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- 2025-12-23 11:38:06
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- GSK’s momelotinib receives orphan drug designation in KOR
- by Eo, Yun-Ho Oct 10, 2023 05:26am
- The new myelofibrosis drug momelotinib has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety announced so through an orphan drug designation notice issued on the 6th. Momelotinib is a treatment for myelofibrosis that blocks the major signaling pathways for JAK1, JAK2, and activin A receptor type 1 (ACVR1). The drug was a candidate drug for Sierra Oncology, but was acquired by GSK last year for USD 1.9 billion (KRW 2.56 trillion) and recently received final approval from the US Food and Drug Administration. Based on its mechanism of action, momelotinib is known to improve systemic symptoms and splenomegaly (enlarged spleen) by inhibiting JAK1 and JAK2, while directly inhibiting ACVR1 to reduce the level of circulating hepcidin, which contributes to anemia. Results of the Phase III MOMENTUM trial conducted on patients with myelofibrosis that was published in the global medical journal, The Lancet, showed that the drug demonstrated significant results in myelofibrosis patients with anemia, where treatment limitations had previously existed. The MOMENTUM study investigated momelotinib versus danazol in 195 patients with myelofibrosis who were symptomatic and anemic and had been previously treated with an approved JAK inhibitor at 107 sites in 21 countries. The primary endpoint was the total symptom score response (≥50% reduction from baseline) rate assessed through MFSAF(Myelofibrosis Symptom Assessment Form). Study results showed that 25% of patients treated with momelotinib met the primary endpoint as compared with 9% in the danazol arm. Also, at 24 weeks, 40% of patients in the momelotinib arm achieved a spleen volume reduction of at least 25% from baseline at week 24, 35% of which did not require transfusion at week 24. The levels were 6% and 17% respectively for the danazol arm. Meanwhile, myelofibrosis is a disease in which fibrous scar tissue replaces blood-producing cells in the bone marrow, and is characterized by abnormally shaped red blood cells, anemia, and an enlarged spleen.
- Company
- Hemgenix receives orphan drug designation in KOR
- by Eo, Yun-Ho Oct 10, 2023 05:26am
- The one-shot gene therapy for hemophilia, Hemgenix, has been designated as an orphan drug in Korea. On the 6th, the Ministry of Food and Drug Safety announced so through an orphan drug designation notice. Hemgenix (etranacogene dezaparvovec-drlb), which is the first and only one-time gene therapy approved for the treatment of adults living with hemophilia B, was first approved by the FDA in November last year. The drug can be used to treat adults with hemophilia B who: currently use Factor IX prophylaxis therapy, have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Hemgenix’s efficacy was confirmed through the pivotal HOPE-B study, the largest gene therapy study in hemophilia B to date. Study results showed that the mean factor IX activity of hemophilia B patients had increased to 36.9 IU/dL after infusion, and showed durable and sustained stable activity levels. Also, the drug reduced the annual bleeding rate (ABR) by 64%. Also, 9 96% of patients discontinued routine Factor IX prophylaxis and mean Factor IX consumption was reduced by 97% at 18 months post-treatment. The drug continued to show effect in the HOPE-B 24-month extension study. There were no serious treatment-related adverse events in the clinical study setting, and the drug was generally well tolerated. Hemophilia B is a congenital bleeding disorder caused by a single gene defect and is caused by a deficiency in coagulation factor IX (blood coagulation factor 9), a protein that helps blood coagulation and is mainly produced in the liver. Moderate-to-severe Hemophilia B is treated using prophylactic infusions of factor IX to temporarily replace or supplement low blood clotting factor levels. Although effective, patients are burdened with having to strictly adhere to a lifelong infusion schedule. Also, patients can experience pain, limited mobility, joint damage, and spontaneous bleeding due to the disease. When these patients are injected with Hemgenix intravenously, they can produce blood coagulation factor IX on their own, lowering the risk of bleeding.
