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- 2026-03-19 02:54:28
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- Pfizer launches Vyndaqel followed by Vyndamax in Korea
- by Eo, Yun-Ho May 18, 2020 06:16am
- Pfizer is expecting to introduce 'Vyndamax' following 'Vyndaqel'. According to the related industry, Pfizer is in the process of approving for Vyndamax (Tafamidis meglumine) by the MFDS, a treatment for cardiomyopathy caused by hereditary transthyretin amyloid polyneuropathy (hATTR-PN) and transthyretin mediated amyloidosis (ATTR-CM). It is expected in the second half of the year. Vyndaqel (Tafamidis meglumine) and Vyndamax have the same active ingredients but differ in indication and dosage. In the case of Vyndaqel, it was already approved in Korea in 2015, and it is currently undergoing an expanded indication for cardiomyopathy indications by ATTR-CM. Both drugs added an indication for cardiomyopathy caused by ATTR-CM following hATTR-PN from the US FDA last year. The efficacy of ATTR-CM has been demonstrated in a phase III study. The primary endpoint of the study was a comprehensive assessment of mortality for all causes and frequency of hospitalization for cardiovascular disease, and the secondary endpoint was a Kansas City survey of 6-minute walking distance tests and quality of life for patients with heart failure. As a result of the study, the two drugs showed statistically significant results in both the mortality rate according to all causes and the hospitalization period due to heart disease compared to the placebo. On the other hand, hATTR-PN is a genetic disease, whereas ATTR-CM is not the only cause. There is a non-genetic factor, and it is more common in men than in women as age increases. The incidence of non-genotype hATTR-CM is higher than that of PN. It is estimated that there are more patients in the world.
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- Hanmi on legal action against Sanofi returning efpeglenatide
- by Chon, Seung-Hyun May 18, 2020 06:14am
- A multinational pharmaceutical company Sanofi has decided to return the rights on antidiabetic candidate medicine efpeglenatide back to Hanmi Pharmaceutical. Apparently, the French-based company is putting an abrupt brake on the development of efpeglenatide, licensed out as the biggest Korean-developed pipeline in 2015. Hanmi Pharmaceutical explains “The decision was solely made by Sanofi with their shift in business plan,” and stated it would review taking a legal response. A view over Hanmi Pharmaceutical headquarters On May 14, Hanmi Pharmaceutical released news that Sanofi has notified the intention to return the licensed out efpeglenatide, currently undergoing a series of phase 3 clinical trials. According to the contract terms, the two companies are to finalize the decision on the retuning of the rights after 120 days of negotiation. Even if the French company returns the right, the Korean company is not subjected to return EUR 200 million (approximately 260 billion won) already received from the partner company. Hanmi Pharmaceutical official elaborated, “We have decided to negotiate with Sanofi to complete the ongoing phase 3 global study on efpeglenatide as it is close to the end,” and said the company “plans to seek for a new global partner company.” A glucagon-like peptide-1 (GLP-1) receptor agonist, efpeglenatide is an innovative bio drug candidate to treat patients with diabetes by administering the drug once-weekly or once-monthly at most. The candidate drug is based on Hanmi Pharmaceutical’s core platform technology ‘Labscovery,’ which prolongs the short half-life period of biologics and reduces administration frequency and dose to lessen the adverse reaction and improve effect. In November 2015, Hanmi Pharmaceutical and Sanofi had signed a license-out deal valued at 390 million euros on the Quantum Project (efpeglenatide, long-acting insulin, efpeglenatide plus long-acting insulin combination). Although the contract terms have been revised twice since then, the deal is still the biggest license out deal a Korean pharmaceutical company holds to the date. Hanmi Pharmaceutical claims Sanofi’s decision to return their rights over efpeglenatide were unreasonable, because the global company is dropping the already agreed upon phase 3 clinical study. Intending to take a legal action, Hanmi Pharmaceutical official said, “Sanofi’s decision was made without discussing with Hanmi Pharmaceutical.” After a new CEO took over the office in last September, Sanofi has unveiled a widely reformed R&D plan to halt diabetes and cardiovascular related research but to strategically concentrate on four main sectors including oncology, hematology, rare disease and neurology. When the announcement was made, Sanofi officially noted the multinational company would give up the rights to commercialize and distribute the antidiabetic pipeline efpeglenatide and search for a new partner, however, the ongoing phase 3 clinical trials would be completed with the company. At the moment, Sanofi is conducting five global phase 3 clinical trials related to efpeglenatide. Hanmi Pharmaceutical stressed Sanofi giving up on the efpeglenatide rights is unrelated to the medicine’s efficacy and safety. Hanmi Pharmaceutical official stated, “As Sanofi has publicly promised affected patients, investigators and Hanmi Pharmaceutical that the global phase 3 clinical trials would be fully conducted, we would demand Sanofi to keep their word,” and “Further legal actions pursuing litigation would be reviewed, if need be.” The Korean company official stressed, “Efpeglenatide is a promising pipeline, as the global GLP-1 receptor agonist market would be worth approximately USD 10 billion by the time the candidate medicine is commercialized,” and “the biologic would be able to find a new global partner at around the end of the year or the beginning of next year, when the outcomes of the superiority trial against efpeglenatide’s competitor Trulicity would be released.”
