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- 2026-05-20 13:12:07
- Company
- Bridion generic makers lose patent dispute after all
- by Kim, Jin-Gu Apr 20, 2020 06:34am
- Product image of Bridion Indicated for the reversal of neuromuscular blockade in people undergoing surgery, MSD’s Bridion (sugammadex) has successfully defended its patent rights. On Apr. 17, the Intellectual Property Trial and Appeal Board has ruled favorable for the original patentee MSD over a patent dispute with CTC BIO. A pharmaceutical market research firm IQVIA reported, Bridion, indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery, has generated approximately 38.0 billion won in Korea last year. ◆After an appeal, generic loses the patent battle at last MSD has released and patented the drug in 2013. The patent term would expire on Apr. 12, 2022. Many of Korean pharmaceutical companies have challenged against the patent. The first trial was to invalidate the patent. In March and April of 2015, nine companies including Navi Pharm, Kukje Pharm, Hana Pharm, Intro Pharm Tech, Han Wha Pharma, Huons, Dream Pharma, Chong Kun Dang, and BC World Pharm have filed the invalidation trial. But BC World Pharm, Dream Pharma, Navi Pharm and Kukje Pharm have immediately withdrew the case. First, the original patentee has won the Intellectual Property Trial and Appeal Board. But in January 2017, Chong Kun Dang, Huons, Intro Pharm Tech and Hana Pharm have filed an appeal against the ruling to the Patent Court. However, the Court also ruled against the generic makers. ◆Retried with different approaches but dropped the case after the Supreme Court’s ruling The Korean companies’ patent challenge did not stop there. Instead of invalidation, they tried to take down Bridion’s patent by requesting a negative confirmation of scope. Accordingly in March of 2018, Chong Kun Dang, Daewoong Pharmaceutical and CTC BIO have requested a negative scope confirmation. Their case claimed a part of the extended substance patent term is not covered by the patent scope. During the proceeding of the case, the Supreme Court has made a crucial decision on the Solifenacin (vesicare) case, which would significantly affect the Bridion case. The Supreme Court has ruled that a generic with modified salt base infringes the original’s extended patent term. Afraid the court’s decision has set a precedent, the Korean pharmaceutical industry was swayed and most of them interpreted it negatively. Ultimately, Chong Kun Dang and Daewoong Pharmaceutical withdrew the case in January and November of 2019, respectively. ◆The original wins at the final trial, patent to be protected until its expiration Regardless of others giving up on the patent dispute, CTC BIO continued its lone tough journey. However, the Supreme Court’s decision has already been set as a precedent. The Intellectual Property Trial and Appeal Board has ruled against the Korean company on Apr. 17. Sources report the company would unlikely to file another appeal. The generic maker does not see another approach to further battle against Bridion. Since the Supreme Court’s ruling, the negative confirmation of scope on modified salt base drug has become useless. And the Korean company has already lost the appeal on the invalidation case. Sources predict Bridion would likely to have its patent protected until April 2022.
- Company
- Half of multinational companies in Korea restructured 2019
- by An, Kyung-Jin Apr 20, 2020 06:30am
- Apparently, one out of two multinational pharmaceutical companies in Korea has downsized last year. The outcome contrasts with Korean pharmaceutical and bio companies that have increased employment in the same time, despite the worsened profitability. Analyzing audit reports submitted to the Financial Supervisory Service (FSS) on Apr. 16, 13 out of 29 multinational pharmaceutical companies in Korea have reported lessened number of employees last year than in the year before. Except for three companies without a change in employment size, basically a half of multinational companies in Korea have reduced the employment. From the end of 2018 to the end of 2019, Galderma Korea’s number of employee has dropped the most from 94 to 73 with a one fifth cut. After hiring 99 employees in 2014, the company has maintained the size for about four years, but the number has dipped significantly in about a year. After the appointment of General Manager Rene Wipperich at the Korean affiliate in August 2018, Galderma Korea has offered early retirement programs twice and the employment number has fallen. The company reported it has been in the red since 2015. Changes in employment size in 29 major multinational pharmaceutical companies (Unit: Number of employee) Source: Financial Supervisory Service In general, the multinational companies with underwhelming performance have restructured. Janssen Vaccines has maintained the same number of employees from 2018 to 2019, but the number actually halved from five years ago at 296. Janssen Vaccines’ performance has been stagnating for a while. Since it made operating loss of 20.9 billion won in 2016, the company has been in the red for four consecutive years. The sales have been rapidly falling from 99 billion won in 2016 to 42.7 billion won and 27.6 billion won in 2017 and 2018, respectively, and at last, the company has made no profit last year. The