- Company
- Dongkook succeeds P3T for its BPH combination drug
- by Chon, Seung-Hyun Oct 06, 2023 05:37am
- On September 25th, Dongkook Pharmaceutical announced that it had confirmed the safety and efficacy of its incrementally modified combination drug for benign prostatic hyperplasia (BPH), ‘DKF-313,’ through a Phase III trial. Based on the positive results, Dongkook Pharmaceutical plans to complete the Phase III trial result report within the year, then apply for its marketing authorizations and release. Pic of Dongkook Pharmaceutica HQ DKF-313 is the world’s first combination of dutasteride and tadalafil. According to Dongkook Pharmaceutical, its combo drug has a dual effect of reducing prostate size while improving urinary disorder symptoms from BPH and can bring better treatment effect than single-agent drugs. The company said, “We were able to confirm the superior effect of DKF-313 in the trial. The drug is expected to improve the convenience and quality of life for patients ailing from a condition that requires long-term medication, as the drug comes in a once-daily, one-tablet dosage form." The company received approval to initiate a Phase 3 trial for DKF-313 from the Ministry of Food and Drug Safety in July 2020 and began full-scale clinical trials to enroll about 650 patients from 18 hospitals nationwide in 2021. Dongkook Pharmaceutical took charge of the development of DKF-313, and three domestic pharmaceutical companies, including Dong-A ST, Shinpoong Pharm, and Dong Koo Bio & Pharma, shared the cost as participants. If the drug succeeds in commercialization, the partner companies will each gain marketing authorization and release it simultaneously. The incrementally modified version of this combination drug will be manufactured and supplied at a facility of the organizing company, Dongkook Pharmaceutical. Professor Choung-Soo Kim, Director of the Prostate Cancer Center at Ewha Womans University’s Mokdong Hospital, said, “The combination demonstrated superiority in improving the International Prostate Symptom Score (IPSS) compared to each agent alone, and there was no statistically significant difference between the combination and single-agent drugs in terms of adverse drug reactions. If the results lead to product launches, it may provide new and significant support in improving the treatment and quality of life of the patients.” A Dongkook Pharmaceutical official said, “We plan to strengthen our stronghold in the domestic market based on our domestic and overseas network and sales power and expand our scope overseas and penetrate the global market.”
- Company
- SCD accelerates EU approval of Eylea biosimilar
- by Nho, Byung Chul Oct 05, 2023 05:27am
- SCD announced on the 4th that it had decided to proceed with final negotiations after receiving confirmation of the details of the due diligence conducted for three days from September 6th to 8th by the Eylea biosimilar European partner company. Inspectors designated by the European partner company visited the SCD Eylea biosimilar CMO production site and inspected production facilities and GMP regulations for three days. As a result, it was concluded that there were no problems with the application for European EMA approval, and it was reported that the first result was confirmed on September 26th. An SCD official said, “This extension of the Binding Term Sheet deadline is not because there was a problem with due diligence or negotiations, and we have not yet received the final report on the due diligence results, so we have inevitably extended the signing of this contract.” SCD explained, “The inspectors are comprised of experts with more than 20-30 years of experience in the European EMA approval review process, so it is almost the same level as the approval inspection.” He added, “Now that all preliminary work for the contract has been completed, we will strive to achieve results within the targeted time.” In addition, it was confirmed that SCD received $3 million (approximately 40.8 billion won) in down payment related to the previous Eylea biosimilar supply contract in Canada.
- Company
- New drugs only account for 8.5% of all drug spending in KOR
- by Eo, Yun-Ho Oct 05, 2023 05:27am
- A study revealed that the expenditures spent on new drugs account for only 8.5% of Korea's total drug cost. On the 4th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) released the results of 'A study on the analysis and rationalization of drug expenditures for new drugs in Korea' conducted by Professor Jong-Hyuk Lee from Chung-Ang University’s College of Pharmacy. Study results showed that the expenditures spent on new drugs from the national health insurance finances accounted for 8.5% of total drug costs and 2.1% of the total national health insurance medical costs. In particular, the financial impact made by new drugs on national health insurance finances was among the lowest when compared with other OECD countries. This study was initiated in recognition of the growing need to strengthen coverage of innovative new drug treatments for domestic patients, and how the new innovative drugs were having difficulties being listed due to the perception that they are a significant burden on health insurance finances. Professor Lee's research team examined Korea's current drug expenditure structure by analyzing the expenditures made by 227 new drugs that were listed during the past 10 years (2012-2021). More specifically, the results showed that the annual drug expenditure spent per new drug