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- 2026-03-18 20:22:39
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- All bets are off for patent dispute of Galvus
- by Kim, Jin-Gu Nov 18, 2020 06:36am
- 가브스 제품사진. The patent dispute over the DPP-4 inhibitor-based diabetes treatment'Galvus (Vildagliptin)' turns around and ends at the KIPO. The Patent Court of Korea sided with Novartis, and Ahn-gook, who lost, gave up the Supreme Court appeal, and the KIPO finally took over the case again. According to the pharmaceutical industry on the 17th, Ahn-gook abandoned its appeal to the Supreme Court after losing the second trial in patent dispute of Galvus with Novartis. With Ahn-gook giving up his appeal, the stage of the dispute is expected to shift back to the KIPO. ◆Conflicting 1st and 2nd Judgment... Material patent invalidation period 187 days → 55 days Ahn-gook and Novartis have been in dispute for more than three years. The issue is how much of the'extended duration' of Galvus material patent of Galvus is invalid. When Novartis first registered the material patent of Galvus, it requested that the patent duration be extended by the time it took to supplement the data required by the MFDS. The request was accepted by the Patent Court of Korea, and the duration was extended by two years and two months. In short, the material patent expiration has been delayed from January 2020 to March 2022. In July 2017, Ahn-gook argued that some of this extended substance patent duration was invalid. The KIPO sided with Ahn-gook. Out of a total of two years and two months, it was decided that '187 days' was invalid. ◆Novartis objected. The KIPO filed a lawsuit in the Patent Court to cancel the trial decision. After the patent court of Korea ruling, Ahn-gook had two options. Through appeal, the Supreme Court had to more actively insist the period of invalidity, or whether to renounce the appeal and return to the Patent Court of Korea to be tried again. Consequently, Ahn-gook chose to abandon the appeal. To choose to go to the Supreme Court, an appeal must be filed within 14 days of the date the decision was reached (October 30), but Ahn-gook did not file an appeal within the deadline. It is said that Ahn-gook was deeply concerned about the decision to abandon the appeal. The reason Ahn-gook struggled was that the second trial ruling was unclear. Ahn-gook benefited from the court's ruling in some of Novartis' prevailing decisions. Although the period of invalidation of Ahn-gook was reduced from 187 days to 55 days, it is still evaluated that it is not practically bad in that some were recognized as invalid. Moreover, considering that there has been no case of overcoming the duration of an original material patent by invalidity even for a single day, it is worth just 55 days. With Ahn-gook's renunciation of appeal, the dispute is expected to continue at the KIPO again. It has a similar shape to the case that the superior judge canceled and returned the lower court in the general court. ◆Will the KIPO accept the judgment of “55 days” The key is whether The KIPO will accept the opinion of the Patent Court of Korea's '55 days of validity'. In the usual remand after reversal case, the lower judge mostly cites the opinion of the higher one. However, in this case, Novartis is strongly opposed to acknowledging the period of invalidity, and the dispute is expected to develop fiercely again. If the KIPO accepts the opinion of the Patent Court of Korea, the release date of Ahn-gook's Galvus generic is likely to be delayed by 130 days from mid-August 2021 to early January 2022. A pharmaceutical industry patent official said, "Novatis, who won the second trial as Ahn-gook gave up the appeal, has legally lost its appeal status. Patent dispute of Galvus is automatically resumed at the KIPO." "The dispute between Novartis and Ahn-gook will be fierce again over how much invalidity will be," he said.
