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- 2026-05-20 21:57:56
- Company
- GSK and Pfizer intensify treatment conflicts after merger
- by An, Kyung-Jin Feb 18, 2020 06:34am
- There is a friction over the integration process of Pfizer Korea and GlaxoSmithKline's Consumer Health Division. Pfizer Pharmaceutical's union raises suspicions that GSK will endorse unfair changes in working conditions in the process of employee succession. There are ten days left to launch an integrated corporation, and a possibility that variables may arise during the merger process if employees refuse to transfer largely. According to the related industry on the 14th, Pfizer Korea’s labor union had an emergency meeting with about 50 employees of Consumer Health Division in the afternoon. The intent is to seek a response to GSK's notification that Pfizer's Consumer Health Division employees must submit a written consent by this coming 17th to agree to transfer to GSK on the condition that they agree to change the disadvantage of working conditions. Pfizer and GSK Korea have been pursuing related procedures since the merger with Consumer Healthcare in 2018. As GSK establishes a joint venture with 68% of the joint venture and Pfizer's remaining 32%, GSK is committed to 100% succession of Pfizer employees. The organization of the headquarters has already completed the establishment of a joint venture and transfer of its employees in August last year, and GSK & Pfizer Consumer Health Korea is expected to launch a corporation on the 24th as the related procedure has reached its final stage. The problem arises from the fact that labor negotiations over working conditions have not progressed even though the date of incorporation is approached ten days in advance. Pfizer's union argues that GSK, the owner of the negotiating bargaining agreement, has asked Pfizer employees to change their working conditions to be 100% identical to GSK, and the gap has not narrowed. It is pointed out that the employee's options were limited because the company insisted employees should approve changes of disadvantages in working conditions if employees want to transfer with GSK for more than two months since last December On the 10th, Pfizer's labor union, Pfizer's human resources officers and GSK's human resources officers agreed that even if employees want to transfer, whether they agree to changes of disadvantages in working conditions are left to the opinion of individuals. But, they took back their words in four hours. It also uncovered that employees of Pfizer Pharmaceutical Consumer Business Division of Korea had to submit an agreement by e-mail by the 17th that they would agree to change the disadvantage of working conditions and change the retirement pension system if they want to transfer work. Yun-gyu Park, the chairman of Korea Pfizer labor union, said, “It is a serious offense to allow GSK transfers under the conditions of work conditions and retirement pension, and employees who were unilaterally notified by e-mail are not able to get out of shock”. Pfizer Korea's HR team tipped off that GSK had an attitude problem and raised objections to the headquarters. According to Park, most employees complain about the wide difference in working conditions such as benefits and ranks. For example, Pfizer has six ranks and GSK has three levels. According to the GSK standard, even if there are paid health leave, sick leave and other leave, medical expenses support, and retirement pension system, the company must bear a considerable disadvantage. Apart from the difference in the basic labor system, he also pointed out that the entire agreement contained many poisonous clauses. It was also predicted that confusion would be inevitable if the majority of the 53 members of the Consumer Health team refused to do so. It is pointed out that the launch of an integrated corporation may have a problem. The two companies have not disclosed their official position. Pfizer and GSK officials said, "There is currently no formal issue that can be revealed, except that the two companies are in the process of merging the consumer healthcare business".
