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- 2026-03-19 04:06:25
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- “No changes in safety and efficacy of montelukast”
- by Kim, Jin-Gu Mar 12, 2020 06:07am
- Medical academics argue there is “no change in safety and efficacy of montelukast,” currently controversial with safety risk. Professor Kim Chang Geun (Director of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center and President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease) Director Kim Chang Geun of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center spoke on Mar. 9 at a roundtable with press. The President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease (KAPARD), Director Kim stressed “The neuropsychiatric event from montelukast has been labeled on the drugs since 2008, which the prescribers are already aware of.” On Mar. 4, the U.S. Food and Drug Administration (FDA) has announced it would require Boxed Warning on montelukast products, including Singulair and generics. The U.S. health authority took the action after learning many healthcare providers, patients and caregivers are unaware of mental health side effect, such as anxiety, depression, sleep disorder and suicidal thoughts. FDA also recommended the drug would be used for “only patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies.” Montelukast is vastly used for patients with asthma and allergy. The used volumes in Korea and Japan are particularly high. Although the alternative options advised by FDA are inhaled steroid and antihistaminic medicines, Professor Kim Chang Geun explains the use of those options would highly unlikely in Korea. Following is his answers to interview questions. -How are patients and caregivers reacting to the news? “A patient asked about the warning and if it would be okay to use it. I answered there is no specific change to the drug’s state of safety or efficacy. The said side effects are not newly discovered. Rather, the medications have been used for over two decades. I reminded the patient to read about the listed side effects carefully.” -Please explain how has treatment for allergic rhinitis been prescribed so far “Montelukast was the go-to medicine. Depending on the symptoms, other medicines were added. Antihistaminic agent was prescribed for serious sneezing, and steroid was prescribed for serious nasal congestion. And if the allergic antigen was clear, then immunotherapy was provided as well.” -Basically, the FDA’s announcement recommended montelukast as a second-line treatment for mild case of allergic rhinitis. Could it affect the trend of prescription on mild case of allergic rhinitis? “The FDA announcement could be summarized to two points; think twice before prescribing the medication to patients with asthma and select other alternative for patients with mild allergic rhinitis. The key is prescription for rhinitis. FDA mentioned three medicines for alternative options—antihistaminic agent, inhaled steroid, and immunotherapy. “Personally, the tendency of my prescription would not change. We do not have that many options to choose from. Patients and caregivers are highly resistant to inhaled steroid in Korea. Healthcare providers also tend to steer away from it, because we are aware of even worse side effects. Antihistaminic medicines are hardly a treatment. And immunotherapy is for limited use only.” -How about leukotriene receptor antagonist instead of montelukast? “Pranlukast would be an option. But it hasn’t got the U.S. FDA approval, yet. Developed from Japan, the medicine is used in Japan, Korea, China, Turkey and Mexico, as far as I know. I heard of zileuton and zafirlukast. But technically, they have not been used at clinical scenes.” -Considering the medicine is indicated to treat pediatric patients over age one, should the parents with young patient worry more about it? “Along with the official statement, FDA has attached a related research result. It compared side effect prevalence between montelukast and inhaled steroid used to treat patients over six. The result is that there is not much difference found between those two. It is not easy to evaluate patients aged one to five. But, with my 20 years of experience in the clinical scene, I have not found such side effect.” -What do you make of the FDA’s decision? “I’m not trying to defend the medication. But what I can assure is that it does not mean a new side effect has been reported. The point of the action was to highlight the neuropsychiatric side effect, labeled since 2008 to be exact, for healthcare professionals and patients to be aware of it. There is no change in the medication’s safety or efficacy. The clinical professionals are well-aware of the side effects. I assume the medication could be used without a problem, as it has been to this date. “Moreover, FDA said the cause and effect has not been clarified, yet. It only stated such case has been reported. So a patient suffering from neuropsychiatric side effect has used montelukast, but it wasn’t the only prescribed medication. It could have been the steroidal medication that caused the event. The disease itself tends to affect mental health as well. Regardless of the prescription, patients complain of anxiety and depression.”
