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- 2026-05-18 13:59:03
- Policy
- MFDS cautious on waiving bridging trial for abortion pill
- by Choi-sun Nov 24, 2021 05:53am
- The Ministry of Food and Drug Safety, which had been accelerating the approval of the induced abortion pill Mifegymiso (misoprosto + mifepristone), has taken a step back in response to the caution urged by the National Assembly among others at the NA audit. Despite being advised to waiver the bridging study by the Central Pharmaceutical Affairs Council, the MFDS turned to take a more reserved position on the exemption of such trials. Considering the progress of the review, as Hyundai Pharm would need to prepare the supplementary data and receive another review for the submitted materials, it is predicted that it will be difficult for the company to obtain approval within this year. According to the MFDS on the 17th, the authorities requested supplementary data for Hyundai Pharm’s application on Mifegymiso but deferred providing a definite answer on whether it will exempt a bridging clinical for the drug. # A bridging study is added when it is difficult to apply foreign clinical trial results locally due to ethnic differences in evaluations. In early September, the MFDS received a recommendation to waiver the bridging trial after holding a CPAC meeting. Since the addition of a bridging trial could postpone the approval of a drug by 2 to 3 years, whether the bridging trial will be initiated was the center of focus to the company as well as women’s and academic societies. At the time, the prevailing opinion was that the MFDS would waive the bridging trial and rapidly progress the approval process in accordance with the advice from external experts. However, the ministry later changed its position, faced with opposition from the Korean College of Obstetrics & Gynecology and the concerns raised on the hasty introduction of the drug. An MFDS official said, “We are aware of the great need for relevant regulations and drugs after abortion was decriminalized. However, we are also aware of the rising concerns over its safety, which is why we need to exercise caution on the matter.” He added, “The ministry had requested Hyundai Pharm’s to submit supplementary data on the approval of Mifegymiso. We had requested supplements after consulting with external experts and conducting data review, and the company has not submitted the additional data yet.” “We have set a deadline for the supplementary data submission, however, the deadline may be extended upon the company’s request. We can only proceed further after we receive the data,” said the official. Regarding the initiation of a bridging study, the MFDS plans to reexamine the issue through further expert review. The MFDS official said, “We have already completed seeking expert advice on conducting a bridging study for Mifegymiso, but did not make a decision at the ministry level on whether to request or waiver a bridging study.” He added, “This seems to be an issue that should be reviewed after the additional data are submitted. We plan to once again review expert opinions on the matter after receiving the supplementary data.”
- Policy
- Nam In-soon's drug price recovery bill excludes rebates
- by Lee, Jeong-Hwan Nov 23, 2021 05:55am
- The "Return and refund of suspension of execution of drug prices" bill proposed by Rep. Nam In-soon of the Democratic Party of Korea varies in scope of application to benefits deletion, suspension of benefits, and drug price reduction due to revaluation of starting drugs. However, Rep. Nam In-soon's bill does not include the disposition of drug price reduction due to the detection of illegal rebates. The two bills differ in that the previously proposed Democratic Party lawmaker Kim Won-yi's bill was subject to redemption and refund of only the original patent expiration drug price and the rebate detection drug price. As Rep. Nam recently proposed an additional revision to the National Health Insurance Act, pharmaceutical companies that have conventionally applied for suspension of execution shortly after the patent expiration drug price was lowered have become more interested in the bill. The National Assembly's Health and Welfare Committee announced the subcommittee on the first bill on the 23rd and 24th. Therefore, it is not yet known whether the bill proposed by the two lawmakers will be reviewed by the end of this year. Rep. Nam's bill laid the groundwork for ex officio adjustment of the benefits, scope of benefits, and upper limit of registration drugs, as set by the Minister of Health and Welfare by Ordinance of the MOHW.(New Article 41-35) In particular, regarding the ex officio adjustment of the Minister of Health and Welfare, the NHIS specified the basis for collecting or refunding losses incurred by pharmaceutical companies filing administrative trials and administrative litigation.(New Article 101-2(1)-6) The ex officio adjustment of the Minister of Health and Welfare includes the expiration of the original patent, the registration of generics, and the deletion of benefits, suspension of benefits, and drug prices due to revaluation of registered drugs. The disposition of drug prices for drugs caught in rebates was excluded. This part is different from Kim Won-yi''s bill. In the case of exclusion or suspension of benefits, the upper limit of losses cannot exceed 40/100 of the difference in medical care benefits. The supplementary provisions stipulate the enforcement date of the bill as the day six months have elapsed since its promulgation. The revised regulations were to be applied from administrative trials or administrative litigation filed for the first time since the enforcement of the law, so that past lawsuits for drug price reduction were not retroactively applied.
