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- The government restricted the exemption to antibacterials
- by Eo, Yun-Ho Oct 19, 2020 06:19am
- The government restricted the exemption from economic evaluation to only antibacterial agents. There is great backlash. The HIRA confirmed the amendment to the regulations regarding evaluation standards and procedures, such as whether or not drugs are eligible for medical care benefits, by publicizing internal regulations on the 8th. The revised bill was announced, narrowing the scope of exemption from economic evaluation from 'antibiotics' to 'antibacterials'. Initially, the plan to expand the exemption from economic evaluation related to antibiotics was supported by both industry and academia. However, there was controversy in terms of 'the definition of antibiotics'. The medical concept of antibiotics refers to 'antimicrobial medicines' that encompass antibacterial agents (treatment of bacterial infections), antifungal agents (treatment of fungal infections), and antiviral agents (treatment of viral infections). The continued increase in antimicrobial resistance (AMR) is one of the most important public health agendas worldwide. The issue is that the concept of antibiotics is generally confined to 'antibacterial agents'. In fact, the government clarified the definition of antibiotics as the government announced its intention to apply limited inquiries to the related inquiries of the Korean Research-based Pharmaceutical Industry Association (KRPIA). ◆Antibiotic Resistance Problems and the International Community's Approach=The WHO defines the concept of AMR as 'a threat to effective prevention and treatment of continuously increasing infections caused by bacteria, parasites, viruses and fungi'. AMR is not limited to the well-known superbacterial outbreak. Antibiotic resistance, also called ``superbugs,'' is a change that occurs when microorganisms (fungi, viruses, parasites, etc.) that cause infection, including bacteria, are exposed to antibiotics and antibacterial drugs such as antifungal and antiviral drugs. AMR is a public health agenda that should be approached, including the risk of resistance to fungi such as Candida and Aspergillus, as well as so-called 'super bacteria' such as Carbapenem-resistant bacteria and Vancomycin-resistant bacteria. The revelation of AMR makes it difficult to treat infections, increases the risk of spread of infectious diseases, occurrence of severe infectious diseases, and death. As a result, the effectiveness of the drug decreases, and the risk of continued infection in the body increases the risk of transmission to others. Worrying about the mutation of COVID-19 even before the development of COVID-19 vaccine is in the same as worrying about the emergence of resistant bacteria that are currently being developed or the treatment does not work. In fact, in the early days of the 'Global Antimicrobial Resistance Surveillance System (GLASS)', which was started to implement the Global Action Plan for AMR in 2016, the focus was on human bacterial (bacteria) infection, but in 2018 Since then, efforts have been made to narrow the information gap in other types of AMR, such as the development of a global surveillance frame for AMR of invasive fungal infections. ◆ Increased risk of secondary infection in COVID-19 confirmed patients = Cases and results of secondary infections caused by these fungi are being published in patients with COVID-19. It is known that the risk of secondary infection in the hospital increases when long-term hospitalization or long-term use of a ventilator, such as a severe COVID-19 patient. There is a need to secure sufficient infectious disease drugs in preparation for new infectious diseases and secondary infections in hospitals. Analysis of the results of a retrospective multicenter cohort study of 191 COVID-19 patients at two hospitals in Wuhan, China, found that 15% of all patients (28/191) and about 50% (27/54) of deaths were secondary infections. According to a study analyzing the prevalence of invasive aspergillosis in COVID-19 patients, about 5% of COVID-19 patients were in critical condition requiring intensive treatment, and these severely ill patients have been shown to have an increased risk of secondary infection with Invasive Aspergillosis. Jeong-Hyun Choi, Chairman of the Korean Society for Antimicrobial Therapy (Department of Infection and Internal Medicine, Eunpyeong St. Mary's Hospital, Catholic University) said, "If patients are hospitalized for a long time or use a ventilator for a long time, such as a severely ill patient with COVID-19, the risk of secondary infection in the hospital increases. In contrast to the opinion of the Society, it is very unfortunate that the concept of antibiotics has been arbitrarily reduced, contrary to the opinion of the Society, while the necessity of securing sufficient drugs for infectious diseases in preparation for new infectious diseases and secondary infections in hospitals is being raised. In addition, he expected that the 'Antibiotic Resistance Management Division' within the Korea Disease Control and Prevention Agency would be established to enable active management of antibiotic resistance. However, the problem of accessibility is on the contrary. I hope that the government will listen to the voices of the infection control site so that it is not limited to only antibacterials.”
