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- 2026-03-19 08:09:25
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- Pfizer's Novasc 10mg packaging will change to 28 tablets
- by Jung, Hye-Jin Jan 16, 2020 06:07am
- Pfizer's Novasc 10mg packaging unit will change from 30 tablets to 28 tablets. In addition, many drugs, including Bayer's antibiotic Avelox and Samjin Pharm's Gelma suspension, were sold out. According to the wholesale industry on the 14th, 30 tablets of Novask tablet 10mg tablet of Korean Pfizer will be discontinued and 28 tablets packaging will be supplied. The only discontinued item is 30 tablets of 10mg, and 30 tablets of 2.5mg, 5mg tablets and 500 tablets of 5mg tablets are supplied unchanged. Due to the delay in global production and supply, 30 tablets packaging of Bayer's Avelox Tablet 400mg is in short supply. Chong Kun Dang, which distributes Avelox, said it will be available by April 20. Samjin Pharmaceutical announced on the 14th that 125 pouch packaging products (25 pouches*5EA) of Gelma Suspension 10g were sold out. The reason for the absence of stock and the timing of resupply were not disclosed. Pfizer's psychoactive drug, Halcion 0.125mg, is also sold out due to a shortage of supplies. The cause is a delay in the supply schedule, which Pfizer expects to be available from March. Allergy medications Montelukast 10mg and Montelukast Chew 5mg and 4mg from Dongkwang Pharm are also in imbalance between supply & demand, and will be supplied again at the end of next month. It will be resupply in mid-March due to the delay. Jeil's 30-pack package of Bondube 60mg for osteoporosis treatment will be resupplyed in mid-March due to delays in product improvement. The packaging of 30 tubes of Ganfort UD 0.4ml, an eye drop solution by Allergan, is also temporarily sold out due to delays in import schedules. It will be resupplyed on February 14.
- Company
- Zejula indicated for late-line therapy on ovarian cancer
- by Eo, Yun-Ho Jan 16, 2020 06:06am
- Anticancer treatment Zejula is now available for a monotherapy prescription on patient with ovarian cancer, who has been treated with fourth-line or later treatment. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated Ministry of Food and Drug Safety (MFDS) has additionally indicated Zejula’s (niraparib) on Dec. 24 for treating patient with relapsed ovarian cancer, who has been treated for more than third-line treatment. From March last year Zejula, the first poly ADP ribose polymerase (PARP) inhibitor used regardless of BRCA mutation, has been approved in Korea for maintenance treatment of adult patients with recurrent epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer), who are in a complete or partial response to platinum-based chemotherapy. And in December last year, the government granted healthcare reimbursement on the indication. However, the first reimbursed indication was limited to patients with BRCA mutation. By expanding the indication, Zejula is now the only PARP inhibitor in Korea indicated for BRCA mutation-positive patient regardless of platinum sensitivity, or hormone recombination deficiency (HRD)-positive adult patients, who have been treated with third-line plus chemotherapy. The indication expansion was based on an open-label multi-center QUADRA study evaluating the safety and efficacy of Zejula treating adult ovarian cancer patients with a record of third-line plus treatment. Treating HRD-positive platinum-sensitive patient group demonstrated objective response rate (ORR), a primary endpoint of the study, of 24 percent, whereas BRCA mutation-positive platinum-sensitive patient group, BRCA mutation-positive platinum-resistant patient group and BRCA mutation-positive platinum-refractory patient group demonstrated 39 percent, 29 percent and 19 percent, respectively, which confirmed the clinically meaningful benefit of the treatment. The secondary endpoint of the study, median duration of response (mDOR) of 8.3 months was observed in HRD-positive platinum-sensitive patient group. The finding confirmed the treatment’s safety profile can be managed by controlling the treatment dose.
