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- 2025-12-24 13:48:42
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- Zerbaxa's benefit in 5 Years
- by Oct 28, 2022 05:57am
- After five years of domestic approval, the MSD super antibiotic "Zerbaxa (Ceftolozane/Tazobactam)" was registered. It is expected to help reduce the recent surge in carbapenem antibiotic resistance. MSD Korea held a press conference at the Koreana Hotel in Jung-gu, Seoul on the 27th to commemorate the registration of Zerbaxa, a multidrug-resistant antifungal antibiotic. Zerbaxa is a combination of new cephalosporin-based antibiotics Ceftolozane and beta-lactam degrading enzyme inhibitors Tazobactam. In response to the main resistance mechanism of pseudomonas aeruginosa, it has proven its activity in multidrug-resistant pseudomonas aeruginosa and ESBL-producing intestinal bacteria. ESCMID and IDSA recommend Zerbaxa as the first treatment in severely infected patients who are difficult to treat due to carbapenem-resistant pseudomonas aeruginosa. Antibiotic resistance has been an issue that has emerged worldwide for many years. In 2016, the British government predicted that 700,000 people worldwide die of antibiotic-resistant bacteria every year and that the death would reach 10 million by 2050 unless special measures were taken. In response, the World Health Organization (WHO) proposed an "Action Plan" in 2015 to prevent the occurrence and spread of resistant bacteria across borders and urged national countermeasures and international cooperation. Korea is also not free from antibiotic resistance. As the use of carbapenem, a wide range of antibiotics increased, the number of strain infections resistant to carbapenem antibiotics increased. According to the Korea Centers for Disease Control and Prevention, 23,311 CRE infections were classified as second-class infectious diseases last year, up 28.7% from the previous year. This year, 24,009 cases of infection were reported by October, already exceeding the number of infected people last year. In particular, it is analyzed that the use of antibiotics increased during the COVID-19 epidemic, which did not have adequate treatments, encouraging resistance. Choo Eun-joo, an infectious medicine professor at Soonchunhyang University Bucheon Hospital, who attended the meeting, said, "In the early 2000s, I didn't think much about carbapenem resistance. However, resistance has increased to more than 80% in eight years, he said. "In Korea, the problem of antibiotic resistance is likely to become more serious due to the rapid aging and the expansion of long-term care facilities." "Antibiotic resistance causes serious problems in that it limits the treatment options that can be selected," he explained. Carbapenem is an antibiotic that was considered the last alternative in severely infected patients. Before the Zerbaxa license, there was no antibiotic that could be replaced if carbapenem resistance occurred in Korea. The American Society of Infectious Diseases presented various new antibiotics as alternative drugs, but Zerbaxa was the only drug in Korea that was approved and released. However, Zerbaxa has been in a state of non-reimbursement for five years due to difficulties in economic evaluation. This is because Zerbaxa was considered to be cost-effective because other antibiotics selected as alternative drugs were so inexpensive. Usually, patients were not convinced that antibiotics were used as non-reimbursement, so Zerbaxa was rarely used in the field for five years. During that period, the number of cases of CRE infection more than quadrupled from 5,717 to 24,000. Professor Choo said, "Even if the effect of Zerbaxa was twice as high as before, the cost was more than 10 times different, so I had no choice but to use colistin, which came out 40 years ago, and this drug was less effective than a new antibiotic and had poor kidney function." Dramatically, as the government included antibacterial agents in the PE exemption list, there was an opportunity to register Zerbaxa's reimbursement. Since October, Zerbaxa has been reimbursed in cases where carbapenem antibiotics have failed to treat complex intra-abdominal infections, complex urinary tract infections, and in-house infectious pneumonia, or if multidrug-resistant rust bacteria have been proven. Professor Choo predicted that Zerbaxa's benefits will help reduce carbapenem resistance. Choo said, "It is difficult to see a dramatic effect in a short period of time, but it will generally reduce cases of infection with Zerbaxa." Of course, Zerbaxa also poses a risk of developing resistant bacteria in the future if its usage increases. No matter how severe a patient is, antibiotics should be used properly to create fewer resistant bacteria and receive other new treatments," Choo said. "In particular, long-term care facilities increase, and antibiotics are frequently used without knowing what resistant bacteria are present. The best way to reduce resistance is to use antibiotics well, Choo explained.