company plans to operate in minimal human resources until it finishes refining anticancer and next generation vaccine production line. It also has opened an opportunity for employees to request for transfer after it closes the Hyangnam manufacturing facility in 2021. Other multinational companies had changes in employment size while reorganizing the businesses. Even Pfizer Korea, currently with the highest number of employees among multinational pharmaceutical companies in Korea, has downsized slightly in a year. In last May, the company has transferred 264 employees to its spin-off company Pfizer Upjohn Korea. The number of total employee in both Pfizer Korea and Pfizer Upjohn Korea combined was 724, with 10 employees less than the year before. Regardless of business restructuring, some companies have increased the number of employees. Although Merck Korea has closed GM sector last year, the company has hired 22 more by the end of the year, reaching the total of 339 employees. The figure was not drastically affected as only a handful applied for the ERP and the number of employees of other non-pharmaceutical sectors like Life Science or Performance Material sectors easily outnumbers that of the Biopharmaceutical sector. Not all Korean affiliates have reduced employment size. As of late December last year, the 29 multinational pharmaceutical companies had 6,884 employees in total, which was 170 more than 6,714 employees in the year before. Among the 29 companies analyzed, Sanofi-Aventis Korea has reportedly hired new employees the most. In last June, Sanofi has legally finalized the merge with Genzyme Korea. As of last December, Sanofi-Aventis Korea had 64 more employees than the year before and had total of 506 employees. Considering Genzyme Korea had 53 employees as of last 2018, the number of employees has increased over a year. Sanofi-Aventis has shown outstanding performance by combining Genzyme Korea’s performance from the latter half of last year. Over the year, the sales has increased by 17.7 percent, marking 438.3 billion won, and operating profit reached 34.8 billion won with 68.4 percent surge. Number of employees in major multinational pharmaceutical companies in Korea as of last 2019 (Unit: Number of employee) Source: Financial Supervisory Service Except for Pfizer Korea and Pfizer Upjohn Korea, Bayer Korea has the highest number of employees as of late 2019. From late 2018 to late 2019, Bayer Korea has downsized from 588 to 562 with 26 less employees, but it still has the highest number of employees as a multinational pharmaceutical company in Korea. Novartis Korea reported it has 542 employees as of last 2019.
- Company
- Pfizer Korea Upjohn, last year's sales were ￦385.8 billion
- by Kim, Jin-Gu Apr 20, 2020 06:30am
- It was confirmed that the annual sales of Pfizer Korea Upjohn, which was split from Korea Pfizer Pharmaceuticals last year, amounted to ￦385.8 billion. Korea Pfizer Pharmaceuticals(￦395.7 billion) is not much different. Considering that Pfizer and the Pfizer Upjohn have a global sales ratio of 8 to 2, the sales share of Pfizer Upjohn in Korea is high. According to the audit report of Pfizer Korea Pharmaceuticals and Pfizer Korea Upjohn submitted to the Financial Supervisory Service on the 9th, the sales of the two companies over the past year (December 2018 to November 2019) totaled a total of ￦745.5 billion. The fiscal year of Pfizer Korea Pharmaceuticals and Pfizer Korea Upjohn is November, and the results are calculated from December of the previous year to November of this year. Of these, Pfizer Pharmaceuticals' sales were ￦395.7 billion. This is a 7.2% increase from 2018's ￦369.1 billion. It recorded an operating loss of ￦1.1 billion. However, in 2018, the operating loss decreased from ￦2.3 billion. The sales of Pfizer Korea Upjohn were ￦385.8 billion. This sales amount is calculated by adding the sales of the patent expiration business departement to ￦205.8 billion and the sales from May 27, 2019 to November 30, 2019, to be ￦ 179.9 billion. This is an increase of 5.6% compared to ￦365.3 billion in 2018. Operating profit was ￦15.8 billion before division and ￦5.4 billion after the division, operating profit fell to a third. Sales of Pfizer Korea in the past 5 years (Unit: ￦100 million, The FSS) The size of Pfizer Korea Upjohn with annual sales of ￦385.8 billion is comparable to that of domestic mid-sized pharmaceutical companies. The share of sales between Pfizer Korea and Pfizer Korea Upjohn is equal to 50.6% versus 49.4%. Considering that Pfizer Korea Upjohn deals only with patent-expired drugs, industry officials say that sales proportion is unusually high. This is analyzed because of the characteristics of the Korean market with high original loyalty. The representative example of Pfizer Korea Upjohn is Lipitor. Since its launch in 1999, Lipitor has been ranked first and second in outpatient prescriptions. Lipitor's 10mg insurance price was cut from ￦1241 to ￦644 in 2007, and as the patent expired in 2009, more than 130 generic products were released, but Lipitor’s prescription amount increased. Last year, Lipitor had the most outpatient prescriptions. It was prescribed ￦176.2 billion, an increase of 8.4% from ￦162.6 billion in 2018. The share of sales in Pfizer Korea Upjohn, which is the highest in Korea, is also confirmed by comparison with global. According to a 2019 report released by Pfizer earlier this year, Pfizer's global sales last year were $51.7 billion (about ￦63 trillion). Of these, Pfizer Korea Upjohn's sales are $10.2 billion (about ￦12 trillion). The proportion is only 19.8%. Global and Pfizer Korea vs. Pfizer Korea Upjohn sales share. Pfizer Korea UpjohnPreviously, Pfizer divided Pfizer Korea Upjohn on May 27 last year. The key is to manage patent expiration drugs by Pfizer Korea Upjohn. Representative items such as Lipitor, Novasc (Amlodipine), and Celebrex (Celecoxib) have been moved to the Pfizer Korea Upjohn. The newly established division, Pfizer Korea Upjohn, plans to merge with Mylan and change its name to Viatris and start again by September.
