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- 2025-12-25 19:20:53
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- Sales of Lyrica's generics sales beat Lyrica in nine years
- by Kim, Jin-Gu Jul 23, 2021 05:57am
- Lyrica (Pregabalin) For the first time, sales of Lyrica's generics, which is worth ₩120 billion a year, surpassed the original sales. It is the first time in nine years that a generic has been released in Korea. The reason why it took a relatively long time to expand generic prescription performance is because the original company, Viatris, has registered material patent & use patent. Use patent of Lyrica has been registered since the expiration of the material patent in 2012, and generic companies have sold generics in earnest since August 2017, when use patent was expired. ◆ Generics ₩16 billion vs Original ₩14.6 billion According to UBIST, a pharmaceutical market research institute on the 21st, the size of Pregabalin market is estimated to be ₩30.6 billion in the second quarter of this year. The size of the market itself is almost the same as that of the second quarter of last year (₩30.6 billion). However, the market share between the original and generics has changed significantly over the past year. The prescription amount of the original Lyrica decreased 12% from ₩16.6 billion in the second quarter of last year to ₩14.6 billion in the second quarter of this year. Sales of generics recorded ₩16 billion in the second quarter of this year. Compared to the second quarter of last year, it increased by 14%. The team beat the original for the first time based on its quarterly performance. It is the first time in nine years since the generic was released in Korea. As of second quarter, market share of generic is 52%. ◆ Generics were sold in earnest after the expiration of the usage patent in 2017 Domestic companies released generics in 2012 in line with the expiration of material patent of Lyrica. However, indication expired at that time was limited to epilepstic seizure. Drugs were not available for neurological pain. Until August 2017, when use patent expired, the sale amount of generic prescriptions was around ₩1 billion per quarter. Its market share also fell below 10%. However, sales of generics have increased in earnest since the expiration of the patent. The market share of generic products rose to 34% in 2018 after the expiration of the patent. It increased to 42 % in 2019 and 49% last year. The difference between prescription amount between original and generic in the first quarter was only ₩100 million. It finally surpassed the original in the second quarter. As of the second quarter, 117 companies have been approved for 330 items. HK inno.N's second-quarter prescription for Kabalin was ₩3.2 billion. Last year, it was the only generic product that had a prescription record of ₩10.7 billion. As of the second quarter, Daewoong Bio's Lyribear's sales were ₩1.5 billion won, Hanmi's Prebalin sales were ₩800 million, Medica Korea's Prelika and Hanlim's Gabaneuro were ₩700 million, Samjin's Neurocover-PG, Celltrion's Lyfrega and Lyreca were ₩600 million, respectively. All of the remaining products are less than ₩400 million.
- Company
- Optimal doses of Effient and Brilinta different for Koreans
- by Eo, Yun-Ho Jul 22, 2021 05:53am
- The theory that East Asians, including Koreans, require dose adjustments when receiving dual antiplatelet therapy (DAPT) prescriptions is gaining strength. In other words, the ‘East Asian Paradox’ theory that antithrombotics' clinical effect and safety are different for East Asians compared to Westerners is now being recognized worldwide. In Korea, with Young-Hoon Jung, director of the Cardiovascular Center at Gyeongsang National University Hospital, marking the start, domestic researchers have emphasized that East Asians show a different response to antithrombotics due to their lower risk of atherothrombotic events and a higher risk for serious bleeding events than Westerners and that an appropriate treatment guideline needs to be developed for Koreans. This opinion had also been reflected in the joint statement published by the Korean Society of Myocardial Infarction last year. As a result, various de-escalation strategies were studied on patients with acute myocardial infarction, all of which significantly reduced bleeding risk. The TICO study that demonstrated the effect of aspirin discontinuation therapy after 3 months, the TALOS-AMI study that showed the effect of switching from 'Brilinta (ticagrelor)' ‘to 'Plavix (clopidogrel)' after 1 month, and the HOST-REDUCE-POLYTECH-ACS that showed the effect of the de-escalation therapy of reducing the dose of 'Effient (prasugrel)' to half, are representative cases of studies supporting dose reduction. In addition, various pharmacokinetic and clinical observation studies that support reduced-dose therapies using Efficient