- Company
- AZ-Abbott to copromote diabetic kidney disease treatments
- by Eo, Yun-Ho Oct 28, 2022 05:56am
- Director Jeong-Seon Heo (left) and Director Il Shim (right) On the 26th, AstraZeneca Korea announced that it had signed a joint promotion agreement with Abbott Korea for the early diagnosis and treatment of patients with diabetic kidney disease. The signing ceremony was held at AstraZeneca Korea’s headquarters in Samseong-dong, Seoul on the 25th ,in the presence of key officials from both companies, including AstraZeneca Korea’s Director Il Shim and Abbott Rapid Diagnostics’ Director Jeong-Seon Heo. The agreement was made between AstraZeneca Korea and Abbott for their mutual cooperation in improving the treatment environment for patients with diabetic kidney disease in Korea to establish a more systemic diabetes treatment and management system. In diabetes, AstraZeneca has been supplying various treatments including ‘Forxiga (dapagliflozin)’ and ‘Onglyza (saxagliptin),’ and Abbott has been supplying technologies such as the point-of-care testing (POCT) ‘AFINION 2™ ANALYSER.’ Il Shim, Director of the Cardiovascular, Renal, and Metabolism (CVRM) Business Unit at AstraZeneca Korea, said, “The current kidney disease screening rate is very low in Korea, especially when considering how 30% of the diabetes patients in Korea are present with diabetic kidney disease. This is why early diagnosis and treatment are important. For this, we will work together to establish a management system for the early detection and treatment of diabetic kidney disease.”
- Company
- Vaccine Development in 100 Days of Pandemic
- by Oct 28, 2022 05:55am
- Vaccine and bio leaders around the world have set a goal of "100 days of vaccine development" as a countermeasure to the "Next Pandemic." To achieve this, it requested organic cooperation from governments, industries, international organizations, and academia. It also predicted that Korea will play an important role in resolving the deepening inequality in vaccine access between countries during the pandemic. The Ministry of Health and Welfare and the World Health Organization (WHO) held the 2022 World Bio Summit at the Grand Walkerhill Hotel in Gwangjin-gu, Seoul for two days from the 25th. The event was co-hosted by the Korean government and the WHO and held for the first time this year. It is a place to invite leaders in the vaccine and biofields of countries, companies, and international organizations around the world to share their experiences in responding to COVID-19 and discuss international cooperation measures to respond to future infectious disease pandemics. Starting with President Yoon Suk Yeol and WHO Director-General Tedros Adhanom Ghebreyesus, President of the Asian Development Bank (ADB) and Ban Ki-moon, Chairman of the Foundation for Better Future, Richard Hatchett, CEO of the International Vaccine Institute, and others delivered keynote speeches. In the ensuing corporate session, representatives of domestic and foreign vaccine, treatment, and raw material companies such as Pfizer and Moderna, SK Bioscience, MSD, Ildong Pharmaceutical, Shionogi, Merck, and Biovac shared their opinions on the theme of "Future Strategy for Post-Pandemic." They cited speed, cooperation, and equality as the most important points in responding to the pandemic, and emphasized active cooperation to ensure that vaccines developed and developed can be supplied equally to the world. CEPI CEO Richard Hatchett stressed that the vaccine development period should be shortened to 100 days to quickly respond to the next epidemic. He said, "There could be more frequent pandemics on a larger scale in the future. Even now, there are risks such as Ebola and monkeypox, he said. He said, "The development of vaccines is essential to prepare for new infectious diseases. "Our goal is to have the ability to develop a vaccine that can respond to new infectious diseases in 100 days," he said. CEO Iso Teshirogi also said, "Japan has established a new emergency system, established a 100-day mission to develop a new vaccine, and is strategically investing research funds to collect information on the development of a new vaccine." Reducing the vaccine development period, which usually takes 10 years, to 100 days, requires full investment and efforts in R&D, flexible regulatory procedures, and close cooperation with domestic and foreign partners. At the time of the COVID-19 pandemic, it took about a year even though Pfizer, Moderna, and Janssen succeeded in developing a vaccine record quickly. Pfizer, Moderna, and SK Bioscience, which developed the COVID-19 vaccine, agreed that the vaccine development period could be shortened due to cooperation with governments, academia, industries, and international organizations. Ahn Jae-yong, CEO of SK Bioscience, said, "SK Bioscience has developed its own vaccine in close cooperation with domestic and foreign partners. Without the partnership, the development would not have been possible, he said. "SK Bioscience recently prepared its own growth strategy 3.0, which is to strengthen global cooperation while preparing for the pandemic." Based on this, we will promise to develop a vaccine within 100 days of the next pandemic, he said. They also stressed Korea's role in achieving the new mission. "Korea is a great example of self-sufficiency in the COVID-19 vaccine," said CEO Hatchett. "We set visible goals and implemented active policies to achieve them," he said. "As we went through this COVID-19, we felt that there was a big gap between inequality in vaccine development and manufacture." "Korea has the ability to share a lot of things with countries around the world," he said. Jan Van Acker, president of MSD Emerging Market, said, "It is important to work with regulatory agencies to find ways to quickly obtain approval for drugs and supply drugs, and I felt that the Korean government could play an important role here. "Korea has also demonstrated flexibility in the regulatory process," he said. He added, "In the future, Korea will play an intermediate role between developed and low-income countries to resolve inequality in infectious diseases."
