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- 2025-12-23 04:22:36
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- GMP issues causing delays in new drug approval
- by Eo, Yun-Ho Jan 08, 2024 06:08am
- The bottleneck in Good Manufacturing Practice (GMP) assessments is causing delays in the approval of global pharmaceuticals. The GMP process, which inspects the manufacturing facilities for pharmaceutical products, has been identified as a contributing factor to the delay in the approval of pharmaceuticals. The Ministry of Food and Drug Safety (MFDS) has acknowledged the issue, but they have not yet addressed alternative solutions. Consequently, the bottleneck in GMP for global pharmaceuticals awaiting approval is worsening. To gain approval for pharmaceuticals in Korea, pharmaceuticals undergo a series of evaluations, including safety and effectiveness evaluation, Good Manufacturing Practice (GMP) evaluation, and quality evaluation. Among these, the GMP evaluation examines the manufacturing facility of the pharmaceuticals seeking approval, and pharmaceuticals produced in international facilities, including global pharmaceuticals, may require an on-site audits as part of the process. The MFDS has demonstrated flexibility in its policy management over the past three years, including implementing remote GMP audits during the COVID-19 pandemic. However, as the audits have shifted back to full on-site audits, concerns are arising about the backlog in audits. According to the industry, these policy changes are exacerbating the backlog of GMP on-site audits for global pharmaceuticals. Currently, the average waiting time per drug is over 20 months. This delay in the domestic approval schedule is particularly problematic for pharmaceuticals, including new drugs and other formulations of already licensed drugs. What would be the solution? During the National Assembly's audit, In Jaekeun, a member of the Health and Welfare Committee from the Democratic Party, raised questions to the MFDS regarding the delay in on-site audits of overseas manufacturing facilities, which has led to the issue of global pharmaceuticals not being supplied to domestic patients in a timely manner. In response to the question about the status of backlog in the GMP on-site audits for global pharmaceuticals, "Our analysis is that on-site audit backlog has worsened due to the inability to conduct on-site audits at global pharmaceutical manufacturing facilities during the Covid-19 pandemic," an official of the MFDS's Pharmaceutical Quality Division answered. In response to the question about specific plans to address the backlog in GMP on-site audits for global pharmaceuticals, "We are working on increasing manpower of GMP investigators responsible for conducting on-site audits," an official stated. Currently, there are 16 GMP-related personnel within the MFDS's Pharmaceutical Quality Division. Based on the schedule of GMP investigators for on-site audits posted on the MFDS website, 11 investigators were scheduled to undertake international business trips for conducting on-site audits in December of last year. The solution proposed by the MFDS, which involves increasing manpower for GMP audits, has a potential pitfall. It requires securing the budget in advance, and the recruitment of new personnel for the division takes time. This means that the MFDS's suggested solution takes some time to implement effectively. The ongoing backlog of global pharmaceuticals awaiting GMP audits in Korea has significant implications for patients waiting for these medications. While increasing manpower is a long-term solution, it's crucial to implement short-term measures to address the immediate problem and reduce delays in approval processes. The pharmaceutical industry has proposed an alternative solution, suggesting a preliminary examination of pharmaceuticals that are in high demand within society. The suggestion aligns with the direction of MFDS. MFDS had announced that they will prioritize conducting an investigation of the pharmaceuticals meeting the following criteria: ▲Pharmaceuticals designated for preliminary examination according to Article 35-4 of the Pharmaceutical Affairs Act, ▲National essential drugs designated as requiring administrative support according to Article 83-4 of Pharmaceutical Affairs Act. "The current criteria for selecting pharmaceuticals for preliminary examination include drugs for the treatment of severe or rare diseases, and in cases where there are ▲no alternative pharmaceuticals, ▲medical gaps due to supply shortages, or ▲when there is a possibility of replacing pharmaceuticals experiencing supply shortages, GMP on-site audits should be prioritized," a pharmaceutical company's approval authority stated. Furthermore, the pharmaceutical industry emphasizes the need to expedite the revision of national essential drugs. Since the change of administration in 2022, national essential drugs have been excluded from policy priorities. It was only in November, almost two years after the last update in December 2021, that some pediatric drugs were added to the list. Many essential drugs required in the healthcare field are still waiting for approval. Therefore, there is a suggestion to consider designating these essential drugs as new national essential drugs to address this issue.
