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- 2025-12-26 10:41:50
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- Sales of EGFR anticancer drug Tagrisso have been put on hold
- by An, Kyung-Jin May 27, 2021 05:56am
- The market for EGFR lung cancer drugs has been put on hold. Sales of Tagrisso, a third-generation drug, have declined since its benefit. As new products emerge one after another, the market is expected to change within this year. According to IQVIA, a pharmaceutical research institute, the size of Korea's market for EGFR tyrosine kinase inhibitors (TKI) in the first quarter of last year was ₩35.5 billion, down 2.9% from ₩36.5 billion a year earlier. South Korea's EGFR-TKI market increased to ₩38.9 billion in sales in third quarter of last year as it continued to grow since first quarter of 2017, but fell for second consecutive quarter. EGFR-TKI is a targeted anti-cancer drug prescribed to patients with metastatic non-small cell lung cancer (NSCLC) accompanied by EGFR mutations. EGFR mutations are a very common mutant type observed in 30–40% of non-small cell lung cancers that account for 80–85% of lung cancer, occurring between exon 18 and exon 21. It is known that Asian markets, including Korea, China, and Japan, are larger because they are more popular than Westerners. EGFR-TKI, which is currently on the market in South Korea, includes first-generation drugs Iressa (Gefitinib), Tarceva (Erlotinib), second-generation Giotrif (Afatinib), and third-generation Tagrisso (Osimertinib). Among the five products, the total size of the market tends to depend on the sales of Tagrisso. Tagrisso's first-quarter sales rose 3.1% year-on-year to ₩24.4 billion. As of first quarter, Tagrisso accounts for 68.9% of all markets. It is maintaining a four-fold gap with Giotrif, the second-largest item in sales. AstraZeneca's Tagrisso was approved by the MFDS in May 2016 for "local progressive or metastatic non-small cell lung cancer patients with EGFR-T790M mutations confirmed after EGFR-TKI administration." It is prescribed as a secondary treatment for non-small cell lung cancer patients who have developed resistance after administration of the existing first and second generations of EGFR-TKI. Tagrisso's sales soared in December 2017 when it was covered by health insurance benefits as a secondary treatment. Tagrisso's sales, which started at ₩2.3 billion in the first year of release and stayed at ₩10.3 billion in 2017, jumped 5.8 times to ₩59.4 billion in 2018. Although it continued to grow rapidly with ₩79.2 billion in 2019 and ₩106.5 billion in 2020, it is not as good as it used to be recently. After setting its own record of ₩27.9 billion in sales in third quarter of last year, it continued to decline for two consecutive quarters. The decline in Tagrisso sales varies. Tagrisso was added to the primary therapy indication in Korea in December 2018, and the reimbursement process has been stalled for more than two years. Tagrisso, which is not covered by insurance, costs ₩217,782 per 80mg, more than ₩6 million a month. Even if it meets the standards, there are many patients who cannot be treated because of the cost burden.The release of generics also seems to have had some impact. Since last year, global clinical subjects have been actively recruiting third-generation EGFR-TKI Leclaza (Lazertinib) therapy developed by Yuhan. Pfizer's Vizimpro (Dacomitinib), a small but second-generation drug, also began to be prescribed late last year after being listed on the benefit. Sales of Giotrif in the first quarter of last year were ₩5.2 billion, up 10.1% year-on-year. This is its biggest sales since its launch in South Korea. The remaining EGFR-TKI sales are sluggish. First quarter sale of Iressa by AZ were ₩4.2 billion, down 29.9% from a year earlier. During the same period, Roche's Tarceva recorded ₩1.5 billion in sales, down 29.6%. Vizimpro's sales in fourth quarter of last year and first quarter of this year are still insignificant. Industries are predicting that changes in EGFR-TKI markets will also accelerate during second half of this year. It is observed that competition between the 3rd generation EGFR-TKI will intensify after the launch of the domestic new drug Leclaza (Lazertinib). Leclaza was approved by the MFDS in January as a treatment for patients with EGFR T790M mutations that had previously been treated with EGFR-TKI. The HIRA's Cancer Drugs Benefit Application Committee, which was held in February, has been properly assessed and negotiated between the Pharmaceutical Benefits Advisory Committee and the NHIS. It is predicted that sales will begin in earnest from the second half of this year after completing the registration process quickly.
