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- 2026-04-17 19:19:01
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- 'Jardiance' reaffirms CV benefits over DPP-4 inhibitors
- by Eo, Yun-Ho Dec 09, 2019 06:26am
- Research shows that SGLT-2 inhibitor ‘Jardiance’ has more cardiovascular benefits than DPP-4 inhibitors. Boehringer Ingelheim and Lilly are the first to analyze Jardiance’s effectiveness of the EMPRISE (Empagliflozin Comparative Effectiveness and Safety) Asia study at the International Diabetes Federation, IDF presented at the General Assembly site. The EMPRISE Asia study included approximately 57,000 adults with type 2 diabetes in Japan, Korea, and Taiwan, with or without cardiovascular disease. The first validity analysis of the study showed that Jardiance has benefits in hospitals due to lower heart failure, end-stage renal failure, and all-cause mortality risks compared to DPP-4 inhibitors in real clinical settings. According to the analysis, Jardiance reduced the risk of death from heart failure by 18%, the risk of developing end-stage renal failure by 63% and the risk of death by all causes by 36% in adults with type 2 diabetes. According to the analysis, Jardiance reduced the risk of death from heart failure by 18%, the risk of developing end-stage renal failure by 63% and the risk of death by all causes by 36% in adults with type 2 diabetes. Daejoong Kim, a professor of endocrine medicine at Ajou University Hospital, a researcher at EMPRISE Asia said “"Jardiane has been shown to reduce the incidence of deaths in people with type 2 diabetes compared to DPP-4 inhibitors, and it is a convincing result that the reduction in death of Jardiance, identified through the EMPR-REG OUTCOME study, can be consistently provided to Korean patients in a real clinical setting”. The results of the EMPRISE Asia study complement the findings of the EMPA-REG OUTCOME study, which shows that Jardiance provides cardiovascular and renal benefits in addition to metabolic effects in patients with type 2 diabetes with cardiovascular disease. In the EMPA-REG OUTCOME study and sub-analysis, Jatdiance reduced the relative risk of hospitalization due to heart failure by 35%, the relative risk of death from all causes by 32%, and the relative risk of developing or worsening kidney disease by 39%.
- Company
- Celltrion, achieved first $1 billion exports in Korea
- by Chon, Seung-Hyun Dec 09, 2019 06:26am
- Celltrion Healthcare announced on the 5th that it won '$1 Billion Export Tower award ' at the 56th Trade Day Ceremony hosted by the Korea International Trade Association. Whole view of Celltrion Healthcare HeadquartersCelltrion Healthcare is the first Korean pharmaceutical bio company to surpass $1 billion in annual exports. Only five companies have received more than $1 billion towers. SK Trading International won $10 billion tower, and Hyundai Construction Equipment, Kumho P&B Chemicals, Nexen Tire received the $1 billion tower with Celltrion Healthcare. Celltrion Healthcare is an affiliate of Celltrion and Chairman Seo, Jung-jin, Celltrion, is the largest shareholder (35.69% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltrion Healthcare's sales represent the export of biosimilars developed by Celltrion. Celltrion sells a total of three biosimilars in Europe and the United States, including ‘Remsima’, ‘Truxima’ and ‘Herzuma’. Remsima's original drug is Janssen's Remicade. 'Truxima' and 'Herzuma' are Mabthera’s and Herceptin’s biosimilar products, respectively. Celltrion Healthcare received a $1 billion export tower four years after winning the $300 million export tower in 2015 as biosimilar sales increased. According to Celltrion Healthcare's quarterly report, the cumulative exports of the three biosimilars in the third quarter totaled ₩7,828 billion. It was 57.9% higher than ₩4,956 billion in the same period last year. Remsima's exports increased 60.1% yoy to ₩399 billion, and Truxima's exports soared 148.3% to ₩34.6 billon. Although Herzuma's exports fell by 42.2%, Remsima's and Truxima's propaganda boosted exports. According to the Ministry of Food and Drug Safety, ‘2018 Domestic Drug Production Imports and Exports’, total drug exports last year totaled $4.67 billion. Celltrion Healthcare accounts for about 20% of annual drug exports. On this day, Hyeong-ki Kim, the CEO of Celltrion Healthcare, received the prize of the Minister of Trade, Industry and Energy's commendation for leading Korea's pharmaceutical exports. The CEO said, “Three biosimilar products have achieved great results in the global market, opening the era of ₩1 trillion in exports of pharmaceuticals to biopharmaceutical companies, and we will focus on expanding exports with the goal of winning the $ 2 billion Export Tower within the next 1-2 years”.
