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- 2026-04-11 09:37:17
- Company
- Samsung Biologics surpassed ₩2 trillion in sales
- by Kim, Jin-Gu Oct 31, 2022 06:06am
- Samsung BioLogics surpassed 2 trillion won in cumulative sales in the third quarter. It exceeded 1.568 trillion won in annual sales last year in three quarters. On the 26th, Samsung BioLogics announced that it achieved 873 billion won in sales and 324.7 billion won in operating profit in the third quarter. Both sales and operating profit rose 94% year-on-year. Cumulative sales are 2.358 trillion won on a consolidated basis. It is the first time since its foundation that Samsung BioLogics has surpassed 2 trillion won in sales. ◆ Samsung BioLogics exceeded sales last year in three quarters Samsung BioLogics explained that it recorded cumulative sales of 1.6896 trillion won and an operating profit of 659.5 billion won in the third quarter, exceeding its annual performance last year (sales of 1.568 trillion won and operating profit of 536.5 billion won). Samsung BioLogics incorporated Samsung Bioepis as a 100% subsidiary in April this year. Samsung BioLogics explained that this results from increased sales of raw material drug CMO (consignment production) and increased profits of CDO (consignment development). On top of that, it added that the rise in the exchange rate led to improved performance. Samsung BioLogics plans to strengthen its business by operating its fourth plant in earnest and expanding orders for CDMO. Samsung BioLogics' fourth plant has the world's largest production capacity with a total of 240,000 liters. It started partial operation this month and will be in full operation next year. When the fourth plant is operated next year, Samsung BioLogics' production capacity will be expanded to 604,000 liters. It is the largest in the global CDMO industry. In the CDO business sector, it has expanded its portfolio by launching a new dual antibody platform called 'S-dual'. The cumulative number of orders is 73 for CMO and 100 for CDO. Cumulative charges amount to $8.5 billion (about 12 trillion won). ◆ Samsung Bioepis' performance decreases Samsung Bioepis recorded 269.8 billion won in sales and 77.9 billion won in operating profit in the third quarter on a separate basis. Sales fell 0.5% year-on-year and operating profit fell 23%. In the third quarter of last year, it received licensed milestones for U.S. and European products. Although its performance declined due to the base effect, the company explained that sales and operating profit are steadily growing this year as product sales growth in the global market. Samsung Bioepis is selling a total of six biosimilars in the global market. In the third quarter of this year, it obtained U.S. permission for the "Humira" biosimilar (SB5) high-concentration formulation. It plans to complete phase 3 clinical trials of Prolia biosimilar (SB16) and Stella biosimilar (SB17) within this year.
- Company
- The commercialization of Camzyos is expected in Korea
- by Eo, Yun-Ho Oct 28, 2022 05:57am
- It is expected that the new HCM drug Camzyos will be commercialized in Korea. According to related industries, BMS Pharmaceutical Korea recently submitted an application to the Ministry of Food and Drug Safety for permission for the NYHA Class 2-3 (class II-III) HCM treatment Camzyos. Camzyos is acquired by BMS for $13.1 billion in 2020 and is a PO drug that targets and inhibits cardiac myosin for functional treatment and symptom improvement of HCM. Camzyos, which was approved by the U.S. FDA in April, is the first and only cardiac myosin inhibitor targeting the source of obstructive hypertrophic cardiomyopathy and has a mechanism to reduce heart muscle contractility and left ventricular hypertrophy by inhibiting the cross-binding formation of excessive myosin actin activity. This drug confirmed efficiency through a phase 3 clinical study of EXPLORER-HCM. As a result of the study, it was found that exercise ability, LVOT closure, NYHA function class, and health status were significantly improved in the Camzyos administration group. 37% of the Camzyos administration group achieved a complex primary evaluation variable defined by achieving pVO2 1.5mL/kg/min improvement, NYHA class improvement, or pVO2 3.0mL/kg/min improvement without NYHA class deterioration, compared to around 17% of these patients in the placebo group, and the most common side effects in the clinical case were dizziness and fainting. Meanwhile, BMS recently submitted an application to the FDA for approval to expand the indication to reduce the need for Camzyos' SRT (Septal Reduction Therapy).