- Company
- Roche’s Lunsumio and Columvi win approval in Korea
- by Jan 05, 2024 05:41am
- Kim Seok Jin, professor of the Department of Hematology and Oncology at Samsung Medical Center. Roche's Lunsumio and Columvi are the first bispecific antibodies for lymphoma treatment, showing effectiveness as a third-line treatment for patients with lymphoma. These two drugs are highly regarded for their clinical advantages, as they have additional specific antigen-binding sites compared to monoclonal antibodies. Roche Korea held a media session on the 3rd, celebrating the Korean approval of CD20/CD3 bispecific antibodies Lunsumio (mosunetuzumab-axgb) and Columvi (glofitamab). Lunsumio is a CD20/CD3 T-cell engaging bispecific antibody that was initially indicated to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL). Lunsumio received approval from the Ministry of Food and Drug Safety (MFDS) as the first medicine to be listed as ‘Global Innovative products on Fast Track (GIFT)’ in October last year. As a result, Lunsumio may be prescribed for the treatment of adult patients with relapsed or refractory DLBCL after at least two or more earlier systemic therapy. Relapsed or refractory DLBCL, a type of non-Hodgkin lymphoma caused by malignant transformation of cells of lymphatic tissues, is associated with poor prognosis with recurrence. As a result, there is a critical need for effective treatment options for relapsed patients. Results from the Phase 2 GO29781 trials have demonstrated the effectiveness of Lunsumio in adult patients with relapsed or refractory DLBCL after at least two lines of previous systemic therapy. Lunsumio has shown effectiveness with a primary endpoint of complete response (CR) rate of 60%, as assessed by the independent review committee. The objective response rate (ORR) was 80%, and the estimated median duration of response rate (DOR) was 22.8 months. In terms of safety measures, the most frequently reported adverse reaction associated with Lunsumio was cytokine-releasing syndrome, and the most frequent severe adverse reaction observed was a reduction in neutrophil counts. Nine patients discontinued the treatment due to side effects of the medicine. "Third-line treatment options for DLBCL are limited, with chemotherapy such as Mabthera being the primary option. Chemotherapy yields a treatment effect of only 15%," Kim Seok Jin, professor of the Department of Hematology and Oncology at Samsung Medical Center, stated. "Lunsumio has shown promising effectiveness in clinical trials and may become a valuable third-line treatment option." Columvi, confirmed effectiveness in DLBCL third-line treatments Columvi was approved in Korea on the 7th of last month as a treatment for patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy. DLBCL is a disease in which B cells, a lymphocyte responsible for protecting the body, either grow or replicate uncontrollably. DLBCL can have a poor prognosis after multiple treatment regimens because of the fast progression of the disease. However, the third-line treatment options are currently limiting for the patients who failed first- and second-line treatment regimens. Columvi has demonstrated effectiveness in the Phase1/Phase2 NP30179 clinical trials enrolling 155 patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy. The clinical outcome has shown that Columvi recorded CR of 40% and ORR of 81%. The effect was consistent in the sub-group analysis. The most frequently reported side effect was cytokine releasing syndrome. Columvi is anticipated to be a valuable third-line treatment options for patients with DLBCL, alongside Kymriah, a Chimeric Antigen Receptor (CAR)-T Cell therapy. “CAR-T treatment and bispecific antibody may complement each other. Patients can start with Kymriah, a CAR-T therapy, in third-line treatment, or they can begin with Columnvi,” the professor Kim stated. “I believe the treatment choice may vary depending on individual patient’s characteristics and the progression of the disease.”
- Company
- Pharma CEOs consider job cuts and reducing hiring in 2024
- by Kim, Jin-Gu Jan 05, 2024 05:41am
- 13% of pharmaceutical and bio company CEOs have announced plans to reduce employment this year. Apart from this, another 12% have indicated the possibility of reducing their workforce this year. Overall, the industry held a more cautious stance toward hiring this year. Compared to last year, the number of respondents who responded that they will increase hiring decreased, while the number of CEOs who plan to decrease employment has increased. Such figures suggest that the prolonged economic recession has deepened CEOs' concerns about hiring. Pharma CEOs more cautious about ‘expanding employment’…...15% last year→9% this year According to Dailypharm's 2024 survey of 53 CEOs in the pharmaceutical and bio industries on their plans for hiring in 2024, 77% (41 respondents) answered that they plan to keep hiring at the same level as last year. Only 9% (5 respondents) plan to increase hiring, and 13% (7 respondents) plan to decrease hiring. This differs from last year's employment plans of the companies. When asked how they expect employment to change compared with 2023, 74% (39 out of 53 CEOs) said it will ‘stay the same’, 15% (8) said it will increase, and 11% (6) said it will decrease compared with the previous year. Compared to the previous year, the companies’ inclination to expand hiring decreased from 15% to 9%, and their inclination to maintain hiring decreased from 77% to 74%. On the other hand, plans to reduce hiring increased from 11% to 13%. In just one year, plans for increasing or maintaining employment as is had decreased while plans for reducing hiring increased among the surveyed companies. Companies that performed worse last year were more likely to reduce employment this year. In fact, of the 6 CEOs who rated their company's performance as "poor" or "very poor" last year, 3 said they would reduce hiring this year. The other 3 said they would maintain their hiring levels. Only 1 CEO rated last year's business performance as "good" but said they would reduce hiring this year. When asked about the possibility of layoffs this year, 4% ‘is planning,’ 8% ‘is considering' reducing workforce Regardless of whether or not they are reducing hiring, 12% (6 out of 53) of respondents said they have ‘plans to reduce’ or ‘are reviewing reducing’ their workforce this year. Of these, 4%(2 respondents) clearly stated that they had plans to reduce their workforce, and 8% (4) said they were considering it. The remaining 89% (47) said they had no plans to reduce the workforce. Responses to the question of potential layoffs, the responses were consistent among domestic and multinational pharmaceutical companies, as well