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- Issues to look into when pricing drug by each indication
- by Eo, Yun-Ho Oct 17, 2020 06:37am
- Amending a regulatory system is not a simple work. Moreover, introducing the indication-specific drug pricing would have to entirely change the premise of the National Health Insurance (NHI) system that grants ‘unified insured pricing on a single drug.’ Regardless of the final result, the government would need to have detailed discussions and survey the public opinion. As for the industry, it is positive that the government is still open to the idea to discuss it further. In fact, Vice Minister Kang Do-tae at Ministry of Health and Welfare (MOHW) spoke during an interview with the industry news media and noted, “The indication-specific pricing could help strengthening the treatment access in severe disease patients. But the feasibility of realizing the novel payment system within the current billing structure and payment system the NHI system uses should be confirmed. And also various views of stakeholders, such as related government bodies, pharmaceutical industry and civic group, should be sufficiently surveyed as well.” And there is already a number of issues raised regarding the subject. Following are the concerned voices on adopting the indication-specific pricing; ◆Issuing a variety of drug codes and the risk of abuse: Inconvenience in administration work is inevitable. Using the indication-specific pricing would mean giving two to three unique codes on a single drug. And the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS) would undergo big changes in their billing system, which could cause confusion in healthcare institutes when inputting the main or sub disease code. Nevertheless, these are literally some ‘inconvenience’ that can be handled. When the government implemented the NHI coverage enhancement initiative and lowered the copayment rate of anticancer treatment expense to 5 percent and differentiated the billing, unique code for the variant copayment rate code was issued. In other words, issuing unique code for each indication on a single drug could be bothersome, but not impossible. However, the issue of the system abuse should be looked into. For instance, a drug could be priced at 100,000 won or 150,000 won when prescribed as a stomach cancer or liver cancer treatment, respectively, according to the indication-specific pricing. Then a healthcare institute may falsely report the drug as a prescription for treating liver cancer, when it was prescribed to a patient with stomach cancer to make profit from the difference. Actually, there are drugs containing same substance but priced individually. Regardless of the same substance, each item is approved under different name with a variety of doses and formulation. An immunosuppressant Certican and anticancer treatment Afinitor both containing everolimus, and enlarged prostate treatment Proscar and hair loss treatment Propecia sharing finasteride are prescribed under different pricing. Recently, Pfizer won separate approvals on Vyndaqel and Vyndamax sharing tafamidis and started the reimbursement listing procedure (Vyndamax). But even with these drugs, there were reported cases of abusing the drugs. People with hair loss receiving prescription of Proscar, instead of non-reimbursed Propecia, are apparently breaking the tablet into pieces to take them in smaller dose. But considering the anticancer treatment prescription scene and the initial talks on indication-specific pricing limited to RSA drugs only, it would be unlikely for the system abuse to be apparent widely. Nevertheless, the regulatory measures to manage such system abuse would be accompanied when implementing the indication-specific pricing. An official from NHIS said, “Even if it is a same drug, a pricing reasonable in one country or payment model could be inappropriate in other countries. Ultimately, it would be wise to select optimized payment model taking in account of unique situations in each countries. We need to have talks on the possibility of realizing the novel payment system within the current billing data structure and payment system.” ◆Patient acceptance and social consensus: The most fundamental issue and the core of the conflict is the patients’ reaction. Literally, the indication-specific pricing would differentiate the price of a drug a patient has to pay depending on the disease they have. And for a cancer patient, it may be difficult to accept the fact that the specific cancer they are fighting against is costing them more. In the end, the public should be aware and create a social consensus recognizing that the indication-specific pricing would ‘accelerate the reimbursement listing for anticancer treatment, and be a solution to drugs struggling to expand reimbursement on additional indication after its first.’ Patients could feel the burden of pricing, but ultimately receiving reimbursed treatment would be a better than no option at all. Also the actual price is subject to change when adjusting refund rate, but the gap would be narrowed when the copayment rate is applied. A market access personnel in a multinational pharmaceutical company urged, “Beyond the issue regarding the international reference pricing (IRP) system, the Korean offices are having more difficulties in getting the headquarters’ approval during the reimbursement expansion process. A company has to give up on expanding the coverage when a drug’s actual price, despite the labeled price, is making a loss. We want the public to understand that what the industry wants from the indication-specific pricing is not to burden the patients, but to improve treatment access for them.”