- Company
- 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.
- Opinion
- [Reporter’s View]Raising price of cold medicines not enough
- by Lee, Tak-Sun Oct 28, 2022 05:56am
- With the shortage of cold medicines remaining unresolved, the government proposed a drug price increase as its final card. The government decided to first take price adjustment applications for dispensed drugs that contain acetaminophen, which is cheaper than other cold medicines. The government had been implementing support measures such as monitoring supply and demand and easing GMP inspections among others to increase the supply of cold medicines that have been lacking due to COVID-19. Also, the government will exclude the amount used for COVID-19 patients from the amount counted for the price-volume agreement system. However, the measures weren’t enough to resolve the shortage. This was why the MFDS Minister Yu-Kyung Oh brought up raising the drug price at the NA Audit as the final card, saying that no other cards were left. Given that this came from the head of the MFDS, not the Ministry of Health and Welfare which is in charge of the price increase, reflects the limitations and frustrations in the support measures for expanding the manufacture of cold medicines so far. However, just a superficial drug price increase will not be enough to resolve the issue, because the ceiling price set for dispensed acetaminophens is too low. Currently, the ceiling price of the dispensed acetaminophen is set at KRW 11-32 for the 0.5g, KRW 26 for the 0.16g, KRW 29 for the 0.325g, and KRW 43-51 for the 0.65g strength. Considering how the over-the-counter 0.65g strength is sold at KRW 200 per tablet, pharmaceutical companies have no choice but to be less active in selling their drug for dispensing purposes. From the companies’ perspective, putting more weight on the over-the-counter products sold at pharmacies or supplying more expensive prescription drugs instead of acetaminophen helps improve company profits. Therefore, the industry believes the government’s price increase will not make a significant impact in increasing the supply if the increased amount is in a superficial range. If the government is to raise the drug price, the rate should be at the extent that considers the suppliers' needs. Moreover, the price should be raised soon. Considering the development of the COVID-19 crisis, applying the price increase in February next year after undergoing all administrative procedures will be too late. Of course, strict screening and negotiations to facilitate smooth supply are required, but if the purpose of the measure is to immediately increase the supply, the procedure should be boldly omitted. Also, prompt action must be taken in advance, as suppliers are likely to stock up on products and defer sales until the price increase is applied. Therefore, the government should also require companies to commit to expanding their supply along with the price increase. The price increase of cold medicines this time is made largely for the public interest of allowing the timely provision of such drugs to patients and long-term care institutions by expanding supply. In consideration of this, the government and pharmaceutical companies should closely work together to achieve the desired effect with the price increase measure.
- 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.
- Policy
- The warning phrase deleting the possibility of Nucynta abuse
- by Lee, Hye-Kyung Oct 27, 2022 05:52am
- The "possibility of abuse," a warning phrase for narcotic painkillers containing Tapentadol, will be deleted. The permit includes a new disorder of resistance and opioid use, and monitoring and addiction patients consider consulting with experts. The Ministry of Food and Drug Safety announced that it will prepare a proposal for a change in permission based on the results of the European Medicines Agency's (EMA) review of safety information on tapentadol oral drugs and conduct an opinion inquiry by the 9th of next month. Tapentadol licensed in Korea are 6 items, including 50mg, 100mg, 150mg of "Nucynta" by Janssen Korea, 50mg of "Nucynta ER", 100mg, and 150mg. Tapentadol, the main active ingredient of Nucynta, is characterized by two mechanisms of action that activate opium-like receptors with one synthetic compound and inhibit norepinephrine reabsorption. Nucynta, which received an item license in June 2016, is actively prescribed when it was registered in the same year. The possibility of abuse is eliminated, and repeated use of this drug can cause Opioid Use Disorder (OUD). The new content is that the abuse or intentional misuse of the drug can cause excessive administration or death. The risk of developing opioid use disorder increases in patients with a personal or family history of drug use disorder (including alcohol use disorder) and patients with a history of smoking or other mental health disorders (e.g., major depression, anxiety, and personality disorder). The Ministry of Food and Drug Safety said, "If having a review opinion on the change of permission, please submit the reason and evidence."
