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- 2026-04-17 08:54:41
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- GSK-Pfizer JV launch in Korea put off indefinitely
- by An, Kyung-Jin Feb 26, 2020 06:18pm
- Pfizer Pharmaceutical Korea and GlaxoSmithKline Korea’s (GSK Korea) Consumer Healthcare Joint Venture launch schedule in Korea took a sharp turn unexpectedly. .Pharmaceutical industry source reported Korean offices of Pfizer and GSK have announced indefinite postponement of launching the consumer healthcare division joint venture .As the opening of the joint venture itself was deferred without a word, the Pfizer employees, who have requested to be transferred to GSK are now at a complete loss .Pfizer Pharmaceutical Korea’s labor union insider said, “In the afternoon of Feb .21, the Human Resources team at GSK convened a town hall meeting via video conference call for the Consumer Healthcare Division employees and informed the kick-off date has been pushed .The meeting was finished in three minutes as they explained the reason or the next schedule cannot be disclosed.” The launching of Consumer Healthcare joint venture between Pfizer and GSK Korean offshoots has been in process from 2018, when the two headquarters have signed the merger deal .As GSK owns 68 percent and Pfizer owns the rest of 32 percent share of the joint venture, GSK was supposed to buyout the entire Pfizer’s Consumer Healthcare Division employees .The headquarters’ joint venture has been established since last August and all the employees have been transferred .The Korean offices have been preparing for the same procedure of transferring business, aiming to complete by Feb .24 .As the Working Condition Agreement has been passed on Feb .20 by the employees’ vote, the transferring employees just had to submit the signed agreement .But four days before the launch, the schedule was cleared without a warning .Apparently, 90 percent of the Consumer Healthcare Division employees of Pfizer Pharmaceutical Korea have already requested either to stay at Pfizer, or to get transferred to GSK before the town hall meeting convened on Feb .21 .Regarding the issue, Pfizer Pharmaceutical Korea official commented, “It is true we could not meet the targeted schedule, but we are not at point in time to disclose details of the reason.” GSK Korea has not issued any official statement of the matter .The labor union officials say they are on to find out the reason behind GSK’s change in decision, and they plan to keep a close eye on further progress .Pfizer Pharmaceutical Korea labor union insider commented, “Employees, who have already handed in the transfer request, are now anxiously and blindly waiting for the postponed launch of the joint venture .The labor union also plans to convene a meeting with the headquarters to ask questions about the launch, and to promptly come up with a next step.”
- 8 years since launch, oral JAK inhibitors topping the market
- by Won, jong-hyuck Feb 26, 2020 06:30am
- Starting from rheumatoid arthritis to psoriatic arthritis, ulcerative colitis, atopic dermatitis and alopecia areata, oral Janus kinase (JAK) inhibitors expanding indications are heating up the prescription competition among themselves. For decades, autoimmune disease area was covered by biological medicines (injection) like tumor necrosis factor alpha (TNF alpha) and interleukin (IL). But lately, the prescription competition has been intensified as oral JAK inhibitors were introduced to the market and tendency of prescription is shifting from injection to oral medication. An oral option of JAK inhibitor with benefit of convenience, was first introduced to the Korean market with Pfizer’s first-in-class Xeljanz (tofacitinib). Later, Lily’s Olumiant (baricitinib) and Astellas Pharma’s Smyraf (peficitinib) have received reimbursement, recently. Other new follow-on medications, such as AbbVie’s Rinvoq (upadacitinib), Gilead’s filgotinib and Pfizer’s atopic dermatitis-specific JAK inhibitor 'PF-04965842 (local administration)' are waiting for the authority’s green light. In fact, oral JAK inhibitor is continuing to grow in prescription volume as its market’s competition has gotten saturated. By expanding indication from treating rheumatoid arthritis to psoriatic arthritis and ulcerative colitis, the medication has globally generated USD 1.77 billion (approximately 2.15 trillion won). The first-in-class medication, Pfizer’s Xeljanz has almost doubled the revenue in the global market as it steadily expanded indication and pushed up the treatment line. Initially limited to treat early stage patients, the expanded indication of JAK inhibitors could have been a significant influence to the growth. Likewise in the Korean market, Xeljanz has attracted new patients, who felt burdened of injection, by expanding indication and enabling prescription on the same treatment level as other biological medicine. This meant the trend in prescription has shifted. And the oral JAK inhibitor’s indication expansion has been notable. First approved as rheumatoid arthritis