- Company
- General hospitals pass antifungal Cresemba for prescription
- by Eo, Yun-Ho Nov 18, 2020 06:35am
- South Korean general hospitals have started registering Pfizer’s novel antifungal Cresemba for prescription. According to pharmaceutical industry sources, the Drug Committee (DC) at the Big Five general hospitals and other healthcare institutes in South Korea, including Seoul Asan Medical Center and Severance Hospital, have cleared Cresemba (isavuconazonium). In last January, the Ministry of Food and Drug Safety (MFDS) has approved Cresemba, indicated to treat adult patients in age of 18 and older with invasive aspergillosis, and adult patients in age of 18 and older with mucormycosis for whom amphotericin B is inappropriate. With a wide variety targeted antifungal spectrum, Cresemba can treat both invasive aspergillosis and invasive mucormycosis. The drug is currently the only azole antifungal in South Korea indicated for invasive mucormycosis. However, the drug faces an issue with the healthcare reimbursement. In last month, the Health Insurance Review and Assessment Service (HIRA) internally revised the regulation on the pharmaceutical reimbursement subject evaluation standard and procedure. HIRA narrowed the scope of prospective subject for pharmacoeconomic (PE) analysis exemption, initially suggested as ‘antibiotics,’ to ‘antibacterials.’ Both the industry and academic scholars supported the government’s plan to expand the subject scope of the PE analysis exemption. But their definition of antibiotics was controversial. Medically speaking, an antibiotic means antimicrobial medicines that cover antibacterial, antifungal and antiviral. And the constant increase of antimicrobial resistance (AMR) is considered as the most critical public health risk around the world. Due to the major public health risk, some were disputing over unifying the definition of the new PE exemption subject—antibiotics—as ‘antibacterial’ based on the variant definitions of antibiotics. And the government sealed the deal by ‘limiting the exemption to ‘antibacterial’.’ Cresemba, categorized as an antifungal, is in shock of the government’s decision. President Choi Jung-hyun (Catholic University of Korea Eunpyeong St. Mary's Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “The risk of secondary nosocomial infection increases higher, when a patient with COVID-19-like severe disease is hospitalized for a long term or uses respirator for a long term. While the demand for securing sufficient amount of infectious disease drug is becoming ever more important to respond against novel infectious disease and secondary nosocomial infection, it is regretful that the government had to neglect the academic society’s advice and narrow down the definition of antibiotics.” Including South Korea, the number of fungal infection cases around the world has been surging as more than one million people reportedly die annually from fungal infection. However, the number of developed antifungal is limited. Among all fungal infection, the invasive aspergillosis is considered as one of three most dangerous invasive fungus to the human race. Even in Korea, the infection is counted as one of most frequent causes of death in patients with immune deficiency, due to increased number of patients receiving anticancer therapy and fighting against AIDS.
- Company
- How can the domestic drug price system be improved?
- by Nov 17, 2020 06:28am
- As drugs that target specific genes or activate the immune system to treat diseases have been released, the use of one drug for various types of cancer has become more frequent. As of 2018, 75% of target anticancer drugs are multiple indications, and in the case of immune anticancer drugs, thousands of single and combined clinical trials for various carcinomas are reached. There are many opinions that the current drug price system needs to be changed. This is because, as indications are added, only the factors that lower the drug price increase, reducing the patient's access to new drugs. How can the domestic drug price system be improved? To find the clues, Dailypharm held the 40th Future Forum on the 11th at the Moonjeong-dong office building under the theme of 'prerequisites for introducing drug prices by indications'. From left, Professor Dongcheol Seo (Chair), Professor Mihye Park, Secretary Kyungho Choi, Manager Younghee Lee, and Chiyoung Ryu The forum was attended by Professor Seo Dong-cheol of the College of Pharmacy at Chung-Ang University. Park Mi-hye, professor of the College of Pharmacy at Sungkyunkwan University, Choi Kyung-ho, secretary of the Department of Health and Welfare Insurance and Pharmaceutical Affairs Department, Lee Young-hee, head of the Drug Price System Improvement Department of the Health Insurance Corporation, and Ryu Chi-young, director of the Korea Global Pharmaceutical Industry Association (KRPIA), attended. Prof. Mi-Hye Park, who came out as a speaker on this day, analyzed the drug price system for each foreign indications under the theme of 'A measure of valuation when expanding indications of new drugs-Focusing on immune anti-cancer drugs and targeted anti-cancer drugs', and suggested the most suitable method for the domestic environment. Currently, Korea is maintaining or lowering drug prices in consideration of the additional usage (additional