- Company
- Influenza epidemic and the launch of generic products
- by Kim, Jin-Gu Oct 28, 2022 05:55am
- GC Pharma Peramiflu, JW Pharmaceutical Fluenpera, Chong Kun Dang Peraonce Product Photo (clockwise from top left)The Peramiflu-based flu treatment market, which was monopolized by GC Pharma, will be reorganized into a system in which 15 companies compete during the flu season this winter. In particular, unlike the past two years, when the number of flu patients plunged due to the prolonged COVID-19, the competition in this market is expected to be very fierce, given that the flu is expected to spread significantly this winter. ◆Peramiflu patent is released, the generic license is expanded According to the pharmaceutical industry on the 11th, a total of 15 companies have been approved for flu treatment containing Permiflu until that day. This original product is GC Pharma's Peramiflu. GC Pharma introduced the product from BioCryst in the United States in 2010. Last year, three companies, Chong Kun Dang, HK inno.N, and JW Lifescience, received generic permits after winning a patent dispute with GC Pharma. This year, an additional 11 companies were added. Analysts say that generic permits are expanding as Peramiflu patents are released. Chong Kun Dang, HKinno.N, and JW Lifescience filed for invalidation of Permiflu's sole patent in December 2019. Generics won the first and second trials in a row. GC Pharma abandoned the Supreme Court appeal after losing the second trial in July this year. The patent court upheld the judgment against the plaintiff. GC Pharma's waiver of appeal completely lifted the Permiflu patent. Three companies, including Chong Kun Dang, have been challenged by invalidating patents, not avoiding them. If it was a challenge to avoid, only three companies that won the first and second trials could have released generic. Still, Chong Kun Dang and others succeeded in invalidating the patent itself, and even companies that did not enter the dispute were eligible to release generic. The three generic companies' generic for exclusivity ended in April this year. All obstacles to the release of the generic have disappeared. As a result, 11 additional companies, starting with Dongkwang in February this year, have received peramiflu generic licenses. ◆ Competition is expected to resume for the first time in three years due to the severe increase in flu patients Unlike the past two years, the pharmaceutical industry predicts that demand for flu treatments will increase significantly this winter. In particular, considering that Peramiflu was rapidly expanding its influence in the flu treatment market just before COVID-19, some predict that competition for heterogeneous generic components will be very fierce this winter. Over the past two years, the market for Peramiflu-based flu drugs has virtually disappeared. This is because the flu has not been prevalent since the COVID-19 crisis due to the effects of wearing masks, personal hygiene management, and social distancing. According to IQVIA, a pharmaceutical market research firm, sales of Peramivir flu drugs steadily increased to 3 billion won in the winter of 2015-2016, 3.6 billion won in the winter of 2016-2017, 4.4 billion won in the winter of 2017-2018, 5.5 billion won in the winter of 2018-2019 and 6.7 billion won in the winter of 2019-2021. Things are different this year. The KDCA issued a flu pandemic warning on the 16th of last month. No pandemic warning has been issued for the past two years since the COVID-19 crisis. The KDCA estimates that this year's flu epidemic is two to four months older than usual. It is the first time in 12 years since 2010 that the Korea Centers for Disease Control and Prevention issued a flu epidemic warning in September. The number of suspected flu patients has rapidly increased since the pandemic warning was issued. In the 40th week of this year (September 25 to October 1), the number of suspected flu patients per 1,000 outpatients was 7.1, up 45% from 4.9 in the previous week. For this reason, the pharmaceutical industry predicts that competition in the generic market for Peramivir will take place in earnest this year. Depending on the situation, some predict that more companies will receive generic permits through consignment and consignment contracts in addition to existing companies. Analysts say that while the Tamiflu generic market is saturated, the Peramiflu generic market has not yet begun to compete in earnest and that the Peramiflu market was growing rapidly until just before the Corona crisis, more companies are entering the competition. Currently, there are eight manufacturers of Peramivir-based flu drugs. Genuonescience entrusts the production of Union Korea Pharm, Hana Pharm, QL Pharm, Genu Pharma, and Kolong Pharmaceutical. JW LifeScience commissioned and produced Shinpoong products, and Penmix commissioned and produced Ilyang Pharmaceutical products. The rest is self-produced.
