issue amid a virus resurgence, clinical practices are frustrated by delayed reimbursement coverage of 'Paxlovid (nirmatrelvir‧ritonavir, Pfizer Korea).' The drug reimbursement application for Paxlovid was submitted to the Health Insurance Review and Assessment Service (HIRA) in early October of last year. After that, HIRA has yet to finish the evaluation. On August 8th, Paxlovid was not considered for HIRA's Drug Reimbursement Evaluation Committee (DREC) review. Initially, Pfizer aimed to acquire reimbursement for Paxlovid for the first half of the year, but it has yet to be considered for the DREC review 10 months after submission. During this period, Pfizer submitted response letters to HIRA six times. The company recently requested HIRA an extended response letter due date. While the reimbursement for Paxlovid is being delayed, the Korean Disease Control and Prevention Agency (KDCPA) discontinued the free-of-charge program in May. Now, patients are required to pay KRW 50,000, which is approximately 5% of the drug price, for the drug. However, it is still provided free of charge for medical reimbursement benefit recipients and those eligible for co-payment reduction due to having the second-lowest income. When the drug became available for co-payment, some clinical practices prescribed Paxlovid to adult patients under different conditions. The basis for Paxlovid approval in South Korea is its efficacy and effectiveness in treating adults with mild to moderate symptoms who are at a high risk of developing severe COVID-19, including hospitalization and death. As a result, prescribing it to adults with mild symptoms still meets the efficacy and effectiveness criteria. However, when the government provided Paxlovid free of charge, it was only used for patients who were senior-aged and had severe symptoms. It seems that when the drug became available for co-payment, clinical practices mistakenly thought it had reimbursement criteria and prescribed it as approved. Recently, the Korea Disease Control and Prevention Agency (KDCPA) officially requested that clinical practices prescribe oral COVID-19 medicines, including Paxlovid, only to high-risk patients who show symptoms. Those who can be prescribed are patients over 60 years old and 12 years old (Paxlovid) or 18 years old and older (Lagevrio) who are immune compromised or with underlying diseases. Additionally, it must prescribed within 5 days of showing symptoms and for patients not needing oxygen therapy. The KDCPA said, "There are no changes to who can be prescribed COVID-19 medicines before or after issuing co-payment in May." They explained, "It can only be prescribed in clinical practices designated for COVID-19 medicines prescription." To prevent such confusion, some have pointed out the necessity of prescription criteria through reimbursement coverage, as well as agreements with pharmaceutical companies for the efficient supply of drugs. A HIRA official said, "Paxlovid will be internally evaluated soon and considered for the DREC review."
- Opinion
- [Column] On patent strategies post Amgen v. Sanofi dispute
- by Kim, Jin-Gu Aug 12, 2024 05:55am
- One of the most significant events that occurred in the bio-pharmaceutical sector in recent years was the ruling made on the Amgen vs. Sanofi patent dispute in the United States. In May last year, the U.S. Supreme Court issued its final ruling on the patent dispute between the two biotech giants. The case received special attention, as the dispute over the validity or invalidity of patents lasted for nearly a decade in the KRW 1 trillion drug market and the first in a long time the U.S. Supreme Court ruled on the 'enablement requirement' of a patent. In 2011, Amgen and Sanofi each patented an antibody for the treatment of hyperlipidemia that binds to the PCSK9 protein, and developed Repatha and Praluent, respectively. Three years later, in 2014, Amgen registered two additional patents for antibodies that bind to the PCSK9 protein and immediately filed a patent infringement lawsuit against Sanofi. In response, Sanofi sought to invalidate both of Amgen's patents, and the dispute came to a head. Amgen was able to file its patent infringement lawsuit in 2014 instead of 2011 for a reason. Amgen's 2011 patent limited antibodies to an amino acid sequence, whereas the 2014 patent claimed antibodies more broadly. Amgen’s patent consists of an antibody that ▲binds to a specific amino acid or epitope of PCSK9; and ▲ prevents PCSK9 from binding to the LDL receptor. Claiming an entire group of antibodies that exhibit this specific function is called a “genus type” claim, which can include millions of individual species antibodies. As a result, genus-type claims have a very broad scope. Despite making such a broad claim, Amgen’s patent specification only disclosed: i) 26 amino acid sequences for antibodies that would block or inhibit PCSK9, and ii) two alternative methods (the roadmap, conservative substitution) for arriving at the remainder of the genus. The court found that the 26 exemplified antibodies were not sufficient to readily produce the entire genus of antibodies and that Amgen's 2 methods constituted separate research projects. The experts ruled Amgen's patents invalid and that they did not meet the enablement requirement because it would require extensive experimentation and trial and error to reproduce the invention. The Supreme Court’s ruling does not overturn the existing view of the enablement requirement, but it does set a clear precedent for the strict application of the requirement, which will have a significant impact on the industry going forward. The Amgen case has several implications. First, it