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- Household brand pain reliever Geworin price goes up
- by Jung, Hye-Jin Mar 12, 2020 06:03am
- Household brand pain reliever Geworin’s price would be raised by 8 percent to 9 percent around March or April. According to pharmacy and pharmaceutical distributor sources, Samjin Pharm has decided to adjust supply price of Geworin after contemplating on it for months. In this week, the company would officially notify the decision to wholesale distributors and pharmacies. The increase in Geworin’s price is first in four years. In February 2016, Samjin Pharm pushed up Geworin’s pharmacy supply price by 15 percent. The price was increased in 2007 before. Regardless, pharmaceutical distribution industry has been anticipating the price increase. Majority of popular brand pain relievers have raised their prices last year, and made Geworin’s supply price surge predictable. Prices of Janssen Korea’s Tylenol and Chong Kun Dang’s Penzal-Q have gone up last year, and Daewoong Pharmaceutical’s EZN 6 joined the club in January. Including Geworin, four popular brands of pain relievers have raised their supply prices in nine months from last June to this month. Janssen Korea took the lead in the series of price increase. The global company announced in last May that prices of all Tylenol items except for the ER tablet would be raised from last July. Janssen Korea followed through with the announcement and the increase rate was not insignificant. The price of Tylenol 500 mg, Tylenol Cold-S, Tylenol Suspension, Tylenol Chewable, and Women’s Tylenol were raised by 18.6 percent, 25 percent, 18.6 percent, 18.6 percent and 14.9 percent, respectively. Also in 2017, Janssen Korea has raised the supply price of Tylenol Cold-S and Chewable by 14.8 percent and 14.2 percent, respectively. It seems the market leader Tylenol has affected the follow-on drugs’ price inflation. A few days after Janssen’s announcement, Chong Kun Dang followed up with an announcement to raise the supply price of Penzal-Q as of June 1. And Daewoong Pharmaceutical also raised the price of EZN 6 from February. The price of EZN 6 series (Any, Eve, Pro, Strong and Ace) has been raised by 8 percent. All companies explained the common reason behind the price bump is ‘reflecting production price increase due to increased raw material price.’ Considering the reason, Samjin Pharmaceutical took its time to adjust the price longer than other companies. So why are these pharmaceutical companies raising the pain reliever drug prices? Sources analyze respective companies’ assertive advertisement campaigns have heightened the intense market competition. Specifically, TV ads tremendously bump up the marketing cost and eventually cause surge in supply price. The fact that among top selling pain relievers—Tylenol, Geworin, Maxibupen, EZN 6, Tak-sen, Carol and Penzal—ones without high-cost TV ads are not planning to raise their price supports the claim. A pharmaceutical industry insider explained, “Pain reliever market is saturated as consumer accessibility is high. Their prices seem to go up often due to high marketing activities to expand market share.”
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- Next-gen insulin medications approved for pediatric patients
- by Eo, Yun-Ho Mar 11, 2020 06:27am
- Next generation insulin medications are actively seeking for expanded indication to treat children and adolescents. Novo Nordisk’s rapid-acting insulin Fiasp FlexTouch (insulin aspart) has recently won indication to treat to children aged under two and adolescents. Fiasp is a next-generation fast-acting mealtime insulin injection that controls high blood sugar effectively and safely. The injection features the addition of vitamin B3 (niacinamide) and L-arginine amino acid to increase the speed of initial insulin absorption and to double the mealtime onset of appearance in the bloodstream. Fiasp has previously won pediatric indication from EU and the U.S. Food and Drug Administration (FDA). The indication expansion was based on the outcomes of ONSET7 trial in 777 children and adolescent with type 1 diabetes. As a result, Fiasp demonstrated effect of hemoglobin A1C control non-inferior against other existing fast-acting insulin ‘NovoRapid,’ and showed no other safety risks. The U.S. FDA also additionally indicated Sanofi-Aventis’ long-acting insulin Toujeo (genetic recombinant insulin glargine) to treat children over six and adolescent with type 1 and type 2 diabetes. Toujeo also successfully received approval on the expanded indication in Europe last October. The new approval was based on the outcomes of EDITION JUNIOR clinical trial. The EDITION JUNIOR trial was conducted with 453 children and adolescents aged between six to 17 with type 1 diabetes, who have been treated for at least a year and showed hemoglobin A1C ranging from 7.5 percent to 11.0 percent at screening. Patients were randomly assigned to either Toujeo or Gla-100 group, and administered the treatment before generic mealtimes. In the end, Toujeo reached the primary endpoint. At week 26, the Toujeo patient group against Gla-100 group demonstrated non-inferior reduction rate of A1C. Korean Diabetes Association official said, “As next generation insulin has resolved the low blood sugar level issues and significantly improved hypoglycemic effect, it would be a helpful treatment option for children and adolescents with diabetes.”