- Company
- The New Testament Era of Rosuzet and K-CAB
- by Chon, Seung-Hyun Oct 28, 2022 05:55am
- Domestic developed drugs continued to be strong in the foreign prescription drug market. Hanmi Pharmaceutical's complex new drug Rosuzet exceeded 100 billion won in prescriptions in three quarters, while HK inno.N's new drug K-CAB booked 100 billion won for the second consecutive year. According to UBIST, a drug research institute, on the 23rd, Viatris' hyperlipidemia drug Lipitor took the lead with a cumulative outpatient prescription amount of 147.7 billion won in the third quarter of this year. Although it decreased by 3.2% compared to the same period last year, it maintained a gap of more than 40 billion won with the second-ranked group and continued to take a relaxed lead. Lipitor was released in Korea in 1999. It has been more than 20 years since its launch in Korea, and more than 100 generics and various combinations are intensively checking Lipitor, but it still has a strong influence in the prescription drug market. Lipitor has been the leader in outpatient prescriptions since 2018, and if this trend continues, it is likely to be the No. 1 for five consecutive years. Rosuzet and K-CAB, developed by Korean companies Hanmi Pharmaceutical and HK inno.N, continued to be super strong. Rosuzet ranked second overall by recording 103 billion won in cumulative prescriptions up 13.3% from the previous year until September. Rosuzet, released in late 2015, is a hyperlipidemia complex composed of two ingredients, Rosuvastatin and Ezetimibe. Rosuzet continues to grow rapidly due to its market preoccupation effect and the popularity of statin and Ezetimib complexes. Statin and Ezetimib complex drugs show excellent effects in lowering LDL-C, and their preference is increasing because the burden of drug prices is not as high as taking two drugs separately. Rosuzet is the first domestic developed drug to surpass 100 billion won in prescription in three quarters. Rosuzet exceeded 100 billion won in prescription performance in 2020 and last year, and confirmed that it exceeded 100 billion won for the third consecutive year. Rosuzet more than tripled in five years from 11.2 billion won in prescriptions in the third quarter of 2017 to 35.6 billion won in the third quarter of this year. Rosuzet has been breaking a new quarterly prescription record for 10 consecutive quarters since it recorded 23.5 billion won in the first quarter of 2020. Since June last year, the monthly prescription has been around 10 billion won for 16 consecutive months. K-CAB's cumulative prescription performance in September was 92.2 billion won, up 18.0% from the previous year. K-CAB, released in March 2019, is a 'P-CAB' anti-an ulcer drug. In gastric wall cells, a proton pump and potassium ion located in the final stage of acid secretion are competitively combined to exhibit an action mechanism that inhibits gastric acid secretion. K-CAB has a faster medicinal effect than existing PPI products and can be taken regardless of before and after meals. K-CAB posted 30.9 billion won in sales in the first year of its release and surpassed 100 billion won last year, the third year of its launch. K-CAB's growth slowed down from 31.5 billion won in prescription performance in the fourth quarter of last year to 30.1 billion won in the first quarter of this year, but it showed an upward trend again in the second quarter. It broke a new record in three quarters, recording 31.6 billion won in prescriptions in the third quarter. K-CAB sequentially secured five indications, including erosive and non-erosive gastroesophageal reflux disease, antibiotic combination therapy for Helicobacter pylori eradication in patients with gastric ulcers and chronic atrophic gastritis, and maintenance therapy after treatment for erosive gastroesophageal reflux disease. Among them, health insurance benefits are being applied to gastroesophageal reflux disease and gastric ulcers. It is analyzed that the demand for prescriptions has increased further as health insurance benefits have been applied to gastric ulcer treatment since November last year. In the third quarter of last year, K-CAB continued to rise despite the release of Fexuclu, a P-CAB-based anti-ulcerative drug that is the same as K-CAB. Fexuclu is a new drug product developed by Daewoong Pharmaceutical. It was approved at the end of last year and was listed on the health insurance benefit list in July, and began selling in earnest. Fexuclu became a sensation in the first quarter of its release, recording 4.5 billion won in prescriptions. It posted a prescription performance of 1.1 billion won in July, and increased