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- 2026-04-13 17:39:02
- Company
- Medytox’s American dream falters with returned botox rights
- by Kim, Jin-Gu Sep 09, 2021 05:55am
- Medytox’s plans to overcome the license revocation in Korea by entering the US market, have come to a halt with AbbVie, which had been conducting global trials for the new botulinum toxin candidate 'MT10109L,’ returning its rights to Medytox. ◆A technology export agreement worth up to ₩400 billion was returned in 8 years On the 8th, Medytox announced that AbbVie has returned the rights concerning MT10109L, an improved botulinum toxin candidate, to its company. The right was returned in 8 years since the technology export. Medytox had signed a licensing-out agreement for its botulinum toxin candidate in 2013 to Allergan (now AbbVie) and handed over the global development and sales right of its product in all countries around the world than Korea and Japan. The agreement including the signing fee and milestone was worth $362 million (₩390 billion) The returned rights by themselves are not bad news to Medytox, as the company has no obligations to return the $100 million (₩120 billion) that it received during the term of the contract. The company had received $65 million upon signing the agreement, and an additional $35 million milestone. company However, the returned rights could be a serious blow considering Medytox’s current circumstances. Medotx’s 6 botulinum toxin products are all on the verge of license revocations. The Ministry of Food and Drug Safety had ordered the disposition to suspend sales and cancel licenses of Medytoxin 50·100·150·200, as well as Coretox, and Innotox. The court accepted Medytox’s request to suspend the execution of the administrative order, however, the MFDS’s disposition served as a major negative factor on Medytox. Medytox earned ₩140.8 billion last year, which was a 32% decrease from the previous year. To Medytox, MT10109L was the key substance that could save the company from the looming crisis. The plan was for MT10109L to enter the US market through AbbVie to overcome the crisis of license revocation in Korea. In addition, the company had planned to use the FDA approval as momentum to receive authorization for MT10109L as a new product. Until earlier this year, the plan seemed to be in smooth progress. AbbVie had started 4 global Phase III trials on a total of 1,308 subjects in December 2018. The trials were completed in March this year. The industry had expected AbbVie to submit a Biologics License Application (BLA) to the US FDA within this year. However, contrary to industry belief, AbbVie suddenly returned its rights to Medytox., putting a stop to Medytox’s plans to enter the US market. ◆Why did AbbVie return the rights after completing Phase III trials? The industry has been speculating on two reasons as to why the company had returned the rights to MT10109L after completing Phase III trials. One is the possibility of trial failure. The results of the Phase III trial may not have been satisfactory, which led to the return of rights of MT10109L to Medytox. The other is the poor relationship it has with Daewoong Pharmaceuticals. In May, Daewoong Pharmaceuticals had submitted an investigation request into MT10109L claiming that its data has been manipulated. Its argument was that MT10109L is the same product as the Innotox that was revoked in Korea, and that Innotox’s data was found to be manipulated during the MFDS investigation. On this, Medytox had refuted the claim, saying that MT10109L is a new botulinum toxin formulation and a clearly different product from Innotox. Innotox is a domestically sold pharmaceutical that complies with the MFDS regulations, however, MT10109L is a product designed for approval in the US and Europe, and is manufactured and produced in compliance with the regulations in those countries. An industry official said, “AbbVie may have determined MT10109L the same substance as Innotox. And even if the company decided the two were not the same, the FDA’s move to launch an investigation into the drug may have been a burden.” Medytox plans to soon decide whether to apply for authorization of the retrieved MT10109L in the US. A company official explained that although the rights were returned from AbbVie, the possibility of applying for approval remains as the development of the product has not been aborted. An official from Medytox said, “We have received the full clinical data from Abbvie. We will be reviewing entry into the global market while conducting data analysis. We have not decided whether to directly apply for approval or seek a new partner. It’s all being reviewed internally.”