- Company
- MSD's HIV market entry to be discussed at June's DREC meetin
- by Eo, Yun-Ho May 26, 2021 06:06am
- MSD is pushing to enter the HIV treatment market in Korea. Industry sources have reported that MSD Korea’s once-daily fixed-dose HIV combination tablet ‘Delstrigo (doravirine/lamivudine/tenofovir)’ will be reviewed by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) meeting held in June next month. Considering that the company applied for Delstrigo's reimbursement listing in January, its listing process is proceeding relatively smoothly. MSD Korea had applied for the reimbursement of Delstrigo for its 'treating HIV-1 infection in adult patients with no prior antiretroviral treatment experience’ indication. Among its ingredients, the ‘doravirine 100mg’ ingredient was approved by the Ministry of Food and Drug Safety (MFDS) on November 22nd, 2019, under the name ‘Pifeltro,' to be administered in combination with other antiretrovirals. Pifeltro and Delstrigo are both indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment experience. Delstrigo’s efficacy was confirmed in the DRIVE-AHEAD trial. In the trial, Delstrigo was non-inferior to the efavirenz/emtricitabine/tenofovir combination. Also, 84% of the patients in the Delstrigo group achieved viral suppression at week 48 ( viral suppression of HIV-1 RNA
- Company
- Sales of obesity drugs have been on the decline
- by An, Kyung-Jin May 26, 2021 06:05am
- The rise in the obesity treatment market, which had high sales, has slowed. The effects of the new products of Saxenda and Qsymia has decreased. According to IQVIA, a pharmaceutical research institute, the domestic obesity treatment drug market was ₩32 billion in the first quarter, down 2.4% from ₩32.8 billion a year earlier. Although its sales in 3rd quarter of last year were at an all-time high of ₩38.5 billion, it fell for the second consecutive quarter. This is similar to the amount of sales immediately after Belviq (Lorcaserin) was removed due to safety issues in the fourth quarter of 2019. The reason why the obesity drug market is sluggish is mainly because of large items. Sales of Saxenda (Liraglutide) by Novonodisk , which remained the No. 1 product in the market, have fallen significantly, and even Alvogen Korea's "Qsymia" (Phentermine/Topyramate), the No. 2 item, seems to have entered a period of stagnation. Saxenda's first-quarter sales fell 25.2% year-on-year to ₩6.7 billion. It fell from ₩9.7 billion in the third quarter of last year to ₩8.8 billion in the fourth quarter of last year and its quarterly sales fell sharply again. It is down 43.7% from ₩19.9 billionin third quarter of 2019 when it set its own best record. Saxenda is the world's first obesity treatment drug licensed as a Glucagon-Like Peptide 1 (GLP-1) similar. The ingredients are the same as Victoza, which is prescribed in patients with type 2 diabetes, but differ only in dosage & indication. Sales have increased significantly over the past two years due to the formation of a perception that it is relatively safe because it acts as the same mechanism as the body's GLP-1 to suppress appetite and induce weight loss. Saxenda ranked No. 1 in sales of obesity drugs in Korea with sales of ₩5.6 billion in the fourth quarter of 2018. Its sales in the first quarter of 2019 were ₩10.5 billion, and it set its own record of ₩1.1 billion in the third quarter of the same year. Saxenda had a market share of 33.7%. Although its sales volume is the largest among obesity drugs still on the market in Korea, its market share has decreased significantly. As of the first quarter, Saxenda's market share narrowed to 21.0% and the share gap with the second-largest product (18.5%). The domestic obesity treatment market ranked second in sales of obesity drugs in Korea at the same time as Qsymia was released in January last year with sales of ₩4.3 billion in the first quarter of last year. Since then, sales have risen sharply due to ₩5.8 billion in the second quarter and ₩ 6.5 billion in the third quarter. Qsymia's accumulated first-year sales amounted to ₩22.5 billion. The domestic obesity treatment market enjoyed an all-time boom despite the negative effects of Covid-19 and the recovery and disposal of Belviq. Qsymia's sales have also declined since its release. Qsymia sold $5.9 billion in the first quarter. It rose 37.2% year-on-year, but has stagnated since the fourth quarter of last year. Qsymia is a combination of Phentermine and Topiramate, where Alvogen Korea secured domestic copyrights from Vivus in the U.S. in 2017. Alvogen Korea signed a joint sales contract with Chong Kun Dang at the end of 2019 and started full-scale sales marketing from early last year. Through the sales experience of Furring and Furimin, it is diagnosed that Qsymia was able to enter the market quickly as the sales power of Alvogen Korea and Chong Kun Dang, which have worked in the domestic obesity treatment market for a long time, created synergy. Although it is an oral drug, the fact that the dose of the psychotropic drug is relatively low and long-term prescription is possible is also considered a success factor. Overall, sales performance of other products except Saxenda and Qsymia is sluggish. Of the 110 products sold in the domestic market, Saxenda and Qsymia have a market share of nearly 40%. More than 110 items are competing for the remaining 60% market. In addition to Saxenda and Qsymia, Daewoong's Dietamin, Huons' Hutermin, and Alvogen Korea's Furing were only five products that exceeded ₩1 billion in sales in the first quarter. Dietamin's first quarter sales were ₩2.1 billion, down 2.2% from a year earlier. Until the fourth quarter of 2019, it was the second-highest-selling item after Saxenda, but its market influence declined sharply with the release of Qsymia. The sales gap with Qsymia is more than double. Sales of Hutermin and Furing fell 5.0% and 13.5% respectively compared to last year.
