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- 2026-03-18 15:06:09
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- What now for Vyndamax failing essential drug designation?
- by Eo, Yun-Ho Feb 08, 2021 06:08am
- A transthyretin amyloid cardiomyopathy (ATTR-CM) new drug Vyndamax (tafamidis) seems to be struggling to receive National Health Insurance (NHI) reimbursement in South Korea. A pharmaceutical industry source reported Pfizer’s new drug treating patients with ATTR-CM Vyndamax (tafamidis 61 mg) has failed to get a treatment-purpose essential drug designation. But as Vyndamax has comparatively normal patient size, it would be unlikely to get listed for reimbursement with the pharmacoeconomic evaluation (PE) exemption. Approved in South Korea to treat patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) in October 2018, Vyndaqel (tafamidis 20 mg) has highly limited patient size for the hereditary type, but its indication can cover wild type caused by old age. Now the problem is on patients. ATTR-CM is considered to have bad prognosis as the patients tend to only survive two to 3.5 years after the diagnosis, or sometimes they are misdiagnosed as simple heart failure and result in detrimental outcome. Vyndamax is basically a treatment option for ATTR-CM. The patient size is extremely limited and they rely or either liver transplant or allopathy. And a multicenter, placebo-controlled Phase III ATTR-ACT study confirmed Vyndamax lowering the risk of cardiovascular event and improving the results of 6-minute walk test. The next action for the expensive drug is up to the government and the pharmaceutical company. Although the subject criteria for PE exemption are widening, the industry still sees a room to grow. If an immediate regulation revision is difficult, the two parties should assertively talk about models fitting the unique quality of drug, such as using a variety of risk sharing agreement (RSA) types. The ATTR-ACT study randomly assigned 441 patients to be administered with 80 mg or 20 mg of tafamidis or placebo in 2:1:2 ratios. The primary endpoint evaluated the frequency of cardiovascular related death and hospitalization. The secondary endpoint was the change in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score from 6-minute walk test taken and compared among the baseline time to 30-month point. In the study, the tafamidis statically improving the lowered risk of death by all causes and hospitalization, compared to the placebo group.
- Company
- Oncaspar for acute lymphocytic leukemia was approved
- by Eo, Yun-Ho Feb 08, 2021 06:08am
- According to the related industry, Servier Korea's Oncaspar (Pegaspargase) was approved from the MFDS as a rare specialty medicine as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL) in children and adults under the age of 8 years. Oncaspar is a drug that dramatically reduces the frequency of administration so that it is administered once every 14 days compared to L-asparaginase, which was previously administered once every other day by maximizing the drug circulation half-life through PEGylation. Considering the high incidence rate of acute lymphocytic leukemia, especially in pediatric patients, it is expected to alleviate the physical pain of pediatric patients suffering from frequent chemotherapy and hypersensitivity reactions from injection because it can be administered every 14 days. In addition, it is expected to have a positive effect on medical expenses such as hospital visits or hospitalization for injection treatment. First approved as a second line treatment for acute lymphocytic leukemia in the United States and Germany in 1994, Oncaspar was recognized as the first line treatment for all acute lymphocytic leukemia in the United States in 2006. Since its birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in 18-year-old children and adults with acute lymphocytic leukemia. Currently, it is recommended first in major international guidelines and treatment protocols such as NCCN, ESMO and Children's Oncology Group (COG) as a treatment for acute lymphocytic leukemia, and is being used in 62 countries. An official from Servier Korea said, "In Korea, patients or guardians have individually applied for Oncaspar through the KOEDC and received limited supply of Oncaspar. Servier Korea has provided Oncaspar to Korean patients with acute lymphocytic leukemia, so we are able to provide a stable supply.”