highlights the need for new patent portfolio management. The U.S. Supreme Court's decision has a significant impact on the global patent industry in general. In the biotech sector, especially for antibodies, it will become more difficult to patent an entire genus of antibodies by function. The number of patent applications will naturally increase, and divisional patent application is expected to increase. Furthermore, the treatment of a double patent varies by country, requiring closer attention. A company that discovers a new target should attempt various different types of patent claims. In the bio field, discovering a new target is like finding a gold mine. Therefore, the company should protect the mine by pursuing the broadest claims possible. "Functional claims," like in Amgen’s case, have the advantage of capturing the best features of the target, but they are more likely to be rejected or invalidated. Therefore, rather than pursuing purely functional claims, claims should be drafted in a way that blends functional and structural elements. It's also a good idea to experiment with multi-step claim construction, such as going from broad to narrow. Deciding when to file is a key point in the bio patent application strategy. Historically, patent strategies had been focused on patent maps during the R&D phase, freedom to operate (FTO), or litigation strategies before the product launch, but companies should now pay more attention to the patent application strategy. In the bio sector, it takes a long time to generate experimental data, so it is especially important to decide when to file the patent, after securing how much data. More data can lead to a broader scope of rights but at the cost of a later patent application date. The patent application date should take into account whether the patent is for a platform technology or a follow-on technology, whether it is in the early research or clinical stage, how large the market is for the product, and how much data can be produced. It is recommended that universities, research institutes, and companies plan their patent application strategies according to their data production capacity. The stricter the patent system interprets the enablement requirement, the more favorable it is for global companies. For example, if a global company and a university discover a disease target "at the same time," the global company will have a better chance of obtaining a broad patent because it can produce a lot of data in a relatively short period of time. If a university, research institute, or startup makes an important early stage discovery, one way to reduce the risk is to find a collaborative research partner or license out the technology to increase data production capacity.
- Company
- Prevenar maintains lead in pneumococcal vaccine mkt
- by Hwang, Byung-woo Aug 12, 2024 05:54am
- The pneumococcal vaccine market, dominated by Pfizer's Prevenar 13, is now facing competition with the introduction of MSD's Vaxneuvance. The Q2 share report, which is the first report issued after Vaxneuvance’s introduction in April, showed that while Pfizer's Prevenar 13 sales remained strong, Vaxneuvance gained a larger share of the non-reimbursed adult pneumococcal vaccine market. (from the left)Pic of Prevenar 13, Vaxneuvance Prevenar 13 was the dominant pneumococcal vaccine in Korea’s market prior to the introduction of Vaxneuvance. It generated KRW 45.8 billion in sales last year (IQVIA data), and the drug occupied 98.9% in March 98.9% among children and 100% among adults (UBIST data). However, since the launch of Vaxneuvance in April, the market’s focus of interest has been on how the emergence of the Prevenar 13’s competitor. The first report card issued in Q2 can be summarized as Prevenar 13’s solid defense despite the strong advance made by Vaxneuvance. According to UBSIT, Prevenar 13 led the pneumococcal vaccine market in June last year, occupying 69.2% of the pediatric pneumococcal vaccine market. The company's market share declined from 99.1% in March to 83.5% in April and then to 77.4% in May, but is still holding the majority of the market. Prevenar 13’s market share (Source: UBIST, Pic: Dailpharm) The gap widens when considering the adult pneumococcal vaccine market. After reaching an 87% share in April, Prevenar 13’s share had dropped to 77% in May, but rebounded to 80% in June, showing even greater market dominance than in the pediatric pneumococcal vaccine market. The industry has linked this to Vaxneuvance’s rapid registration into the National Immunization Program (NIP). Vaxneuvance entered the pediatric NIP within a month of its approval late last year and was covered through the NIP upon its launch. As a result, MSD focused on the pediatric market launch, using up most of its initial supply for NIP. The company's strategy was to aggressively target the NIP market, where it can expect stable sales. At a media seminar held on August 6, MSD said that it has been gaining a double-digit share every month. While the pediatric NIP market is likely to remain competitive, the adult market, where Prevenar 13 has an 80% share, is likely to be a concern for MSD. Contrary to how the NIP market is less commercially driven, the off-patent market is more likely to reflect the company’s marketing capabilities. Prevenar 13 and Vaxneuvance’s price competition on siteThis means that MSD would need to overcome Prevenar 13’s long-standing recognition among physicians and patients, with the cost of vaccination also serving as a competitive factor. It may be difficult for Vaxneuvance, which is relatively new to the market, to compete on price. MSD is emphasizing that