its increase to 1.5 billion won and 1.9 billion won, respectively, in August and September. It is evaluated that Fexuclu is leading the expansion of the P-CAB-affiliated market by creating a new market or targeting the PPI-affiliated drug market without encroaching on the prescription market for the same drug. Among the domestically developed drugs, Daewoong's Gliatamin, Chong Kun Dang's CKD Gliatilin, and LG Chem's Zemimet ranked at the top of the prescription. Gliatamin and CKD Gliatilin, brain functional stimulants composed of Choline alfoscerate, continued to rise with accumulated prescriptions of 83.7 billion won and 72.2 billion won, respectively, in the third quarter. Zemimet, a diabetes complex developed by LG Chem, ranked eighth overall in the total, recording 69.9 billion won in prescription performance, up 4.8% from the previous year, until September. Zemimet is a complex that combines Metformin with Zemiglo, a DPP-4 inhibitor-based diabetes drug developed by LG Chem. Daiichi Sankyo's anticoagulant Lixiana ranked in the top 10 with 66.4 billion won in the third quarter, up 6.4% from the previous year. It also promoted patent-expired new drugs from multinational pharmaceutical companies such as Flavix of Sanofi Aventis and Twynsta of Beringer Ingelheim. Plavix, an anti-thrombotic drug, ranked fourth overall, up 4.6% from the previous year with 88.3 billion won in prescriptions until the third quarter. Plavix has joined the sale of Dong-Wha since 2017. Twynsta's cumulative prescription amount in the third quarter was 70.8 billion won, up 3.0% from the previous year.
- Company
- Dexeryl for atopic dermatitis lands in Korea
- by Oct 27, 2022 05:52am
- Pierre Fabre Korea announced that it had launched its medical device cream ‘Dexeryl’ in Korea on the 26th. Dexeryl is an MD cream that represents the 60-year-old French pharmaceutical company, Pierre Fabre. It is used to treat dryness of the skin and symptoms from skin conditions, such as atopic dermatitis, pruritus, diabetic foot disease, itching, psoriasis, ichthyosis, and radiodermatitis. It consists of a minimum formula of 13 ingredients that excludes the 43 types of steroids, 7 types of parabens, lanolin, or odoriferous substances. As an O/W(Oil in Water) formulation, it applies smoothly and has excellent moisturizing power. Dexeryl, called the ‘Nation’s MD cream’ in France, recorded No.1 in sales in Europe It is currently sold in 57 countries around the globe and can be prescribed at hospitals and clinics in Korea starting at the end of November. At the product launch press conference held the same day, Alain Delaurue, Global Medical Director of Pierre Fabre Group, said, “Dexeryl was developed based on our company’s extensive clinical experience and expertise, and owns clinical data on skin conditions such as atopic dermatitis published in renown journals including the Journal of the European Academy of Dermatology And Venereology (JEADV).” In a clinical trial conducted on 335 children aged 2-6 years with mild to moderate atopic dermatitis, Dexeryl lowered the frequency of acute exacerbation of atopic dermatitis and steroid use compared to the patient group that did not use moisturizers or used comparators. During the clinical trial period, the rate of patients who experienced acute exacerbation more than once was 67.6% in patients who did not use MD creams, 52.6% in the control group, and 35.1% in the Dexeryl-treated group. Also, the steroid use in the Dexeryl group decreased by 57.1% compared to those that did not use any MD creams. Also, Dexeryl was found to be effective in treating xerosis, one of the major symptoms of atopic dermatitis. In a Phase III trial on 251 children aged 2-6 years with atopic dermatitis xerosis for 28 days, The Dexeryl-treated group’s lesions from xerosis improved by 42.5%. The rate was 29% for the control group. Patients who discontinue the use of MD creams during the study period showed relapse, but then showed improvement in symptoms again when resuming the use of creams. Also, regular use showed improvement even in a group of patients who did not respond to initial use, demonstrating the importance of long-term use of Dexeryl. Hye-One Kim, Professor of Dermatology at Hallym University Kangnam Sacred Heart Hospital, said, “Patients with atopic dermatitis need to regularly use moisturizers such as MD cream twice a day because their skin barrier function is damaged, even if the symptoms are invisible. Although the common perception is that MD cream is a cosmetic product due to the low awareness but for patients suffering from skin diseases, it is an important item that should be used every day like a treatment.”