treatment in Korea in 2014, Xeljanz was green lit to treat ulcerative colitis and psoriatic arthritis with 5 mg tablet in September of 2018. It was first time a JAK inhibitor in 5 mg dose was indicated to treat those diseases. American College of Gastroenterology’s (ACG) ulcerative colitis clinical treatment guideline that has been showing major changes from 2010, also favored oral JAK inhibitor as recommendation. The updated list of recommended biological medicines included TNF inhibitors Remicade (infliximab) and Humira (adalimumab), both used for over a decade, but also the list highlighted anti-integrin medication vedolizumab (trade name: Kynteles) and JAK inhibitor Xeljanz for patients showing no response with TNF alpha inhibiting therapy. The fact that ACG guideline ‘strongly recommends’ JAK inhibitor Xeljanz for treating patients with severe and active ulcerative colitis as first-line treatment and for patients who have failed from TNF inhibitor therapy, means the Xeljanz has more prescription market to grow into. Professor Choi Chang Hwan of Chung-ang University College of Medicine evaluated, “Although biological medicine induce great initial response, injection could be inconvenient and protein drug could develop an antibody and tolerance, and lose treatment response.” The professor added, “Orally administered Xeljanz is convenient and theoretically the treatment response would be maintained.” Expanding indication from ulcerative colitis to atopic dermatitis and psoriatic arthritis Lily’s Olumiant, considered as Xeljanz’ competitor, is also worth a look. Following after Xeljanz, Olumiant has received reimbursement and is now speeding up on expanding other various indications. Differentiating from Xeljanz, the follow-on drug chose atopic dermatitis treatment market with vast amount of patients. Olumiant is considered second to win the indication to treat rheumatoid arthritis after the first-in-class, Xeljanz. But that is why its indication expansion calls for attention. Most of JAK inhibitors in same class have ongoing clinical trial on atopic dermatitis like Olumiant has, so prescription competition in the market would be unavoidable. Besides, Olumiant has initiated a transnational clinical trial 'BRAVE-AA1’ since last March to confirm its efficacy in treating severe case of alopecia areata. The Phase 2/3 transnational clinical trial is ongoing, targeting to treat 725 participants from 11 major university hospitals including Seoul National University Hospital, Gangdong Kyung Hee University Hospital, and Catholic University of Korea St. Paul’s Hospital. Moreover, AbbVie’s Rinvoq and Astellas Pharma’s JAK inhibitor Smyraf are also busy applying for approval. Rinvoq was indicated to treat severe rheumatoid arthritis by the U.S. Food and Drug Administration (FDA) in last August, and it started seeking for approval around the world, whereas Smyraf has been launched in Korea in last January. On last Jan 23, Smyraf jumped into the once-daily oral administration market. The company aims to treat patients not responding to disease-modifying antirheumatic drugs (DMARDs). Although oral JAK inhibitors are late in the game, their companies are assertively expanding indication to treat other immune disease. Pfizer is also in process of conducting a clinical trial on atopic dermatitis. The global company was fast to start Phase 3 trial for another JAK inhibitor 'PF-0496584' that received Breakthrough Therapy designation by the U.S. FDA. Also, Gilead’s filgotinib and AbbVie’s Rinvoq, not yet commercialized, have already started clinical studies simultaneously to expand indication later. Rinvoq has even unveiled Phase 3 clinical study treating atopic dermatitis, and received Breakthrough Therapy designation from FDA. First targeting Crohn’s disease and ulcerative colitis, Gilead is in process of running a clinical program. After receiving FDA’s approval in last August, Rinvoq has presented second Phase 3 study on treating psoriatic arthritis, 'SELECT-PsA 1 and 2’ in the beginning of the year, and demonstrated efficacy in treating patients with severely active psoriatic arthritis. The key finding in the study was that the patient group had not been treated with biological medicine before. Based on the result, Rinvoq could compete against Xeljanz, Olumiant, and even psoriatic arthritis-treating IL-17A inhibitor Cosentyx (secukinumab) and Taltz (ixekizumab) Endless adverse reaction issues, what should be done? Regardless of settling into the market, many of the oral JAK inhibitors are also faced with challenges. The issue constantly raised since the beginning of the marketing is risk in blood clots in lung when treated with high dose. The U.S. and European health regulators have issued a warning in last July about increased risk of developing pulmonary embolism (PE) when using high-dose of 10 mg formulation. Based on the post-marketing surveillance result, the health regulator has decided to insert Black Box Warning on Xeljanz and Xeljanz XR items’ label explaining the medication’s risk of PE and death. The warning