financial requirements) of already approved drugs. This is a method that recognizes only the first value assigned at the time of listing of the first salary and not the value of other indications. For this reason, as the standard is expanded, the drug price gradually decreases. Based on the standard anticancer drug, as the number of supplementary extensions increased, the tendency of drug price cuts was more pronounced, and as indications increased, the dropping rate was found to be greater. Professor Park Mi-hye Prof. Park pointed out that the current method, which does not recognize the value of additional indications, is also contrary to the 'value-based evaluation system', which determines whether or not to pay benefits based on relative clinical usefulness and cost-effectiveness when listing new drugs. .This is because even if an unlicensed drug proves high value in a new indication, it is excluded .There are also concerns about this .Professor Park Mi-hye explained, "If the value of the additional indication is higher and it is not recognized as a drug price, there is a possibility that pharmaceutical companies will not promote the expansion of the standard." In the light of research by Cole et al., "If the value of each indication is recognized, high-value indications can receive high drug prices .Therefore, pharmaceutical companies will be more active in research and development on new indications, so that patients' treatment options can be wider .Therefore, social welfare can be further increased.” Differential structure of drug prices by actual indication, such as Australia and Italy How to determine reimbursement of multiple indication drugs abroad ?As a result of an analysis of the survey published this year by Professor Park by the OECD, it was found that there are no countries that explicitly operate the drug price system by indication, but some countries are implementing a structure in which the price of drugs by indications is substantially different for certain drugs .As a result of the OECD survey, Australia, France, Greece, and Italy said that when an indication is added, they concluded a new RSA and the drug price was substantially different Norway and the UK charge all indications at that price when cost-effective .Australia and Germany calculate single-weighted pricing for each indication, reflecting the cost-effectiveness of the patient group for each indication when determining drug prices for multiple indications .In addition, Italy, Belgium, France, Switzerland, etc .negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different .Professor Park said, "Typically, Australia is making changes by calculating a single weighted average price by referring to the Medicare data collected during the prescription period." "Also, Italy has established a registry very well for nearly 20 years, so that which drug is suitable for any indication of a patient .It is possible to track how much it has been used .Based on this, different types of risk-sharing drugs are implemented for each indication even for the same drug." In addition, Italy, Belgium, France, Switzerland, etc .negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different With the increasing number of anticancer drugs with multiple indications, what is the most appropriate drug price system considering the domestic environment ?Prof .Park disclosed the results of the survey to practitioners related to drug prices of pharmaceutical companies registered with the Korea Global Pharmaceutical Industry Association (KRPIA), the Korea Biopharmaceutical Association (KoBIA), and the Korea Pharmaceutical Bio Association (KPBMA) .System 3 is the most supported from▲ Calculation of a single weighted average price according to the value of each indication (system 1), ▲ application of a different risk-sharing system for each indication (system 2), and ▲ different drug prices for each indication (system 3) .Professor Park said, "The majority of respondents evaluated the current system as negative in terms of improving access to new drugs and reflecting appropriate values, and more than 90% agreed with System 2, which received an overall positive evaluation in the direction of system improvement." He said that the way to give different drug prices is practically limited .Based on this, Professor Park proposed to introduce a method that practically differentiates drug prices by applying different types of risk-sharing system for each indication, as in Italy .Professor Park said, "In Korea, RSA is already being implemented, and since 2018, selective benefits have been introduced to medicines, and a system that differentiates the level of reimbursement for each patient has been established, so it seems to be a sufficiently accessible policy." Even when considering harmony, it is considered the most feasible solution." He added, "Currently, the RSA application is operated on a relatively strict basis, so it is difficult to apply it to all drugs for which indications are expanded .This part requires coordination." Professor Park said, "In the future, the possibility of expansion of the indications for anticancer drugs is very high, but the potential risk is left alone .If this situation is repeated, the damage will eventually be suffered by the patients .It is time for a future-oriented policy alternative."
