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- 2026-05-11 20:25:47
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- “Considering treatment options for ankylosing spondylitis”
- by Eo, Yun-Ho Apr 27, 2020 06:10am
- Professor Nam Seoung Wan In the autoimmune disease area, where tumor necrosis factor alpha (TNF alpha) inhibitor is leading the prescription market, various options of oral Janus kinase (JAK) inhibitors have been released so far. Guidelines on treating ankylosing spondylitis and spondylarthritis in Korea and other countries have a tendency to emphasize starting the first-line treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients showing symptoms. And for patients not sufficiently benefiting from NSAIDs, the treatment guidelines recommend using biologics like TNF alpha inhibitor, considering the patient’s disease activity. And in 2016, a guideline by Assessment of Spondyloarthritis International Society/ European League Against Rheumatism (ASAS-EULAR) recommended using TFN alpha inhibitor for first-line biologics with the most amount of clinical data accumulated, but also recommended switching to other TNF alpha inhibitor or interleukin (IL)-17 inhibitor options when showing no response to the initial option. Moreover, American College of Rheumatology (ACR) and Spondyloarthritis Research and Treatment Network (SPARTAN) updated their guidelines last year and made a notable recommendation of using oral JAK inhibitor Xeljanz (tofacitinib) with an ongoing Phase III clinical study, besides using biologics like TNF alpha inhibitor (injection) and IL-17 inhibitor. Also, instead of using Cosentyx (secukinumab) that received approval first, the updated recommendations mentioned of using Taltz (ixekixumab) and TNF alpha’s biosimilars approved for use in Korea recently. Professor Nam Seoung Wan of Rheumatology Department at Wonju Severance Christian Hospital explained “Other than tofacitinib, various JAK inhibitors like upadacitinib have been tried on treating patients with ankylosing spondylitis. Compared to other biologics, JAK inhibitors have a great advantage in medication convenience with oral administration.” However, the professor stated the treatment’s limitation is its underperforming response rate at week 12 compared to existing TNF alpha inhibitor and IL-17 inhibitor options, regardless of its better effect confirmed in head-to-head Phase II study. Professor Nam stressed, “Continuous search for more treatment options in diverse biologics are encouraging for patient treatment, because each biologics have different effects on various symptoms apparent in many organs including ankylosing spondylitis, and also they bring out respective adverse reaction like risk in tuberculosis relapse.” However, the professor claimed the prescribers should be well aware of issues regarding tolerance development when using biologics for a long term. Professor Nam said, “Repetitive use of biologics could possibly diminish the effect of the drug gradually due to patient’s immune response on the drugs like developing an antibody on specific medicine. As for rheumatoid arthritis, there was a report claiming such tolerance is less likely to be developed when combining TNF alpha inhibitor and methotrexate (MTX). But there has not been any clinical evidence reported on the benefit of using MTX combination therapy on ankylosing spondylitis.” The professor added, “However, a number of treatment strategy could be considered depending on the patient’s clinical state, as various biologic treatment options have been recently introduced to treat patients with ankylosing spondylitis. And each biologics show different rate of antibody development and reaction depending on the patients.”
- Company
- Keytruda to finally get Cancer Committee nod after 2years?
- by Eo, Yun-Ho Apr 24, 2020 06:27am
- After waiting for two long years, MSD is committed to receive the Korean health authority’s approval on Keytruda’s coverage expansion this time. According to pharmaceutical industry sources, the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee’s deliberation on Keytruda (pembrolizumab) has been scheduled on Apr. 29 after it has been delayed twice due to the COVID-19 outbreak. Although the deliberation would review Keytruda’s reimbursement expansion on the added indication as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), MSD has reportedly submitted related economic evaluation data. For a reimbursement expansion case, the committee assesses financial impact but it does not ask for a submission of economic evaluation data. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication in September 2017 and continued to talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. And in October last year, MSD Korea has reapplied for reimbursement expansion on Keytruda’s five indications including pembrolizumab monotherapy and combination therapy as first-line treatment in NSCLC, monotherapy as second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. So far at the broken off talks with the government, key issues like conditionally limiting the reimbursement to ‘patients showing response to the treatment,’ and ‘the trade-off (a government initiative to recognize the value of new drug while compensating the cost with reduced pricing of off-patent drugs)’ were addressed. MSD’s desperation is also apparent on the negotiating table due to the long wait. Prior to the coming deliberation, MSD has reportedly expressed its intention to accept the government’s proposal on sharing financial burden of expanded reimbursement by lowering drug pricing. The global company official stated, “Over the span of two years, the company has been negotiating and narrowing the gap with the government over expanding Keytruda’s reimbursement, and we think the two parties have been engaged enough to have better understanding of each other. Based on the experience, the company is making sure to receive the expanded reimbursement this time.” The National Comprehensive Cancer Network (NCCN) guideline has added pembrolizumab plus chemotherapy combination therapy as a Category 1 first-line treatment in all patients with metastatic NSCLC, which is also listed as preferred. The pembrolizumab monotherapy is also listed as preferred for first-line therapy in patients with positive PD-L1 expression over 50 percent.
