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- Opinion
- [Desk’s View] No external reference pricing next year?
- by Lee, Tak-Sun Dec 24, 2024 06:22am
- The plan to reevaluate drug prices based on foreign drug prices (external reference pricing), which was expected to be announced by the end of the year, has been delayed. The agenda did not make this year's list at the last Health Insurance Policy Review Committee meeting set for Friday (27th). It is unlikely that the plan will proceed as scheduled due to the impeachment of the president and the government's transition to an emergency system. This does not mean that the reevaluation plan for the next year has been completely scrapped. The government initially planned to announce the plan within the year with the goal to conduct the reevaluations next year and adjusting the drug price in the second half of the year. Due to the political situation, the announcement of the reevaluation plan has been delayed, but the goal of adjusting drug prices in the second half of next year may still be intact. The reevaluation plan could resurface at any time once the situation stabilizes. For the government, which prioritizes the stabilization of health insurance finances, reducing drug prices to save finances can be an attractive card. After freezing the health insurance premium 2 years in a row, the government is unlikely to expand government support in the face of a tight budget. Also, the authorities will not dare touch the rebellious physicians' service fees in the current state, so the easy way out would be to tighten the pharmaceutical companies' pockets. But the situation is not easy at all. Since the political turmoil following the imposition of martial law on December 3, economic growth forecasts for the next year have been lowered to 1%. Year-end specials have also disappeared, with group dinners being canceled one after another due to the unrest. Many have said that they cannot feel the Christmas spirit this year. Pharmaceutical companies are also worried about their livelihood next year. With the won-dollar exchange rate soaring to KRW 1,450, domestic pharmaceutical companies that rely on imports for raw materials are facing a heavy cost burden. Last year, the self-sufficiency rate of raw drug materials reached 75%. Under such circumstances, it is obvious that reducing the price of domestic chronic disease drugs with expired patents compared to foreign drug prices will further deteriorate the profitability of pharmaceutical companies. The industry expects losses worth tens of billions of won per company. While healthcare finances are important, we also need to look at the companies' pocket situation. Korean pharmaceutical companies have recently begun to show results in overseas markets based on their excellent human resources. The performance of pharmaceutical companies comes from research and development. However, if profits cannot support R&D, new drug development will have to be reduced. The government should not postpone the announcement of the external reference pricing reevaluation business plan, but at least declare that it will not be carried out within 2025 due to the recession and uncertainties. Delaying the announcement of the business plan will only increase the uncertainty of pharmaceutical companies' livelihoods next year. The government should urgently scrap next year's plan to conduct external reference pricing reevaluations, at least to revitalize the economy.
- Policy
- MFDS' drug data protection to be implemented next year
- by Lee, Hye-Kyung Dec 24, 2024 06:22am
- Starting next year, innovative new drugs (IND) or those developed with new indications will have their approval data protected for up to six years, drawing attention to whether this will encourage domestic pharmaceutical companies to conduct more clinical trials. The Ministry of Food and Drug Safety (MFDS) will implement the Pharmaceutical Data Protection System starting February 21 to enhance the current post-marketing surveillance (PMS) system. The new data protection system has been established as a regulatory measure for integrating the systems for post-marketing safety, including the re-examination system and risk management plan. Under this system, clinical trial data submitted for marketing authorization of a drug will be protected to ensure it cannot be used by any entity other than the original submitter to obtain approval for a similar product. The amendment specifies that data protection will apply to drugs with significant changes to their active ingredients or other essential