- Company
- Tylenol sales up 43% for use ‘after COVID-19 vaccination'
- by Kim, Jin-Gu May 26, 2021 06:05am
- Sales of Tylenol surged 43% YoY, compared to the same quarter of the previous year in the OTC pain medication market. This is in stark contrast to the double-digit decline in sales of other pain medications. Analysts believe that this increase in sales was influenced by the government’s guidance to ‘use Tylenol when experiencing side effects after COVID-19 vaccination.’ However, in the prolonged Tylenol shortage, companies with other analgesic brands have been employing aggressive marketing strategies targeting the gap, which may affect their Q2 sales and thereafter. ◆₩10.2 billion → ₩14.7 billion in one year… Tylenol makes new quarterly sales record According to the market research firm IQVIA, Tylenol sales recorded ₩14.7 billion in Q1 this year. This is a 43% increase from the ₩10.2 billion recorded in Q1 of the previous year and a new record in its quarterly sales. Analysts believe the guidance by the disease control and prevention authorities in Korea influenced the increase of Tylenol sales. Since starting COVID-19 vaccinations earlier this year, authorities have directed the vaccinated subjects to ‘take Tylenol if side effects such as fever occur.’ Upon strong opposition on the use of a specific product name by relevant groups including the Korean Pharmaceutical Association, the authorities explained that they “used the product name (Tylenol) to enable better understanding for the public and the elderly, as they are more familiar with the brand name.” After the incident, the authorities have changed their wording from ‘Tylenol' to ‘acetaminophen.' Despite such modification, frontline pharmacies say that customers still keep coming for Tylenol. In fact, most pharmacies voice that the Tylenol shortage has worsened after the authorities' guidance. “Almost all customers who come looking for Tylenol are those that will soon be vaccinated,” a pharmacist from Daejeon said. “Even when I recommend a different product with the same ingredient because have we're out of stock, 8 to 9 out of 10 people refuse to buy anything else but Tylenol.” Some analysts see this as an increased tendency of patients and consumers to prefer buying highly recognized products due to the prolonged COVID-19 pandemic. An industry official said, “Tylenol has constantly made strong sales in the COVID-19 pandemic. The guidance from the authorities and increased preference for known brands seem to have made a combined impact." ◆Other acetaminophen products all see a decrease in sales However, most major analgesics other than Tylenol have seen a decline in sales in the same period. In particular, even other analgesics with the same acetaminophen ingredient were not able to avoid a sales decline. Sales of Geworin, the second-most sold analgesic in Korea, fell 44% YoY from ₩6.6 billion in Q1 last year to ₩3.7 billion in Q1 this year. Chong Kun Dang’s Penzal’s sales also fell 26% from ₩1.3 billion to ₩1 billion. Sales of Dong-A Pharmaceutical's acetaminophen product, Champ Syrup, and its ibuprofen product, Champ Ibufen, fell by 53% and 59%, respectively. Most ibuprofen products also saw a sales decline. Sales of Daewoong Pharmaceutical's EZN6 fell 15% from ₩2 billion to ₩1.7 billion. Hanmi Pharmaceutical’s Maxibupen fell nearly half from ₩1.4 billion to ₩7 billion. Sales of Ahn-Gook Pharmaceutical’s Anyfen also fell 37%, and Samil Pharmaceutical’s Brufen fell 44%. GC Pharma’s Taxen was the only major analgesic other than Tylenol to see an increase in sales. Its sales increased 28% from ₩1.4 billion in Q1 last year to ₩1.7 billion in Q1 this year. However, the sales decline of most analgesics may be due to the unusually high sales recorded in Q1 last year. In Q1 last year, the spread of COVID-19 had raised public anxiety, which led to a temporary increase in sales of all household medicines including analgesics. ◆Domestic companies start ‘vaccine's side effect marketing… may turn around sales in Q2 Attention is focused on how the market may change after Q2. With the prolonged Tylenol shortage, pharmaceutical companies with acetaminophen products have started active marketing activities targeting the use of their drugs for the ‘management of side effects after vaccination.’ Samjin Pharm and Daewoong Pharmaceutical had already strengthened relevant marketing activities, and sales of some analgesics such as Geworin Cooldown, EZN6 Ace have already started to increase gradually. “Considering that the vaccination rate in Korea has not even reached 10% yet, the high demand for acetaminophen is expected to continue for a while,” an industry official said. “If the Tylenol shortage continues, sales of other analgesics with the same ingredient may increase.”