is applicable for XR formulation for patients taking 10 mg high-dose tablets twice-daily to treat ulcerative colitis, not rheumatoid arthritis. Similar risk was also found in Olumiant as well. As high dose of the medication has raised blood clot issue, only the low dose of Olumiant has been approved partially to market. While preparing for launch, Gilead’s filgotinib and AbbVie’s Rinvoq have noticed the issue. Filgotinib has attracted the industry’s attention as it received approval in shortest time last year, but its approval application procedure has been hindered as its safety confirmation data submission has been delayed. The long-term analysis result unveiled last year did not find abnormal signs of severe infectious disease or blood clot. The medication’s safety profile has been confirmed by outcomes of 24 week-long Phase 3 FINCH 1, 2 and 3 and DARWIN 3 (Phase 2b), and now it is expected to expedite the global market approval review process. In this month, AbbVie’s Rinvoq has disclosed the outcomes of late-stage clinical study on efficacy in treating psoriatic arthritis. The researchers analyzed ongoing Stage 3 Select-PsA 2 trial’s data and found the Rinvoq patient group had improved joint pain and edema more than the placebo group. Also, the patients have experienced improved daily-life body function, such as putting clothes on or having a meal. Treated for 16 weeks, patients did not report any adverse reaction like PE. The company announced its plan to request for approval based on psoriatic arthritis indication.
- Company
- Sales activities messed up by COVID-19 crisis
- by Chon, Seung-Hyun Feb 26, 2020 06:29am
- Pharmaceutical companies have already been struggling with earnings this year. Concerned about COVID-19 infection, people are reluctant to visit medical institutions, and their business activities for medical staff are virtually suspended. According to UBIST on the 25th, the total outpatient prescription amount last month was ￦1.25 trillion, down 4.4% from the same period last year. It was 4.6% lower than last month. The January prescription amount is unusual compared to the annual increase of more than 5%. Last year's prescriptions increased 8.5% compared to January 2018. In January 2018, prescriptions were up 18.2% year-on-year. In 2016 and January 2017, prescription amounts increased 5.4% and 7.6%, respectively. Monthly outpatient prescription amount (Unit: ￦100 million, Source: UBIST) Decrease in prescriptions in this January, the decrease in the number of business days due to the Lunar New Year holiday, which came earlier than usual, may have had some effect. However, the analysis predominates that COVID-19 may have been the biggest factor in reducing prescriptions. After the first COVID-19 confirmed in Korea last 20th, the alert for new infectious diseases has increased in earnest. Since then, patients have been reluctant to visit medical institutions. Indeed, prescriptions amount for major drugs sold heavily through outpatient prescriptions declined. Pfizer's Lipitor, ranked No.1 in prescriptions, fell 10.6% YoY to ￦15.5 billion. Daewoong Bio's brain function improver 'Gliatami' decreased 6.1%. Over the past month, prescriptions for large-sized medicines, such as Twynsta, Plavix, Crestor, Viread, Exforge and Amosartan showed a steady decline compared to the previous year. The outpatient prescription amount of AstraZeneca's anti-cancer drug Tagriso increased by 45.7% over the past month. Presumably, this is because the proportion of patients who were taken at home while avoiding hospitalization increased. Pharmaceutical companies are worried that earnings will be sluggish this month. The situation has worsened since the sudden increase in COVID-19 confirmers since the 19th. COVID-19 spread rapidly in Daegu, Gyeongbuk, and more than 900 confirmed as of 25th. On the 23rd, the government upgraded the COVID-19 crisis alert to the highest level of 'serious'. The government issued a serious step only 11 years after the swine flu crisis in 2009. Patients with mild illnesses, except those with severe or chronic illnesses, are reluctant to visit medical institutions because they are concerned about infection with COVID-19. The drop in the number of patients leads to a decline in drug sales. Pharmaceutical companies' sales activities are actually “open without any business”. At the end of last month, telecommuting of sales staff, which was adopted by multinational pharmaceutical companies, is spreading. Hanmi Pharm, LG Chem, GC Pharma, CJ Healthcare, Dong-A ST, and Dong-wha Pharm have banned sales people from visiting medical institutions. One medical institution restricted access to pharmaceutical salespersons. This is because sales people may be exposed to the risk of infection with COVID-19 due to frequent visits to medical institutions. There are also concerns that salespeople can be a powerful carrier if they are infected with COVID-19. If there are confirmed patients among pharmaceutical salespeople, the company can not avoid blaming for spreading COVID-19. While allowing salespersons