- Company
- Bavencio cost support provided in non-reimbursed areas
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Pharmaceutical expense support for the cancer immunotherapy drug ‘Bavencio’ in non-reimbursed areas has begun. According to industry sources, Merck and Pfizer have started a patient support program to refund part of the expenses patients spend on Bavencio (avelumab) as first-line monotherapy for metastatic Merkel cell carcinoma and as first-line maintenance treatment for the recently approved locally advanced or metastatic urothelial carcinoma. Both companies plan to support part of the pharmaceutical expenses borne by patients who were prescribed Bavencio without reimbursement and must bear the full price. In particular, the Early Access Program (EAP) gained attention as it supports the recently approved urothelial carcinoma indication that lacks treatment options. Bavencio is an anti-PD-L1 immunotherapy that was first authorized in 2019 to treat Merkel cell carcinoma, then as a first-line maintenance therapy last August for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after using platinum-based chemotherapy by the Ministry of Food and Drug Safety. The indication was approved based on the Phase III JAVELIN Bladder 100 trial that compared the outcomes between the best supportive care (BSC) and Bavencio+BSC. Study results showed the median overall survival (OS) was extended by over 7 months for patients who received Bavencio+BSC compared to BSC care alone, and the risk of death was also reduced by around 31%. Jae-lyun Lee, professor of Oncology at Seoul Asan Medical Center, said, “Urothelial carcinoma, which is the most common type of bladder cancer, accounts for around 90% of all diagnosed cases. Around 12% of patients are diagnosed at an advanced stage, and the 5-year survival rate of patients who have distant metastasis is only around 6%, showing the dire need for a suitable treatment that could treat or extend the life of these patients.” Bavencio was approved as second-line treatment for Merkel cell carcinoma in March 2019 and was first listed for reimbursement last October for the same indication.
- Company
- Myungin signed an exclusive license agreement for Parkinson
- by Nov 23, 2021 05:54am
- Myungin announced on the 22nd that it has signed a license and investment contract with Israeli pharmaceutical company Pharma Two B (P2B) for commercialization of Parkinson's disease treatment in Korea. P2B001, which is being developed by P2B, is a new combination of low-dose sustained-release drug Rasagilin and sustained-release drug Pramipexole, which is widely used for Parkinson's disease. It is manufactured to solve unmet demand while minimizing side effects by combining two drugs that act as different pharmacological mechanisms. P2B001 is taken only once a day, and dose control is not required. P2B completed multinational phase 3 clinical trials of P2B001 in 70 regions of North America and Europe. It is planning to announce the results of phase 3 top line within this year. The goal is to release the product in 2023 after applying for permission in the U.S. and Europe in the second quarter of next year. With this contract, Myungin has the right to commercialize and manufacture P2B001 exclusively in Korea. To this end, Myungin will invest $5 million (about 5.9 billion won) to make equity investments. "P2B001 has the potential to become a new treatment that combines different mechanisms for patients suffering from Parkinson's disease," said Lee Hae-myung, chairman of Myungin. "We hope that cooperation with P2B will provide necessary treatment for patients with Parkinson's disease in Korea."