- Company
- Sales of Prevenar 13 in the first quarter fell 46%
- by Chon, Seung-Hyun May 26, 2021 06:05am
- Sales of Pfizer's pneumococcal vaccine Prevenar 13 fell by half year-on-year in the first quarter. Although sales soared after the spread of Covid-19 last year, it seems to have returned to the previous year's level this year. According to IQVIA, a pharmaceutical research institute on the 24th, Prevenar 13's sales in the first quarter fell 46.7% year-on-year to ₩9.4 billion. It shrank from $17.6 billion in the first quarter of last year to half in a year. Compared to ₩21.1 billion in the fourth quarter of last year, sales decreased by 55.5% in the first quarter. Quarterly sales of Prevenar 13 trend (unit: ₩1 million, data: IQVIA) Prevenar 13 posted quarterly sales of around ₩10 billion. It broke sales record in first quarter of last year by increasing 52.2% from previous year to ₩17.6 billion. In the second and third quarters of last year, Prevenar 13 set a new record for consecutive quarterly sales. It soared to around ₩20 billion in the quarter. Over the past year, Prevenar 13 posted sales of ₩81.3 billion, up 64.8% from a year earlier. Prevenar 13 is PCV13 that prevents infection to 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). It is a vaccine that can be inoculated at all ages over 6 weeks of age, with Chong Kun Dang for adults in charge of nationwide distribution and Korea Vaccine for infants and children. Although Prevenar 13 does not prevent pneumonia caused by COVDI-19, demand for inoculation among adults surged last year as some experts argued that it could help weaken pneumonia symptoms. However, as COVID-19 pandemic has been prolonged, sales of Prevenar 13 have also returned to the previous year's level. Sales of Prevenar 13 fell 18.9% in the first quarter from the first quarter of 2019. Quarterly sales of Prevenar 13 fell below ₩10 billion in about two years since the second quarter of 2019. As about a year has passed since the COVID-19 pandemic, fears of COVID-19 decreased and demand for Prevenar 13 has returned to the previous year's level as vaccinations have begun in earnest. Some analysts say that demand has decreased relatively this year because people who planned to vaccinate pneumoniae temporarily flocked last year.