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- Celltrion, apply for European license for CT-P17
- by An, Kyung-Jin Mar 11, 2020 06:27am
- HumiraCelltrion is the first in the Humira (Adalimumab) market for its global sales of ₩20 billion. Celltrion announced on the 9th that it has completed application for Humira biosimilar 'CT-P17' to the European Medicines Agency (EMA) on the 6th (local time). Humira, the original drug of CT-P17, is the most sold blockbuster product in the global market. According to Abbvie, the original developer, the company recorded global sales of $19.17 billion last year. Humira's bio patents expired in October 2018, and it is competing with Samsung Bioepis’ Imraldi, Amgen’s Amgevita, Hyrimoz by Sandoz and Mylan·Fujifilm’s Hulio. Humira's European sales declined 31.1% last year due to the price-competitive release of biosimilars. If Celltrion is going to sell its CT-P17 in Europe one year later, it will have to overcome the limitation of generic drug. Celltrion's differentiation strategy is that CT-P17 is the first high concentration formulation of Adalimumab-based biosimilars. The patient's convenience is maximized by reducing the dose by half compared to conventional biosimilar products. Another advantage is that it eliminates citrate, which can cause pain when injecting. Celltrion is demonstrating its influence in the market of TNF-α inhibitors with its first product globally, 'Remsima'. According to IQVIA's global market research institute, 'Remsima' surpassed original products with 59% market share in the third quarter of last year. Following the recent release of the subcutaneous injection type, Remsima SC in Germany and the UK, it plans to Expand Autoimmune Disease Therapeutics Portfolio through commercialization of Humira's biosimilar 'CT-P17'. An official at the Celltrion company said that it is preparing to expand the market for TNF-α inhibitors by completing the application of CT-P17's EMA license following Remsima SC, which received EMA sales license in November last year and we will do our best for the early launch of CT-P17 which has differentiated product from the existing Humira Biosimilar.
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- Drug industry's ‘Corona Blue,’ “We miss our mundane life"
- by Chon, Seung-Hyun Mar 11, 2020 06:27am
- “Life with COVID-19” 50 days have passed since the 2019 novel coronavirus (COVID-19) started infecting Korea. COVID-19 has consumed the whole of Korea in merely 20 days after 31st patient was confirmed with infection on last Feb. 19. As of last Sunday 4 p.m., 7,313 people were confirmed with COVID-19 in Korea. As the COVID-19 outbreak has been lingering longer than expected, a new term, ‘Corona Blue,’ has emerged. Apparently, it means the symptom of feeling depressed or lethargic from COVID-19 outbreak changing the lifestyle. The outbreak also entirely changed the pharmaceutical industry workers’ lives. The commuting route has been simplified to home and office. To avoid infection, salespeople started working from home at early stage as they usually visit number of healthcare institutes. Most of office employees are also working from home or visit offices only when needed. Chats between colleagues are almost non-existent. Meetings with vendors and clients are avoided as much as possible. This is a scope into the lives of pharmaceutical industry experiencing small and big changes amid COVID-19 outbreak. ▶Sales Director of 11 years “Working from home but still restless” Director Kim working at Sales Division in a Korean pharmaceutical company starts his day from home. When the number of confirmed COVID-19 patients surpassed a thousand on Feb. 26, all salespeople were ordered to stay put and work from home. “I’m all up for not commuting…” But will they me for plummeted sales? Although working from home is convenient without the hustle and bustle of public transportation, Kim is getting anxious day by day with the company pressuring on the sales performance. He worries greatly of prescription rate dropping as he stopped visiting his clients. But then again, visiting a healthcare institute is also terrifying. If Kim contracts COVID-19 while visiting hospitals and clinics, all of them would have to close temporarily. The damage is unfathomable. His company could be reproached for not managing a salesperson properly. The company seems to be encouraging sales activity through online or social media channels, but it is not as effective. Pressured by the boss ordering him to thoroughly manage his accounts, Director Kim visits a hospital despite he is supposedly working from home. Meeting the director of hospital was easy with far less patients visiting, but the director asked him “to refrain from visiting hospital for a while with the outbreak.” ▶Veteran pharmacy salesperson Senior Director Cho ”Cannot even visit pharmacy with a long line of customers buying masks” Senior Director Cho is a veteran salesperson with 18 years of experience in pharmacy sales. He has never struggled with sales like this before. Judging that pharmacy would be less exposed to the risk of infection, Cho prefers to visit pharmacy than hospitals or clinics. And because of unique quality of pharmacy sales, he has much to handle at pharmacies. “If I line up, could I please have a chat with the pharmacist?” However, an ordinary sales activity is impossible as every pharmacy is in chaos selling masks. Cho was exhausted for a while as pharmacists requested him to get supply of masks. As pharmacists asked him not visit last month, he missed out on a month-worth of due and did not meet his target payment. It is not easy to even talk about his products lately, when the pharmacists vent their tremendous stress. Pharmacists are deeply worried about the plunging number of prescription from neighboring healthcare institutes. They are tensed up about managing customers lining up from early morning to buy masks and dealing with the complicated procedure of supplying government-issued masks. Although Cho wants to ask about the sales of a newly released product that the neighboring hospital has started prescribing, he can barely step into the pharmacy with a long line of crowd waiting outside to