- Company
- A heated panel discussion on indication-basis drug pricing
- by Eo, Yun-Ho Nov 17, 2020 06:27am
- In this day and age of a single drug offering a variety of indications, the problem now lies on the drug pricing. The negotiation between the South Korean government and pharmaceutical company is slowing down and the patients have to wait longer as the country’s drug pricing system cuts the pricing when a drug expands its uses. From left: Professor Suh Dong-churl as speaker, Professor Park Mi Hye, Deputy Director Choi Kyung-ho, Director Lee Young-hee and Senior Manager Ryu Chiyoung On Nov. 11, Daily Pharm convened the 40th Future Forum on the topic of priorities in introducing the drug pricing system by indication. The pharmaceutical industry, government and academic society representatives gathered to find the answer of unending question of treatment access and appropriate pricing. Professor Suh Dong-churl of Chung-ang University College of Pharmacy led the forum as a speaker, where Professor Park Mi Hye gave a keynote speech on ‘Introducing Indication-basis Drug Pricing to Improve Patient Access,’ followed by a heated discussion among panelists like Deputy Director Choi Kyung-ho of the Ministry of Health and Welfare (MOHW) Pharmaceutical Benefits Division, Director Lee Young-hee of National Health Insurance Service (NHIS) Drug Pricing System Improvement Division and Senior Manager Ryu Chiyoung of Korean Research-based Pharmaceutical Industry Association (KRPIA). Senior Manager Ryu Chiyoung ◆The need of introducing the indication-basis drug pricing system: The indication-basis drug pricing system decides the price of a drug by each indication and its innovativeness. Last month, the industry finally solved the problem of applying risk sharing agreement on follow-on drugs that have treatment level on par with a first-in-class drug and favorable cost-effectiveness. However, the government has added another condition; while allowing follow-on drugs to sign RSA, any drug seeking to expand reimbursement, regardless of being the RSA subject, would have to prove cost-effectiveness (administration cost comparison or pharmacoeconomic (PE) analysis). In other words, when the Health Insurance Review and Assessment Service (HIRA) requires cost-effectiveness evaluation, a drug would be priced at lowest level compared to either PE or clinical evidence with reference drug, and have the price reduced according to the same standard as the first-in-class drug. Senior Manager Ryu Chiyoung stated, “These days, a single drug now gains 15 to 20 indications through various researches. But if their pricing drops as they expand indications, then which company would voluntarily take an additional action to actually expand the indication? KRPIA proposes the government to apply weighted average pricing by indication or to adjust refund rate, if it looks for cost-effectiveness when approving additional indication.” Deputy Director Choi Kyung-ho He added, “Besides the system revision, many of market access managers in multinational companies are struggling to negotiate with the headquarters on supplying new drugs in South Korea. Increasing number of other countries using the international reference pricing (IRP) is worsening the risk of the ‘Korea Passing’ phenomenon.” ◆The unavoidable issue of ‘financial burden’: When the reimbursement scope of a drug is extended, patients receive the benefit, but at the same time the financial burden also gets bigger. Under the National Health Insurance (NHI) system, the government has to contemplate on cost-effectiveness whenever it lists a new drug. The controversial premise of ‘reducing drug pricing when use is expanded’ is also a result of the contemplation. Deputy Director Choi Kyung-ho said, “Taking a look at immunotherapy, the indication expansion of the drug in South Korea has been sluggish compared to the company’s expectation. Two to three indications are added a year. If the talks on reimbursement are delayed, more and more indications would be left non-reimbursed.” But the deputy director also explained, “The additional expenditure for the expanded reimbursement is through the roof and the indication-basis pricing is unprecedented. The government does see the issue, and it would try to find the point of agreement through thorough discussion.” Regardless, the academic scholars highlighted another means of approaching the issue. Director Lee Young-hee Professor Park Mi Hye advised, “The NHI finance is both about drug pricing and the use. But the country heavily relies on the drug pricing that it is losing flexibility in the financial management, which is also why the industry and the government are in a deadlock for a longer period of time. It may be better to shift the paradigm away from reducing the expenditure simply through drug pricing.” However, the government is also highly concerned of the drug pricing increase due to the indication-basis pricing. Director Lee