- Company
- Maven Clad can be prescribed in Big 5
- by Eo, Yun-Ho Nov 23, 2021 05:54am
- Maven Clad, a new drug for multiple sclerosis, has completed its entry into the Big 5 Advanced General Hospitals. According to related industries, Merck's highly active multiple sclerosis treatment Maven Clad (Cladribine) has currently passed DC of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, AMC, and Sinchon Severance Hospital. MavenClad is the first short-term oral treatment to show overall significant effects in terms of the degree of progression of physical disability, annual recurrence rate, and number of active lesions shown in MRI (magnetic resonance imaging) tests. The efficacy of this drug was confirmed through long-term follow-up data of the 8-year prospective observational registry PREMIERE study, along with CLARITY Phase III study and CLARITY Phase II study, which corresponds to CLARITY expansion clinical trials. In a two-year CLARITY 2 and 3 study, post-analysis of patients with high disease activity showed a 67% reduction in annual recurrence rate in patients with Maven Clad, and an 82% reduction in extended disability status scale (EDSS) indicating disability progression in the Maven Clad administration group. However, lymphocytopenia and shingles can occur as significant adverse reactions when administered with Maven Clad, so patients' lymphocyte levels must be measured before and during administration of Maven Clad to patients with multiple sclerosis. Maven Clad administration is prohibited in certain groups, including patients with impaired immune function and pregnant women. Maven Clad recently released retrospective observational study data and analysis results related to COVID-19 vaccination in patients with multiple sclerosis. In the case of patients receiving immunosuppressive treatment for autoimmune diseases such as multiple sclerosis, vaccination is recommended because they are more vulnerable to COVID-19 infection and are more likely to be severely transmitted if infected. A recent independent study in Israel targeted 23 patients with recurrent dysplasia (at least 4.4 months after treatment) treated with Maven Clad. As a result of the study, all 23 patients were confirmed to have a protective IgG antibody response to the COVID-19. Dimitrios M. Karussis, a neurologist at Hebrew University in Israel, explained, "If immunity is reduced due to immunosuppressants, the immune response of the COVID-19 vaccine may decrease or affect its efficacy, so patients and medical staff were deeply concerned." In addition, he added, "This study is very encouraging data for multiple sclerosis patients and medical staff in such a situation, and it is also meaningful because no unexpected safety problems were found compared to healthy ordinary people when vaccinated with Maven Clad."
- Policy
- Brilinta’s price cut 30%, Nexavar’s premium stays 1 year
- by Kim, Jung-Ju Nov 23, 2021 05:54am
- The insurance price of AstraZeneca Korea’s Brilinta tab. 90mg (ticagrelor) and Daxas tab. 500μg (roflumilast) will be reduced by 30% through the government’s ex-officio adjustment starting next month. On the other hand, the price of Bayer Korea’s Nexavar 200mg (sorafenib tosylate) will be maintained at its level for one more year. The price of Hanlim Pharm’s Entelon, whose indications for blood circulation and ophthalmologic diseases survived the Pharmaceutical Benefit Adequacy Assessment, was voluntarily lowered by 2.6-2.9% for each dose. According to the industry, the Ministry of Health and Welfare is working to apply the ‘Amendment to the drug reimbursement list and reimbursement ceiling price table’ that contains the abovementioned changes by December 1st. First, two drug items that were newly applied premiums will end in December. The government applies a 59.5% premium or one year from the listing of the first generic. For innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated. The two items subject to this form of price cuts are Handok Teva’s ‘Teva Bendamustine Inj. (bendamustine hydrochloride)’ 25mg and 100mg. The price of the two drugs will fall 10% each from coming March 1st, 2022. One product will be maintained the premium pricing status. The government allows premium pricing period extensions for drugs produced with identical ingredients by 3 or fewer companies. The product that will be subject to an extension this time is Bayer Korea’s Nexavar 200mg. Although Nexavar’s premium pricing period was set to expire, it was able to maintain its premium due to 3 or fewer companies producing drugs with identical ingredients. Therefore, Nexavar’s premium pricing will be terminated on December 1st, 2023. If the company applies for an evaluation to maintain its premium pricing, the government and HIRA would need to conduct an evaluation to determine whether to continue applying premium. If the authorities decide to terminate the term, the price falls 23.5%. The premium pricing period for Hanmi Pharmaceuticals’ Mirabeg 50mg (mirabegron) has also expired, and its price will be cut 21.3% from the first of next month. Also, the price of Astellas Korea Betmiga (mirabegron), which had been fluctuating due to the suit filed by the company to cancel the government’s price cut decision, will be reduced by 23.6% on the same day due to the premium pricing period expiry. Three items will undergo price cuts next month through ex-officio adjustments. The government makes ex-officio price adjustments to the first-listed product and the product with the same route of administration, ingredient, and formulation as the first-listed product. The three items are AstraZeneca Korea’s Brilinta tablets and Daxas tablet. The price of Brilinta 90mg will be cut by 30%, 60mg by 29.9%, and Daxas 500μg by 30%. The premium pricing period of the ex-officio price adjusted items is set to expire on November 2022. When a generic is listed for the first time, the price of the first-listed product is given a 70% premium for a year, then returned to the original level. If 3 or fewer companies sell the same product with the identical ingredient, the government allows the company to maintain the premium for up to 5 years until the number of companies becomes 4 or more. The price of Brilinta will be reduced by 23.5% for each dose from November 21st, 2022, and the price of Daxas 500μg will be reduced by 23.5% from November 1st, 2022.