as large and small pharmaceutical companies. Of the 6 companies planning reductions, 4 were domestic pharmaceutical companies and 2 were Korean subsidiaries of multinational pharmaceutical companies. Also, the responses came 3 each from large and small pharmaceutical companies. While the majority of respondents have no plans to reduce their workforce, it is expected that the wave of restructuring in the pharma and bio industry that started last year may continue this year, with some companies taking the lead. Among domestic pharmaceutical companies, GC Biophamra, Ildong Pharmaceutical, KyungDong Pharm, Yuyu Pharma, Aprogen Pharmaceuticals, and Genome & Company started restructuring last year. Among the Korean subsidiaries of multinational pharmaceutical companies, MSD Korea, Pfizer Korea, and Novartis Korea conducted restructuring last year, and Sandoz withdrew its service in Korea. In particular, the restructuring decisions of large pharmaceutical companies like GC Biopharma and Ildong Pharmaceutical have spread anxiety across the pharma-bio industry. Both companies had received poor business reports last year. This raises concerns that the restructuring trend could spread across the industry if this year's results are weaker than expected. Hiring area priorities, Sales/Mareketing >R&D>Manufacturing/Control Amidst the overall hiring atmosphere, CEOs have forewarned plans that they aggressively hire for sales and marketing positions. Of the 53 respondents, 43% (23) said sales and marketing will be their top hiring priority this year. This was followed by 36% (19) in R&D, 13% (5) in production management, then 8% (4) in other roles. No respondents chose finance/accounting or IT/security. By company size, large and small/mid-sized pharmaceutical companies differed in their hiring plans for production management positions. 18% (6 out of 35) of the large pharma respondents indicated that they are prioritizing production management positions, compared to 1 out of 17 among small and midsize pharma respondents. Large pharma (38%) and small pharma (35%) were similarly likely to prioritize hiring R&D positions. There was no significant difference between large pharma (41%) and small pharma (53%) in their plans to focus on sales and marketing roles.
- Company
- Koselugo commences prescription with insurance coverage
- by Eo, Yun-Ho Jan 05, 2024 05:41am
- AstraZeneca Korea’s Koselugo (selumetinib), a neurofibromatosis treatment, has recently passed the Drug Committee (DC) of tertiary hospitals. Hospitals have started prescribing Koselugo, a treatment for pediatric neurofibromatosis. AstraZeneca Korea’s Koselugo (ingredient: selumetinib), a neurofibromatosis, has recently passed the Drug Committee (DC) of tertiary hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Some of these hospitals have assigned a prescription code for Koselugo following emergency DC. Koselugo has been listed for reimbursement starting this year. As a result, it is anticipated that more hospitals will be able to prescribe the drug in the future. On the third try, Koselugo passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee on the 7th of last month and settled in negotiations for reimbursement pricing with the National Health Insurance Service (NHIS) at the end of the year. Koselugo was the first drug to be designated by the ministry as a priority drug under the accelerated review system in October 2020. Subsequently, in May 2021, Koselugo won approval from the Ministry of Food and Drug Safety (MFDS) and was listed for reimbursement after approximately two and a half years. The reimbursement criteria for Koselugo apply to pediatric patients aged 3 to 18 years who have neurofibromatosis Type 1 (NF1) with inoperable plexiform neurofibromas and their condition meets any of the following: ▲Located in the head, neck, or other areas with a risk of airway obstruction or vascular damage ▲Causing compression or functional impairment of major nerves or nerve structures ▲Encasing vital blood vessels or organs, leading to significant functional impairment ▲Physical deformities resulting in motor or sensory dysfunction ▲Severe pain that persists despite the use of neuropathic pain medications, significantly affecting daily life ▲Other conditions where drug therapy is deemed necessary. Until now, patients with neurofibromatosis have relied on general remedies with no specific treatments available. Neurofibromatosis is a rare disorder characterized by tumors that develop in nerve tissue, bones, skin, and other parts of the body. Approximately 85% of cases are classified as type 1 (NF1), resulting from a mutation in the NF1 gene on chromosome 17. The prevalence of NF1 is about 1 in 3,000 individuals. The onset of neurofibromatosis typically starts during childhood. In most cases, the first symptom appears as 1-3cm sized coffee-colored patches on the skin. Around the age of 6, some children develop optic pathway glioma, a type of tumor, and between the ages of 6-10, many children develop scoliosis. In adult patients, Lisch nodules, which are tiny hamartomas affecting the iris, are commonly found. Currently, the treatment regimen for neurofibromatosis involves surgical removal when possible or anti-cancer and radiation therapies. However, even with surgery, these tumors often recur, and most surgeries are major procedures, posing a significant burden on both medical professionals and patients. Particularly in pediatric patients, frequent recurrences may require multiple surgeries, leading to the need for ongoing pain management and potentially resulting in language and motor impairments in many cases. Koselugo is a treatment jointly developed by AstraZeneca and MSD. The drug inhibits the activation of MEK and suppresses the growth of the cancer. In the Phase 2 SPRINT clinical trials that served as the basis for approval, Koselugo achieved an objective response rate (ORR) of 68% by reducing tumor size by 20% or more in treated patients. Furthermore, among patients who showed partial response, 82% maintained their response for over 12 months. Patients who did not receive treatment typically experienced disease progression within 1.5 years, while those treated with Koselugo had only about 15% experiencing disease progression even up to 3 years. “NF1 with plexiform neurofibroma is a severe condition that can involve symptoms such as severe pain, visual impairment, and spinal deformities. Furthermore, it can progress into a life-threatening malignant disease. The listing of Koselugo for reimbursement will be of great help in extending the lives and improving the quality of life for pediatric patients in the future,” Lee Beom-hee, Professor of Pediatric Endocrinology and Metabolism at Asan Medical Center, commented.