- Company
- The KPBMA promotes of co-development of COVID-19 treatments
- by Lee, Seok-Jun Apr 24, 2020 06:26am
- The KPBMA promotes joint development of COVID-19 treatment. This is the first 'co-investment and joint development' method among member companies. The KPBMA held a board of directors meeting on the 21st to discuss this. Participants decided to aggregate their competencies at the industrial level, not individual companies, based on the prospects of domestic and foreign experts that another COVID-19 outbreak would occur frequently. In addition, they considered ways to establish joint ventures with co-investments by companies and to establish private and public joint funds such as the European IMI (Innovative Medicines Organization). In the future, if the KPBMA materializes joint investment and joint development plans through consultation with related experts, the industry will actively participate. An association official said that the joint R&D situation among member companies for developing new drugs is more mature than ever before, and they agreed that it is necessary to change the concept of sharing profits if profits arise and sharing risks if they fail for new drugs. Chairman Hee-mok Won emphasized, "In order to overcome a crisis that can be repeated in the future, such as COVID-19, a revolutionary idea change is needed. The cross-border energy with joint research and development efforts of the industry and full support from the government must be brought together."
- Company
- Amid COVID-19, March drug export hits record high
- by Kim, Jin-Gu Apr 24, 2020 06:26am
- A monthly export volume of Korean pharmaceuticals has reached a record high in last March. Sources view the COVID-19 outbreak has not affected the pharmaceutical production and export significantly. According to the import and export statistics data published by Korea Customs Service (KCS), Korea has exported USD 538.09 million (approximately 660.2 billion won) worth of pharmaceuticals in March. The Korean-made pharmaceutical export volume has gone up by 51.3 percent, compared to March 2019 at 356.52 million dollars (approximately 437.1 billion won). Also, the volume increased by 51.3 percent as well only in a month from February (355.57 million dollars) to March 2020. Korean pharmaceutical volume in March 2020 has marked the record high (Unit: USD 1,000) Source: KSS In the same period, the import volume has also reached the highest in the history at 688.78 million dollars (approximately 845.1 billion won). Compared to the year before, the volume was increased by 27.5 percent from 540.36 million dollars (approximately 663.0 billion won). The huge surge in export volume has noticeably improved the pharmaceutical trade balance. In March, Korea has made trade deficit of 120.69 million dollars. Compared to the two months last year, the deficit figure was reduced by 18.0 percent. However, the overall export volume in Korea has gone down by 0.7 percent from 47.03 billion dollars to 46.69 billion dollars in the same period. This is why the pharmaceutical export volume has emerged as the highlight of the month. The COVID-19 outbreak does not seem to have directly affected production or export of pharmaceuticals in Korea. ◆Export to Germany and Japan soars, when export to the U.S. and China drops Sorting by country, the export to Germany and Japan has significantly increased. On the other hand, the export to the U.S. and China has diminished. In March alone, the exports to Germany have generated 164.42 million dollars. The figure has tripled from 48.19 million dollars in the year before. More specifically, the exports to Germany exceeded last December’s record high volume at 112 million dollars. The exports to Japan soared by 53.5 percent in March at 28.33 million dollars, compared to 18.45 million dollars last year. Meanwhile, the volume exported to the U.S. has been decreased by 16.3 percent than the previous year at 64.11 million dollars. And the export volume to China in the same month has plunged by 26.0 percent from 24.44 million dollars last year to 18.58 million dollars this year. Trend in export volume with major pharmaceutical trading countries (Unit: USD 1,000) Source: KSS) The pharmaceutical ingredient distribution issues in China and India that the industry insiders were concerned about does not seem to have surfaced in the export statistics. On the contrary, the Chinese and Indian-made pharmaceutical import volumes have rather increased than the year before. 90 percent of pharmaceutical active ingredients are currently imported from China and India. Korea has been importing pharmaceuticals from China, which the volume has grown by 33.8 percent from 7.52 million dollars in March last year to 10.06 million dollars in March this year. Comparing the figure in March to February at 7.53 million dollars, the volume has gone up by 33.5 percent. The pharmaceutical import from India has reached 5.64 million dollars in March. Compared to the year before at 4.91 million dollars, the volume was increased by 14.9 percent, but compared to Febraury at 1.95 million dollars, the March figure has skyrocketed by 189.5 percent.
