- LOGIN
- MemberShip
- 2026-04-17 15:11:30
- Policy
- China's "New Law" tightens safety and quality management
- by Kim, Jung-Ju Jan 08, 2020 06:15am
- China is to reinforce overall pharmaceutical management and monitoring regulation covering from pharmaceutical production, launch, clinical trial to counterfeit drug. The so-called ‘New Drug Administration Law’ would mainly focus on safety and quality. China’s National Medical Products Administration (NMPA) had taken the revised law in effect from last month. Considering the time it needs to settle in with the entire system, the new law would be enforced from the beginning of this year. The revision consists of pharmaceutical marketing authorization holder system, clinical trial institute record management, Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) management, review and approval on chemical ingredient, and tightened investigation and prosecution over illegal practice. First, the Drug Marketing Authorization Holder (MAH) system has been toughened stringently. The system stipulates a pharmaceutical company or manufacturer, with registration number-marked drug registration certificates and imported drug registration certificate, should strictly perform the MAH obligations. The authorization holder has liability for the entire life-cycle of a drug from development to production and management to ensure drug safety, efficacy and quality. The new law also tightened clinical trial institute’s record management. The Chinese regulator has adopted a form of pre-management system that would process clinical trial institute certification according the regulation, if it has not been completed before last December. The revised law would also strictly regulate GMP and GSP certification. A company cannot apply for the certification if charged with illegal practice in R&D, production or management, and the Chinese regulator would also conduct on-site audit as stated by the regulation. And the regulator’s review and approval for chemical ingredient manufacturer would be integrated within the existing registration procedure. Each regional regulatory authority has to ultimately enhance drug safety effectively by strictly following the said regulation and also by stringently imposing penalty on illegal practice. The Chinese government plans to promptly set and announce further details of the New Drug Administration Act.
- Company
- Pfizer Korea is looking for a new office
- by Kim, Jin-Gu Jan 07, 2020 06:29am
- Pfizer Korea Myeongdong Office Pfizer Korea is pursuing the sale of its Myeong-dong office, which has stayed for the past 13 years. Location of new office is planning Yeouido, Jamsil or Pangyo. According to the pharmaceutical industry on the 6th, Pfizer Korea is considering the sale of its office and relocation of its office. Currently, Pfizer Korea is located at 110 Toegye-ro, Jung-gu, Seoul (1-11 Hoehyeon-dong 3-ga). An industry official said, “We believe that Pfizer has pursued the sale of the Myeong-dong headquarters since last year, and we have selected a real estate asset manager to manage the sale at the end of last year”. Another official said, "We were thinking about the most suitable place such as Jamsil, Pangyo, or Yeouido, and the company made an internal decision to one of the three recently considering the accessibility and the rental price." The specific sale and transfer dates are not confirmed. However, Pfizer Upjohn is expected to coincide with the launch of a joint venture with Mylan, according to the US Pfizer headquarters plan. Earlier, Pfizer signed a merger and acquisition agreement with Mylan, a generic pharmaceutical company in last July. It is the launch of a joint venture between Pfizer's business division in charge of patent expiry medicine and Mylan. The merger will be finalized this year. The new corporation was named Viatris. As it is a separate corporation, Pfizer Upjohn's Korea subsidiary is reportedly seeking a third place separately from Pfizer. Pfizer Pharmaceuticals moved to the current Myeong-dong office from Gwangjang dong, Gwangjin-gu, Seoul in June 2007. Prior to this, Myeong-dong office was purchased in June 2006. At the time, the purchase price was reported to be ₩58 billion. According to officials from the real estate industry, the price of Pfizer Korea’s Myeongdong offices is currently set at around ₩100 billion to ₩120 billion. Profits of more than ₩60 billion were generated In 13 years.