- Company
- Different use different price for same substance drugs?
- by Eo, Yun-Ho Oct 15, 2020 06:06am
- One says “Why should drugs cost the same when their effects, target patient sizes and values are different?” Another argues, “Why should I pay more for a drug that shares a common substance with other drugs?” In some way, both of those arguments make sense. And it is considered a conventional conflict of interest between a seller and a consumer. An ‘indication-specific drug pricing’ means granting a pricing on a drug based on each indication with different value of innovation the drug owns to reflect the recent changes in drugs having various indications. So far, an organization representing multinational pharmaceutical companies, the Korean Research-based Pharmaceutical Industry Association (KRPIA), has been focusing on expanding risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption eligibility. But now it is advocating differentiated pricing based on specific indication of the drug. The industry trend of one drug having numerous indications has been apparent for at least five years, considering the South Korean market only. Lately, various indications not only applicable for different lines of treatment, but also for different disease treatments have been added constantly. But why now? ◆Reactions on expanded RSA: The revised RSA system is the reason why KRPIA and multinational pharmaceutical companies have been closely following the indication-specific drug pricing. On Oct. 8, the industry was relieved to see a follow-on drug now eligible for RSA. The revised regulation provides an option of RSA to cost-effective drug (latecomer) with treatment level equivalent to first-in-class drug. However, the South Korean government also added another clause as well. Although the regulation was alleviated on follow-on drugs, the government now demands for cost-effectiveness confirming evidence (administration cost comparison or PE) from a RSA drug when expanding its reimbursement regardless of having RSA-eligible indication or not. After the said revision was disclosed, KRPIA officially addressed of ‘indication-specific drug pricing’ in an official statement submitted. At the time, KRPIA claimed “The cost-effectiveness evaluation standard’s consistency and predictability of the final price could be improved, if the drug pricing was decided based on indication. The labeled price could be kept the same, but the patients’ treatment access could improve if the contract is signed to apply differentiated indication-specific refund rate based on the actual cost-effective price for each indication.” At a glance, the indication-specific drug pricing and regulation to confirm cost-effectiveness in a drug seeking to expand RSA reimbursement, but it is far from it. Previously, RSA-applied drug coverage expansion was processed by the Health Insurance Review and Assessment Service (HIRA) setting the reimbursement standard without reviewing cost-effectiveness evidence and the National Health Insurance Service (NHIS) negotiating based on increasing patient size and use volume and adjusting the refund rate. Of course, nowadays the Cancer Deliberation Committee is the biggest hurdle for the pharmaceutical companies, but the said course of action was considered typical. But basically, it means the latecomer drugs’ pricing are lowered with the same standard as the first-in-class drug, because the authority grants minimum pricing after comparing against alternative options’ administration cost and PE results. And it creates a synergy effect when overlapped with latecomer’s drug approval, because the lowest pricing goes down as the number of follow-on drug listed with RSA goes up and listed indication expands. In other words, the industry is complaining “Why should the drug pricing always fall and never get raised? If the cost-effectiveness of an added indication is higher than the previously listed induction, then the pricing should be adjusted accordingly.” Various types of novel payment models in other countries◆The basic frame of indication-specific drug pricing as explained by the industry: Their argument is actually not a farfetched idea. The background of KRPIA and the industry’s claim is that the introduction of the indication-specific drug pricing in South Korea would highly likely to be limited to RSA-applied drugs (preferentially considered) that also adjust the refund rate. Currently, Australia, Switzerland and the U.S. are using the indication-specific pricing that mostly maintains the initial labeled price but adjusts the refund rate. And other types of novel payment models (NPM), such as combination-based pricing and over-time payments are used in Australia, Switzerland, the U.S. and Italy to improve access to new drug. The industry experts seem to agree the indication-specific pricing is the most suitable model in the South Korean market. And from the government’s perspective, the notion is not to be dismissed blindly. The self-explanatory term, ‘indication-specific pricing,’ literally means pricing a drug based on the value of each indication. If the system, as described by KRPIA, adjusts the refund rate based on the value of the indication assessed through PE while maintaining the labeled price, the government could find more grounds to lower the drug pricing. It is also important to note that most of new drug’s additional indications tend to be less innovative than their first indication. The industry’s market access associate commented, “At this point, the reimbursement listing of a latecomer drug’s first indication may be easy, but growing number of companies has started to give up on listing additional indications with complications they face. And now the patients are left behind only to watch their access to treatment get further out of reach.”