- Company
- 1st reimb. discussion to start on 2 tumor-agnostic therapies
- by Eo, Yun-Ho May 25, 2021 06:04am
- Two types of tumor-agnostic therapies seek reimbursement listing in Korea. Industry sources say Roche Korea’s Neurotrophic tyrosine receptor kinase(NTRK) Rozlytrek (entrectinib) and Bayer Korea’s ‘Vitrakvi (larotrectinib)’ will be up for deliberation by the National Health Insurance Service's (NHIS) Cancer Drug Review Committee meeting on the 26th. Rozlytrek and Vitrakvi are indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. In other words, the two drugs may be used in virtually all cancer types confirmed with an NTRK gene. Both drugs will seek to receive reimbursement approval through the pharmacoeconomic evaluation (PE) exemption track. As the two drugs are in the same class, the government will be discussing reimbursement listing in coordination with the two companies Rozlytrek and Vitrakvi were approved based on a single-arm study that did not involve a control arm. As it already meets subparagraph 2 of the PE exemption criteria, if the committee deems the other conditions are also met, it is likely that the drug will have not much difficulty in receiving the exemption. Rozlytrek’s approval was based on results from the Phase I/II STARTRK-NG study in pediatric patients, as well as data from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials. In the Phase II STARTRK-2 trial, over half of the patients with NTRK fusion-positive, advanced solid tumors receiving Rozlytrek demonstrated a reduction in tumor size with an objective response rate (ORR) of 56.9%. Objective responses to Rozlytrek were observed across 10 different solid tumor types, and the median duration of response (DoR) was 10.4 months. Vitrakvi’s approval was based on data from the Phase II NAVIGATE trial in adult and pediatric patients 12 years or older and the Phase I/II pediatric SCOUT trial in pediatric patients 1 month or older to 21 years with advanced cancer or with primary CNS tumors. Efficacy results from three clinical trials in 55 patients with confirmed NTRK gene fusion showed that Vitrakvi demonstrated an ORR of 75% and partial response rate of 53% in numerous tumor types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumor, thyroid cancer, melanoma, colorectal cancer, gastrointestinal stromal tumors (GISTs), cholangiocarcinoma, gallbladder cancer, breast cancer, and pancreatic cancer).
- Company
- Keytruda leads domestic market sales … Perjeta·Prolia also
- by Chon, Seung-Hyun May 25, 2021 06:03am
- The cancer immunotherapy ‘Keytruda’ firmly held its lead in the domestic pharmaceutical market. This is the 5th consecutive quarter from the first quarter of last year that the drug has recorded top sales among all pharmaceuticals in Korea. Also, the new biopharmaceuticals introduced by multinational pharmaceutical companies like ‘Perjeta,’ and ‘Prolia’ showed rapid growth. Among locally developed new drugs, K-cab showed the most rapid growth. According to the pharmaceutical research firm IQVIA on the 23rd, MDS’s Keytruda recorded the highest sales of 44.1 billion won in the first quarter this year. This is a 27.0% year-on-year increase from the same quarter of the previous year, and comfortably exceeded sales of 'Lipitor,’ which took second place. Since taking the lead in the first quarter last year with 34.7 billion won in sales, Keytruda has held its top place for 5 consecutive quarters. Keytruda is an immune checkpoint inhibitor that was released in Korea in 2015. The drug inhibits the ‘PD-1’ protein expressed at the cell surface of activated T cells. It has boasted overwhelming performance in over 30 types of cancer starting from melanoma to lung cancer, head and neck cancer, stomach cancer, cervical cancer, etc. Immediately after its release, Keytruda’s quarterly sales remained around 3 billion won. However, its sales rose rapidly after the health authorities granted its reimbursement for second-line NSCLC from August 2017. In the first quarter of 2018, Keytruda’s sales exceeded 10 billion and exceeded 30 billion in the second quarter of 2019. In the first quarter of last year, Keytruda caught up with Lipitor, which had kept the lead since the fourth quarter of 2015 in sales, and rose to the top. Since then, Keytruda has maintained its strong growth, increasing the sales gap to 9 billion won last quarter. Among the top ranks, Perjeta, Prolia, and K-cab showed marked growth. Sales of Roche’s Perjeta rose 29.6% YoY in the first quarter of this year to record 21.4 billion Korean won and gained its place in the top 10. Perjeta indicated for use in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their disease. Perjeta was approved reimbursement as first-line treatment for HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy in 2017. In May 2019, the drug was granted selective reimbursement, and its sales surged as the Perjeta and trastuzumab combination became the established standard of care in the neoadjuvant treatment environment. Sales of Amgen’s Prolia increased 38.1% YoY to record 19.9 billion won in the first quarter of this year. Prolia is a biologic therapy that was released in Korea in November 2016 for treating osteoporosis by targeting RANKL, an essential protein for the formation, function, survival of osteoclasts that destroys bone. Prolia’s sales started growing since 2017 after it received reimbursement as second-line treatment. After the reimbursement was extended to cover first-line treatment since April 2019, Prolia’s sales increased exponentially. Its effort to strengthen its sales power through a partnership with Chong Kun Dang was also cited as a factor for Prolia’s sales growth. HK Inno.N’s new anti-ulcer drug K-cab showed strong growth amidst the chart full of drugs from multinational pharmaceutical companies. K-cab recorded 19.7 billion won in sales, a 56.7% YoY increase from the first quarter last year, and was the only locally developed drug to land in the top 10 sales. ‘K-cab (tegoprazan)’ is an anti-ulcer potassium-competitive acid blocker (P-CAB) that was released in March 2019 by HK Inno.N (previously known as CJ Healthcare). Its new mechanism of action competitively binds the proton pump, the final common pathway for acid secretion in gastric parietal cells, with potassium ions to inhibit acid secretion. After first receiving approval for as gastroesophageal reflux disease (GERD) therapy, K-cab’s prescription surged with the indication expansion to the treatment of stomach ulcers. K-cab has recorded the most amount of sales among all drugs developed in Korea.