- Policy
- A bill to revise some of the Jeju Special Law
- by Lee, Jeong-Hwan Sep 09, 2021 05:55am
- The bill banning the opening of for-profit hospitals and pharmacies in Jeju is aimed at preventing controversy over the Greenland International Medical Center by deleting special provisions on the opening of foreign medical institutions and foreign-only pharmacies. The plan aims to eliminate controversy that could cause confusion in the domestic medical system by abolishing a conditional permit system that allows the opening of foreign medical institutions and foreign-only pharmacies with permission from the Jeju Governor based on the Foreign Investment Promotion Act. Representative Wi Sung-gon of the Democratic Party of Korea submitted a bill to the National Assembly to revise some of the Jeju Special Law as of the 7th. The most important contents of the amendment are to delete Article 307 of the current Jeju Special Act, "Special Cases concerning the Opening of Medical Institutions" and Article 308 "Special Cases concerning the Opening of Foreign-only Pharmacies." Article 307 of the current law allows corporations established by foreigners to open foreign medical institutions through the approval process of the governor of Jeju Island. When permitting the establishment of a foreign medical institution, the Policy Delivery Committee for Health and Medical Service must be reviewed, and the provincial governor also included a clause approved by the MOHW. Foreign medical institutions are stipulated not to be included in medical institutions under the National Health Insurance Act and medical institutions under the Medical Benefit Act. This is the part of the provision that allows for profit-seeking medical practice. Article 308 allows foreign-only pharmacies that are not allowed by the Pharmaceutical Affairs Act to be opened after the Foreign Investment Promotion Act and the registration of the provincial governor's opening. Pharmacists engaged in foreign-only pharmacies cannot dispense and sell medicines to Koreans. However, foreign pharmacies can also be prepared and sold to Koreans in the prescription issuance group at foreign medical institutions. Foreign-only pharmacies are also not included in medical institutions under the Health Insurance Act. Article 310 allows foreign license holders to work at foreign medical institutions and foreign-only pharmacies. It also includes a clause that mandates foreign-only pharmacies to clearly indicate that they are foreign-only pharmacies inside and outside the pharmacy so that Koreans can know they are foreign-only pharmacies. A foreign license holder engaged in a foreign medical institution or foreign-only pharmacy in violation of the amendment shall be punished by imprisonment for up to five years or a fine of up to KRW 50 million. Even if foreign-only pharmacies are not properly marked, they will be sentenced to up to one year in prison or fined up to 10 million won. Rep. Wi Sung-gon abolished the special cases of foreign medical institutions (Article 307) and foreign-only pharmacies (Article 308), while carefully pointing out all provisions related to foreign medical institutions and foreign-only pharmacies. This is expected to block the possibility of opening for-profit hospitals and pharmacies regardless of the Foreign Investment Promotion Act, while eliminating the concept of foreign medical institutions and foreign-only pharmacies itself. Rep. Wi added a clause to promote the reinforcement of the publicity of health care in Jeju. Article 306 added reinforcement of publicity and development, while newly establishing matters related to major health care business plans, financing, and management. The health impact assessment of residents on climate change and other matters deemed necessary for strengthening and developing health care publicity were also added to the health care development plan. The above bill should be implemented from the date of promulgation of the enforcement date of the revised law in the supplementary provisions, and those who obtained permission to open foreign medical institutions or foreign-only pharmacies according to the previous regulations at the time of enforcement of the law can open and operate. Controversy over the legality surrounding the cancellation of the Greenland International Medical Center's permission to open remains. Jeju Island submitted an appeal to the Supreme Court against the judgment of the appeal trial on "a lawsuit to cancel the cancellation of the permission to open a foreign medical institution."