- Company
- Terramycin out again, Pfizer says February next year
- by Jung, Hye-Jin Dec 09, 2019 06:26am
- Pfizer Korea’s Terramycin ophthalmic ointment (3.5 g) is out of stock yet again. Pharmacies are expecting to fall into confusion as the versatile ointment is used vastly with affordable reimbursed price for various conditions. Pfizer Korea notified distributors and pharmacies recently that the production schedule of Terramycin ophthalmic ointment has been delayed and accordingly the supply would be suspended temporarily. The company expects drug supply would resume in around February next year. The ointment was experiencing a long-term shortage for 18 months from 2016 to 2017, and gained the title of ‘problematic out-of-stock drug.’ At the time, Korean Pharmaceutical Association (KPA) demanded Ministry of Food and Drug Safety (MFDS) for a countermeasure as hospitals and clinics continued to prescribe Terramycin ointment despite the shortage. Terramycin ophthalmic ointment is popular among patients as it is used to treat a wide variety of superficial ocular infections, such as corneal ulcer and conjectivitis, and also because of its affordable price. The usage volume has surged lately as increasing number of pet owners started applying the ointment on their pets Besides, the reimbursed price of 385 won is another attractive factor of the product. The prescribed ointment sold about 180 million won, or about 470,000 units in the first half of the year alone. Even before Pfizer Korea disseminated an official notice, online shops and major distributor have gone out of stock. A number of major online shops have out-of-stock notice on their websites, and distributors are doing their best to find leftover stock. A drug distributor source explained, “When the rumor about the shortage spread, the stock level had already plummeted since the beginning of November. The shortage seems to have begun earlier as some concerned pharmacies have ordered excessive amount than usual”.
- Hesitation of Biosimilar in the immune disease market
- by Kim, Jin-Gu Dec 06, 2019 10:40am
- In the market of TNF alpha inhibitors used to treat autoimmune diseases, domestic biosimilars are showing opposite results. While Celltrion's 'Remsima' has achieved its performance, Samsung Bioepis' Remaroche, SB4, and LG Chem's ‘Eucept' have a weak presence. According to drug research agency IQVIA on the 5th, the market size of TNF alpha inhibitors in the third quarter of this year is ₩56.9 billion. The company has been changing record highs every quarter for the past three years. Compared to ₩37.1 billion in the third quarter of 2016, it increased by 53.0%. Market growth is being driven by Abbie's Humira and Janssen's Simponi. Humira posted sales of ₩ 24.4 billion in the third quarter of this year. It grew 63.8% from ₩39.4 billion in the third quarters 2016, exceeding overall market growth. The market share is still overwhelming at 42.9%. Simponi is the fastest growing. In the third quarter, the company's sales reached ₩8 billion, nearly double that of three years ago (₩4.3 billion). The market share of the entire TNF alpha inhibitor market is 14.1%, which is second only to Remicade (20.5%). Domestic Biosimilar Polarization… Less than ₩1 billion excluding Remsima. Four domestic biosimilars have challenged the TNF alpha inhibitor market. Remsima and Remaroche are remicade's biosimilars, while Etoloche and Eucepl are Enbrel's biosimilars. However, their performance is staggered by item First of all, if you look at the infliximab (remicade and biosimilar) market, all three products are steadily increasing. Among them, Remicade's sales increased 27.2% from ₩9.3 billion in the third quarters 2016 to ₩11.7 billion in the third quarter. It is analyzed that it is leading the challenge of biosimilar. In the same period, Remsima increased 60% from ₩4 billion to ₩6.4 billion. Among biosimilars, he received the most successful report cards. However, it is pointed out that the explosive power does not show as much as in Europe. According to Celltrion, Remsima's European share was 52% at the end of last year, surpassing the original Remicade. Launched in July 2016, Remaroche had virtually no results, but sales began in the second quarter of last year. In the first quarter, sales increased from ₩150 million to ₩800 million in the third quarter. Compared to other products, the sales volume is minimal. In the etanercept market, both original and biosimilars are sluggish. Enbrel is the only decline in sales among all TNFalpha inhibitors. the third quarter sales amounted to ₩4.4 billion, down 9.1% from the third quarter 2016's ₩4.8 billion. Three years ago, it was overtaken by Simponi and Remsima in third place, and now ranks fifth. Etoloche increased more than 13 times from ₩600 million in the third quarter of 2016 to ₩900 million in the third quarter of this year. Eucept, which reported its first sales in the fourth quarter of last year, has grown almost four times in a year, from ₩86 million to ₩383 million. However, the sales volume and proportion of both products are insignificant. Currently, Enbrel and Etoloche + Eucept only account for 77.8% versus 22.2%. Although the share of 1% has risen to 22% over the past three years, the impact from the decline in Enbrel's sales is small. An industry official said, "Because the market is expanding rapidly, biosimilars are not easy to settle except for Remsima." “Unlike generics, the price competitiveness is not high, and we are struggling with the influence of other original products, such as Humira or Simponi".