- Company
- Pharmaceutical industry focuses on Spread of COVID-19 again
- by An, Kyung-Jin May 15, 2020 06:05am
- Pharmaceutical companies are also nervous again as the spread of COVID-19 from Itaewon Club in Seoul. Pharmaceutical companies seem to be cautious about unexpected situations when they tried to earnestly engage in sales marketing activities with the government's distancing in daily life. According to the industry on the 13th, a domestic pharmaceutical company e-mailed to all employees to inform the personnel team that they have visited a entertainment area in Itaewon, Seoul, and Gyeonggi Province, or immediately contact a personnel team after the visit to the entertainment district, individuals with personal health problems were notified immediately to contact the human resources team. Most companies recommend self-isolation for 2 weeks after self-examination to employees who have visited Itaewon entertainment store or suspected of symptoms related to corona19 such as fever, cough, sore throat. Samsung Bioepis asked to check the visit to Itaewon through a mobile interview last weekend. During this period, employees who visited nearby Itaewon also made strong preventive measures, such as recommending self-examination. Korean corporations of some multinational pharmaceutical companies such as AstraZeneca Korea and Janssen Korea plan to continue working for a long time with flexible operation of autonomous hours, such as every other day. Panoramic view of an office building lobby in Jung-gu, Seoul with a lot of floating Pharmaceutical companies are keen on the further spread of COVID-19 by employees who recently visited the Itaewon Club. If the spread of COVID-19 was concentrated in Daegu, Gyeongbuk 3 month ago, it is concentrated on young people in the metropolitan areas such as Seoul and Incheon, which intensifies the anxiety in the industry. In the case of COVID-19 confirmed patients in departments with high proportions of young employees, such as production facilities, research institutes, and sales departments, it is fatal to the operation of the company. In particular, in buildings where it is not possible to work from home, such as production facilities and research institutes, pharmaceutical companies become more nervous in that they have to stop operating for a while if there is one confirmed patient. In fact, a bio company that has a production facility in the metropolitan area said that employees who visited the area near Itaewon were suspicious until they received a negative result for COVID-19. The two companies in Seoul Square building where corona19 confirmed patients visited Itaewon were also nervous. MSD Korea and Mundipharma entered emergency telecommuting on the 11th after receiving a notice that Pernod Ricard Korea’s employee was confirmed on the 10th floor of the same building after visiting a local area near Itaewon in Seoul. Both companies seemed to be confused after ending their three-month telecommuting job and trying to approach work normalization. MSD Korea only started working at the office for only two weeks, but decided to switch to telecommuting and watch the trend. On the evening of the 11th, a management meeting decided to extend telecommuting until the 13th, and instructed employees not to stay in the office. Mundipharma also banned working at the office. Although building disinfection has been completed, it maintains a conservative position to set the time for resumption of work while paying close attention to the guidelines of the quarantine authorities. Companies are strengthening their guidelines to refrain from entering enclosed spaces The Yonsei Severance Building, where Boeringer Ingelheim of Korea resided, suffered a tumult on the news that the employee on the 11th was in close contact with COVID-19 confirmed patient. It turned out that Hyundai Shell Base Oil executive, the resident of the 7th floor of Yonsei Severance Building, ate with COVID-19 confirmed patient last weekend. Some of the companies in the same building immediately noticed the news and immediately left the company to work and urgent telecommuting was conducted for a day on the 12th, and Boeringer Ingelheim, who resided on the 16th floor, continued normal work. Although the close contact employee finally ended in happening after receiving a negative result, Boeringer Ingelheim, which resumed normal work from the 11th, passed the crisis of returning to home work in one day. An official from the pharmaceutical industry said, "The companies that tried to normalize the management after social distance was relieved by distancing in daily life was again in state of emergency and worried because there were a lot of young employees. but it is also not easy to recommend. The greater the psychological anxiety, the more the business disruption will continue. ”