- Policy
- Benefit for 46 generics for Eliquis will be kicked out
- by Kim, Jung-Ju Nov 22, 2021 05:52am
- BMS won the patent dispute between BMS' Eliquis (Apixaban) and it's generics, which had a patent dispute between companies due to generics released before the patent expired. Dozens of generics have been forced to withdraw their benefits. Generics will be legally removed from the list immediately on the 1st of next month due to the establishment of patent infringement, and the original drug, Eliquis, will return to its original price (upper limit price). According to the industry, the MOHW is pushing for a revision (proposal) of the drug benefit list. This lawsuit is a patent dispute after being released after listing the benefit before the expiration of the original patent. Patents related to Lactam-Containing Compounds and Derivatives thereof asFactor Xa Inhibitors' are valid until September 9, 2024. In the case of original drug prices, when generic is listed, prices fall under the collective drug price reduction system. Accordingly, a lawsuit was filed against the MOHW in July 2019 and has continued to this day. In December of the same year, the MOHW already won the first trial, but in April this year, a patent registration invalidation lawsuit against generic companies was reversed and remanded, and in August, BMS Korea won the case. Until now, coordination between the MOHW and BMS is still underway. The mediation plan included ▲ adjusted and announced by promptly proceeding with the Eliquis adjustment procedure,▲ deletion the benefits of the previously listed Apixaban products ▲transitional measures not applied to drugs that have been adjusted for non-reimbursement. The MOHW is sequentially taking follow-up measures accordingly. The number of Apixaban's generics currently listed on the list is 46 items. Generic price is 635 won per tablet. The government has decided to delete these drugs' benefit as of December 1. This is because drugs recognized for patent infringement cannot be sold immediately according to Article 13(4)5 and Article 13(4)16 of the "Rules on Standards for National Health Insurance Medical Care Benefits". Therefore, all of these drugs will not be available for sale on December 1st without any further transitional measures. At the same time, the original drug, Eliquis, recovers its existing drug price on the same date. This is because all competitive generics disappear as the patent court recognizes all generics for Eliquis as patent infringement drugs. The original price is 1,132 won per tablet as a result of the Price-Volume Agreement. However, the actual drug price of Eliquis in the field of medical institutions is expected to remain unchanged. Because when the legal battle for this drug began, the drug price remained unchanged because the company immediately applied for a suspension of execution and the court accepted.