- Policy
- Introduction-development-turn, and the price reduction
- by Kim, Jung-Ju Dec 06, 2019 09:46am
- The pharmaceutical industry's reaction to the ambitious post-evaluation of the high-priced drugs, ambitiously issued by the government and insurance authorities, is cold. The pharmaceutical community understood the big direction of follow-up of drugs for rational fiscal expenditure, coupled with enhanced security. At the same time, it is a matter of responding to various drugs and drug prices that are popping up around the market in a way that reduces prices At the site of ‘the Public Hearing for Establishment of Post-Drug Evaluation Criteria and Methods’ held by the HIRA on the 3rd, the officials of the pharmaceutical industry censure in the plan proposed by the HIRA and the MOHW. Pharmaceutical officials who came to the public hearing did not leave after the event and contacted the insurer. The biggest problem for the pharmaceutical industry is that the re-evaluation of effectiveness (clinical utility) planned by the HIRA is a repetition of the registered contract list maintenance project from 2007 to 2011. This is a problem of overlapping hurdles, namely safety effectiveness. For governments and insurers, the market entry for licensed items and the positive gateway for payroll entry are distinctly different, but this also leads to overlapping regulations in the industry of developing and selling drugs to patients. An official of a large pharmaceutical company who attended the audience complained of fatigue, saying, “I agree with the purpose of the reevaluation, but I don't understand the results and performance of the 2011 reimbursement item’s list, and am feeling of overlapping with the application of the business at that time”. The official also said, "If the MFDS reevaluates and revokes the revoked or revised permit, anyone can agree, but we have no choice but to argue against it." There was a continuation of the question of whether the government could cover the value of drugs with a revaluation to be introduced. Another official said, “If there is no difference from the evaluation made during the MFDS approval process, and if the level of clinical literature quality evaluation is uplifted, will separate the wheat from the chaff?” “We are qualitatively evaluating the effectiveness passed by the MFDS on a document-based basis. If we don't meet the criteria, we can be perceived as an ineffective drug”. This post-evaluation also voiced the need for a social consensus whether or not the policy was appropriate for the principle of insurance in terms of the so-called 'trade off', which the government explained earlier this year. An official of the pharmaceutical industry said, “Our country is already managing the drug price in the screening system. We have already passed the validity of MFDS before entering the reimbursement”. Eun-young Park, head of the Drug Management Division, in charge of improving the evaluation of the MFDS, said, “The reevaluation of MFDS is the least effective for safety, and what we see is the framework of randomized clinical trials.” "We've improved our standards, and we want to create a clinically useful environment for how cost-effective it is to patients on the reimbursement list after screening." The industry's doubts have not eased despite clarifications that pharmaceutical companies intend not to deny the safety efficacy of drugs that they have been working hard on, but rather to see their value and adequacy. Even after the public hearing, pharmaceutical workers were seen talking about the policy in the lobby. Concerns have also been raised about foreign policy prices. It is because the evaluation criteria can be completely changed according to the will of the government, and there are also controversies and risks about how to set the comparison method and the index. The Korea Pharmaceutical Bio Association said, "It is only a reference because the government and academia are not able to confirm the actual selling price of foreign countries when talking about the new drug price controversy." "Comparing prices in eight countries" is an unreasonable attempt. " KRPIA also criticized the government's direction to lower the price of medicines to solve various issues surrounding pharmaceuticals. An official of KRPIA stressed that “the factors that determine finances are price and usage, we should ignore the focus on usage and avoid the direction that leads to drug price-oriented policies”.