properties (called incrementally modified drugs) to improve safety·efficacy·utility, and other necessary data protection cases. According to Article 31-6(1)(3) of the Pharmaceutical Affairs Act, drugs with significant changes to their active ingredients or other essential elements are granted a data protection period of six years. Specifically, ▲Clinical trial data submitted at the time of approval to demonstrate the efficacy of combination therapies for prescription drugs with a different composition or ratio of active ingredients compared to already approved drugs ▲Clinical trial data submitted at the time of approval for prescription drugs with the same active ingredients as already approved drugs but with a different administration route. For example, clinical trial data for drugs where the route of administration is changed from continuous intravenous infusion, requiring more than 24 hours after hospitalization, to subcutaneous injection to improve patient convenience will be protected for six years. Clinical trial data for combination drugs with different active ingredients compared to already approved drugs will also be protected for six years. Meanwhile, combination drugs that are developed using two active ingredients, both already approved for combination therapy, do not qualify for data protection Under Article 31-6(1)(4) of the Pharmaceutical Affairs Act, a data protection period of four years is granted for 'Other cases that require data protection.' In detail, ▲Clinical trial data submitted to demonstrate clearly different therapeutic effects or to add distinctly different indications ▲Clinical trial data submitted at the time of approval for studies conducted in children under 12 years old ▲Drugs deemed necessary for data protection by the MFDS (such as new isomers, salts, formulations, or dosage strengths of already approved drugs to improve usage and dosage. These cases will be reviewed individually based on newly submitted clinical trial data) ▲Drugs for which expert consultations, such as those conducted by the Central Pharmaceutical Affairs Advisory Committee (CPAC), have determined that data protection is required. Phase 3 clinical trial data can also be included for pharmaceuticals deemed necessary for data protection by the MFDS. Pharmaceuticals eligible for data protection criteria indicate that each case will be reviewed individually for clinical trial data (Phase 3) submitted to demonstrate improvements in dosage and administration for already approved drugs and data submitted for adding 'other indications or effects' that are not distinctly different from existing uses of the same active ingredients and administration routes. Technically, clinical trial data eligible for protection must consist of new data required for approval. Data submitted for the approval of drugs that are identical to existing ones (regarding active ingredients, specifications, dosages, forms, indications, and routes of administration) do not qualify for protection.
- Company
- Soyun Oh appointed to head Organon Malaysia
- by Whang, byung-woo Dec 24, 2024 06:22am
- Organon Korea announced today that Soyun Oh, who currently heads the company’s Sales and Customer Department, has been appointed Country Lead for Organon Malaysia, effective January 1, 2025. With more than 26 years of experience in the industry, Oh has been with Organon since its inception in Korea and has successfully led the company's growth as its Sales and Customer Lead. As Sales and Customer Lead, Oh strengthened leadership in the chronic disease space, rapidly expanded the company's presence in women's health, stabilized the company's operations, and established a foundation for the company’s growth. Throughout her career, Oh has maximized revenue, expanded the portfolio, and driven multiple commercial successes through management strategies for key products including Atozet, Propecia, Singulair, Vytorin, and Cozaar. She has also demonstrated exceptional leadership and management skills in leading a sales organization that consists of over 150 people, contributing to the growth and development of the organization. In her new role as Country Lead of Organon Malaysia, Oh will leverage her wealth of experience and leadership capabilities to drive the company to new heights with the Malaysian team. Prior to Organon Korea, Mr. Oh held various leadership roles at MSD Korea, including Director of Primary Care (PC) and Director of Diversified Brands (DV) (Respiratory, Dermatology, Urology, etc.), with an initiative to drive the development and growth of the industry.
