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- 2026-03-18 10:27:56
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- “The framework to list ultra-expensive new drugs exists"
- by Eo, Yun-Ho Apr 14, 2021 06:07am
- We are living in an era where a single injection may completely cure cancer. The catch is that the 'single dose' would cost 500 million won. Such ultra-expensive advanced new drugs are not an item of our dreams – it is already within our reach. In addition to the CAR-T (Chimeric Antigen Receptor T cells) therapy Kymriah (tisagenlecleucel) that was approved in Korea, dozens of other gene therapy and cell therapy candidate drugs are also under development, some of which are being developed by domestic biopharmaceutical companies. The regulatory authorities have also passed the ‘Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ in 2019 to reflect the changes in the new era. However, for these paradigm-shifting advanced medicines that overturn the existing concept of drug therapy to be used in real life, the lingering issue of their ultra-high ‘drug price’ needs to be resolved. How should the company that wants rightful compensation for the innovation, and the government that needs to take care of the public’s health with a limited budget, reach a consensus on the matter? Professor Hyung Ki Lee, SNUH In search of the answer, government and industry officials gathered at the 41st Pharmaceutical Industry Future Forum, "Finding the correct solution for the ultra-expensive drug listing system," held by Dailypharm at its Moonjeong-dong office. Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital, chaired the event. Various industry and government officials including Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea participated as panelists for discussion. ◆ Now is the time to fully implement the Pre-listing Post-evaluation system = The key to pre-listing and post-evaluation is ‘speed.’ The system allows drugs to skip the deliberation on the appropriateness of reimbursement and be listed first, then decide whether to continue its reimbursement by evaluating the efficacy, use amount, etc. based on real-world data. The system would speed up the listing process, however, it may also cloud the transparency of the process. People are voicing concerns about whether the cancellation mechanism of already-listed drugs would definitely work, and whether the patients will be able to accept the reimbursement discontinuation of drugs they have been taking. There also lies the controversy over the method of accumulating RWD or RWE data and its and reliability. Officer Kyungho Choi, MOHW At the event, Deputy Director Choi said, “The ‘continuity of care’ issue of pre-listing post-evaluation drugs cannot be ignored from the government’s perspective. There are problems such as difficulties in adjusting drug prices when the pharmaceutical companies do not accept the evaluation results, as well as the issue of the system weakening the drug negotiation power of NHIS.” However, the industry had a strong aspiration to implement the system as a means to ‘introduce ultra-expensive drugs to Korea.’ Of the three industry panelists that participated in the forum, KRPIA director Min-Young Kim, and Novartis's Departement Head Jae-Ho Jeong pointed to the pre-listing post-evaluation system as the top priority solution. Kim explained, “The system can be well-managed. We already have had experienced similar cases like ‘Evoltra,’ the first therapy to be listed under the Risk Sharing Agreement (RSA). The government was unable to evaluate the cost-effectiveness of Evoltra at the time of its listing, and the drug was listed under conditional coverage with evidence development. After 4 years, the company underwent data collection and a re-evaluation process maintains its reimbursement.” “The pre-listing post-evaluation system needs to be accepted as a type of RSA. The industry has long conducted negotiations and signed agreements with HIRA and NHIS for the stable supply of its products," added Jeong. "The government should show some trust based on its accumulated experience with the companies. The potential risks and countermeasures can be discussed while conducting a pilot project.” Executive Director Minyoung Kim, KRPIA The government has consistently maintained a conservative attitude on implementing the pre-listing post-evaluation system. However, at the forum, MOHW did not rule out the possibility of implementing such a system. Deputy Director Choi said, “I agree that now is the time to seriously consider the implementation of such systems. If the industry proposes a detailed action plan, we will review the plan with HIRA and NHIS. However, one thing that I hope the industry also bears in mind is that the continuity of care is not an issue that impacts the listing or delisting of a single drug product; It is an issue that needs to be considered collectively for the sustainability of NHI finances.” ◆ Considerations on ‘cost-effectiveness,’ the first criteria considered in drug evaluations = Cost-effectiveness is central to Korea’s reimbursement listing system. Industry officials agree that is an essential criterion for the system while pointing out that too much stress is being laid solely on cost-effectiveness. In addition to cost-effectiveness, the Principles on Determining Eligibility of Long-term Care Benefits