- Company
- Xolair reimbursed in China, Concerns over Korea Passing
- by Kim, Jin-Gu Dec 06, 2019 09:46am
- Novartis' Xolair is listed as a reimbursed drug in China. Analysts say that 'Korea Passing' is a reality in the industry Xolair, a chronic rash treatment drug, has been cited as one of the leading examples of Korea Passing, 'withholding or withdrawal of reimbursement in Korea to be listed in China and other countries'. China's National Health Insurance Corporation recently released the 'National Basic Medical Insurance Drug List', which is a list of Korea's health insurance benefits. Seventy new drugs are on the reimbusement list Since August, the Chinese government has held a 'medical insurance drug access negotiation', which corresponds to Korea's reimbursement adequacy evaluation and drug price negotiations. Negotiation targets were 119. In the end, 70 new drugs reached an agreement in the drug price negotiation. Xolair withdrew his reimbursement in Korea, finally on the Chinese reimbursement list The most noticeable item is Xolair. Novartis' Xolair passed the Drug Benefits Evaluation Committee in December last year. It was 11 years in Korea. However, Novartis abruptly withdrew from the drug negotiations with the National Health Insurance Corporation. The cause was China. China added Korea as one of its reimbursed reference countries, and Novartis headquarters decided to rule out 'a situation where the reimbursed price could be lowered' in the Chinese market, where purchasing power is 20 times that of Korea. The result was China's listing of reimbursemt. Xolair is listed as one of the 70 reimbusement items listed. However, the listed price of Xolair is not conveyed. The Chinese government has decided to keep the specific reimbursed price secret from this negotiation. Xolair's listing suggests much to Korea in that Korea's passing has become a reality. In Korea, concerns about Korea Passing have been growing over the past two years. An industry official said, "It was finally confirmed that global pharmaceutical companies withdrew from China or gave up their reimbursement in Korea, with the Chinese market in mind." He said, "If Novartis reapply for reimbursement in Korea, the damage is expected not to be small". China has finalized its reimbusement listing policy for 70 new drugs. Chinese Medical Insurance Bureau Website Captured Reimbursement entry including Humira, Lynparza, Forxiga, Zepatier The newly listed new drugs include 70 items, including 18 Chinese medicines. Anticancer agents, diabetes treatment agents, TNF alpha inhibitors, hepatitis C treatment agents, pulmonary arterial hypertension treatment agents, HIV treatment agents and the like. In case of anticancer drugs, ▲Roche's lung cancer treatment agent 'Alecensa' ▲ AstraZeneca's colorectal cancer treatment 'Tomudex' ▲ AstraZeneca's breast cancer and ovarian cancer treatment 'Lynparza' ▲ 'Jakavi' from Novartis, a treatment for myelofibrosis, a type of rare blood cancer entered the reimbursed list Chinese pharmaceutical companies named their own anticancer drugs. Daboshu ( Sinnatimab), a treatment for Hodgkin's lymphoma jointly developed by Innovent Biologics, in collaboration with Eli Lilly; Hutchison China MediTech's Colorectal Cancer Treatment 'Elunate' (Fruquintinib), The anti-pharmaceutical treatment for breast cancer 'Henrui'(Pyrotinib) is also on the list. Diabetes treatments have also entered the reimbursed list. The GLP-1 series includes AstraZeneca's Byetta and Sanofi's Lyxumia, and among the SGLT-2 lines, AstraZeneca's Forxiga, Boehringer Ingelheim’s Jadiance, Jansen’s Invokana. Etc. were included. Autoimmune disease treatment was also applied as a benefit. Abbvie's Humira, Jansen's 'Remicade', Pfizer's Xeljanes as JAK inhibitor, and , Novartis' 'Xolair' as IgE (immunoglobulin E) inhibitors, respectively are on the list. The hepatitis C treatments included MSD's Zepatier, Gilead's Eplusa and Harvoni. Two new HIV treatments were added, Gilead's Genvoya and Descovy. In addition, GSK's' Trelege Ellipta 'and Novartis' Ultibro' as a COPD therapy inhalation, Novartis' Entresto as a chronic heart failure treatment, Bayer's ‘Eylea 'as a treatment for macular degeneration, and retinal diseases Allegan's Ozurdex was included as a treatment. This is a list of major drugs listed. 8 Chinese-developed drugs have been listed on the reimbursement list, including 3 anticancer drugs in the red box. 70 New Drugs Cut Average Price by 61% "Hepatitis C pill, the world's lowest" This reimbursement update is shown in 'Drug cost reduction'. According to major Chinese media, including Xinhua News Agency, the average price cut of 70 new drugs is 61%. Like Korea, China is deeply concerned about the increase in reimbursement and drug costs. Since 2017, China has updated its list every year since 2017, and has been negotiating drug prices with global pharmaceutical companies. The high marketability of the population of more than 1.4 billion is the backdrop for the Chinese government to demand strong drug prices from pharmaceutical companies. In fact, most negotiated drug prices are among the lowest in