Vaxneuvance has 2 more - 22F and 33F - unique serotypes compared with Prevenar 13 and with confirmed good immunogenicity. The Korean Society of Infectious Diseases recently recommended Vaxneuvance as a priority in the revised 2024 Adult Vaccination Guidelines. However, how the doctors will regard the difference of adding the 2 serotypes - 22F and 33F - in practice will be key, as the 10A serotype is found more in children and 3 and 19A serotypes in adults in Korea, and 19A and 19F serotypes are the most frequent serotypes among serotypes preventable through children’s vaccines. The next variable in the competition between the 2 vaccines will be Pfizer's follow-on vaccine, Prevenar 20. Industry insiders expect Prevenar 20 may be approved later this year and launched at the end of the year at the earliest. Although the new vaccine will not be able to influence the NIP market or guidelines in the short term, from the perspective of Vaxneuvance, the emergence of Pfizer's follow-up vaccine less than a year after its market launch can rise as a concern when expanding its share. Regarding this, a Pfizer representative said, "It is difficult to predict the timing of Prevenar 20’s approval, but we are working to launch the vaccine as soon as possible."
- Company
- Rare disease drug Ilaris is reimbursed 9 yrs after approval
- by Hwang, Byung-woo Aug 11, 2024 04:46pm
- Expectations are rising in the field for the hereditary recurrent fever syndrome Ilaris (canakinumab), which was granted reimbursement 9 years after approval. As a treatment for an extremely rare disease with a small number of patients, its reimbursement is expected to address unmet needs in an area with no treatment option. However, due to the nature of rare diseases, many patients suffer through a diagnostic odyssey, so efforts to diagnose patients quickly, such as by improving disease awareness, would be necessary to maximize the reimbursed use of Ilaris. Novartis Korea held a press conference on the 8th to highlight the implications of the health insurance reimbursement coverage of Ilaris for hereditary recurrent fever syndromes (CAPS, TRAPS, FMF) Novartis Korea held a press conference on the 8th to highlight the implications of Ilaris’s reimbursement coverage for hereditary periodic fever syndrome (CAPS, TRAPS, FMF) in Korea. Hereditary periodic fever syndromes are a group of rare auto-inflammatory diseases characterized by periodic episodes of unexplained fever and rashes throughout the body, including cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), and familial Mediterranean fever (FMF). In addition to ▲CAPS, ▲TRAPS, and ▲FMF, Ilaris can be prescribed in Korea for ▲hyperimmunoglobulin D syndrome/mevalonate kinase deficiency (HIDS/MKD) and ▲systemic juvenile idiopathic arthritis (JIA). In the case of the CAPS indication, it is further categorized into the following symptoms: ▲Familial cold autoinflammatory syndrome (FCAS)/ familial cold urticaria (FCU) ▲Muckle-Wells syndrome (MWS) ▲Neonatal onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous and articular syndrome (CINCA). "All three of these indications are extremely rare diseases, and many patients suffer through a diagnostic odyssey that prevents them from receiving an accurate diagnosis," said Dae-Chul Jeong, professor of Pediatrics at Seoul St. Mary's Hospital, "even after diagnosis, their treatment options were very limited, which was frustrating for them and us as medical professionals." Dr. Dae-Cheol Jung, Professor of Pediatrics, Seoul St. MaryIn this situation, Professor Jeong believes that the long-awaited Ilaris's reimbursement approval will enable higher utilization of the drug. Ilaris is an interleukin-1 (IL-1) inhibitor recommended for the treatment of CAPS in the 2021 international guidelines of the European Congress of Rheumatology and the American College of Rheumatology. In a Phase III study, the drug demonstrated significant clinical benefit in remission after a single dose and remission rate at 6 months and can be administered every 8 weeks in patients with CAPS, improving the quality of life for patients and their caregivers. In the CLUSTER study, which included 46 patients with TRAPS and 63 patients with colchicine-resistant FMF, 45% (n=10/22) of TRAPS patients treated with Ilaris 150 mg and 61% (n=19/31) of colchicine-resistant FMF patients achieved a complete response at week 16. "With the reimbursement of Ilaris, patients with hereditary recurrent fever syndrome who had limited treatment options will be able to benefit from the use of standard therapy," said Keun-Sung Lee, Director of Medical Affairs at Novartis Korea. "The reimbursement approval is significant as it will allow patients and their families to benefit from the improved quality of life by reducing the number of dosing required, as these diseases require long-term treatment.” Also, the importance of diagnosis in order to access the benefits of Ilaris had been emphasized at the conference, as it is a treatment for extremely rare diseases. This means that efforts need to be made to prevent the so-called “diagnostic odyssey” of the patients. "Publicity about the disease is the most needed, and we believe that we can raise awareness about the disease through symposiums at the society level,” said Professor Jeong, “I think that the introduction of genetic testing will further increase diagnosis.” "Since NGS is performed in most university hospitals, the number of tests is increasing in line with the awareness of the disease," he added, "There are problems in FMF diagnosis in adults, so we need to raise awareness step by step, such as by promoting it to internal medicine specialists."