- Company
- Celltrion to divest prescription drugs acquired from Takeda
- by Kim, Jin-Gu Jan 04, 2024 05:33am
- (Credit: Celltrion) The Celltrion group is selling divestiture of primary care business rights in the Asia-Pacific region acquired from Takeda Pharmaceutical in 2020. Among the business rights acquired from the previous deal, Celltrion group will initiate the sales of business rights for prescription drugs, excluding those intended for the domestic market. They will also engage in separate negotiations with a different company for the business rights related to the over-the-counter (OTC) drugs. Celltrion group announced on the 2nd that the company will sign a contract to divest the primary care business rights in the Asia-Pacific region, which it acquired from Takeda Pharmaceutical. In 2020, Celltrion acquired the primary care business rights of Takeda Pharmaceutical for US$278.3 million (approximately 310 billion won). This acquisition included prescription drugs such as the DPP-4 inhibitor class diabetes medicine ‘Nesina (alogliptin)’ series, TZD class diabetes medicine ‘Actos (pioglitazone)’ series, and ARB class of hypertension treatment ‘Edarbi (azilsartan)’ series, as well as OTC drugs such as cold medicine ‘Whituben’ and stomatitis medicine ‘Albothyl’. The current divestiture encompasses the business rights for prescription drugs like Nesina and Actos in the Asia-Pacific region. The business rights of OTC drugs and domestic prescription drugs are excluded from the divestment. Major items that Celltrion acquired from Takeda Pharmaceutical in 2020. (Clockwise from the upper left) Product photos of Nesina, Actos, Edarbi, Albothyl, Whituben, and Nesinamet. The acquisition target is CBC Group, a Singapore-based global healthcare-focused private equity firm. CBC Group has established an overseas special purpose company (SPC) called 'HP Bidco 2 Limited' to proceed with the acquisition. The future business rights transfer agreement will be signed between Celltrion APAC and HP Bidco 2 Limited. The sales price is 5.58 billion Thai Baht (THB, approximately 210 billion won). Celltrion explained that the sale price for the business rights was determined based on a 3-year post-acquisition evaluation, considering increased business value resulting from revenue growth for related items (with an average regional sales growth rate of 13%) and cost savings through production internalization after the acquisition. The value of the business rights for prescription drugs in current sales represent approximately half of their value compared to when Celltrion acquired them in 2020. Celltrion explained that if the value of the items were recalculated based on 2020, it would amount to approximately 138 billion won, equivalent to 46% of the total value at that time. Celltrion will retain the business rights for domestic prescription drugs that were excluded from this sale. The company expects to maintain sales revenue from products like Nesina and Edarbi in the domestic market as before. Additionally, Celltrion plans to use these products as a foundation for developing incrementally modified drugs. At the same time, Celltrion has secured exclusive supply rights for Edarbi and Nesina series within the Asia-Pacific region. Celltrion Pharm will produce Edarbi and Nesina for supply to the CBC Group, which will then distribute these products in the Asia-Pacific region. This arrangement is anticipated to provide Celltrion Pharm with a stable source of revenue through the exclusive supply of the Edarbi and Nesina series. Celltrion is currently in negotiations with another company regarding the sale of the entire OTC drugs business rights for the rest of the Asia-Pacific region, including Korea. Celltrion has stated that it is in the final stages of negotiations with a strong candidate company. After re-selling the licensing rights after three years, Celltrion has generated considerable profit. By selling the licensing rights for prescription drugs in the Asia-Pacific region, excluding Korea, Celltrion has generated a profit of around 70 billion won compared to the initial investment of around 140 billion won. If the remaining negotiation for the sale of licensing rights for OTC drugs proceeds smoothly, Celltrion is expected to generate even higher investment profit. Celltrion views the sale of these business rights as a steppingstone to creating a foundation for integrated Celltrion to focus on its core businesses. "Selling the business rights was based on the strategic decision at a time when we are on the verge of significant growth upon the launch of integrated Celltrion. We have successfully concluded the sale, securing stable revenue through maintaining domestic business rights for core prescription drugs and acquiring exclusive product supply," a representative from Celltrion Group stated. "The proceeds from the sale will be invested in strengthening the new product portfolio and establishing a foundation for the sustainable growth of the Celltrion Group," the representative added.