the world. For example, three hepatitis C treatments reported that the average price was reduced by 85%. Existing hepatitis C treatment prices ranged from ¥ 30,000 to 70,000 (about ₩ 505 to 11.78 million). On the basis of this, it is possible to calculate ¥4500-4500 (about ₩760,000-17.7 million). The Chinese press describes it as "the lowest price in the world." Self developed anticancer drug surpasses Keytruda and Opdivo, listed Another point is the protection of homegrown medicines. Of the 70 drugs added, eight drugs, including Daboshu-Elunate, were developed by Chinese pharmaceutical companies. In particular, Daboshu attracts attention as it is the first to be paid for PD-L1 immunocancer drugs. Other PD-L1 immunocancer drugs, Keytruda and Opdivo, are not yet listed Daboshu is the result of the creation of a major drug, part of China's national science and technology project. After getting a marketing license in December last year, it quickly entered the reimbursement list. This year, the Chinese Society for Clinical Oncology (CSSO) revised its guidelines for lymphoma treatment and encouraged Dabosche's prescription. Elunate is similar. After getting a marketing license in September last year, it entered the reimbursed list relatively quickly. This is a part of the Chinese government's view of in-house developed medicine.
- Company
- High-risk osteoporosis should increase bone formation first
- by Eo, Yun-Ho Dec 06, 2019 09:43am
- KSBMR Chair Chung Ho-yeon “For a high-risk patient, it would be better to use effective bone-forming agent from the beginning.” Amgen Korea held a press conference held on Dec. 4 for the launch of Evenity (romosozumab-aqqg), where Chair Chung Ho-yeon of Korean Society for Bone and Mineral Research (KSBMR) stressed on the importance of top-down style prescription with the new option of osteoporosis treatment. He urged medical professions should choose prioritized option recommended as a medication strategy for patients at high risk and in need of urgent treatment effect. Particularly, Chung highlighted 12-month Evenity treatment showed increased bone formation effect in vertebral and hip fracture, more than with teriparatide. A number of clinical data confirmed Evenity, compared to single therapy with alendronate, notably reduces risk in new vertebral or non-vertebral fracture. “The prevalence rate of osteoporosis in age group over 50 has been constantly rising after 2008. More than anything, osteoporosis within a year results in hip fracture for one out of five patients, and in vertebral fracture for one out of ten patients, which can lead to possible deaths”, Chair Chung emphasized. Korean Ministry of Food and Drug Safety (MFDS) granted approval on Evenity in May 31. Now Evenity can be used on treating severe osteoporosis in postmenopausal women at a high risk of fracture, and to increase bone mineral density for men with osteoporosis at a high risk of fracture. A target therapy Evenity is the first dual-acting osteoporosis drug that increases bone growth by inhibiting the activity of sclerostin, a protein that regulates bone formation, and also inhibits bone resorption. The treatment is administered once-monthly in two separate subcutaneous injections (105 mg each, 210 mg in total) on different body parts. After administering full 12 doses, maintenance therapy with bone resorption inhibitor is needed. MFDS’ approval was based on Phase 3 FRAME and ARCH studies treating postmenopausal women with osteoporosis, and Phase 3 BRIDGE study treating men with osteoporosis. First, the Phase 3 FRAME trial compared Evenity with placebo in menopausal women with a T-score of -2.5 to -3.5 at the total hip or femoral neck. And the result showed that the treatment lowered risk of new vertebral fracture. Treated with Evenity for 12 months, the risk of new vertebral fracture was reduced by 73 percent compared with placebo. Patients who switched to Prolia for 12 months after 12-month Evenity treatment had a 75 percent lower risk of new vertebral fracture compared to patients who switched to Prolia from placebo. In the Phase 3 ARCH trial, comparing Evenity and alendronate, romosozumab showed outstanding preventive effect on postmenopausal women with osteoporosis and high risk of fracture by lowering incidence of both vertebral fracture and clinical fracture. A group of patients, who switched to alendronate after 12-month Evenity treatment, lowered risk of new vertebral fracture by 50 percent at 24-month compared to a group with alendronate treatment only. Also in BRIDGE trial comparing Evenity with placebo treating men with osteoporosis, 12 months of the treatment increased patient’s bone mineral density by 12.1 percent more than placebo, demonstrating a meaningful improvement in bone mineral density. “The U.S. Endocrine Society’s (ENDO) guideline revised in 2019 recommends bone formation agent as a first-line treatment for osteoporosis patient with fracture. With dual effect of increasing bone formation and reducing bone resorption, Evenity can be considered as a prioritized option recommended for treating osteoporosis at super high risk”.