- Company
- Recommending ezetimibe, “The lower the LDL-C, the better”
- by Eo, Yun-Ho Jan 15, 2020 06:30am
- 김효수 교수 With robust evidences of efficacy, ezetimibe is now one of major options for treating dyslipidemia. “The lower the better.” The result of clinical trial IMPROVE-IT, with the slogan claiming the lower the low-density lipoprotein cholesterol (LDL-C) is the better the health benefit, earned its recognition when it was announced in 2015. Numerous pharmaceutical companies in Korea raced each other to release combination drugs with ezetimibe plus either atorvastatin or rosuvastatin. The products landed themselves on the market safe and sound. Given the positive response, some wondered about the unexpected recommendation addressed in Guidelines for the Management of Dyslipidemia 2018 published by Korean Society of Lipid and Atherosclerosis’ (KSoLA). While American Association of Clinical Endocrinologists (AACE) updated its guideline in 2017 with new ‘extreme risk’ category and advised medical professionals to bring the LDL-C level down to under 55 mg/dL, the KSoLA’s latest guideline maintained the target treatment level of LDL-C for ultra-high risk group at 70 mg/dL. Meanwhile, European Society of Cardiology (ESC) has recently recommended setting treatment target LDL-C level for extreme risk group at under 40 mg/dL. With an expectation of more assertive use, ezetimibe was also listed as second-line treatment option following statin treatment. Despite the release of new medicine like PCSK-9 inhibitors, the Korean guideline generally took the conservative approach. And what are the thoughts of Korean clinical doctors on dyslipidemia treatment strategy after the newest edition of the guideline was published more than a year ago? Daily Pharm interviewed Kim Hyo-soo, the then Professor at Department of Internal Medicine of Seoul National University Hospital, on the issue. At the time of publishing, he was the chairman of the society and has actively supported prescription of ezemitib at any time. - About setting 'treatment target of LDL-C level 55 mg/dL' and 'ezetimibe as first-line treatment,’ did you think it was too soon? In my opinion, ezetimibe is not in any way insufficient to be a first-line treatment. But many did not see a good reason to add ezetimibe to the first-line treatment option, when a patient can reach the target level with statin monotherapy. So the guideline recommended medical professionals to prescribe the medicine to patients struggling to manage the cholesterol level only with statin. Treatment target level of LDL-C actually differs among many clinical trials. When setting 70 mg/dL as an idealistic level, the needs for ezetimibe as a first-line treatment are low to be honest. But it’s another story when setting the level at 55 mg/dL. Usually the level is unreachable with statin monotherapy. It needs a combination therapy with ezetimibe. Personally, I prescribe statin-ezetimibe combination therapy as first-line treatment. In other words, each doctor’s level of lowest value varies, so the guideline had to take a rather careful approach. On a side note, I did suggest setting 55 mg/dL as target LDL-C level when we were updating the guideline. Now I’m looking into 35 mg/dL, even. - What had enabled ezetimibe to lower LDL-C level and to ultimately prevent cardiovascular events? LDL-C can be divided into apolipoprotein B (ApoB)-48 and ApoB-100. Previously, only ApoB-100 was considered to be accumulated as plaque, but apparently studies have found ApoB-48 also works the same. Now it’s more convincing that statin’s ApoB-100 synthesis inhibition combined with ezetimibe’s ApoB-48 absorption inhibition is lowering LDL-C level more effectively. For a long time, hyperlipidemia treatment was solely dependent on statin and the practice has prescribed a high dose of it. Combination therapy with non-statin class, previously quite unpopular, is now gaining the attention and PCSK-9 inhibitor, expensive but powerful in dropping LDL-C level, is also used more often. The time has changed, eventually. - Is there a particular patient group you would especially recommend ezetimibe combination therapy? Cholesterol absorption is accelerated in diabetic patients. With more favorable condition for cholesterol absorption than non-diabetic patient, ezetimibe could deliver more dramatic effect. Ezetimibe would also be effective for patient group with high blood sugar level, because it does not increase chance of diabetes onset when used, whereas statin does. Postprandial hyperglycemia is a vital issue for a diabetic patient, but newer studies say postprandial lipidemia is also as bad. Ezetimibe inhibits postprandial lipidemia, which would be beneficial to diabetic patients. For my clinical practice, I have often used ezetimibe to lower diabetic patients’ cholesterol level. As a matter of fact, I conducted a research on less explored area of effect of the drug on blood glucose. The researchers are currently analyzing data collected from about 200 people. - Many have mentioned of PCSK-9 inhibitor, but apparently it tends to be administered once-monthly (originally indicated for once-biweekly) as the drug use is mostly non-reimbursed, despite its outstanding efficacy. Is it alright to change the interval? For a patient, relapsed disease like acute coronary syndrome (ACS), myocardial infarction (MI) and peripheral artery disease (PAD) are critical to their condition. And those patients’ LDL-C level has to be lowered more aggressively. And if adding ezetimibe does not work, then PCSK-9 inhibitor has to be used. But, it is expensive. And that is why many of them are administered once a month, but their LDL-C level ranging from 70 mg/dL to 80 mg/dL is usually halved or more. A patient that ticks off more than two of high-risk conditions—diabetic, hypertension, age 65 and up, cigarette smoking, hypercholesterolemia—is advised to take PCSK-9 inhibitor. I personally consider using PCSK-9 inhibitor when a patient’s cholesterol level is not controlled with rosuvastatin-ezetimibe combination therapy.