- Company
- Genome & Co acquires US firm to enter CDMO business
- by An, Kyung-Jin Sep 09, 2021 05:55am
- The KOSDAQ listed Genome & Company has acquired a manufacturing facility in the US to enter the microbiome contract development and manufacturing organization (CDMO) business. Through the acquire, the company aims to rise to a leader in both R&D and production in the microbiome market, a field with high growth potential. On the 8th, Genome & Company announced that it had acquired 966,502 shares of List Labs in the US in cash. This is equivalent to 27.17% of the company’s net worth. To internalize the production of microbiome treatment and diversify the company’s business, Genome & Company acquired 60% of List Lab’s shares and became the major shareholder of List Labs Genome & Company is a biotech company that specializes in new drug development. It was listed on KOSDAQ in December last year. The company has been using microbiomes to develop immunotherapy drugs for cancer and treatment for autism, as well as new antibody therapies. List Lab is a specialized CDMO business with 43 years of history. It owns a 2498m² sized FDA cGMP certified facility in San Jose, California that produces consigned microbiomes and biotoxins. The company had accrued an average of $9.7 million in sales annually. The company’s operation of 7 independent manufacturing spaces within the facility was positively reviewed as it allows separate production of aerobic and anaerobic microbiome-based drugs. List Labs’ manufacturing facility (Source: Genome & Company) Genome & Company’s management held an online discussion session to explain the company’s mid-to-long term vision regarding its entry into the new business area. By incorporating List Labs as the company’s subsidiary, the company aims to internalize the production of its self-developed microbiome pipeline and more stably operate clinical trials. Even after acquiring the management rights, the management said that List Lab will maintain its independent operations but expand new production facilities to increase the size of the business. The company plans to become a global microbiome CDMO leader by expanding its business area from the existing model that focused on early-phase clinical trials to late-phase clinical trials and consignment production for commercial use. The company also mentioned that it is considering listing Lists Lab on NASDAQ or other markets after the global CDMO business is in place. Microbiomes refer to a community of microorganisms. With increasing interest and attempts to affect the creation of the microbial environment for use in rare disease and cancer treatment, the microbiome industry has emerged into a blue ocean in the field of new drug development. Genome & Company expects the demand for production capacity to rise steadily in line with the continued rapid growth of the microbiome treatment market. According to the Ministry of Food and Drug Safety data, 204 microbiome treatments are currently being developed worldwide. The market size is expected to increase approximately 167 times, from $56.3 million(₩62.4 billion) in 2018 to $9.38 billion (₩10.87 trillion) in 2024. Jisoo Pae, CEO of Genome & Company who attended the session said, “Success of a microbiome-based new drug development depends on its prompt release and market preoccupation. I believe securing a CDMO will become an important factor for success in the microbiome market," He also expressed his expectations that the company’s entry into the microbiome CDMO business will add a new profit model to the company, increasing the speed of new drug development, and ultimately push the company up to a ‘first-mover’ in the global microbiome industry. Genome & Company’s microbiome CDMO project plan (Source: Genome & Company) The management had stressed that the ₩30 billion paid out in the acquisition process was 100% self-funded. The company does not plan to receive investment from external institutional investors nor intend to issue new shares. Pae emphasized, “The few media reports that Genome & Company plans to make paid-in capital increases because of the acquisition are not true. However, we may need to attract investment to expand the factory in the U.S. However, we will be attracting investments around List Labs and the U.S. subsidiary, therefore the HQ’s equity will not be affected or diluted in any way.”
- Company
- Leclaza can be prescribed at general hospitals
- by An, Kyung-Jin Sep 09, 2021 05:54am
- Leclaza Leclaza(Lazertinib Mesylate Monohydrate), a new domestic drug, is targeting the domestic lung cancer treatment market. As more than 30 major medical institutions nationwide were able to prescribe in about eight months of domestic permission, it has entered the domestic market competition, which forms 150 billion won a year. According to the industry on the 6th, Yuhan's Leclaza passed the drug committee of more than 30 medical institutions within two months of the launch of the benefit. It can be prescribed at Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, as well as upper-level general hospitals called "Big 4," National Cancer Center, Bundang Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. Leclaza became the 31st new drug to be developed in Korea with conditional approval from the MFDS on January 18 this year. Patients with T790M-resistant local progressive or metastatic non-small cell lung cancer such as Iressa (Gefitinib), Tarceva(Erlotinib HCl), and Giotrif (Afatinib Dimaleate) are subject to administration. It is a mechanism that inhibits the proliferation and growth of lung cancer