- Company
- Sanofi disturbs distributors with first vaccine bidding
- by Feb 08, 2021 06:08am
- Sanofi Pasteur, a first pharmaceutical manufacturer to jump into the vaccine bidding market and stir up the pharmaceutical distributor industry, could not ink the final procurement agreement. The company dropped its agreement offer as it failed to meet the bidder qualification standards. A pharmaceutical distributor industry reported on Feb. 4, although Sanofi Pasteur won the military camp hepatitis A virus vaccine procurement bidding via the Korea Online E-procurement System late last month, the company did not pass the bidder review. Valued at 6.3 billion won, the bidding was intensely competitive with total 47 companies participating. And Sanofi Pasteur was the only pharmaceutical manufacturer among pharmaceutical distributor bidders. Sanofi Pasteur apparently offered the lowest price among all bidders (80.576 percent of the previously procured price), and was selected as a top choice. And the pharmaceutical distribution industry was thrown into turmoil as the multinational pharmaceutical manufacturer won the initial bidding. So far, by tacit agreement, the vaccine bidding market was exclusively owned by distributors. But Sanofi Pasteur broke the unspoken rule and entered the bidding. And because of the surprise participation, the general bidding price dropped. Sanofi Pasteur also joined the meningococcal vaccine bidding opened around the same time. The company did not win the bidding, but the distributor industry definitely noticed the shocking action. Regarding the distributor industry’s fierce disapproval, Sanofi Pasteur firmly responded the direct bidding participation is not problematic, but the company had an unforeseen issue. The Public Procurement Service selected the multinational company as a top choice, but the manufacturer failed to meet certain conditions. The government agency official said, “Sanofi Pasteur voluntarily withdrew from the bidding due to unqualified review score. The agency is currently reviewing the second choice of the bidder.” It indicated the end of Sanofi Pasteur’s attempt in the bidding, but the industry is still tensed up from the happening, because a pharmaceutical manufacturer directly bidding for a government procurement deal could threaten the existence of the distributor industry. The manufacturer also mentioned of possibly participating in other biddings in the future. On Feb. 3, the Vaccine Business Committee associated under Korea Pharmaceutical Distribution Association was convened to talk about response strategy against similar prospective issues. The committee stressed mutual understanding and consideration from the vaccine manufacturer and importer are needed, and agreed that the government and each pharmaceutical company should clarify their scope of bidding. Particularly, the current bidding system only stipulates the basic qualification for the bidders to be a pharmaceutical wholesale distributor. The committee members raised their voices that the regulation should be amended to consider a bidder’s refrigerated transportation and vaccine distributing capacity to properly select the winning bidder. A pharmaceutical distributor industry insider said, “At the moment, the number of vaccine distributors is limited. But if manufacturers start taking over the bidding, then vaccine distributors would be unable to survive the market. Pharmaceutical manufacturers and distributors should form to a mutual relationship.” The association plans to disseminate official statement to each manufactures to request for cooperation, and to file a formal complaint to the authority to revise the relevant regulation.