- Company
- Sanofi Pasteur GM Baptiste de Clarens to leave Korean office
- by Eo, Yun-Ho May 15, 2020 06:04am
- The General Manager at Sanofi Pasteur Korean office, Baptiste de Clarens is to leave the office at the end of May. According to pharmaceutical industry sources, the resignation of General Manager Baptiste de Clarens has been decided by the headquarter. The decision was apparently made as his term in Korea is ending and a new general manager would be take charge of the Korean office from July. Like the other previous general managers of Sanofi Pasteur Korean office, the new general manager has reportedly led the Asian-Pacific regional office. After leaving the Korean office, General Manager Baptiste de Clarens would be appointed at the Sanofi Pasteur headquarter in Lyon, France to oversee the vaccine business. Since joining the French-based company in 2006, the general manager has worked on enhancing efficiency in general marketing and sales at the Lyon headquarter office and developed his global expertise. He has also supervised the company’s business operation in Asia in Singapore, before he was appointed as a general manager in offices in Malaysia, Singapore, Brunei, and in South Korea from July 2017. Currently, Sanofi Pasteur supplies various vaccines to Korea, including influenza vaccine, diphtheria plus tetanus plus pertussis vaccine, DTaP-IPV Combo vaccine, meningococcal vaccine, live attenuated virus vaccine against Japanese encephalitis, hepatitis A vaccine, and yellow fever vaccine.
- Company
- Ibrance and Verzenio settle pricing for Faslodex combination
- by Eo, Yun-Ho May 14, 2020 06:24am
- At last, Faslodex plus CDK4/6 inhibitor combination therapy would be accessible as an actual treatment option for patients. According to Korean pharmaceutical industry sources, two cyclin-dependent kinases 4/6 (CDK4/6) inhibitors including Pfizer’s Ibrance (palbociclib) and Lilly's Verzenio (abemaciclib) treating patients with HER2-negative breast cancer have successfully settled on drug pricing with National Health Insurance Service (NHIS) as combination therapy with AstraZeneca’s Faslodex (fulvestrant). The listing would be finalized in June, if the Health Insurance Policy Deliberation Committee (HIPDC) would approve of it. Since the first reimbursement expansion, Pfizer took two years and Lilly took a year for the Faslodex combination therapy to get listed. The demand for the combination therapy has been present since the so-called Ibrance incident from 2017. However, Ibrance was freshly listed as a first-line therapy in Nov 2017, and individual listing for Faslodex was not even cleared. In fact, Faslodex has been approved in the Korean market for over a decade. The Korean health authority and the drug maker have struggled to find a middle ground on the cost-effectiveness of the monotherapy. However, the demand on the providing reimbursement on the drug has surged since the Ibrance combination therapy started receiving the public’s interest. Despite the challenges, the first attempt to list the combination therapy has been submitted in 2018. AstraZeneca applied for reimbursement on the Ibrance-plus-Faslodex combination therapy, while Pfizer also requested for reimbursement expansion. As the monotherapy of Faslodex has not been listed, the Korean health authority, however, requested AstraZeneca to withdraw the reimbursement application and rejected Pfizer’s application. Since then, AstraZeneca has decided to accept the pricing below the weighted average of alternative options to list Faslodex’ monotherapy, and successfully listed the drug in April last year via negotiation-exemption track. Pfizer then jumped on and submitted the second application to expand reimbursement for the Faslodex combination therapy, as soon as the drug’s listing was finalized in March. Lilly also submitted the listing application in May last year, immediately after its marketing approval. Verzenio was able to apply for the healthcare reimbursement via the risk sharing agreement (RSA) track as CDK4/6 inhibitor-plus-Faslodex combination therapy as a main indication has not been listed by any other drug.