and Brilinta were recently published in Korea and are expected to be used to revise the treatment guidelines in the future. First, Professor Young-hoon Jeong’s team published the results of a multicenter A-MATCH study that was conducted at 8 university hospitals on acute coronary syndrome (ACS) patients in the latest issue of the international journal, Thrombosis and Haemostasis. In the study, ACS patients before discharge were assigned to a standard-dose prasugrel 10mg, half-dose prasugrel 5mg, or platelet function test (PFT)-guided group for a 1-month treatment. Results showed that the ratio of patients that show an appropriate antiplatelet effect was 3.8 times and 3.5 times higher in the latter two groups compared to the Effient 10mg treated group. Bleeding frequency was also lower by 42% and 45% in the other two groups compared to the Effient 10mg treated group. Patients who experienced bleeding were around twice more likely to change drugs within the 1-year treatment period. Professor Jeong explained, “The standard-dose prasugrel had shown excessive strong platelet inhibition in Koreans. On the other hand, the half-dose prasugrel showed a clear reduction in bleeding risk and appropriate antiplatelet effect.” Also, in the HOPE-TAILOR study published in the international clinical medicine journal, J Clin Med, in June by Dong-A University Hospital’s Professor Mooh Hyun Kim and his Circulatory Internal Medicine team, the half-dose Effient and Brilinta demonstrated a more adequate optimal platelet reactivity (OPR) than the standard dose. However, the half-dose Brilinta treatment still showed excessive strong platelet inhibition and had significantly increased bleeding events in the 9-month treatment period compared to half-dose Effient, and standard-dose Plavix (31.6% vs. 12.2%, HR=2.93), also presenting the need for a large-scale clinical study on the optimal drug and dose for Koreans. Pusan National University Hospital’s Professor Jin Sup Park and his Circulatory Internal Medicine team also published their results of the BLEEDING-ACS study that was conducted on ACS patients in the latest issue of an international medical journal. The researchers randomly assigned ACS patients with low platelet reactivity (LPR) to standard-dose (90mg) or half-dose (45mg) of Brilinta to compare their frequency of bleeding events and dyspnea. Results showed that the frequency of bleeding events and dyspnea were similar between the two groups at 6 months, and was most frequent within 3 months of treatment, then decreased over time. However, the researchers also saw a 70% reduction of the Bleeding Academic Research Consortium (BARC) events (BARC type ≥2) in the low-dose Brilinta group. This reduction was more prominent in patients with a BMI of less than 25 kg/m2 or patients over 65 years of age. As in the case of Effient, the result suggests that reducing Brilinta’s dose in patients with a higher risk of bleeding, such as older or underweight patients, may have a more noticeable effect. Professor Park said, “No increase in ischemic events were observed in Korean patients with ACS when reducing the dose of ticagrelor by half. The dose reduction only significantly reduced risk of serious bleeding events.”` Meanwhile, studies on the appropriate dose of Brilinta for Koreans are currently underway, just like the HOST-REDUCE-POLYTECH-ACS studies that demonstrated the effect of half-dose Effient. The EASTYLE study, which is being conducted by Professor Mooh Hyun Kim and Professor Young-Hoon Jung's team, is studying the clinical efficacy of a de-escalation strategy, using 60mg Brilinta (45mg for older and underweight patients), and a hybrid therapy of discontinuing aspirin after 3 months in 2,000 Korean patients
- Company
- Celltrion's Regkirona was approved for EUA in Indonesia
- by Kim, Jin-Gu Jul 22, 2021 05:52am
- Celltrion said on the 20th that the coronavirus 19 antibody treatment drug Regkirona (Regdanvimab) has obtained an emergency approval (EUA) from the BPOM. The Indonesian government has approved the emergency use of Regkirona for minor and secondary patients in the high-risk adult group with COVID-19. According to the COVID-19 real-time statistics site "Worldometer," Indonesia's confirmed case of COVID-19 reached 2.88 million people and the death reached 73,600 on the 19th. The spread of delta mutations has led to a surge in the number of people infected with COVID-19. Celltrion said it recently confirmed Regkirona's neutralizing ability in animal testing of the delta mutation virus. Regkirona is expected to help prevent the spread of COVID-19 in Indonesia. A Celltrion official said, "We have obtained approval for EUA from the BPOM by proving its efficacy based on Regkirona's global clinical and quality data." "With this, we expect that Regkirona's export negotiations will go well. We will do our best to supply products globally quickly."
