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- 2026-05-20 13:11:45
- Company
- Labor union protests against Lundbeck Korea for 50 days
- by An, Kyung-Jin Jun 10, 2020 06:09am
- Labor union picketing in front of Lundbeck Korea office on June 8 The conflict is deepening between Lunbeck Korea and employees regarding a recent layoff. On June 8, the Lunbeck Korea Chapter of Korea Democratic Pharmaceutical Union protested in front of the company’s head office in Songpa-gu, Seoul. Denouncing the unfair labor practice by the company management, the labor union has been picketing outside the building during commuting and lunch time for 50 days. And 10 of the Korea Democratic Pharmaceutical Union associates were present at the site as well. Lundbeck Korea Labor Union is a negotiating body established in July last year. The labor union joined the umbrella union as a new chapter, because the employees felt insecure in their job when the company unilaterally changed the regulation on employees in between job assignments. Lundbeck Korea Labor Unions’ long fight started from two months ago. According to Korea Democratic Pharmaceutical Union, a former employee at the company has received a letter of dismissal on Apr. 16. Three days after convening the disciplinary committee, the former employee has been informed of the dismissal and the decision was publicly opened as a ‘personnel order’ via company email. According to the employment regulation, the affected employee was supposed to be able to request for an appeal and practice the right to receive reassessment. But the labor union argues the company officially announcing the dismissal even before the appeal is an unfair labor practice. Head of Lundbeck Korea Chapter Lee Kyung-Soo said, “When firing our member of the union, the management did not inform the union. The company is clearly trying to oppress the labor union,” and “many of us employees are feeling oppressed and intimidated by the company disregarding the basic right of defense and unjustly handling the dismissal.” The labor union is demanding the company to sincerely apologize to the employees. At the negotiation table a month ago, apparently, the union representatives stated, “The protest would be halted without any other condition, if the company acknowledges its fault.” The union plans to take the justification of the disciplinary action to Regional Labor Relations Commission and National Labor Relations Commission. Reportedly, the labor union officials are working on the affected former employee’s relief application with the Regional Labor Relations Commission and the former employee is also individually following up with a legal procedure. The labor union’s picketing was seemingly subsiding when it was temporarily suspended last month. But it resumed in five days and today marks the 50th day. The union claims their fight against the company resumed as the company did not deliver the promise. Lee reproached, “The HR sent out another email elaborating the incident, but it was not an apology but it was deceiving the labor union and employees. The management has notified the union the negotiation would not be conducted unless the outside office protest is ended. And they have not even started salary and employee benefit negotiation for 2020, yet.” However, the company management says otherwise. The reason behind the employee dismissal cannot be disclosed, but they claim the procedure was done by the book. The employee was not eligible to join the union, and it was irrelevant to the labor union suppression as the decision was made after a long discussion with the headquarters. A Lundbeck Korea insider explained, “A personnel order is applicable after the first decision is made by the disciplinary committee. The management thought the news of dismissal had to be disclosed as soon as possible to prevent a gap in work flow.” The insider added, “As it was an unprecedented personnel decision made ever since the Lundbeck Korea was established, we understand the confused sentiment of the employees. But their claim that the company is oppressing the employees is unacceptable,” and “unless the union stops the protest, the negotiation would not be conducted properly.”
- Company
- Accelerating the market entry of JAK inhibitors
- by Kim, Jin-Gu Jun 10, 2020 06:08am
- JAK inhibitors, oral rheumatoid arthritis drugs, are increasing sales in the autoimmune disease treatment market. Xeljanz (left) & Olumiant However, the major item Xeljanz (Tofacitinib) is faltering. For the first time, quarterly sales fell. It is an analysis that the growth of Olumiant(Baricitinib) had an effect. In addition, generics such as Smyraf (Peficitinib) and Rinvoq (Upadacitinib) will begin in earnest, the competition for the JAK inhibitor market is expected to intensify. According to the drug research agency IQVIA on the 8th, the sales of JAK inhibitors in the first quarter amounted to ₩5.4 billion. It has grown more than 6 times in three years from ₩800 million in the first quarter. JAK inhibitors are known as oral rheumatoid arthritis drugs. It is evaluated that it has overcome the limitations of the most widely used TNF alpha inhibitors in the market for autoimmune diseases. It was pointed out that TNF alpha inhibitors are injections despite expanded indications. The main indication is rheumatoid arthritis, which is more limited than a TNF alpha inhibitor. However, last year, Xeljanz is expanding its scope by adding indications for ulcerative colitis and psoriatic arthritis. In addition, studies on atopic dermatitis, Crohn's disease, ankylosing spondylitis are also reported to be in progress. Among the related products, sales in the first quarter were ₩3.9 billion for Xeljanz and ₩1.5 billion for Olumiant. However, the recent sales changes have led to the first quarterly decline in Xeljanz. It decreased by 4% to ₩4.9 billion in the fourth quarter of 2019, On the other hand, luminescent increased 44% from 1 billion won to 1.5 billion won during the same period. It is reported that in the fourth quarter of last year, it surpassed Xeljanz in the prescription share of new patients. The gap between the two is expected to be further narrowed if Olumiant acquires indications for atopic dermatitis. Quarterly sales of Xeljanz & Olumiant (Unit:₩100 million, Source: IQVIA) In January, Astellas' Smyraf (Peficitinib) was approved by the MFDS. On the 4th, Abbvie's Rinvoq was approved. Both products are expected to enter reimbursement categories within this year, unless there is a big deal. Some products are waiting to be released. Gilead Sciences completed the clinical phase III of Filgotinib last year, and is currently applying for a product license in the United States, Europe and Japan. Pfizer is targeting atopic dermatitis and is conducting Phase III clinical trial of the second JAK inhibitor, PF-04965842.