- Company
- Korean companies to showcase clinical data at ASCO 2020
- by An, Kyung-Jin May 14, 2020 06:24am
- A view of ASCO 2019 from last year in Chicago The American Society of Clinical Oncology Annual Meeting (ASCO) 2020 is coming up in a couple of weeks. The 56th ASCO is one of the biggest pharmaceutical and bio industry events along with JP Morgan Healthcare Conference. Every year, about 40,000 pharmaceutical and bio industry and academic representatives are invited to the conference in Chicago from 76 countries around the world to see the up and coming research trends and technologies. For five days from May 29 to June 2 local time, thousands of new anticancer treatment clinical results are scheduled to be presented, virtually. Affected by the COVID-19 pandemic, the organizer of the event has announced the event would be held online. On May 3, the organization official stated, “Due to the COVID-19 pandemic, all events of ASCO 2020 would be conducted virtually in late May. Putting the safety of oncology researchers and their patients first, the online presentations would be provided according to the announced schedule.” Korean pharmaceutical companies like Yuhan, GC Pharma, Genexin Hanmi Pharmaceutical and Alteogen are planning to unveil data from their novel anticancer treatment in development at ASCO 2020 Virtual Scientific Program. At 5 p.m. local time on May 13, ASCO would publish their selection of research abstracts its website. In the poster presentation session, Yuhan is presenting three sets of clinical data related to a next-generation lung cancer treatment Lazertinib (YH25448). The data is collected from a follow-up study on the phase 1/2 study conducted in Korea, which was presented during the poster session in ASCO 2019. Three Korean healthcare provider participants—Professor Kim Sang-we (Seoul Asan Medical Center), Professor Han Ji-youn (National Cancer Center Korea) and Professor Lee Ki Hyeong (Chungbuk National University Hospital)—are to respectively provide detailed analysis and key findings in efficacy and safety of Lazertinib 240 mg in patients with epidermal growth factor receptor (EGFR) T790 mutation; Lazertinib’s antitumor effect on patients with non-small cell lung cancer (NSCLC) and brain metastases; and Lazertinib’s impact on circulating tumor DNA (ct DNA) in the bloodstream. Yuhan’s third generation EFGR-targeted therapy Lazertinib has been licensed out to Janssen Biotech in 2018. The novel anticancer treatment has been evaluated as a promising first-line treatment in patients with EGFR-mutation positive NSCLC and as a second-line option for EGFR T790-mutated patients with NSCLC. Yuhan has signed the joint development deal potentially worth USD 1.25 billion with Janssen Bitotech for all exclusive rights around the world, except in Korea. The Korean company has received upfront payment of 50 million dollars (approximately 56 billion won) and another 35 million dollars recently as the targeted therapy was a part of an initiated combination therapy clinical study with Janssen’s investigational anticancer treatment 'JNJ-372.' As a poster, GC Pharma is to present phase 1b/2a study outcome on its investigational drug ‘GC1118’ in joint development with Mogam Institute for Biomedical Research. The interim report analyzes outcome of combining GC1118 and other chemotherapies including irinotecan and FOLFIRI for treating patients with metastatic colorectal cancer (mCRC). The company is coming back to ASCO meeting in four years since 2016 to present the newest findings in the drug. GC1118 is a novel monoclonal antibody targeting overexpressed EGFR. By binding with EGFR that triggers proliferation of tumor cell and metastasis, the targeted therapy inhibits proliferating cancer while promoting killing of tumor cells by activating lymphocytes. The Korean company would