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- 2026-03-18 05:51:34
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- 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.”
- Company
- Prolonged Galvus patent dispute… results to come next year?
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- The patent dispute surrounding Novartis’ anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ may be prolonged and not be concluded within this year. With the substance patent of the said product to expire in March of next year, the benefits of early release will disappear for generic companies if the ruling comes after then. However, generic companies plan to continue the legal dispute to the end in consideration of the impact this case will have on future pharmaceutical patent strategies set by the industry in general. ◆4 years of legal dispute over invalidation of the extended period for a substance patent deepens Supreme Court’s concerns Pic of Galvus1According to the pharmaceutical industry, the legal dispute between the original drugmaker Novartis and generic companies centered around Ahn-Gook Pharmaceutical is ongoing for 4 years now. The case is currently pending in the Supreme Court. In November last year, Novartis filed an appeal to the Supreme Court despite the partial win it received in the second trial. The period for the dismissal of appeal to the Supreme Court had passed, and the Supreme Court will now officially review the legal dispute. However, negative prospects on whether the Supreme Court will make a final decision soon are being raised, as the court will have to carefully examine this new type of legal dispute that had not existed in the past. A legal official said, “Many legal suits to invalidate the extended period of substance patents for pharmaceuticals had been filed; however, the claims had never been recognized in the first or second trial. The Galvus case was the first ruling by the court that accepted the invalidation claim to shorten the extended term of a patent.” “Due to these issues that require careful consideration, the Supreme Court seems to be seriously contemplating on the case. Even the parties in dispute will not be able to predict the date of the Supreme Court's ruling, and there is a possibility that a final decision will not be reached within this year," he added. ◆Despite substance patent expiry in March 2022, generic companies are 'in for the whole fight' The key is whether the Supreme Court will make its ruling before March 4th of next year. March 4th is the date when the substance patent for Galvus expires. If the court’s ruling comes after May 4th, the generic companies will not be able to reap the benefits of overcoming Galvus’s patent or from the early release of its generic. According to UBIST, Galvus and Galvusmet sold 8.1 billion and 36.4 billion won in outpatient prescriptions last year. If the ruling comes after March, the generic companies will lose the opportunity to acquire the right to exclusive marketing approval of their generic in the prescription market that amounts to 40 billion won per year. Despite the risks, the generic companies plan to fight the full battle, as the results of this legal dispute may set a new milestone for generic companies in establishing patent strategies for generics in the future. If the generic companies succeed in invalidating even just one day of the extended patent term, this will may start a series of challenges on substance patents of original drugs, an area that had been considered impregnable. ◆187 days vs 55 days vs 0 days… What will the Supreme court’s judgment be? The Supreme Court‘s ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid. The conflict began 4 years ago in July 2018 when Ahn-Gook Pharmaceutical requested a trial claiming that part of the term extended for the substance patent of Galvus is invalid. Hanmi Pharmaceutical later joined in the fight. Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the protection term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Ahn-Gook Pharmaceutical claimed that the 187 days of the extended term for Galvus’s substance patent was invalid. IPTAB accepted Ahn-Gook claim and ruled the 187 days invalid. Novartis appealed, and the case went to the hands of the Patent Court of Korea. Intellectual Property Trial and Appeal Board had overturned the first instance judgment to take Novartis’ side. However, the court ruled that only 55 of the 187 days are invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. As a result, Novartis once again appealed, and the case is not being reviewed by the Supreme Court.
- Company
- Emtuen became the largest shareholder of SillaJen
- by An, Kyung-Jin Jul 19, 2021 05:56am
- SillaJen said that Emtuen paid ￦60 billion for 18.75 million shares. Emtuen will become SillaJen's new largest shareholder starting with the payment, seeking to normalize its management and strengthen its expertise in bio-industry companies. On the 13th of next month, SillaJen will hold an extraordinary shareholders' meeting at the Korea Broadcasting Center in Yangcheon-gu, Seoul and appoint new board members. According to SillaJen, the new board consists of people who can normalize management and develop bio expertise. GreenFireBio.LLC personnel, a U.S. drug development company with Emtuen as the largest shareholder, are also expected to join the board of directors of SillaJen. "We will do our best to become a pioneer in the bio industry as well as responsible management as the new largest shareholder," an Emtuen official said. "We will make efforts to establish a virtuous cycle model for the bio industry that leads to Emtuen, Sillazen and GFB." "With capital and expertise, Emtuen is truly pleased to be the new largest shareholder," said SillaJen. "We will do our best in research and development as SillaJen is able to make a new leap forward." Emtuen sets the entire new shares to lock-up period for three years to advocate responsible management as the largest shareholder and guarantee minority shareholders rights.