to visit medical institutions, criticism may have been made that they exposed the risk of infection to COVID-19 and caused damage to medical institutions. The Korean Medical Practitioners Association also sent an official letter to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association on the 20th requesting that sales representatives refrain from visiting. Promotional events such as product briefings are also being canceled. An official of a pharmaceutical company said, “We are forced to cancel a pre-scheduled meeting or briefing session for physicians and pharmacists because of concerns about the infection of COVID-19”. In fact, face-to-face sales activities have ceased. Some pharmaceutical companies expect to benefit from masks and some over-the-counter drugs with COVID-19, but most of them are concerned about sales impact because their major businesses are Prescription drugs. Disruption of business activities is inevitable for domestic pharmaceutical companies that are highly dependent on generics. Sales of generic drugs with the same product power depend on their sales force. Innovative new drugs with no alternative drugs or new drugs without generics are unlikely to hurt sales. For pharmaceutical companies, they suffered from poor performance in the fourth quarter of last year due to an impurity issue. The Ministry of Food and Drug Safety banned the sale of all anti-ulcer drug Ranitidine at the end of last September. The market exit was virtually determined for the detection of carcinogen N-nitrosodimethylamine (NDMA) excess. Pharmaceutical companies with ranitidine-based products suffered significant losses from sales bans, recalls, and disposals. GC Pharm, Jeil Pharm, JW Pharma, and Ildong Pharmaceutical recorded losses in the fourth quarter of last year. An official of a pharmaceutical company said, “The spread of COVID-19 has effectively stopped sales activities, and it is inevitable that there will be a considerable impact on performance, and in order to minimize prescription drug sales gap, there is a lot of concern in preparing effective marketing strategies in addition to traditional sales activities”.
- Policy
- National Assembly also shocked by COVID-19
- by Lee, Jeong-Hwan Feb 26, 2020 06:29am
- Parliament and politicians were also shocked by COVID-19. Recently, the plenary session was urgently canceled as the delegation of the debate held at the congress hall in the parliament building was confirmed by COVID-19, and a 24 hour closure measure was established for defense. Representative Jae-cheol Shim and a member Jeon Hee-kyung, who were known to have contacted COVID-19 infected patients, also moved to the hospital for COVID-19 test. On the 24th, the National Assembly decided to conduct full-scale protection of the National Assembly and members of the House of Representatives in order to respond to COVID-19 crisis. The two buildings will begin quarantine at 6 pm on the day and will be temporarily closed for 24 hours. As a result, the plenary session scheduled for 25th was automatically canceled. The main building and the House of Representatives decided to open again on Wednesday 26th at 9 am. A spokesman for the National Assembly, Min-soo Han, held an emergency briefing at the National Assembly's controversial hall, explaining that "attendees at the event turned out to be COVID-19 confirmers and conduct full-scale protection of the parliament hall and main building". The measures are in accordance with Article 47 of the Act on the Prevention and Management of Infectious Diseases. It is a provision that allows necessary measures such as temporary closure and disinfection of sites where they are considered to be contaminated with infectious disease pathogens. The background of the National Assembly's entry into the sphere of influence of COVID-19 was that Yoon-su Ha, chairman of the Korean Federation of Teachers' Associations, was confirmed in a few days after a debate held in the House of Representatives. Charman Ha and his wife were both confirmed COVID-19, and it was reported that Jae-cheol Shim, representative of United Future Party and Hee-kyung Chun, a member sat next to them during the debate. The United Future Party urgently canceled the general assembly, which was scheduled for the 24th, and the plenary session, which was scheduled to be held at 2:00 pm, and the government questions in politics, diplomacy, reunification and security. It was the result of the Democratic Party's proposal to postpone after hearing about the infection news, which the Unification Party accepted. As expected, the ruling party was expected to handle the agenda at the plenary session, including electing the National Assembly's permanent chairman (chairman of information and chairman of the education), handling appointing candidates for the Supreme Court Justice Tae-ak Roh, electing a member of the National Rights Commissioner, and organizing the National Assembly COVID-19 special committee. Subsequent questions were scheduled in the fields of politics, diplomacy, and unification security.