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- The patent dispute over Otezla is expected to be fierce
- by Kim, Jin-Gu Oct 15, 2020 06:06am
- OtezlaThe patent dispute over the psoriasis treatment 'Otezla (Apremilast)' is expected to be fierce. In 15 days, eight companies had a patent challenge. Considering the fact that this treatment has not yet been officially released in Korea, it is evaluated that it is receiving great attention from domestic companies. According to the pharmaceutical industry on the 14th, four companies including Mothers Pharm, Yuyu, Huons, and Cosmaxpharma challenged two patents related to Otezla on the 13th. A trial for invalidation was filed for use patents expiring in March 2028, and a trial for passive confirmation of scope of rights for formulation patents expiring in December 2032. As a result, a total of eight pharmaceutical companies challenging Otezla patents have increased. After Daewoong and Dong-A ST challenged two patents on the 29th of last month, Chong Kun Dang (5th) and Dongkoo Bio & Pharma (8th) joined. In 15 days, eight companies had a patent challenge. In the industry, there is also a possibility that more pharmaceutical companies will challenge this patent. Interestingly, Otezla has not yet been officially released in the domestic market. Otezla was originally Celgene's item. In November 2017, it was approved in Korea. At the same time, it failed to get on the reimbursed list due to the difference on the price between the insurance authority and the company. With BMS' acquisition of Celgene earlier last year, Otezla's plans to launch in Korea began to become more entangled. Initially, BMS tried to bring Otezla's copyright to it, but the Federal Trade Commission (FTC) caught up. This was the reason that BMS would be concerned about monopoly in the psoriasis treatment market if it acquired the copyright to Otezla. Eventually, BMS sold the Otezla copyright to Amgen. In August of last year, Amgen acquired global copyright for the drug for $13.4 billion. Accordingly, the domestic copyright was transferred to Amgen. It is still unclear whether the reimbursement will be applied. Even though it has not been officially released in the domestic market, companies that have challenged the patent are expecting this treatment to be sufficiently possible in Korea. It is an evaluation that it has already been verified in the global market. Otezla's global sales in 2018 were $1.6 billion (about ₩1.83 trillion). In the industry, global sales are expected to expand to $2.5 billion (about ₩2.86 trillion) by 2023.
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- SK Biopharm, to export technology for XCOPRI to Japan
- by An, Kyung-Jin Oct 15, 2020 06:05am
- XCOPRI SK Biopharm announced on the 13th that it has signed a technology export contract for the development and commercialization of XCOPRI (Cenobamate), a new epilepsy drug, in Japan with Ono Pharma. With this contract, SK Biopharm secured ¥5 billion (approximately ₩54.5 billion) in a down payment without obligation to return it. It is worth ¥48.1 billion (approximately ₩524.3 billion) for technical fees (milestone) by stages according to the achievement of permission and commercialization. Separately guaranteed royalties equivalent to two-digit percent of sales. XCOPRI is a brand for Cenobamate that was independently developed by SK Biopharm and received approval for sale by the US Food and Drug Administration (FDA) in 2019. It is prescribed for adult epilepsy patients with partial seizure symptoms. As a positive allosteric modulator of γ-Aminobutyric acid type A (GABAA) ion channel, it is known to reduce repetitive firing of nerve cells through blocking voltage-translating sodium current, thereby reducing seizure symptoms. SK Biopharm is currently pursuing large-scale phase III clinical trial to commercialize Cenobamate in three Asian countries, including Japan, China, and Korea. In the Japanese market, SK Biopharm plans to perform phase III clinical trial, and the two companies will cooperate in development and product approval. Through this contract, SK Biopharm has