- Company
- Yuhan acquires new drugs from biotech venture firms
- by Chon, Seung-Hyun Aug 09, 2024 05:34am
- Yuhan significantly increased its research and development (R&D) investment. Over the past five years since acquiring new drug technology from biotech venture companies, Yuhan's R&D investment size has reached its peak. This expansion of outward investment seems to be the company's outlook for securing a new portfolio. According to Yuhan on July 31st, the company's R&D cost in Q2 amounted to KRW 53.5 billion, up 39.8% from KRW 38.2 billion year over year (YoY). It increased 17.0% from the previous quarterly investment amount of KRW 45.7 billion. Yuhan's quarterly R&D investment amount exceeded KRW 50 billion in four years since Q4 2020. In 2020, its R&D investment spending significantly increased due to conducting the global Phase 3 trial for the new anticancer drug Leclaza monotherapy. Yuhan's quarterly R&D investment amounts (unit: 1 million, source: Yuhan). Yuhan's expanded R&D investment for this year is attributed to acquiring promising technologies from biotech venture companies. In Q2, Yuhan invested KRW 8 billion in two biotech ventures. In March, Yuhan signed contracts with Cyrus Therapeutics and KANAPH Therapeutics to acquire technology transfer of anticancer drug candidates based on the SOS1 inhibitor mechanism. The contract value amounted to KRW 208 billion, including milestones for future development, approval, and sales. Cyrus Therapeutics is a biotech venture developing targeted anticancer drugs and targeted protein degraders through medicinal and pharmaceutical chemistry-based technology. KANAPH Therapeutics is developing the next-generation new drug for the field of cancer and autoimmune diseases based on pharmaceutical convergence technology. The SOS1 inhibitors that Yuhan acquired are anticipated to increase treatment effectiveness in synergy with KRAS inhibitors or EGFR inhibitors and help solve tolerance to conventional therapies. SOS1 is a protein regulating the activity of RAS, involved in cell proliferation, and it is regarded as a promising target for anticancer function regardless of various RAS mutant types or cancer types. KRAS and EGFR mutations are common causes of lung cancer, colorectal cancer, pancreas cancer, and cancers with unmet medical needs. Targeting these is expected to have significant potential in terms of the market. Cyrus Therapeutics and KANAPH Therapeutics discovered non-clinical candidate products through joint research. At the American Association for Cancer Research (AACR) conference last year, they presented results showing advantages in pharmacological properties, including superior anti-cancer efficacy in xenograft animal models compared to competitive drugs and improved drug dynamics within the body. In the second quarter, Yuhan Corporation paid KRW 3 billion in royalties to the biotech company J INTS BIO. J INTS BIO is focused on developing anticancer drugs. In 2021, J INTS BIO secured a new pipeline by entering into a transfer agreement for a novel drug candidate developed by Dr. Kwang Ho Lee from the Korea Research Institute of Chemical Technology (KRICT) and Professor Byoung Chul Cho, Director of the Lung Cancer Center at Yonsei Cancer Hospital. Yuhan entered into a partnership with J INTS BIO by investing KRW 20 billion each in equity in 2021 and 2022. Last May, Yuhan signed a licensing agreement with J INTS BIO for the targeted therapy 'JIN-A04.' Yuhan has secured exclusive global rights to develop and commercialize J INTS BIO's tyrosine kinase inhibitors that target HER2 and EGFR. The technology transfer agreement has a total contract value of KRW 429.8 billion, with a non-refundable upfront payment of KRW 2.5 billion. On August 5th, Yuhan received approval from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 Investigation New Drug (IND) under the code name YH42946. The study will evaluate the safety, drug tolerance, pharmacokinetics, and anti-tumor activation following oral administration of YH42946 in patients with locally advanced or metastatic solid cancers harboring HER2 mutation and EGFR exon 20 insertion mutations. Yuhan focuses its R&D investment on acquiring external technology to uncover new growth opportunities. A prime example of Yuhan's success in open innovation is its cancer drug, Leclaza. Yuhan obtained the development rights for Leclaza from Oscotec and its