- Company
- The unfinished aftershocks of COVID-19
- by Chon, Seung-Hyun Oct 26, 2022 05:50am
- The market for outpatient prescription drugs was the largest ever. This year, the prescription market has grown significantly due to the expansion of prescriptions such as cold medicine due to the rapid increase in the number of COVID-19 confirmed patients. The size of Expectant prescriptions used to relieve COVID-19 symptoms has more than doubled in a year. According to UBIST, a pharmaceutical research institute, on the 25th, the total amount of outpatient prescriptions in the third quarter was 4.3011 trillion won, up 5.4% from the same period last year. The third-quarter prescription amount is the largest ever. It easily surpassed the previous new record of 4.22 trillion won recorded in the fourth quarter of last year. The domestic prescription drug market has regained its previous year's upward trend this year after the spread of COVID-19. Prescriptions in the first quarter were 4.1248 trillion won, up 6.5% from the previous year, and 5.7% from the previous year in the second quarter. The prescription amount in the first and third quarters was 12.58 trillion won, up 5.9% from the same period last year. In 2020, when COVID-19 began to spread, the size of outpatient prescriptions was 15.6365 trillion won, up 2.7% from the previous year. Last year, the outpatient prescription performance was 16.1126 trillion won, up only 3.0% from the previous year. In 2018 and 2019, the amount of prescriptions increased by 8.1% and 8.2%, respectively, compared to the previous year. The growth rate has fallen to one-third for the second consecutive year since the spread of COVID-19, which means that the growth rate of the prescription drug market is about twice as high this year compared to the past two years. The expansion of the prescription drug market this year is analyzed to be due to the rapid increase in the number of COVID-19 confirmed patients. Since the beginning of this year, there have been many COVID-19 confirmed cases, and prescriptions of antipyretic painkillers, cold medicines, and antibiotics used to relieve COVID-19 symptoms have increased significantly. The supply of cold medicine and other medicines continues to be in short supply. Recently, as tens of thousands of COVID-19 confirmed cases have occurred every day, the demand for COVID-19 symptom relief treatments is increasing. The prescription of Expectant, which is widely used for treating cough and phlegm, a representative symptom of COVID-19, has increased significantly. In the third quarter of last year, the amount of outpatient prescriptions was 70.5 billion won, up 112.5% from the same period last year. In general, Jinhae Gosamje shows a pattern of increasing use in winter and then decreasing in summer when the number of cold patients increases.The amount of expectant prescriptions in the third quarter is 35.2% higher than 52.2 billion won in the fourth quarter of last year. Recently, even though it is summer, there were more spectacular prescriptions than last winter. The amount of expert prescriptions recorded KRW 91.6 billion in the fourth quarter of 2019, but it began to decrease significantly in the second quarter of 2020, when COVID-19 began to spread in earnest. In the second quarter of 2020, it fell 47.6% year-on-year to 40.8 billion won, and in the third and fourth quarters, it shrank 29.8% and 50.0% from the previous year, respectively. The expectant prescription market fell to 32.2 billion won in the third quarter of last year, but then began to rebound in the fourth quarter of last year and continued to grow this year. According to Expectant's prescription performance, it was 44.1 billion won in the third quarter, up 95.0% from the previous year. The amount of expectant prescriptions recorded 54.5 billion won in the fourth quarter of 2019 but remained in the 20 billion won range from the first quarter of 2020 to the third quarter of last year. It rose to around 30 billion won in the fourth quarter of last year and recovered to the level before the COVID-19 pandemic this year. Antitussive compound drugs received 14.4 billion won in prescriptions in the third quarter, up 122.1% from the same period last year. Antitussive complex drugs decreased from 20.3 billion won in prescriptions in the fourth quarter of 2019 to 9 billion won in the second quarter of 2020, when COVID-19 began to spread in earnest. It exceeded 10 billion won in the fourth quarter of last year for the first time in seven quarters and has been on a steep rise this year. The antitussive single system recorded 16.8 billion won in the fourth quarter of 2019 but plunged to 4.1 billion won in the third quarter of last year. The prescription amount more than doubled to 14.6 billion won in the first quarter of last year and continued to grow in the second and third quarters. In the third quarter of last year, the prescription amount was KRW 12.1 billion, up 192.7% from the previous year.