- Company
- SNU professor investigates new anti-cholesterol medicine
- by Eo, Yun-Ho Jan 07, 2020 06:29am
- 김효수 교수 Researchers in Korea are onto developing a next generation anti-cholesterol medicine. Pharmaceutical industry reported on Jan. 7, a team of Seoul National University researchers led by Professor Kim Hyo-soo is preparing a Phase 1 clinical study on candidate medicine inhibiting cyclase-associated protein 1 (CAP1). Previously, Seoul National University Hospital’s Research-driven Hospital Project—Inflammation/ Metabolism Unit Program led by Professor Kim Hyo-soo and Professor Jang Hyun-duk discovered CAP1 protein essential for protein convertase subtilisin/kexin type-9 (PCSK9) to destroy low-density lipoprotein (LDL)-receptor and identified the mechanism. LDL-cholesterol, when combined with LDL-receptor on the surface of hepatocytes, enters into the hepatocyte through a pathway called clathrin. Then the LDL-cholesterol is broken down, while LDL-receptor moves back to the cell surface and is reused. After then, CAP1 carries PCSK9 combined with LDL-receptor to an intracellular pathway, caveolin, where LDL-receptor is broken down by lysosome without getting reused. In short, PCSK9 is essential for CAP1 to break down LDL-receptor. Interestingly, CAP can be found in every organ of a human body, which means CAP1-inhibiting mechanism could be effective not only for lowering cholesterol level but also for other disease. In fact, the CAP1-inhibitor, currently under investigation by Professor Kim’s team, is targeting for indication on treating fatty liver and cancer. Professor Kim Hyo-soo stated, “With the six-year-long research, we have confirmed possibility of the investigational medicine, and we are planning for a Phase 1 trial on the medicine. Although PCKS9-inhibitor has been commercialized and demonstrated effectiveness, CAP-inhibitor could be another treatment option.” The team has already conducted a study with CAP1-inactivated mice. The outcome found the mice lacking CAP1 had hepatocyte surface with increased LDL-receptor and had significantly lower the level of LDL-cholesterol level in its blood. Also when intentionally breaking down LDL-receptor in liver of mice injected with PCSK9 antibody, the symptom of degraded LDL-receptor has been improved noticeably in mice without CAP1. Moreover, the research team analyzed PCSK9 gene mutation in people with considerably low LDL-cholesterol and found mutated PCSK9 could not properly bind with CAP1 to be functional.
- Company
- Ildong starts distribution of GSK generic drugs
- by Jung, Hye-Jin Jan 07, 2020 06:28am
- From the 6th, Ildong will begin supplying nine OTC drugs from GlaxoSmithKline. Orders from wholesalers and direct-selling pharmacies began on the 3rd, and the products are shipped from the 6th, depending on the order amount Under the co-promotion agreement with GSK, Ildong has sold a comprehensive cold medicine 'Theraflu', an ophthalmic drug 'Otrivin', a smoking cessation drug 'Nicotinell', a hyperhidrosis drug 'Driclor', and an external anti-inflammatory drug 'Voltaren', denture attachments 'Polident', toothpaste 'Sensodyne' and 'Parodontax', and co-band medical expander 'BreatheRight'. Last year, domestic sales of nine products stood at about ₩46 billion. These products have been sold by Dong-wha until last year. Traders are interested in supply prices. In particular, it is common practice for OTC drugs to raise their supply prices when their sales corporation changes. First, pharmacies that deal directly with Ildong will receive their products at prices similar to those offered by Dong-wha. An official at Ildong said, “It is an internal decision that there is no price increase on a direct pharmacy basis. OTC drugs are particularly easy to raise when prices change due to higher drugstore and consumer resistance, but considered pharmacy convenience as much as possible”. On the other hand, the purchase price of wholesalers is likely to be slightly adjusted. Some wholesalers are adjusting their orders because nine items will see a 3% price increase overall. A wholesaler said, “It is reported that the price will increase by 3-4%. The exact price will be known next week.” Unlike reimbursed drugs with a fixed insurance premium, non-paid drugs, over-the-counter drugs, are sold by margins by wholesalers at supply prices set by pharmaceutical companies. In general, wholesalers spend about 8% of their supply on distribution, so over-the-counter drug margins are determined within 8-10%. When wholesaler prices rise, pharmacy sales and consumer prices go up. However, Ildong responded that there will be little price increase due to the high proportion of direct pharmacies. It is because Ildong operates Ildong Shop, a pharmaceutical online mall, and since Ildong is a pharmaceutical company with a high proportion of OTC sales among domestic pharmaceutical companies, most of them are directly dealing with pharmacies. An official of Ildong said, “The high proportion of direct pharmacies is also beneficial to correct the distribution order, in the case of GSK products, we would like to maintain stable sales by increasing the proportion of direct drug sales rather than wholesale supply”.