- Company
- Belviq was withdrawn voluntarily by Ildong
- by Chon, Seung-Hyun Feb 18, 2020 06:34am
- Ildong Pharmaceuticals voluntarily discontinued the sale of its obesity drug, Belviq. In the United States, it was advised to withdrawal of permission because of the risk of developing cancer, and it has preemptively discontinued sales in Korea. According to the industry on the 14th, Ildong Pharmaceutical decided to stop selling Belviq in Korea. Ildong Pharmaceutical said, “The FDA recommended discontinuing sales in the US because of the increased incidence of cancer,and we are proactively discontinuing Belviq's sales and are discussing with MFDS for further actions”. In this regard, the US FDA recommended Belviq’s withdrawal. Due to the increased risk of developing cancer, and has asked Belgian developer Belviq’s developer, Eisai to withdraw of the market. The FDA said last month that the results of Belviq's safety assessment trials indicate a new increased risk of cancer during the trial. In a clinical trial involving 12,000 patients in a five-year trial to evaluate heart-related problems by Eisai, patients taking Lorcaserin(generic for Belviq) were more likely to be diagnosed with cancer than those taking placebo. .In Korea, the official position of the Food and Drug Administration has not been determined in relation to Belviq's sale or discontinuation of prescriptions .Although the MFDS has not decided, Ildong plans to discontinue its sales and follow up with safety verification .Belviq was the drug that had been expected to be a safe obesity drug since its introduction to the market .Belviq, which was domestically licensed in February 2015, is a new drug approved for weight control by the FDA in 13 years .Belviq is a drug that selectively acts on the serotonin receptor, a neurotransmitter that regulates appetite and emotions, suppressing appetite and improving satiety .According to drug research institution IQVIA, Belviq ranked No.1 in obesity treatments with 2018 sales of ₩9.8 billion in Korea .After the emergence of Saxenda in the second quarter of 2018, it was handed over to the top spot for obesity treatment, but it was still regarded as a highly preferred obesity treatment .Cumulative sales for the third quarter of last year stood at ₩6.6 billion .However, the sale was put into the worst crisis due to this withdrawal .Ildong Pharmaceuticals official said, “We will implement further measures as soon as consultation with MFDS is completed, and will faithfully do all measures with the patient's health first”.
- Policy
- The MFDS collects 900 Metformins & tests for carcinogens
- by Lee, Tak-Sun Feb 17, 2020 06:26am
- The MFDS is conducting extensive testing of carcinogens in the drug 'Metformin', which is used as the primary treatment for type II diabetes. It is known that as many as 900 items to be inspected. As the US FDA announced the results of the survey yesterday, the MFDS is expected to speed up the survey in order to advance the publication date. According to the Ministry of Food and Drug Safety on the 4th, after conducting a raw material system survey with Metformin manufacturers in last December, the raw materials stored by the companies are collected and tested for impurities. On the 15th of last month, NDMA (N-nitrosodimethylamine) test method for carcinogens using GC-MS / MS has been announced, The MFDS is said to have identified the raw materials to be investigated based on systematic investigations. Nevertheless, it is explained that the survey period is getting longer because there are about 900 items. Currently, there are 640 finished products containing Metformin. The MFDS has been investing a lot of people recently to address COVID-19 infection issues. In particular, 30 people were dispatched to investigate the excessive profits of masks, and related departments are checking daily supply and demand, making it difficult to take the plunge on the Metformin survey. However, some research has been conducted, and results from other countries are coming up one after another. The investigation into NDMA, which is a carcinogen for Metformin, began on Dec 4 when Singapore health authorities recovered three Metformin products. At the time, Singapore health officials said more than 96 ng of NDMA were detected per day in Metformin products. The MFDS confirmed that the ingredients of the same manufacturer of the product recovered by the authorities of Singapore were introduced in Korea, and carried out a full-fledged investigation. Afterwards, a systematic investigation was conducted to ask domestic manufacturers to submit data on the source of production items. Meanwhile, the US FDA reported on the 4th that a sub-standard NDMA was detected in six lots of two of the 10 products. However, it is safe to use because it has a small amount of 10 to 20 nanograms per tablet. To date, no country has issued a prohibition on sales or a recovery order because no NDMA above the baseline has been detected in Metformin products except Singapore. Therefore, the prospect that Korea will have no problem is coming out cautiously. Major domestic manufacturers and sellers are also reporting that NDMA has not been detected through their own research. The domestic market for Metformin preparations is about ₩400 billion, which is widely used in both single and combination drugs. Single drugs include Diabex of Daewoong Pharmaceutical, Glucophage of Merck. If NDMA is detected above the threshold and sales bans or recovery measures are taken, a huge impact is expected, and the pharmaceuticals are unable to let go of tensions.