- Company
- General hospitals to prescribe obesity drug Qsymia
- by Eo, Yun-Ho Apr 23, 2020 06:27am
- Gaining popularity in the obesity treatment market, Qsymia has entered its prescription code in Korean general hospitals. According to pharmaceutical industry, Qsymia (phentermine hydrochloride plus topiramate), co-marketed by Alvogen Korea and Chong Kun Dang, has been recently passed by Drug Committees at the Big Fives including Severance Hospital and Seoul Asan Medical Center and other major institutes like Korea University Anam Hospital and Ajou University Hospital. Qsymia is available in four doses (3.75 mg/ 23 mg, 7.5 mg/ 46 mg, 11.25 mg/ 69mg, and 15mg/ 92mg) at a price of 4,000 won. The daily costs of Belviq, Contrav and Qsymia are about the same in Korea and the U.S. A clinical study on the drug has found Qsymia, compared to other FDA-approved long-term prescribed obesity treatments, demonstrated the most effective weight loss benefit and confirmed safety profile better than Saxenda and Contrav. The study conducted a retrospective meta-analysis on five weight loss medications, which analyzed 28 randomized clinical trials with 29,018 participants. Qsymia showed the highest efficacy in losing more than 5 percent of a person’s body weight, which Saxenda, Contrav, Belviq and Xenical followed after in the order. 54 percent, 34 percent, 30 percent, 25 percent and 20 percent of participants who were administered with Qsymia, Saxenda, Contrav, Belviq and Xenical, respectively, lost more than 10 percent of their body weight. Saxenda and Contrav had the highest risk of adverse reaction, while Belviq had the lowest. Qsymia’s risk in adverse reaction was about in the middle between Saxenda and Belviq. According to data published by UBIST, 310 million won and 614 million won worth of Qsymia were prescribed in last January and February, respectively. The drug’s prescription volume in February followed after Saxenda (875 million won), Dietamin (847 million won) and Hutermin (780 million won) in the market.
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- Global companies made KRW 21M per employee last year
- by An, Kyung-Jin Apr 23, 2020 06:26am
- Korea Otsuka Pharmaceutical has generated the highest operating profit per employee last year among Korean branches of multinational pharmaceutical companies. Each employee at the multinational company has made 108 million won worth of operating profit. On Apr. 21, an analysis on 30 multinational pharmaceutical companies in Korea surveyed audit reports submitted to the Financial Supervisory Service (FSS) and found the companies operating profit per employee. Last year’s operating profit per employee in top multinational pharmaceutical companies (Unit: KRW 1 million) Source: FSS Last year, 30 Korean branches of multinational pharmaceutical companies have generated overall operating profit of 115.8 billion won with total 5,620 employees. Basically, respective employee has made average of 21 million won worth of operating profit, which is 10 million won less than in 2018 with 31 million won. Operating profit per employee in multinational companies in Korea is approximately a half of the figure in Korean pharmaceutical and bio companies. According to Daily Pharm’s survey on 30 companies with highest sales last year based on their business reports, each employee has generated average operating profit of 36.98 million won. Fundamentally, the pharmaceutical industry is considered as an industry with comparatively low operating profit. Its investment scale is exponential with R&D and sophisticated facilities, and the industry is actually labor-intensive with strong sales force. And Korean affiliates of multinational pharmaceutical companies have unique structure of supplying finished pharmaceutical product from overseas headquarters, which sometimes lowers profitability against sales volume due to high total cost of goods sold. Moreover, the profitability of many multinational companies in Korea is diminishing after their blockbuster drugs’ patents have expired, which also seems to have reduced operating profit per employee. Among the surveyed companies, only Korea Otsuka Pharmaceutical has made over 100 million won operating profit per employee. 