purchase a mask. ▶Factory workers “Contracting the virus means substantial loss to the company” Manager Ahn, in charge of production management at a pharmaceutical manufacturing factory, dreads to go to work these days. As for factory employees like himself, working from home is a distant story. If any one of the employees is confirmed with COVID-19, then all manufacturing has to be stop for disinfection while the factory is closed for days. One confirmed case in the factory could cause a massive loss for the company. Manager Ahn is always on pins and needles in case one of the employees is infected. “It could’ve been us…” His heart dropped when he heard an employee at a pharmaceutical company’s R&D facility was reportedly confirmed with COVID-19 infection. Manager Ahn checks COVID-19 infection among the employees around the clock. Some managers ask employees of who they met the day before. Infrared thermometers have been installed around the facility, and employees’ body temperatures are checked constantly. As some managers are threatening the employees to not contract COVID-19, colleagues are avoiding close encounters. It is even more depressing to hear the news of nearby kimchi stew place he frequently visited is now not serving the lunch menu. ▶Senior Manager Suh at Government Affairs Team "Bioequivalence test and overseas on-site inspection all suspended " Senior Manager Suh at Government Affairs Team of a Korean pharmaceutical company has been extremely stressed out. The company is in emergency state as a healthcare institute supposed to execute bioequivalence test for the company’s generic product has informed it would suspend all face-to-face meetings for next two weeks. “Calling MFDS is more difficult than buying a mask” To prepare for the revised drug pricing system coming in effect from July, Senior Director Suh has fully scheduled bioequivalence tests to be done before. Suh fears the unexpected break would get longer with the prolonged COVID-19 outbreak. Suh keeps on tossing and turning at night thinking about how generic drug business strategy would be affected, as well as about failing to defend the current pricing of already released generics. The senior manager is tempted to call and ask about the situation to Ministry of Health and Welfare (MOHW) and Ministry of Food and Drug Safety (MFDS), but it is not that easy with the government bodies responding to the outbreak like managing government-issued masks. Since the virus has been spreading, pharmaceutical approval procedure has slowed as well. Companies have gone the distance to sign marketing deals for Korea with overseas companies, but MFDS is hesitant to conduct overseas on-site inspection. Actually, the overall approval procedures are halted with many of foreign countries closing their doors on Korean travelers. It is now even more frustrating as the office employees have been given an order to work from home. Meeting up with vendors and teammates would unlikely to happen from now on. ▶Director Chung from Personnel "Hiring a new employee is like guerilla tactic” Director Chung from a new biopharmaceutical company’s Human Resources Team just spent a hectic week. Concerned of unwanted break in business operation from an employee contracting COVID-19, the team has proactively coming into office in rotation to minimize the infection risk. But the whole team was in a panic mode as an employee, who has recently returned from an overseas business trip, had cold-like symptoms. “First time convening a video conference…” It’s time for lunch when everyone is finally online Ordering the team members to self-quarantine has almost pulled the plug on the company’s operation. As the team never had sufficient number of employees, the team was complaining about the workload surged from covering for the self-quarantined employee. Although the team tried online video conference call but it was a sluggish process with not everyone familiar with the system. The situation worsened around Feb. 26, when the number of confirmed cases in Korea exceeded one thousand. A day before the interview session with prospective employees, the company has decided to push down the date by a week during an emergency meeting. Chung had to individually contact the interviewee and explained the situation apologetically. The situation has not gotten any better, yet. Big companies could simply postpone the recruitment, but Chung’s company is relentlessly requesting for additional employee. The director could not help it but to schedule an online video interview. And as the interview date approached, Chung is getting restless for any technical difficulties during the interview. ▶PM Lee at a global pharmaceutical company “I miss the days I went to the office” Project Manager Lee working with Marketing Division at a multinational pharmaceutical company is getting depressed growingly after working from home for about a month. Productivity seems to falter as most of the meetings are conducted through social media. And marketing activity is out of the question as various academic conferences and seminars are canceled. A regular marketing meeting convened with Korean company for the co-marketed product has been postponed indefinitely. While the first quarter of the year is already ending, the marketing team did not even get to initiate the ambitious promotional strategy targeting medical doctors and pharmacists. “I miss my mundane life at work” It feels as if the company is watching Lee, when working from home on a laptop with security program installed. And it is upsetting when the boss accuses him of not working, while he actually worked even more than usual. PM Lee is even hesitant to go out to a nearby café for a cup of coffee. Working at the office with temperature check after a crowded metro commute might feel better at this point. Is it because of the stagnating performance? The executives seem to nag more than usual. In a group chat, criticisms and orders are given ceaselessly. “Nagging might even sound better in person. I’ve never thought that I would miss the mundane life so much. Hopefully, the outbreak would be contained soon so I can go out and enjoy a nice refreshing glass of beer with my colleagues.”