subsidiary, Genosco, in 2016, just before the drug reached the preclinical stage. The total contract value was KRW 1.5 billion. Under the terms of the agreement, the partner received a fixed technology fee of KRW 1 billion within 30 days of the contract signing and an additional KRW 500 million upon approval of Phase 1 clinical trials. Yuhan entered into a global licensing agreement with Ubix Therapeutics for prostate cancer treatment in May. Ubix Therapeutics is a Korean biotechnology company developing new anticancer drugs. Yuhan secured global exclusive rights from Ubix Therapeutics to develop and commercialize a targeted protein degradation (TPD) agent that degrades androgen receptor. The contract value was up to KRW 150 billion. An upfront payment was KRW 5 billion, and Ubix Therapeutics could earn up to KRW 145 billion based on development, approval, and sales milestones. The contract also requires Yuhan to pay royalties based on the net sales of the drug it directly markets. Additionally, if Yuhan enters into a third-party technology transfer agreement for the product, the revenue from such a technology transfer will be distributed according to the drug's development stage when the agreement is signed.
- Opinion
- [Reporter's View] Fostering Korea’s Pharma-Bio industry
- by Hwang, Byung-woo Aug 09, 2024 03:11am
- "Realistically speaking, it is not easy for the domestic pharmaceutical and bio industry to stand out in the global market. It's time we set a specific and clear direction and strategy." An industry expert with over 20 years of experience in pharmaceuticals in the U.S. who is currently serving as an advisor to government agencies in Korea responded so when asked about the status of Korea’s pharmaceutical and bio industry. While a few domestic companies are making a mark in the global market, the expert explained that Korea still has a long way to go in the big picture. The expert pointed to the difference in investments as a key example. When considering the trillions of won invested in R&D by global pharmaceutical companies every year, a natural gap in capabilities has to exist. Especially as R&D investments need to be made continuously rather than in the short term, the gap is bound to widen. The pharma and biotech industry has also been calling for the pooling of capabilities and resources at the national level to foster the industry. For example, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) submitted a statement to the 22nd National Assembly, calling for the government to fuifll its pledge made during general elections and increase R&D investment for new drug development. The government is also making efforts to foster the industry, including the launch of the Biohealth Innovation Committee under the Prime Minister's Office. However, much remains to be desired, as the K-Bio-Vaccine Fund is only half operational, and the Bio-Health Innovation Committee is operated under the Prime Minister’s Office instead of the President's Office. The industry pointed out the lack of synergy between policies caused by the various ministries involved in the development as one of the issues, leading to the rise of budget allocation issues, lack of direction, and fragmented communication. "The industry and policy direction needs to be aligned to support the expansion of Korea’s bio industry,” said Seung-kyou Lee, Vice President of the Korea Biotechnology Industry Organization, at Bioplus Interphex Korea 2024 in July. The time has come for the domestic industry to draw a bigger picture than the fragmented strategies devised by each ministry in finance, regulation, and global policy. The U.S. presidential election and the implementation of the IRA are opportunities that the domestic industry should not miss. Some advise against falling into the trap of thinking that the rise of a few companies is the rise of the entire domestic pharma and biotech industry. They caution against the pitfalls of focusing on where Korea ranks in the global market. In fact, when asked about the awareness of the Korean biotech industry, an overseas VC candidly replied, "Compared to China, Korea's is less known.” In order for the domestic pharmaceutical bio industry to become the next growth engine, the entire industry needs to step up, not just a few leading companies. It is time to think about policies and strategies that can move the industry in that direction.