product was about KRW 6.1 billion, with the total drug expenditure spent over the past 10 years being KRW 164.2 trillion. The study also analyzed the financial impact made by new drugs according to their cost-effectiveness verification method (economic evaluation, economic evaluation exemption, weighted average price, etc.), and the proportion of expenditures spent on new drugs listed under the risk sharing agreement (RSA) system, and the financial impact of new drugs according to their serious disease classification status. In this analysis, the financial expenditures spent on items that were waived pharmacoeconomic evaluation data submissions and were subject to RSA, which account for most of the new drugs used to treat serious diseases such as cancer and rare diseases, were low at 0.3% and 2.7%, respectively, of the total drug cost. In addition, when analyzing the financial impact of new drugs according to their serious disease classification status, drug expenditures spent on new drugs for severe and rare diseases (cancer, rare diseases) were found to be only account for 3.3% of the total drug costs, suggesting the low treatment access available for domestic patients with severe and rare diseases. Professor Lee said, “The 10-year financial expenditures spent on domestic new drugs that were analyzed in our study were lower than what was previously known, confirming that their impact on finances was lower than the general perception.” He added, "In particular, new drugs that are exempt from submitting from pharmacoeconomic evaluation data, which account for the majority of new drugs being introduced recently, not only have a low financial impact, but also have a low annual drug cost per item, and the ratio of finances spent for new drugs for severe rare diseases is also low. Therefore, the expenditure structure requires some improvement in terms of improving access to treatment." Meanwhile, PhRMA (Pharmaceutical Research and Manufacturers of America) also shared its report on the international comparison of accessibility and financial impact of new drugs in each country (based on IQVIA data) of 460 global new drugs approved in the U.S., Europe, and Japan over the past 10 years (2012-2021). According to PhRMA’s analysis results on the financial impact of new drugs of each OECD country, as of 2021, Korea's financial impact of new drugs was 4%, ranking 30th out of 32 countries, the third from the last, followed by Turkey, Greece, and Mexico. Korea’s financial expenditure structure for new drugs was at a similar level. In addition, compared to major developed countries, Korea had the lowest financial expenditure ratio for new drugs, with a 3~6 times difference from major countries such as the United States stands at 26%, Germany at 19%, the United Kingdom at 18%, and Japan at 14%.
- Company
- GSK Korea appoints Maurizio Borgatta as new General Manager
- by Oct 05, 2023 05:27am
- On the 4th, GSK Korea announced it appointed Maurizio Borgatta, former General Manager of GSK Portugal as its new general manager. After joining GSK in 2015, the new GM is known to have successfully launched and sold GSK’s treatments and vaccines in the European region, including Belgium, Spain, Italy, and the UK. Also, he contributed to increasing patient access to treatments in various countries including the United States, Japan, and Germany by launching a treatment for severe eosinophilic asthma and expanding indications. Since 2021, he served as general manager of GSK Portugal, where he successfully achieved the expansion of indications for 8 innovative drugs and enabled the market entry of 2 new vaccines. He said, “With employees and executives at GSK Korea, we will strive to strengthen access to GSK's broad vaccine portfolio and other innovative treatments for Korean patients and ensure stable supply to stay ahead of disease and contribute to improving the quality of life of patients in Korea.” Rob Kempton, who led GSK Korea since 2020 until recently, was appointed Head of the Vaccines Market in Europe.
- Company
- The reimbursement process for Cosentyx and Taltz
- by Eo, Yun-Ho Oct 05, 2023 05:27am
- The insurance reimbursement registration process for IL-17A inhibitors as first-line treatment for ankylosing spondylitis has been at a standstill for a long time. As a result of the investigation, the two IL-17A inhibitors approved in Korea, Cosentyx of Novartis Korea and Taltz of Lilly Korea completed discussions on expanding the HIRA level of coverage in February, but the application has not yet been implemented. These drugs simultaneously submitted applications for reimbursement expansion based on the ‘ASAS-EULAR axSpA treatment recommendations 2022’ in July last year. Interleukin drugs are already available for prescription as first-line treatment for ankylosing spondylitis in more than 30 countries. In Korea, both drugs are approved for reimbursement only as second-line therapy after a prescription for a TNF-α inhibitor. According to the ASAS-EULAR guidelines revised last year, IL-17A inhibitors were upgraded to the same recommendation grade (A) and level of evidence (1a) as TNF-α inhibitors. It was mentioned that both agents are currently being used as first-line biological agents for the treatment of ankylosing spondylitis, and it was officially confirmed that the therapeutic positions between the two agents are the same. Additionally, in the case of TNF-α inhibitors, there are concerns about tuberculosis. For this reason, treatment for latent tuberculosis