- Policy
- The NHIS agreed the drug price negotiation rate to 95.5%.
- by Lee, Hye-Kyung Apr 20, 2020 06:30am
- The NHIS last year negotiated drug prices on 176 items, including new drugs. Of these, 96.5%, 168 items, completed the drug price negotiations, and 8 items had to be broken. Looking at the current status of the NHIS, which Dailypharm confirmed on the 7th, has negotiated the drug price in the past 6 years, a total of 870 drug price negotiations have been introduced since 2014. Among them, 840 items were negotiated, and 30 items were broken. In the NHIS' reimbursement strategy division, the Drug Price Negotiation Department, the Drug Price Post-Management Department, and the Drug Price Department are in charge of negotiating six items such as new drugs, risk-sharing (RSA) contracts, expected claims, expanded scope of use, and Price-Volume Agreement (PVA). The price of the new drug is negotiated between the NHIS and the pharmaceutical companies and it is listed after the Health Insurance Policy Deliberative Committee. Some IMDs and generic drugs omit drug price negotiations and are decided based on calculation standards. On December 29, 2006, as part of the plan to optimize drug costs, the health insurance listing method of medicines was changed to a positive method, and the NHIS is negotiating drug prices. In the case of last year's drug price negotiations, 56 items increased compared to 2018, which was analyzed because the price of eye drops was reduced due to PVA (Price-Volume Agreement).
- Policy
- Strong sanctions, to expel drugs through re-evaluation
- by Lee, Hye-Kyung Apr 17, 2020 06:22am
- It was suggested that strong sanctions to ban prescriptions as a way to expel drugs that have not been proven safe and effective through re-evaluation of benefits. It is necessary to take effective administrative measures beyond the preparation of a plan for drug withdrawal by the Minister of Health and Welfare, based on the National Health Insurance Act. This opinion was presented through the 'Research plan to improve the re-evaluation of preliminary benefits (Researcher Kwon Yong-jin, Seoul National University Public Health and Medical Center)', which was conducted as an external research service for the Health Insurance Review and Assessment Service. Currently, the withdrawal of drugs is possible through the disposition of the Minister of Health and Welfare's reimbursed list deletion based on Article 13 of the Rules on National Health Insurance Benefits Standards. However, the research team pointed out that, in the case of reimbursed list deletion, it is not a strong sanction means because the medical institution can arbitrarily delete the benefit of the benefit to the patient as non-reimbursement. As a result, it was said that for effective administrative measures, it could be considered to indirectly impose prohibition obligations through disposition of unfair profit or disposition of business suspension to medical institutions that is acting as an evacuation plan. However, according to Article 12 of the Medical Act, the implementation of medical technology by medical personnel cannot be interfered with unless there is a restriction by law. He added that there should be clear regulations as a law to impose prohibition obligations on medical personnel or medical institutions while devising plan after reevaluating benefits. Meanwhile, this study was conducted to prepare a plan to improve laws related to the preliminary benefit policy included in the health insurance coverage expansion policy (Moon Jae-in Care) announced by the government in August 2017. The Positive list system is a policy that aims to put the targets that appear to be close to non-payment rather than cost-effectively into the framework of the reimbursement first, if the provisions are to be differentiated before the change of wages for a specific item. In the case of the screening benefit, the ratio of copayment is 50%, 80%, but in the preliminary benefit, the ratio is further subdivided into 50%, 80%, and 90%, and drugs are included. In the case of drugs, clinical usefulness (therapeutic effectiveness), cost effectiveness, replaceability, and social needs were comprehensively evaluated to determine the application rate and self-pay rate. The research team said, "The basic purpose of re-evaluating Preliminary Reimbursement is to determine whether the reimbursement standards are met or not satisfied, and to determine the maintenance of reimbursement, preliminary reimbursement, and the suspension of benefits. And it can be used as a basis for price renegotiation to minimize the impact on insurance finance."
