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Company
Sales of PPI antiulcer agents rise 30% in 2 years
by
An, Kyung-Jin
Aug 05, 2021 06:03am
The ranitidine impurity issue gave wings to the rising prescription of proton pump inhibitors (PPIs). The share of PPI prescriptions in the antiulcer agent market grew 30% in only 2 years after the drugs containing ranitidine – which used to occupy the largest share of the H2 receptor antagonists - were pulled from the market. Hanmi’s incrementally modified drug ‘Esomezol’ gained marked influence over the antiulcer drug market with the impurity issue and COVID-19 as momentum. ◆PPI prescriptions increase 5%...reaps benefits despite prolonged COVID-19 crisis According to the pharmaceutical market research institution UBIST on the 4th, outpatient prescription of PPIs recorded ₩616.7 billion in Q2 this year, which is a 5.0% year-on-year increase from the same period of the previous year. Compared to Q2 2019, sales had risen 29%. Despite the overall contraction of the prescription drug market due to the prolonged COVID-19 pandemic, PPI prescriptions have maintained quarterly sales of over ₩160 billion during the past year. The cumulative PPI prescriptions in the first half of this year amounted to ₩323.6 billion, which was a 7.3% year-on-year increase. Proton pump inhibitors (PPIs) block the final step of acid secretion and maintain a high pH level in the stomach to treat peptic ulcer disease and gastroesophageal reflux disease (GERD). Since recording ₩335.8 billion in outpatient prescription sales in 2015, sales of PPIs have increased over 10% each year to account for the largest share of anti-ulcer drugs prescribed in Korea. The rate of increase became greater since 2019. The ranitidine impurity issue was pointed to as the reason for the surge in PPI prescriptions. Analysts believe the suspended sales of 'ranitidine' products among H2 receptor antagonists that used to hold the largest proportion of prescriptions and had a similar prescription target to PPIs, led to PPIs receiving the benefit. ◆Sales of Esomeprazole jump 33%·rabeprazole 22%...polarization intensifies in PPI prescriptions The ranitidine impurity first led to an improvement in the prescription performance of all the 7 PPI ingredients. However, after two years, the different PPI ingredients saw mixed results. Prescription of esomeprazole and rabeprazole, which accounted for a large proportion of prescriptions, have continued to rise after their prescription performance surged in Q4 2019, while the upsurge in the rest of the ingredients was only temporary, showing the intensifying gap between the ingredients. The esomeprazole ingredient that is prescribed the most has continued to make double-digit growth despite the COVID-19 crisis. Outpatient prescriptions of esomeprazole amounted to ₩70.4 billion in Q2. This is a 4.0% increase from the previous year and a 33.3% increase from the year before the last. In Q3 2019, esomeprazole sold around ₩53.7 billion, however, after ranitidine was removed from the market in Q4 2019, its sales rose sharply to reach ₩67.9 billion. The upward growth continued afterward to reach ₩70.8 billion in Q4 last year. The rabeprazole ingredient sold ₩38.1 billion in Q2, marking a 4.5% year-on-year increase. Rabeprazole’s sales in Q4 2019 rose to ₩36.5 billion and continued its rise to reach ₩ 41 billion in Q4 last year. Compared to 2Q 2019, prescriptions rose 22.0% in just 2 years. Although the increase was not as prominent as in esomeprazole or rabeprazole, Ilaprazole also benefited from the market withdrawal of ranitidine. Ilaprazole’s outpatient prescriptions reached ₩8 billion in Q2. This was an 8.8% year-on-year decrease, but a 2.3% increase from 2 years before. The other PPI ingredients received less impact from the impurity issue. Omeprazole sold ₩6.4 billion in Q2. This was a 10.2% and 6.6% decrease from the same period a year and 2 years ago. In the same period, pantoprazole sold ₩9.6 billion, an 11.2% and 6.5% decrease from the previous year and 2 years ago. Outpatient prescriptions of lansoprazole in Q2 was ₩3.9 billion. This