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- 2026-04-17 07:39:45
- Company
- 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.”
- Policy
- Court suspends execution of Forsteo price reduction
- by Kim, Jung-Ju Mar 12, 2020 06:03am
- Price reduction of Lilly Korea’s osteoporosis treatment Forsteo (teriparatide) is temporarily deferred, although it was notified earlier to be executed this month. The company has reportedly filed a lawsuit to cancel the government-authorized price reduction. On Feb. 28, Seoul Administrative Court has granted suspension of execution on the revised List of Reimbursed Drugs and Maximum Reimbursed Price (Notice number 2020-38) due to the litigation filed by the pharmaceutical company against Ministry of Health and Welfare (MOHW). The medication received reimbursement for treating osteoporosis in post-menopausal women and men with high risk of fracture. Initially, MOHW has decided to authorize pricing reduction of the drug by revising the List of Reimbursed Drugs and Maximum Reimbursed Price as of March. The ministry applies ‘Half-priced Drug’ system on generics receiving reimbursement, which lists the first generic at 53.55 percent of the original’s price but grants weighted pricing of 70 percent of the original for one year. However, if the number of companies manufacturing the same generic is three or less, the weighted pricing benefit is sustained until the fourth company lists the generic, despite a year has elapsed. The multinational pharmaceutical company filed litigation against MOHW as Forsteo was included in the government-authorized drug pricing reduction list. The osteoporosis drug was originally listed at 326,358 won per injection, but the government revised the price down to 228,451 won. As the legal proceeding has started, the court has decided to suspend the execution of pricing reduction until it makes a final decision. In other words, the original price of 326,358 won would be temporarily sustained. The suspension of the execution is to last until Aug. 24. MOHW would withhold the pricing reduction until the date, and notify any further changes made.
- Company
- 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.”
- Company
- 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.
- Company
- 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.”
- Company
- 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.
- Policy
- Ibrance & Besivo were added to the price-volume agreement
- by Lee, Hye-Kyung Mar 10, 2020 01:43pm
- Ildong’s Besivo (Besifovir dipivoxil maleate) & Pfizer Korea’s Ibrance (Palbociclib)75mg/100mg/125mg were added to the price-volume agreement negotiation monitoring of the first quarter of this year. Novartis Korea's Entresto (Sacubitril/Valsartan Sod Hydrate) 50mg/100mg/200mg & Myung In Pharm's Q pam (Levitiracetam) 500mg are also being monitored. The NHIS recently released its first-half 2020 price-volume agreement negotiation (type A and type B) drugs to be monitored. The price-volume agreement negotiation system divides the risks of health insurance finances by the NHIS and the pharmaceutical company. In the case of drugs whose usage has surged, the drug price is lowered through negotiations with the NHIS. The first quarter’s monitoring targets are 194 items in 105 pharmaceutical groups. Drugs monitored for consumption from January to March of this year are Merck’s Gonal F pen (Follitropin alfa) 20IU/45IU/75IU/90IU, Pfizer Korea’s Vyndaqel (Tafamidis meglumine) 20mg, Gilead’s Vemlidy (Tenofovir alafenamide) and Hanmi’s Olita (Olmutinib). Celgene's Revlimid (Lenalidomide), Ahn-gook pharm's Rupafin (Rupatadine fumarate), and Takeda’s Edarbi (Azilsartan medoxomI) are also subject of the price-volume agreement negotiation. The price-volume agreement negotiation type A is the case when the same product group claim with agreed billing amount increased by more than 30% from the estimated bill amount by negotiation with the NHIS, negotiation of estimated bill amount, negotiation of adjustment of drug price increase, negotiation of expansion of scope of use, etc. Type B is the case which is negotiated by type A or is for the same product group four years after the initial listing date without Type A negotiations, where the previous type A is at least 60% more than the previous year's charge or at least 10% & more than ₩5 billion every year from the day following the end of the analysis period. Meanwhile, drugs with an annual billing amount of less than ₩1.5 billion, drugs with lower upper limits than the arithmetic mean of the same ingredient, low-cost drugs, and shortage prevention drugs are excluded from the price-volume agreement negotiation system.
- Company
- 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”.