- Company
- First TYK2 inhibitor Sotyktu will enter Korean market
- by Eo, Yun-Ho Oct 26, 2022 05:50am
- The oral TYK2 inhibitor for psoriasis will soon be introduced to Korea. According to industry sources, BMS Korea applied for domestic marketing authorization for its tyrosine kinase 2 (TYK2) inhibitor ‘Sotyktu (deucravacitinib) in Korea. The drug was approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy by the US FDA. Sotyktu is the first TYK2 inhibitor to ever be approved in the world (first-in-class), and the first oral drug introduced in 10 years to treat moderate-to-severe plaque psoriasis. The approval is based on results from the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials, which compared the efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla in 1,684 adult patients aged 18 years and older with plaque psoriasis. The study demonstrated superior efficacy of Sotyktu compared to placebo at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks. In the POETYK PSO study, the most common adverse reactions shown in patients at 16 weeks were upper respiratory infections (19.2%), increase in blood creatine phosphokinase (2.7%), mouth ulcers (2.9%), folliculitis (1.7%), and acne (1.4%). Also, 2.4% of the patients who were administered Sotyktu and 5.2 % of the patients who were administered Otezla discontinued their treatment due to adverse reactions. When BMS acquired Celgene, the company had given up Otezla and sold it to Amgen. Ever since then, the company had focused on developing Sotyktu. Sotyktu is being studied for various autoimmune diseases including lupus, Crohn's disease, and ulcerative colitis. Priovant, which was jointly established by Pfizer and Roivant is jointly established, is also developing a TYK2 inhibitor.
- Company
- Xarelto sales fall 30% due to generics and price cuts
- by Oct 26, 2022 05:50am
- The quarterly prescription of new oral anticoagulants (NOAC) containing rivaroxaban, which had reached KRW 15 billion, has shrunk to KRW 13 billion. This decrease is interpreted to be reflected by the price cut of Bayer’s original ‘Xarelto.’ Its generics that entered the market 1 year ago have been starting to slowly increase their share in the market, making KRW 2.4 billion in total. ◆Xarelto takes a direct blow from drug price cuts...Quarterly sales record KRW 11.3 billion According to the market research institution UBIST on the 25th, the domestic outpatient prescriptions of rivaroxaban recorded KRW 13.7 billion in Q3 this year, falling fell 16% compared to the KRW 16.4 billion it recorded in the same period last year. Sales of the original, Xarelto, fell 29% from KRW 15.9 billion to KRW 11.3 billion. Quarterly outpatient prescriptions of Xarelto fell from KRW 15.9 billion in Q3 last year, to KRW 15 billion in Q4, then to KRW 14.2 billion this year, to KRW 13.9 billion in Q1, then sunk to KRW 11.3 billion in Q3. This reduced sale is analyzed to have been greatly influenced by the drug price cut that had been made in August. The Seoul High Court ruled in favor of the Ministry of Health and Welfare in the lawsuit Bayer filed against MOHW to cancel the disposition on lowering Xarelto’s price. With the ruling, the drug price of all strengths(2.5·10·15·20mg) of Xarelto was reduced by 30% from August 22nd. Xarelto’s price had first been set to be reduced in May last year when the generics were first listed for reimbursement, but Bayer filed a suit on the unjustness of the price cut, claiming that the generics were released before Xarelto’s patent expiry, thus the execution of disposition should be suspended. As a result, the price cut had been suspended until the judgment on the merits. After about a year and two months, the final ruling had been made and the drug price was reduced. Considering the 30% price cut, there was no significant change in prescription volume compared to the same period last year. With this, the prescription amount of Xarelto is expected to be in the lower KRW 50 billion range. Its annual prescriptions last year were nearly KRW 60 billion. ◆Generics account for 18%...Sole lead held by Chong Kun Dang Xarelto’s generics have been increasing their influence in the market. In Q3, Xarelto generics made KRW 2.4 billion in total. In Q2 last year, the amount was KRW 0.3 billion, which rose to KRW 0.5 billion in Q3, to KRW 0.9 billion in Q4, then to the KRW 2 billion range this year. In Q1 2022, prescriptions rose to KRW 1.6 billion in Q1 and then KRW 2.1 billion in Q2. In Q3, generics have also been increasing steadily, accounting for an 18% share of the rivaroxaban market. With the sales of the generic increasing slightly and the original dropping significantly, the share of generics in the market rose 5%p from the previous quarter. Even though there was no change in the prescription amount of the original drug, the prescription amount of generics increased with the generic companies’ pioneering of new markets. Generic companies focused their marketing