- Company
- Twice-delayed amid COVID-19 Cancer Committee rescheduled
- by Eo, Yun-Ho Apr 17, 2020 06:22am
- The Cancer Deliberation Committee’s meeting, postponed twice already, has been rescheduled. The Korean pharmaceutical industry sources reported the Health Insurance Review and Assessment Service (HIRA) has decided to resume the Cancer Deliberation Committee’s talks on expanding anticancer treatment coverage on Apr. 29. Amid COVID-19 outbreak, the committee’s earlier meeting schedule has been postponed on Feb. 26 and on Apr. 8. In February, the committee was supposed to review major items like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab). And in the April agenda, reviews on BMS’ multiple myeloma treatment Revlimid (lenalidomide) and MSD’s immunotherapy Keytruda (pembrolizumab) were initially included. However, the delayed meeting schedule would add more items on the committee’s agenda, and likely to put off some items to May agenda depending on their priority level. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso has an ongoing deliberation over expanding its reimbursed indication to cover a first-line treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication as a second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Moreover, Revlimid was targeting reimbursement expansion on its maintenance treatment indication as a monotherapy, and Keytruda’s reimbursement expansion application included an indication as a first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also included two new indications—first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel.
- Company
- Merck's retirement allowance of ￦9.3 billion last year
- by An, Kyung-Jin Apr 17, 2020 06:21am
- Retirement benefits and # of employees in Merck Korea 2009-2019 Merck KGaA spent nearly 10 billion won last year as employee severance pay. With the sale of two types of hypertension and diabetes treatments, retirement payments related to restructuring jumped four times from the previous year. According to Merck KGaA's audit report submitted to the Financial Supervisory Service on the 14th, last year, it paid ￦9.4 billion in retirement benefits. This is an increase of 303.3% compared to the previous year's retirement allowance of ￦2.3 billion. Since 2009, Merck KGaA has introduced the retirement pension system and recognized the contributions to be paid during the annual accounting period as retirement benefits. Starting with ￦1 billion in 2009, the amount of retirement benefit recognition increased, and the retirement benefit in 2018 was about ￦2.3 billion. In the audit report, Merck KGaA said, "In the current period, we set the unpaid expenses related to restructuring. The retirement benefit recognized in relation to the restructuring was ￦6.87 billion." The retirement expenditure increased by ￦7 billion from the previous year as the General Medicine (GM) division, which was in charge of treating hypertension and diabetes last year, was reorganized and restructured. The retirement benefit spent by Merck KGaA last year is equivalent to the cumulative amount of retirement benefit paid for five years from 2014 to 2018. In last November, Merck KGaA officially reorganized the GM business division by announcing that it signed a sales contract with GC Pharma for the treatment of diabetes, 'Glucophage'. Subsequently, Daewoong Pharmaceutical announced the signing of a sales contract for hypertension treatment 'Concor' and the time to organize the divisions was set at the end of November. From January of this year, GC Pharma and Daewoong Pharmaceutical are in charge of sales activities such as promotion of each product and operation of sales personnel. Merck KGaA Biopharmaceuticals decided to keep only the licenses for the items, and the existing sales and marketing personnel went through restructuring procedures. At that time, Merck KGaA was reported to have provided GM employees with the number of working years X2 months + 8 months' salary. In addition, it has attached a clue that it can receive ￦20 million annually or receive a lump sum ￦20 million for two years for the cost of a master's degree such as an MBA. It was confirmed that 24 people out of 35 employees belonging to the GM business division were resigned after receiving the ERP application in a total of two cases, and 11 people are currently discussing conversion arrangements. The number of employees increased regardless of the restructuring. According to the audit report, as of 2019, the number of employees at Merck KGaA was 339, an increase of 22 from 317 last year. In addition to the biopharma division that is in charge of the pharmaceutical industry within the Merck Group, it is the number of employees from other departments such as Merck Life Sciences and Merck Functional Materials. An official from Merck KGaA Biopharmaceutical said, “11 out of 35 employees belonging to the GM division received an order from the Seoul branch because they did not apply for ERP. We are considering various methods including supporting other departments. "By looking at the number of biopharma employees, it has decreased from 125 at the end of 2019 to 102 at present." The company turned to a deficit last year with an operating loss of ￦3.2 billion. During the same period, sales were ￦269.8 billion, an increase of 9.1% from the previous year's ￦247.3 billion.