showcase GC1118’s promising data as a second-line treatment option in EGFR mutation positive patients with metastatic colorectal treatment. Hanmi Pharmaceutical is planning to release various clinical data with a number of license out partners. The company’s U.S. partner Athenex is reportedly preparing for a presentation on phase 2 clinical study on Oraxol, developed based on Hanmi Pharmaceutical’s platform technology, Orascovery. The study has tested the anticancer treatment’s effect and safety in patients with unresectable cutaneous angiosarcoma. In December 2011, Hanmi Pharmaceutical has licensed out novel anticancer medicine candidate Oraxol to the U.S.-based Athenex (then named Kinex). The Korean company combined Orascovery platform technology to turn intravenously injected paclitaxel into an oral form, and enhanced the absorption rate by integrating an oral absorption enhancer, encequidar. The enhancer blocks off p-glycoprotein that inhibits oral absorption of anticancer treatment. With the upcoming ASCO presentation, the U.S. company plans to initiate the commercialization procedure of Oraxol. Last month, Athenex representative reportedly had a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) officials to fine-tune the application submission date. The company plans to expand the market scale in the future by adding more indications in treating metastatic breast cancer, angiosarcoma, gastroesophageal cancer, bladder cancer and NSCLC. Hanmi Pharmaceutical’s another partner, Spectrum Pharmaceutical is anticipated to present a new lung cancer drug Poziotinib, following the presentation at American Association for Cancer Research Annual Meeting (AACR) 2020. Similar to the prior presentation, the company would talk about the first cohort analysis from phase 2 global clinical study, ZENITH20 conducted on EGFR Exon 20 insertion-mutated patients with NSCLC. Poziotinib is a pan-HER2 anticancer therapy licensed out by Hanmi Pharmaceutical in 2015. The partner company, Spectrum now owns the development and commercialization rights over poziotinib in the global market, except for in Korea and China, and it has been seeking for the drug’s various oncologic uses including the treatment in NSCLC. Late last year, the company has gone through a detrimental experience as its stock price dropped by more than 60 percent after announcing it has failed to meet primary phase 2 trial endpoint. Regardless, the company reaffirmed its determination to press on with the pipeline by recently revising the research model. Other Korean biopharmaceutical companies are getting ready to give presentations at the ASCO 2020. Unveiling positive outcome in DNA vaccine 'GX-188E' at AACR 2020, Genexin is planning to present another set of clinical data in a combination therapy at ASCO 2020. The findings are from phase 1b/2 clinical study testing the hyleukin-7 plus immune checkpoint inhibitor Keytruda (pembrolizumab) combination therapy in patients with advanced triple-negative breast cancer (TNBC). Apparently, the TNBC advances faster than other types of breast cancer and shortens patient’s survival period. According to Genexin, the immune checkpoint inhibitor’s treatment rate in relapsed patients was recorded at around 5.2 percent. The company’s poster at ASCO 2020 would list out detailed outcome of enhancing TNBC patient’s treatment rate in different dosage of hyleukin-7 plus pembrolizumab. ASCO 2020 also selected the abstract of a first-in-human clinical study on Alteogen’s breast cancer treating antibody-drug conjugate (ADC) ‘ALT-P7.’ MedPacto is to reveal phase 1 clinical data testing a transforming growth factor beta (TGF-β) inhibitor vactosertib plus leukemia treatment Gleevec. NK Max reported it would publish phase 1/2a clinical study results in ‘SNK01,’ used to enhance anti-tumor effect in targeted therapy.