- 3 variables of Xcopri ahead of US release
- by Kim, Jin-Gu Feb 17, 2020 06:26am
- SK Biopharm's most anticipated product, Xcopri (Cenobamate) is making its debut soon in the US. SK Biopharm aims to release the US in the second quarter There are three major variables that will determine Xcopri's success of the US market. Its competitive effect with existing leading products such as 'Vimpat', conservative prescription trends, and direct sales influence. It is very optimistic on the stock market. It is expected to increase from about ₩30 billion in 2020, the first year of launch, to ₩155.1 billion in 2021 and ₩257.5 billion by 2022. ◆Seizure suppression effect is better than ₩1.5 trillion 'Vimpat' First is a competitive drug. When Xcopri is released, it is expected to compete with UCB's Vimpat. Vimpat has annual sales of ₩1.5 trillion in the US market. Vimpat is classified as a third generation epilepsy treatment. It is prescribed for intractable patients who do not improve with existing primary and secondary treatments. This intractable patient is estimated to be around 30% of the total. Currently, there are about 3.33 million people with epilepsy in the United States. Arithmically, more than 1 million people use third-generation drugs. In clinical trials, the efficacy and effectiveness of Xcopri have been shown to be ahead. Xcopri has demonstrated superior seizure suppression effects in its control trial with Vimpat. The median frequency of seizures in Xcopri was 55% in Study 013·17. Given that 20~40% of competing drugs, including Vimpat, Xcopri is competitive enough as a new drug. In addition, complete seizure loss effect that was not found in other products is also observed. In the relevant trials, 28% of the treated groups had a complete seizure loss. In addition, the expansion of indications in 2023 is another factor that adds expectations. Xcopri currently has indications for partial seizures only. The successful completion of clinical trials for ongoing systemic seizures is expected to increase indications as early as 2023. SK Biopharm ◆Conservative trends, how much will change Second is the uniqueness of the US market. Efficacy itself has a comparative advantage, but it may not lead directly to earnings. Like South Korea, US physicians are said to be conservative in changing prescriptions. It is predicted that it will be hard to skip the proven effects and safety based on 10 years of experience. The US healthcare system, which is built around private insurance, will also be a factor. According to how each insurer evaluates Xcopri, it will affect the doctor's prescription to some extent. The key is the drug price. Depending on the price of Xcopri, private insurers are expected to evaluate the value of Xcopri differently. ◆Direct sales, ‘like a double-edged sword’ Third is the sales distribution network. SK Biopharm has declared direct entry into the US for the first time among the domestic pharmaceutical industry. The company intends to have a local distribution network without a sales contract. SK Biopharm's direct sales are attributed to the disease characteristics of epilepsy. There are not many patients, and the doctors who care for them are more limited. In fact, there are between 12,000 and 14,000 neurologists who deal with epilepsy in the United States. As few doctors prescribe most prescriptions, SK Biopharm expects to build a sales network that closely marks them. It is pointed out that this direct sales strategy is like a double-edged sword. It is clear that direct sales can maximize profit margins. But it is also true how strange new drug companies will be in the conservative US healthcare system. A pharmaceutical industry official said, "It is difficult to predict the results because it is the first time a Korean pharmaceutical company is directly challenged in the United States. It depends on how quickly the doctor's prescription pattern for Vimpat, which has been used in the past 10 years, is quickly converted to Xcopri". It is very optimistic on the stock market. In a recent report, Yuanta Securities expects sales to exceed ₩1 trillion in 2023, the fourth year in the US.