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- 15 domestic pharmaceuticals, focus on 'COVID-19' treatment
- by Nho, Byung Chul Mar 11, 2020 06:27am
- Domestic pharmaceutical bio companies and government agencies are concentrating on developing COVID-19 vaccines and treatments. In response to COVID-19, opinions are urged to strengthen government support and expand public-private cooperation in order to preemptively respond to similar infectious diseases. According to the KPBMA, 15 domestic pharmaceutical bio companies are undertaking or preparing to develop COVID-19 vaccines and therapeutics. Four government agencies have also started to develop their own vaccines and treatments. In the case of preventive vaccines, the development is centered on companies that already have development capabilities such as flu vaccines such as GC Pharma or SK Bioscience. As they have the capacity to produce their own vaccines, they will be able to supply domestically if they successfully develop vaccines. However, even if the vaccine is immune to COVID-19, it will take about 1 year and 6 months to confirm the safety and effectiveness. Therefore, the vaccine should be developed in the long term. Development Status of Korean Pharmaceutical Company for COVID-19 related vaccines (Source: the KPBMA) In the case of therapeutics, development will be done by finding new candidates that can cure COVID-19, or by verifying the efficacy of COVID-19 in existing drugs. Hanmi, Celltrion, Komipharm, Immunemed, and Panafax are among the leading companies that are actively developing COVID-19 treatments. In particular, the Korea Research Institute of Chemical Technology and the Pasteur Institute of Korea are expected to find candidates for COVID-19 therapeutic drugs by analyzing the drug efficacy of 5000 drugs last month and provide them to leading doctors by early next month. Immunemed is launching a clinical trial of its own antiviral drug for the treatment of COVID-19 and is currently preparing for phase II after completing phase 1. Komipharm and Cellivery will be conducting clinical trials as candidates to suppress cytokines, an immune overexpression reaction. Development Status of Korean Pharmaceutical Company for COVID-19 related treatment (Source: the KPBMA) Public-private cooperation models are also being activated, in which domestic government agencies, research institutes, and pharmaceutical companies converge to develop vaccines and treatments. The Korea National Institute of Health has recently announced eight research projects for the development of rapid diagnostics, vaccines, and therapeutics necessary for quarantine. The Ministry of Science and ICT is conducting collaborative research with various research institutes in Korea such as Korea Research Institute of Bioscience and Biotechnology. As the development of vaccines and treatments is difficult to achieve in a short period of time, in terms of regulations and technical aspects, such public-private cooperation is expected to speed up development and increase the probability of success. The KPBMA stressed that benchmark overseas cases, such as the European Innovative Medicines Initiative (IMI) and the National Institutes of Health's AMP (New Drug Development Promotion Cooperation), should be benchmarked to accelerate the development of vaccines and treatments, and increase the possibility of development completion. The IMI is a joint venture between the European Commission and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which is one of the world's largest public-private partnerships in the field of biohealthcare. Academia, industry, patient groups, regulatory and medical technology evaluation agencies have joined together to carry out a variety of projects, and invested €45 million (approximately ₩59 billion) on COVID-19 to develop therapeutics and diagnostic products. In addition, the Coalition for Epidemic Preparedness Innovations (CEPI), an international non-profit organization for the prevention of infectious diseases and vaccine development, is supported by four governments, as well as by non-profit foundations such as the Bill Gates Foundation. Current Status of government-affiliated organization for COVID-19 related R&D (Source:the KPBMA) In Korea, public-private cooperation projects are under way, supported by the government, including ₩36.8 billion in R&D projects related to COVID-19, especially in universities and government-funded research institutes). However, it is pointed out that public-private cooperation system should be established in order to increase the effectiveness of the project, such as bold government support and research results leading to the actual product development and release. Hee-Mok Won, President of the KPBMA, said that special measures are needed to protect medicinal sovereignty, including the rapid development of vaccines and treatments in national disaster situations. Also, He added that he will overcome the crisis based on public-private cooperation supported by the government in the pharmaceutical bio industry's R & D capacity. Currently, alternative medicines used in COVID-19 include AIDS treatment Kaletra, malaria treatment Chloroquine, ebola treatment Remdesivir, swine flu treatment Avigan, antiviral (interferon) combination therapy, and hepatitis C treatment Ribavirin.