- Company
- Reimbursed ALL new drug Besponsa lands code at Big 5 fast
- by Eo, Yun-Ho Jan 14, 2020 06:29am
- After the green light from Korean health authority, the reimbursed Besponsa (inotuzumab) injection has quickly found its position on general hospitals’ prescription code list. According to pharmaceutical industry sources, an antibody-drug conjugate (ADC) prescribed for acute lymphoblastic leukemia (ALL), Besponsa injection has been listed for reimbursement in October last year and currently, landed its code on every Korea’s Big Five tertiary hospitals’ prescription code list. Drug Committee (DC) at Samsung Medical Center and Seoul Asan Medical Center passed the injection’s code, while Emergency DC at Seoul National University Hospital, Severance Hospital and Seoul St. Mary’s listed the code. Their prompt action proves how doctors had significant needs for Besponsa. Besposa’s reimbursed indications are for secondary or tertiary remission induction therapy in adult patient aged over 18 years with relapsed or refractory B-cell precursor ALL. To this day, the only therapy option a relapsed or refractory ALL patient could take for curing the condition is hematopoietic stem cell transplantation (HSCT). And for the patients to receive HSCT, they first have to reach complete remission (CR) before the procedure. So far, Glivec changed the whole landscape of chronic myelocytic leukemia (CML) in the leukemia treatment sector. Since then, a number of competitive target therapy options, such as Tasigna (nilotinib), Sprycel (dasatinib), and Supect (radotinib), were released in the market. But for acute leukemia, especially for ALL, there was no more novel treatment other than Blincyto. Compared to other existing anticancer therapy, Besponsa easily doubles CR rate and help the patient to go through HSCT and to get cured. Last year, National Comprehensive Cancer (NCCN) Guideline recommended Besponsa as a category 1 treatment option. A hematologic academic society official commented, “For patients with ALL, having an access t ADC or immunotherapy before their condition worsens would take them to completely different treatment landscape.” In the Phase 3 INO-VATE ALL trial, a randomized open-label study to compare Besponsa and other existing anticancer therapy, the CR rate or CR with incomplete platelet recovery (Cri) for patients treated with the ADC was 80.7 percent compared to 29.4 percent with chemotherapy. Also, 48 percent of patient administered with Besponsa had HSCT, demonstrating improved figure than the 22 percent patients treated with chemotherapy. Minimal residual disease (MRD) negative result indicates small number of cancer cells in the body after anticancer treatment and also provides important prognosis works as a prognostic factor. As for the clinical trial, patients treated with Besponsa showed MRD negative of 78.4 percent, and other group treated with chemotherapy showed 28.1 percent. Whereas two-year overall survival rate and three-year overall survival rate in patients treated with Besponsa reached 22.8 percent and 20.3 percent, respectively, comparatively higher than chemotherapy-treated patients with 10 percent and 6.5 percent, respectively.