- Company
- α-GPC has been prescribed more than twice in 3 years
- by Chon, Seung-Hyun May 14, 2020 06:23am
- Sales of Choline alfoscerate, a brain function improving agent, continue to grow. The effectiveness controversy has recently been raised, but the market size has increased by more than 20% this year. Over the past three years, the market size has doubled, exceeding the quarterly prescription size of ₩100 billion. However, the decline was slightly lower than in the fourth quarter of last year, and the upward trend was somewhat slow. According to UBIST, a drug research agency on the 6th, the outpatient prescription amount of Choline alfoscerate-based drugs in the first quarter was ₩109.9 billion, up 22.2% from the same period last year (₩89.9 billion). Choline alfoscerate is a drug used to improve brain function, such as decreased sense of memory and confusion and reduced concentration. The prescription amount of Choline alfoscerate has been increasing rapidly over the past few years. The total prescription amount in the first quarter of 2015 has more than tripled in 5 years from ₩34.7 billion. it has doubled comparing to the first quarter of 2017, three years ago. Since the prescription amount exceeded ₩100 billion in the third quarter of last year, it has been recording ₩100 billion for the third consecutive quarter. Quarterly outpatient Rx amount for Choline alfoscerate (Unit: ₩1 million, Source: UBIST) Despite the recent controversy over the effectiveness of choline alfoscerate, it continued to rise. 식품의약품안전처는 지난해 11월 제약사들로부터 콜린알포세레이트제제의 유효성 자료를 제출받았다. 허가사항의 효능·효과별 유효성을 입증하는 자료와 국내외 사용현황을 토대로 허가변경 여부를 검토하겠다는 의도다. 복지부도 콜린알포세레이트제제의 급여 타당성을 검토 중이다. The MFDS received data on the effectiveness of Choline alfoscerate formulations from pharmaceutical companies in November last year. The intention is to examine whether or not to change the permit based on data proving the efficacy and effectiveness of the permit, and the status of domestic and foreign use. The MOHW is also considering the feasibility of supplementing Choline alfoscerate. Since last year's government audit questioned the effectiveness of Choline alfoscerate formulations and spending on health insurance finances, it began to verify efficacy. In a state audit, In-Soon Nam, Democratic Party of Korea asked that we should promptly re-evaluate the clinical usefulness and efficacy of the Choline alfoscerate formulation and reasonably re-establish health insurance coverage standards.” Although Choline alfoscerate is not a drug that fundamentally treats dementia, it is analyzed that the market size has expanded rapidly as pharmaceutical companies have focused on the brain functioning market aimed at the rapidly growing elderly. However, compared to the previous quarter, the growth trend is somewhat slow. Prescription results for choline alfoscerate in the first quarter fell 0.2% from the fourth quarter last year. The market for Choline alfoscerate products has declined from the previous quarter for only two years since the fourth quarter of 2017. The industry has analyzed that the market growth has slowed somewhat due to COVID-19 outbreak along with the recent controversy over effectiveness. It is possible that the number of new patients has decreased as patients are reluctant to visit medical institutions, Looking at the prescription amount by item, Daewoong Bio's 'Gliatamin' recorded the highest prescription amount of ₩23.6 billion. It was 4.3% higher than the same period last year. Chong Kun Dang's 'CKD Gliatilin' recorded prescription results of ₩19.6 billion in the first quarter, up 7.9% from the previous year. Both the prescription amounts of Gliatamin and CKD Gliatilin were slightly lower than the previous quarter. Gliatamin's 1st quarter prescription amount decreased 3.2% from the fourth quarter of last year and CKD Gliatilin decreased 1.1% from the previous quarter. Yuhan's Alfoatilin, Korea Prime Pharm’s Gria, and Daewon Pharmaceutical’s Alfocholine were prescribed more than ₩4 billion in the first quarter with a growth rate of more than 15% compared to the previous year.