cells by interfering with signaling involved in lung cancer cell growth. Yuhan released it on July 1. and applied for insurance registration on December 30 last year before the item license using the "Drug Approval-Patent Linkage System," and achieved high-speed registration 165 days after the license. Despite its therapeutic effectiveness and safety comparable to AstraZeneca's Tagrisso (Osimertinib Mesylate), which acts as the same mechanism, it was recognized for its adequacy by offering low drug prices. Academic organizations consisting of clinical specialists such as the Korean Cancer Study Group, The Korean Cancer Association, Korean Society of Medical Oncology, and Korean Association for Long Cancer also showed similar efficacy and safety to Tagrisso and had a low risk of heart toxicity. It will be a new treatment alternative for patients with local progressive and metastatic non-small cell lung cancer with EGFR T790M mutations." EGFR mutation is a very common type of mutation observed in 30-40% of non-small cell lung cancers that account for 80-85% of lung cancer, occurring between exon No. 18 and 21. It is known to be more prevalent in Asians. EGFR-TKI, which can be prescribed in Korea until the release of Leclaza, is the first-generation drugs Iressa and Tarceva, Giotrif, Vizimpro, and Tagriso. According to IQVIA, a pharmaceutical research institute, five EGFR-TKI types formed a market worth 74.3 billion won in the first half of this year. Tagrisso, classified as a third-generation drug like Leclaza, accounts for 70% of the total market with 52 billion won in sales. Based on the recommended daily dose, Leclaza's insurance upper limit is about 206,900 won. It is about 10,000 won cheaper than Tagrisso (217,782 won). An official from Yuhan said, "We are happy for Leclaza to pass the DC of major university hospitals and general hospitals nationwide at the same time as insurance benefits.With the start of Leclaza prescription in July, positive treatment effects are being derived from the treatment site." He said, "If more medical institutions can prescribe within this year, we will contribute to improving the unmet medical needs of cancer patients in Korea."
- Company
- Alunbrig proves the effectiveness of epilepsy patients
- by Sep 09, 2021 05:54am
- Competition is fierce for the first standard treatment as the second and third generation drugs, which are next-generation drugs, appear one after another in the ALK-positive non-small cell lung cancer treatment market. Target anticancer drugs targeting ALK mutations include the first generation Xalkori (Crizotinib), the second generation Zykadia (Ceritinib), "Alecensa (Alectinib HCl), and the third generation Lorviqua (Lorlatinib). A generational shift is taking place in Xalkori, which has long been the first standard treatment. Except for Lorviqua, which still has only secondary treatment indications, Roche's Alecensa and Takeda's Alunbrig are the most fiercely competitive drugs in Korea. Both are second-generation drugs and are similar, showing excellent effects on patients with brain metastasis. Alunbrig, which was released relatively late, has different convenience and tolerability from Alecensa. Dr. Ross Camidge ( University of Colorado Cancer Center), who participated in the Alunbrig online media session held by Takeda Pharmaceutical Korea on the 3rd, showed similar results that he was superior to Xalkori through phase 3 clinical trials of Alunbrig and Alecensa. This is also the case in patients with epilepsy, he said. The secondary factors Dr. Ross Camidge refers to convenience, safety, tolerability, and cost. In this respect, he said Alunbrig is a good drug to choose from as the primary treatment. Looking at the convenience, Alcensa needs to be taken 8 capsules a day and Alunbrig needs to be taken only once a day (two tablets a day in some countries). In terms of quality of life, Alunbrig maintains a high quality of life for a long time. Dr. Ross Camidge explained, "In Alunbrig clinical trials, the time point at which the Crizotinib group recorded a lower quality of life than Alunbrig was faster than expected." Early-Onset Pulmonary Events (EOPE) were also concluded to improve when the drug was stopped for a while and then taken again. Referring to this, Dr. Ross Camidge added, "If you are worried about lung abnormalities, you will not take 90mg for seven days from the beginning, but 30, 60, and 90mg for three days each, and the method of slowly increasing will be effective." Lorviqua, a third-generation drug, was diagnosed with great side effects. He said, "The PFS risk ratio of Lorviqua's phase 3 CROWN study shows the best number among existing treatments," but added, "However, there are significant side effects, with about 80% of patients taking additional drugs with cholesterol levels, and half suffer from central nervous system functional problems. Even when looking at the quality of life data, the quality of life deterioration patterns of Lorlatinib and the control group (Crizotinib) overlap considerably, he said. For this reason, controversy still persists over whether Lorviqua should be viewed as a primary treatment option. Dr. Ross Camidge said, "Personally, Lorviqua is better to be used in secondary or higher treatment situations," adding, "In particular, ALK-positive lung cancer means that there is no need to use highly toxic drugs from the beginning of treatment." He said, "If we have to use Lorlatinib as a secondary drug like Korea, we will choose Alunbrig, which has better convenience and resistance, rather than Alecensa, as the primary treatment."