- Company
- SK Biopharmaceuticals records profit for 3 quarters
- by Kim, Jin-Gu Aug 09, 2024 02:55am
- SK Biopharmaceuticals succeeded in recording an operating profit for the third consecutive quarter. SK Biopharmaceuticals, which had been in the red for a long time until Q3 last year, has been in the black since Q4 last year. This is due to the strong performance of its epilepsy drug Xcopri (cenobamate) in the U.S. market. Xcopir’s sales in the U.S. exceeded KRW 100 billion in Q2 this year. Successfully achieved a profit for 3 consecutive quarters since Q4 last year On the 8th, SK Biopharmaceuticals posted an operating profit of KRW 26 billion in Q2 last year according to the Financial Supervisory Service. SK Biopharmaceuticals, which posted an operating loss of KRW 18.9 billion in Q2 last year, succeeded in turning to a profit for the first time in 1 year. The company has been recording an operating profit since Q4 last year. SK Biopharmaceuticals, which had been posting an operating loss for a long time until then, turned to a profit in Q4 last year with an operating profit of KRW 14.8 billion. Since then, the company posted consecutive operating profits of KRW 10.3 billion in Q1 and KRW 26 billion in Q2 this year. The company's revenue has also improved significantly during the same period. Until Q3 last year, SK Biopharmaceuticals' revenue was less than KRW 100 billion. However, after recording KRW 126.8 billion in Q4 last year, the company generated more than KRW 100 billion in sales every quarter, including KRW 114 billion and KRW 134 billion in Q1 and Q2 this year, respectively. Xcopri’s U.S. sales exceeded KRW 100 billion...green light lit to achieving annual sales target The company’s positive results are largely attributed to Xcopri’s strong performance in the United States. In Q2 last year, Xcopri recorded sales of KRW 105.2 billion in the U.S. market. This is the first time that Xcopir’s sales in the U.S. exceeded KRW 100 billion. SK Biopharmaceuticals launched Xcopri in the U.S. market in Q2 2020. In Q1 2022, sales exceeded KRW 30 billion. In Q1 2023, it crossed the KRW 50 billion mark and then surpassed the KRW 100 billion mark in less than a year. At the beginning of the year, SK Biopharmaceuticals set a U.S. sales target of USD 300 million (KRW 410 billion) to USD 320 million (KRW 440 billion) for Xcopri. At this rate, the company expects it will be able to achieve the upper end of the target. In addition, the company exceeded the target royalties and other service revenues it had set at the beginning of the year. In Q2, the company generated service revenue by out-licensing SKL22544. In April, SK Biopharmaceuticals signed an agreement to transfer the technology of SKL22544, a non-narcotic analgesic candidate, to Chinese joint venture Ignis Therapeutics. The deal includes an upfront payment of USD 3 million (approximately KRW 4.2 billion) and development and milestone payments of up to USD 55 million. SK Biopharmaceuticals plans to reinvest the excess cash generated from the growth of Xcopri’s performance. The company plans to accelerate the expansion of Xcopri’s indication. The company is currently conducting Phase III clinical trials in Asia for primary generalized tonic-clonic (PGTC) seizures and partial onset seizures. It is also running a Phase III clinical trial to expand the pediatric age indication. The company plans to submit an NDA for the indication expansion next year. At the same time, the company is working on discovering a second Xcopri. The company is conducting a global Phase III clinical trial for carisbamate, a candidate for a rare pediatric epilepsy Lennox-Gastaut Syndrome. Relenopride, which targets a rare neurological disease, is in Phase II trial. The company is also developing SKL13865 for attention disorder, SKL20540 for schizophrenia, and SKL24741 for epilepsy.