list factors such as medical significance (clinical utility) and social benefits as factors for consideration. However, industry officials say that these other factors are not sufficiently reflected during reimbursement evaluations. At the forum, Director Hyeon-seok Na from JW Pharmaceutical Corp. said, “The industry does feel that the government is too focused on cost-effectiveness. Such focus on cost-effectiveness would lead so many drugs to be not approved for reimbursement listing. We hope that the weight of other factors such as social benefit should be increased” Senor Manager Hyeon-seok Na, JW Pharm. Professor Hyung-Ki Lee who chaired the event added, “This reminds me of a paper published by HIRA. It was a 2006 study that tracked the standards used by HIRA in deciding reimbursement for drugs. Results showed that drugs that had lower prices were listed and at a faster rate than those with high clinical utility.” Cost-effectiveness is a staple topic in the discussion of improving the domestic drug reimbursement system. The difficulty in demonstrating cost-effectiveness leads to requests for improving the ICER threshold and the exemption of PE assessment. On this, the government’s response is that considerations of cost-effectiveness are just a matter of order. “The government does not solely focus on cost-effectiveness in the reimbursement decision-making process. For a drug to receive reimbursement, it first needs to prove its clinical utility,” said Choi. ”Only drugs that are determined to be clinically effective are then evaluated for their cost-effectiveness. The strict evaluation criteria may be worth discussing; however, it does not mean that we have had made no efforts to resolve the issue.”
- Company
- Generic for Eliquis, stop selling after supreme court loss
- by Kim, Jin-Gu Apr 14, 2021 06:07am
- Eliquis (Apixaban)’s generic companies stop selling one after another. This is a strategy after the Supreme Court ruled in favor of the original company BMS in the Eliquis patent dispute. This is a measure to reduce the risk even a little in preparation for future lawsuits for claiming damages. According to the pharmaceutical industry on the 13th, Chong Kun Dang, Yuhan Corporation, Samjin Pharm, and Hanmi Pharm, which are selling Eliquis generics, have either stopped or stopped selling the product. An official from a company selling generics said, "We have already stopped selling them." An official from another pharmaceutical company also said, "We are actively considering a plan to stop the sale." Another pharmaceutical company official, whose sales performance of generics is not large, said, "We will follow the choices of other companies." The reason they stop selling is because of the burden of a lawsuit for damages in the future. Claims for damages are proportional to product sales. This is because the more sales, the more compensation. In preparation for this, the sale is stopped in an effort to reduce the amount of compensation even a penny. BMS officially announced a claim for damages immediately after the Supreme Court ruling. Korea BMS Pharmaceutical CEO Kim Jin-young said, "As the validity of the Eliquis patent has been confirmed, we will take all possible legal actions, including claims for damages, for any act that infringes on the patent." ◆"The amount of damages will be less than the actual sales. Fierce legal disputes expected" In the pharmaceutical industry and the legal community, damage compensation is expected to be calculated less than the actual sales of generic products. According to the drug market research institute UBIST, the cumulative combined prescription amount of generic items is a little less than 10 billion won as of the end of last year. Since its launch in July 2019, it has been prescribed 1.2 billion won that year and 8.3 billion won last year. By item, Chong Kun Dang Liquisia 3 billion won, Samjin Pharmaceutical Elxaban 1.8 billion won, Yuhan Apixaban 1.3 billion won, etc. Typically, the amount of damages due to patent infringement is determined from operating profits, not from sales of the generics. This is because the'profit' obtained as a result of patent infringement is calculated as the amount of compensation. However, it goes through a very complicated calculation process as to how much the actual profit will be viewed. For example, raw material prices are generally excluded from damages. If the generic had not been released, the raw material would not have been bought, so it is subtracted from the damages. An official in the legal profession said, "Other items are added or subtracted from the calculation of damages," and "Another legal dispute between BMS trying to receive even a penny more in relation to the calculation of damages and a generic company trying to reduce even a little will develop very fiercely." . Generic companies are also preparing for destruction and repatriation along with the suspension of sales. This is because the legal battle has not yet ended. Earlier, the Supreme Court remanded the case to the Patent Court while making a decision on the side of BMS. In general, the remand of revocation is based on the judgment of the superior judge. However, if a new allegation is raised at the remand of revocation trial, the opposite decision may be made. Accordingly, generic companies are looking for new logic to deny Eliquis' material patent.