- Company
- It would have been a big trouble if no improvement
- by Chon, Seung-Hyun Sep 08, 2021 06:07am
- Pharmaceutical companies are actively working on transferring drug copyrights. As drug prices of transfer and transfer drugs are allowed, the transfer of permission rights due to mergers and acquisitions or corporate separation is speeding up. It is trying to enter the new generic market by receiving expensive products from other companies. According to the MOHW on the 7th, Celltrion's Actos 15mg will be newly listed on the health insurance benefit list at 626 won starting this month. The copyright of Actos 15mg will be changed to Celltrionl. Takeda Korea's Actos 15mg was removed from the list. It is a follow-up measure to Celltrion's acquisition of Takeda's drugs. Celltrion acquired Takeda's primary care division in the Asia-Pacific region for $278 million in June last year. Takeda has all rights to patents, trademarks, and sales of 18 pharmaceutical products sold in Korea, Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. In Korea, Celltrion will take over the rights of Takeda products acquired by Celltrion. Celltrion is in the stage of completing the transfer of rights in Korea through the procedure of changing permission rights and registering drugs. The price of Actos 15mg remains the same as the previous drug price of 626 won. The previous upper limit of 626 won was maintained as the drug price succession rule was newly established in January. If the right to Actos 15mg was changed last year, drug prices are likely to have fallen significantly. Due to the reorganization of the drug price system in July last year, the drug price system was implemented, where the drug price fell as the registration time was delayed. If there are more than 20 identical registered products, generic will have a 15% lower drug price. At this time, the transfer drug was listed at the lowest price among the same products due to the application of the step-type drug price system. If the drug license is changed, it goes through a procedure of deleting and re-registration. Even if it was a previously registered product, it was inevitable to apply a step-type drug price system. When the pharmaceutical industry pointed out that it was unfair to register transferred drugs in the same way as newly registered products, the MOHW accepted the improvement of the system improvement. With the revision of the regulations, Actos was able to maintain the previous drug price of 626 won. Singulair Chewable 4mg of Organon Korea has been listed at 693 won since this month. As the license was changed to Organon, a new corporation spun off from MSD Korea, it was newly listed on the health insurance benefit list. The 4mg Singular Chewable has 59 identical products listed. If 4mg of Singular Chewable is recognized as a newly registered product, it cannot exceed 322 won. As drug prices were allowed to succeed, drug prices avoided falling below half. Organon's Vytorin 10/10 and Vytorin 10/20 were listed at 782 won and 1,093 won, respectively. Vytorin 10/10 and Vytorin 10/20 each have 48 generics listed, so new licensed products are subject to the step-type drug price system. If Vytorin 10/10 is applied as a newly registered product, it cannot exceed 481 won. However, due to the improvement of the system, the previous drug price was applied as it was.
- Opinion
- Clear standards needed for direct purchase of drugs overseas
- by Kim JiEun Sep 08, 2021 06:06am
- The world’s leading online e-commerce platform Amazon joined forces with one of the top e-commerce companies in Korea to set foot into the Korean market. The entry of this global direct purchasing giant into Korea had raised industry concerns that it would increase the illegal direct purchase of pharmaceuticals overseas and void the government’s efforts to eradicate the expanding market for such items. Aware of such concerns, 11street had prepared a separate guide on ‘precautions for direct purchase of drugs and health functional foods overseas’ to its Amazon store website and blocked the transaction of pharmaceuticals and health functional foods that contain ingredients that are not permitted in Korea. While answering that they feel partially reassured by such measures, pharmacists stressed that a more fundamental standard and measures are necessary to regulate online transactions of pharmaceuticals at a time when the direct purchase of goods overseas is being established as a culture in the midst of the rise of the e-commerce. The Pharmaceutical Affairs Act in Korea completely prohibits the sale of pharmaceuticals online. However, the Customs Act recognizes overseas transactions of pharmaceuticals as legal to a limited extent, leading to a conflict between the two Acts. In addition, the standards for overseas transactions stipulated in the Customs Act are obscure. The law stipulates that up to 3 months' worth or 6 bottles of OTCs that do not contain specific products or ingredients may be brought into the country for self-use, which leaves much room for interpretation. Some pharmaceuticals contain 100 tablets or even 1,000 tablets per bottle. The ‘Pharmacists’ Community for Future Pharmacy’ pointed out that the customs regulations mentioned above are unclear and meaningless, as a consumer may abuse the regulation and purchase up to 6,000 tablets at most to bring into the country. The illegal direct purchase of pharmaceuticals overseas had been carried out openly in many e-commerce open markets in Korea. Leading e-commerce platforms in Korea have allowed transactions of pharmaceuticals through direct purchase from overseas, including many unauthorized drugs as well as prescription drugs that should not be traded between individuals. Times have changed. E-commerce has taken over the offline retail market, and the market for direct purchases from overseas is also growing at a rapid pace. With the growth, the direct purchase of illegal pharmaceuticals has also increased explosively. This is why the government can no longer hold back revising the related laws while weighing the different perspectives held by the ministries.