- Policy
- Domestic vaccine for COVID-19 developed within 2 years
- by Kim, Jung-Ju Apr 17, 2020 06:21am
- Taeho Yoon, the head of the quarantine, the Central Emergency Government Headquarters of the Ministry of Health and Welfare is conducting a regular briefing of COVID-19 at the government building as an online live broadcastThe government will immediately implement measures to support for the development of COVID-19 treatment and vaccines. The goal is to release antibody drugs as early as next year, blood plasma treatment within 2-3 months, and vaccines within 2 years. Tae-ho Yoon, the head of the quarantine, the Central Emergency Government Headquarters of the Ministry of Health and Welfare, today, on the morning of the 14th, said through a press after the video conference of COVID-19 Central Disaster Safety Countermeasures Headquarters. At this meeting, the progress of COVID-19 treatment and vaccine development and future plans were discussed. The government said that it was preparing a government support system to develop anti-corrosive drugs and vaccines to overcome COVID-19. In the case of therapeutic drugs, the government is ▲rapidly supporting drug re-creation clinical trials by expanding the range of use of existing drugs to develop drugs that can be treated within the year, and ▲is pursuing the development of antibody drugs and blood device drugs using confirmed patient’s blood. Antibody drugs are being jointly researched by the Korea National Institute of Health & Celltrion, and are expected to be available as early as next year with the goal of entering clinical trials this year. Blood plasma treatment is also under joint research with a domestic company, and if a large amount of blood is secured, the Central Disaster Safety Countermeasures Headquarters expects to develop a therapeutic agent within 2-3 months. In the field of vaccine development, there is a development gap of about 6 months with the United States, but various platform vaccine researches are under way to develop domestic vaccines in the second half of 2021 or 2022 through public-private cooperation and international cooperation research. Vaccines are synthetic antigen vaccines, nucleic acid (DNA) vaccines, and virus delivery (mRNA) vaccines. The government will continue to ▲streamline the provision of blood for cured people, ▲rationalize the application of regulations such as exemption from institutional IRB ▲expand investment in infectious diseases R&D to discover promising tasks, and study the possibility of virus mutations against resurgence ▲build a platform to discover candidates for AI-based treatment ▲the Public Vaccine Development Center ( Completion of this October), expansion of research infrastructure such as the vaccine commercialization project team ▲support for strengthening international cooperation in infectious disease research. Along with this, the government has a support system for the development of COVID-19 treatment and vaccine development system and is operating immediately. Taeho Yoon, the head of the quarantine said that as mentioned by the President, therapeutic drugs and vaccines are a must to overcome in order to completely overcome COVID-19, and plans to establish the government support system so that treatment and vaccine development can succeed early, and provide policy and institutional intensive support. The Minister of Health and Welfare and the Minister of Science and ICT are co-directors, and the 'Corporate Support Group' for COVID-19 treatment and vaccine development is established. ▲Domestic COVID-19 treatment and vaccine development status is checked and ▲Support measures are identified by identifying difficulties in the field. "The government will quickly establish a working group with related ministries and industry, academia, research institutes and hospitals to support the pan-government support group," said Yoon, the head of the quarantine.
