- LOGIN
- MemberShip
- 2026-05-20 20:56:14
- 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.
- Policy
- Early market entry of Gabsmet salt-modifying drugs are noted
- by Lee, Tak-Sun Jan 06, 2020 06:21am
- The salt-modifying drug 'Galvusmet', a DPP-4 inhibitory diabetes drug, applied for approval for the first time in Korea on the 24th of last month. It is therefore noteworthy whether it will be released to the market early. According to the MFDS on the 24th, Vildagliptin HCl-Metformin HCl combination was applied for the first time to the patent holder, Novartis. The salt is different from the original 'Galvus', which is a combination of Vilagliptin-Metformin HCl. Therefore, the industry has made an observation that Hanmi which has been developing Galvus salt modification drugs, has applied for a license. Hanmi also reportedly filed an application for a license for the Vildagliptin HCl formulation, a Galvus' monolithic salt change product, in July. However, it has not yet obtained a product license. On November 22, last year, Anguk received the first approval of generic drugs and obtained a exclusivity for generic product following the successful patent challenge. However, since the company succeeded in invalidating part of the extended period of the patent, the exclusivity for generic product of sale is not applied immediately, and it is enforced for nine months from August 30 2021. Galvusmet's salt-modifying drug, one of material patent is also likely to be on the market at this time. This is because Anguk and Hanmi have succeeded in invalidating patents that survive after August 29, 2021. Nevertheless, Galvusmet, a latecomer of DPP-4 diabetes, is expected to be the fastest case to enter the market. Galvus recorded outpatient prescriptions of ₩9 billion on UBIST basis in 2018, and Metformin-included Galvusmet is a blockbuster drug with a record earnings of ₩35.1 billion. If first-latecomers enter the market early through patent challenge, they will benefit from the preemptive effect.
- Company
- SK gets world’s first quadrivalent flu vaccine PQ by WHO
- by Lee, Seok-Jun Jan 06, 2020 06:20am
- For the first time in the world, a quadrivalent influenza vaccine passed prequalification (PQ) by the World Health Organization (WHO). SK Bioscience announced on Jan. 2 WHO has completed the seven-month long PQ evaluation and granted a certification of PQ on its Sky Cellflu Quadrivalent. This marks the first time in the world history for a cell-cultured quadrivalent influenza vaccine to pass WHO’s PQ evaluation procedure. Even including egg-based vaccines, only three quadrivalent influenza vaccines, except Sky Cellflu Quadrivalent, have passed the PQ. WHO’s PQ evaluation follows strict set of criteria to verify safety and efficacy of vaccine by assessing the finished pharmaceutical product’s manufacturing procedure, quality and clinical trial outcomes. The evaluation procedure includes technical document review of clinical trial and quality test data, sample quality test, and due diligence on GMP and quality control system. A company with PQ certification is eligible for international bidding for vaccine procurement called by UN-affiliated UNICEF and Pan American Health Organization (PAHO). As of last year, the PAHO’s market volume for influenza vaccine has reached about USD 700 billion (about 81.4 billion won). Sky Flucell Quadrivalent is a vaccine preventing four types of influenza viruses. Unlike typical egg-based vaccinea, the Korean-made quadrivalent vaccine is produced with top-of-the-line aseptic culture system, which does not require preservative. With the unique qualities, the vaccine has less risk of allergic reaction or adverse reaction from egg or antibiotics when administered. Besides, the vaccine can be manufactured quickly as its production time is close to a half of other vaccine’s. Since its split from SK Chemical in July 2018, SK Bioscience has been specializing in vaccine production. The company’s vaccine portfolio includes Korea’s first trivalent cell-cultured influenza vaccine ‘Sky Cellflu,’ the world’s first quadrivalent cell-cultured influenza vaccine ‘Sky Cellflu Quadrivalent,’ the world’s second shingles vaccine ‘Sky Zoster’ and the second Korean-made varicella vaccine, ‘Sky Varicella.’
- Company
- Nexavar reimbursement cleared for severe HCC patients
- by Eo, Yun-Ho Jan 06, 2020 06:20am
- From this year, reimbursed prescription would be granted on liver cancer treatment Nexavar treating patient with severe liver dysfunction. According to the new pharmaceutical listing, reimbursement on Nexavar (sorafenib) would be provided for a patient, including pediatric patient, with advanced hepatocelluar carcinoma (HCC) who is unable to undergo local treatment like surgery or transarterial chemoemoblization (TACE), and qualifies condition of being classified as class A or B7 according to Child-Pugh scoring; in Stage III or more advanced; or classified as Grade 0 to 2 of ECOG Performance Status. Provided by the newly revised listing, treatment access to Nexavar has been expanded not only for patients with good liver condition graded by Child-Pugh scoring, but also for patients with HCC with severe liver dysfunction. The coverage expansion has been decided based on the safety profile confirmed in the GIDEON study incorporating HCC treatment guideline from home and abroad and numerous HCC patients classified in class B7 by Child-Pugh scoring. With 3,371 participants around the world with unresectable HCC, GIDEON study evaluated safety of sorafenib by treating the subgroup patients with 800 mg of sorafenib daily, reduced when necessary. The study found consistent safety profile in over 70 percent of the participants, specifically in Child-Pugh A patient group (61 percent) and Child-Pugh B7 patient group (11 percent). Consistent incidences of adverse events were reported from Child-Pugh A and Child-Pugh B7 patients groups with 69 percent and 67 percent, respectively. Commonly reported drug-related adverse reaction from Child-Pugh B7 group was diarrhea (27 percent), hand-foot syndrome (20 percent) and fatigue (16 percent). And in the subgroup analysis of GIDEON on 482 Korean patients, the safety profile was consistent in Child-Pugh A patient group (56.8 percent) and Child-Pugh B patient group (21.8 percent). The subgroup analysis found overall patient group treated with sorafenib (n=482), including Child-Pugh B patients, reached median overall survival of 8.5 months, which was not too far off from the median overall survival of 10.2 months in Child-Pugh A patients only group. Commonly referred by cancer academics, the U.S. National Comprehensive Cancer Network (NCCN) Guidelines (Version 3.2019) and HCC Treatment Guideline in Korea (2018) recommends Nexavar as systemic treatment for HCC patients with specific tumor condition including Child-Pugh A and B7 class of liver function. Professor Kim Yoon Jun of Gastroenterology Department at Seoul National University Hospital commented, “Preserving the liver function is crucial in HCC treatment, but patients with already dysfunctional liver or cancer-damaged liver had not have many treatment option. However, even the patients with severe liver condition, who used to be inaccessible to systemic anticancer therapy, can now access to higher level treatment option with expanded reimbursement.”