- Company
- Industry is less inclined to expand investment this year
- by Kim, Jin-Gu Jan 04, 2024 05:33am
- One in four CEOs of pharma and biotech companies announced that they will expand their investment in 2024. This is down by half compared to the response received in the survey last year when one in two CEOs said they would expand investment. This is likely a reflection of the growing economic uncertainty in Korea and abroad. 1 in 4 CEOs "will expand investment"...half of last year's level According to the 2024 Business Management Strategy Survey Dailpharm conducted for 2024 on 53 CEOs of pharma and biotech companies, 25% (13 respondents) responded that they plan to expand investments this year compared to the previous year. 68% (36 out of 53) said they plan to keep the scale of investment at a similar level to last year, while 8% (4) said they plan to reduce it. Compared to the results of the 2023 survey, the number of respondents who responded that they will increase investment has decreased significantly. Last year, when Dailypharm asked the same question to 61 pharma and bio industry CEOs, 53% (32) said they would increase, 33% (20) said they would maintain, and 15% (9) said they would decrease their investment this year. So in just one year, CEOs who plan to increase investment have decreased from 53% to 25%. The number of respondents who plan to reduce their investment is similar to last year, while the number of respondents who plan to maintain their investment at the same level more than doubled from 33% to 68%. Overall, this suggests that companies are taking a conservative approach to new investments this year despite the strong performance that they had made last year. In the pharmaceutical industry, it is believed that the increased uncertainty due to the prolonged economic downturn has led to a reduced capacity for new investments. When asked about their business performance in 2023, 49% of respondents (26) chose ‘very good’ or ‘good.’ 40% of the respondents (21) said ‘moderate,’ and only 11% (6) said ‘poor’ or ’very poor.’ In particular, small and medium-sized pharmaceutical companies were more cautious about making new investments. Of the 17 CEOs of small and medium-sized pharma companies with less than 300 employees, 18% (3) said they would increase investment. In contrast, 28% (10 out of 36) of CEOs of pharma companies with 300+ employees said they have plans to increase investment. 7 in 10 CEOs "expects operating profit to improve this year" In contrast to the investment expansion plans, CEOs were optimistic about their performance results in 2024. 8 of 10 CEOs (81%) expected revenue to increase and 7 in 10 (68%) expect profitability to improve in 2024. 81% (43 of 53) responded that they expect revenue to increase. Of these, 11% (6) expected an increase of 20% or more, 36% (19) expected an increase of 10-20%, and 34% (18) expected an increase of 0-10%. Only 6% (3) expected sales to decrease this year compared to the previous year. The remaining 13% (7) expected their revenue to remain similar to last year. In terms of operating profit, 68% of respondents (36 out of 53) expected an increase over the previous year. 17% (9) expected an increase of 20% or more, 23% (12) expect an increase between 10-20%, and 28% (15) expected an increase between 0-10%. Only 8% (4) expected a decrease in operating profit, while 25% (13) expected their operating profit to remain at the same level as last year. Managerial priority focuses on 'Launching new products' the most...followed by R&D investment, then strengthening sales power ‘New product launches’ was selected as the most common managerial priority (26 responses) by the CEOs. This was followed by ▲ R&D investment (25), ▲ strengthening sales power (22), ▲ improving manufacturing facilities and expanding production capacity (18), ▲ improving cost structure (17), ▲ securing excellent human resources (14), ▲ entering new businesses (9), and ▲ external investment such as mergers and acquisitions (M&A) (5). 3 other priorities - Expanding exports, expanding markets, and improving access to patients – were also selected once each. There were some differences in management priorities by company size. CEOs of large pharmaceutical companies (300+ employees) often chose "R&D investment" (18) as their top managerial priority for the year. This was followed by improving manufacturing facilities, expanding production capacity, and launching new products (15 each). Small and medium-sized pharmaceutical companies focused more on ’new product launches (11).’ This was followed by strengthening sales power (10) and then securing talent and R&D investments (7). In general, large pharmaceutical companies are focusing on long-term investments such as investing in R&D improving manufacturing facilities, and expanding production capacity, while small and medium-sized pharmaceutical companies are focusing on short-term results such as launching new products and strengthening sales power. There were also differences between domestic pharmaceutical companies and the Korean subsidiaries of multinational pharmaceutical companies. CEOs of domestic pharmaceutical companies most often cited "strengthening R&D" as their management priority (22), followed by improving manufacturing facilities and expanding production capacity (17) and improving cost structure, and launching new products (16 each). On the other hand, Korean subsidiaries of multinational pharmaceutical companies selected ‘new product launches’ as their top managerial priority (10). All but one of the 11 CEOs of Korean subsidiaries of multinational pharmaceutical companies responded that they would focus on launching new products this year. This was followed by strengthening sales power and talent acquisition (7 each).