- Company
- Geo-Young is interested in distributing botulinum products
- by Nho, Byung Chul Apr 14, 2021 06:06am
- Geo-Young and Zuellig entered the competition for the storage and distribution of Xeomin of Multz, Germany, which is the best importer of botulinum toxin products. According to the pharmaceutical industry on the 9th, Multz is conducting a competitive bidding ahead of the expiration of the contract with Zuellig, an existing Xeomin storage and distribution company, in December of this year. Xeomin's bidding is highly likely to serve as a business expansion for Geo-Young and Zuellig. Zuellig has been in charge of botulinum toxin formulations, a multinational pharmaceutical company. Geo-Young also has experience in supplying small quantities of botulinum toxins to general hospitals, but the maintenance of various systems according to the expansion of the nationwide network is a task that cannot be overlooked. This is the reason Geo-Young is making great efforts in this bid because it is highly likely to have a significant impact on the expansion of distribution rights for vaccines and biological products, including other botulinum toxin products, depending on how high the rating is received in the construction of the Xeomin storage and delivery system. An industry insider said, "Zuellig has an edge in terms of botulinum toxin distribution know-how, experience and network. However, Multz has the potential to give additional points to Geo-Young, which has a lower distribution cost compared to competitors." The storage temperature of the botulinum toxin formulation is between 2 and 8 °C, so it is important to secure a cold chain from manufacturing to distribution warehouse, hospital delivery, and final treatment stage. There are five distribution warehouses with Geo-Young's refrigeration system: Incheon Logistics Center, Gimpo West Logistics Center, Uijeongbu North Center, Seoul Gangbuk Center, and Gyeonggi Gunpo Center. Geo-Young plans to establish a new vaccine business headquarters in August, which will be in charge of marketing of biological products such as botulinum toxin, vaccine and biopharmaceuticals. The estimated number of personnel in the organization is about 30 to 40 people. Geo-Young official said, "It has not been confirmed whether Xeomin products will only be in charge of refrigeration or distribution. Zuellig has also participated in this bidding. The final contract will be decided in a month. In addition, the establishment of the vaccine division is also in the review stage, and it is not a final issue.” The earnings of Xeomin and Xeomin 50 in 2018 and 2019 are totaled at 4 billion, 600 million, and 5.6 billion and 100 million, respectively. Xeomin is the first product to remove complex proteins, and since its launch in Germany in 2005, it has been approved for safety through US FDA approval, EMA, and the MFDS, and is used in 65 countries around the world. In 2009, Han Wha signed a contract with Multz and made plans to enter the'Botox' market, such as working on an agency to acquire Xeomin's domestic license, but it is known that with the establishment of Multz Korea in 2011, it is known that when Multz Korea was established in 2011, it is known that the license rights have been renounced. Meanwhile, imported finished botulinum toxin items include Allergan's 50 units of Botox, Botox, and Ipsen's Dysport.