- Opinion
- [Column] Pharmacist's role during COVID-19 outbreak
- by Jung, Heung-Jun Feb 17, 2020 06:26am
- “Do you have hand sanitizer?” “Do you have masks?” These were the most frequently asked questions at my pharmacy starting from Lunar New Year holiday season when the first case of COVID-19 in Korea was confirmed. It is disheartening to see people looking for hand sanitizer in every pharmacy as if not owning one would kill them. Obviously, a public place required have one is unavoidable. But thinking that hand sanitizer would give immunity to virus is a problem. I tried to tell people to carry personal liquid soap and wash their hands at public restrooms as Korea has clean and convenient facilities. But it frustrates me to see people trusting information from the Internet. Nevertheless, I am glad the government and the people are reacting much better after experiencing a number of major respiratory virus outbreaks. During the 2009 flu pandemic, the health authority took almost two weeks to disseminate responsive guideline. The country was confused and restless for a long while, because disease preventive guideline was not presented promptly. I owned a small pharmacy back then as well. I remember informing customers, based on the fact the novel flu’s pathogen is an influenza virus, soap and alcohol could kill the virus and simple single-use mask would also be effective to prevent droplet infection even if it is not difficult to acquire N95 mask. And obviously, my expertise as a pharmacist has helped me to make a judgment. Lately, health issues affecting the society have been occurring more frequently. Besides respiratory virus outbreaks, events with harmful and toxic substances have also been reported. Humidifier disinfectant incident was a case that toxic substance stirred the public. Presumably, the consumers were shocked even more as disinfectant, supposedly protecting human body, was actually damaging the people. Pharmacist should not only talk about drugs. All pharmacists study toxicology at university. As Paracelsus said, “All things are poison,” all chemical substance found in daily life could be toxic or bad for human body. So it is pharmacist’s social responsibility to warn and advise about toxic substance or health risk the public is unaware of. We do need to reflect back on ourselves to see if the pharmacist organization has been playing a key role when a social health issue breaks out. We also need to ask ourselves if we are playing the role of a watchdog forewarning an upcoming risk. The pharmacist organization could not raise a voice to warn about the humidifier disinfectant. Regardless of being an expert of substance acting on human body, the organization could not even explain the problem or present a counteraction plan when the problem arose. If the pharmacists have been constantly warning about various toxic substances, the public would have listened to the pharmacists opposing against the government opening the pharmaceutical market to convenient store. This was a quite regretful incident. It is unfortunate that today’s pharmacy visitors are looking for hand sanitizer and not listening to my advice. But before I blame such state, we need to ponder over what should do as an expert rebuilding trust and authority. Korean Pharmaceutical Association (KPA), representing Korean pharmacists, should always explore health risks and constantly speak up on various safety issues. And also they should be able to promptly provide trustworthy information whenever public health incidents surface. Credibility of a person continuing to speak up for good cause would naturally solidify. I can assure such effort would change the attitude of pharmacy-visiting consumers.
- Policy
- The TF agrees on COVID-19 treatment, 2 tabs of Kaletra BID
- by Kim, Jung-Ju Feb 17, 2020 06:25am
- Although the development of 'COVID-19' treatment has not been completed, the principle has been established that the treatment can be considered by administering two tablets of Abbvie’s Kaletra twice a day. Chloroquine, an antimalarial drug, is also considered, but not domestically distributed. Instead, Hydroxychloroquine, which is used as a drug for autoimmune diseases, may be considered. The National Medical Center held the 6th video conference with the COVID-19 Central Clinical TF, which consists of medical staff and experts in the COVID-19 confirmed patients care hospital nationwide, and agreed on the treatment principles on the 12th. According to the TF, there are currently no treatments for COVID-19 that have proven effective in humans. Therefore, the agreement is the most important clinical decision of the attending physician for the decision of antiviral treatment, the selection of treatment, and the duration of treatment. However, the summary of the agreement is based on the scientific literature published and the experience of TF team members, and is an important reference for treatment. According to the agreement of the TF, if the symptoms of young and healthy patients without the underlying disease are relatively mild, they can be observed without antiviral treatment. In particular, if more than 10 days after onset and symptoms are relatively mild, anti-viral therapy may be less likely. Conversely, antiviral therapy should be considered in patients with old or underlying disease and in patients with relatively severe COVID-19. If the patients are treated with antiviral treatment, it may be theoretically helpful to start dosing as soon as possible. Administration of Kaletra as an antiviral therapy may be considered. The TF can consider two tablets of Kaletra once a day (LPV/ r 400mg/100mg po bid) or Chloroquine 500mg po qd, but Chloroquine is not distributed in Korea, so Hydroxychloroquine 400mg po qd could be considered. It is the TF's judgment that there is no evidence that the combination of Kaletra and Chloroquine (or hydroxychloroquine) is superior to monotherapy. Combination of these drugs can cause serious arrhythmias and drug interactions with increased QT interval (electrocardiogram QRS wave time). Therefore, this combination therapy should be administered carefully in very limited cases. Antiviral treatment, on the other hand, may seem appropriate for 7 to 10 days, but may be shortened or extended depending on the patient's progress at the clinical site. The TF said that Ribavirin, hepatitis C treatment and Interferon, a substance that inhibits viral infection and proliferation in the human body, are not recommended as they have severe side effects, and the use of Ribavirin or Interferon are considered in limited circumstances where Kaletra or Chloroquine(or Hydroxychloroquine) is ineffective or difficult to administer.