- Policy
- Proposal of a bill to abolish special cases for Jeju
- by Lee, Jeong-Hwan Sep 08, 2021 06:05am
- A bill has been proposed by the National Assembly to abolish special cases for the opening of Jeju for-profit hospitals. The move is aimed at resolving the controversy over the establishment of for-profit hospitals by deleting special cases for opening foreign medical institutions. On the 7th, Representative Wi Sung-gon of Democratic Party of Korea (Seoguipo City) proposed an amendment to the Special Act on the Establishment of Jeju Special Self-Governing Province and the Creation of Jeju Free International City. The amendment is to abolish the special cases for the establishment of medical institutions stipulated in Articles 307 and 308 of the Special Act. With the permission of the provincial governor, the provisions for opening medical institutions established by foreigners will be abolished. The abolition of the provisions for opening foreign-only pharmacies and the abolition of special telemedicine for medical personnel working in foreign medical institutions were also included in the bill. Measures to strengthen the public health of Jeju Free International City were included in the bill. This is to strengthen the publicity of medical care, which is supposed to be established under Article 306 of the Special Act. It is mandatory to add projects linked to the Framework Act on National Health and Medical Service, major health and medical project plans and financing and management matters, and evaluation of the impact of residents' health on climate change. Rep. Wi Sung-gon explained, "We abolished the provisions for the establishment of Jeju for-profit Hospital, which had been in great social conflict due to controversy over the damage to the public nature of medical care, and started to improve the system on ways to expand public health at the local level." He said, "As the importance of public health care has grown even more in the COVID-19 era, we will do our best to ensure that this amendment is passed by the National Assembly."
- Policy
- 3 companies voluntarily recall varenicline products
- by Lee, Jeong-Hwan Sep 08, 2021 06:05am
- Results of the safety investigation conducted by the Ministry of Food and Drug Safety on the N-nitroso-varenicline (NNV) impurity that was found in the smoking-cessation aid varenicline showed that the impurity’s risk of harming the human body was very low. However, all drugs that contain over ‘733ng (nanograms)/day’ of NNV will be voluntarily recalled by the companies in line with the standards set by the U.S regulators, Varenicline products that will be voluntarily recalled include those manufactured (consigned products included) by CTC Bio, and consists of 2 lots of Zerocotine tab. from Vivozone, 2 lots of Nicobreak tab. from CTC Bio, and 15 lot of Nokotine S from Hanmi Pharmaceutical. The MFDS announced the results of the NNV safety investigation on the 7th. With NNV detected in all products currently distributed in Korea, the Ministry plans to conduct phased safety management measured to assess its effect on administered patients, set standards on the acceptable level of NNV intake, prepare measures for each amount of NNVs detected, and issue guidelines for HCPs and patients. According to the MFDS, the NNV detected in varenicline products distributed in Korea was very low (16.70~1849ng/day). More specifically, NNV detected in varenicline products that were sold in Korea were: 16.70~1849ng/day for Jeil Pharmaceuticals’ products, 151~632ng/day for Pfizer Korea’s, and 812~1859ng/day for CTC Bio’s products. Products from Jeil Pharmaceuticals and CTC Bio were manufactured in Korea (including consigned products), and Pfizer’s was imported. Assessment of NNV’s effect on the human body also showed a very low level of concern. The safety investigation results were conducted according to the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) standards, in consideration of the daily maximum dose of intake, NNV test results, the actual period of administration for patients who participated in the NHIS’s smoking cessation treatment support project. Assessment of NNV’s effect on the human body showed that the NNV brought further cancer risk to 0.194-0.391 out of 100,000 people. The ICH guideline defines the risk to be at a 'negligible level' if the probability is less than 1 in 