357 employees of the multinational company combined have reached operating profit of 38.5 billion won. It adds to making operating profit of 108 million won per employee. Although the company’s healthcare product sales has been impacted by the Koreans boycotting Japanese goods, Korea Ostuka Pharmaceutical’s prescription drug sales has soared. First time since its establishment in Korea, its sales has marked 180 billion won and the operating profit was increased by 23.0 percent than the previous year. Korea Otsuka Pharmaceutical is one of a few multinational pharmaceutical companies with its own manufacturing facility in Korea. When Janssen Korea closes a plant in Hyangnam City, Korea Otsuka Pharmaceutical’s facility in Hyangnam City and Janssen Korea’s vaccine manufacturing plant in Songdo Bio Cluster would be the only two pharmaceutical manufacturing facilities in Korea owned by multinational companies. Generating 91 million won per employee last year, UCB Korea was ranked on the second place. As of late last year, the company reported the total number of employees was 36. Although the operating profit has gone down by 8.4 percent (30 million won) compared to 35.88 million won in 2018, UCB Korea has continued to make surplus with a limited number of employees and maintained the relatively higher productivity. Stuck in the reds for three consecutive years, GlaxoSmithKline (GSK) has turned around and finally generated surplus last year and made 18 million won per employee. The operating profit per employee in AbbVie Korea, Janssen Korea, Sanofi Pasteur, Allergan Korea and Guerbet Korea has grown by over 10 million won last year compared to the previous year. On the other hand, Alcon Korea has made operating profit of 2 million won per employee last year, not even reaching 10 million won. Menarini Korea, Janssen Vaccines, Galderma Korea, Roche Korea and Merck KGaA have ended up making deficit last year. Excluding the companies in the reds, 11 out of 23 surveyed companies have made operating profit per employee last year lower than the year before. In 2018, Sandoz Korea marked the highest operating profit per employee with 178 million won, but the figure plummeted last year and marked 31 million won per employee. Plunged by approximately 40 million won from 112 million won in 2018, Kyowa Kirin Korea has only made 74 million won operating profit per employee last year. As for Genzyme Korea, the operating profit in 2018 was at 62 million won per employee, but the last year’s figure was omitted from the report due to the merge with Sanofi-Aventis.
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- COVID-19 hinders Italian API distribution causing stock-out
- by Jung, Hye-Jin Apr 22, 2020 06:03am
- Due to temporary suspension of active pharmaceutical ingredient (API) distribution amid COVID-19 pandemic, many drugs have been reportedly sold out. The industry experts see that the restricted international logistics of human and material resources during the pandemic has affected a number of drugs to be stocked out for a long and short term. The latest stock-out news was from Conjuran injection 2 ml/ 1s. Indicated for treating arthritis pain, the injection is manufactured by Pharma Research Product. But the company says the restock would only be feasible after May at earliest as importing API has gotten extremely difficult with COVID-19. The active pharmaceutical ingredient of Conjuran is imported from Italy. Pharma Research has said the production line has been halted for the entire month of April, because of the ingredient export from the country has been shut down. Kuhnil Pharm’s diuretic Amilo tablet has recently been sold out. Amilo imports its API from India and manufactures intermediate product in China before it is imported to Korea. And drug struggled with the outbreak spreading in China and the lock down in India. Artemisia Princeps leaf extract, widely used as gastrointestinal agent, has also recently came out of the woods. The distribution of the leaf extract was temporarily stopped from the production facility in China, due to COVID-19. However, the ingredient stock-out was shortly resolved and distribution to Korea resumed soon after. Other items, such as Ilsung Pharm’s Ilsung Isoptin (40 mg and 80 mg/ 250 and 30 tablet packages), LG Chem’s Ralobon Plus (60 mg/ 30 tablet package), Samjin Pharm’s Gelma Suspension, Yuhan’s MG TNA 1053 ml injection, have recently notified their temporary stock-out. The affected companies have commonly explained they are facing difficulties in importing active ingredients, which ultimately caused the stock-out. Although they cannot pinpoint at COVID-19 as a direct cause, the pharmaceutical companies view the outbreak has either directly or indirectly influenced the logistics between countries for past three months. A pharmaceutical industry insider commented, “Usually a drug stock-out is caused by a delay in finished product import, but lately it has been mostly caused by trouble in ingredient distribution.” “Nowadays, importing pharmaceutical ingredients from China, India and even from Europe has become unstable with the lock down orders,” the insider added.