- Policy
- Derazantinib-Tecentriq trial approved in Korea
- by Lee, Jeong-Hwan Jan 07, 2020 06:28am
- A global clinical trial to test a combination therapy of anticancer treatment derazantinib and immunotherapy Tecentriq (atezolizumab) was approved in Korea to treat patients with urothelial cancer. The clinical trial has been put together as derazantinib developer Basilea Pharmaceutica and Tecentriq developer Roche have signed a collaborative deal to investigate immunotherapy combination to treat urothelial cancer in January last year. On Jan. 3, Korea’s Ministry of Food and Drug Safety (MFDS) announced approval of a Phase 1b/2 multi-cohort open-label study to explore combination therapy of derazantinib and atezolizumab in patients with urothelial cancer with confirmed FGFR mutation. Apparently, National Cancer Center, Inje University Busan Paik Hospital, Seoul National University Hospital, Seoul Asan Medical Center, Korea University Hospital and Seoul National University Bundang Hospital are healthcare institutes executing the clinical trial in Korea. Derazantinib inhibits fibroblast growth factor receptor (FGFR) kinase that helps cell proliferation, differentiation and migration and demonstrates five to 30 percent gene alteration in liver, bladder, breast, liver and stomach cancers. An ongoing study approved earlier had announced interim data finding objective response rate (ORR) of 21 percent in 29 patients with intrahepatic cholangiocarcinoma (iCCA). Six of the patients demonstrated 83percent of disease control rate (DCR). Basilea in-licensed derazatinib from U.S.-based biopharmaceutical company ArQule in 2018. Meanwhile, Seattle Genetics is initiating a clinical trial in Korea as well with ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC), to treat breast cancer. The approved Phase 2 protocol aims to confirm efficacy of ladiratuzumab vedotin targeting unresectable locally advanced or metastatic solid cancer. The list of clinical trial centers consistsd of Seoul National University Boramae Medical Center, Ajou University Hospital, Seoul National University Hospital, Dong-a University Hospital, Seoul National University Bungdang Hospital, Catholic University Seoul St. Mary’s Hospital, Chonnam National University Hwasun Hospital and Korea University Guro Hospital.
- Policy
- Eliquis' price cut has been reserved
- by Kim, Jung-Ju Jan 06, 2020 11:00pm
- Against the government's lower policy price cut, the former drug price of BMS Eliquis (Apixaban), which is appealing to the court, will be temporarily held. Currently in progress at the Seoul High Court, if it is terminated, additional price cuts are scheduled for June 1st. The Seoul High Court's 9th Executive (2019-Ah1617) decided to temporarily suspend the price cuts related to this drug in “ the list of pharmaceutical benefits and the maximum reimbursement schedule”, which included a decision to lower the price of the Ministry of Health and Welfare. Earlier, the Ministry of Health and Welfare decided to drop the Eliquis’ price by 30% by content through some revisions. Eliquis was the target for lowering the maximum price of the most listed products and the same route, ingredients, and formulations. BMS disagreed with the objection and currently in progress in the Seoul High Court. There are 2.5mg and 5mg tablets, and the amount the Ministry of Health has decided to cut is ₩830 each. According to the court's decision, the drug will remain at the original upper limit of ₩1185 until 30 days after the sentence of judgment on the 3rd. On the other hand, on June 1, the Ministry of Health and Welfare plans to further reduce the price of drugs to ₩635 each.