must precede the use of TNF-α inhibitors. However, despite anti-TB treatment, the occurrence of tuberculosis due to the use of TNF-α inhibitors is still reported in several studies. Therefore, for some patients who are at high risk of infection, such as tuberculosis, or who have comorbid conditions, such as heart failure, for which it is difficult to prescribe TNF-α inhibitors, other treatment options are needed. Hong Seung-jae, insurance director of the Korean Society of Rheumatology (Department of Rheumatology, Kyung Hee University Hospital), said, "IL-17A inhibitors are already widely used as first-line treatments overseas, and the 2022 overseas treatment guidelines also state that for patients with ankylosing spondylitis accompanied by skin diseases such as psoriasis, IL-17A inhibitors are already widely used as first-line treatments overseas. “As 17A inhibitors are recommended with priority over TNF-α inhibitors, we hope that coverage for IL-17A inhibitors will be expanded in Korea as soon as possible so that we can provide customized treatment tailored to patient characteristics,” he said. Meanwhile, the number of ankylosing spondylitis patients has rapidly increased by nearly 50% over the past 10 years (35,592 in 2013, 52,616 in 2022). It is a disease that mainly develops at a young age, and domestic patients go through a waiting period of about 40 months until they receive an accurate diagnosis. In addition, the disability level of ankylosing spondylitis is the highest level 2, making it a serious disease that qualifies people with severe disabilities and even exemption from military service. Among domestic ankylosing spondylitis patients, 72.6% are male, and one in two male patients are in their 30s and 40s, and are most socially active, so there are concerns about a decline in occupational ability due to symptoms. In fact, in a study targeting domestic patients, patients were absent from work due to their symptoms, and the annual cost of lost productivity time due to this was approximately 14 million won, and this increased as disease severity and functional limitations increased.
- Company
- Price cuts for 35 generics suspended…only 0.5% of all
- by Chon, Seung-Hyun Oct 04, 2023 05:35am
- The second case of suspension of execution of price cuts among 7,000 generic drugs emerged on the 5th. The price cuts for 12 generic items from Hutecs Korea will be suspended for 9 months. The number of products for which drug price reductions have been suspended, including the 17 drugs whose price cuts have been temporarily suspended, has increased to 35. However, the number of items that received a stay of execution is so small that it only accounts for 0.5% of all the generics that received price cuts. According to the Ministry of Health and Welfare on the 25th, the price cuts for 13 Hutecs Korea’s items will be suspended until June 30 next year. The prices of A Cet SR Tab, Alzpezil Tab 5mg, Lyreca Cap 75mg·25mg·50mg, Exforte Tab. 5/160mg, Amolvikar Tab 5/20mg·5/40mg·1/40mg, and Crestibe Tab. 10/5mg·10/10mg have been reduced by up to 15% on the 5th, but their prices will be kept at the level before the price reduction for 9 months. The MOHW announced price cuts for about 7,000 drugs from the 5th through a partial amendment announcement of the ‘drug reimbursement list and reimbursement ceiling price table.’ However, Hutecs Korea filed an administrative lawsuit and suspension of execution, claiming that it could not accept the drug price cuts for 13 items, after which the court decided to put the drug price cuts on hold. As a result, price cuts for 17 items from two companies received a stay of execution for 7 to 9 months after filing an administrative lawsuit. Previously, the Seoul Administrative Court decided to suspend Medica Korea's drug price cuts for 5 items, including Telmisartan Tab 40mg, until April 30, 2023. In the case of Hutex Korea, this is the first case where the drug price cut was reverted due to a lawsuit after the drug price cut had been implemented. Not only Medica Korea, but also Abbott Korea, SS Pharm, NBK Phparm, and Youngil Pharm filed a lawsuit to cancel the drug price cut, which resulted in a temporary suspension of execution before the drug price cuts were implemented. The products for which the companies filed lawsuits to cancel the drug price cuts had their drug prices reduced due to procedural inadequacies even though they submitted data that met the highest price requirements, such as conducting bioequivalence tests, and thus pursued legal action. For example, there was one case where a drug’s price was reduced after a bioequivalence test was performed and the conversion was completed because the company did not submit the change permit. There are also cases where the company conducted bioequivalence tests that cost hundreds of millions of won, but permit changes were not completed due to schedule delays. Also, even though companies proved that they fulfilled the requirements for the use of registered APIs, some have been classified as being subject to drug price cuts by raising issues over other ingredients listed in the authorization permit. However, among the total 7,355 drugs whose prices have been reduced, the number of products whose execution of price cuts has been suspended accounts for only 0.5%. There are a total of 179 pharmaceutical companies subject to drug price cuts, and only 3.4% of them filed administrative lawsuits. As there is no legal justification to claim unfairness in the drug price