was an 11.6% year-on-year increase, but a 12.2% decrease from the 2 years ago, showing less performance than usual. ◆Prescriptions of Hanmi’s 'Esomezol' rise 45%...Products see mixed results from COVID-19 The key PPI products have experienced a sharp change in their prescription performance during the past 2 years, with the lessening impact of the impurity crisis and the increasing impact of the COVID-19 crisis. Hanmi Pharmaceutical’s ‘Esomezol’ showed the most marked growth. In 1H this year, Esomezol sold ₩23.3 billion in outpatient prescriptions. Despite the COVID-19 crisis, prescription of the drug increased 14.2% year-on-year to exceed ‘Nexium’ and become the leader in the PPI prescription market. Esomezol is a salt-modified drug of esomeprazole. The impurity issue led to an upsurge in prescription demand for Esomezol, with outpatient prescriptions rising 44.8% in just 2 years. AstraZeneca’s Nexium sold ₩18.7 billion in outpatient prescriptions in Q2. This is a 17.6% decrease from the year before and a 5.8% decrease from 2 years ago. Due to the COVID-19 crisis, prescriptions of Nexium decreased significantly, enough to hand over its long-held lead in the PPI prescription market. Nexium is the original esomeprazole brand that is distributed and sold by Daewoong Pharmaceutical in Korea. The other items were also not free from the impact of COVID-19. Il-Yang Pharmaceutical’s ‘Noltec’ sold ₩16.2 billion in 1H this year. This was a 4.3% year-on-year decrease, but also a 4.7% increase from 2 years ago. Noltec was able to maintain its 3rd place among prescriptions of single-agent PPIs. Noltec, an ilaprazole PPI agent developed by Il-Yang Pharmaceutical, was released as the nation’s 14th new indigenous drug at the end of 2009. Takeda Pharmaceuticals Korea’s ‘Lanston LFDT’ also rose to the ranks in H1 this year, selling ₩13.8 billion in outpatient prescriptions. In the same period, Daewon Pharm's ‘Eswonamp’ sold ₩8.3 billion. After the ranitidine issue, Eswonamp had enjoyed a profit with the annual prescription amount exceeding ₩20 billion for the first time, but prescription performance fell 17.3% this year. In addition to the impurity issue, analysts believe that the COVID-19 pandemic has acted as a variable that increased the gap between prescriptions of the products. HK Inno.N’s release of the antiulcer agent ‘K-Cab (tegoprazan) that has a new mechanism of action, has also intensified the change in the dominion of antiulcer drug prescriptions.
Company
Restylane Kysse has been approved in Korea
by
jung, sae-im
Aug 05, 2021 12:41am
Galderma Korea announced on the 2nd that Hyaluronic acid filler Restylane Kysse was approved by the MFDS on July 26 for the purpose of temporarily expanding the volume of lips for adults aged 21 or older. Restylane Kysse, which received Korea's first permission for lip fillers, was developed by Galderma as Optical Balanced Technology( OBT). Customized procedures can be performed to suit the patient's skin condition, and lip volume can be restored to create natural and beautiful lip volume. More than 78% of all patients who participated in Restylane Kysse's clinical trial said they were still satisfied with the results of the procedure a year later. The effect of Restylane Kysse was confirmed by a clinical trial. A total of 270 people were evaluated for the validity and satisfaction of the product by measuring changes after the lip enlargement procedure every eight weeks for 12 months. Clinical results showed that it lasted up to a year and showed high treatment satisfaction not only in middle-aged people who lost lip volume due to aging but also in young patients who wanted natural and thick lips. Based on this, it was approved by the FDA on March 26 last year as a lip filler. Lee Jae-hyuk, executive director of Galderma Korea's Aesthetic Division, said, "We reaffirmed the technical skills of Galderma, which developed the Hyaluronic acid filler Restylane Kysse. We will continue to make efforts as a helper to complete each person's skin through products like Restylane Kysse. We have been constantly innovating for healthy and beautiful skin."