- Company
- Cenobamate, received the grand prize for KNDA
- by Lee, Seok-Jun Feb 26, 2020 06:29am
- SK Biopharmaceuticals announced on the 24th that a new epilepsy drug, Cenobamate (USA Product Name: Xcopri), was selected as the grand prize for Korea New Drug Award (KNDA). This year's 21st KNDA is the only award in the domestic and international pharmaceutical biohealth industry new drug development sector, sponsored by the private sector and supported by the government (the Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Trade, Industry and Energy ). The Korea Drug Research Association was established in 1999. According to SK Biopharmaceuticals, Cenobamate is the First-in-class drug approved by the US FDA for the treatment of partial seizures in adults. FDA approval was based on two randomized, double-blind, placebo-controlled trials and large-scale, multi-center open-label safety trials in patients who were taking 1~3 epilepsy medications and did not stop partial seizures. Cenobamate recorded statistically significant 'seizure reduction rate' and 'complete seizure loss rate'. Complete seizure loss means that the seizure does not occur during the medication period and the patient's routine returns to normal. SK Biopharm independently conducted the entire process from the discovery of pipeline drugs to clinical development, application for marketing authorization (NDA). Cenobamate is the first domestic drug that has been developed independently without technology exports and has been approved for marketing by the US FDA. US sales are expected in the second quarter. SK Life Sciences, a US subsidiary of SK Biopharm, will directly launch the marketing and sales of Xcopri.
- Policy
- Only 6% of domestic medical staff received the vaccines
- by Lee, In-Bok Feb 25, 2020 06:12am
- A large number of university hospital staff in Korea are treating patients without even receiving a preventive vaccine recommended for medical workers. Even 93.5% of administrators for Hospital Infection did not have all the recommended vaccines. As most of the reasons for the difficulty in vaccinating are the cost burden, the government needs financial support. #The Korean Society Healthcare-associated Infection Control & Prevention (KOSHIC) conducted a large-scale national investigation of vaccinations among infection managers and healthcare personnel at member hospitals and published the results in the Journal of korean medical science on the 24th (doi.org/10.3346). /jkms.2020.35.e76). Since May 2018, researchers have surveyed vaccination status in a self-administered questionnaire in 652 member hospitals, of which 200 responded to specific surveys. The questionnaire includes the designation of an administrators for Hospital Infection, a hospital-level immunization policy, and the recommended immunization. The recommended vaccinations included influenza, MMR (measles, mumps, and rubela), TDAP (tetanus, diphtheria, pertussis mixed vaccines), and hepatitis vaccines, jointly recommended by the KCDC and the KSID. As a result, 172 hospitals (86%) have a vaccination policy, and there is an infection control room and medical staff to plan this. Of the 200 hospitals, 151 (75.5%) said they had a screening program for at least one antibody before recruitment. The most common screening program was hepatitis B, which was conducted at 74 % of hospitals before recruitment, with rubella (19%), measles (18%) and mumps (17%). However, less than 6% of the hepatitis A infections were tested beforehand. #196 (98%) hospitals were given vaccination against at least one vaccine related to the recommended vaccination. The most common is influenza vaccine, with 97.5% being inoculated, followed by hepatitis B vaccine with 69%. However, only 24.5% of MMR vaccines were vaccinated, 18.5% had chickenpox, and 11% had TDAP. Only 6.5% of hospitals included all five vaccines recommended by the KCDC and the KSID. 93.5% of hospitals have only one or two