- Company
- New CKD drug Kerendia is expected to receive reimb soon
- by Eo, Yun-Ho Jan 04, 2024 05:33am
- Bayer’s new chronic kidney disease drug ‘Kerendia’ is expected to receive reimbursement status in Korea. New chronic kidney disease drug ‘Kerendia’ is expected to receive reimbursement status. According to the industry, Bayer has reached a settlement with National Health Insurance Service (NHIS) in negotiations for the reimbursement pricing of its drug Kerendia(finerenone), which is used to treat chronic kidney disease in patients with type 2 diabetes, at the end of the year. When it passes the Heath Insurance Policy Review Committee in January, Kerendia is expected to be listed for reimbursement starting February. Kerendia received approval in Korea last year. It is indicated to reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate, eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. CKD is one of the most common complications in type 2 diabetes and is an independent risk factor of cardiovascular diseases. While CKD is a progressive disease, it can be difficult to detect because the disease can progress without showing obvious signs until just before the late-stage renal failure occurs. Also, with late-stage renal failure, patients require dialysis or kidney transplants to sustain life. This can pose a socio-economic burden and have a profound impact on a patient’s quality of life. For patients with type 2 diabetes, frequent monitoring and assessment of kidney damage and kidney function are essential. Early detection and appropriate treatment are critical to slowing down the progression of the disease and reducing the risk of cardiovascular diseases. In type 2 diabetes, the three key factors causing kidney disease are hemodynamic changes, metabolic abnormalities, and inflammation or fibrosis. However, in current therapy, treatments targeting hemodynamic and metabolic factors are only available, while treatments targeting inflammation and fibrosis are lacking, highlighting the need for new treatment approaches. Kerendia is a novel therapeutic approach targeting inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes. It is the first non-steroidal, selective mineralocorticoid receptor antagonist. Overactivation of the mineralocorticoid receptor can lead to inflammation and fibrosis, which can result in permanent damages to kidney. Kerendia inhibits the overactivation of the mineralocorticoid receptor, reducing inflammation and fibrosis, and thereby preventing kidney damage. Kerendia demonstrated its effectiveness in the Phase 3 FIDELIO-DKD trial. The FIDELIO-DKD trial enrolled approximately 5,700 patients from 48 countries globally, and Kerendia is indicated to inhibit the progression of chronic kidney disease and reduce the risk of cardiovascular events in adult patients with chronic kidney disease accompanying type 2 diabetes. Patients participating in the study received either Kerendia at doses of 10mg or 20mg in addition to standard therapy or a placebo. The primary composite endpoint of the study was a sustained decline of more than 40% in eGFR, end-stage kidney disease. In the trial, Kerendia reduced risk of death by approximately 18% compared to placebo. In addition, the secondary endpoint was cardiovascular death, nonfatal myocardial infarction, and a reduction of approximately 14% in hospitalization for stroke or heart failure. The outcomes of major adverse events or the rate of adverse events related to acute kidney damage were comparable between the two groups. Meanwhile, the European Society of Cardiology (ESC) revised its ‘2021 ESC Guidelines for the Diagnosis and Treatment of Acute or Chronic Heart Failure’ and listed Kerendia as a Class 1A recommendation to prevent hospitalization due to heart failure in patients with chronic kidney disease accompanying type 2 diabetes. Additionally, the ESC recommended an annual measurement of eGFR and urinary albumin levels to screen for the development of chronic kidney disease in diabetes patients.