- Company
- Tae-han Kim, CEO of Samsung BioLogics, attends JP Morgan
- by Lee, Seok-Jun Jan 13, 2020 06:27am
- Samsung BioLogics will present the main event space (Grand Ballroom) for two consecutive years at the JP Morgan Healthcare Conference. It is the first Korean company to make a main event space presentation. President Tae-han Kim makes a presentation by himself. Kim's attendance at the JP Morgan conference was unclear due to the prosecution's investigation into Samsung Biologics intentional accounting fraud. Tae-han Kim, CEO of Samsung Biologics, is presenting at the 2019 J.P. Morgan Healthcare Conference.Samsung BioLogics announced on the 12th that it will participate in the JP Morgan Healthcare Conference, the world's largest global investment event, held in San Francisco, USA. Samsung BioLogics was assigned the Main Track in 2017 and 'Grand Ballroom' last year and this year. Both are the first Korean companies. The Grand Ballroom is a large 800-seat presentation venue. Only a few major global pharmaceutical companies, such as Pfizer, Roche and Johnson & Johnson, are known to be assigned. The announcement will be made by CEO Tae-han Kim and Vice President John Lim. Samsung Biologics will present its achievements, 2020 goals, and mid- to long-term visions under the theme of 'Innovation and Growth of Samsung in Biologics Industry' in a presentation on Wednesday afternoon 15th. Meanwhile, the JP Morgan Conference, which marks its 38th anniversary this year, is the largest investment event in the healthcare sector, in which 500 pharmaceutical bio companies from around the world, invited by the global investment bank JP Morgan, announce major business results and visions.
- Company
- Hana secured copyright for anesthetic drugs in 6 countries
- by Lee, Seok-Jun Jan 13, 2020 06:26am
- Hana Pharm Co. announced on the 9th that it signed an exclusive contract with six countries in Southeast Asia for anesthetic drug, Remimazolam. Remimazolam is a new anesthetic drug that is considered to be a Propofol alternative. After finishing phases III in each country, they are getting global approval for Japan, USA and Europe. The original developer is Paion by Germany, and Hana has acquired the rights of six Southeast Asian countries following Korea. According to the disclosure, Southeast Asian countries are Vietnam, Indonesia, Thailand, Philippines, Singapore and Malaysia. The other party is Paion and the contract is €1.5 million (about ₩2 billion). Phased permits, launches, and sales-linked milestones will be paid separately. Remimazolam has a global license ahead. Depending on the country partner, Japan's Mundipharma issued a permit application in December 2018, Cosmo Pharmaceutical U.S.A., 2019, and European Paion in November. In Korea, Hana completed the application for approval on December 30 last year. It is likely to be the first to be approved in Japan. If the permit is granted, it will have a positive effect on domestic approval. OEM Europe and Japan Export Challenge Hana is setting export targets for Europe and Japan in addition to the Remimazolam copyright contract. The region plans to advance to Paion's 2nd Vendor OEM. There are only four Remimazolam producers in the world, including Hana. Hana's strategy is to establish a global market base through Southeast Asian copyright and European and Japanese consignment production. Hana is also expanding its facilities to meet the demand for Remimazolam. Hana decided to invest ₩58.5 billion in November to construct a new injection plant and introduce facilities. The new plant's production capacity is estimated at ₩200 billion for injection. Operation is expected in 2022. In last February, the facility invested. In order to secure the site for the new factory, the company purchased the sale of the Pyeongtaek Dreamtech General Industrial Complex. Kepa has not been decided yet, but the new plant will be completed by 2025. An official of the company explained, "Remimazolam can be produced in existing factories, but is investing in facilities to meet the growing demand".
- Company
- Sanofi recruits 4943 patients in three clinical trials
- by Chon, Seung-Hyun Jan 13, 2020 06:22am
- Hanmi Pharmaceutical's new technology, "Efpeglenatide", exported to Sanofi, continues commercializing smoothly.. Three cases were recruited out of five phase III trials. In three clinical trials, a total of 4943 patients were recruited, accumulating the scientific evidence to prove the competitiveness of Efpeglenatide. The whole view of Hanmi Pharmaceutical HeadquartersAccording to Clinical Trials, a clinical information site run by the National Institutes of Health (NIH), Sanofi recently completed a recruitment of one of the Phase III trials of Efpeglenatide. This is a Phase III clinical trial comparing the combination of Efpeglenatide and Metformin with the competing drug Trulicity ( Dulaglutide). Sanofi began the trial in September 2018 and after enrolling 481 subjects, changed the clinical stage to “Active, not recruiting” on the 7th.. The target completion date is next February. Sanofi has completed three of the five trials of Efpeglenatide in Phase III trials. Efpeglenatide is a GLP-1-based diabetic drug that extends daily injections from once a week to up to once a month. It is based on Hanmi’s 'Lapscovery' technology. Lapscovery is a platform technology that increases the short half-life of biopharmaceuticals and reduces the number of doses and dosages to reduce side effects and improve efficacy. Hanmi signed a technical export contract with Sanofi’s Efpeglenatide in November 2015, and holds the record of the largest contract ever for four years. In November 2015, Hanmi signed a contract with Sanofi to export technology for a total of €3.9 billion