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- Next-gen flu drug Xofluxa revs up for reimbursement listing
- by Eo, Yun-Ho Mar 10, 2020 06:29am
- Next-generation flu treatment Xofluza is now seeking for National Health Insurance reimbursement. Pharmaceutical industry sources reported, Roche Korea has submitted a reimbursement listing application for Xofluza (baloxavir). Finally approved after two-decade-long reign of Tamiflu (oseltamivir), Xofluza grabbed the industry’s attention with its new mechanism of blocking endonuclease and convenient one-dose oral administration (Five-day administration for Tamiflu). Antiviral drug could always develop tolerance, and no other drug except for neuraminidase inhibitors is recommended for influenza treatment at the moment. Although Korea has the top vaccination rate in the world, approximately 2.26 million people have contracted influenza virus in 2018. As the public’s interest on antiviral agent has been heightened amid COVID-19 outbreak, the reimbursement review on Xofluza would be timely conducted. Xofluza’s approval in Korea was based on CAPSTONE-1 study on healthy patients aged 12 to 64 years who were diagnosed with symptomatic, uncomplicated influenza, and CAPSTONE-2 study on patients aged 12 and older who were at high risk of complications from the flu. The key outcomes of CAPSTONE-1 with healthy adult and adolescent patients found Xofluza’s median time to symptom alleviation was 26.5 hours shorter than placebo. Also, Xofluza showed faster virus shredding than placebo. In about 24.0 hours, Xofluza halved the viral shedding, which was significantly shorter than placebo (96.0 hours) and Tamiflu (72.0 hours). During the CAPSTONE-2 study with high-risk influenza patient groups including senior and chronic disease patients, the high-risk patient group treated with Xofluza demonstrated median symptom alleviation time of 73.2 hours, which was about 29 hours shorter than placebo group (102.3 hours). In the same study, Xofluza halved the viral shedding in 48.0 hours, improved by approximately 50 percent than placebo (96.0 hours) and oseltamivir (96.0 hours). Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”.
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- How long do pharmaceuticals have to work from home?
- by Kim, Jin-Gu Mar 10, 2020 06:28am
- More domestic pharmaceutical companies have decided to work from home to prevent the spread of COVID-19. Following Dong-A ST and GC Pharm, Chong Kun Dang joined the ranks of all employees from home. Chong Kun Dang said five days ago that it will start working from home for all employees. it will be up to the 13th. Chong Kun Dang and its affiliates do not go to the office, not only salespeople, but also internal employees, except for core employees. On that day, the entire headquarters became quiet as if it had been muted. Among major domestic pharmaceutical companies, Dong-A ST, LG Chem, and GC Pharm made a decision to work from home. In the case of Dong-A ST, the trigger was COVID-19 confirmed staff at the Yong-in R&D Center. On the 27th of last month, Dong-A ST research staff member A was confirmed and the Yong-in research center was closed. Dong-A ST decided to work from home at the head office on the next day. GC Pharm has joined the full-time workforce from the 2nd. This was a quick response to concerns over community infections, including the first confirmed person in Yongin, Gyeonggi-do, on the 23rd, and five more people confirmed by March 1. With Chong Kun Dang's joining, the decision to work from home is spreading among domestic pharmaceutical companies. A Chong Kun Dang official said, “We extended the telecommuting scope to all employees to prevent the spread of COVID-19 and protect our employees”. Most multinational pharmaceutical companies have already started telecommuting. At the end of last month, when the KPAI conducted a questionnaire, none of the 10 surveyed members went to work normally. It has been confirmed that all employees have worked