- Company
- SK Bioscience and Sanofi reinforce vaccine R&D partnership
- by Dec 24, 2024 06:22am
- SK Bioscience has expanded the scope of its vaccine development partnership with global pharmaceutical giant Sanofi. The goal is to develop a next-generation vaccine that is more advanced than the existing jointly developed pneumococcal protein-conjugate vaccine. The expanded agreement is more than 10 times larger in total value than the original agreement signed by the two companies a decade ago. When including the technology export agreement that SK Bioscience signed with Sanofi in 2018, SK Bioscience will receive more than KRW 160 billion from Sanofi. On the 23rd, SK Bioscience and Sanofi announced that they have entered into an agreement to jointly develop a next-generation pneumococcal protein-conjugate vaccine for infants, children, and adults that will provide broader protection than commercially available products. The agreement expands the scope of the companies' existing collaboration to develop and commercialize GBP410, a 21-valent pneumococcal protein conjugate vaccine candidate. In 2014, SK Bioscience signed an agreement with Sanofi to co-develop and commercialize a next-generation pneumococcal vaccine. Under the expanded agreement, the two companies plan to develop an innovative next-generation pneumococcal vaccine that is more advanced than the 21-valent vaccine. Under the new project, SK Bioscience will receive an upfront payment of EUR 50 million from Sanofi. Additional milestone payments will be made upon achievement of milestones until development is completed. The total value of the agreement is EUR 350 million (approximately USD 528.7 billion). R&D costs for the vaccine will be shared equally by the two companies. All costs related to commercialization will be borne by Sanofi. Upon commercialization, SK Bioscience will be responsible for sales of the vaccine in Korea, and Sanofi will be responsible for global sales. Revenue will be shared in a defined ratio based on product sales. Previously, SK Bioscience and Sanofi signed an agreement in 2014 to co-develop and market a next-generation pneumococcal vaccine with an upfront payment of USD 23 million (approximately KRW 25.6 billion). The total worth of the agreement, including upfront technology fees and milestones, was $45 million. The worth of the expanded agreement is more than 10 times larger in total value than the previous agreement signed by the two companies 10 years ago. In terms of down payment, this agreement is approximately 3 times larger than the previous agreement. This is the 10th year of R&D collaboration between the 2 companies and further strengthens their partnership. In 2018, SK Bioscience also exported its cell culture-based high-efficiency influenza (flu) vaccine production platform to Sanofi. The contract is worth USD 155 million, including a USD 15 million upfront payment and a USD 20 million milestone payment upon completion of the technology transfer. The flu vaccine production platform agreement was terminated at the end of 2021 with Sanofi returning the rights. However, SK Bioscience has no obligation to return the upfront payment of USD 35 million (approximately KRW 40 billion). SK Bioscience had received all the payments for the GBP410 agreement signed in 2014. Including the payments from the Sanofi technology export agreement and this expansion agreement, SK Bioscience's total payments from Sanofi amount to KRW 165.5 billion. Last year, SK Bioscience and Sanofi also jointly invested in the expansion of manufacturing facilities for the commercialization of GBP410. In October 2023, SK Bioscience decided to invest KRW 81.5 billion to expand its vaccine production facility in Korea, the Andong L House. The investment amount, which will be decided by SK Bioscience's board of directors, will be combined with Sanofi's co-investment to build a new production facility of approximately 4,200㎡(1,300 pyung) at Andong L House. The expanded production facility will be utilized for the production of GBP410, which is being co-developed by the two companies. The facility is expected to be completed by May next year. GBP410 is currently in a Phase III clinical trial. GBP410 entered a multi-country Phase III clinical trial last week and started administration first subject. The GBP410 multinational Phase III study will compare the immunogenicity and safety of GBP410 to licensed pneumococcal vaccines after up to 4 doses in more than 7,700 infants, children, and adolescents aged 6 weeks to 17 years. SK Bioscience and Sanofi confirmed the efficacy and safety of GBP410 in a Phase II clinical trial in June last year. The study, which included an initial and booster dose of GBP410 and a control vaccine (Prevenar 13) in 140 children aged 12 to 15 months and 712 infants and toddlers aged 42 to 89 days, confirmed that the immunogenicity of GBP410 and the control vaccine was equivalent. In terms of safety, no serious vaccine-related adverse events were reported in the GBP410 arm. Equivalent immunogenicity and safety to the control vaccine were also demonstrated when coadministered with other recommended vaccines for infants and children, including tetanus, diphtheria, pertussis, polio, and Haemophilus influenza type B vaccines. GBP410 is the first vaccine candidate to enter Phase III clinical trials in infants and children to include more than 20 serotypes. With this, SK Bioscience believes GBP410 will contribute significantly to reducing the frequency of invasive pneumococcal disease (IPD) in infants and young children. &160;“The agreement expansion between SK and Sanofi is based on the high success potential of the 21-valent vaccine, positive market outlook, and mutual trust,” said Jae-Yong Ahn, President and CEO of SK Bioscience. ”As a Korean vaccine and bio leader, we will do our best to secure vaccine sovereignty and the successful launch of a blockbuster vaccine.