in quantum projects (Efpeglenatide·sustained insulin· Efpeglenatide·sustained insulin). The down payment is €400 million. In December 2016, Hanmi signed an amendment agreement with Sanofi to return one of its technology transfer projects. Hanmi returned €196 million to Sanofi out of the €400 million received from Sanofi. Sanofi announced a detailed development plan at the end of 2017, two years after taking the rights of Efpeglenatide. Sanofi began five clinical trials in late 2017 after the first phase III trial comparing Efpeglenatide to placebo. In last June, 4076 people were enrolled in the AMPLITUDE-O, which is considered the core clinical trial of Efpeglenatide. In last October, the recruitment of AMPLITUDE-M compared to placebo was completed. A total of 4943 patients were enrolled in the three clinical trials that were completed. It is accumulating scientific evidence to secure market competitiveness while demonstrating the safety and effectiveness of Efpeglenatide in large patients. Efpeglenatide survived the reorganization of Sanofi's harsh R&D pipeline. Efpeglenatide is the only diabetic drug among the five R&D pipelines that Sanofi has set for NDA within two years. Sanofi suddenly stopped developing GLP-1 based triple agents (SAR441255) last year. It also returned the rights of the SGLT-1/2 double inhibitor ‘Zynquista(Sotagliflozin)’, which was introduced in 2015. Sanofi announced in last December that Sanofi increased its investment in four areas: cancer, blood disease, rare disease, and nervous system disease and stopped research into cardiovascular disease. Efpeglenatide is in a position to complete development and search for a new vendor.
- Company
- “RSA expansion, a foundation to expedite new drug listing"
- by Eo, Yun-Ho Jan 10, 2020 06:26am
- A ‘new drug’ holds the foremost value of the pharmaceutical industry. And global pharmaceutical companies’ eyes are currently fixated on the ‘adequate value of new drug’ than ever before. As the era of high-cost drug has come, government and pharmaceutical industry’s gap in views of drug pricing has never been so apart. Korea Research-based Pharmaceutical Industry Association (KRPIA), representing the voices of global pharmaceutical companies in Korea, is stepping forward seeking the middle ground of the two. A consensus between them does exist. For an instance in last year, the Korean health authority expanded scope for risk sharing agreement (RSA) and announced a plan to apply RSA on follow-on drug and to expand pharmacoeconomic evaluation (PE) exemption system. The year 2020, the time of changes and expectations, marks Chair Avi Benshoshan’s third year serving KRPIA. And Daily Pharm interviewed him for this year’s plan of the organization. Chair Avi Benshoshan#- New Year’s greetings and message for the member companies. As you may be aware, this year would be another year of economic recession and sluggish growth as predicted by major economic indicators. However, we hope to create a regulatory environment that recognizes value of innovation to maintain the growth engine of pharmaceutical and bio industry this year as well. And I wish everyone has a year full of keen wisdom to seek an opportunity in crisis, like a small but bright mouse. - KRPIA member companies share a common theme of ‘new drug.’ But each of them has diverse field of expertise in anticancer, rare disease, chronic disease and off-patent treatments, which comes with different interest groups. Respective member companies have their own specialized field, but in a bigger frame, they are all heading for the same goal of improving patient’s health. In the same sense, KRPIA is planning to present more concrete basis for new drug to strengthen the ‘patient-centered healthcare policy,’ and to reinforce the organization’s role as a communicator between government and healthcare sector stakeholders. The organization ultimately aims for a mutual growth through raising awareness of social value in new drug and improving policy. We think the government, global pharmaceutical companies and the organization also share a same goal of adequately providing new drug to patients in urgent need and lowering barrier of new drug access to prevent disheartening catastrophe of patients giving up on treatment for financial reasons. - It could be considered quite limited, but the organization’s long-awaited drug pricing system revision is in process. The organization sees it as a positive change as RSA scope expansion and PE-exemption system amendment are all part of regulatory reform to improve patient’s access to new drug. We fully understand the government’s contemplation on soaring medical expense. However, considering on how ‘Korea Passing’ phenomenon was a prevalent issue throughout the pharmaceutical industry, decision on new drug reimbursement has reached a difficult point in time as it has to take account of other countries as well. We have a great anticipation on the government’s decision to expand scope of RSA as it was their solution balancing between stable National Health Insurance (NHI) finance and patient’s access to new drug. And also it could be a starting point of regulatory reform to adopt fast-track listing. Although the government has not unveiled any specifics, yet, the organization plans to cooperate with the government to deliver the complete effect of regulatory change to the patients. -Last year, the government presented a research outcome on new drug review period. What do you suggest is needed to enhance the review system? The last year’s research holds a significant meaning to it as it investigated, for the first time in Korea, the actual time taken for new drugs to be reviewed and approved in Korea.” The average time taken for review and