from home or only those who wish to work from home. Other pharmaceutical companies that have not made a full-time telecommuting decision are responding flexibly. Only sales workers with a high risk of infection or transmission will be telecommuted or decided to work from home at the discretion of the team leader or general manager. It includes Yuhan Corporation, Daewoong pharm, Hanmi, Ildong, Jeil Pharm, Dong-Wha, Daewon, Korea United Pharm, LG Chem, Whan In Pharm, and Samil-Pharm. ◆Distributed working system' spreads instead of working from home, every other day Recently, more and more companies are doing distributed work instead of working from home. Two or three teams are organized to work from home once every two days or once every three days. Samjin Pharm has all of its sales staff working from home. In the case of in-office work, two groups are organized to distribute work days. Kolmar Korea and CJ Healthcare are similar. Internal workers have been telecommuting every other day since this week. SK Chemicals has been working in three groups and working from home on every fourth day since the 4th. The first group works at home and the other two companies. Instead, they ordered them to work in different spaces, even if they went to work. It is a compromise between normal work and telecommuting. A pharmaceutical company who introduced distributed work explained, "It is intended to reduce the inefficiency caused by all employees' telecommuting work, and to prevent large gaps in case of COVID-19 confirmed patients". ◆No choice but to determine the length of work from home based on the situation While a few pharmaceutical companies have entered the COVID-19 special action, attention is focused on 'How long will telecommuting work period?' Companies that actually decide to work from home are notified whether they are working from home on a weekly or daily basis. The complaint is currently being raised, but the company is in a difficult position to announce in advance because the situation is so urgent. A domestic company official who is working at home or working at office voluntarily said, “The decision, including the extension of telecommuting, is at the discretion of the company's senior management, which is difficult at this point and the extension will be decided based on the situation”. An official at another pharmaceutical company that has started all employees' telecommuting said, “Work from home was decided until this week. The COVID-19 situation is very urgent, and if the company goes to work normally, it is being discussed to exclude all salespeople or sales workers in Daegu-Gyeongbuk region first”. In response to this, the government announced in a regular briefing on the 5th that the number of new COVID-19 confirmed patients will gradually decrease. According to the government, the number of confirmed patients has declined to 400 at midnight on the 5th after peaking at 813 on last Feb 28. As the mass inspection of Shincheonji Believers in Daegu was completed, it is carefully judged that the biggest peak was passed. Daily COVID-19 confirmed patients status (Based on March 5, 0:00, Source: the KCDC) The government has delayed the opening of kindergartens and elementary and high school schools nationwide by Mar 23. Given this situation, it is cautious that each pharmaceutical company will resume its normal work in the second week (March 9) or third week (March 16). An official of a domestic pharmaceutical company said, “We are waiting for the government to lower the crisis alert stage from serious to boundary. However, it is not easy to continue working from home without worry. We expect to return to normal work before the 23rd, the beginning of elementary and secondary school”. A foreign pharmaceutical company official who has been working from home for about a month said that the employees who are working from home are complained of decreased work efficiency and increased fatigue, and the company is discussing a resumption next or next week.