- Company
- Rinvoq was approved in Korea
- by Eo, Yun-Ho Jun 09, 2020 06:28am
- Domestic market competition among JAK inhibitors is fierce. According to the related industry, Pfizer's Xeljanz (Tofacitinib), Lilly's Olumiant (Baricitinib), Astellas' Smyraf(Peficitinib) and Abbvie’s Rinvoq (Upadacitinib) were approved on the 4th. Rinvoq's permission is based on five phase III SELECT clinical trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-EARLY) involving 4,443 patients with moderate to severe active rheumatoid arthritis. As a result of phase III clinical trials, Rinvoq showed lower disease activity and improved clinical remission rate compared to placebo, MTX or Humira (Adalimumab) group when used alone or in combination with conventional synthetic DMARD (csDMARD). However, it is not yet as effective as biological products in the market. Relatively, indications of JAK inhibitors are limited in areas other than rheumatoid arthritis. Xeljanz, which was first developed, added indications such as ulcerative colitis and psoriatic arthritis last year, and Generics are also under study to expand indications for autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis. If the commercialization of Gilead's Filgotinib, which is in the process of approval in the United States and Europe, is achieved, the market size of the JAK inhibitor itself with the convenience of oral medication is also expected to expand. Meanwhile, these JAK inhibitors have the same mechanism of blocking inflammatory cytokine signaling pathways JAK (enzymes such as JAK1, JAK2, JAK3, TYK2, etc.), but there are detailed differences. Xeljanz blocks JAK1 and JAK3, and Olumiant blocks JAK1 and JAK2, and Smyraf blocks JAK1, JAK2, JAK3 and TYK2. Rinvoq & Filgotinib are related to JAK1.
- Policy
- Kolmar begins patent challenge
- by Lee, Tak-Sun Jun 09, 2020 06:28am
- More and more domestic pharmaceutical companies are greedy with generic drugs from Novartis' DPP-4 diabetes treatment drug 'Galvus'. On the 5th, Kolmar Korea filed a passive trial to confirm the scope of a patent right to avoid patents. It has been 7 months since it was approved for bioequivalence test for development of generics in November last year. Normally, patent challenge and commercialization are developed at the same time, but Kolmar entered the patent trial later. This is because Galvus' patent challenge results could not be easily predicted. As such, Kolmar seems to have been following the referee situation requested by the Korea United Pharm and Hanmi as it proceeds with product development. In addition to Kolmar, Hanmi and Korea United Pharm are in the process of patent challenge with the exception of patented indications. The rest of the indications have already expired. In other words, the product they made was claimed by the Intellectual Property Trial and Appeal Board. Hanmi’s Vildagle was already approved as Galvus' salt-modifying product in January, and acquired an insurance price of 403 won per tablet as of April. Korea United Pharm, which was approved for the bioequivalence test in November, has not yet obtained an item license. Hanmi has not yet released a product. The patent trial request has not been made yet. Novartis is currently filing a patent infringement lawsuit against Hanmi, and is pressing the MFDS through a lawsuit for revocation of permission. However, if the claims are cited in the patent trial expected this month, the product will be released soon. Product releases from Korea United Pharm and Colmar are also expected to follow. It is a pity for Ahn-gook Pharm, which has already received an item license and is waiting for release. Ahn-gook Pharm's patent extension period of 187 days was invalidated, and the launch was confirmed from August 30, 2021. it also obtained a generic exclusivity, and a monopoly on the generic market for nine months from the time of release. However, it is said that the competitors may use other strategies to preoccupy the generics market of Galvus.