- Policy
- CSL Behring steps into hemophilia treatment market in Korea
- by Lee, Tak-Sun Mar 10, 2020 06:29am
- CSL Behring, a subsidiary of Australian-based global pharmaceutical company CSL, is to join the hemophilia treatment competition in Korea. The company acquired approval on hemophilia B treatment Idelbion injection on Mar. 5, after receiving a marketing license on Afstyla infection, a hemophilia A treatment developed based on SK Chemicals’ license-out pipeline, in last January. The approval process has handled by Zanovex Korea, an offshoot of Zuellig Pharma. CSL Behring is a global pharmaceutical company with line-ups of genetic recombinant technology-based hemophilia and rare disease treatments. As a subsidiary of Australian-based parent company CSL Limited, the global biopharmaceutical company has offices in 60 countries around the globe. Its headquarter is housed in Pennsylvania, U.S. Although the company has been active in China and Japan, it had not stepped into Korean market until its Korean office opened January last year in Gangnam Finance Center, Seoul. The Korean office is led by General Manager Sohn Ji-young, a seasoned global pharmaceutical industry expert. Graduated from Ewha Womans University College of Pharmacy, the general manager served in Pfizer Korea’s Marketing Management and Strategic Planning Unit and Roche Korea’s Oncology Business Unit after earning MBA from Korea University. The name of CSL Behring grabbed the Korean pharmaceutical industry’s attention since the deal signed with SK Chemicals. The Australian biopharmaceutical company licensed in hemophilia A treatment Afstyla, developed by the Korean company, in 2009. After winning the U.S. Food and Drug Administration’s (FDA) nod in May 2015, Afstyla was also cleared in EU in January 2017. Korea’s Ministry of Food and Drug (MFDS) also approved the treatment on Jan. 20. Hemophilia causes prolonged bleeding due to blood clotting process slowed by mutation in gene on X chromosome. Approximately one out 10,000 suffer from the condition, which is divided into either hemophilia A or B depending on the deficient blood clotting factor. Among all hemophilia patients, 80 percent is diagnosed with hemophilia A and 20 percent with hemophilia B. Sources report there about 2,000 hemophilia patients in Korea. The treatment market volume is at around 180 billion won, and the hemophilia A treatment market is led by Shire Pharma’s Advate and GC Pharma’s Greengene F. On the other hand, over 90 percent of the hemophilia B treatment market is taken up by Pfizer’s Benefix. Considering the strong competitors in the market, CSL Behring’s challenge would not be the easiest ride. However, their two items have advantage of effect lasting longer than other existing options providing improved administration convenience. Doubling the existing option’s acting time, patients could benefit from administering Afstyla by only administering two or three times a week. Most of the currently available treatments are administered three to four times a week. Advate, for instance, has to be administered three to four times a week to prevent bleeding. Administered once-weekly, Idelbion has a longer half-life than Benefix that prevents bleeding by administering once in three to four days. However, CSL Behring would have to overcome the increasing intensifying competition between long-acting hemophilia treatments with new competitors emerging to the market. Meanwhile, the original developer of the hemophilia treatment, SK Chemicals’ blood product subsidiary SK Plasma would be in charge of the marketing and sales of Afstyla in Korea.
- Policy
- Remdesivir, clinical trial at the SNUH
- by Lee, Tak-Sun Mar 10, 2020 06:29am
- Gilead's COVID-19 drug candidate, Remdesivir is conducting a clinical trial at Seoul National University Hospital. The trial is a multinational researcher-led clinical trial led by the National Institutes of Health (NIH) under the auspices of the World Health Organization. The MFDS approved Remdesivir’s multinational phase II clinical trial plan, led by Seoul National University Hospital. The trial is a multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of Remdesivir in patients with COVID-19. It is held at SNU Boramae Medical Center, Seoul National University Bundang Hospital and Seoul National University Hospital. The number of domestic subjects is known to be 100. The trial is an NIH-led researcher's clinical trial. In the United States, clinical trials are being conducted at the University of Nebraska Medical Center, and 50 countries are reported to participate in the administration of 394 patients worldwide. Meanwhile, a large commercialized clinical trial led by Gilead was approved on the 2nd in Korea. 195 patients with severe and severe COVID-19 were included. Commercialized clinical trials are conducted at Kyungpook National University Hospital, National Medical Center, and Seoul Medical Center. An official from the MFDS said, "As a matter of urgency, this trial is likely to be administered immediately after the first patient enrollment." In general, other clinical trials have been reported to take up to a week after the first patient enrollment report with MFDS.