100,000 people. In consideration of the toxicity value set for NTHP, another nitrosamine-class substance with a very similar structure to NNV, the MFDS set the acceptable amount of daily intake of NNV to 37ng/day. This is the same as the level set by regulation institutions abroad and was determined after consultation with the Central Pharmaceutical Affairs Council. The acceptable amount of daily intake is the amount that increases the probability of developing cancer by 1/100000 when a substance is taken for a lifetime (70 years), apart from the naturally occurring cancer. The MFDS decided to allow the lot release of varenicline products that contain NNV of 185ng/day or less for the time being. This is the same level of standards as the one that was temporarily set by the U.S. The MFDS decision was affected by the fact that the NNV detected in varenicline was at almost no health risk as found from the NNV human impact assessment, and that it is difficult to immediately reduce the NNV amount to less than the acceptable amount of daily intake (37ng/day). The MFDS comprehensively reviewed the US's temporary approval of the lot release at 185ng/day, accessibility to smoking cessation drugs for patients, and advice from the Central Pharmaceutical Affairs Council. In particular, all drugs that are currently in the market whose NNV content exceeds 733ng/day will be voluntarily recalled by the companies. This is in line with the decision made by the U.S. to distribute drugs that contain 733ng/day or less without recall. Accordingly, all lots of the 6 varenicline products from 3 companies that were manufactured by CTC Bio will be voluntarily recalled. The MFDS plans to continue working with the pharmaceutical industry so that the amount of NNV detected can be reduced below the acceptable amount of daily intake as quickly as possible, and will announce the results after the reductions are complete. In addition, the MFDS recommended that patients who have already been prescribed the said products (lot numbers) should not arbitrarily discontinue the use of the drug but consult with his/her doctor or pharmacist on continuing taking the drug or switching to a different medication. If a patient needs to switch to an alternative drug after consultation with his/her doctor or pharmacist, the patient will need to receive a prescription for the alternative smoking cessation treatment from a medical institution participating in the National Health Insurance Service’s smoking cessation treatment support project.
- Policy
- GSK's Shingrix has been granted
- by Lee, Tak-Sun Sep 08, 2021 06:05am
- GSK's shingles virus vaccine has been approved in Korea. As a result, competition between MSD and SK Bioscience is expected to take place for the lead in the market. The MFDS approved GSK's gene recombinant shingles vaccine Shingrix on the 6th. This product is a vaccine used to prevent shingles in adults over the age of 50 and those who are expected to have high risk of shingles due to disease or treatment or immunosuppressants. It is a product that injects 0.5ml IM once and twice every two months. Shingrix was approved by the U.S. FDA in October 2017. In the United States, it is recognized for its product power by beating its competitors and ranking first in market share within a year of its launch. The strong defense effect shown in clinical trials is emerging as market competitiveness. Shingrix demonstrated an ERA of 97.2% in a 3.2-year follow-up in clinical trials (ZOE-50) in adults over 50 years of age, and 89.8% in 3.7-year follow-up in 70 years of age (ZOE-70). Compared to the fact that MSD's Zostavax had a 51% ERA in patients over 50 years of age and 41% in patients over 70 years of age, Shingrix is very superior. Sky Zoster, developed by SK Bioscience, is a product that proves non-inferiority compared to Zostavax. With the launch of Shingrix, the domestic shingles vaccine market, divided by Zostavax and Sky Zoster, will inevitably be reorganized. As of last year's IQVIA, sales of Zostavax and Sky Zoster were 43.2 billion won and 29.1 billion won, respectively. However, sales of shingles vaccines are on the decline this year due to COVID-19 vaccination. When COVID-19 subsides, sales are expected to rebound again. The MFDS classified Shingrix as a new drug and designated it as a drug subject to reexamination (PMS) by September 5, 2027.