- Policy
- “Genetic testing not required for reimbursed Soliris use"
- by Lee, Hye-Kyung Feb 17, 2020 06:25am
- Health Insurance Review and Assessment Service (HIRA) has disseminated a press release to explain a news article raising issues on preliminary review on atypical hemolytic uremic syndrome (aHUS) treatment Soliris injection (eculizumab). Apparently, a news article has reported the government deferring and rejecting preliminary approval on Soliris has caused 12 deaths out of 59 patients, and criticized patients are losing their golden time as the government is demanding genetic testing, not a part of the usual procedure, despite the drug qualifies 18 other reimbursement standards. Before using an expensive drug like Soliris, costing 6.04 million won per vial, a healthcare institute using the drug has to apply for HIRA’s preliminary review applied, and it can administer the approved drug to patient within 60 days. HIRA refuted, “In case of emergency, Soliris can be administered as soon as the preliminary review application is submitted. The news report on patients dying due to delayed or rejected approval is not true.” Reimbursement standard on Soliris stipulates qualification standard of administration subject (standard of disease determination, standard of active thrombotic microangiophathy, standard of renal damage) and also administration exemption (same type of malignant tumor, transplantation, thrombotic microangiophathy caused by infection due to autoimmune disease) HIRA’s press release explained, “The standards have been set based on foreign country guidelines, related academic societies’ consultation, and foreign country reimbursement listing standards. Korea's reimbursement listing is on par with other countries’ standards, such as Canada and Australia. HIRA requires healthcare institute to submit genetic testing results, when submitting a monitoring report after two months into the treatment.” In other words, HIRA says the administering standard of Soliris’ reimbursement does not stipulate genetic test, but it is required for the monitoring report. HIRA stated, “The news article claiming HIRA demanding genetic testing, regardless of qualifying other standards, is false. HIRA would continue to do its best to provide coverage on safe medical service and treatments saving patient’s life.”
- Policy
- Nocdurna to receive reimbursement from next month
- by Kim, Jung-Ju Feb 17, 2020 06:25am
- Nocdurna sublingual tablet identification photo (Source: Korea Pharmaceutical Information Center) Ferring Korea’s Nocdurna sublingual tablet (desmopressin acetate) is to get listed for reimbursement next month. On Feb. 12, Ministry of Health and Welfare (MOHW) issued an administrative notice on amending ‘Pharmaceutical Reimbursement Listing Standard and Method,’ and plans to collect public opinions until Feb. 20. Ministry of Food and Drug Safety (MFDS) has indicated the drug to treat nocturia due to idiopathic nocturnal polyuria. As other drugs with desmopressin acetate have different content, only a part of Nocdurna’s indication would be reimbursed. Desmopressin acetate has received reimbursement for treating patients aged over five with primary nocturnal enuresis and adult patient with any nocturia symptoms related to nocturnal polyuria. According to the government’s approval details, Nocdurna’s indication to treat primary nocturnal enuresis in patients aged over five would not receive reimbursement. The listing would be limited to treating adult patient with nocturia due to idiopathic nocturnal polyuria. The approved contents of Nocdurna are 25 μg and 50 μg. After reviewing collected public opinions until Feb. 20, MOHW would revise the reimbursement standard as of Mar. 1. Desmopressin acetate is available in Korea as Ferring Korea’s Minirin tablet, Hanmi Pharmaceutical’s Demoresin POWD, Nex Pharm Korea’s Newlitan tablet, Pharmbio Korea’s Denirin granule and Dongkoo Bio Pharm’s Demorin fine gradule.