Company
Roche’s Polivy can be prescribed at general hospitals
by
Eo, Yun-Ho
Aug 05, 2021 12:40am
The new lymphoma drug Polivy can be prescribed at general hospitals. According to related industries, ADC that combine with conventional BR therapy (Bendamustine/ Rituximab) treatments for diffuse large B-cell lymphoma (DLBCL) that have poor non-responsive prognosis of Roche. However, Polivy is still a non-reimbursed drug. Roche applied insurance benefit earlier this year, but failed to pass HIRA's Cancer Drugs Benefit Appraisal Committee in April. Roche is attempting to register Polivy in the future. Diffuse large B-cell lymphoma, which accounts for the highest percentage of non-Hodgkin lymphoma, is a type of aggressive lymphoma that requires immediate treatment due to its fast progression. More than half of patients have good treatment response rates to reach related levels, but 30 to 40% of patients do not respond to the standard therapy, R-CHOP, or experience recurrence after the first treatment. Most patients experience recurrence within two years, and the disease is fatal enough to last only six months. Recurrent and nonresponsive diffuse large B-cell lymphoma has been an area that lacks effective treatment options. Polivy is the first ADC drug to target CD79b, which binds to CD79b expressed in B cells and has the mechanism of inducing apoptosis. Polivy was validated by phase 1b/2 clinical trials in 80 patients with recurrent or diffuse large B-cell lymphoma patients who could not receive hematopoietic stem cell transplants and had more than one treatment experience. It was designated as a rare drug in Korea in October last year. Studies have shown that the Polivy co-therapy group extends CR, Complete Response and OS and Overall Surviva compared to the BR therapy group. Ko Young-il, a professor of hematology at Seoul National University Hospital, said, "Polivy has confirmed its usefulness through clinical use and is a treatment option recommended by international guidelines, which is significant in that it has proposed a new alternative to re-use or diffuse large B-cell lymphoma treatment.
Company
Will regulations on ERP be established?
by
Aug 03, 2021 08:24pm
Presidential candidate Lee Nak-yeonLee Nak-yeon, a presidential candidate for the Democratic Party of Korea, mentioned the need to draw up regulations on the Early Retention Program (ERP) of foreign-invested companies, including foreign pharmaceutical companies. Attention is focusing on whether frequent ERP regulations in the pharmaceutical industry will be possible. He made the remarks at a recent meeting in Gwangju Metropolitan City, "How to improve the working environment and secure the right to survive for workers in office research jobs and foreign-invested companies." "Recently, foreign-invested companies, including multinational pharmaceutical companies, have unilaterally implemented corporate changes such as division, acquisition, merger, and transfer of operations, and the government's investment in the name of internal restructuring. He agreed, "Changing legislative and public policies for new types of workers with different working conditions from existing production service jobs is an important task." "We need additional protective measures to regulate reckless abuse of voluntary retirement," he said. "We will make efforts to respect the value of labor in the future and not ignore the legal system for workers who are not legally protected in blind spots other than existing production, service, and even those who are not properly protected," he said. ERP of foreign pharmaceutical companies is being implemented more frequently following the outbreak of COVID-19. Sanofi, Lilly, and Roche conducted ERP in the second half of last year, and five to six companies, including Viatris, Astellas, GSK and Roche, conducted ERP in the first half of this year. He also said, "The comprehensive wage management is a structure in which it is difficult to reflect the opinions of workers because there is a possibility that users will unilaterally decide," adding, "We need to think about ways to increase the bargaining power of office research." The meeting, hosted by LG Electronics' human-centered office workers' union and the Korea MSD labor union, and organized by Daesang LLF, drew attention from unions of three pharmaceutical companies as representatives of foreign investment companies. They emphasized the reality that Korean branch employees are harmed by unilateral M&As at the global level and the need to pass legislative proposals for safety measures.