- Policy
- Lixiana latecomers apply for approval as an ODT
- by Lee, Tak-Sun Nov 22, 2021 05:52am
- Latecomers of Daiichi Sankyo’s novel oral anti-coagulant (NOAC) ‘Lixiana (edoxaban tosylate hydrate)’ were found to have applied for approval to the Ministry of Food and Drug Safety. Although Lixiana’s substance patent does not expire until November 10th, 2026, with the PMS (post-marketing surveillance on new drugs) period expiring on August 24th, the companies have immediately applied for the approval of their latecomers. One characteristic of the latecomer drugs is that they are orally disintegrated tablets (ODT) that dissolve or disintegrate in the tongue without water. According to the MFDS on the 21st, other edoxaban tosylate hydrate products that contain the same ingredient as Lixiana applied for approval on August 25th. Latecomer drugs were blocked from applying for approval during Lixiana's PMS period, which lasted August 24th. Therefore, companies applied on the 25th, immediately one day after the end of the PMS period. On how many companies have applied for approval remains unknown. However, considering the number of companies that filed patent challenges, around 10 companies could have applied for approval at the same time, because the companies need to apply for the approval to receive first generic exclusivity. 10 companies including Boryung Pharmaceuticals have succeeded in avoiding Lixiana's composition patent (which lasts until August 21st, 2028). Boryung Pharmaceutical was the first to file a passive trial to confirm the scope of the patent in July 2018 and receive confirmation in July last year. Hanmi Pharmaceutical and Chong Kun Dang followed and received confirmation. The decision was finalized after the patentee Daiichi Sankyo did not file an appeal. However, Lixiana’s substance patent stays effective until November 10th, 2026, therefore the latecomer drugs will have to wait 5 more years before their release. The latecomer drugs that applied for approval this time are orally disintegrating tablets (ODT). On the other hand, Daiichi Sankyo’s Lixiana was approved in 3 doses, all in traditional tablet formulations. However, in Japan, Daiichi Sankyo had also released orally disintegrating tablet (ODT) formulation of Lixiana. ODTs dissolve in the mouth without water and is useful for older adult patients who have difficulty swallowing traditional oral tablets. However, unlike in Japan, the Korean market prefers traditional tablets over ODTs. Therefore, the latecomers' ODT formulations are interpreted to be a means to evade the composition patent rather than market preference. DongA-ST is already conducting a bioequivalence test for its latecomer ODT formulation. Lixiana is the lead product in the domestic NOAC market over other NOACs including Xarelto, Eliquis, and Pradaxa. The market recorded ₩17.2 billion in prescriptions in Q2 alone. Also, the anticoagulant treatment market was reorganized around NOACs, supporting the steady growth of the market. In line with the trend, domestic companies have been continuously knocking to enter the latecomer NOAC market. After many twists and turns, the Xarelto latecomer market opened its doors in October this year. Domestic latecomer companies are targeting clinics to expand sales as promotion of the original drug was focused around large hospitals.
- Company
- Prolonged delay in GSK vaccine supply may cost ₩30 bil
- by Nov 22, 2021 05:52am
- The discontinuation in the supply of many GSK vaccines is causing greater ripples. With the rising possibility that the situation may be prolonged, concerns continue over the sales gap, and procurement of substitutes is rising. GSK had announced the supply setbacks of 9 of its vaccines to primary clinics and hospitals on the 25th. The vaccines that were discontinued include: ▲Rotarix (rotavirus vaccine), ▲Cervarix (cervical cancer vaccine), ▲Synflorix (Pneumococcal conjugate vaccine), ▲Manveo (meningococcal conjugate vaccine), ▲Havrix (Hepatitis A vaccine), ▲Priorix (MMR vaccine), ▲Boostrix (Tdap vaccine), ▲Infanrix-IPV, IPV/Hib (DTaP vaccine) The supply of the vaccines was suspended due to errors found in the Common Technical Document while reviewing registration logs. Since the errors are documentation-related and unrelated to quality, GSK had said it will resume shipment after submitting supplementary documents. The problem lies in the possibility of the prolonged GSK supply gap. In the field, it is said that the delay may last up to 6 months at most considering the time necessary to prepare the supplementary documents and the MFDS review period. GSK’s revenue gap from the suspended products also seems inevitable. Annual sales of its main product, Rotarix, was ₩11.7 billion. In addition, Havrix sold ₩6.8 billion, Manveo ₩4.6 billion, Synfloris ₩4.1 billion, Cervarix ₩3.3 billion, and the annual sales of all 9 vaccines grossed to approximately ₩30 billion Also, many of the vaccines that were suspended supply belong to the National Immunization Program and may interfere with essential immunizations for infants and young children. To address this concern, the Korea Disease Control and Prevention Agency advised cross-vaccination with vaccines from other manufacturers. In general, cross-inoculation of vaccines that require multiple doses is not recommended, however, due to the delay that may occur for those who already received their first dose with GSK products, the cross-inoculation was approved as an exception. The situation is better for the DTaP vaccine Infanrix-IPV and IPV/Hib, and they can be substituted with Sanofi’s ‘Pnetaxim,’ ‘Tetraxim,’ Boryung’s ‘Boryung DTaP, IPV.’ However, other vaccines have only one option each as a substitute. The pneumococcal conjugate vaccine Synflorix can be substituted with Pfizer’s ‘Prevenar 13,’ cervical cancer vaccine Cervarix with MSD’s ‘Gardasil.’ The rotavirus vaccine Rotarix can be substituted with MSD’s ‘RotaTeq.’ The concern is that since most are imported products, procurement of the substitutes may be difficult. On this, GSK said, “We are unclear on how long the process will take, but the company will make the most effort to close the gap as soon as possible.” Also, MSD, which owns RotaTeq and Garadsil said, “We are closely monitoring the situation, and will do our best to prevent any disruptions arising in the domestic vaccine supply. Also, we will work closely with the government if necessary.”