- Company
- ↑38% of drug exports in the first half
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- In the first half of the year, Korea's pharmaceutical exports recorded about ￦4.5 trillion. There is a possibility that it will surpass ￦10 trillion within this year. In particular, exports of medicines to Germany have increased significantly. In the first half of this year alone, more than ￦1.5 trillion was exported to Germany. Germany's share of domestic pharmaceutical exports exceeded one-third of the total. According to the Korea Customs Service on the 15th, Korea's pharmaceutical exports in the first half of this year are estimated at $3,915.86 million. The figure rose 38% from $2843 million in the first half of last year. Due to the prolonged corona crisis, it is observed that it is consistently performing well in drug exports. Semi-annual drug exports were in the mid- to late $1 billion by the second half of 2019, but have been in the middle of more than $2 billion since the first half of last year when the corona crisis began in earnest. In the first half of the year, imports of drugs amounted to $3.989 billion. The trade balance of drugs, which deducted imports from exports, was $6.92 million. It turned from a deficit of $847.22 million in the first half of last year to a surplus. This is the second consecutive surplus since second half of last year. Attention is focusing on whether it will change its record-high export performance recorded last year. Semi-annual drug exports since 2017 (Unit: $billion, Korea Customs Service) Total exports of drugs last year amounted to $6.89355 billion, the highest ever. In particular, more than $4 billion was concentrated in the second half of the year. Assuming that it will produce export performance similar to last year in second half of this year, it is predicted that it will be able to surpass ￦10 trillion by end of this year. Top 10 countries in drug exports in the first half of 2020 and the first half of 2021 (Unit: $billion, Korea Customs Service) By country, exports of medicines to Germany were high. In the first half of the year, $1.352.63 billion of medicines were exported to Germany. It accounted for more than one-third (34%) of domestic pharmaceutical exports. Last year, exports to Germany accounted for 22%. Exports of drugs to the United States, the largest exporter of drugs, have declined significantly. It was $46.72 million in the first half of last year, but fell 32% to $274.83 million in the first half of this year. Exports to Japan rose 30% ($168.23 million → $219.38 million dollars), the Netherlands 345% ($45.1 million → $288 million), and China 14% ($119.27 million → $136.47 million). Exports to Turkey fell 54% ( $327.31 million → $149.83 million), while Brazil also fell 9% ( $96.37 million → $87.32 million).
- Company
- Onivyde is expected to be eligible for insurance coverage
- by Eo, Yun-Ho Jul 16, 2021 05:54am
- The new pancreatic cancer drug Onivyde is expected to be listed on the insurance benefit. According to the industry, Servier recently concluded a negotiation with the NHIS for the listing of Onivyde(Irinotecan HCl). As a result, it is expected that new insurance benefits will be available in pancreatic cancer treatment. Onivyde is eligible for the benefit if it passes the final procedure, the Health Insurance Policy Committee. It is the first achievement in about four years since domestic approval was made in August 2017. The drug has passed the DC of major medical institutions, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. Combination of Onivyde and 5-FU/LV are available for patients who fail primary treatment based on Gemcitabine. Through a global NAPOLI-1 study, Onivyde significantly improved treatment performance by combining with the existing secondary treatment option 5-FU/LV in patients who failed Gemcitabine based primary treatment. It has become a reminder of the importance of sequential treatment strategies in treating metastatic pancreatic cancer. If Gemcitabine-based chemotherapy is used as a secondary chemotherapy for metastatic pancreatic cancer, it is the only treatment recommended by NCCN to be Category 1. Onivyde was approved by the Food and Drug Administration (FDA) in October 2015. Since then, Baxalta has acquired permission in Europe in October last year, and Shire has taken over development and sales rights in the global market except for the United States and Taiwan. Servier took over Shire's anti-cancer drug division and was granted permission from 2019.
- Company
- SMA tx Evrysdi has been applied for insurance benefits
- by Jul 16, 2021 05:54am
- Roche's Evrysdi, the second treatment for spinal muscular atrophy (SMA) in Korea, began the process of registering insurance benefits eight months after approval. According to the pharmaceutical industry on the 15th, Roche Korea applied to the HIRA earlier this month for the registration of the oral SMA treatment Evrysdi(Risdiplam). Evrysdi is the second domestically licensed treatment for spinal muscular dystrophy after Biogen's Spinraza. Although it was approved in November of last year, it has not been officially released in markets yet. A third treatment for spinal muscular dystrophy, Novartis' Zolgensma, has been approved. Novartis completed the application last month using the evaluation linkage system. Evrysdi was approved first, but Zolgensma's reimbursement was faster. Evrysdi is expected to be easy to register because it is cheaper than the previously listed Spinraza. Zolgensma are most expensive, so there are many concerns about which pay model to apply. Spinraza was also not easy to register at a high cost of nearly ₩100 million per vial at the time of the process. It took months before it was presented to the Pharmaceutical Benefits Advisory Committee. The final price of Spinraza is ₩9,2359,131. It costs ₩554.15 million per person in the first year, and ₩277.07 million from the following year. Patient's copayment is 10% of the total cost. Since Spinraza, which is already more expensive, has been reimbursed, it is not difficult to register if Evrysdi's drug price negotiation goes well. Evrysdi is also likely to follow the Expenditure Cap (RSA) applied to Spinraza. Zolgensma is a "one-shot treatment" that is only taken once in a lifetime, but the price is about ₩2.5 billion (based on the U.S.), the most expensive drug in Korea. The government and the company are considering ways to reduce the financial burden of health insurance. The company proposed a value-based RSA. The government are reviewing the Amortized Payment model. However, the only drug listed as Value-based RSA is "Evoltra," an acute lymphocytic leukemia treatment, and the Amortized Payment model is a new model that is attempted for the first time. It is expected to take some time to set detailed items such as standards and evaluation methods. Meanwhile, Evrysdi met the criteria for 'sitting without help' in BSID-III 12 months after treatment in the FIREFISH clinical trial of 41 infants from 2.2 to 6.9 months of age. 88% of patients on Evrysdi over two years survived without respirators for two years. In addition, the SUNFISH study of 180 patients aged 2-25 demonstrated improvement in motor function evaluation scale MFM-32 of Evrysdi in the 12th month of treatment.