vaccines. As a result, as of 2017, 43 cases of medical staff were exposed to infectious diseases. Chicken pox was the most common (15 cases) and hepatitis B (11 cases). As such, each hospital was passive in vaccination because of the cost. When asked what was the biggest obstacle to implementing the recommended vaccination policy, 77% said it was due to financial burden. In addition, 21% of the respondents said that the awareness of vaccination was less than expected, and 21% of hospitals said they were due to the absence of vaccination campaigns. #In fact, the influenza vaccine, for example, the more the number of beds tended to increase the inoculation rate. As for the percentage of free vaccination projects, more than 700 beds recorded 100%, but 500 ~ 699 beds were 81.3%, 200 ~ 499 beds were 77%, and less than 200 beds were 72.1%. Sung-ran Kim, a professor of infectious medicine at Kyunghee University Hospital, who conducted the study, said, “The exposure to infectious diseases in hospitals is a serious problem that can lead to paralysis of hospital function. It is a big threat to the situation". Professor Kim said, “The biggest obstacle to the recommended immunization policy was the hospital's financial burden,and this means there is a limit to lowering these barriers without financial support from the government".
- Company
- COVID-19 delays Cancer Deliberation Committee review
- by Eo, Yun-Ho Feb 25, 2020 06:12am
- The 2019 novel coronavirus, COVID-19, is even affecting pharmaceutical reimbursement listing procedure. According to pharmaceutical industry source, the Korean health authority has canceled the Cancer Treatment Deliberation Committee’s meeting initially scheduled on Feb. 26. Pharmaceutical companies that have been waiting for the deliberation outcome are at a loss. The February’s review agenda had star anticancer treatments like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s Opdivo (nivolumab). Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso has an ongoing deliberation over expanding its reimbursed indication to cover a first-line treatment for EGFR-mutated non-small cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication of second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Due to the canceled meeting, the listing procedure would get delayed as well. The government means to decide whether to reschedule it in March or to review the agenda in the next regular meeting in six weeks, depending on the COVID-19 outbreak status. A global pharmaceutical company insider commented, “We think it was an inevitalbe call made due to the state of emergency. However, it is regrettable that patients in need for the treatment would have to wait longer with delayed listing approval.” A few pharmaceutical companies, on the other hand, gained some time with the delayed schedule. MSD with PD-1 inhibitor Keytruda (pembrolizumab) is the case. Keytruda was anticipating for the committee to deliberate reimbursement feasibility of its expanded indication in February. The company’s application included the indication as first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also two new indications of first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel were included as well. However, the government did not include Keytruda’s expanded reimbursement review on the February agenda. Details of the reason were not disclosed, but now that the meeting schedule is pushed, MSD has a chance to appeal Keytruda’s need for reimbursement and financial impact before the rescheduled meeting. Moreover, the Cancer Deliberation Committee was expected to review Ipsen’s Cabometyx (cabozantinib) in the February meeting as well. After receiving reimbursement as a second-line treatment for advanced renal cell carcinoma, Cabometyx aims to receive more reimbursement on its liver cancer indication. Cabometyx could be a second-line treatment option for the indication covered by Eisai’s Lenvima (levatinib).