- Company
- Oral contraceptive market expands
- by Whang, byung-woo Dec 23, 2024 04:19pm
- As the oral contraceptive market expands, Yaz seems to maintain its market share despite the introduction of generics. According to a report by global market research firm Research and Markets, the global oral contraceptive market is expected to grow from approximately KRW 33.8 trillion (USD 23.6 billion) in 2023 to around KRW 67.3 trillion (USD 47.1 billion) by 2028. The South Korean market also shows a consistent growth rate, similar to the global trend, with a market size of approximately KRW 42 billion in 2023, encompassing both prescription drugs and over-the-counter drugs. Contraceptives, which contain hormones such as estrogen and progesterone, are classified into four generations. The first-generation drugs have been withdrawn from the market due to side effects. Second- and third-generation oral contraceptives are available as over-the-counter medications and are distributed through pharmacies. The third-generation contraceptives minimize the side effects of the second-generation, such as acne, hirsutism, and weight gain. Bayer's Yaz (drospirenone/ethinyl estradiol) has the largest market share. In 2023 (based on IQVIA), the sales of Yaz amounted to KRW 17.4 billion, holding 41% of the market share and remaining as the No.1 drug in the market. After obtaining domestic approval in 2008, Yaz has been increasingly prescribed over the past 15 years. Contrary to expectations for heightened competition following the patent expiration of Yaz in 2020, it is meaningful that Yaz has maintained its status as the market leader. The five-year sales of Yaz amounted to ▲KRW 14.4 billion in 2019 ▲KRW 15.9 billion in 2020 ▲peaked at KRW 19.8 billion in 2021, and slightly decreased to KRW 17.5 billion in 2022. Although the sales declined due to the introduction of generics, the original product seems to maintain its impact in the market. Currently, generic versions of Yaz are available as ▲Hyundai Pharm's Yaroz ▲GL Pharma's Plan-A ▲Alvogen Korea's Gvez ▲TheU Pharmaceuticals' Yamiz ▲Kwang-dong Pharm's Esleesi. Besides Yaroz generating KRW 2.1 billion last year, the rest of the generics have not had a significant impact in the market. The analysis is Yaz's impact stems from being the fourth-generation original oral contraceptive as well as having indications for various menstruation-related conditions, such as ▲dysmenorrhea ▲premenstrual dysphoric disorder, and ▲moderate acne treatment. The number of patients with menstruation-related conditions in South Korea has been steadily increasing over the past five years. Dysmenorrhea showed an increase of approximately 85% (162,020 in 2017→299,115 in 2022), while premenstrual dysphoric disorder (PMDD) increased by approximately 34% (11,442 in 2017→15,296 in 2022). Regarding this, Bayer emphasizes that they have obtained results of Yaz from real-world studies involving 410 patients with dysmenorrhea. This study demonstrated that short-term and long-term administration of Yaz immediately relieved pain and symptoms and recovered endometrial thickness to normal. Additionally, in a real-world study conducted at 68 domestic hospitals involving 770 healthy women aged 18&8211;50 who visited gynecologists for contraception regardless of premenstrual dysphoric disorder status, 92.3% of participants reported an improvement in premenstrual dysphoric disorder symptoms after six cycles of treatment with Yaz. Expert analysis indicates that real-world data (RWD) from various studies have impacted the prescription of the drug, considering that the contraception and menstruation-related diseases require long-term administration. "Menstruation diseases, such as dysmenorrhea, significantly impact women's lives, and the disease prevalence rate is increasing, requiring more attention to treatments," Dr. Yun Bo Hyun, Professor of Severance Hospital's Department of Obstetrics and Gynecology, said. "The disease requires long-term and frequent treatments. When choosing a treatment option, patients' conditions must be considered for potential incompatibility in combining oral contraceptives." Dr. Yun added, "Yaz has 15 years of prescription history in South Korea, and it is a treatment option with confirmed benefits of improving symptoms related to menstrual diseases and established safety based on numerous studies."
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