- Company
- Samsung Biologics, commissioned to produce Moderna vaccine
- by Kim, Jin-Gu May 25, 2021 06:03am
- Samsung BioLogics signed a contract with Moderna on the 22nd (local time) to commission the production of COVID-19 vaccines. After producing undiluted corona vaccine abroad, Samsung BioLogics will charge and pack it in Korea. Samsung BioLogics CEO John Lim and CEO Stéphane Bancel Moderna attended the "Korea-U.S. Vaccine Company Cooperation Event" held in Washington, D.C. on the same day and signed the same day. Samsung BioLogics plans to start aseptic charging, labeling, and packaging of hundreds of millions of vaccines to markets outside the U.S. starting in the third quarter. "The Moderna vaccine is the most important vaccine for people around the world fighting COVID-19," said John Lim, CEO of Samsung BioLogics. "We have set a quick production schedule for commercial procurement early in the second half of this year in response to global demand for vaccines." "We expect this contract to help us continue to expand our production capacity outside of the United States," said Juan Andres, chief technology officer (CTO). This is the fourth contract by a foreign pharmaceutical company to be commissioned to produce in Korea by COVID-19 vaccine. Earlier, AstraZeneca, Novavax, and Sputnik V vaccine of Russia signed a consignment production contract with a domestic company. Among them, AstraZeneca vaccine is currently being supplied to South Korea. At the event, there were three MOUs (Memorandum of Understanding) in addition to a modern contract with Samsung BioLogics. The South Korean Ministry of Trade, Industry and Energy will cooperate with Moderna's investment support and business activities in Korea, while Moderna will make efforts to invest in and recruit mRNA vaccine production facilities. Moderna also signed an MOU with the Korea National Institute of Health to develop an mRNA vaccine. In addition, Novavax, SK Bioscience, and the MOHW signed MOU on research and development including COVID-19 vaccine. A total of four contracts and MOUs, including those of Samsung BioLogics, are interpreted as the outcome of the South Korea-U.S. summit on the previous day. President Moon Jae-in and President Joe Biden is epidemic to empower a coordinated response by 21, a joint statement has promised to 'Global Alliance for Vaccines and build a global partnership'.
- Company
- Organon’s spinoff from MDS to be completed in June
- by Eo, Yun-Ho May 24, 2021 05:51am
- Organon’s spinoff from MSD will soon be complete. Industry sources expect the administrative spin-off at the global headquarters of MSD and Organon to be completed within the next month (June). Following the spinoff, Organon & Co. will launch as a completely independent corporation in Korea as well. Organon’s Korean subsidiary has already moved into the shared office 'WeWork Gwanghwamun’ located in The K Twin Tower in Junghak-dong, Jongno-gu, Seoul last year, and has undergone the necessary processes for its separation. However, the legal procedures of the spinoff may take a while. Organon is currently undergoing procedures to change the license holder for its products, etc. The delay in implementing the re-revised ‘Criteria for Decision or Adjustment on Drugs’ by the health authorities that will withdraw the stepped pricing system applied to the transfer of original products has been affecting the transfer of licenses in spinoffs including Organon. MSD had officially announced the spinoff of Organon last February and initiated the spinoff process. Through the spinoff, Organon was to become a newly established corporation focusing on women's health, off-patent drugs, and biosimilars. By product, ▲ ‘Renflexis,’ ‘Brenzys,’ and ‘Ontruzant,’ biosimilars developed by Samsung Bioepis commercialized by MSD; ▲ ‘Nexplanon,’ an etonogestrel implant; ▲ hyperlipidemia treatments ‘Zetia’ and ‘Vytorin’; ▲the respiratory drug ’Singulair'; as well as around 90 off-patent drugs will be transferred to Organon. Based on its leading contraception and fertility treatment business, the new Organon plans to invest in ‘innovation’ to meet the distinct healthcare needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still a great need for these treatments. Meanwhile, Organon’s Korean subsidiary has appointed Kim So-Eun, MSD's ex external affairs Lead, as its first CEO. At the time of her appointment, CEO Kim had said, “In the Korean subsidiary, we plan to build a corporate culture where employees can enjoy various opportunities for growth in a horizontal and flexible environment while pursuing continuous growth and leadership for the company as well."