also secured a co-promotion option to jointly carry out commercialization with Ono Pharm. Ono Pharm is a research and development-oriented pharmaceutical company headquartered in Osaka, Japan. The main item is 'Opdivo' (Nivolumab), an immune checkpoint inhibitor, and it is focusing on the development of First-in-class drugs for diseases with cancer, immune diseases, and nervous system diseases. CEO Jo Jung-woo of SK Biopharm said, "With this contract, we are expanding SK Biopharm's position in Japan, one of the largest pharmaceutical markets in Asia." Sagara Gyo, CEO of Ono Pharma Korea said, "We are very pleased to be able to cooperate with SK Biopharm to commercialize Cenobamate. We believe that Cenobamate will be a new treatment option for Japanese patients suffering from epilepsy. "
- Company
- Law firms hire drug industry personnel to expand clients
- by Eo, Yun-Ho Oct 14, 2020 06:23am
- Former Director Lee Dong Uk (left) and Former Director Yoo Hee-sang Law firms in South Korea are busy scouting pharmaceutical industry specialists to attract pharmaceutical company clients. The related industry sources reported law firms like Kim & Chang, Lee & Ko, Yulchon and Shin & Kim have recruited external experts for their healthcare teams for the last month. Shin & Kim has welcomed a former director in Ministry of Health and Welfare (MOHW) and a former Deputy Minister of Health in Uzbekistan, Lee Dong Uk as a senior adviser. Joining the healthcare team in the firm, Senior Adviser Lee has served in MOHW for three decades as a director of Health Insurance Policy Bureau and a director of Healthcare Policy Bureau and led the National Health Insurance (NHI) and healthcare policies. In particular, he has been revered as the best specialist in NHI reimbursement policy like NHI drug pricing decision and adjustment and drug listing for reimbursement. Lee & Ko appointed Yoo Hee-sang, a former director of Medical Device Management Division at Ministry of Food and Drug Safety (MFDS), as a senior adviser. He used to be in charge of medical device management policy for 16 years in MFDS. His milestones were consigning public agency to review and approve low-risk medical device, compiling a safety management guideline for medical purpose mobile app and exempting business registration, introducing bill to set a separate Medical Devices Act, and exempting heart rate measuring device for sports and leisure activity. Although Lee & Ko shook hands with former Director Yoo, the firm bided farewell to Senior Consultant Byun Young-sik (former Senior Director at AstraZeneca) newly joining Kim & Chang. He began his career in the pharmaceutical industry from Janssen in 1994 and experienced more drug pricing and market access tasks for a decade in AstraZeneca. He was leading the reimbursement listing process for the third generation lung cancer targeted therapy ‘Tagrisso,’ and the first ever pharmacoeconomic evaluation-exempted drug and medullary thyroid cancer treatment, ‘Caprelsa.’ Based on his rich career, Lee & Ko scouted him in 2018. But with his new contract with Kim & Chang, Senior Consultant Byun would rub shoulders with Senior Advisor Lee Byeongil (former director of Pharmaceutical Management Department at Health Insurance Review and Assessment Service) and Senior Consultant Koh Su-kyung (former senior director at Norvatis). In the first half of the year, Yulchon recruited Associate Huh Na Eun (former Legal Counsel of Regulatory Reform and Legislation Division at MOHW), and the company welcomed Consultant Jung Hye Yeon (former Senior Director at Bristol-Myers Squibb) and Patent Attorney Kim Tae Kyung (former director of New Drug Listing Division at HIRA). They are a group of seasoned experts in drug pricing and NHI reimbursement listing. An associate from a multinational company commented, “The law firms are constantly contacting personnel who have experience in healthcare business from both government and the industry. As the firms are committed to expand business in new drug reimbursement consulting, more personnel from pharmaceutical companies would move to those firms in the future.”