- Company
- Boryung, acquires domestic sales rights for Lilly's GemZar
- by Kim, Jin-Gu May 13, 2020 05:53am
- GemZarBoryung acquired the domestic right for the anticancer drug 'GemZar (Gemcitabine HCl)' held by Eli Lilly. Boryung announced on the 8th that it had signed a contract to transfer assets to Eli Lilly and Gemzar. Through this agreement, Boryung has all rights, including domestic rights and licenses of Gemzar. Boryung and Eli Lilly have been conducting 'Gemzar' co-promotion since 2015. Gemzar is widely used in pancreatic cancer, non-small cell lung cancer, bladder cancer, breast cancer, ovarian cancer, and biliary tract cancer. It is used alone or in combination therapy in primary and secondary treatment. As of last year, Gemzar's domestic sales totaled ₩14.2 billion (based on IMS). Boryung expects to strengthen its anticancer drug portfolio and maximize its market share and profit margin. Currently, Boryung has a high market share in the domestic anticancer drug market with Oxalitin (Oxaliplatin) and Genexol (Paclitaxel). As of the fourth quarter of last year, among domestic pharmaceutical companies, it ranked No. 1 in the market for anti-tumor drugs and immunomodulators. David A. Ricks, chief executive officer of Eli Lilly said "I hope this contract will help further improve the treatment performance of Korean cancer patients," Jae-Hyun Ahn, Boryung’s CEO, emphasized, "Boryung, which is building the best anti-cancer drug business in Korea, can strengthen the line-up of anti-cancer drugs and make more stable profits with this brand acquisition." He said, "In the future, we will strengthen our portfolio for the anti-cancer area as well as grow it as a representative business of Boryung through active investment such as open innovation."
- Company
- Itaewon club-linked COVID-19 threatens the industry
- by An, Kyung-Jin May 12, 2020 06:28am
- Seoul Square building in Jung-gu, Seoul The pharmaceutical industry is straining as the number of confirmed COVID-19 from Seoul Itaewon Club increases. Pharmaceutical companies in the Seoul Square building where COVID-19 confirmed patients visited Itaewon went into emergency telecommuting, and nearby pharmaceutical companies are also watching closely. According to the industry on the 11th, MSD Korea and Korea Mundipharma, who entered the Seoul Square building in Jung-gu, Seoul, entered an emergency telecommuting work on this day. This is due to the fact that an employee of Pernold Ricard Korea, a company that imports and distributes alcoholic beverages, was confirmed COVID-19 after a visit to the area near Itaewon in Seoul. Pernold Ricard Korea has an office on the 10th floor of Seoul Square. Seoul Square carried out quarantine of the entire building over the weekend and closed the 10th floor. The policy is not to close the entire building immediately, but to decide whether to close the building based on the results of the epidemiological investigation. On the 10th, MSD Korea and Korea Mundipharma, which had received notice of outbreak of confirmed cases, decided to carry out telecommuting for one day on the 11th and implemented their own quarantine. These companies have just started working in the office again, and are worried about whether they will return to work from home. MSD Korea has returned to normal business since the 27th of last month. The office workers work in the office, and the sales positions are made to be flexible depending on the workplace. Mundipharma has also applied its own guidelines to resume office activities as far as possible, while office workers go to the office three times a week from the end of April. Both companies are observing the trend for one day on the 11th and then deciding whether to go to work on the 12th through management meetings. Pharmaceutical companies that are not companies in Seoul Square are also watching carefully. Companies near the building with confirmed patients are more nervous. Beringer Ingelheim Korea is located in the Yonsei Severance Building, just next to Seoul Square. Employees of Boehringer Ingelheim are currently working normally on the 11th. Instead of switching to telecommuting right away, they are watching the occurrence trend of Itaewon's confirmed cases, including the news of the partial closure of the Seoul Square building. GSK and Janssen Korea, which have offices in Yongsan-gu, Seoul, do not have any changes in their attendance policy at this time. GSK ended telecommuting on the 6th and began to go to the office, and Janssen Korea has been applying for a policy to go to work every other day since the end of April. The two companies worked in telecommuting in February when a confirmed patient occurred in the office on the 16th floor of the same building. It is said that the situation is being watched by the spread of Itaewon club-linked COVID-19 and measures to close nearby buildings, but there are no plans to resume telecommuting at this time. The Yongsan LS Tower, where GSK and Janssen Korea resides, is located a 10-minute walk from the LG Uplus Yongsan office building, which was closed from the 11th. LG Uplus, a telecommunications company, shut down the Yongsan office building in Seoul for three days from the 11th, when an employee went to the Itaewon Club on the 10th and was confirmed positive. An official from the pharmaceutical industry said that the company attempted to resume sales marketing activities while switching to distancing in daily life, but concerns about COVID-19 re-proliferation are increasing. He said he was worried about going back to a month ago.