- Policy
- Tightening electronic review on antiinfectives from October
- by Lee, Hye-Kyung Jun 09, 2020 06:28am
- Korea’s Health Insurance Review and Assessment Service (HIRA) is tightening the electronic review system regarding the antiinfectives for systemic use. The list of electronic review subjects include AbbVie Korea’s Mavyret, Gilead Science Korea’s Biktarvy, Ildong Pharmaceutical’s Besivo and many other chronic hepatitis type B and C treatments. To prevent drug overuse and abuse, HIRA sets down and uses electronic inspection criteria based on drug label (effect, benefit, dose and administration method) and reimbursement standard (issued by Ministry of Health and Welfare) established by Ministry of Food and Drug Safety (MFDS). When a drug is used not according to the approved indication and reimbursement criteria decided by MFSD, the electronic inspection system could automatically deduct the reimbursement. Xarelto and Pradaxa’s electronic inspection program would be developed following the drug label and electronic inspection criteria principle. And reimbursement deduction or other adjustment would be executed when incompliant with the drug label. Currently, the government is building the review programs on antiinfective drugs for systemic use including ATC code of J01, J02, J04, J05, H, P and L. Not only does Group J include hepatitis treatments, but also other various drugs like Chong Kun Dang’s Amoxapen, Yuhan’s Cefaclor, Dongwha Pharm’s Fucidin, Gilead Science’s Harvoni and Hanmi Pharmaceutical’s Hanmi Flu. Nocturnal enuresis treatments (Hanmi Pharmaceutical’s Demoresin, JW Shinyak’s Desonic) and hypothyroidism treatment (Bukwang Pharmaceutical’s Synthyroid, Kyowa Kirin Korea’s Regpara) are listed for reimbursement and categorized under Group H. From Group P, rheumatoid treatment (Elyson Pharm’s Oxiklorin, Korea PMG Pharm’s Duroc), and trichomoniasis treatment (Sinil Pharmaceutical’s Tinidazin, Austin Pharm’s Austin Tinidazole) would undergo the electronic review. Group H includes colorectal cancer treatment (Ildong Pharmaceutical’s Xelobig, Roche Korea’s Xeloda), chronic myelogenous leukemia treatment (Dong-A ST’s Gleenib, Boryung Pharmaceutical’s Glima, Chong Kun Dang’s Leukeevec) and non-small cell lung cancer treatment (Roche Korea’s Tarceva, Teva-Handok’s Teva Erlotinib). The basic principle of the electronic review relies on MFDS-approved indication—effect, benefit, dose and administration method—and other reimbursement standard would be reflected for the review. HIRA would complete building and introducing the program around June to September and enforce the electronic review from October. Healthcare institutes would have to properly cooperate with the government agency for all subject drugs to be prescribed and administered, appropriately.
- Company
- Will COVID-19 Vaccine be specially imported?
- by Kim, Jin-Gu Jun 09, 2020 06:26am
- The government is reviewing the vaccine being developed by AstraZeneca as a special import for COVID-19. Although it is still in the development stage, it is said that the government and the company had contacted with the plan to urgently introduce it in the form of special import if the clinical trial succeeds. According to the pharmaceutical industry on the 5th, officials from the MOHW and AstraZeneca Korea from South Korea held a meeting once in Seoul. It is confirmed that In-taek Lim, director of the Health Industry Policy Division, participated in this meeting. The two sides discussed the progress of the clinical trial of the DNA vaccine currently being developed by the Jenner Institut in the UK. The government previously decided to make a special import for Gilead Science's “Remdesivir”, which is being developed as a treatment for COVID-19. In addition, the government is also considering ways to specially import the COVID-19 vaccine developed by AstraZeneca and developed by the Jenner Institut at Oxford University in the UK. Currently, major companies and organizations that are developing COVID-19 vaccines include CanSino Biologics in China, Moderna Therapeutics, and Inovio Pharmaceuticals in the United States. The Jenner Institut started late, but it was the fastest to develop. It predicts that vaccine production will be possible as early as September this year. The reason that the Jenner Institut was able to speed up this is because safety was confirmed in clinical trials of vaccines developed for the prevention of MERS, the same coronavirus disease last year. It is said to have been successful in animal tests conducted this year in the case of COVID-19 vaccine. The clinical trial scale is also the largest. The clinical trial phase I was launched on April 24, and the number of participants reached 1,100. It overwhelms the clinical trials of other companies and institutions. In the case of Moderna and Inovio, which had entered clinical trials earlier, dozens of participants were conducted in Phase I trial. In May, it was approved by the British government to conduct Phase II/III trials simultaneously. The size of the clinical trials are about 5000. AstraZeneca plans to produce a vaccine that can be dosed by 2 billion people worldwide by as early as September, assuming that the trial will be completed successfully. Pascal Soriot, CEO of AstraZeneca in an interview with an American press, said, "We plan to introduce vaccines to the United States and the United Kingdom from September or October." AstraZeneca and the government have been in a good relationship since President Moon Jae-in's visit to Sweden last year. In June of last year, President Moon Jae-in visited Sweden and met with Leif Johansson, Chairman of AstraZeneca. Chairman Johansson promised to invest $630 million in Korea over the next five years. In December of last year, Chairman Johansson visited Cheongwadae with an economic mission headed by Swedish Prime Minister Stefan Löfven. Through the visit, Chairman Johansson reaffirmed his commitment to invest $630 million, and specified the investment market. If the COVID-19 vaccine is successfully commercialized, it is expected that Korea's special imports will be proceeded well.