- Company
- Tagrisso's 1st-line reimb. necessary based on its OS benefit
- by May 24, 2021 05:51am
- With ‘Tagrisso (osimertinib)’ winning recognition as the first-line standard treatment for epidermal growth factor receptor (EGFR)-mutated advanced and metastatic non-small cell lung cancer, the demand for its reimbursement as first-line in Korea has also been increasing. At the Lung Cancer 1 session of the 19th Annual Symposium & General Assembly of the Korean Society of Medical Oncology that was held online on the 21st, Ji-youn Han, Head of the Lung Cancer Center at the National Cancer Center Korea emphasized the need for Tagrisso’s reimbursement based on the clinical data of Tagrisso. As a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), Tagrisso is indicated as first-line for EGFR mutated patients, but as its reimbursement is only applied when used as second-line, the drug is virtually used as a second-line treatment in Korea. This is in contrast to the reimbursement approved for first-line in other major countries around the world including the U.S., Germany, Italy, U.K, France, and Japan. Also, the National Comprehensive Cancer Network guidelines recommend Tagrisso as a category 1 preferred regimen in first-line in EGFR-mutated NSCLC. The issue arose due to the sub-analysis results of the Asian subset in the Phase III FLAURA trial. The trial demonstrated an improvement in the overall survival (OS) in all patients, however, the hazard ratio for OS in Asian patients in the sub-analysis was 0.995. This means that there is only a 0.005 reduction in risk, which signifies that there is virtually no difference with the control group. This result had raised the question of whether there was any OS benefit in Asian patients. “The FLAURA study demonstrated a statistically significant OS improvement in the Targrisso arm compared to the control arm despite the crossover (allowing patients to switch treatments) that was ethically allowed for the control group, which could have affected the OS data,” said Han. With the crossover, only 5% of the 277 patients in the control group were able to maintain treatment with their original first-line treatment, 1st generation EGFR TKI (gefitinib or erlotinib). 65% crossed over to a different treatment, and around half of these patients, 47%, crossed over to Tagrisso. On the other hand, 22% of the 279 patients in the Tagrisso arm maintained their Tagrisso treatment, and 48% crossed over to different treatments. 68% of these patients received chemotherapy. The subgroup analysis results showed that HR was near 1 only in Asian patients and L858R-mutated patient groups. However, Han explained that Tagrisso’s benefit is also evident in these subgroups. Han said, “In non-Asians, the OS graph shows that Tagrisso and the control group show similar outcomes until year 1, then shows maintained OS improvement. However, in the Asian group, the graph shows a clear difference from the start. And the graph intersects after 3 years,” he explained. “So looking at the OS curve, you can see that the OS improvement is well maintained for over 3 years.” On the reason why the Asian and non-Asian group shows different graph movements, Han explained: “Considering that patients with L858R mutation showed similar graph movements, one can suspect that the L858R mutation rate may have been higher in Asians.” He added, “EGFR subtype by race shows that L858R mutation, which shows unfavorable prognosis, is half that of those with Exon19-deletion in the non-Asian group, however, in the Asian group, the L855R mutation accounted for two-thirds of those with Exon19-deletion. Han’s conclusion was that the OS graph evidently shows Tagrisso’s effect as a first-line treatment. As the progression-free survival (PFS) of Tagrisso is approximately 20 months, not many patients can afford to use Tagrisso without reimbursement in the first-line setting. This is also why doctors tend to consider a narrower scope for the use of Tagrisso. Han said, “At a time when the world is changing to Tagrisso for EGFR-mutated metastatic NSCLC, we are being faced with this barrier of reality and moving backward against the global trend. Oncologists should first consider Tagirsso as first-line treatment, and (the government) should solve the economic issues associated with its use.”