- Company
- Multinational companies show significant gap in performance
- by An, Kyung-Jin Apr 17, 2020 06:21am
- Multinational pharmaceutical companies in Korea showed drastically polarized performance last year. Their revenue fluctuated depending on how well the emerging driving forces took over the position of now-off-patent blockbuster drugs. Most of the companies had a drop in operating profit, but companies like Alcon, AbbVie and Sanofi-Aventis have successfully killed two birds with one stone expanding business and improving profit growth by changing up their top selling product line-ups. Analyzing last year’s performance of 28 multinational pharmaceutical companies in Korea on Apr. 14, the last year’s gross operating profit reached 165.4 billion won, which was 7.0 percent less than the year before at 178.0 billion won. And the last year’s gross revenue at 5.27 trillion won was 6.3 percent more than the year before. Meanwhile, the operating margin was decreased by 0.5 percent from 3.6 percent to 3.1 percent. The summary is based on 26 audit reports submitted to the Financial Supervisory Service (FSS) until Apr. 13 by Korean branches that settled the accounts in December. Although Servier Korea settled the account in September, their data was included. Despite Pfizer Korea and Pfizer Upjohn Korea settled the account in November, their data was dropped from the analysis due their split affecting the data. Apparently, the performances between companies varied significantly. 13 out of 26 companies had over 10 percent jump in revenue. Alcon Korea’s revenue last year skyrocketed by over 60 percent and showed the biggest increase rate among the companies. The company’s record high sales performance was possible due to the revised eye drop pricing system surging the prescription volume in sodium hyaluronate-based Kainix eye drop. Their operation profit finally turned around and generated surplus after three years in the red. Both sales revenue and operating profit in AbbVie Korea showed 43 percent surge. The hepatitis C virus (HCV) treatment Mavyret, released in the fourth quarter of 2018, outdid other competitors and took up 80 percent of the total HCV prescription market. The treatment has expanded the business for AbbVie and improved profitability in the market. The revenue growths in Novo Nordisk (24.5 percent), Sanofi-Aventis Korea (17.7 percent), Janssen Korea (17.5 percent), Lundbeck Korea (15.9 percent), Teva-Handok (15.5 percent), Roche Korea (15.5 percent) and AstraZeneca Korea (14.6 percent) were recorded relatively high. Due to the effect of Pfizer Korea’s split-off, Novartis Korea has topped the multinational pharmaceutical sales revenue rank after seven years since 2012. Marked at 493.4 billion won, Novartis Korea’s revenue last year was 4.1 percent more than the year before. For the first time in Korea, Novartis has generated almost 500 billion won with new line-ups like chronic heart failure treatment Entresto and antipsoriatic Cosentyx firmly taking roots in their respective markets, while the company’s major line-ups line macular degeneration treatment Lucentis, ARB-based hypertension treatment Exforge and leukemia treatment Glivec maintained their growth in revenue. Also maintaining two-digit revenue growth for another consecutive year, AstraZeneca Korea’s annual revenue last year has generated over 400 billion won for the first time in Korea. Top profit-making multinational pharmaceutical companies in Korea based on last year’s revenue (Unit: KRW 100 million) Source: Financial Supervisory Service On the other hand, most of the companies without other means of revenue source besides their off-patent drugs have experienced a steep fall in operating profit. The operating profits of 15 out of 28 companies either fell or maintained the deficit, which means one out of two multinational pharmaceutical companies in Korea is struggling to make profit. Janssen Vaccines that used generate over 300 billion won annually, manufacturing and selling vaccines, has made no profit in Korea last year. Marking operating loss at 31.6 billion won last year, the company has recorded four consecutive years of deficit. The company’s main source of revenue has been cut as the demands on hepatitis B virus vaccine Hepavax-Gene and pentavalent vaccine Quinvaxem took a drastic fall. Although excluded from the analysis, Pfizer Korea’s sales volume has halved as it underwent a split-off with Pfizer Upjohn Korea. Spinning off an off-patent drug business sector, Pfizer Korea has generated 395.7 billion won last year with 7.2 percent increase from the year before, leveling neck and neck with Bayer Korea (374.1 billion won). Pfizer Korea’s performance contrasted with Pfizer Upjohn Korea that recorded operating loss of 1.1 billion won and operating profit of 5.4 billion won in the first year of the split. In last year, Kowa Korea Company has made 18.2 percent less than the year before. Ruling out Janssen Vaccine making no profit at all, Kowa Korea Company has made the least amount of sales volume. Their operating loss was at 1.8 billion won, turning back into the red after a year in the black. GlaxoSmithKline Consumer Healthcare Korea has stagnated as its revenue and operating profit respectively have dropped by 11.6 percent and 9.7 percent drop, compared to the year before. Against the year before, last year’s operating profits were dropped by over 20 percent in Novartis Korea (85.8%), Bayer Korea (40.9%), Boehringer Ingelheim (24.7%), Novo Nordisk (33.7%), Kyowa Kirin Korea (35.%) and Sandoz Korea (84.7%). Both Roche Korea and Merck were turned into the red, whereas Menarini Korea continued to stay in the red.