- Company
- Why Keytruda’s smile wavers after passing CDRC deliberation
- by Eo, Yun-Ho Jul 21, 2021 05:52am
- The drug finally was able to pass deliberations by the Review Committee for Cancer Diseases, but still, the company's smile wavers due to the bitter aftertaste left by the committee’s ‘conditional’ approval. With MSD Korea’s cancer immunotherapy ‘Keytruda (pembrolizumab)’ passing deliberations by the Review Committee for Cancer Diseases in July, industry expectations are rising on the possibility of the drug’s benefit coverage being expanded to first-line in non-small cell lung cancer (NSCLC) However, under the air of anticipation there lies concerns as the Review Committee for Cancer Diseases had put forward a condition for granting the nod to Keytruda. During deliberations, the Review Committee for Cancer Diseases once again mentioned Keytruda’s equity with Tecentriq to MSD Korea, requesting additional modifications to be made to the cost-sharing plan. This indicates that the drug pricing negotiations with the Pharmaceutical Benefit Appraisal Committee or the National Health Insurance Service will act as a variable in the discussion of Keytruda's benefit expansion to the lung cancer indication. The agenda to expand Keytruda’s reimbursement to first-line in lung cancer had been introduced to the Committee for Cancer Diseases meeting 9 times, which took almost 4 full years. As a winning bid, MSD Korea had submitted what MSD Korea’s newly appointed managing director Kevin Peters described as an “unprecedented financial sharing plan” at the last meeting, determined to receive approval this time. Despite such effort, a serious ‘condition’ was attached to the approval. Due to this, some believe that the Review Committee for Cancer Diseases has 'passed' Keytruda's reimbursement mainly due to the ‘burden’ of leaving the agenda pending. This goes to show how much influence the condition to ‘cover the initial 3 cycles’ worth of administration cost’ that Roche Korea had accepted in the reimbursement process of ‘Tecentriq (atezolizumab)’ has in the drug reimbursement process. MSD had repeatedly proposed compromises and revised plans to the government and expressed that their proposal meets the requested condition. However, there is no doubt that the company finds it difficult to accept the 3-cycle cost burden as is. With no time to relish the joy of passing deliberations by the Review Committee for Cancer Diseases, the company immediately convened a meeting to discuss countermeasures. Keytruda's benefit expansion to the lung cancer indication can once again fall through in the process of drug pricing negotiations with the Pharmaceutical Benefit Appraisal Committee or the National Health Insurance Service. How the reimbursement journey for Keytruda will progress after the Review Committee for Cancer Diseases handed over the baton to the next regulators, and whether the government and pharmaceutical company will be able to reach an agreement remains to be seen. An official from the Review Committee for Cancer Diseases said, “We cannot estimate the price cut that would be applied to both drugs based on the ‘visible’ listed price as it is not the actual price. However, the additional discount requested for Keytruda will be quite significant. Although the agenda passed deliberations by the Review Committee for Cancer Diseases, whether the drug will be reimbursed is still unclear.”