- Policy
- Investing KRW 4 tn fostering Biohealth as ‘Post-semiconduct
- by Kang, Shin-Kook Dec 06, 2019 09:43am
- Until 2025, the Korean government is to assertively invest four trillion won on fostering biohealth industry as a ‘post-semiconductor industry.’ On Dec. 4, Deputy Prime Minister Hong Nam-ki led the fifth Innovative Growth Strategy meeting and the 28th Economic Ministerial meeting and discussed about next generation innovative growth engine, related validation process and additional plans. First, the government has decided to concentrate the state capability on developing biohealth industry, because new drug export volume was tripled from 1.4 trillion won in 2017 to 4.4 trillion in 2018, expanding the foundation of technology. Deputy Prime Minister Hong Nam-ki presiding at Innovative Growth Strategy meeting (middle) The government aims to grow biohealth industry as a next generation economic growth engine, or so-called ‘post-semiconductor industry’, by investing four trillion won on R&D until 2025 and developing and emerging technology. The government’s plans are to set a roadmap for biohealth regulation reform within this month to implement it from next year, and to establish human resources development center for biotechnology training two thousand experts at a time. Moreover, the government is also working on innovation strategy and plan for the service industry. The plan is to expand total service industry based on three major types of Manufacturing as a Service (MaaS), Healthcare as a Service (HaaS), and Financial Accounting Advisory Service (FAAS). MaaS is to be expanded centering a voucher program supporting companies in need of manufacturing service, whereas HaaS would develop pilot programs and validate and expand it in different regions. FAAS is to open encrypted big data of credit information provided by Korea Credit Information Services. However, the government officials expressed regret as the key regulatory reform plans for remote medicine, sharing economy and more are surrounded by fierce dispute between stakeholders and social conflicts. Specifically, the officials pointed sluggish process of revision of the three data protection laws essential for the growth of emerging industry, and that it is limiting the industries’ performance. The three information protection laws are; Personal Information Protection Act; Act on the Protection of Information and Communications Infrastructures; and Credit Information Use and Protection Act. Deputy Prime Minister stated “The government plans to foster biohealth as the next generation economic growth engine following the footsteps of semiconductor, and also it would set state-led artificial intelligence strategy, create data economy, and activate startup ecosystem for all product cycle.” “The Economic Policy Plan 2020 would contain policy focus and goals immediately in effect from next year and it would be presented to the public all together by the end of the month. To propel the innovative growth in stable and effective fashion, refining legal and regulatory foundation with legislation would be crucial,” the Deputy Prime Minister added.
- Company
- 3rd PARP inhibitor Talzenna readies for Korean market
- by Eo, Yun-Ho Dec 06, 2019 09:39am
- A pharmaceutical industry source reported on Dec. 6 that Pfizer Korea has recently submitted an application to Ministry of Food and Drug Safety (MFDS) for an approval on PARP inhibitor Talzenna (talazoparib). When it gets the green light from the ministry, it would be the third PARP inhibitor medicine in Korea to enter the market, following AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib). The application is for an approval on a single therapy indication to treat locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer in women with an inherited BRCA mutation. The treatment has been approved in Europe last June and the U.S. in October last year. Talzenna demonstrated its efficacy during EMBRACA trial with 431 patients. As a result, Talzenna arm well-surpassed the standard chemotherapy arm’s 5.6-month median progression-free survival (PFS) as it was extended to 8.6 months. Talzenna arm also demonstrated an objective response rate (ORR) of 62.6 percent, significantly higher than that in the standard chemotherapy arm with 27.2 percent. The most common adverse reactions of patients receiving Talzenna were fatigue, anemia, nausea, neutropenia, thrombocytopenia, headache, hair loss, diarrhea, and loss of appetite. In Korea, AstraZeneca’s Lynparza was the first PARP inhibitor to be listed for reimbursement. With the economic evaluation exemption system, Lynparza signed an expenditure cap type risk sharing agreement (RSA) in October 2017. Just recently, the treatment expanded approval on indication as a first-line maintenance therapy for advanced ovarian cancer, a first and second-line therapy on ovarian cancer with additional administration type (tablet), and a treatment for HER2-negative metastatic breast cancer. Meanwhile, another PARP inhibitor Zejula was granted with reimbursement starting from this month. The treatment can be prescribed as a single maintenance therapy for platinum-sensitive adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. However, Zejula’s first reimbursement scope is limited to patients with BRCA mutation.