- Company
- Prescription guidance and label change for Xeljanz on UC
- by Nho, Byung Chul Feb 25, 2020 06:11am
- The Korean health authority is predicted to narrow down the use of Pfizer’s treatment for patients with ulcerative colitis, Xeljanz (tofacitinib citrate) soon. Ministry of Food and Drug Safety (MFDS) is expected to conclude its decision on pharmaceutical safety and revising related indication of Xeljanz, as discussed in-depth with Pfizer Korea over last year. MFDS could not disclose details of the revised indication, but the ministry would highly likely to follow decisions by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). In last July, the U.S. FDA has pushed down the treatment line of Xeljanz from first-line treatment for ulcerative colitis to second-line treatment. After negotiating with FDA, the U.S. headquarter of Pfizer has inserted Black Box Warning in its labeling, and changed its indication for treating ulcerative colitis. With the change in the U.S., now Xeljanz is reserved to treat patients with ulcerative colitis, who have failed or do not tolerate conventional therapy, or tumor necrosis factor (TNF) blockers. In last November, EMA has recommended that 10 mg high-dose of Xeljanz should not be prescribed to all patients at high risk of blood clots in lung, including individuals taking hormonal contraceptives or hormone replacement therapy or scheduled to have a major surgery, unless there is no other option. The European authority has recommended patients with high risk of blood clots, who absolutely need high-dose of treatment for ulcerative colitis, should avoid Xeljanz but use other alternative option. After reviewing interim data from ongoing safety clinical trial of Xeljanz and TNF blocker-class Humira and Remicade, the U.S. and European health authorities have made the decisions. According to the interim data, 19 cases of blood clots in the lung out of 3,884 patient-years of patients administered with Xeljanz demonstrated a meaningful difference compared to three cases out of 3,982 patient-years in patients administered with TNF blockers. Xeljanz is indicated to treat patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. 5 mg dose is administered twice-daily for rheumatoid arthritis, and for ulcerative colitis, 10 mg is administered twice-daily for eight weeks and continue the process with either 5 mg or 10 mg of Xeljanz twice-daily depending on treatment response. Ministry of Health, Labour and Welfare of Japan has also added venuous thromboelism as a ‘serious adverse reactions’ on Xeljanz’ label in last August. The ministry recommended medical professionals to consider other alternative when prescribing the drug on patients with high risk of cardiovascular events.
- Company
- Fresenius labor union conflict with management intensifies
- by An, Kyung-Jin Feb 25, 2020 06:11am
- The conflict between labor union and the management of Fresenius Medical Care (FMC) has emerged as the union intensified the fight against the management, who has been uncooperative in paying employees over 14 months and inking an agreement. Korea Democratic Pharmaceutical Union’s FMC Chapter has co-convened a press conference with UNI-Global Union on Feb. 21 at a National Assembly conference hall and denounced the company’s violation of Labor Standards Act. Headquarters in Bad Homburg, Germany, Fresenius is a large healthcare company earning EUR 30 billion annually from 100 countries around the globe. The company has 290,000 employees at the moment. Fresenius Kabi Korea, mainly supplying nutritional supplements in Korea, and Fresenius Medical Care, providing kidney dialyzer, dialysate, and dialysis service, are two business branches in Korea. The FMC Korea Chapter was founded in November, 2018, as a part of Korea Democratic Pharmaceutical Union, consisting of Korean pharmaceutical industry employees. Currently, 140 employees of FMC Korea are part of the chapter. Banners denouncing FMC violating the Labor Standards Act are hung in front of FMC Korea office located in Gangnam-gu, Seoul UNI-Global Union claimed, despite high-income structure of FMC, the company has not paid the Korean employees for their overtime and paid-vacation. And even after two years since the labor union was founded, the company has been refusing to discuss basics like recognition of labor union and time-off for the union staff, and deliberately delaying the negotiation procedure. UNI-Global Union official urged, “We have been reported by the Korean employees at FMC that the company has not responded to their request to negotiate with disrespectful attitude. We have confirmed that the management is persisting on basic rules in negotiating various benefits, such as the labor union’s participation in Penalty Committee, and overtime, night-work and paid-vacation payment.” The official added, “Not only has the management violated basic positive law, like providing a labor union office space and time-off for the union staff, but also it tried to minimize the membership of the union. Such deeds of gravely violating labor rights are unforgivable.” According to the provided statement, FMC labor union has conducted 20 sessions of negotiation with the management over 14 months, but the talk fell through on Feb. 6. On Feb. 10, the union has requested National Labor Relations Commission Seoul Office for arbitration. The first session was