- Company
- Only 1 of 10 CEOs ‘positive’ about drug regulations in KOR
- by Chon, Seung-Hyun Jan 03, 2024 07:28pm
- 2024 Pharma-Bio CEO Survey: Business strategies and perceptions on regulations in Korea A survey showed only 1 in 10 CEOs of pharmaceutical companies were found to be satisfied with the Korean health authorities' regulatory policies for the pharmaceutical industry. In all major regulatory areas such as approvals, drug pricing, and sales, the satisfaction rate of CEOs was more negative than positive towards the set regulations. In particular, the CEOs expressed the least satisfaction with Korea’s drug pricing and reimbursement regulations. According to a survey Dailypharm conducted on 53 CEOs of pharmaceutical companies on their perception of government regulations in Korea, only 8% of the respondents expressed positivity towards the government regulations made for the pharmaceutical industry in Korea. Of the 53 CEOs surveyed, only two responded that they were "very positive" and "positive” towards the regulations each. The proportion of respondents who showed a negative attitude towards government regulations (42% was more than 5 times higher than the proportion of respondents who expressed a positive attitude towards government regulations. Those who expressed "very negative" and "negative" feelings toward the government regulations accounted for 8% and 34% of the respondents, respectively. Around half of the respondents expressed a ‘moderate’ feeling towards government regulations. Also, CEOs of pharmaceutical companies perceived that the government regulation was having a negative impact on their company’s business management. Nearly half of the respondents (49%) said government regulations had a negative impact on their business. "Very negative" and "negative" responses accounted for 9% and 40% of all responses, respectively. Only 6% said government regulations had a positive impact on their company management. In particular, the CEOs expressed the most dissatisfaction with the government’s drug pricing and reimbursement regulations. When asked to name the most unreasonable regulation, 57% of the respondents cited reimbursement and drug pricing regulations. This means that 3 out of 5 pharma CEOs perceive reimbursement and drug pricing regulations as the most unreasonable. 25% of respondents cited approval, production, and quality control regulations as the most unreasonable. Only 11% said distribution, sales, and marketing regulations were the most unreasonable. In terms of satisfaction for each type of regulation, the average satisfaction rate was in the 3-4 range for all categories. In all 3 major categories of regulations – approval/production/quality control, drug pricing/payment, and distribution/sales/marketing – the scores were rated below 5. To quantify the CEOs’ degree of satisfaction, respondents were asked to answer on a scale from 0 to 10. A higher score indicated greater regulatory satisfaction. Pharma CEOs were the least satisfied with drug pricing and reimbursement regulations. When asked about their satisfaction with drug pricing and reimbursement regulations, they gave an average score of 3.15. Only 2 respondents gave scores above 5 regarding satisfaction with Korea’s drug pricing and reimbursement regulations. More than half (53%) of the CEOs gave satisfaction scores below 3 for Korea’s drug pricing and reimbursement regulations. The most urgent area in need of improvement among drug pricing and reimbursement regulations was new drug listings, which 22% of the respondents had selected. Companies expressed dissatisfaction over the disruptions they experience in their businesses from delayed listing or non-designation of an appropriate price for their new drugs after spending a long time and considerable expense on developing a new drug based on their R&D capabilities. The next urgent area in need of improvement, which 18% of respondents selected, was improving the post-listing drug price cuts of generics. This is due to the great deal of dissatisfaction that arose from last year's generic drug price reevaluations. Last year, the government lowered the drug prices of more than 7,000 generic drugs through generic drug price reevaluations. After the reform of the drug pricing system, which was implemented in July 2020, was applied to listed generic drugs, the prices of products that had not undergone bioequivalence tests were lowered in large quantities. It is analyzed that pharmaceutical companies' dissatisfaction grew as the drug price cuts made on the products already in the market affected the companies’ performance. More than 10% of the respondents said that it is urgent to reform the drug pricing system, by improving the reimbursement evaluation system, price-volume agreement system, external price referencing, and listing of generic and incrementally modified drugs. The average satisfaction level of pharma CEOs gave for the approval, production, and quality control regulations was 4.00. This is higher than the CEO’s satisfaction rate for drug pricing or reimbursement regulations, but there were still more complaints than compliments. Only 4 of the 33 respondents rated their satisfaction level as 6 or higher. 9 out of 10 respondents had a negative stance in terms of satisfaction with Korea’s approval, production, and quality control regulations. In terms of the area in need of the most urgent improvement among approval, manufacturing, and quality control regulations, an overwhelming majority of respondents (55%) pointed to the period of approval. The companies saw that the development of new drugs and incrementally modified drugs were not leading to the prompt approval expected by the companies, and has negatively affected company business. Clinical reevaluations and improved GMP regulations were the next top priorities, accounting for 15% and 12% of all CEO respondents, respectively. On average, pharma CEOs rated their satisfaction with distribution, sales, and marketing regulations at 4.22. This was higher than the satisfaction they expressed for approval, production, quality control, or drug pricing and reimbursement, but still more negative than positive. The CEOs most frequently cited the regulation of CSOs (CSOs) as the area in need of most improvement among distribution, sales, and marketing regulation. 48% of respondents cited the need to regulate CSOs. Recently, there has been an increase in companies using CSOs and reducing their own sales force, especially among small and medium-sized pharmaceutical companies. There is a growing recognition of the need for strong regulations to regulate the CSOs' aggressive sales activities that can lead to overheated and confused market competition. Among the distribution, sales, and marketing regulations, 33% of respondents said that advertising regulations should be improved. There is a common perception that strict drug advertising regulations hinder companies' sales.