- Company
- Delay in choline alfoscerate reimbursement reevaluation
- by Kim, Jin-Gu May 12, 2020 06:28am
- Popular brand drugs with choline alfoscerate, Gliatamin and Gliatirin The sources speculate the Korean pharmaceutical industry’s hot potato, the reimbursement feasibility reevaluation on choline Alfoscerate would be postponed to the latter half of the year. On May 11, pharmaceutical industry sources reported the reimbursement reevaluation on choline alfoscerate has been pressed on since the last year’s National Assembly audit. Answering to Democratic Party Lawmaker Nam In-soon’s criticism on the underwhelming efficacy of choline alfoscerate during the audit session, the Minister of Health and Welfare Park Neung-hoo said, “The reevaluation would be promptly completed by June next year (2020).” From then on, the choline alfoscerate’s efficacy has been questioned increasingly. Ultimately, Health Insurance Review and Assessment Service (HIRA) convened a meeting for Drug Reimbursement Evaluation Committee (DREC) in last February addressing the plan to reevaluate the said substance. Seemingly, the reevaluation plan was close to being set on stone, but the committee meeting did not get to officially discuss over the subject, because it was addressed within ‘reporting agenda,’ not ‘deliberation agenda.’ Regardless, the table has turned as the novel coronavirus started spreading rapidly in Korea from March. As HIRA fully concentrated its capacity on COVID-19 treatment related work, other pharmaceutical affairs have been pushed aside indefinitely. After the February meeting, none of choline alfoscerate reevaluation related vis-à-vis meeting, expert consultation or pan-governmental collaboration have been progressed. Amid the pandemic, HIRA has confirmed ‘completing the reevaluation by June’ is practically impossible. On a phone interview with Daily Pharm, a HIRA official stated, “Due to the COVID-19 pandemic, it is true that [the discussion on the reevaluation] is getting delayed,” and “Since [the DREC meeting in] February, the government agency has not seen any progress on the matter. None of prospective scheduling has been set.” The official explained the agency would be unable to fully conclude the reevaluation within June as the actual time is running out, even if HIRA resumes the discussion immediately. For the reevaluation to rekindle the discussion and to proceed to reimbursement adjustment, the procedure would have to undergo consultation with industry officials, finalize the reevaluation decision, set detailed reimbursement standards, and have the Minister of Health and Welfare to notify the reimbursement standards. The overall procedure would take at least over a month. The pharmaceutical industry also gave a similar outlook. An industry official commented, “Technically, the government’s initial plan to reevaluate the substance in June is unlikely to happen,” and “The practical discussion could resume only in the latter half of the year.” The pharmaceutical industry seems to be relieved by the delayed talks on the reimbursement reevaluation. Prior to the outbreak, the industry officials have continuously requested the government to postpone the listed drug reevaluation. In March, the Federation of Korean Industries (FKI) claimed “The listed drug reevaluation should be postponed for a year.” And in April, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) again urged the government to “defer the listed drug reimbursement reevaluation.” Currently, Ministry of Food and Drug Safety (MFDS) and Ministry of Health and Welfare (MOHW) are respectively deliberating the choline alfoscerate reevaluation discussions. MFDS is contemplating on whether to remove a part of three approved indications during a Special Reevaluation session after the drug renews its item license. With HIRA, MOHW is considering on reducing reimbursement on some of the drug’s indications or switching the reimbursement type to selective reimbursement. As MOHW has constantly expressed negative stance on providing reimbursement on choline alfoscerate, the ministry would highly likely to reduce reimbursement on some of the three approved indications or to turn the reimbursement type into selective benefit. At the moment, choline alfoscerate has been indicated to treat patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome— impairment of sense of direction, motivation, judgment and concentration due to confusion and degenerated memory, judgment and motivation; changes in emotions and behaviors—emotionally insecure, hypersensitive to stimulation, and indifferent to surrounding; and senile pseudo-depression.