- Opinion
- [Reporter’s View] Not penalty but incentive to generics
- by Lee, Tak-Sun Jun 09, 2020 06:26am
- Under the grandeur name of ‘strengthening market competitiveness,’ Korean-made generics are to face various changes in policy in the future. Concerned of excessive number of generics weakening the market competitiveness, the Korean government has already attempted to restrict joint bioequivalence test and reduce pricing of generics with cosigned bioequivalence test result. But it was scrapped by the Regulatory Reform Committee. However, Ministry of Food and Drug Safety (MFDS) is unceasingly reviewing a number of plans to better manage generics with public-private consultative body. So far, they have mentioned of specially labeling package of drugs that conducted individual bioequivalence test, setting bioequivalence quality assessment indicators, and building a database on generic products by each substance. Regardless, only the time will tell, if all these actions would effectively improve generic products’ competitiveness. Unfortunately, most of the competitive enhancement plans are focused on ‘penalty.’ The policy to bring down the pricing of generics without individual bioequivalence test result is a good example. The public-private consultative body was on the same page about being more selective with generics. Naturally, the products at the end of the line would feel penalized. Nothing is more inspiring than a compliment. And we would have to see if the Korean-made generics, tattered by restricting regulation, would survive in the market with so-called ‘strengthened competitiveness.’ Rather, these restraints may even advertise generic as a lower-quality version of the original. Therefore, a means to grant incentives to well-developed good-quality generics should be discussed as well. For instance, the government should consider policies to provide benefit on patent-evading generic with preferential sales approval, generic with an overseas export deal and products contributing to save NHI finance through lowered price. Only when the government promotes the good side of generics, the market would be confident enough to trust those generics. Hopefully, the government would seek for policies granting incentives, besides the penalties, to improve generics’ market competitiveness.
- Policy
- AZ-China joint venture Dizal tests drug in Korea
- by Lee, Tak-Sun Jun 08, 2020 06:15am
- Dizal Pharma, a joint venture company by AstraZeneca and a Chinese firm, is initiating a clinical trial in Korea on non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) or human epidermal growth receptor 2 (HER2) mutation. The pharmaceutical industry is paying a close attention on the Chinese company’s clinical trial, as Hanmi Pharmaceutical and Takeda are also developing a treatment targeting both patient groups either with EGFR mutation or HER2 mutation. On June 5, Korea’s Ministry of Food and Drug Safety (MFDS) has approved of the transnational phase 1/2 clinical trial protocol on 'DZD9008,' submitted by a global clinical CRO firm Covance Korea. The clinical trial aims to confirm the safety, tolerability, pharmacokinetics and antitumor activity of DZD9008 in advanced NSCLC patients with EGFR or HER2 mutation. DZD9008 is an investigational anticancer agent in development by a Chinese-based company, Dizal Pharma. The pharmaceutical company is a joint venture company by a global pharmaceutical company AstraZeneca and China Future Industry Investment Fund (FIIF). In April last year, China’s National Medical Products Administration (NMPA) approved a clinical protocol on DZD9008, and soon after the joint venture company submitted an Investigational New Drug Application. EGFR mutation is frequently expressed in NSCLC patients and HER2 mutation in breast cancer patients. Targeted therapies for respective cancer types have been developed. However, a drug to cover both patient groups with EGFR or HER2 mutation has not been approved to date. In Korea, clinical trials on Hanmi Pharmaceutical’s poziotinib (phase 2 trial on NSCLC patients with EGFR or HER2 exon 20 mutation) and Takeda’s mobocertinib (phase 1/2 trial testing EGFR/HER2 inhibitor in NSCLC patients) are in progress at the movement. The clinical trial on DZD9008 would call for 44 participants in Korea (180 participants worldwide) and conducted in Catholic University of Korea—St. Vincent’s Hospital, National Cancer Center, Seoul Samsung Medical Center, Seoul National University Hospital and Seoul Asan Medical Center. So far, none of Chinese-based pharmaceutical company has made it in Korean market, and even a finished product from China is rare to find. But a couple of Chinese pharmaceutical companies are reportedly conducting clinical trials in Korea.