- Company
- 5-year ‘Botox War’ to end this year
- by Kim, Jin-Gu Jan 06, 2020 11:00pm
- The legal dispute between Daewoong Pharmaceutical and Medytox over botulinum toxin strain would come to an end this year. While the industry predicts the final decision would be made in coming June, legal experts see either one of them losing the case would take a heavy blow. According to industry sources on Jan. 3, the U.S. International Trade Commission (ITC) has scheduled to have Daewong Pharmaceutical-Medytox strain trial in February, preliminary decision in June and final decision in October. ITC has announced a specific schedule of the trial on June 5 EST. The question of has Daewoong Pharmaceutical stolen Nabota’s botulinum toxin strain as accused by Medytox or it was discovered by Daewoong Pharmaceutical as it claims would be answered on June 6 in Korea. Unlike other general court litigation, the U.S. ITC patent investigation is dealt in a unique style. What differs the most is the role of Staff Attorney. The staff attorney is a third party, apart from either the complainant or defendant, appointed by the judge. The assigned staff attorney takes a role of investigating honest and fair proceedings of the two disputed parties during “discovery” and representing “public interest” during trials as an independent party. Specifically, the staff attorney conveys their position on the patent infringement accusation to the judge. The judge, on the other hand, is not mandated to accept the staff attorney’s position, but it is perceived as significant influence on the outcome, according to patent dispute experts. It has been reported Korean-American attorney Brian Koo has been appointed as a staff attorney for the case. Basically, other than the judge, the attorney is holding the key to the litigation result. After the preliminary decision has been forwarded to the two parties in June, the proceeding would end with the final decision in October. Generally, the preliminary decision goes unchanged for the final result, but it could be flipped. The judge rules the preliminary decision, while the Commission makes the final decision. After the final decision has been forwarded, each company can file an appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC) within 60 days. However, CAFC would decide whether or not to accept the appeal. Regardless of the result, industry and legal experts say either one of the parties would take a significant impact. Several tens of billions have been spent on the litigation already. The two companies’ financial statement from the third quarter last year found that Medytox and Daewoong Pharmaceutical have spent 7.8 billion won and 10.4 billion won, respectively. Meanwhile, their financial burden would snowball after they initiate civil suit proceedings after the final ITC decision.
- Policy
- Industry speculating on special clause for IMD
- by Lee, Jeong-Hwan Jan 06, 2020 06:22am
- While the government’s announcement on the revised drug pricing regulation has been delayed, the pharmaceutical industry is seemingly speculating on a possible new special clause of the regulation to exempt incrementally modified drug (IMD) with recognized non-obviousness. The industry predicts the government is more likely to make an exception for IMD, because Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) and the pharmaceutical industry have been consistently voicing the necessity of maintaining weighted pricing benefit for IMD and National Assembly Health and Welfare Committee have also expressed concerns about the issue as well. According to sources from pharmaceutical industry and National Assembly on Jan. 5, companies dealing with IMDs are keeping their eye close to Ministry of Health and Welfare’s (MOHW) finalized drug pricing system revision. For now, the industry does not have much to complain about the government’s intention to lower generic pricing. As MOHW has shown its firm determination to strictly regulate drug pricing, the industry seems convinced about the need of shifting companies’ business focus. However, the industry is strongly urging the government to establish a special clause on the revised drug pricing regulation to exempt IMDs from the generic pricing reduction. Basically, the industry is expecting the government’s smart regulation to set a different regulation for IMD that protects industry’s willpower to develop pharmaceutical cash cow in the future. The industry’s voice has gotten even louder, because recently a court ruled against a generic challenging an original’s patent by changing its saline base. The Patent Court in last December has decided some of generic-makers’ strategy to change saline base of the original Champix (varenicline) is patent infringement. Prior to the Patent Court’s decision, the Supreme Court also did not concede with generics claiming to have evaded infringement of term-extended patent by changing the saline base of the original overactive bladder treatment Vesicare (solifenacin). Technically, it was the end of the saline-based patent evasion strategy. As a result, generic makers have lost its one of major income sources as they used to launch their generics after challenging and shortening an original’s patent term. Now that the saline-based patent evasion is not an option anymore, generic makers argue at least pricing benefit for IMDs with proven non-obviousness should be kept. A Korean pharmaceutical company insider commented, “We are quite curious about the finalized drug pricing regulation of MOHW, because IMD is the only technical strategy and cash cow business model in Korean pharmaceutical market saturated with excessive amount of generics. The government should set forth a special clause providing pricing benefit for IMDs, at least, regardless of tightened pricing regulation on simple generic or general combination drug.” Another company’s insider claimed, “Up to date, saline-based patent evasion strategy has been a legitimate and prominent means to push up generic launch date and generate profit. Without the strategy, pharmaceutical companies would struggle to develop any drug and generate profit from it. Only when the government recognizes pricing benefit for IMDs, more companies would endeavor to develop IMDs with non-obviousness.”