Young-hee claimed, “The drug pricing could be increased when a number of indications receive weighted average pricing or differentiated refund rate on a single labeled pricing. NHIS can only pay when it has money. The agency has no choice but to be careful about the indication-basis pricing as it is directly related to the sustainability of NHI.” The industry representative gave a clear answer on the government’s concern. Senior Manager Ryu disputed, “No company would demand for pricing increase, when adding an indication with the revised system. But, what we are saying now is that we need to adjust the current pricing reduction measure.” ◆The realistic difficulties and hastiness: The change in administration could only be cumbersome. Giving different pricing for each indication would have to input two to three codes for a single drug. Accordingly, the billing system HIRA and NHIS operate would have to undergo a significant change, and even the healthcare institute could get confused by inputting the major and minor disease codes. Professor Park Mi Hye Director Lee noted, “When applying differentiated refund rate, various side effects, such as erroneous claim, claim omission and the system abuse by the healthcare institute, could break out. Generally considering the detailed execution plan, the indication-basis pricing requires comprehensive revision on the system and other supplementary actions.” Some argue introducing the indication-basis drug pricing to the South Korean market could be a hasty decision at the moment. Director Lee elaborated, “From 2013 through 2017, total 45 novel anticancer treatments were released in the Korean market, and the number indications surged from 265 to 935. So far, only six countries have adopted the indication-basis pricing, although all countries are experiencing the same issue with indications and pricing. It testifies how the system is difficult for everyone accept.” KRPIA official rebutted the claim straight on. Senior Manager Ryu said, “The current billing system in South Korea allows input up to top ten. I beg to differ that the disease code monitoring could get difficult and cause confusion. South Korea is one of the few countries that have successfully unified and systematized the billing system. Only because other countries are not adopting the system, it would not make sense for Korea to be hesitant to take the lead and revise the system.”
- Company
- Korus Pharm is in charge of Russian COVID-19 vaccine
- by Kim, Jin-Gu Nov 17, 2020 06:27am
- COVID-19 vaccine Sputnik V product photo developed by Russia (Photo by BBC) It was confirmed that Korus Pharm, a small and medium-sized pharmaceutical company, is in charge of the Korean production of the Corona 19 vaccine developed by Russia. According to the pharmaceutical industry on the 13th, GL Rapha signed a three-party contract with the Russian Direct Investment Fund (RFID) and Yas Pharmaceuticals of the United Arab Emirates (UAE) for the production and supply of Sputnik V in September. Korus Pharm, a subsidiary of GL Rapha, is responsible for the production and supply of this vaccine. All vaccines produced by Korus Pharm are supplied to the Middle East through Das Holdings, known as a UAE pharmaceutical company. The supply is estimated to be 150 million doses per year. Korus Pharm's main business is the overseas export of antibiotics and generic drugs. The unlisted company's sales last year were about ₩38 billion. Although there is no history of directly developing and producing vaccines, it is reported that the company recently expanded its business to biopharmaceutical research and development and built related facilities. The specific contract amount related to this production and supply contract is not known, but it is estimated to be tens of billions of dollars. Vaccine production is handled by two factories located in Chuncheon and Andong. Although it has not entered full-scale production yet, it is expected that initial shipments will be possible in the first half of next year. However, Korus Pharm explained that there are no plans to sell this vaccine in Korea. An official from Korus Pharm said, "It is a plan to supply all vaccines to the Middle East according to the contract." Earlier, in August, Russia approved the world's first Sputnik V as a vaccine for COVID-19. Since then, Tthe CEO revealed the possibility of Korean production, and attention was focused on where the company was in the domestic pharmaceutical industry. However, domestic vaccine companies and CMO companies denied consignment production of Russian vaccines. GC Pharma, SK Bioscience, Ilyang, Eu Biologics, Celltrion, and Samsung Biologics. Russia chose Korus Pharm, a small and medium-sized pharmaceutical company, over Korean vaccine companies and CMO companies. Russia chose Korus Pharm because the UAE's Yas Pharmaceuticals brokered it. Korus Pharm had exported medicines to the Middle East even before the corona vaccine supply contract.