- Company
- Customized Rx considering the patient's condition is needed
- by Eo, Yun-Ho Jun 08, 2020 06:13am
- The need for patient-specific prescriptions is emerging in the field of obesity treatment. At the recently held 'Saxenda e-Class' (Saxenda.livesympo.com), Professor Hye Jin Chun of the dept. of Family Medicine at Cha University Bundang Medical Center had a time to cover information about treatment for obesity. On this day, Professor Hye Jin Chun focused on six types of obesity treatments including Saxenda (Liraglutide), Xenical (Orlistat), Dietamin (Phentermine), Qsymia (Phentermine+ Topiramate), Belviq (Lorcaserin), Contrave (Naltrexone HCl/ Bupropion) that passed the approval standards of the MFDS. Of these, drugs that have been approved by the US FDA and European EMA are Saxenda, Xenical, and Contrave. She said, "In the case of appetite suppressants that act on the central nervous system, such as Phentermine or Phentermine/Topiramate combinations, anxiety or depression may worsen in patients taking psychiatric drugs, and attention to suicidal behavior is necessary. The prescription is contraindicated for patients who are mentally very anxious or excited." Saxenda was the preferred treatment option for these patients. Prof. Jeon said, "Saxenda is 97% similar to GLP-1, an appetite regulating substance in the human body that is naturally secreted in response to food intake, and is an obesity treatment that has confirmed efficacy and safety through long-term clinical data for 3 years." Saxenda's globally licensed clinical trials show that 63% of patients with an overweight loss of 5%, 33% of patients with weight loss of more than 10%, and 14% of patients with weight loss of more than 15%, 9 out of 10 Showed weight loss effect. In addition, it was the only obesity treatment to obtain indications in obese patients with pre-diabetes, and it proved the effect of improving various metabolic risk factors such as blood sugar, blood pressure, and blood lipid levels in addition to weight loss. Professor Jeon also introduced a case study of a patient who actually lost weight through Saxenda. The patient was a woman in her 50's and was overweight with a BMI of over 32kg/m2. At the time of the first treatment, she showed resistance to injection treatment, enjoyed a late night snack, and had a high craving for food, so Contrave was prescribed, but after 4 days of taking, she complained of severe headache and nausea, and changed the drug to Dietamin. After 2 weeks of treatment, the weight was slightly reduced, but the prescription drug was changed to Saxenda by complaining of insomnia, dry mouth and throbbing, which are typical characteristics of Phentermine. She also complained of stomach discomfort and proceeded to increase slowly than the basic increase schedule as she administered Saxenda and lost weight to 28.3kg/m2 BMI through Liraglutide combination with improved lifestyle. Professor Jeon said, “It is necessary to guide patients who visit hospitals for obesity treatment by identifying drugs that can be prescribed for a long period of time so that patients can be prescribed safe treatments. Safe and effective treatment must be achieved through the proper application of drugs based on the evidence."
- Policy
- The copayment of Remdesivir is supported by the government
- by Kim, Jung-Ju Jun 08, 2020 06:11am
- While the government announced that it would make special imports of Remdesivir, which is being evaluated as COVID-19 treatment, the quarantine authorities said that the cost of treatment is likely to be paid by the NHIS, and the patient's cost of liability is likely to be paid by the government. Eun-kyung Chung, the head of the Central Disease Control Headquarters, made a statement today (4th) regarding the special import of Remdesivir in the regular briefing Q&A. According to her, the current government has begun to negotiate a secured supply with Remdesivir for imports. In this process, the drug price will be decided, it has not been determined how much will be secured and how much it will cost. However, since this drug will be brought into Korea in the form of an orphan & essential Drug, the cost of this drug is likely to be borne by the health insurance finances and national finance. "This drug is an orphan & essential Drug, so the government will secure it and proceed with treatment in consideration of indications," said she. "Currently, COVID-19 is the first-class infectious disease. The charges are borne by NHIS and it is highly likely that the patient's co-payment will be enforced by the country." She said that detailed guidelines will be summarized and announced when plans to secure products such as drug prices and volumes become detailed in the future.