- Company
- KRPIA and members clash over Sean Kim’s resignation
- by Eo, Yun-Ho Apr 16, 2020 06:36am
- Apparently, the multinational pharmaceutical companies in Korea have disputed KRPIA’s approval on the resignation of Senior Director Sean Kim. The pharmaceutical industry sources reported Sean Kim, a Senior Director of Market Access and Healthcare Policy at Korean Research-based Pharmaceutical Industry Association (KRPIA), has expressed his intention to resign and CEO Lee Youngshin has made a discretionary approval on his resignation with her delegated authority. Senior Director Kim has been decided to leave the organization on Apr. 17. The decision was called without consulting with KRPIA Board of Directors (BOD), consisting of member companies’ leaders, and the organization has not officially announced the news, yet. Caught up with the news late, KRPIA Market Access and Healthcare Policy (MA and HC Policy) Committee and Regulatory Affairs Committee have requested an explanation from the organization and 20 or so members of the committee and the CEO were convened on Apr. 14 for an online meeting. However, the organization official did not specify Senior Director Kim’s reason for resignation at the meeting and left it as ‘personal matter.’ The sources confirmed CEO Lee has apologized for the lack of communication when processing the resignation and briefed their plan to recruit a successor in June, if feasible. Senior Director Sean Kim◆Question One: Was it a proper processing of resignation? The main complaint of the MA and HC Policy Committee and Regulatory Affairs Committee on the Senior Director’s resignation is the process. As stated above, the senior director’s resignation was approved discretionarily by CEO Lee. According to the KRPIA regulation, the CEO has a rightful authority over personnel, which means it was processed by the book. However, the point of issue lies on how a resignation of a board member-level Senior Director Kim, a major decision-maker of the organization, has been approved without prior discussion with the BOD. And the organization’s lack of official notice to the member companies on the matter has fired up the industry’s backlash. Senior Director Kim has served in the government policy sector for eight years since 2012, and led most of government affairs and communication efforts regarding drug pricing system reform. He also took a crucial role in the Korean government making decisions on expanding eligible subject for risk sharing agreement (RSA) and applying RSA on follow-on drugs. KRPIA and the member companies would take a heavy blow without a MA and HC Policy expert like Senior Director Kim or the former CEO Lee Sang Suk with actual experience in a government agency. The member companies argue, regardless of the CEO’s authority, the resignation approval should have been finalized after a thorough discussion and internal communication. An insider of a multinational company commented, “It is quite disappointing to find out about Senior Director Kim’s resignation not through the organization, but through word of mouth. His experience and expertise are unmatched, and the industry is imminently facing a crucial government announcement regarding the drug pricing system revision. We need the organization’s proper explanation and their prospective plan.” ◆ Question Two: Was his resignation ‘voluntary?’ Another point of the dispute is unclear reason and background of the senior director’s resignation. For the organization members, the Kim’s resignation was completely unexpected, raising a few questions to the story. Senior Director Kim has inked a contract with KRPIA in last December that extended his term for two years until November 2021. After signing the contract, he was at MA and HC Policy Committee meeting in January and vowed that he would “retire honorably in 2021 after putting all efforts to contribute in protecting appropriate pricing for new drugs and in expanding coverage until the end of the term.” In other words, he had no other reason to resign except for his health issue. This is also why no one in the industry saw his resignation coming. And the question still remains and it even brews other suspicion as to what internal discrepancy or pressure could have been the real reason behind it. Another associate of a multinational company said, “His reinstatement should be considered depending on the situation, although his intent should come first in making the decision. If there was an unfair treatment, then it should be corrected. Most of government affairs associates in the industry are hoping for him to return.”