- Company
- MNC employees earn ₩91 million on average
- by An, Kyung-Jin Apr 13, 2021 05:19pm
- GSK Consumer Healthcare Korea employees received on average a salary of 150 million won last year. Employees at GSK Korea, Boehringer Ingelheim Korea, Sanofi Pasteur, Viatris Korea, Kyowa Kirin Korea, Galderma Korea, Pfizer Korea, and Abbvie Korea also received an average salary of over 100 million won. According to the Financial Supervisory Service on the 13th, employees and executives working at 24 Korean subsidiaries of multinational pharmaceutical companies had earned 91 million won on average last year. The amount is based on the salary of 471,742 executives and employees at 24 Korean subsidiaries of multinational pharmaceutical companies that submitted audit reports to the Financial Supervisory Service by April 12th. The average salary per person was calculated by dividing the total salary paid by the number of employees and executives listed in the audit report. Only the salary item in the selling and administrative expenses (SG&A) of the audit report was counted, and other items including the welfare benefits, bonuses, performance-related pay, and retirement allowances were excluded from the calculation. However, the amount may differ somewhat from the actual net pay received by employees depending on the description method of labor cost in each company. GSK Consumer Healthcare Korea paid a total of 12.861 billion won in employee wages last year. The number of executives and employees working at GSK Consumer Healthcare Korea as of last year was 87. As the number of executives and employees stayed the same while the total salary increased by 30.7% from the previous year, the average salary per employee rose by nearly 35 million won. GSK Consumer Healthcare Korea also paid nearly 20 billion won to its retired employees last year. Among the SG&A items, expenses listed as retirement allowance were 1.59 billion won, and 17.31 billion won was retirement bonuses. However, as the number of employees was the same as the previous year, it is difficult to determine the specific number of resignations. GSK Korea, which had kept its position as the top-paid multinational pharmaceutical company based on annual salary until 2019, ranked second place this year by a narrow margin. GSK paid 61.64 billion won in salaries last year, a 3.1% increase from the previous year. The number of executives and employees working at GSK as of last year was 434. With 7 less employees than the year before, the average salary of its people rose by 4.6%. However, as the increase rate fell short of the rate of GSK Consumer Healthcare Korea’s, GSK Korea’s rank fell one level. Boehringer Ingelheim Korea’s average salary rose by 27.4% per employee, which was the second-highest rate of increase after GSK Consumer Health Korea. Boehringer Ingelheim Korea paid 21.26 billion won in salaries last year. The company ranked 3rd place with an average salary of 133 million won, a 28 million won increase from the previous year. Sanofi Pasteur executives and employees received 129 million won on average as annual salary last year. As its number of employees decreased from 61 in 2019 to 53 at the end of 2020 while its total salary increased by 11.1%, the average salary per person rose 27.9% from the previous year. Also, companies including Viatris Korea (126 million won), Kyowa Kirin Korea (118 million won), Galderma Korea (103 million won), Pfizer Korea (102 million won), and Abbvie Korea (100 million won) also had an annual salary that exceeds 100 million won. Among the 24 companies surveyed, 9 companies had an average salary of over 100 million won, and 17 companies had an average salary of over 80 million won. The net pay that the executives and employees actually received may be higher depending on their individual performance. In the audit report, Sanofi-Aventis Korea had stated that it had paid bonuses and wages (2.8 billion won) and performance-based pay (3.3 billion won) in addition to the 47.8 billion won as labor costs. Sanofi Pasteur also listed bonuses and wages (0.4 billion won) and performance-based pay (0.8 billion won) separately from salaries. Amgen Korea had also paid 3.2 billion won as bonuses apart from the 13.8 billion won paid as salaries. In companies that have local manufacturing facilities such as Korea Otsuka Pharmaceutical and Janssen Korea, the actual net pay received by employees was found to be much different from the average salary listed in the audit. As these companies list wages of factory employees as production cost and the salary of clinical team employees and R&D cost., the method dividing the salary listed on SG&A by the number of employees could not accurately reflect the net pay received by their employees. As of last year, the average pay received by executives and employees of multinational pharmaceutical companies far exceeded the amount received by those at listed companies in Korea. Last year, the average salary of 30 KOSPI and KOSDAQ-listed biopharmaceutical companies were 70.4 million won. The amount is an average of the total salary of 2.43 trillion won that was paid to 34,323 employees and internal directors in the 30 companies. Simply calculated without considering the continuous years of service or position of the employees, the average salary per person in domestic pharmaceutical companies is lower by 20 million won. 24 companies - GSK Consumer Healthcare Korea, GlaxoSmithKline, Boehringer Ingelheim Korea, Sanofi Pasteur, Viatris Korea, Kyowa Kirin Korea, Galderma Korea, Pfizer Korea, AbbVie Korea, Lundbeck Korea, Sanofi-Aventis Korea, Amgen Korea, UCB Korea, Bayer Korea, Servier Korea, Lilly Korea, AstraZeneca Korea, Baxter Korea, Guerbet Korea, Novo Nordisk, Menarini Korea, Teva-Handok, Korea Otsuka Pharmaceutical, Janssen Korea - were included in the survey. Among the 25 Korean subsidiaries of multinational pharmaceutical companies that submitted an audit report by April 12th, Janssen Vaccine was excluded as it had minimized its operation of production facilities as well as operating personnel until the production line around its anticancer drugs and next-generation vaccines is reorganized.