- Company
- What is the expert evaluation of the single dose COVID-19 va
- by Whang, byung-woo Feb 08, 2021 06:07am
- Johnson & Johnson's COVID-19 vaccine, which has the advantage of a single vaccination, has been evaluated as not as expected, revealing 66% of the preventive effect. Experts are suggesting that approval is expected as long as they exceed the minimum standards of the WHO, but the evidence should be supplemented. On the 29th, Johnson & Johnson released the results of clinical trials for its vaccine (Janssen vaccine) at local time. Clinical results show that this vaccine has an average of 66% prophylactic effect (72% in the US, 66% in Latin America, and 57% in South Africa). These results are relatively low compared to Pfizer 95%, Moderna 94.1%, and Novavax 89.3%, which is not good even considering the strength of single dose. This is same as when there was an announcement that AstraZeneca's COVID-19 vaccine had a prophylactic effect of about 62%. However, experts explain that the Janssen vaccine can be approved based on the efficacy criteria of the vaccine published by the WHO. Choi Won-seok, a professor of infectious medicine at Korea University Anam Hospital, said, "When COVID-19 vaccine was first developed, the criterion that we thought we could respond to the epidemic was about 50% of the prevention effect. All the vaccines available so far, including Janssen, have exceeded this standard." He said, "The standard for responding to COVID-19 epidemic is 70%. Janssen recorded an average of 66%, but in the US clinical trials, the result was more than 70%, so it will meet the US Food and Drug Administration (FDA) standards." Johnson & Johnson plans to apply for Emergency Use Authorization from the Food and Drug Administration (FDA) as early as this week, and a preliminary review has been requested in Korea. In this regard, Kang Jin-han, director of the Vaccine Bio Research Institute at Catholic University of Medicine, said, "It is said that if the vaccine prevention effect is more than 50%, it is normal and it is good if it is more than 70%. if the prevention effect is more than 50%, it will be approved." However, he said that while evaluating that a single dose of Janssen vaccine is meaningful, it is also clear that the preventive effect is lower than expected. He said, "The data aren't all public and can't be concluded. The evidence is not clear on how long a single dose lasts independent of the seroconversion rate. It should be said that the preventive effect should be sustained like the two doses, but it is unfortunate that this part is not clear." The Janssen vaccine is a single vaccination and is easy to distribute and store. Who is vaccinated? In addition to the single vaccination, the Janssen vaccine has the advantage of being easy to set up an inoculation plan because it remains effective for more than 3 months in refrigerated distribution and storage, and is delivered in a 5-dose vial package that does not require dilution. The vaccine for 6 million people will be supplied from the second quarter, and Johnson & Johnson is confident that there will be no disruption in the contracted supply. Experts believe that it is effective to first inoculate the elderly living in the facility. Professor Wonseok Choi said, "It is difficult to judge a specific profile before knowing it, so we should prioritize storage and accessibility. However, if there is a limited supply and there is no option of a vaccine, we have no choice but to inoculate at the currently selected priority." He stressed, "If the characteristics of each vaccine are similar and do not have a significant effect, we will have to prioritize vaccination, which shows clinically more effective."
- Company
- Elyson challenges patent of Entresto
- by Kim, Jin-Gu Feb 05, 2021 10:09am
- Novartis' heart failure treatment Entresto (Sacubitril / Valsartan) is expected to be challenged by domestic companies. Interest is focused on whether domestic companies can overcome Entresto's patents, in which a total of 4 patents are registered. According to the pharmaceutical industry on the 4th, Elyson recently filed a judgment against Novartis to confirm the scope of passive rights against Entresto's crystalline patent. In addition to this patent, which expires on September 21, 2027, a total of four patents for Entresto are registered. Product patent expired in July 2027, and two patents for composition expired in November 2028 and January 2029. It is explained that the remaining three patents must be overcome in order to early release generic for Entresto. If all four patents are successfully overcome, Elyson will be able to release the generic after April 13, 2022, when Entresto's PMS expires. Entresto is a heart failure treatment that Novartis launched in Korea in October 2017. In fact, after recording an outpatient prescription amount of ₩6.3 billion in 2018, the first year of its release, it has grown more than three times in two years to ₩20.3 billion last year. For this reason, many domestic companies have shown interest in launching generic for Entresto. It is reported that some companies have also initiated biological equivalence tests. However, there was no company that started a patent challenge. Elyson is expected to challenge the patent of Entresto, which will add challenges from other companies. A pharmaceutical industry official said, "Since last year, not a few pharmaceutical companies have shown interest in patent challenge for Entresto. With Elyson's first patent challenge, there is a possibility that other pharmaceutical companies will continue the patent challenge in about two weeks to meet the initial request for trial."