- Company
- Verzenio pricing negotiation to overlap with Ibrance
- by Eo, Yun-Ho Mar 09, 2020 08:00am
- Ibrance and Verzenio After passing Ibrance, Health Insurance Review and Assessment Service (HIRA) continuously passed Verzenio. The newly passed drug would likely to overlap its pricing negotiation with Ibrance. Korean pharmaceutical industry source reported Lilly’s cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor Verzenio was given a green light for National Health Insurance (NHI) reimbursement from HIRA’s Drug Reimbursement Evaluation Committee (DREC). The medication is in process of settling risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). As soon as Ministry of Health and Welfare (MOHW) gives a nod, Lilly would initiate negotiation with National Health Insurance Service (NHIS) for 60 days. Pfizer’s Ibrance, already at the negotiation table with NHIS after DREC’s clearance, would overlap its negotiation period with Verzenio. And as Faslodex’ financial impact evaluation data has been submitted, the two would be competing against each other intensely. On the other hand, Cancer Deliberation Committee has cleared another competitor, Novartis’ Kisqli (ribociclib), in last January. The industry is also keen on the third CDK4/6 inhibitor’s listing process. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 clinical study. Besides for patients with early stage breast cancer, the CDK4/6 inhibitor showed consistent effect on patients with stage 4 metastatic breast cancer that affected their lungs and bones. As for Verzenio, recently completed MONARCH2 study attracted the industry’s interest as it not only improved PFS, but also improved overall survival (OS). The achievement was unprecedented for a DDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
- Company
- Tylenol leads the pain relief market
- by Kim, Jin-Gu Mar 09, 2020 07:59am
- Tyreno made the most sales in the antipyretic analgesic market last year. Tylenol 8hrs ER performed poorly due to safety controversy, but overall brand sales increased slightly as Tylenol sold more. Geworin, the second-largest product, has grown significantly in the last five years. However, the sales gap between the 1st and 2nd places is unlikely to narrow. 2018~2019 Sales Change of Major Antipyretic Analgesic Brands (Unit: ₩100 Million, Source: IQVIA) ◆Tylenol ranks first with ₩29.8 billion Tylenol 8hrs ER's sales impact was minimal. According to drug research institute IQVIA on the 5th, Janssen's Tylenol series posted sales of ₩29.8 billion last year. It is up 5.8% from 2018's ₩28.2 billion. Expanding the scope to the past five years, the increase is 7.8% from ₩27.7 billion in 2015. The change in sales of individual items is very interesting. The two flagship products, Tylenol and Tylenol 8hrs ER , are plotting opposite sales figures. First, Tylenol tablets are steadily increasing. The company recorded ₩11.7 billion in 2015, ₩12.3 billion in 2016, ₩13.1 billion in 2017, ₩14.5 billion in 2018, and ₩18.3 billion in 2019. On the other hand, Tylenol 8-hour ER is showing signs of slowing. The figure is decreasing every year, including ₩13.8 billion in 2015, ₩13.3 billion in 2016, ₩12.9 billion in 2017, ₩10.8 billion in 2018, and ₩8.5 billion in 2019. In 4 years, it has dropped 38.0%. Sales changes of Tylenol and Tylenol 8hrs ER in the last five years (Unit: ₩100 Million, Source IQVIA) This is attributed to the safety controversy of Tylenol 8 hour ER. This product has been constantly worried about liver damage caused by misuse. As a result, the Ministry of Food and Drug Safety implemented measures to strengthen safety in 2018. In the process, the Tylenol ER was renamed Tylenol 8hrs ER . In addition to Tylenol 8hrs ER, other slow-release tablets are observed to be on a similar path. Since 2015, Penzal's 8-hour ER has decreased by 19.3% and Maxibufen ER by 23.0%. ◆Geworin 25% increase over 4 years Samjin's flagship product, Geworin was followed. Geworin's revenue last year was ₩15.2 billion, up 9.7% from ₩13.8 billion in 2018. This is an increase of 25.1% compared to 2015, five years ago. However, the gap between the 1st and the 2nd places did not seem to narrow. The gap between Tylenol and Geworin remains around ₩15 billion, including ₩15.6 billion in 2015, ₩14.2 billion in 2016, ₩16 billion in 2017, ₩14.4 billion in 2018, and ₩14.7 billion in 2019. Sales changes of major antipyretic analgesic brands in recent 5 years (Unit: ₩100 Million, Source IQVIA) Third place was Hanmi’s Maxibufen. Last year, it recorded sales of ₩7.5 billion. It has been ranked third for five years in a row, but sales are on the decline. Compared with 2015 (₩8.5 billion), it decreased 11.7%. In addition to the Maxibu fen ER, the sales of Maxibufen are also on the decline. Daewoong Pharm's EZN series ranked fourth with ₩6 billion. Contrary to Maxibufen, the growth rate is steep. It is up 82.5% from last year's ₩3.3 billion. The ranking in the antipyretic analgesic market also jumped from eighth to fourth in the same period. In addition, GC Pharma's Taksen (₩5.6 billion), Ildong’s Carol (₩5.5 billion), Chong Kun Dang’s Penzal (₩5.5 billion), Ahn-gook’s Anyfen (₩5.2 billion), Samil’s Brufen, and Dong-A’s Champ were in the top ten. In addition to last year's rankings, the increase in sales over the last five years has increased for Tylenol, Geworin, EZN, Taksen, Carol, Champ, Advil, and Gnal-N. In particular, growth of Champ (246.6%), Gnal-N(91.5%), and EZN (82.5%) is noticeable. On the other hand, Maxibufen, Penzal, Anypen, Brufen, and Trisfen have generally lost sales. The reduction ranged from a minimum of 1.5% to a maximum of 61.7%.