Company
Samsung launches Humira Biosimilar ‘Adalloce’ in Korea
by
Eo, Yun-Ho
Aug 03, 2021 07:04am
Domestic supply of the domestic biosimilar of ‘Humira’ has begun in full scale. According to industry sources, Adalloce, a biosimilar of the TNF- alpha blocker Humira(adalimumab)’s that was developed by Samsung Bioepis and sold by Yuhan Corporation in Korea, passed the Drug Committees (DCs) of 20 medical institutions including the Big-5s such as the Samsung Medical Center (SMC), Asan Medical Center (AMC), and Severance Hospital. Adalloce was the first biosimilar adalimumab product to receive marketing approval in Korea. It is a tumor necrosis factor (TNF)-alpha-blocker that is used to treat autoimmune conditions including rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. The commercialization of Adalloce will enable a more affordable prescription of adalimumab products in Korea, including the originator Humira. Adalloce’s listing will lead to Humira’s price being cut. According to the ‘Criteria for Decision or Adjustment on Drugs,’ the government can make a single price adjustment to the original drug as well as the generic with the same route of administration, ingredient, and formulation or combined nutritional infusion fluids with the same ingredient to be set at 53.55% of the original price. After received marketing approval for Adalloce from the Ministry of Food and Drug Safety in September 2017, Samsung Bioepis has been preparing for its release through a licensing agreement with the original drug developer. Adalloce was first released in Europe in October 2018 under the brand name ‘Imraldi,’ and has generated cumulative sales of $417 million (₩450 billion) by the end of 2020. In the United States, the drug received marketing authorization in May 2019 under the brand name ‘Hadlima.’ Under the licensing agreement made with AbbVie, the company plans to release Adalloce in July 2023. Meanwhile, Yuhan Corporation is also in charge of domestic sales of Samsung Bioepis’ Enbrel biosimilar ‘Etoloce’ and Remicade biosimilar ‘Remaloce’ in the domestic market.
Company
Beijing Hanmi's 2Q operating profit increased by 50%
by
Chon, Seung-Hyun
Aug 02, 2021 08:37pm
Hanmi Pharmaceutical's second-quarter performance improved. In the domestic market, self-developed new drug products have done well. Sales of Beijing Hanmi have more than doubled despite the sluggishness caused by COVID-19. Hanmi announced on the 29th that its operating profit in the second quarter increased 49.6% year-on-year to ₩15.9 billion. Its sales increased 14.7% year-on-year to ₩279.3 billion, while its net profit expanded 43.1% to ₩8.3 billion. Quarterly sales (left) operating profit (unit: ₩1 million, data: Financial Supervisory Service) Hanmi explained, "The stable prescription sales of self-developed products and the explosive growth of Chinese local Beijing pharmaceuticals caused strong sales." Rosuzet, Amosartan, and Esomzol are the reasons for this. The hyperlipidemia compound Rosuzet rose 11.% year-on-year to ₩26.9 billion in prescriptions in the second quarter. It is expected to surpass ₩100 billion in annual prescription amount this year, following the second-largest outpatient prescription among all medicines last year. Amosartan, a hypertension drug, recorded a prescription record of ₩18.9 billion in the second quarter. Although it decreased 7.4% year-on-year, it strengthened its position as a major drug. Amosartan is a combination of Amlodipine and Losartan. Esomezol posted a prescription amount of ₩12.2 billion in the second quarter, up 22.8% from the previous year. Beijing Hanmi overcame last year's slump and posted ₩59.5 billion in sales in the second quarter of this year, up 119.9 percent% year-on-year. It is the biggest sales in the first half of this year. Beijing Hanmi saw its sales drop 52% year-on-year in the second quarter of last year due to worsening market conditions caused by COVID-19. In the second quarter of this year, Ambrocol, one of Beijing Hanmi's flagship products, posted sales of ₩19.4 billion, more than 20 times the year-on-year. Sales of the children medicine Medilac-Vita increased by 147.6% to ₩13.6 billion, while constipation drug Lidong achieved sales of ₩15 billion.