approval on 115 investigational new drugs in Korea was approximately 300 days, similar to that in other advanced countries. Unlike other countries with already set predictability of the review system, however, Korea’s approval period showed large gaps between different items and in different years. Predictability is a crucial factor for a business, therefore, the government should consider including additional supplementary material submission period as part of the review processing period to raise regulatory predictability like the other countries. And for rare disease treatment with urgent and highly unmet medical need, the government should activate preferential review system, differentiated from general approval procedure and implement practical policies for better effectiveness. - Regarding regulations, in which part does KRPIA try to improve or recommend? To enhance Korea’s medical and bio companies’ capacity and support their global market expansion, KRPIA has been operating ‘Global Pharmaceutical Company-Startup Co-incubating Platform’ with KOTRA since March 2018, targeting about 100 medical and bio startups. And in 2019, we have organized ‘Global Open Innovation Korea’ with KOTRA, Ministry of SMEs and Startups and Korea Institute of Startups & Entrepreneurship Development (KISED) as an effort to meet the government’s biohealth industry fostering policy. We highly appreciate the government's commitment designating the biohealth industry as one of top key emerging industries and also their aggressive investment on the industry. Nevertheless, it is unfortunate to see multiple government bodies executing different biohealth industry fostering policies resulting in overlapped actions and inefficient communication in between the policies. Based on other cases in overseas, the massive scale of government’s investment, determined to assertively support the bio industry, is as important, but also we believe focusing investment efficiently among various government policies would bring a success to the policy. As Korea already has an outstanding infrastructure in basic science, life science and clinical study for development of biohealth industry, it would be wise to fine tune policies between government bodies to maximize the investment effect. –How about a word of determination and ambition for the New Year’s? For the year 2020, KRPIA plans to provide even more concrete basis for new drug to strengthen ‘patient-centered healthcare policy’, and to raise awareness of social value in new drug. Also, the organization would engage with government and healthcare sector interest groups better to improve existing policies. And we would endeavor to grow deeper mutual relationship between Korean and global pharmaceutical companies in various fields like technology co-development and overseas market co-marketing. Last but not least, the organization would fully support Korea to become a pharmaceutical powerhouse by hosting more clinical trials and increasing R&D investment. We hope the pharmaceutical industry could bring better health to the people and result in fruitful outcome to contribute improving the people’s happiness.
- Company
- The controversy of Eliquis' fluctuating price
- by Jung, Hye-Jin Jan 10, 2020 06:25am
- The price of Eliquis, an anticoagulant drug, Apixaban, has fluctuated several times. Wholesalers and pharmacies dealing with dispensing and distribution are also confused. In particular, as the most recent provisional disposal application that Korea BMS applied for was accepted earlier than expected, some pharmacies and wholesalers had to pay the difference, but Korea BMS showed a negative attitude toward settlement. Initially, the Ministry of Health and Welfare announced that as of January 1 this year, the Eliquis insurance price, which is ₩1185, will be reduced to ₩830 , a 30% reduction. Accordingly, Korea BMS has proceeded with the original lawsuit to prevent the price cut, and has defended the price cut right now by applying for suspension of execution. The BMS filed an application for disposition shortly after the suspension of drug price reduction was lifted after the first trial decision by the Ministry of Health and Welfare. As the court accepted it, the drug price, which was lowered on January 1, recovered to ₩1185 from two days later. The problem is that the provisional decision was unexpectedly fast and was shipped at a reduced price on the first two days of January. There was no time for wholesalers and pharmacies to cope. January 1 2020 was a public holiday, but during the two-day weekday, wholesalers and pharmacies nationwide charged Eliquis at ₩830. Even though pharmaceutical companies need to settle balances on shipments made during the day, Korea BMS has been controversial, stating that it will only settle for prescription quantities. Personal information such as the patient's prescription is required to check the quantity of the prescription. But, wholesalers or pharmacies cannot provide the personal information to pharmaceutical companies under the Personal Information Protection Act. A wholesaler said, “As the result of the application for disposable treatment on the afternoon of January 3, we had a hard time reprocessing all the shipments that were shipped on the morning of the day at the original medicine price, and if a drug company wants to settle the balance only for the prescription of a hospital, it is like evading settlement”. The official pointed out that BMS is the first Korean pharmaceutical company to announce such a settlement method. A BMS official explained, “The company anticipates the problems that may arise as the price of medicines has been reduced, and has countermeasures, and will confirm the specific details and answer”.