capabilities on local clinics as the original drug is mostly prescribed in hospitals or higher institutions. Instead of competing directly with the original, the companies focused on pioneering new markets. Although more than 60 companies have received approval for Xarelto generics, only Chong Kun Dang and Hanmi Pharmaceutical have made meaningful sales. Chong Kun Dang’s ‘Riroxia’ made KRW 0.8 billion in outpatient prescriptions in Q3, and accounted for 1/3 of the generic market. Chong Kun Dang released Riroxia in May last year, 5 months before patent expiry, and worked to preoccupy the market. Although other generic companies started to enter in October of the same year, unlike Chong Kun Dang which continuously made prescriptions after preoccupying the market, sales of the other generics remain in the KRW 0.1 billion range. Among generics, Hanmi Pharmaceutical’s ‘Riroxvan’ made KRW 0.5 billion in Q3 and is the only generic chasing Chong Kun Dang’s Riroxia’s sales in the market. Hanmi Pharmaceutical succeeded in avoiding Xarelto’s patent with SK Chemical and entered the market with generic exclusivity. Riroxvan, which sold KRW 0.2 billion in Q1, rose to KRW 0.4 billion in Q2, then KRW 0.5 billion in Q3. More than half of the approved generics have not yet released their versions in the market. With the lower dose of Xarelto (2.5mg) being listed for reimbursement from Q3, how this will affect the market is also gaining attention. 16 low-dose versions of Xarelto generics were listed for reimbursement in July. Rivaroxaban 2.5mg is mainly used in combination with aspirin to reduce the risk of cardiovascular events in patients with coronary artery disease and peripheral arterial disease.
- Company
- Genuone challenges Trajenta’s non-listed patent...Why?
- by Kim, Jin-Gu Oct 25, 2022 05:46am
- Genuone Sciences has challenged the unlisted patents of Trajenta (linagliptin). Industry interpretations are that the move is the company’s strategy to remove uncertainties in releasing generic versions of Trajenta and to additionally attract CMO deals” According to industry sources on the 24th, Genuone Sciences filed a trial to confirm the passive scope of patent rights and invalidation trials for the 5 Trajenta patents, 3 of which are use patents set to expire in May 2027, and one substance and one process patent set to expire in April 2027. One interesting thing to note is that all these patents are not listed on Korea’s patent register. As the patents are not listed on the register, the companies will have no problem obtaining approval for their generic versions even if they do not overcome the patents. However, the situation is different in terms of releasing the products into the market. Administratively, generic drugs can be released when the listed patents expire, but this carries the burden of being involved in a patent infringement lawsuit with the original company. If the original company files an application for an injunction to block the release of the product at the same time it files the patent infringement lawsuit, the release date of generics can be delayed for companies. Also, if generic companies lose the patent infringement lawsuits, this may lead to lawsuits for damages. This is why many generic companies have been challenging unlisted patents to remove uncertainties. Genuone Sciences’ challenge of Trajenta’s unlisted patents is also interpreted to be along this line. There is also the interpretation that Genuone Sciences challenged the unlisted patents of Trajenta to attract additional CMO deals. Genuone Sciences succeeded in avoiding and invalidating the existing Trajenta patent but was unable to receive generic exclusivity (first generic marketing exclusivity) for the drug because it wasn’t able to satisfy the ‘initial request for trial’ condition. 19 companies including Alvogen Korea own generic exclusivity for Trajenta generics. In this context, other companies will be interested in the CMO manufacture of Trajenta generics if Genuone Sciences succeed in removing uncertainties by avoiding and invalidating the unlisted patents. Genuone Sciences CMO Trajenta generics for White Life Science and Pharmgen Science. The company made agreements to manufacture the 2.5mg/1000mg dose only for White Life Science, and manufactures the 5mg/500mg and 2.5mg/850mg dose for White Life Science and Pharmgen Science. By formulation, this means that the company may take on 1-2 more companies for manufacture. Trajeta is Boehringer Ingelheim’s DPP-4 inhibitor antidiabetic. Its outpatient prescription sales had been KRW 130.7 billion for the single agent (Trajenta) and combination agent (Trajenta Duo) last year. Trajenta raised KRW 94.2 billion in sales until Q3 this year. The patent for the product is set to expire in June 2024. 65 companies have overcome Trajenta's patent and received approval to manufacture its generics. The companies are expected to release their products at the time of Trajenta’s patent expiry.