- Company
- Celltrion achieved highest ever sales in Q2
- by Hwang, Byung-woo Aug 08, 2024 03:37pm
- Celltrion has topped quarterly sales of KRW 800 billion the first in the company's history, driven by the successful sales of newly launched biosimilar product. According to Celltrion's consolidated income statement on August 7th, its sales this year amounted to KRW 874.7 billion, up 66.9% year over year (YOY). This figure is a record high in quarterly sales. Increased sales are attributed to successful sales of existing biosimilar products and solid increased sales of latecomer products, leading to solid sales performance. In particular, the company's primary biosimilar business recorded sales of KRW 775 billion in Q2, up 103.6% YoY. The company's operational profit in Q2 was KRW 72.5 billion. Due to the temporary rise in cost rate from inventory accumulation and amortization of intangible assets, operating profit decreased compared to the previous year. However, it increased by 370.8% compared to the last quarter. Celltrion's sales in the second quarter (source: Celltrion IR presentation report). Expanded biosimilar sales are attributed to each product's increased market share. According to IQVIA data, Remsima recorded 59% of the European market in Q1 of this year. In Q1, a subcutaneous (SC) formulation of Remsima, Remsima SC, maintained 75% of the market share in five major European countries (Germany, England, France, Italy, and Spain). Remsima SC alone reached 22% of the market share and also reached 87.5% in England, 78% in Spain, and 72.7% in France. Additionally, through stabilizing direct sales in Europe and successful bids in major countries, Truxima and Herzuma achieved market shares of 25% and 21% respectively in Europe. Celltrion anticipates continued growth in market share as the direct sales systems in Europe and other major global markets stabilize and as success in national bids increases. Celltrion's detailed report on sales in the second quarter (source: Celltrion's IR presentation report). Zymfentra under contract with one of the top three PBMs in the U.S….anticipating increased sales in the second half of the year Celltrion also anticipates increased sales with the growth of Zymfentra (U.S. product name of Remsima SC). Recently, Celltrion has secured a prescription listing agreement with Express Scripts (ESI), one of the top three PBMs (Pharmacy Benefit Managers) in the U.S., achieving coverage of 75% of the total U.S. insurance market. After successfully entering the U.S. market, the largest pharmaceutical market in the world, with its next-generation primary product 'Zymfentra (U.S. product name of Remsima SC),' Celltrion forecasts sales expansion. The company has begun receiving insurance reimbursement for Zymfentra since June, recording net sales of KRW 2.2 billion by the end of the current quarter. Celltrion has signed contract with one the the top three PBMs in the U.S. for Zymfentra…anticipating increased sales in the second half of the year. Celltrion's U.S. subsidiary plans to launch a media advertising campaign starting next month, leveraging the successfully secured insurance coverage. The strategy is to emphasize that Zymfentra is the only subcutaneous formulation of infliximab, a key treatment for inflammatory bowel disease (IBD), and to accelerate revenue growth rapidly. Additionally, with the completion of the amortization of the large-scale intangible asset rights affected by the merger in Q2, an increase in operating profit is anticipated. Sales growth and the rapid depletion of existing inventory are expected to accelerate the improvement in the cost-of-sales ratio, thereby strengthening the company’s financial stability.
- Company
- Revisions to the guidelines for atopic dermatitis treatment
- by Hwang, Byung-woo Aug 08, 2024 09:25am
- As the market for atopic dermatitis rapidly shifts due to the introduction of new drugs, domestic guidelines are being revised in nine years, and therapeutic guidelines are also changing. The guidelines now suggest a higher recommendation grade for treatments, including biological agents and JAK inhibitors, for use in patients with moderate-to-severe symptoms. They also include detailed recommendations to solve the issue of replacement therapy, which experts focus on. (Clockwise from upper left) Product photos of Dupixent, Rinvoq, Olumiant, Adtralza, and Cibinqo. The Korea Atopic Dermatitis Association (KADA) announced on July 31st the '2024 Guidelines for the Treatment of Atopic Dermatitis in Korea.' This guidelines have been revised after nine years, since 2015. Biological agents (injectable medicines), such as Dupixent (dupilumab, approved Oct. 2018), and JAK inhibitors, such as Olumiant (baricitinib, approved May 2021), have completely changed the paradigm of the treatment for atopic dermatitis. Changes in therapeutic strategy have been reflected in the guidelines following the introduction of new medicines, which can now be prescribed with less economic burden due to reimbursement coverage. The degree of recommendation for biological agents depends on domestic approval. Dupixent and Adtralza (tralokinumab, approved August 2023) were rated as Grade A, the highest recommendation, for treating patients with moderate or severe symptoms that cannot be treated with topical therapy. The basis for a high recommendation grade for these two medicines was based on having real-world studies aligning with clinically shown effects. Considering this factor, medicines that have yet to receive domestic approval, such as lebrikizumab and nemolizumab, were rated as Grade B. Additionally, JAK inhibitors that received domestic approval for treating atopic dermatitis, including Olumiant, Rinvoq (upadacitinib, approved Oct. 2021), and Cibinqo (abrocitinib, approved Nov. 2021), were all rated as Grade