Company
ACRC "Hemlibra's reimb. standards need to be reexamined"
by
Kim, Jin-Gu
Aug 02, 2021 06:05am
On the 30th, the Anti-Corruption & Civil Rights Commission (ACRC) has expressed the opinion that the reimbursement standards for the hemophilia treatment Hemlibra should be reexamined. In addition, the ACRC forwarded their official statement to the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA). Whether the opinion will provide an opportunity for the Hemlibra issue, in which pediatric patients under the age of 12 are currently discontinued from receiving treatment using the drug, may be resolved is gaining attention. ACRC's opinion does not have legal force, however, as the MOHW already expressed its intention to reexamine Hemlibra's reimbursement standards, there is a high possibility the current standards could be improved. The ACRC had previously received civil petitions for grievances from hemophilia patients imploring reexamination of reimbursement standards for Hemlibra. Upon receiving the complaint, ACRC held a roundtable with HIRA and patient groups to exchange opinions regarding the standards involved. Under the current standards, pediatric patients with severe hemophilia A who are less than 12 years of age need to receive immune tolerance induction (ITI·antibody removal) therapies for 2-3 years before receiving prescriptions for Hemlibra with reimbursement. Hemophilia patients had to receive intravenous injections every 2-3 weeks for nearly 3 years to meet the criteria. However, a considerable amount of pediatric patients are unable to even attempt ITI therapy because it was difficult to secure venous blood vessels for the intravenous injection. HCPs of patients in this special condition had prescribed Hemlibra and claimed insurance benefits for such prescriptions from February to March this year. However, HIRA rejected the insurance claims on the grounds that there was insufficient objective data to prove that ITI therapy was impossible. This led to a discontinuation of Hemlibra administrations in hospitals from April. Some of the patients were unable to receive treatment with Hemlibra due to the burden of its uninsured cost, which costs nearly 7.2 million won for 4 weeks. As a result, the ACRC issued their opinion that the reimbursement standards for Hemlibra need to be reexamined so that severe Hemophilia A patients under the age of 12 that 'have difficulty attempting ITI therapy that requires the endurance of great pain in the long-term due to their young age and weak blood vessels' could receive reimbursement for Hemblibra. ACRC referred to how ▲No prerequisite ITI therapy conditions exist for reimbursement of Heblibra in the U.K or Australia ▲ The guidelines by the World Federation of Hemophilia does not restrict Hemlibra's administration to after ITI therapy, and that ▲ it is too harsh to require ITI therapy, a treatment which is accompanied by immense pain, to patients under 12 years of age, as its grounds for making the recommendation. Also, the academic society's opinion that the 'long-term use of Hemlibra can reduce the development of various complications in the long-term' was taken into account. The ACRC's recommendation for correction has no legal force, however, the institution that receives the recommendation needs to inform the ACRC on whether it will or will not accept ACRC's recommendation within a month. Jin Hong Lim, the ACRC adjudication for civil petitions for grievances said, "It is unreasonable to require younger patients to receive a treatment that brings long-term pain to receive reimburse prescription of an effective treatment." Lim continued, "The current insurance benefit standard needs to be reexamined." Pic. of HemlibraPrior to delivering the ACRC's opinion delivery, the Minister of Health and Welfare Kwon Deok-Cheol said in June that he would comprehensively review improving the reimbursement standard of Hemlibra in consideration of the characteristics of pediatric patients with many experts when the National Assembly pointed out that the Hemlibra benefit standard for pediatric patients was too strict. Hemblibra is the first subcutaneous injection formulation for hemophilia treatment introduced by JW Pharmaceutical to Korea from Chugai Pharmaceutical in Japan. The drug was approved in 2019, and granted reimbursement in May last year. Unlike existing treatments, Hemlibra can be easily administered subcutaneously and has its strength in its convenient method of administration. Patients had to find their own veins to directly inject the previous drugs. Moreover, the intravenous injection method was more inconvenient as many of the patients were children.