- Company
- Amgen-CKD ink co-promotion deal on Evenity
- by Nov 16, 2020 06:03am
- CEO Kim Young-joo of Chong Kun Dang (left) and General Manager Noh Sang-kyung of Amgen Korea are photographed after signing an agreement On Nov. 12, Amgen Korea (General Manager Noh Sang-kyung) and Chong Kun Dang (CEO Kim Young-joo) announced they signed a co-promotion agreement on a novel osteoporosis drug Evenity (romososumab) on Nov. 11. The two companies also renewed the Prolia (denosumab) co-promotion deal as well. According to the agreement, Amgen Korea would focus on the Prolia and Evenity sales and marketing in general hospital accounts, whereas Chong Kun Dang would center semi hospital. Their partnership is expected to consolidate the synergy effect between Amgen Korea’s all bone disease related treatment and Chong Kun Dang’s resources within the treatment area. Launched in November in the South Korean market, Prolia is an osteoporosis drug that inhibits bone absorption by targeting receptor activator of nuclear factor-κB ligand (RANKL), which is a key to survival and formation of osteoclasts. Prolia, administered once every six month, has confirmed its efficacy in reducing the risk of vertebral, non-vertebral and hip fracture. And also the drug demonstrated the effect of increasing bone density and bone fracture reduction with extensive clinical data of 10 years, unprecedentedly long for an osteoporosis drug. Evenity is an osteoporosis drug targeting the protein sclerostin that hinders bone formation, and it can be used on patients with high risk in bone fracture. The drug was released in December 2019 in the South Korean market as a first and the only treatment option with a dual effect that increases bone formation and to a lesser extent reduces bone resorption. General Manager Noh Sang-kyung of Amgen Korea stated, “We are exhilarated to extend our partnership with Chong Kun Dang for Amgen’s novel osteoporosis treatment portfolio including Prolia and Evenity to provide the treatment options to patients in South Korea.” CEO Kim Young-joo of Chong Kun Dang commented, “Chong Kun Dang would do its best to benefit even more patients with the innovative treatments by utilizing the company’s excellent sales force and the market presence.”
- Company
- Dong-A ST introduces SHR-1701 in China
- by Chon, Seung-Hyun Nov 16, 2020 06:02am
- Dong-A ST announced on the 11th that it has signed a contract with Jiangsu Hengrui Medicine to introduce the next-generation immune anticancer drug 'SHR-1701' in Korea. With this contract, Dong-A ST has secured the exclusive domestic development and sales rights of fusion protein, which is undergoing phase I and II clinical trials in China by Jiangsu Hengrui Medicine. The down payment is $2.29 million (about ₩2.5 billion). The technical fee (milestone) according to the stage of development is $8.46 million (about ₩9.5 billion). Jiangsu Hengrui Medicine will supply the finished drug to Dong-A ST. Dong-A ST headquartersAccording to the company, SHR-1701 is a fusion protein that suppresses both PD-L1 and TGF-βRII at the same time, and is expected to show anticancer efficacy against various carcinomas. It suppresses immune evasion and metastasis of cancer cells, and suppresses fibrosis of cancer cells in the tumor microenvironment, thereby removing the physical barrier that protects cancer cells from immune cells and therapeutic agents. Currently, TGF-β is known as one of the causes of the low response rate, which is the disadvantage of immuno-anticancer drugs in the mechanism of inhibition of PD-(L)1. Therefore, researches that increase the effectiveness of immuno-anticancer drugs by simultaneously inhibiting PD-(L)1 and TGF-β at home and abroad have been conducted. It is actively in progress. The company said, “SHR-1701 is expected to have improved anti-cancer effect compared to single-dose therapy and combination therapy of PD-L1 inhibitor or TGF-β inhibitor, and it is possible to reduce development cost and secure pharmaceutical price competitiveness compared to combination therapy with one single substance. That's an advantage.” SHR-1701 is currently undergoing phase I and II clinical trials in China for solid cancers such as non-small cell lung cancer, pancreatic cancer, biliary tract cancer, and cervical cancer. Jiangsu Hengrui Medicine, established in 1970, is a Chinese longevity pharmaceutical company with strengths in anticancer drugs, anesthesia, and pain relievers. Last year, it achieved ₩3.9 trillion in sales, and invested ₩620 billion, 16% of its sales, as R&D expenses. An official from Dong-A ST explained, "Through the introduction of this next-generation anti-cancer drug, we have secured competitiveness in the anti-cancer drug pipeline and the domestic anti-cancer drug market at the same time." He said, "Based on close cooperation with Jiangsu Hengrui Medicine, we will strive to help patients suffering from cancer through successful domestic development."