convened on Feb. 18, but no progress has been made. In last May, the company’s malpractice was reported to Ministry of Employment and Labor, which indicted the company for violating the related law and transferred the case to prosecutors. The FMC labor union plans to initiate strike against the management if it fails reach the middle ground at the second arbitration session scheduled on Mar. 2. Already 97 percent of 140 members have agreed to join the fight. Kim Gyu-nam, the FMC Chapter Head of Korea Democratic Pharmaceutical Union, reproached the company that “A German company with advanced labor relations culture has been ignoring an enforced labor law in Korea and refusing to recognize the labor relations. Over 70 employees are suffering from 30,000 hours of overtime every year. In payment, it would be worth around 600 million won.” Kim argued the management has never acknowledged the existence of the labor union by ignoring the duty of the labor union head, limiting labor union membership, and enforcing Early Retirement Plan (ERP) on employees working over 15 years. These are direct violation of Article 56 of the Labor Standard Act. Prior to Fresenius stockholders’ general meeting scheduled in coming May, UNI-Global Union forewarned of globally voicing the malpractice of Fresenius management at a forum co-organized by UNI, PSI, and IndustriALL. The forum would denounce the suspected tax avoidance of Fresenius executives and urge them to honor the labor rights. UNI-Global Union is the world’s biggest labor union, specifically protecting office workers in finance, mass media, IT, commerce, media and entertainment, postal service, sports and game industry. It represents 15 million members from over a thousand labor unions in 120 countries. Regarding the talks between the management and the union, the German company official was unable to provide detailed comments. FMC official said, “The management has continued to engage with the labor union to find the best means for everyone in past one year. And we have reached agreement on some of the topics. We respect their establishment and activity of the union, according to the Korean law. The company would continue to strive for consolidating advanced labor relations and to settle one an agreement.”
- Company
- Pneumonia vaccine & immune booster sales surged
- by Kim, Jin-Gu Feb 25, 2020 06:11am
- COVID-19 outbreak lasted for one month, and sales of pneumococcal vaccines and immune boosters also increased. Prevenar 13According to the industry on the 20th, Pfizer's pneumococcal vaccine, Prevenar 13, Prevena 13 sales soared during COVID-19 outbreak. According to Chong Kun Dang, which is currently in charge of domestic sales of Prevenar, Prevena 13 sales soared since February, when the COVID-19 crisis began in earnest in Korea. An official from Chong Kun Dang said, "There is no accurate statistics, but the sales volume so far has increased by 50% compared to last month. By the end of this month, it is expected to grow 900% from last year". "Vaccinations are usually the highest in October-December because of the nature of vaccines, and it is currently observed that sales volume is at the level of November-December", he said. In some regions, there are also concerns about out of stock. An official of Pfizer Pharmaceuticals, a manufacturer, said, "We understand that the sales volume has increased, and we’ll our best to supply smoothly". Chong Kun Dang has been in charge of domestic distribution of prevenar for adults since December 2017. Previously, Yuhan Corporation was in charge of distribution. Prevenar is the top seller in the global pneumococcal vaccine market. In Korea, the company records annual sales of ￦30 billion. Prevenar has not been shown to be effective in preventing pneumonia caused by COVID-19. Prevenar, a pneumococcal vaccine, is literally a vaccine against pneumococcal infection. Pneumococci are one of the leading causes of pneumonia, accounting for 27-44% of the causes of pneumonia. The causative organism is different from COVID-19, and in principle it is impossible to prevent it. However, some experts recommend that inoculation of pneumococcal vaccines may help relieve symptoms. Although pneumonia caused by COVID-19 cannot be prevented, it helps to pass through only the mild symptoms of pneumonia. Aronamin productsIn addition to Prevenar, sales of immunity-related products also surged. It is a vitamin B·C product. Ildong Pharmaceutical's Aronamin product is a typical example. Ildong Pharmaceutical official said, "As we know, the sales volume of the aronamine product has increased by 40~50% compared to in January". In addition, Daewoong's 'Impactamine' and Chong Kun Dang's 'Benfobel' are reported to have increased in February. It is analyzed that it is influence of COVID-19 outbreak. Although it is not a vitamin product, Echinaforce, a respiratory immune enhancer of Hanwha Pharm, suffered a temporary out of stock situation early in the outbreak. According to Hanwha Pharmaceutical, the supply of this product was resumed on the 20th. An official of Hanwha Pharm said, "COVID-19 is showing signs of spreading, which is unexpected, leading to inquiries about products, and we did our best to supply urgently". Echinaforce is mainly derived from the raw material Echinacea. Hanwha Pharm explained that it could help to boost antiviral, anti-inflammatory and immunity.