Company
Daewoong recovers with record 2Q sales of ₩289.7 billi
by
An, Kyung-Jin
Jul 30, 2021 05:48am
Daewoong has continued its good performance for 2 consecutive quarters. By overcoming the heavy blows it took from the impurity issue in ranitidine and the lawsuits from its botulinum toxin strain dispute, the company was able to raise its quarterly sales to the highest level despite the COVID-19 crisis. Daewoong Pharmaceuticals has posted its operating profit of ₩26.7 billion in Q2 this year and marked a turnaround compared to the same quarter of the previous year. The company turned into a profit this quarter with its sales revenue increasing 20.8% to ₩273.1 billion and a net income of ₩14.5 billion. Its cumulative sales revenue in the first half of this year was ₩514.7 billion, a 13.3% year-on-year increase. Daewoong Pharmaceuticals had suffered from a poor performance last year. The detection of impurities in the heartburn treatment ingredient ranitidine led to a large sales gap in its key product ‘Albis.’ Also, the company had spent much expense in lawsuit over the botulinum toxin strain dispute with Medytox. In this year, the company has seen an improvement in its profitability with the revenue accrued from ‘Fexuprazan,’ which the company is developing as a treatment of gastroesophageal reflux, and the risk from ‘Nabota’ lawsuits being resolved. Also, the increase in sales became greater due to strong performance in the domestic market and in exports. Sales of the botulinum toxin product ‘Nabota’ has more than quadrupled in Q2 to record ₩23.2 billion, compared to the ₩5.6 billion in Q2 last year. With the risk from suits in the U.S. fully resolved, its U.S. market share has started to expand in earnest, and Daewoong Pharmaceuticals is also stepping up its efforts to expand to new markets overseas for ‘Nabota,’ including in Latin America and the Middle East. Sales in the prescription drugs sector recorded ₩196.1 billion, an 8.7% increase compared to the ₩179.4 billion in the same period of the previous year. Sales of Daewoong’s self-developed drugs including the liver drug ‘Ursa (ETC),’ anticancer drug ‘Luphere Depot,’ and combination hyperlipidemia drug ‘Crezet,’ as well as the drugs it introduced to Korea such as the anti-diabetic ‘Forxiga,’ anti-coagulant ‘Lixiana,’ and its 3-drug combination for hypertension ‘Sevikar’ had all increased evenly. In the OTC sector, the company recorded average sales - from ₩29.6 billion in the same period last year to ₩28.6 billion this year. Its high-dose vitamin B complex, ‘Impactamin,' and the liver function enhancer ‘Ursa(OTC)’ have maintained stable sales. Also, the technological fee from R&D projects has become a new source of revenue for the company. In Q2, the company made ₩11.1 billion from a U.S. licensing-out contract for ‘Fexuprazan,’ a new drug for gastrointestinal reflux.
Company
SK Group's Pharma companies make successive success
by
Lee, Seok-Jun
Jul 30, 2021 05:48am
SK Group’s pharmaceutical companies have successively succeeded in raising large-scale funds. The analysis is that being able to invest in independent corporations differentiated by business characteristics attracted market investment. SK Group’s pharmaceutical companies, which all use the SK name, are operated in different areas by SK or SK Discovery without mixed shares. SK operates SK Biopharmaceuticals (new drug development) and SK Pharmteco (CMO). SK Discovery operates SK Chemical (pharmaceutical business), SK Plasma (blood products), and SK Bioscience (vaccines). SK Plasma, a non-listed company, recently raised ₩110 billion through a third-party allocation paid-in capital increase. SK Plasma receives ₩40 billion from SK Discovery and ₩30 billion each from Tiumbio and Korea Investment Partners as an investment. SK Plasma was established in March 2015 as a spin-off from SK Chemicals. It manufactures and sells various plasma-derived products including the Human Normal Immunoglobulin Liv-Gamma SN Inj., Human Plasma-derived Hepatitis B Immunoglobulin Hepabulin SN Inj., Human Albumin Solution Albumin inj., SK Antithrombin III Inj., Tetabulin SN Inj., etc. COVID-19 vaccine developer SK Bioscience raises ₩1.4918 trillion at IPO SK Bioscience and SK Biopharmaceuticals raised large-scale funds through IPOs. SK Bioscience, which made its debut on KOSPI on March 18th, raised ₩1.4918 trillion at an offering price of ₩65,000 a share. SK Bioscience is a company specializing in vaccines that was spun off from SK chemicals in July 2018. It carries out the total process from R&D in the vaccine sector, production, sales to distribution. SK Bioscience was the first Korean company to apply for a Phase III trial for a COVID-19 vaccine candidate (GBP510) on the 28th of last month. The company is also developing another COVID-19 vaccine candidate (NBP2001). SK Biopharmaceuticals, which has two US-approved new drugs, raise ₩959.3 billion SK Biopharmaceuticals also raised ₩959.3 billion in funds at an IPO price of ₩49,000 on July 2nd of last year. SK Biopharmaceuticals is a new company that is in charge of new drug development and sales that was founded after a spilt-off of SK’s life science business in 2011. 2 new drugs that have been developed by SK Biopharmaceuticals are currently released globally. 'Sunosi,' a treatment for sleepiness developed by SK Biopharmaceuticals in 2011 and licensed out to Jazz Pharmaceuticals, was approved in the U.S. in March 2019. Also, its independently developed epilepsy treatment ‘ExcoFree’ was approved in the U.S. in November 2019.