- Company
- Antibiotic sales are decreasing due to prolonged COVID-19
- by Chon, Seung-Hyun Jul 21, 2021 05:51am
- The outpatient prescription market has also changed significantly as COVID-19 epidemic has been prolonged. The pharmaceutical market, which is mainly used for infectious diseases such as antibiotics, anti-septic drugs, and influenza (flu) treatments, has shrunk significantly. The flu treatment market has shrunk 99.9% in two years. According to UBIST on the 20th, the amount of outpatient prescriptions for Cephalosporin PO in the first half of last year was ￦87.7 billion, down 20.6% year-on-year. Compared to the first half of 2019, the amount of prescriptions decreased by 33.7% over two years. Cephalosporin is an antibiotic widely used in pneumonia, sore throat, tonsillitis and bronchitis. According to the amount of Cephalosporin prescribed on a quarterly basis, it fell 32.1% from ￦72.5 billion in the fourth quarter of 2019 to ￦49.2 billion in the fourth quarter of last year. The prescription amount of Cephalosporin in the first quarter of this year was ￦42.8 billion, down 32.8 % from a year earlier, and the prescription performance in the second quarter decreased 3.9%. As COVID-19 outbreak began in earnest, the market size of Cephalosporin has also decreased significantly and sales have decreased significantly until the first half of this year. It is analyzed that the antibiotic market has shrunk due to the prolonged COVID-19. Since the spread of COVID-19, sales of antibiotics have also decreased significantly as the flu outbreak has decreased due to strengthening personal hygiene management such as washing hands and wearing masks. Sales of major antibiotics have decreased significantly since the spread of COVID-19. The amount of prescription for Penicillin PO in the first half of last year was ￦46.8 billion, down 26.8% from a year earlier. Penicillin PO also decreased in size from the first half of last year when COVID-19 outbreak began in earnest. The prescription amount of Penicillin PO in the first half of last year was ￦63.9 billion, down 30.8% from a year earlier, and down 39.2% from a year earlier in the second half of last year. The amount of prescriptions in the first half of this year is only half that compared to ￦92.4 billion in the first half of 2019. Other antibiotics such as Macrolides also had similar circumstances. Macrolides and other prescriptions for the first half of the year were ￦37.9 billion, down 24.1% from a year earlier. It fell 41.3% compared to 2 years ago. In June of this year, the total amount of antitussive drugs was ￦24.8 billion, down 47.5% from ￦47.3 billion in the first half of last year. Compared to two years ago, it fell 59.0%. Since the spread of COVID-19, the amount of outpatient prescriptions for expectorants has decreased by one-third. Sales of antitussive drug (single) decreased by 62.8% from two years ago to ￦10 billion in first half of the year, while sales of antitussive drug's(combination) decreased by more than half from ￦33.6 billion in first half of 2019 to ￦14.8 billion in two years. In the first half of the year, the amount of outpatient prescriptions for Expectorants was ￦48.1 billion, down 32.9% from the same period last year. It has halved from ￦85.2 billion in the first half of 2019. As the number of flu patients decreased, the flu treatment market has virtually disappeared. In the first half of the year, the amount of prescription for flu treatment was only ￦14 million. It decreased 99.8% from ￦8.3 billion in the first half of last year, and the market size was only 0.1% compared to ￦14.4 billion in the first half of 2019.
- Company
- Harvoni’s growth spurt despite Hep C market downturn
- by Nho, Byung Chul Jul 21, 2021 05:51am
- With the domestic hepatitis C treatment market externally contracting from ₩120 billion to ₩68 billion in three years, the rapid strides of growth made by Harvoni in the market is drawing attention. On the 20th, Dailypharm analyzed the hepatitis C treatment market based on IQVIA data. The overall sales in the Hep C market amounted to ₩121.2 billion·₩89.9 billion·₩85.2 billion·₩68.8 billion in the years 2017·2018·2019·2020. The leading product in the market was AbbVie’s Maviret, which recorded ₩47.9 billion in sales last year. Maviret still is the sole lead product that accounts for 70% of the market, however, its sales fell ₩10.4 billion compared to 2019. Externally, Zepatier·Sovaldi·Daklinza·Sunvepra also showed sales of ₩2.6 billion·₩0.7 billion·₩0.6 billion·₩17 million in 2020 and recorded a decline in sales compared to the previous year. While products in the market showing negative growth, Gilead’s Harvoni was the only one showing an upward trend. Harvoni’s performance in the last 3 years (2018·2019·2020) was ₩6.8 billion·₩15.7billion·₩18.4 billion. With regards to its growth