- Company
- Lilly spent ₩9.7 billion in severance pay last year
- by An, Kyung-Jin Apr 13, 2021 05:46am
- Lilly Korea spent nearly ₩10 billion last year as employee severance pay. At the end of last year, the Hope Retirement Program (ERP) was launched for all employees of the sales department, and the amount of severance pay has jumped more than five times from the previous year. According to Lilly Korea's audit report submitted to the Financial Supervisory Service on the 10th, the company recognized ₩9.4 billion last year as retirement benefits. It is 5.4 times more than the ₩1.8 billion recorded in the previous year's retirement benefit. Lilly Korea has submitted an audit report for 15 years since 2006. The retirement benefits stated in the audit report submitted in 2006 amounted to ₩1.6 billion in 2004 and ₩1.8 billion in 2005. It is estimated that the reorganization carried out at the headquarters level last year had an effect. Eli Lilly headquarters last year reorganized with the aim of strengthening non-face-to-face sales activities such as digital programs and promoting productivity and efficiency within the organization. In November, the Korean subsidiary also operated ERP for 100 salespeople, including non-core fields. At that time, Lilly Korea was reported to have offered annual consolation benefits in addition to salary for years of service x 2 months + 8 months as ERP compensation. As of the end of last year, Eli Lilly had 232 employees. Actually, the number of employees who have completed the resignation procedure through ERP is not confirmed. However, compared to the 347 employees reported in 2005, the number of employees decreased by 115 in 15 years. The company has implemented ERP four times since 2014. Lilly Korea's sales last year were ₩162.8 billion, up 2.6% from the previous year. Compared to ₩113.9 billion in 2005, the scale of sales increased by 42.9% in 15 years. Operating profit was ₩10.3 billion and net profit rose 2.3% and 19.9% respectively to ₩9.5 billion.
- Company
- Yuhan distributed gold rings to all employees
- by Kim, Jin-Gu Apr 12, 2021 05:55am
- A gold ring recently issued by Yuhan to all employees. LECLAZA is engraved on the outside of the ringYuhan recently handed out gold rings to former employees, showing Leclaza (Lazertinib)'s commitment to success. According to the industry on the 11th, Yuhan provided a gold ring with LECLAZA to all employees at the end of last February. It was only a month after receiving Conditional Marketing Authorization (CMA) as the 31st Korean drug on January 18th. Yuhan's officials congratulated Leclaza for permission and wished for success in the future. An official from Yuhan said, "A ring was distributed in commemoration of the achievement of the long-aspired work." He wished the success of Leclaza and gave the entire temple a gold ring. Immediately after CMA earlier this year, a gold ring engraved with LECLAZA was delivered. Formation of a marketing team of around 10 people, preparing for full-scale market entry in June Yuhan recently handed out gold rings to former employees, showing Leclaza (Lazertinib)'s commitment to success. According to the industry on the 11th, Yuhan provided a gold ring with LECLAZA in English to all employees at the end of last February. It was only a month after receiving Conditional Marketing Authorization (CMA) as the 31st Korean drug on January 18th. Yuhan officials congratulated Leclaza for permission and wished for success in the future. An official from Yuhan said, "A ring was distributed in commemoration of the achievement of the long-aspired work. I know that the rings have been distributed to all employees as a means of encouraging the R&D department that has struggled with Leclaza permits, and at the same time supporting other departments that will lead Leclaza to success in the future." Another Yuhan official said, "Even though employees who have worked for 10 years or 20 years have received gold as a concept of long-term service, this is first time that all employees have given gold rings." Immediately after CMA earlier this year, a gold ring engraved with LECLAZA was delivered. In addition to this, it is reported that the company