- Company
- New antibiotic to be listed for reimb, following Zerbaxa
- by Eo, Yun-Ho Jan 03, 2024 05:40am
- Pfizer Pharmaceutical Korea is currently in negotiations for reimbursement pricing for its Zavicefta Inj (ceftazidime·avibactam). Zavicefta, the next-generation antibiotic, is progressing towards reimbursement listing. According to the industry, Pfizer Pharmaceutical Korea is currently in the final round of discussions with the National Health Insurance Service (NHIS) to settle the reimbursement pricing negotiations for its Zavicefta Inj (ceftazidime·avibactam). Zavicefta received approval from the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee in September 2023, and its negotiations began in November. When negotiations reach a settlement without any delays, it is anticipated that Zavicefta will be able to get listed for reimbursement next month. Until now, apart from MSD Korea’s Zerbaxa Inj (ceftazidime·tazobactam), new antibiotics have not produced satisfactory results. Therefore, it is noteworthy to watch whether Zavicefta will successfully receive reimbursement listing. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant, such as multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae. Zavicefta, an intravenous injection, is targeted for use in the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was initially developed by AstraZeneca and later became the property of Pfizer when Pfizer acquired AstraZeneca’s antibiotics business in 2016. Securing new alternative treatments for carbapenem-resistant Gram-negative pathogens is a global health priority, as announced by the WHO. Multi-drug resistant P. aeruginosa has seen a global increase and is causing serious problems in recent healthcare-related infections. The WHO has appointed carbapenem-resistant Gram-negative pathogens as one of the pathogens requiring high-priority research and development of new antibiotics. The rate of gram-negative pathogens exhibiting carbapenem resistance in Korea is 30.6%, ranking as the second highest among the countries surveyed, with Greece being the highest. ESBL-producing Enterobacteriaceae confers resistance to most cephalosporins-class antibiotics, which are typically effective against a broad range of gram-negative pathogens. To date, new antibiotics introduced in Korea include MSD’s Zerbaxa (ceftazidime·tazobactam) and Pfizer’s Cresemba (isavuconazonium), etc. Zavicefta has recently passed the Drug Committee (DC) of the “Big 5” hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. It has secured prescription in approximately 40 hospitals in Korea.
- Company
- ‘Drug pricing and reimb' needs most regulatory improvement
- by Chon, Seung-Hyun Jan 03, 2024 05:40am
- CEOs of both domestic and multinational pharmaceutical companies alike identified 'drug prices and reimbursement as in need of most regulatory improvement. CEOs of multinational pharmaceutical companies only gave a 2-point range satisfaction score in terms of satisfaction with Korea’s drug pricing and reimbursement regulations. This indicates how CEOs are even more dissatisfied with regulations that affect the management of pharmaceutical companies, such as new drug registration, generic reevaluation, and reimbursement reevaluations. According to Dailypharm's survey of 53 CEOs of pharmaceutical companies, CEOs of both domestic and multinational pharmaceutical companies had a negative perception of government regulations. Among the 42 CEOs of domestic pharmaceutical companies, 34% said that their attitude towards government regulations was negative, which is three higher than the 10% who said they had a positive attitude. More than half of domestic pharma CEOs described government regulation as ‘moderate.’ CEOs of multinational pharmaceutical companies were even more towards government regulations. Of the 11 multinational pharmaceutical company CEOs, 73% had a negative view of government regulation. "Very negative" and "negative" responses accounted for 18% and 55%, respectively. Not one respondent had a positive view of government regulation. The area with the most common complaints was drug pricing and reimbursement.’. When asked to name the most unreasonable regulations, 57% of respondents cited reimbursement and drug pricing. This means that three out of five pharma CEOs perceive reimbursement and drug pricing regulations as the most unreasonable. 25% of respondents cited licensing, production, and quality control as having the most unreasonable regulations. Only 11% said distribution, sales, and marketing regulations were the most unreasonable. Both domestic and multinational pharma CEOs were most dissatisfied with drug price and reimbursement regulations. Nearly half, 48%, of the 42 CEOs from domestic pharmaceutical companies said that reimbursement and drug pricing regulations were the most unreasonable. Licensing, production, and quality control followed at 29%. More than 10 out of 11 (90%) multinational pharma CEOs perceived that the drug pricing and reimbursement system was unreasonable. It is noteworthy that the multinational pharmaceutical companies, which are responsible for a sizable proportion of new drug listing and sales, are most dissatisfied with drug pricing and reimbursement listing regulations in place for market entry. The dissatisfaction with the drug pricing and reimbursement system among MNCs was also evident in the specific indicators. CEOs of multinational pharmaceutical companies gave a satisfaction score of 2.90 points for Korea’s drug pricing and reimbursement system. This is significantly lower than the 3.24 score given by domestic pharmaceutical CEOs. 73% of multinational pharma CEOs said that new drug approval is in need of the most urgent improvement. Even if a new drug is developed and approved by company headquarters after a long period of research and development (R&D), there are many cases where their launch is delayed or abandoned in Korea due to inadequate drug prices or reimbursement. CEOs of domestic pharmaceutical companies perceived post-generic drug price reductions as the most problematic. Last year, the government lowered the prices of more than 7,000 drugs through generic drug price reevaluations, and the industry complained that repeated generic drug price reductions due to system changes threaten business. CEOs of domestic pharmaceutical companies also pointed out the need to improve reimbursement reevaluations (21%) and price-volume agreement systems (18%).