rate, it has ranked second to Maviret, accounting for 4.35%·13.88%·19.88% of the market. In the same period, Maviret’s market share was 12.50%·69.80%·75.43% The recent negative growth seen in sales of hepatitis C treatments recently is presumed to be due to the decreased inpatient treatment rate of hepatitis C in the COVId-19 pandemic. In addition, the reasons for Harvoni's sole increase in market share in the domestic market is attributed to its changed indication that allows its use in patients with renal impairment in March last year, and its reinforced safety and cost-effectiveness from the RWD presented at the Liver Week in May this year. In March 2020, Harvoni’s indication was changed to allow its use in patients with any degree of renal impairment, including end-stage renal disease (ESRD) on dialysis without dosage adjustment in addition to the previously approved for patients with mild-to-moderate renal impairment, allowing its use and prescription to a wider patient population. Also, the first multicenter RWD(Real World Data) on Harvoni in Korea was presented at Liver Week 2021, reinforcing the strengths of Harvoni, the only PI-free DAA agent in Korea, and having a positive effect on the domestic market share. As most hepatitis C treatments have excellent treatment effects, we now need to consider drug safety, cost-effectiveness, and convenience of administration, including drug-drug interactions (DDI) in addition to getting cured. Harvoni is the only hepatitis C DAA agent that does not contain a protease inhibitor (PI). This allows less drug-drug interactions, and therefore may be used in patients with comorbidities that require multiple drug intake, and is safe to be used by people with all stages of liver disease. Protease inhibitors can cause serious liver damage when taken by hepatitis C patients with severe liver disease. The U.S. Food and Drug Administration (FDA) had stated that patients with moderate to severe liver disease (Child-Pugh B, C) should take caution in using drugs containing protease inhibitors. In addition to such precautions, as DAA agents containing protease inhibitors have a narrower scope of use than Harvoni, this also may have had an impact on Harvoni's market share expansion. Harovni’s strength is not limited to its antiviral effect and safety. It is also cost-effective. Over 98% of the hepatitis C patients in Korea belong to genotype 1 and 2 of the virus, with over half of the patient population (45-59%) having genotype 1 of the virus. In this context, the 8-week treatment regimen of Harvoni that allows a cost reduction of 30% compared to existing hepatitis C treatments gained attention as the treatment option that can reduce the treatment burden for patients with genotype 1 of hepatitis C virus. Harvoni’s 8-week treatment regimen can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL. Also, Harvoni can be taken orally once a day in a single tablet without regard to food. This simple administration method increased convenience in administration for patients. Other hepatitis C treatments have limitations in administration, requiring more than 1 table intake during or after meals, but a single tablet of Harvoni is taken orally once daily with or without food. The World Health Organization (WHO) had proposed eliminating hepatitis by 2030, by raising awareness of the viral infectious disease hepatitis C and expand active prevention, testing, and treatment of the disease. Hepatitis C is a type of infection in which the blood or body fluids of a patient infected with the hepatitis C virus is transmitted through the injured skin or mucous membrane of normal people. With no vaccine available for its prevention, and new infections usually being asymptomatic, 70-80% of the patients are diagnosed after developing chronic HCV infection. 30% of these patients develop cirrhosis or liver cancer, therefore prevention and prompt treatment and diagnosis are required. Hepatitis C can be cured with only 8 to 12 weeks of treatment without concern about developing resistance with the introduction of direct-acting antivirals (DAA).
- Company
- Domestic Rx sales are showing strength in H1
- by An, Kyung-Jin Jul 21, 2021 05:51am