is preparing for marketing in earnest by forming a dedicated Leclaza team. Yuhan has formed a marketing team of about 10 people before and after the Leclaza license. It is known that they are already conducting marketing to key doctors in general hospitals and hematologic oncology specialists. The procedure for listing benefits is also going smoothly. As soon as possible, it is expected to enter the market in earnest after being listed on the benefit list in June. Leclaza was evaluated as appropriate as a benefit by the HIRA's Cancer Drugs Benefit Appraisal Committee on February 24, more than a month after CMA. The committee is the first step to benefit. On the 8th, the Pharmaceutical Benefits Advisory Committee recognized the appropriateness of the benefit, and even passed the second step. The only remaining step is actually negotiating drug prices with the NHIS. Yuhan plans to negotiate drug prices with the NHIS within the next 60 days. After that, it is finally listed through the resolution of the Health Insurance Policy Committee of the MOHW. Assuming that the drug price negotiations were successful, Leclaza took only 5 months from application to registration for the MFDS. Other anticancer drugs took an average of 34 months from approval. Leclaza was first approved as a second-line therapy for lung cancer in patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who had previously been treated with EGFR-TKI. Based on the results of a phase 2 clinical trial (therapeutic exploratory clinical trial) conducted in Korea, it was approved under the condition that a phase 3 clinical trial should be conducted after marketing. Currently, in Korea, the first-generation drug AstraZeneca's Iressa (Gefitinib), Roche's Tarceva (Erlotinib), and the second-generation drug Giotrif (Afatinib )and Vizimpro (Dacomitinib), and EGFR TKI such asTagrisso (Osimertinib) of AstraZeneca, a third-generation drug such as Leclaza, are being prescribed.
- Company
- Price hike of ‘Rotarix’ after ‘RotaTeq’ adds burden
- by Apr 12, 2021 05:54am
- The price of rotavirus vaccines for newborns is expected to increase altogether, with GSK also deciding to increase its supply price of ‘Rotarix’ after MSD’s price hike on ‘RotaTeq.’ Kwang Dong Pharmaceutical, the company in charge of the domestic supply of GSK’s Rotarix, recently sent a notice to clinics and hospitals on the decision to increase Rotarix’s supply price. The price will increase approximately 12% from the current late-70,000 won range to reach the mid-80,000 won range per dose (VAT included). The change in Rotarix’s supply price will be applied from May 1st. Prior to GSK, MSD had also raised the price of its rotavirus vaccine RotaTeq by 17%. With the price hike, RotaTeq is being supplied at a 50,000 won range starting this month. With both rotavirus vaccines increasing their supply price simultaneously, the price paid by consumers for each vaccination is also expected to increase. The current vaccination price at first-line hospitals is around 70,000-100,000 won for RotaTeq and 100,000-130,000 won for Rotarix. As Rotateq is administered 3 times and Rotarix 2 times, the total cost of vaccination would range around 210,000-300,000 won for RotaTeq and 200,000-260,000 won for Rotarix. GSK had already increased the price of Rotarix by 20% in 2019. The company explained that the price increase was inevitable due to the increased production cost. MSD also cited the rising input cost as the reason for its price hike. However, such an increase in the price of non-reimbursed drugs is expected to increase the financial burden borne by parents, as the rotavirus vaccine is regarded as an essential vaccine for infants aged 2 months. Rotavirus, a major cause of acute gastroenteritis in infants and toddlers, is a common virus that 95% of children around the globe are infected with before the age of 5. Symptoms include vomiting, fever, diarrhea, stomachache, etc. It is very contagious, therefore the World Health Organization recommends rotavirus vaccines to be included in all national immunization programs (NIPs). However, as rotavirus vaccines are not included in Korea’s NIP, they are administered as non-reimbursement in Korea.