- Company
- Daewoong's subsidiaries are all expected to turn profits
- by Oct 12, 2020 06:16am
- Daewoong's eight overseas subsidiaries are expected to make a profit this year. In the first half of this year, seven have already made a surplus. It has been about 10 years since the global organization has been in full swing. Daewoong has been the most actively seeking overseas expansion among domestic pharmaceutical companies. Starting with Indonesia in 2012, it established local subsidiaries in major Asian countries such as China, Philippines, Thailand, Japan, and the United States. Overseas subsidiaries, which have been reducing losses through steady investment for 10 years, began to turn to a surplus in the first half of this year. Daewoong Infion, an Indonesian subsidiary, recorded a net profit of ₩1.2 billion in the first half of this year from a net loss of ₩1.3 billion last year. Beijing Daewoong in China also turned to a surplus of ₩200 million in the first half from a loss of ₩500 million last year. Hyun-Jin Park, head of the global business division of Daewoong, said at a meeting with Dailypharm, “Although it has suffered a deficit while building infrastructure such as local research centers and factories, it is expected that most overseas subsidiaries will turn into a surplus this year as investments are completed and local sales continue to rise.” Director Park has been in charge of planning and executing Daewoong's global business strategy for 10 years from the organization of the global headquarters in 2010 to the present. In 2019, she succeeded Jeon Seung-ho as the head of the global business division. Daewoong seeks to enter the market in a way that targets the drug and potential market needed locally. It is focusing on biopharmaceuticals in Indonesia and liquids in China. It is a strategy that goes further from exporting flagship products that are usually sold well in Korea to foreign companies. There are many difficulties in the early stages, but if the foundation is built and successful, the synergy effect is great. In fact, Daewoong has enjoyed the infrastructure benefits it has accumulated over the years in COVID-19 situation. Due to the limited number of domestic patients, clinical trials were quickly approved through overseas subsidiaries. She said that we are thinking of a R&D corporation in Europe and other places as a plan to expand overseas in the future, and Daewoong's goal is to be among the top 10 pharmaceutical companies. The following is questions & answers of Park. Hyun-Jin Park, head of the global business division of Daewoong ▶This year, overseas subsidiaries are making a surplus. There are 7 local subsidiaries that showed a surplus in the first half of the year, including Daewoong Infion, Daewoong Thailand, Beijing Daewoong, and Daewoong India. In the meantime, it took a lot of cost and time to set up a local research institute, factory, and marketing. Sales grew steadily, but the infrastructure construction cost was forced to record a deficit. Now, most of the investments have been completed and sales are increasing, making a turnaround. All eight are expected to turn to profits by the end of the year. ▶Among the countries that entered the market, Indonesia, China, and Vietnam were selected as the core. What is the reason? All three countries are rapidly growing. However, it is only possible to enter the market only if there are local production plants. There are many advantages such as bidding if it is produced locally. Daewoong Pharmaceutical has already established a manufacturing plant and is implementing a strategy to operate it like a local company, so it was determined that this strategy can be maximized. However, the ways of entering the three countries are slightly different. Indonesia and China formed joint ventures with local companies, while Vietnam chose to invest in equity. While a local company called Trapaco already had a new factory, it was better to share R&D instead of using existing resources with equity investment, rather than investing in new plant resources because of lack of R&D know-how for the products produced. Trapaco's stake may be expanded in the future depending on the company's potential, etc. Each joint venture or equity investment has advantages and disadvantages. We are choosing an appropriate method according to each country's situation. ▶Daewoong is choosing and developing its flagship drugs according to local conditions. Indonesia's biopharmaceuticals, China's digestive medicines, and Thailand's aesthetics. In general, why do you go on a difficult path without choosing a method of using drugs that are popular in Korea as your flagship products? This is because the domestic and pharmaceutical environments are often different. For example, complex medications are popular in Korea, but not in Southeast Asia such as Vietnam. There is a way to lead a combination drug in advance, but Daewoong Pharmaceutical's strategy is to analyze and develop drugs needed locally. The Chinese plant analyzes and plans medicines needed for the Chinese market and develops them at the research institute. If locally planned and responded drugs are suitable for the Korean market, reverse export is possible. Planning and research can be done according to each local situation. ▶It has been seeking global advancement for 10 years, and it is paying off recently with a turnaround. It seems that building up infrastructure and networking for a long time was not easy. Both China and