- Lipitor Pfizer's treatment for dyslipidemia ranked first in outpatients in the first half of the year. Drugs developed with domestic technologies such as "Rosuzet" and "Zemimet" led by HK-Inoen's "K-CAB" have increased their market influence despite the chaos of COVID-19 outbreak. The originals of multinational pharmaceutical companies, which once had sales, have stagnated since the expiration of patents. According to UBIST, a pharmaceutical research agency on the 19th, Pfizer's Lipitor topped the list with a cumulative prescription amount of ￦86.5 billion in the first half of this year. Lipitor (Atorvastatin) is a treatment for dyslipidemia, which was introduced to the domestic market in 1999 by Pfizer Korea. Since the expiration of the patent, insurance drug prices have fallen by half and more than 130 generics have been released, but they are still showing strong sales in the prescription drug market. Except for 2017, it has topped the prescription list for the past 10 years. Viatris, which was launched in November last year with the merger of Upjohn and Mylan, which have been in charge of Pfizer's patent-expired drugs, is in charge of sales. However, looking at the quarterly performance, the upward trend has slowed somewhat since COVID-19 outbreak began in earnest. By 2019, the average amount of Lipitor prescription per quarter was close to ￦48 billion, but the average of last year was barely over ￦46 billion. This year's performance was ￦43 billion in the first quarter and ￦43.5 billion in the second quarter, which is not up to its peak performance. The cumulative amount of prescriptions for the first half of the year decreased by 8.1% from ￦94.1 billion a year earlier. The prolonged COVID-19 situation is believed to have been affected by the contraction of hospital visits and the overall foreign prescription market. During the same period, Hanmi's Rosuzet ranked second in prescriptions, with outpatient prescriptions rising 13.8% year-on-year to ￦53.4 billion. Rosuzet is a combination drug composed of Ezetimibe and Rosuvastatin. Since its release in late 2015, it has ranked first in the market among the same ingredients. Analysts say that Hanmi's strategy to enter the composite market before its competitors was effective as it secured Ezetimibe license from patent holder MSD. Sales of Rosuzet rose more than 10% year-on-year every month even at a time when face-to-face sales marketing activities were severely restricted due to COVID-19 last year. In the second half of last year, the monthly prescription amount exceeded ￦8 billion, surpassing Gliatamin as the second-largest outpatient prescription. This year, the company set its own record of ￦9.4 billion in monthly prescription amount, narrowing the gap with No. 1 Lipitor. Sales of Daewoong Bio's Gliatamin was ￦46.3 billion in outpatients in the first half of last year, down 3.5% from a year earlier. Gliatamin is generic of the brain functional enhancer Choline alfoscerate. The government has received two sanctions, including a reduction in benefit. However, Gliatamin's influence in the prescription drug market remains robust. The competition item, Chongkundang Gliatirin, increased 0.4% year-on-year to ￦40 billion in outpatient prescriptions over the same period. The amount of outpatients for K-CAB in the first half of the year increased 47.8% year-on-year to ￦45.4 billion. If the current trend continues, it is predicted that the amount of outpatients will easily exceed ￦100 billion by the end of the year. K-CAB (Tegoprazan) is a flagship product of HK Inno.N (formerly CJ Healthcare), which is about to be listed. It is a new type of anti- ulcer drug called "P-CAB," which competitively combines proton pumps and potassium ions located in the final stage of acid secretion in stomach wall cells, thus inhibiting gastric acid secretion. Sales of K-CAB rose to ￦5 billion in the first year of its release, compared to ￦1.7 billion in monthly prescriptions. It secured gastrointestinal reflux disease as its first indication, and added gastrointestinal ulcer treatment in July of the same year. In the first half of this year, when most of the drug performance was sluggish, it rose to fourth place in prescription, threatening third-place Gliatamin. The joint sales strategy with Chong Kun-dang, which has a differentiated mechanism from the existing PPI. The increase in prescriptions for products developed by domestic companies was noticeable. The amount of outpatients for LG Chem's diabetes combination drug Zemimet in the first half of this year was ￦41.1 billion, up 8.4% from the previous year. Zemimet is a second compound that combines Metformin with Zemiglo (Gemigliptin), a new diabetes drug developed by LG Chem. It has been co-selling with Daewoong Pharmaceutical since 2016. Due to changes in the diabetes treatment market, which prefers multi-drug prescriptions, it has surpassed the performance of Zemimet. In the top 10 outpatient Rxs, sales of prescriptions for the past six months have fallen. The amount of outpatient prescription for Sanofi's anti-thrombotic drug Plavix was ￦44.8 billion, down 2.3% from the previous year. Boehringer Ingelheim's hypertension combination drug Twynsta and Gilead Science's hepatitis B treatment Viread fell 8.1% and 6.7% in the first half, respectively. AstraZeneca's treatment for dyslipidemia, Crestor, decreased 9.2% from the previous year to ￦38.8 billion in the first half of the year, ranking among the top 10 outpatients Rx.