- Product
- Taltz for interleukin Psoriasis expands Rx Area in hospitals
- by Eo, Yun-Ho Jan 06, 2020 06:22am
- Lilly's interleukin IL-17A antagonist, Taltz, is settling on its prescription area at general hospitals. According to the related industry on the 6th, psoriasis treatment Taltz (Ixekizumab) passed the drug commitee (DC) of Seoul National Hospital recently after Asan Hospital and Severance Hospital among the Big Five. In addition, prescription codes have been made into major hospitals such as Seoul National University Bundang Hospital and Pusan National University Hospital. Taltz, which was released in late 2018, was slower to be priscribed in general hospitals compared to Janssen's IL-23 antagonist Tremfya (Guselkumab), which had entered the same period. Novartis' Cosentyx (Secukinumab) which has the same mechanism as Taltz, entered the market earlier. For this reason, Taltz had difficulty, but it is gradually expanding being prescribed. Accordingly, the issue is how the competition between interleukin drugs in the psoriasis treatment field will change. Lilly has also published the latest IXORA-R study in patients with moderate-to-severe plaque psoriasis , which directly compares the efficacy of Tremfya and Taltz. As a result, the Taltz-administered group achieved a statistically significant level of skin improvement compared to the Tremfya-treated group, which achieved 41.3% of patients with complete clean skin (PASI 100), the primary endpoint at week 12. All major secondary endpoints were also met. The reaction rate were higher than Tremfya at the 2nd PASI 75 ratio, the 4th and 8th PASI 90 ratio, the 4th and 8th and 24th PASI 100 ratio, the 12th week's static Physician's Global Assessment (sPGA) 0 ratio, and the 1st PASI 50 ratio. Andrew Blauvelt, Ph.D., working at the University of Oregon Research Center, USA, said, “The results of IXORA-R showed that Taltz is an effective treatment that helps more patients reach complete clean skin at week 12 of treatment, as early as the first week of treatment, skin plaque lesions improved by 50%”. In the IXORA-R clinical trials, the safety profiles of Taltz and Tremfya were similar to those reported previously. Lilly plans to announce in 2020 the results of the 24th week PASI 100 attainment rate, one of the key secondary endpoints for the IXORA-R trial.
- Company
- BMS re-applied for suspension about Eliquis
- by Kim, Jin-Gu Jan 06, 2020 06:21am
- Eliquis' price has dropped by 30% since last 1st. This is in accordance with the Seoul Administrative Court's decision at the end of last year. However, It is also likely that drug prices will rise again in the 2nd course of legal disputes. The Ministry of Health and Welfare recently announced that Eliquis' suspension of price cuts has been lifted as of January 1 through a notice of the ‘Pharmaceutical Benefit List and Reimbursement Limit Table’. Eliquis’ price has been reduced from ₩1,185 to ₩830. The action is in response to a decision made by the Seoul Administrative Court on December 19 last year. The administrative court went for the defendant, welfare department in a minimum lawsuit for the adjustment of the upper limit on the amount of drug adjustments filed by BMS against the minister. It was ruling that Eliquis' disposal of the drug price was justified following the launch of the generic.. Eliquis' price was initially to be reduced to July 1. However, BMS has filed a series of petitions for suspension of drug price reduction and a minimum lawsuit. The court accepted the BMS' claim. The decision was made to suspend the price cut. The Ministry of Health and Welfare delayed the Eliquis’ price cut twice. The suspension lasted until December 31 of last year. The court ruled in favor of the Ministry of Welfare, leaving approximately two weeks before the suspension of the Ministry of Welfare. The suspension was lifted. The price was automatically lowered from January 1 Eliquis' price may rise again. This is because BMS who lost the first trial appealed to the Seoul High Court. Indeed, BMS, the legal representative of BMS, was confirmed that the Ministry of Health and Welfare applied for suspension from the Seoul High Law immediately the day after the Ministry of Health and Welfare announced the suspension of drug price reduction. The application for suspension shall be decided by the court, independent of a trial on an appeal case(Original suit). The decision of the original case and the decision to suspend execution were allotted to the ninth administration of the Seoul High Court. It is unknown whether the court will accept the BMS’ application. The relevant trial date has not been set yet. In general, most courts cite the application for suspension of drug price reduction, but it is difficult to predict easily that there is also the opposite case. In the first trial, part 14 of the Seoul Administrative Court accepted the application for suspension of BMS. On the contrary, in last September, part 6 of Seoul Administrative Court rejected the application for price reduction’s suspension of the disposable eye drops from 21 domestic pharmaceutical companies.