- Policy
- Announcement of drug price reform is delayed
- by Kim, Jung-Ju Jan 04, 2020 08:47pm
- The reform of the drug price system, which the government plans to announce last month, is delayed somewhat. The pharmaceutical industry is all on edge because of the reorganization of generic drug prices, improved risk-sharing contract (RSA), economic exemption system, and insurance policy supplementary agreement (sub-contract). ◆Generic price restructuring= Among the many cases where drug price restructuring is expected, the focus of the industry is on the final revision of the 'Determination and Adjustment Criteria for Drug Price Revision', which contains the generic price restructuring. The government planned to announce the final announcement no later than last month, but it was slightly delayed, with some revisions to the earlier this month. It is essential to calculate this system by linking the MFDS' item permission to the Ministry of Health and Welfare’s drug price system. It is largely divided into generic cascade drug price reform and cut line system. The requirement for a cascading drug price reform is to conduct its own bioequivalence test and to meet the registered use of the Drug Master File (DMF). If both criteria are met, the price is estimated at 53.55% of the cost of the original drug (before generic listing). However, if one or not met, then the price is multiplied by 0.85 based on 53.55%, depending on the level of fulfillment of the criteria. They are cut by 15%. In addition, the 'cut line system' is a price condition that is lowered separately from the permit linkage. Starting from the 21st order of health insurance, the drug price is estimated at 85% of the lowest price regardless of whether the criteria are met. For example, the 21st generic is estimated at 85% of the lowest price in 20 products, while the 22nd generic is 85% of the 21st generic price. The government has announced that the drug price reform will be finalized by the middle of this month and planned to be implemented in July. ◆Completion of RSA, reimbursement decision, the economic evaluation exemption system and additional contract creation subjects=In the current drug price system, issues that require expansion or reorganization of the reimbursement gateway stage are also overhauled. The government has continually improved the drug price system without changing the fundamentals of the system since the implementation of the positive list system. However, as the groundbreaking reinforcement of security continued, the awareness of the need to reorganize and upgrade the positive list system continued. The improved drug price system can be divided into: ▲expanding the scope of RSA coverage ▲complementary details of reimbursement determination ▲complement of economic evaluation exemption system ▲expansion of generics for writing subsidies when reimbursement listed. First of all, in the case of RSA improvement, one of the new drug listing tracks, it is important to expand the gateway to be able to apply the RSA target criteria that could be applied only to the current selection drugs. In the meantime, drugs that have the same therapeutic position but have not been covered by RSA just because of late-release drugs will have a wider benefit opportunity. In addition, high-priced drugs that are subject to phase III conditional approval are considered to have greater uncertainty, and thus, improvements are made in the direction of raising benefits by reimbursed them within the framework of the RSA. In the case of reimbursement determination, some socially disturbing reimbursed priorities are supplemented. The government is currently making reimbursement in consideration of medically feasible or medically significant materiality and treatment effects, as well as patient costs and social benefits. In the future, it will be added to determine detailed principles or priorities in consideration of the financial status of health insurance. In other words, it reflects the decision of reimbursement to the financial level that health insurance can cover, along with the characteristics of pharmaceuticals and the necessity of the times. The economic evaluation exemption system will also be supplemented. The government plans to improve the system by adding antibiotics, tuberculosis treatment, and emergency detoxification drugs, which are difficult to evaluate, to reflect the voice of expanding the scope of drugs that are difficult to evaluate. Lastly, it is a revised plan that includes a generic agreement that is included when insurance is listed. The contracting parties are the Korea Health Insurance Corporation and pharmaceutical companies. The main contents of the contract are to fulfill supply obligations and accept price cuts when disposing of rebates. The government aimed to implement the midterm this year after outlined this month's reorganization plan based on improving the positive list system and promoting administrative notice. Evaluation adopted by the government during the maintenance of the list of registered agreements from 2007 to 2011 ◆Re-evaluation of listed drugs=The government is currently setting up a 'post-evaluation of pharmaceuticals', that is, a re-evaluation guideline for already listed reimbursed drugs and collecting expert opinion. The evaluation is based on the revised List of Contracts, which was carried out 12 years ago, but the standard is expected to be more detailed. Reevaluation targets are selected from anti-cancer drugs, rare disease drugs, and drugs of uncertain clinical usefulness. Of these, ▲drugs that need to confirm clinical usefulness through effects re-evaluation ▲drugs that need to be managed due to increase in population structure and usage ▲other drugs that require evaluation taking into account social impacts and other effects on health care at ex post evaluation Sub-committees become standards. The government plans to announce the final reassessment soon and finalize the system within the year.