- Company
- Patent ruling changes NOAC market…Eliquis surpasses Xarelto
- by Kim, Jin-Gu Jul 20, 2021 05:47am
- The Supreme Court’s ruling shook up the new oral anticoagulant (NOAC) market in the second quarter of this year. With Daiichi Sankyo’s ' Lixiana (Edoxaban) still in the lead, 'Eliquis(apixaban),’ which had experienced a decline in sales after its generics were released, made a successful rebound. On the other hand, Eliquis’s generics that had once rapidly expanded its share in the market virtually disappeared. The Supreme Court’s ruling in April had directly affected the disappearance of generics. The other two NOAC products - ‘'Xarelto (rivaroxaban)’ and ‘Pradaxa (dabigatran)’ - however, saw a continued decline in its prescription performance. ◆Original drug maker’s sales 7%↑ vs. generic companies 40%↓ after Supreme Court ruling According to the market research institution UBIST on the 20th, the overall size of the NOAC prescription market in Q2 this year amounted to 46.7 billion won. This was a 2% YoY decrease from Q2 of the previous year. The 4 original NOAC products saw mixed results in prescription performance. Prescription for Daiichi Sankyo’s Lixiana and BMS’s Eliquis had increased, whereas the same for Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa fell. Lixiana still kept a solid lead in Q2 this year. It sold 17.2 billion won in prescription sales ins Q2 this year, an 8% YoY increase from Q2 of the previous year. Prescription sales of Eliquis also increased by 7%, from 12.1 billion won to 13 billion won in the same period. Eliquis’ sales had fallen continuously since its release until Q1 this year and then made an upward turn for the first time in Q2 this year. In this process, the NOAC market’s rank also changed. Until Q1 of this year, Xarelto was second place in the NOAC market, but Eliquis outsold Xarelto and took second place in Q2. The Supreme Court’s ruling in April is predicted to have been the direct cause of the change in sales. In April, the Supreme Court overturned the first and second trial judgments in the dispute over Eliquis’s substance patent and ruled in favor of BMS. The ruling had alternate effects on Eliquis’s original drug maker and its generics. Immediately after the ruling, Eliquis’s sales turned upward. On the other hand, sales of Eliquis’s generics were nearing '0'. Companies that used to sell Eliquis generics, including Chong Kun Dang, Yuyu Pharma, Samjin Pharm, Hanmi Pharmaceutical, Aju Pharm, and Yoo Young Pharm rushed to discontinue sales of their products in response to BMS’s forewarning of filing a claim for damages. The cumulative sales of the generics had increased continuously from 0.3 billion won in Q3 2019, 0.6 billion won in Q4 2019, 1.2 billion won in Q1 2020, 1.7 billion won in Q2 2020, 2.2 billion won in Q3 2020, 2.6 billion won in Q4 2020, and 3 billion won in Q1 2021. However, after the supreme court’s ruling, its sales fell sharply to 1 billion won in Q2 this year. The 1 billion won sold in the second quarter is believed to be prescriptions on previously released quantities to distributors. ◆Xarelto·Pradaxa↓…Will the decline continue due to the release of generics? The other two NOAC products – Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa – continued to see a decline in their prescription performance. Xarelto's sales fell by 9% from 12.5 billion won in Q2 last year to 11.4 billion won in Q2 this year. In the same period, Pradaxa’s sales fell 15%, from 1.7 billion won to 1 billion won. In addition, generics of Xarelto and Pradaxa are expected to be released in the second half of this year, reinforcing the prospect that their prescription performance will continue to decline. Exclusive marketing approval for Pradaxa’s generics was approved on the 18th. Under the approval, Intro Biopharma, Aju Pharm, Jin Yang Pharmaceutical, and Huons may now release Pradaxa’s generics until April next year. For Xarelto, Hanmi Pharmaceutical and SK Chemicals succeeded in overcoming the original’s patent. The companies may release the 2.5mg formulation of Xarelto’s generics from October 4th this year.