- Company
- GA leads newly appointed at KRPIA and global companies
- by Eo, Yun-Ho Nov 11, 2020 06:10am
- Multinational pharmaceutical companies in South Korea are busy processing a wave of new recruit changes, specifically happening around government affairs jobs. The pharmaceutical industry sources reported many of pharmaceutical companies, as well as Korean Research-based Pharmaceutical Industry Association (KRPIA), have announced a series of personnel news related to their Government Affairs (GA) and Market Access (MA) divisions. On Nov. 5, KRPIA welcomed Senior Manager Kim Minyoung as a successor to Senior Director Sean Kim to oversee MA and healthcare policy relevant tasks. Previously in charge of new drug listing at Amgen Asia Pacific, Senior Manager Kim has rich experience in marketing, GA and MA. Janssen Korea, on the other hand, appointed Senior Manager Kim Yeonhee to lead the MA team as of October, as the former MA Director Lim Kyunghwa was promoted to Janssen Asia-Pacific. Senior Manager Kim joined Janssen in 2000 as sales, and managed marketing and sales in Janssen China and Asia Pacific Region Office. Now she would also cover MA tasks as well. The anticancer drug part at MSD Korea recruited former Executive Director Park Dongjoon at Novartis as a new Senior Director in GA. Formerly affiliated under Daily Pharm as a reporter, Senior Director Park was in charge of government policy at Novartis since 2011. MSD seems to be expanding the anticancer drug business around an immunotherapy Keytruda to consolidate as a more independent sector. On the contrary, Novartis is currently in search of Park’s successor. Former MA Lead Kim Bo Kyung at UCB has apparently moved on to LG Chem as a MA Leader. UCB has not decided who would fill up Kim’s former position. Former MA Executive Director at Eisai Korea, Kim Kyongsun joined IQVIA as a part of Regulatory Affair (RA) division. Accordingly, Eisai is also looking for a new MA lead. A multinational company GA division insider commented, “As the division is an exceptionally specialized area, most of the specialists are highly sought after to take over the job immediately. So the industry frequently experiences a series of recruitment at once. But for GA in particular, some companies reach out to the National Assembly or news media outlet for the job offer.”