- Company
- Delstrigo seeks reimbursement to join the HIV drug market
- by Eo, Yun-Ho Feb 05, 2021 05:51am
- MSD’s HIV new drug Delstrigo has started the National Health Insurance (NHI) reimbursement application process. The pharmaceutical industry reported, MSD Korea has submitted an application for the NHI reimbursement on an once-daily fixed-dose combination tablet Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate) treating human immunodeficiency virus type 1 (HIV-1). The South Korean authority approved Delstrigo as a treatment for HIV-1 infection in adults with no prior antiretroviral treatment experience. One of the combined agents, doravirine received South Korea’s Ministry of Food and Drug Safety (MFDS) approval as of Nov. 22, 2019, with a brand name of Pifeltro. The drug is indicated to be administered with another antiretroviral agent. Both Pifeltro and Delstrigo are indicated to treat HIV-1 infection in adults with no prior antiretroviral treatment experience. A Phase III DRIVE-AHEAD trial confirmed Delstrigo’s non-inferior efficacy compared to efavirenz (EFV)-emtricitabine (FTC)-tenofovir disoproxil fumarate (TDF). At week 48, 84 percent of the Delstrigo-administered patient group reached the viral suppression of HIV-1 RNA less than 40 copies/ mL, whereas 80 percent of the EFV-FTC-TDF group reached the level. As for clinical adverse reaction suspending the treatment, 3 percent and 6.6 percent of the patient groups reported adverse reactions, respectively, showing Delstrigo group had lower risk of adverse reactions. Currently, Gilead, GSK, MSD, Janssen, AbbVie and Bristol Myers Squibb (BMS) are competing in the HIV treatment market in South Korea, while Gilead and GSK are dominating 90 percent of the market share.
- Company
- Viatris’ Korean subsidiary has changed the name to Viatris
- by Feb 04, 2021 10:22am
- The Korean corporate name of the global healthcare company Viatris group will be officially changed to Viatris Korea from the 1st. Viatris’ Korean subsidiary (CEO: He-young Lee) was launched in November 2020 by combining Upjohn, a business division of global Pfizer, and Mylan, a global healthcare company. As the procedure for changing the domestic corporation name was recently completed, the company name changed from Pfizer Upjohn Korea to Viatris Korea from the 1st. Viatris is derived from the Latin words ‘via,’ meaning path, and ‘tris,’ which means three. Viatris Korea said, "The company's core value is expanding patient access to medicines, Leadership leading innovative healthcare solutions, and Trusted Partnership. We want to be a healthcare company that helps people live healthier in every stage of their lives." Viatris' major portfolio comprises more than 1,400 approved substances, including branded products, Rx drugs , generics, biosimilars, and over-the-counter (OTC) drugs for non-infectious and infectious diseases. Viatris Korea plans to provide quality treatments for non-infectious diseases such as cardiovascular, neuropathy, psychiatry, urology, and ophthalmology in the future, while reinforcing efforts for healthier lives for patients with non-infectious diseases. Based on the global product portfolio, it is planning to introduce various product portfolios and pipelines required by domestic patients such as new products in the field of infectious disease treatment including respiratory, biosimilars such as anti-cancer fields, and general medicines. An official from Viatris Korea said, "Viatris Korea provides innovative health solutions to patients and health care professionals, manages diseases and improves awareness, and provides various CSR (Corporate Social Responsibility) campaigns, including healthy aging campaigns. And we will contribute to the development of the healthcare industry and a healthy Korean society through various partnerships with the medical community, academia, government agencies, and NGOs."