- Policy
- “Providing as much clinical information for patients”
- by Lee, Tak-Sun Dec 05, 2019 06:23am
- Director Kim Jeong-mi of Clinical Trial Management Division Since the end of last October, the Korean Ministry of Food and Drug Safety (MFDS) has expanded scope of information on approved investigation new drug’s (IND) protocol uploaded on its website. Previously, only the names of clinical trial, sponsoring client, IND, targeting disease and clinical trial institute were publicly disclosed, but now more information, including comparison drug, contact information of the institute, subject selection and exemption standards are also uploaded online. Anyone can now check a company’s R&D progress in detail on the website, and patients can search information and actively participate in a clinical trial by contacting the clinical institute directly. At a press conference held on Dec. 3, Director Kim Jeong-mi of Clinical Trial Management Division at MFDS explained, “Although clinical trial information has been disclosed since 2007, we’ve been thinking that we are not meeting the patients’ expectation. We recognized the need to publicly provide similar level of information as other countries, so we formed a consultative body for clinical trial system development to specify expansion of the provided information.” “Our principle is to disclose as much information as the U.S. or EU. But the update has been slow as double-checking accurate information is taking more time than we expected,” Director Kim added. Expanding provided scope of clinical protocol information is expected to support patient’s right to know and their active participation in clinical trials. Revealing contact information of the healthcare institute was to meet the existing demands of patients seeking opportunities to participate. “These days, patients have gotten sophisticated so much to actively look for related information and to get highly knowledgeable in particular medicines. Naturally, they are curious about contact information of clinical institute and doctors in charge. Some are even eager to transfer the hospitals to participate in clinical studies”, Director Kim elaborated. Disclosed clinical protocol information has been expanded partially, but the website still lacks in system stability and promotion. Particularly because MFDS’ Drug Information System website (www.nedrug.mfds.go.kr) provides a vast amount of information on drugs, searching for IND approval status on the website takes a long time. Moreover, many people still do not realize the website provides IND information. The director said, “We still need to contemplate on how to provide the information with easier access. Also we are considering on making information search easier for IND developers and researchers.” In August, MFDS announced the Five-year Master Plan on Developing Clinical Trial System. The five-year plan aims to strengthen safety control over clinical trials and enhancing international competitiveness. Director Kim commented, “We have had a lot to ponder as transnational clinical trials have been stagnating recently and we want to create an advanced clinical environment and protocol review system in Korea attractive enough for Korean companies to develop global IND. The five-year plan has details of strengthening safety management and international competitiveness, communicating better of clinical trials and shifting public’s bias.” One of the highlights of the plan was making drug safety update report (DSUR) mandatory. The director explained, “Unlike late-phase clinical trials, earlier-stage trials have more prevalent risk of safety issue and adverse reaction. And to promote the earlier stages of trials, the ministry plans to tighten evaluation on trial sponsor and safety control on trial conductor. DSUR has been filed by multinational pharmaceutical companies, but we are also asking Korean companies to file them with the amendments.” Review on early phase clinical trials would be strengthened as well. By forming Innovative Early-phase Clinical Trial Review Team, MFDS plans to conduct overall review not only for INDs, but also on pharmacology test, quality, and statistics. “Without removing negative bias on clinical trials, Korea would struggle to acquire clinical competitiveness. We are planning to extend communication channel and to raise better awareness of clinical trials by working closely with Korea National Enterprise for Clinical Trials (KONECT) and consultative body for clinical protocol review,” Director Kim said. Nevertheless, the director stressed, “In other countries, clinical trial participation is considered as a ‘volunteer service’ with a side of treatment opportunity. But in Korea, clinical trials are regarded negatively rather than necessary. When the majority of the public can agree clinical trial is essential to the society, the need of new drug development and industrial benefit of drug development could be emphasized.”