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- The Effects and Challenges of Vitrakvi
- by Jul 20, 2021 05:46am
- Bayer's "Vitrakvi" has been able to treat cancer patients who are positive for NTRK gene fusion, regardless of cancer type. The NTRK gene plays an essential role in the physiology, development and function of the nervous system through the TRK protein, which causes problems when unrelated genes are combined. This phenomenon, called NTRK gene fusion, produces a fusion TRK protein that transmits abnormal signals. Eventually, the downstream pathway becomes hyperactive, causing problems in cell growth and survival, leading to cancer. All cancers can be caused by NTRK gene fusion, but they vary in frequency from cancer to cancer. There are very few cases of NTRK gene fusion in commonly known small cell lung cancer (SCLC) or direct colorectal cancer. On the other hand, NTRK gene fusion is frequently found mainly in rare cancers such as secretive salivary gland cancer, secretive breast cancer, and infant-type fibrous sarcoma. So far, there have been no treatments targeting NTRK gene fusion. In May last year, Bayer's "Vitrakvi (Larotectinib)" was approved, paving the way for treatment of patients positive for NTRK gene fusion in Korea. Vitrakvi is a targeted anti-cancer drug developed exclusively for NTRK gene fusion. It is also an anti-cancer drug that can be used in patients who are positive for NTRK gene fusion. In Korea, less than 50 cancer patients are known to show NTRK fusion-positive casers every year. Vitrakvi demonstrated superior effectiveness in NTRK gene fusion positive patients. Clinical results for 159 patients published in the international journal Lancet last year showed an objective response rate (ORR) of 79%, and a median response period of 35.2 months (mDoR). It has shown therapeutic effects for about three years. There were also 24 cases (16 per cent). At the time of announcement, the median value of the overall survival period (mOS) was 44.4 months and the median value of the progressive survival period (mPFS) was 28.3 months. Vitrakvi has been effective not only in adults but also in pediatric patients. Twenty-four patients under the age of one were also included in the clinical trial, which showed equal efficacy without difference from adults. Vitrakvi is therefore licensed for use regardless of adults or children. Oh Do-yeon, a professor of oncology at Seoul National University Hospital, said, "As a result of prescribing Vitrakvi in a 6-year-old pediatric patient with thyroid cancer, the cancer mass spread to the lungs was so good that video findings showed few feared side effects." The professor said, "I've been taking medicine for four years, and it's been working well so far." The challenge for Vitrakvi is data. For now, medical staff are not aware of NTRK fusion-positive casers. It is also unknown whether there will be a consistent effect on each type of cancer. Professor Oh Do-yeon also said, "If you look at each type of cancer, the number of patients is very small, so it is difficult to determine whether 80% of ORR can be maintained for each type of cancer." The professor explained, "If there are more parameters over time, the answer will come out." Professor Oh said, "There is a lot of controversy over when to treat Vitrakvi among the standard treatments established for each cancer species." If NTRK fusion-positive casers are found, they will use Vitrakvi before other treatments, but different medical staff members have different ideas. "If data accumulates more and medical staff's perception of NTRK gene fusion improves, we expect to use Vitrakvi in the early stages." Another stumbling block for Vitrakvi is whether to register pay.Vitrakvi passed the first stage of the HIRA's Cancer Drugs Benefit Appraisal Committee in May with the same NTRK targeted drug Roche's Rozlytrek. Bayer is pushing for a quick listing as a pharmacoeconomic study and PE study exemption track. Attention is focusing on Vitrakvi's move as there have been no cases of anti-cancer drugs being registered as salaries regardless of cancer.
- Company
- ‘Tagrisso’ tenaciously attempts reimb. for 1st line NSCLC
- by Eo, Yun-Ho Jul 19, 2021 10:34am
- AstraZeneca Korea is attempting to receive insurance benefits for ‘Tagrisso’ once again after modifying its reimbursement standards. Industry officials said that AstraZeneca Korea had recently reapplied for expansion of insurance benefit for its 3rd generation EGFR TKI Tagrisso (osimertinib) to first-line treatment in non-small cell lung cancer (NSCLC). The key strategy for the approval of insurance benefits this round is in the reduced benefit standards. In its application, AstraZeneca reduced the scope of its reimbursement to provide the benefit to those who have a high treatment need rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits. Narrowing the scope of reimbursement would also naturally allow for a broader discussion on its fiscal impact. Thus, whether the agenda will be put up for deliberation at the Health Insurance Review and Assessment service’s Review Committee for Cancer Disease meeting planned in September is gaining attention. If reviewed, this will be the fourth time the agenda is discussed by the Review Committee for Cancer Disease As the committee passed MSD’s cancer immunotherapy ‘Keytruda (pembrolizumab)’ for the first-line treatment of lung cancer at the meeting in July after 4 years of deliberation, attention is focused on the committee’s decision for Tagrisso as well. Tagrisso, which added its indication for first-line treatment of lung cancer in Korea in December 2018, aimed to expand its reimbursement to the indication in 2019. However, after deliberation by the Review Committee for Cancer Disease in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in first-line is disclosed. Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) that there was an issue with the drug’s clinical efficacy. AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the first-line reimbursement of Tagrisso.”