reduction process, the number of administrative lawsuits filed by pharmaceutical companies is expected to be minimal. Hutecs Korea filed a lawsuit to cancel only 13 of its 153 products that received drug price cuts, which amounts to only 8.5%. Hutecs Korea reduced the price of three dosage forms of Exforte tablets but filed a lawsuit to cancel the price cut for only one, 10/160mg dose, product. Medica Korea filed a lawsuit to cancel only 5 of the 91 products that were set to receive drug price cuts, which amounts to only 5.5%. This means that it accepted drug price cuts for 86 of its items. However, it is highly likely that the number of products for which drug price cuts will be suspended will continue to increase. The temporary stay of execution of price cuts made for the 15 items from 3 companies may receive a formal stay of execution before the end of the provisional suspension period. The execution of drug price cuts for 3 items, including Abbott Korea's Lypsta Plus Tab 10/5mg, has been suspended until the 28th of this month. The drug price reduction for 9 items including SS Pharm's S-nofen Tab, 2 items including NBK Pharmaceutical's Cebicox Cap 200mg, and 3 items including Youngil Pharmaceutical's Necfo Tab 5/160mg will be put on hold until the 29th. With cases of drug price cut suspensions rising, there is a possibility that other pharmaceutical companies may also file additional administrative lawsuits. This is because the companies can reduce financial losses during the suspension of the execution period, regardless of the success or failure of the drug price cut cancellation lawsuit. For example, the 35 items for which drug price cuts were suspended did not incur any losses due to price reductions.
- Company
- New urothelial cancer drug Padcev attempts reimb in KOR
- by Eo, Yun-Ho Oct 04, 2023 05:35am
- Padcev, the first targeted antibody-drug conjugate (ADC) for urothelial cancer, is attempting reimbursement in Korea. According to industry sources, Astellas Pharma Korea recently submitted a reimbursement application for its Padcev (enfortumab vedotin), its antibody-drug conjugate (ADC) that is directed against Nectin-4. The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet. The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. Therefore, the industry’s eyes are on how well Padcev can fare in Korea’s drug reimbursement process this year. Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 39% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group. Mi-so Kim, Professor of the Department of Oncology at Seoul National University Hospital, explained, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later line therapies after using immunotherapy in the second-line due to the lack of a standard later line treatment option. Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and will open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.” Urothelial cancer is the most common type of bladder cancer that accounts for around 91% of all bladder cancers. 8 of 10 patients are over the age of 60, and due to its prevalence in the elderly and its frequent recurrence and metastasis, it is a fatal disease with a 5-year survival rate of around 5%. It had been considered a representative disease that has a large unmet need due to its limited treatment options and the low quality of life caused by accompanying urinary disorder symptoms such as hematuria, frequent urination, and residual urine.
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- Padcev can be prescribed at tertiary hospitals in KOR
- by Eo, Yun-Ho Sep 27, 2023 05:44am
- Padcev, the first targeted treatment for metastatic urothelial cancer, can now be prescribed at tertiary hospitals in Korea. According to industry sources, Astellas Pharma Korea’s Padcev (enfortumab vedotin) has passed the review of drug committees (DCs) at all of the ‘Big 5’ tertiary hospitals in Korea - the Samsung Medical Center, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, Sinchon Severance Hospital, with the Seoul National University Hospital being the last. Padcev is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4. It is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet. The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. In the trial, Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy group's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 38% reduction in risk of disease progression or death. The median progression-free survival (PFS) for Padcev was 5.6 months and 3.7 months for the control group. Mi-so Kim, Professor of the Department of Oncology at Seoul National University Hospital, explained, “Urothelial cancer is the most common type of bladder cancer that accounts for around 91% of all bladder cancers. 8 of 10 patients are over the age of 60, and due to its prevalence in the elderly and its frequent recurrence and metastasis, it is a fatal disease with a 5-year survival rate of around 5%. It had been considered one of those representative diseases with a large unmet need due to its limited treatment options and the low quality of life caused by accompanying urinary disorder symptoms such as hematuria, frequent urination, and residual urine." Kim added, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later-line therapies after using immunotherapy in the second-line due to the lack of a standard later-line treatment option. Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and therefore may open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.”