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- GSK Korea pays the highest average salary at KRW 136M
- by An, Kyung-Jin Apr 22, 2020 06:02am
- Among all Korean affiliates of multinational pharmaceutical companies, employees at GlaxoSmithKline (GSK) Korea have received the highest average salary of 136 million won. Employees working at Sanofi Pasteur, GSK Consumer Healthcare Korea, Galderma Korea, Allergan Korea, Boehringer Ingelheim Korea and AbbVie Korea have received average salary of over 100 million won. Average salary per employee at major multinational pharmaceutical companies in 2019 (Unit: 1 million won) Source: FSS On Apr. 18, an analysis of 31 audit reports submitted to Financial Supervisory Service (FSS) by multinational pharmaceutical companies found GSK’s average salary at 136 million won was the highest among the surveyed companies. The average salary per employee was calculated by dividing the total paid out salary of respective companies last year by the number of employees, confirmed in the audit report. The figures were found in the ‘selling and administrative expense’ section of the submitted reports excluding benefit expense, bonus, incentives and severance payment. The wages of Korea Otsuka Pharmaceutical and Janssen Korea’s facility staffs were calculated from production cost and the wages of clinical trial staffs were calculated from R&D cost. Compared to the year before, GSK’s overall employment salary in 2019 has gone down by 1.8 percent at 59.8 billion won. In 2019, total 444 employees were reportedly working at GSK. Although the overall salary payout was lower than the year before, the number of employees went down as well in 2019 by 14, which increased the average salary per employee by 1.3 percent. Continuing from 2017 to last year, GSK has topped the highest salary rank for the multinational pharmaceutical companies in Korea. Compared to the runner-up Sanofi Pasteur, the gap between the two top companies’ average salary per employee is approximately 17 million won, which has been narrowed slightly from the previous year. The employees at Sanofi Pasteur have been paid the average salary of 119 million won last year. The number of employees was reduced from 65 in 2018 to 61 in 2019, but the total salary has gone up by 1.1 percent, bring up the average salary by 7.7 percent compared to the year before. The report analysis confirmed the average salary per employee at GSK Consumer Healthcare Korea (113 million won), Galderma Korea (112 million won), Allergan Korea (107 million won) and AbbVie Korea (102 million won) exceeded over 100 million won. More than half of the companies, 19 out of 31 multinational companies have paid out average salary of over 80 million won. As for Sanofi-Aventis Korea, last year’s average salary per employee was at 68 million won, reduced by 11.0 percent compared to the previous year at 76 million won. The multinational company has merged with Genzyme Korea last year and the number of employees has surged by 64 from 442 to 506. Considering the overall salary payout has gone up only by 1.9 percent from 33.73 billion won in 2018 to 34.37 billion won in 2019, the average salary per employee has technically gone down. However, the net pay per employee could have gone up depending on their respective performance. Sanofi-Aventis reported last year that it paid out bonus and extra pay (1 billion won) and incentives (2.6 billion won), besides the overall salary of 34.4 billion won, as personnel expenses. The employees at Genzyme Korea have received average salary of 73 million won last year, and the yearly comparison data is unavailable since the merge with Sanofi-Aventis. Among all 31 companies, employees at Janssen Vaccines have been paid the least with average salary of 4 million won. According to the report, the company has paid out overall 647 million won as personnel expenses for 145 employees, reported as of late last year. Since 2016, Janssen Vaccines has been in the red for four consecutive years. Regardless, the reported total personnel expenses are questionable, as the company intends to minimize operating personnel and reduce production volume while reorganizing the anticancer treatment and next-generation vaccine production lines. Moreover, the analysis is likely to be inaccurate in parts, because calculating the average salary by dividing the selling and administrative expense by the number of employees would not fully reflect the accurate figures of companies with production facility in Korea like Korea Otsuka Pharmaceutical and Janssen Korea, as they reflect the facility employee wage as production cost. Spun off from Pfizer Korea last year, Pfizer Upjohn Korea has reported overall personnel expenses of 15 billion won. Dividing the total by the number of employee reported late December, the 264 employees have received average salary of 57 million won per person. But as the report omitted the figures before the spin-off (May 27, 2019), the actual figure could differ from their net pay. Last year, Pfizer Korea has paid approximate average salary of 92 million won per employee, slightly lower than 97 million won in 2018 before the split with Pfizer Upjohn Korea.