- Company
- Delstrigo by MSD was approved
- by Eo, Yun-Ho Feb 14, 2020 06:36am
- MSD aims to expand market share in AIDS According to the industry, the MFDS recently approved a fixed-dose HIV complex, Delstrigo (Doravirine, Lamivudine, Tenofovir), once daily. Delstrigo has been approved for the treatment of human immunodeficiency virus (HIV-1) infections in adults without prior antiretroviral treatment. Doravirine 100mg is approved by the MFDS on November 22 2019 under the brand name 'Pifeltro' and is intended to be used in combination with other antiretroviral drugs. Both Pifeltro and Delstrigo approved indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients without previous antiretroviral treatment. This drug has been validated through the DRIVE-AHEAD trial. In this trial, Delstrigo demonstrated non-inferiority to Efavirenz, Emtricitabine, and Tenofovir such as Atripla. At 48 weeks, the percentage of patients who reached virological inhibition (less than HIV-1 RNA 40copies/mL) was 84% in the Delstrigo treatment group and 80% in the EFV/FTC/TDF treatment group. The rate of discontinuation due to adverse events was 3% and 6.6%, respectively, which was lower in the Delstrigo treatment group. An MSD official said, "The company is currently preparing for Deltrigo's insurance coverage and launching. We are also planning to expand further indications".
- Policy
- Opposition buys time with Covid-19 delaying HIPDC meeting
- by Lee, Jeong-Hwan Feb 14, 2020 06:35am
- Due to the Covid-19 outbreak, the pilot program for providing reimbursement on Korean herbal medicine would inevitably be delayed. Initially, the government was planning to particularly discuss of coverage on herbal medicine at a Health Insurance Policy Deliberation Committee’s (HIPDC) subcommittee meeting, right as Korean Herbal Medicine Reimbursement Consultative Committee unveils the pilot program plan. But all schedules have been halted, because of the state emergency. Some of healthcare and pharmaceutical professional organizations, who have been opposing against the pilot program, seem to be busy preparing statement and related resources regarding safety issues of the herbal medicine reimbursement system. According to healthcare and pharmaceutical groups on Feb. 13, Ministry of Health and Welfare (MOHW) has not finalized the schedule for the HIPDC subcommittee meeting on Korean herbal medicine reimbursement, originally scheduled on Feb. 6. Pharmaceutical industry explains the meeting has been indefinitely postponed until Covid-19 outbreak is contained and the country feels safe again. The industry source also added, individual issues like coverage on herbal medicine would be set aside for now, as MOHW has urged healthcare and pharmaceutical groups, such as Korean Medical Association, Korean Pharmaceutical Association, Association of Korean Medicine, and Korean Nurses Association, to focus on promptly responding to the state emergency and infectious disease prevention task. However, related organizations are showing anxiousness with the indefinitely postponed talks on the agenda, as the issue is strongly conflicted between medical, pharmaceutical and Korean medicine industries. Postponed HIPDC deliberation would mean delayed procedures of reimbursement feasibility evaluation and related industry negotiation, which would eventually push down the whole timeframe of the pilot program. In fact, MOHW is currently unable to pin down when the subcommittee meeting could be convened. MOHW insider hinted, “Discussion between Korean Herbal Medicine Reimbursement Consultative Committee and other related organizations is essential to the pilot program. While the government and the country’s interest and response capacity are all locked on Covid-19, related schedule would be unlikely to get fixed, yet. This would affect the entire schedule of the pilot program.” Now, the medical, pharmaceutical and Korean herbal medicine industries on the opposing side have earned some time to prepare data pointing out prospective issues and risks of reimbursement on herbal medicine. The urgency the organizations felt, when preparing for opposing statement until the initial HIPDC and subcommittee meeting schedules, seems to be somewhat relieved. Korean Medical Association and Korean Pharmaceutical Association have actually warned of the organizations cooperating to disapprove of the Korean herbal medicine reimbursement. Association of Korean Medicine also has been reprehending MOHW’s pilot program planning by constantly issuing an opposing statement. A member of the Korean Herbal Medicine Reimbursement Consultative Committee disapproving of coverage on the herbal medicine claimed, “As I have been on the side to stop the pilot program, the delay in schedule is a good news. By vastly researching more about the safety issues of Korean herbal medicine, we should strategize resistance against the plan with those on the same side from the consultative committee and HIPDC.” The member added, “All capacity of healthcare and pharmaceutical organizations is on containing Covid-19 at the moment. When it is in the fairly controlled state and MOHW notifies the HIPDC meeting schedule, the industry organizations’ conflict would surface.”