- Company
- Yuhan has secured 260 billion won in technology fee in 3 yrs
- by Chon, Seung-Hyun Nov 22, 2021 05:52am
- Yuhan Corporation is creating a case of securing additional technology fees by advancing to the development stage even after exporting new drug technologies. It has secured a total of 260 billion won in new drug technology exports over the past 3 years. It has secured more money with additional technology fees than the down payment secured by exporting new drug technologies. According to the industry on the 17th, Yuhan Corporation will receive $10 million milestone for entering phase 1 clinical trials of YH25724, NASH treatment transferred to Beringer Ingelheim. YH25724 is a drug that Yuhan Corporation exported up to $870 million in technology to Beringer Ingelheim in July 2019. Under the terms of the contract, the down payment that is not obliged to return is $40 million. Yuhan Corporation received a total of $50 million in technology exports of YH25724. Yuhan Corporation is achieving results in acquiring additional technology fees by advancing to the development stage of technology export tasks. Yuhan Corporation has signed a total of five new drug technology export contracts since July 2018. In July 2018, it transferred YH14618 technology to Spine Biopharma, a treatment for degenerative disc disease. It received a down payment of $650,000 and was guaranteed $2175 million with step-by-step milestones based on development, permission and sales. Yuhan Corporation launched Janssen Biotech's anticancer drug in November 2018. Lazertinib' technology was exported. The total contract size, including $50 million in down payment, which is not obligated to return, is up to $1.25 billion. In January 2019, Gilead Science signed a license and joint development contract for new drug candidates acting on two drug targets for NASH treatment. It is a condition that receives a down payment of $15 million and receives $777 million milestones according to development, permission and sales. In August last year, it signed a technology transfer contract with Processa Pharmaceuticals in the United States for YH12852, a candidate for treating functional gastrointestinal diseases. Yuhan Corporation received a down payment of $2 million as a stock that was not obliged to return. Yuhan has secured additional technology fees four times due to progress in the development stage after exporting new drug technologies. Yuhan Corporation received Lazertinib's milestone of $35 million from Janssen in April last year. Janssen provided additional milestones to Yuhan Corporation at the time, starting clinical trials of combination therapy between Amivantamab and Lazertinib. Yuhan Corporation received an additional $65 million in additional milestones in November last year when it began recruiting subjects for a phase 3 clinical trial of Janssen's own anticancer drug Amivantamab and Lazertinib. YH25724, which Beringer Ingelheim started clinical trials this time, agreed to receive $10 million out of the $40 million down payment when the non-clinical toxicity test was completed, but received the remaining down payment last year. As a result, Yuhan Corporation has secured $2176.5 million (about 260 billion won), including additional milestones over the past three years. Of the technical fees received by Yuhan Corporation, milestones exceeded the down payment of $110 million. The technology fees secured by Yuhan Corporation are contributing to improving its performance. Yuhan Corporation has recognized technology fee profits for 11 consecutive quarters since the first quarter of 2019. The cumulative technology fee revenue reflected for two years and nine months amounted to 217.3 billion won.