Indonesia are famous for having difficult licensing. Especially in Indonesia, where it first entered the market, it suffered a lot of trial and error. The important point was to derive a model of cooperation with health authorities while expanding local research cooperation. We have presented the Indonesian government with a vision to foster Indonesia as a bio hub in Asia. In addition, although it is a for-profit company, it is also important to present parts that can win-win with each other. Therefore, it contributed socially by lowering the insurance price of Epodion in Indonesia to 55%. By providing economic support to areas where the medical environment is less favorable than in Korea, many citizens can benefit from medical care. Currently, we are continuing cooperation with UI Universitas Indonesia, the best university in Indonesia, while conducting bio research, and we are providing support for nurturing such as establishing a bio research center and hiring local personnel to provide research opportunities in Korea. Presenting this vision, it was possible to complete the process from the factory to the license within 4-5 years. Not only domestic companies that were preparing to enter Indonesia, but also local companies were surprised that the speed was very fast. ▶Was building up local networking a great help in this COVID-19 outbreak? Since the local subsidiary has a network with both health authorities and clinical CRO companies, it was possible to quickly obtain clinical approval for the treatment of COVID-19. 'DWRX2003 (Niclosamide)', which is being developed as a treatment for COVID-19, was the first to be approved in India among countries that submitted a clinical approval plan at the same time. This was due to the fact that Daewoong Infion has been building a network so that it can be considered a local company, and has been conducting several clinical trials in India for a long time. It was also able to enter clinical trials quickly in the Philippines. ▶Over the past 10 years, it has advanced into the global market with the concept of creating 'another Daewoong'. What are the plans of the global business division for the next 10 years? If the process has been focused on generics locally until now, over the next 10 years, we will develop many new drug items through research cooperation. 'Fexuprazan', which is currently undergoing examination for approval of new drugs in Korea, is trying to enter the global market through simultaneous clinical trials in Asia. By accelerating new drug programs in Asian countries, we are trying to create a virtuous cycle in which the sales value of new drugs increases. To this end, we are considering a R&D company as a local corporation to be built in the future. In the local area, I felt that the amount of information shared and the level of collaboration change depending on whether or not there is research cooperation. Although no specific plan came out, I think it would be nice to have a research company in Europe that has not yet entered the market. we are also considering establishing R&D companies in Shanghai, China. Daewoong will try to make it one of the top 10 pharmaceutical companies in major global countries in the next 10 years.
- Company
- Pfizer seeks for approval on NSCLC drug ‘lorlatinib’
- by Kim, Jin-Gu Oct 12, 2020 06:15am
- A product image of Pfizer’s ALK-positive NSCLC treatment lorlatinib (brand name Lorbrena) Pfizer has taken a first step to launch a non-small cell lung cancer (NSCLC) treatment ‘lorlatinib’ in the South Korean market. According to a pharmaceutical industry source on Oct. 7, Pfizer Pharmaceutical Korea has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) to request an item approval on lorlatinib. After getting designated as an orphan drug in March by MFDS, the company initiated the approval application preparation in South Korea. In November last year, the product has been approved in the U.S. under the brand name Lorbrena. Lorlatinib is a latecomer to Pfizer’s anaplastic lymphoma kinase (ALK)-positive NSCLC treatment Xalkori (crizotinib). There are three generations of ALK-positive NSCLC treatments—after the launch of the first generation Xalkori, Roche’s Alecensa (alectinib), Novartis’ Zykadia (ceritinib), and Takeda’s Alunbrig (brigatinib) have emerged as the second generation drugs. Currently, Xalkori, Alecensa and Zykadia as first-line therapy and Alecensa, Zykadia and Alunbrig as second-line therapy are available to treat patients with ALK-positive NSCLC. Technically, however, there were no other treatment option for patients who have relapsed after using Xalkori as a first-line therapy and a second generation ALK-positive NSCLC treatment as a second-line therapy. Lorlatinib has received high expectation from those relapsed patients and their healthcare providers. In fact, MFDS approved of total 326 items for treatment purpose uses, and 134 cases (41 percent) were for lorlatinib. The item definitely topped the treatment purpose use approval record in this year. The clinical trials on lorlatinib disclosed so far have found the drug demonstrates meaningful level of treatment efficacy in patients who have developed tolerance to other options. Also, it was reportedly effective on patients with brain metastasis. Pfizer Pharmaceutical Korea avoided making an immediate comment about the plan after the item approval. An official from the company said, “The company would do its best to expand patients’ access to lorlatinib in South Korea.”