- Company
- Lipitor tops outpatient market again amid COVID-19
- by Chon, Seung-Hyun Apr 21, 2020 06:27am
- The 2019 novel coronavirus infection (COVID-19) seems to not have affected the top outpatient prescription drug rank in Korea. Dyslipidemia treatment Lipitor remained on the top of the leader board with a big gap. The prescription volumes of anticancer Tagrisso and cholesterol-lowering combination drug Rosuzet have also continued to skyrocket. But off-patent drugs that grew significantly in volume last year, actually showed an underwhelming growth. According to pharmaceutical industry research firm UBIST on Apr. 20, Pfizer’s dyslipidemia treatment Lipitor has made 47 billion won in the first quarter of the year, topping the outpatient prescription volume rank. Although the volume was 0.2 percent lower than last year’s first quarter, it easily defended the top place with almost double the volume of runner-up Tagrisso and Gliatamine. Comparison of prescription volume of major outpatient prescription drugs in first quarters of 2020 and 2019 (Source: UBIST) Lipitor, released in the Korean market in 1999, has been prescribed the most to outpatients for two consecutive years from 2018 to 2019. AstraZeneca’s anticancer treatment Tagrisso shined through in the market and ranked itself on the second place with 23.9 billion won in the quarter, surging by 18.2 percent from the previous year. It was exceptional for an anticancer treatment, mostly used for inpatient, to be ranked so close to the top. Tagrisso by AstraZeneca Tagrisso is a second-line therapy prescribed to patients with non-small cell lung cancer (NSCLC), who have developed resistance in existing epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), such as Iressa, Tarceva and Giotrif. Overcoming the drug resistance issue, the drug has been labeled as a third-generation. Tagrisso’s prescription volume has been surging since it was listed for National Health Insurance (NHI) reimbursement in December 2017. The treatment’s outstanding effect, compared to other alternative options, and administrative convenience have seemingly accelerated the prescription volume growth. Rosuzet by Hanmi Pharmaceutical Skyrocketed by 27.4 percent from last year, Hanmi Pharmaceutical’s Rosuzet has achieved the highest annual growth among others reaching the prescription volume of 22.8 billion won in the first quarter this year. A rosuvastatin plus ezetimibe dyslipidemia-treating combination drug, Rosuzet was released to the market in late 2015. After acquiring the rights over ezetimibe from the patentee MSD, Hanmi Pharmaceutical was able to enter the market faster than other competitors and it has been predominantly leading the same-substance market ever since. The combination drug has made 81 billion won from prescription last year. Taking the rapid growth of Rosuzet into account, the sources even project the drug could be the first Korean-made drug to surpass annual prescription volume of 100 billion won. LG Chem’s combination agent diabetes drug Zemimet has made 15.6 billion won in the first quarter last year, and the volume was increased by 18.8 percent this year at 18.5 billion won. Zemimet has combined Zemiglo, a new diabetic drug with DPP-4 inhibitor solely developed by LG Chem, and metformin. A combination agent for dyslipidemia Atozet showed a 20.8-percent growth in prescription over a year and generated 17.9 billion won in the first quarter. Released by MSD in 2015, Atozet is an atorvastatin plus ezetimibe combination drug. Currently, Chong Kun Dang holds the co-sales deal signed by the multinational company. In the first quarter, off-patent drugs have shown stagnant growths. Boehringer Ingelheim’s hypertension treatment Twynsta has generated 23.6 billion won and made only 1.7-percent growth from the year before. The prescription volume of Sanofi’s anticoagulant drug Plavix grew 1.7 percent from the year before and marked 23.6 billion won in the quarter. Compared to last year, AstraZeneca’s dyslipidemia treatment Crestor and Gilead’s Viread have recorded 5.8 percent and 26.5 percent decrease in prescription volumes, respectively. The prescription volumes of Eisai’s Alzheimer’s disease treatment Aricept and of Astellas’ benign prostatic hyperplasia treatment Harnal-D also had each dropped by 5.7 percent and 8.5 percent. Except for Viread, these off-patented originals had a significant surge in prescription last year. In 2019, Lipitor has grown 8.4 percent from the year before and generated 176.2 billion won. Plavix’ prescription volume reached 88.9 billion won last year with 17.3 percent surge from the year before. Some original drugs like Crestor and Arisept marked a 10-percent growth in prescription volume last year, when Harnal-D also grew by 6.5 percent. However, the research firm analyzed the originals’ prescription volumes have diminished this year as the generics have performed better. The industry views that the continuous spread of COVID-19 has influenced the outpatient prescription market. When the multinational pharmaceutical companies preemptively stopped visiting healthcare institutes due to the outbreak, the Korean pharmaceutical companies could have persuaded the prescribers to switch to generics.
- 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.