- Company
- Local companies in panic over ‘Eliquis’ patent suit result
- by Kim, Jin-Gu Apr 09, 2021 05:56am
- The winner and loser of the long patent suit were reversed in the end. After losing the first and second trial, BMS finally got the upper hand in the fight with the generic manufacturers with a favorable ruling by the supreme court. On the other side, the generic companies are in hot water due to the unexpected result. In addition to immediately discontinuing the sale of its generics, the companies are expecting a massive damages claim will be filed by the original drug’s company. The ruling will also affect the price cut that was previously ordered for Eliquis. If the ruling is finalized, the price cut disposition will be pushed back to the patent expiry date. ◆Case remanded to Patent Court… Attention on whether the final ruling sides with the Supreme Court's decision On the 8th, the Supreme Court’s Special 3rd Division reversed and remanded the original ruling of the patent invalidation suit in the appeal filed by BMS against Navipharm, Huons, Intron Biotechnology, and Alvogen Korea. The lawsuit is linked to multiple other suits filed by BMS including the patent infringement suit as well as the administrative suit filed in objection to the disposition to reduce the ceiling price of Eliquis. Considering the gravity of the issue, the Supreme Court rendered an en banc decision. The Supreme Court’s ruling is not final. As the Supreme Court reversed the original judgment, the case will once again be tried by the Patent Court. However, as most trials for remanded cases follow the higher court’s decision, which would be the Supreme Court’s decision in this case, expectations are leaning towards BMS’s victory. ◆Patent infringement suit to pace up… generic sales highly likely to be discontinued With the victory, BMS expects to be able to achieve three goals. First is the discontinued sale of generics. The prescription of Eliquis has been dwindling with the release of its generics. According to U-BIST, outpatient prescription sales of Eliquis had increased annually from 19.5 billion won in 2016 to 49 billion won in 2019. However, its sales dropped 3% to 47.7 billion won last year. On the other hand, prescription sales of generics of Eliquis have been rapidly increasing, from 1.2 billion won accrued from July to December in 2019 to the 8.3 billion won last year. The numbers suggest that the release of generics had some effect in reducing Eliquis prescriptions. BMS also plans to speed up the patent infringement suits filed against each generic company. Around 10 relevant suits are currently in progress. The cases were waiting for the Supreme Court's judgment on this case to determine whether the generic drugs infringed upon BMS Korea's patent right. If BMs wins the patent infringement suit, BMS will also be able to enjoy reflective benefits from the discontinuation of its generics. ◆ Full-fledged claim for damages deemed inevitable.…calculation of the compensation amount is key BMS's second purpose is to file claims for damages against the generic companies. The Supreme Court's ruling recognized the validity of the drug substance patent. If the court recognizes the patent infringement of the generic companies in subsequent infringement lawsuits, BMS will meet all the requirements to claim compensation for damages. Eliquis generics that were released since June 2019 include ▲Chong Kun Dang’s ‘Liquisia’ ▲Samjin Pharm’s ‘Elxaban’ ▲Yuhan Corp’s ‘Yuhan Apixaban’ ▲Hanmi Pharm’s ‘Apixban’ ▲Aju Pharm’s ‘Eliban’, and ▲Yooyoung Pharm’s ‘Yupix.’ Last year, prescription sales of Liquisia were 2.6 billion won, and 1.1 billion won for Yuhan Apixaban. The key lies in the reinforced standards used for the calculation of compensation for damages since last December. Last year, the National Assembly passed an amendment to the Patent Act that would strengthen the standards used to calculate damages caused by patent infringement. Previously, the compensation was calculated by multiplying the 'range of production capacity' by the 'profit per unit.' However, the newly amended act that took effect in December last year adds an amount calculated by multiplying the 'amount exceeding range of the production capacity' by the 'reasonable royalty.' For instance, under the previous law, if the patent holder's production capacity was 100 but the infringer sold 1000, the patent holder was unable to receive compensation for the 900 that exceeds the patent holder's production capacity. However, the amended act allows for the company to receive compensation for the exceeding 900 products as well. At first sight, the prescription amount of the original Eliquis overwhelms the amount of generics prescribed. However, experts believe the result may differ depending on how 'production capacity' is interpreted. Nevertheless, faced with potential claims for damages by BMS, generic companies are now moving to voluntarily discontinue sales of their generic products. An unnamed official of one company that sells a generic of Eliquis stated, "After the ruling, we are considering whether we should voluntarily stop selling our product." ◆Price cut disposition for Eliquis may be suspended until September 2024 The third is to nullify the drug price cut disposition. In July 2019, the government had notified BMS that it would lower the price ceiling of Eliquis by 30% with the reason being the release of its generics. However, BMS had filed a suit with the Administrative Court to suspend the price cut as the final ruling has not been made on its substance patent suit. BMS's request was to suspend the execution of the price cut disposition until the Supreme Court's ruling. The court accepted the company's request, therefore Eliquis is currently being sold at the same price, at 1,185 won per tablet. With the Supreme Court's ruling adding support, the government's justification to execute price cuts based on the introduction of generics will not be able to stand. The substance patent of Eliquis will expire on September 9th, 2024. If the Patent Court ruling is in line with the Supreme Court ruling, the launch of Elquis's generics will be postponed to September 2024. Also, in that case, it is highly likely that the price of Eliquis will be lowered in October 2024.