Company
Emgality and Ajovy were also approved
by
Kim, Jin-Gu
Jul 30, 2021 05:47am
Following Lilly's Emgality (Galcanezumab), Teva's Ajovy (Fremanezumab) were released in Korea as a new medicine for migraine prevention. Attention is focusing on whether CGRP (calcitonin gene-related peptide) drugs, which have entered the domestic migraine treatment market without suitable treatments, will become popular. Emgality, Ajovy, and Aimovig Aimovig is not yet authorized in Korea. On Wednesday, the MFDS approved Teva Handok's migraine prevention drug Ajovy. It is the second CGRP drug after Lilly's Emgality. Emgality was granted permission in September 2019. It was released in December of that year as non reimbursed drug. Amgen is reportedly aiming for another CGRP drug, Aimovig (Erenumab), to enter Korea. If Aimovig is released, competition for three drugs is expected to proceed as well as in the global market. The three drugs combine with CGPR, known as migraine-causing substances, to block the action of receptors. It is the first preventive treatment that targets migraines only. In the U.S., it was approved one after another from May to September 2018 in order of Aimovig, Ajovy, and Emgality. As of last year, global sales include Aimovig $378 million, Emgality $199 million, and Ajovi $165 million. There have been no suitable migraine treatments in the domestic market. Although both acute and preventive treatments were possible, existing treatments had clear limitations. General painkillers such as Acetaminophen and Ibuprofen, which are used to treat acute conditions, and triptans-based drugs have different effects, and they have caused drug-induced headaches when overused. The triptane series has also reported side effects of excessive blood vessels contracting. In the case of preventive treatment, beta blockers, CCB (calcium channel blockers), ABR (angiotensin receptor blockers), antidepressants, and epilepsy treatments, which are high blood pressure drugs, were partially. However, it was not widely used in that it was not developed for the purpose of treating migraines. Recently, Botulinum toxin injections have been actively attempted. However, it is only for chronic migraines, and it was burdensome for patients to get about 30 injections every three months. The market size of migraine drugs in Korea is not large. According to UBIST, prescription amount of triptans-related drugs in Korea was only ₩15.5 billion as of last year. If the remaining drugs are added to this, it will be around ₩30 billion per year. The new line of drugs is expected to increase sales in the migraine market. According to the Korea Headache Society, the prevalence of migraines in Korea is around 6%. In fact, 2.6 million people have migraines. However, the actual number of patients treated for migraines in hospitals was 550,000 (the HIRA's statistics) as of 2020. In other words, there are about 2 million potential patients. The key is whether or not the benefit will be applied. Emgality, which was first released in Korea, submitted an application for health insurance benefits in March. Currently, it is between ₩500,000 and ₩700,000 at a time as non-reimbursement in Korea. Ajovy from Teva Handok is also expected to apply for insurance benefits soon.
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