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- Roche Diagnosis provides COVID-19 customized diagnostic test
- by Oct 08, 2020 06:23am
- Roche Diagnostics Korea, which celebrates its 30th anniversary, has promised to provide rapid diagnostic tests in the pendemic. On the 6th, Roche Diagnostics Korea held an online press conference to commemorate the 30th anniversary of its founding, highlighting the value of diagnosis and the role of Roche Group in the situation of COVID-19. At this meeting, Hyung-ju Kim, head of Roche Diagnostics Korea, said that it has quickly provided the most suitable diagnostic method according to the progression of COVID-19." Hyung-ju Kim, head of headquarters, presenting at the press conference for the 30th anniversary of Roche Diagnosis Korea In February, when COVID-19 began to spread in Korea, the company first supplied nucleic acid extraction reagents, the core of the kit, to Korea in order to receive the Emergency Use Authorization (EUA) for a diagnostic kit that can screen patients with COVID-19. In addition, in preparation for the spread of COVID-19 around the world, it was the first to receive EUA approval from the US Food and Drug Administration (FDA) on March 12. In May, Roche Diagnostic's new antibody test 'Elecsys', which measures COVID-19 antibody in the blood and helps to identify the immune response, was additionally approved in the United States. At a time when the number of COVID-19 confirmed patients around the world increased rapidly, on-site test kits were released that can be diagnosed quickly. Most recently, in preparation for twindemic, where two viruses are simultaneously prevalent due to influenza (influenza), it has provided a field test that can simultaneously detect the flu virus and COVID-19. Currently, a screening for the COVID-19-flu simultaneous diagnosis kit is underway in Korea. Director Kim said that Roche Diagnosis is a standardized large-capacity PCR test system for the detection of flu and COVID-19 to help patients with respiratory infection symptoms receive accurate treatment. Also he added that the test system supports patients with respiratory infection symptoms so that they can receive accurate treatment, speed and medical access have been improved since nucleic acid extraction and testing can be performed in one system. He added, "In the future, we will make great efforts to quickly respond to the COVID-19 situation." In addition, Korea's rapid response system was supported, and it was selected as an exemplary case for quarantine in the world. Kwon Gye-cheol, chairman of the Korean Society for Diagnostic Laboratory Medicine, said, "We were able to actively respond from the early days of the outbreak of COVID-19 while maintaining close cooperation with the Roche Diagnosis and other related institutes, and successfully establish a quarantine model." Also he added that we hope that Roche Diagnosis and the academic community can continue joint research to respond to infectious diseases.”
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- MSD on final stretch with Keytruda coverage expansion
- by Eo, Yun-Ho Oct 07, 2020 06:09am
- MSD Korea made the last move for the Keytruda coverage expansion. Now it is back to the government’s turn to make the decision. Related industry sources confirmed, MSD has submitted the final financial expense sharing plan to Health Insurance Review and Assessment Service (HIRA) after revising the detailed strategies regarding the reimbursement expansion of immunotherapy Keytruda (pembrolizumab) in treating patients with non-small cell lung cancer (NSCLC) as a first-line therapy. Accordingly, the Cancer Deliberation Committee would be able to revisit the matter on Oct. 14 at earliest. The next session would be Keytruda’s eighth Cancer Deliberation Committee review. If the upcoming session does not include Keytruda in the agenda, the reimbursement expansion talks would be delayed by more than a month. The Cancer Deliberation Committee deferred Keytruda’s reimbursement expansion once again on Aug. 26, claiming the expense sharing plan was insufficient. HIRA then relayed the financial plan discussed among the committee to MSD in early September and demanded a revised version. The health insurance authority actually took the version positively as it was flexible on the conflicted clause of ‘the pharmaceutical company to pay for the initial three-cycle administration cost.’ As the MSD’s global headquarters was unconvinced of the clause, the company certainly seemed like it won a wiggle room in expanding the coverage. However, the government proposed MSD to resubmit a financial plan including a new clause equivalent to the initial clause. The company immediately started revising the plan, and sent in the latest version right before the Chuseok holiday. It seems like the company has a similar clause that could replace the clause of ‘initial three-cycle administration cost payment.’ If the Cancer Committee refuses the new financial plan, Keytruda’s attempt to expand coverage would be technically over. MSD official noted regarding the issue that “The company has presented a new version of Keytruda expense sharing plan to receive reimbursement as a first-line therapy treating NSCLC, prior to the eighth Cancer Deliberation Committee session. The revised version has thoroughly reflected the recommendations made by the committee in August, and increased the company’s part of the expense sharing as a final stretch.”