- Company
- Tagrisso’s 1st-line reimbursement rejected once again
- by Eo, Yun-Ho Apr 09, 2021 05:55am
- With ‘Tagrisso’ once again failing to expand its reimbursement, it seems that it may take a while for 3rd generation EGFR TKIs to be prescribed as 1st-line in Korea. According to industry sources, the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) decided it was inappropriate to expand the reimbursement of Tagrisso to first-line in non-small cell lung cancer (NSCLC). After receiving approval to extend its indication to first-line treatment in December 2018, AstraZeneca first applied for the expanded reimbursement in 2019. However, the Cancer Disease Review Committee in October that year decided to defer the decision until full data from the Phase 3 FLAURA trial, which studied the overall survival (OS) of NSCLC patients treated first-line, is disclosed. AstraZeneca then submitted the full FLAURA data and expressed the will to accept most of the budget sharing plan proposed by the government. However, faced with strong opposition from committee members (specialists), the company failed to expand Tagrisso's reimbursement to first-line last May. AstraZeneca had attempted to reverse the decision once more by submitting OS data from FLAURA China that confirmed Tagrisso’s OS benefit in Asian patients, but the committee’s response was, once again, a ‘No.’ In the FLAURA China trial that studied a cohort of Chinese patients, 71 patients were randomly assigned to the Tagrisso-treated group, and 65 patients in the control group. Patients in the control group were allowed to cross over to 2nd-line Tagrisso when their disease progressed with T790M mutation. Among the 65 patients, 22 continued their treatment with Tagrisso. In the trial, the median OS of the Tagrisso-treated group was 33.1 months, which was 7.4 months longer than the 25.7 months of the control group. Also, Tagrisso reduced the risk of death by 15.2%.
- Company
- Qsimia's sales exceeded ₩200 billion
- by An, Kyung-Jin Apr 09, 2021 05:55am
- Alvogen Korea surpassed ₩200 billion in annual sales for the first time since its launch in Korea. Qsymia, an obesity treatment drug released at the beginning of last year, and the obesity treatment Qsymia, which was released earlier last year, produced the largest sales. According to the Financial Supervisory Service on the 7th, Alvogen Korea's sales last year reached ₩211.1 billion, up 11.3% from the previous year. For the first time since the establishment of the branch, annual sales exceeded the ₩200 billion. Operating profit was ₩17.3 billion, up 19.3% from the previous year. Sales and operating profit of Aalvogen Korea by year (Unit: ₩100 million, Source: the FSS) The predecessor of Alvogen Korea is KEUNWHA, founded in 1958. Alvogen Group, a foreign company, entered the domestic market with the acquisition of KEUNWHA in 2012. Alvogen acquired Dream Pharma, which was owned by Hanwha Group with funds raised through KEUNWHA in 2014, and changed its name to Alvogen Korea by merging the two companies the following year. The product with the highest performance ever is Qsymia. Alvogen Korea was launched from Vivus in the US in 2017. After securing the domestic copyright of Qsymia, a combination of Phentermine and Topiramate, it launched in partnership with Chong Kun Dang at the beginning of last year. After its release, Immediately after its release, Qsymia shook the domestic obesity treatment market with Saxenda by NovoNordisk. In the first quarter of last year, it ranked second in domestic obesity treatment sales with sales of ₩4.3 billion, and sales increased to ₩5.8 billion in the second quarter and ₩6.5 billion in the third quarter. Last year's cumulative sales of Qsymia reached ₩22.5 billion, and the market share reached 15.7%. Alvogen Korea’s sales declined slightly for the first time in 2019. However, both sales and operating profit have rebounded after a year due to the success of the new product. Alvogen Korea posted a net profit of ₩6.9 billion last year. This is a 49.3% increase from the previous year. The company is paying a cash dividend of ₩8.5 billion in 7 years since 2014. The largest shareholder of Alvogen Korea is Alvogen Korea Holdings Co., Ltd. (100% stake).