- Company
- Eisai Parkinson’s disease drug Equifina listed and launched
- by Eo, Yun-Ho Feb 04, 2021 06:08am
- Eisai’s Parkinson’s disease treatment Equifina has been released to the South Korean market on Feb. 2 with the National Health Insurance (NHI) reimbursement. The Ministry of Health and Welfare (MOHW) notice issued on Jan. 29 granted the NHI benefit on Equfina (safinamide) as an adjuvant treatment to levodopa for idiopathic Parkinson’s disease patients, as well as the nursing insurance reimbursement for using the drug within its approved label and general principles of anti-Parkinson’s disease treatment. South Korea’s Ministry of Food and Drug Safety (MFDS) authorized the treatment on June 24, 2020, as a once-daily oral add-on therapy to levodopa for patients with Parkinson’s disease. A new third-generation monoamine oxidase B (MAO-B) inhibitor, working dual mechanism on dopaminergic and non-dopaminergic neurotransmission, Equfina conducted a Phase III trial and demonstrated a significant efficacy in Parkinson’s disease patients with motor fluctuation. Mostly, levodopa is used as a standard of care in Parkinson’s disease, but the drug has reportedly shown 75 percent risk of complications when used for over five years. And apparently, Equfina, as an add-on to levodopa, increases the drug effect period that could wear off if administered for a long term. A Phase III SETTLE study evaluated the efficacy and safety of Equifina in patients with Parkinson’s disease showing motor fluctuation symptoms, and confirmed the drug significantly improving the “on” time in patient group who have taken the drug for 24 weeks, compared to the placebo group. Equifina has also proved to reduce the “off” time of levodopa, and shortened the “off” time of the other combined drug regardless of the drug type or severity of the motor fluctuation symptoms. In the SETTLE study, the Parkinson’s Disease Questionnaire (PDQ-39) was given out to the participating patients to assess their quality of life, and the group administered with 50-100 mg per day showed changes of -3.17 from the baseline, which was an improved result compared to -0.68 in the placebo group. Another Phase III trial, Study 016 also found statistically meaningful result of PDG-39 in Equifina-administered group (100 mg) compared to that of the placebo group. Particularly in the mental wellbeing questionnaire, the Equifina group’s changes from the baseline to week 24 marked -5.14, which improved compared to the placebo group. CEO Koh Hong-byung of Eisai Korea noted, “By releasing Equifina, I am happy to provide a new treatment option to Parkinson’s disease patients in South Korea, who were short of treatment options. And as we launch the drug with the healthcare benefit, we hope to lessen the financial burden on those patients in South Korea.”
- Company
- Stomach ulcer drug rebamipide market makes over KRW 100 bln
- by An, Kyung-Jin Feb 03, 2021 06:10am
- The impurity contamination in ranitidine was discovered in 2019 has in turn expanded a gastritis treatment rebamipide market. Although the market was sluggish for a long time, rebamipide prescription surged and broke through the 100 billion won point last year. The impurity contamination incident impacted the entire stomach disorder drug market including H2 receptor antagonist, proton pump inhibitor (PPI) and wormwood-induced natural medicine. A pharmaceutical market research firm UBIST reported on Feb. 2, the rebamipide prescription market last year generated 110.6 billion won, growing by 14.8 percent compared to the year before. The market’s annual growth has been stagnating around 4 percent, marking 85.4 billion won, 88.2 billion won and 91.9 billion in year 2016 through 2018, respectively. But the figure soared 20.4 percent last year compared to two years ago. Rebamipide treats gastroduodenal ulcers by increasing the blood flow in the stomach mucous to protect them. The substance is also indicated to treat stomach ulcer and enhance mucosal defense. About three decades ago, Korea Otsuka Pharmaceutical released an original Mucosta, and 239 generics entered the market since 2003. Regardless of the expanded options, the prescription volume did not change significantly. But similar to PPI and wormwood-induced natural medicine, the industry experts say the rebamipide market benefited from the impurity contamination incident. The South Korean Ministry of Food and Drug Safety (MFDS) banned the sales of all products of H2 receptor antagonizing antiulcer drug ranitidine due to unacceptable amount of cancerous N-Nitrosodimethylamine (NDMA) found in late September 2019. Ranitidine drugs used to form a large market making about 180 billion won annually as of 2018. But the overall sales ban drove the prescribers to seek after other drugs with similar indications. The analysis on quarterly prescription volume of rebamipide found the volume started increasing from the fourth quarter of 2019. In the third quarter of 2019, the rebamipide drug prescription generated 21.5 billion won only, but it leapt to 29.6 billion won as of 2019 fourth quarter. Although patients avoided visiting hospitals amid COVID-19 last year and the general prescription volume faltered, the quarterly rebamipide prescription volume was maintained at around 27 billion won. The prescription volume by item showed fluctuating differences. Generally, the generics had more significant increase in prescription. The original Mucosta’s prescription fell 5.5 percent last year, despite making 17.3 billion won, compared to the year before. The best-selling generic Samjin Pharm’s Bamedin prescription also fell by 3.3 percent last year compared to the previous year and marked 4.6 billion won. Meanwhile, Huons’ Mucoramine prescription soared by 61.9 percent compared to the year before and narrowed the gap with Bamedin. KyungDong Pharmaceutical’s Rebamide prescription volume grew 11.8 percent from the year before and marked 3.8 billion won, when CMG Pharmaceutical’s Remipid and Celltrion Pharm’s Rebat grew by 11.3 percent and 35.8 percent, respectively. The industry projects the rebamipide market competition would get even more intensified this year with extended release products launching. Four South Korean companies like Yuhan Corporation, GC Pharma, Daewoong Pharmaceutical and Daewon Pharmaceutical won the health authority’s approval on extended release rebamipides late last year. And the authority also granted approval on Korea Otsuka Pharmaceutical’s Mucosta SR tablet last month. Although some of their indications differ from each other a bit, the administration convenience improved from three times a day to twice-daily.
- Company
- Pfizer's Vizimpro can be prescribed at general hospitals
- by Eo, Yun-Ho Feb 03, 2021 06:09am
- Pfizer's EGFR TKI and Vizimpro are now available in general hospitals with insurance benefits. According to related industries, Vizimpro (Dacomitinib monohydrate), a second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), listed in December. It passed the drug committee (DC) of general hospitals such as International St. Mary's Hospital, Chonnam National University Hwasun Hospital, NCC, SMC, KCCH, Konyang University Hospital, Kosin University Gospel. Hospital, and Pusan National University Yangsan Hospital. Vizimpro is a second-generation EGFR mutant-positive non-small cell lung cancer targeted anticancer drug that was designated as a priority review by the US FDA in January 2018 and was approved in September of the same year. Currently, it is prescribed in the United States, the European Union, and Japan. Vizimpro was approved in Korea as a first-line treatment for locally advanced or metastatic EGFR mutant non-small cell lung cancer in February this year. It has indications for the treatment of locally advanced or NSCLC (Non-Small Cell Lung Cancer) with an EGFR exon 19 deletion or exon 21 L858R substitution mutation with no previous experience. In Korea, the first-generation drug AstraZeneca's Iressa (Gefitinib), Roche's Tarceva (Erlotinib), Giotrif (Afatinib), and AstraZeneca's Tagrisso (Osimertinib). EGFR TKI is being prescribed, and Leclaza (Lazertinib) was recently approved. Giotrif, a competing drug has already settled in the market, Vizimpro chose a track to skip drug price negotiations. It passed the HIRA's Cancer Drugs Benefit Appraisal Committee in July last year, passed the Pharmaceutical Benefits Advisory Committee in October, and succeeded in listing in December. From this year, fierce competition among the first and second generation EGFR TKIs is expected for the first line therapy for non-small cell lung cancer. The listing of insurance benefits in the first-line therapy of Tagrisso and Leclaza is also of interest. The effectiveness of Vizimpro was proven through ARCHER 1050, a phase III clinical trial. The study directly compared Vizimpro with the first-generation drug IRESSA((Gefitinib), and a total of 452 non-small cell lung cancer patients were enrolled. As a result, Progression-Free Survival (PFS) reduced the risk ratio by 41% compared to Iressa, and the median PFS value was 14.7 months for Vizimpro, ahead of 9.2 months for the Iressa group.