A. However, the recommendation was based on the premise that Olumiant and Rinvoq, which also have indications to treat inflammatory diseases, may be more effective than Cibinqo, which is indicated only to treat atopic dermatitis. Furthermore, unlike biological agents, JAK inhibitors were granted a Grade A recommendation based on conducting early diagnostic monitoring testing. The KADA emphasized that patients be tested for hemocyte count and kidney and liver function four weeks after the treatment for monitoring, and re-assessment every three months during the treatment. The KADA emphasizes replacement therapy…"should be allowed to be used when there are insufficient medicines" Despite the growing number of atopic dermatitis treatment options, clinical practices advocate lifting restrictions on replacement therapy. The issue arises because replacement therapy is authorized for psoriasis within the same dermatology practice. Therefore, itt has been included in the revised guidelines. The main point of the argument is that patients with atopic dermatitis may have different responses. Although biological agents may be effective in treating moderate-to-severe atopic dermatitis, some patients may not respond well to the treatment. Insufficient response, as defined by the KADA, is 'Meeting one or more criteria of having not reached 50% in Eczema Area and Severity Index (EASI) score, suffering from daytime or nighttime pruritus with NRS score ≥4, or having Dermatology Life Quality Index (DLQI) ≥6. The KADA explained, "There are no useful biomarkers to predict the treatment outcomes of biological agents or JAK inhibitors for atopic dermatitis treatment." They added, "Currently, when patients with moderate atopic dermatitis do not respond well or have adverse reactions to the treatment with biological agents or JAK inhibitors, they cannot switch to other medicines for effective treatment." However, the revised guidelines have not specified which biological agents and JAK inhibitors can be used for replacement therapy. Some studies suggest concrete clinical evidence for replacement therapy, but studies with low-grade evidence exist. The KADA stresses that it will not set a hurdle for replacement therapy between biological agents and JAK inhibitors when patients do not respond well to initial treatments. During a press conference, Professor Ahn Ji Young at the National Medical Center, stated, "The sequence for replacement therapy has not been determined as we have not yet concluded the appropriate medicines for this purpose. The KADA hopes that replacement therapy will be possible regardless of types of medicines used." According to the pharmaceutical industry, unlike the initial request for authorization of replacement therapy, the government may be more willing to bring changes now. For instance, the Health Insurance Review and Assessment Service (HIRA) has recently requested supplementary documents. Therefore, replacement therapy may be considered based on KADA's suggestion for patients with insufficient response. An industry official said, "The revised guidelines in South Korea and other countries, such as the United States and Europe, now include various recommendations and evidence for replacement therapy when a patient fails initial treatment." He added, "We cannot predict an accurate date for change, but we hope that accumulating evidence will be used toward opening positive discussion."
- Policy
- 4th PVA negotiations complete for Prolia
- by Lee, Tak-Sun Aug 08, 2024 09:25am
- The government completed price-volume agreement (PVA) negotiations for Prolia Prefilled Syringe (denosumab), the leading product in the domestic osteoporosis treatment market, with Amgen Korea. Whether the drug’s price will be adjusted for the 4th time under the PVA is gaining attention. According to industry sources on the 4th, Amgen Korea and the National Health Insurance Service recently agreed on PVA negotiation terms for Prolia. The current upper insurance price for Prolia is KRW 156,100. Prolia is a biological drug that targets the RANKL protein, which forms osteoclasts that destroy the bone. The drug is co-marketed by Amgen Korea and Chong Kun Dang in Korea. Ever since the drug was granted reimbursement in October 2017, the drug immediately dominated the domestic osteoporosis drug market. In April 2019, the drug was granted extended reimbursement, covering its use as a first-line therapy, which rapidly increased its use. According to IQVIA, Prolia’s domestic sales in Q1 amounted to KRW 41.2 billion, ranking second among all drugs. With sales rising steadily, the company inevitably had to negotiate Prolia’s price under the price-volume agreement system. Prolia's price has already been adjusted 3 times through negotiations. The first was a "Type A" negotiation in December 2020, which resulted in a 6.5% reduction. Type A negotiations are applied when the drug’s expected use amount increases by over 30%. The second was a "Type B" negotiation that was applied in August 2022. Type B negotiations are applied when the expected use amount increased by 60% or more compared to the previous year or increased by 10% or more but the total amount exceeds KRW 5 billion. The third was also a ‘Type B’ negotiation, which resulted in a 3.7% price cut in Prolia’s insurance price ceiling in August last year. If the drug price is adjusted this time, it will be the 4th PVA price reduction. In May, Prolia's insurance price ceiling was lowered from KRW 162,600 to KRW 156,100 due to the reimbursement extension. Prior to the reimbursement extension, patients with a bone mineral density measurement of -2.5 (T-score) or less were eligible for 1 year of benefits, but after the reimbursement extension, patients with a T-score of -2.0 or less and to -.2.5 are eligible for up to 2 years of reimbursement.