- Company
- A study on Korean patients by Nebilet are released
- by Nov 11, 2020 06:08am
- Menarini Korea (CEO Park Hye-young) presented the results of a BENEFIT subgroup study of Nebilet(Nebivolol, β-blocker) at the 53rd Fall International Conference on the Korean Society of Hypertension (Hypertension Seoul 2020). It was revealed on the 9th. The conference, which was held for two days from the 6th to the 7th, was conducted in the form of online streaming to prevent the spread of COVID-19 At this meeting, Seung-ju Cha, a doctor at Hanyang University Hospital, annonunced 'Impact of baseline pulse rate on the efficacy of Nebivolol in a real world clinical study for hypertension patients ', and Jaewon Lee at Hanyang University Hospital, said ‘Efficacy and safety of 2.5mg dose of Nebivolol in hypertension patients in a real world studies in Korea.’ In addition, Professor Sang Ki Cho of Kwangju Christian Hospital served as the chairman, and Professor Hak-Ryung Kim of SNU Boramae Medical Center introduced ‘Approaches to HTN Treatment with β-blockers : Findings from Real World Evidence.’ In addition, Professor Jong-young Lee of Kangbuk Samsung Hospital published the abstract of 'Efficacy and Safety of Nebivolol in the management of hypertension associated with coronary artery disease: BENEFIT-KOREA Research Results', who participated as the first author. Nebivolol is a third-generation β-blocker of hypertension treatment that selectively blocks β-1 receptors, which are mainly distributed in the heart. The advantage is that it produces Nitric oxide to dilate blood vessels, and that there is little risk of side effects of bronchospasm caused by β-2 blockade. Due to its high cardiac selectivity, it is advantageous for patients with high blood pressure with angina pectoris, myocardial infarction, tachyarrhythmia, or fast pulse. Menarini Korea conducted a BENEFIT study in 66 hospitals in Korea from July 2015 to March 2017 in which Nebilet was administered to 3250 adult hypertensive patients to observe the treatment effect for 24 weeks. The research results released on this day are the presentation of analysis results for subgroups as part of the BENEFIT study. Park Hye-young, CEO of Menarini Korea explained, "Nebilet, a third-generation β-blocker, is a product that minimizes side effects such as bradycardia, bronchospasm, and the effects of blood sugar and lipids, which were pointed out as disadvantages of the first-generation β-blockers, and enhances the blood pressure lowering effect." In addition, she said, "We will continue to prove the efficacy and safety of Nebilet through various studies to provide useful treatment options for Korean hypertensive patients."
- Company
- Daewoong,enters phase III of indications for Enavogliflozin
- by Nov 10, 2020 06:05am
- Daewoong (CEO Seung-ho Jeon) announced on the 30th of last month that it had received approval for a phase III clinical trial from the MFDS for the combination therapy of Enavogliflozin, Metformin, and DPP-4 inhibitor, which are being developed as a new drug for diabetes treatment. Enavogliflozin is a new drug for the treatment of SGLT-2 diabetes being developed by Daewoong for the first time among Korean companies. In this phase III, the hypoglycemic effect and safety of the three-drug therapy will be confirmed in 250 patients with type II diabetes who do not sufficiently control blood sugar even if Metformin and a DPP-4 inhibitor are administered together. Clinical trials are conducted in about 20 large hospitals nationwide, including the Catholic University of Bucheon St. Mary's Hospital. As Daewoong is approved for this clinical trial, from Enavogliflozin's monotherapy and combination therapy with Metformin, to three-drug therapy, Enavogliflozin will be used as a treatment for patients whose blood sugar is not controlled even when co-administered with existing diabetes treatments. Daewoong plans to expand its market share by adding indications for Enavogliflozin. In particular, Enavogliflozin was designated as Korea's first rapid review target (Fast Track) drug, allowing the period of new drug approval to be shortened. Daewoong is aiming to be released in Korea in 2023. Seung-Ho Jeon, president of Daewoong said, "Daewoong is making further efforts to expand the indication for Enavogliflozin to help control blood sugar in type II diabetes patients from mild to moderate. Enavogliflozin is also planning to expand its treatment benefits by expanding various indications besides diabetes, as it is expanding into therapeutics.” Enavogliflozin is an SGLT-2 inhibitor that selectively inhibits the SGLT-2 transporter involved in the reabsorption of glucose in the kidneys and directly excretes glucose into the urine. As a result of the phase II study, when compared with placebo alone after 12 weeks of administration in type II diabetic patients, the change in glycated hemoglobin (HbA1c), a major indicator of blood sugar control, decreased by about 0.9% compared to placebo. This is the result of a reduction of more than about 30% compared to the existing SGLT-2 inhibitors that were conducted in Westerners. In addition, the global standard diabetes control target, 'the proportion of patients who reached below 7.0% of glycated hemoglobin' reached a maximum of 61%, and the proportion of patients whose glycated hemoglobin decreased by more than 0.5% compared to before treatment reached a maximum of 72%. As a result, it showed superior blood sugar reduction effect compared to the existing SGLT-2 inhibitor.