- Company
- Valsartan's third payment deadline has expired
- by Chon, Seung-Hyun Jan 10, 2020 06:24am
- The third payment deadline for the Valsartan damages claim urged by health authorities has ended. Most of the companies that did not pay the compensation were refused to pay. The health authorities say they will continue to incentivize payments, but a lawsuit filed by pharmaceutical companies will conclude the legitimacy of government action. According to the industry on the 7th, the third payment deadline for the Valsartan indemnity claims by the National Health Insurance service has expired on December 31 last year. In October last year, the NHIS asked for 69 drug companies to pay ₩2030 million in compensation. It is a follow-up in accordance with the Ministry of Health and Welfare's decision to return the amount of money invested in pharmacies since the outbreak of the impurity Valsartan issue in 2018 for the remainder of the prescription. The NHIS sent the first reminder to the pharmaceutical companies that did not pay the compensation, by last October 31. Again, due to low payment rates, the NHIS sent a second reminder last December. In order to increase the collection rate, three payment deadlines were given. However, most companies that did not pay the initial deadline were reportedly refused to pay. According to data submitted to the Democratic Party's lawmakers by In-soon Nam last November, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. Pharmaceutical companies refused to pay about 80% of the proceeds. The company has already entered a lawsuit with the NHIS, especially those with large amounts of compensation. Pharmaceutical companies filed a lawsuit to confirm the absence of debt against the National Health Insurance Service on November 27 of last year. It preemptively filed a lawsuit stating that it was not responsible for Valsartan damages claimed by the NHIS. Companies involved in litigation include JW PHARMACEUTICAL CORPORATION , JW SHINYAK CORPORATION, SK Chemicals, Khunil Pharmaceutical, Kwang Dong Pharmaceutical , Guju Pharmaceutical, Kukje Pharmaceutical, Nexpharm Korea, Dasan Pharmaceutical, Daewoo Pharmaceutical, Daewon Pharmaceutical, DAE HWA Pharmaceutical Co., Ltd., DongKoo Bio Pharmaceutical, Mother's Pharmaceutical, MyungMoon Pharm. Co., Ltd., BINEX.CO.LTD, Samik Pharmaceutical Co., Ltd., SAMIL PHARMACEUTICAL CO.,LTD , CMG Pharm, Ajou Pharm, Unimed Pharm, Inist Bio Pharm, Eden Pharma, Reyon Pharm, Chong Kun Dang, Jinyang Pharm, Terragen Etex, Hana Pharm, Korea Kolmar, Hutecs, Hanlim Pharmaceuticals, Hanwha Pharmaceuticals, Whanin Pharmaceuticals, Huons, Huons Medicare, etc. Most companies with large amounts of compensation were involved in litigation. LG Chemical did not participate in the lawsuit among six companies, including Daewon Pharm, Hutecs, LG Chemical, Hanlim Pharm, JW SHINYAK CORPORATION, and Korea Kolmar. Pharmaceutical companies are claiming that they are not responsible for Valsartan claims claimed by the government. Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity Valsartan. Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan issue, is a hazardous substance in the Valsartan raw material that has no standard. Neither governments nor pharmaceutical companies were aware of the risk of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that a defect was not found at the level of science and technology at the time the manufacturer supplied the product, it would be liable for damages.