- InterView
- "Lilly rises in anticancer and autoimmune diseases"
- by Eo, Yun-Ho Oct 27, 2022 05:52am
- The pharmaceutical company Lilly is known for their strong diabetes treatment pipeline. As the world’s first developer of insulin, Lilly has solidified its position in the field, introducing DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 analogues into its pipeline. However, Lilly has transformed. It did not give up diabetes, the company just added more ‘weapons to its arsenal.’ From some point, the company began to exert its influence in the fields of cancer and autoimmune diseases. In the lung cancer drug market, where the company had made no significant impact other than with ‘Alimta,’ Lilly released the VEGFR-inhibitor 'Cyramza,’ and also introduced the first-in-class RET-targeted therapy ‘Retevmo.’ Also, its ‘Verzenio’ CDK4/6 inhibitor latecomer for breast cancer has successfully landed in the market with a successful insurance reimbursement strategy. The company is also showing marked growth in the autoimmune disease market. Its second JAK inhibitor ‘Olumiant’ has been targeting atopic dermatitis, and secured the first indication for alopecia areata among same-class drugs. Also, Interleukin-17A inhibitor ‘Talz’ is continuing to expand indications to psoriatic arthritis, ankylosing spondylitis, etc. In addition, the company’s new migraine drug ‘Emgality’ was recently listed for reimbursement. Dailypharm met with Mira Kwon (44), Lilly Korea’s Specialty Care BU Lead who oversees all of the products above. Mira Kwon, Sr. Brand Manager of Specialty Care BU, Lilly Korea-Please give us a brief introduction of yourself. I entered Lilly/s marketing team in 2006. Lilly runs an open talent development program that allows employees to experience various departments, through which I was able to experience various departments including the sales department, external affairs department, and also the oncology department at a time when the insurance drug pricing system was changing rapidly. I became the marketing lead of the Oncology department after working in Market Access, and since the company restructured the departments into Business Units, I have been in charge of the Specialty Care BU, which is the Oncology and Immunology Departments. -Lilly has undergone dynamic changes. It seems that your BU is in charge of the new growth engine of the company. Since Lilly acquired the anticancer drug company, Loxo Oncology in 2019, the company had been able to establish a strong pipeline in oncology as well, including Retevmo. The company is also developing and preparing launches of other candidate substances. In the field of autoimmune diseases, our main products are Olumiant and Talz. New indications were added in major areas in the past 2 years, and with new indications also set to be added next year, the pipeline is expanding quickly. At a recent global meeting, clinical data on the atopic dermatitis treatment that is currently undergoing clinical trials were also reviewed. - Autoimmune disease is one area that Lilly lacked experience in. It is also an area that has a high entry barrier in Korea, so it was surprising that Lilly jumped into this market. Despite the many companies that have already built a reputation in the field for more than 15 years, we have been receiving much feedback on how good and diverse Lilly’s portfolio is. We own both psoriasis and atopic dermatitis treatments with clinical trials being actively conducted on new indications. -The marketing points for anticancer drugs and autoimmune disease treatments may be different. What areas do you focus on for each in the promotion process? The oncology department, like the diabetes department, is Lilly Korea’s key area of focus, therefore, its sales division has experts with more than 13-15 years of experience and expertise. Due to the nature of anticancer treatments, we conduct various activities with various departments including Medical to produce domestic research data to meet the needs of patients and HCPs in Korea. The immunotherapy market is very competitive. With so many options available within the same class, we ponder ways to differentiate Lily's portfolio from others. In the case of the new indications that had been introduced during the COVID-19 period, our team has focused on activities that allow two-way communication via digital channels rather than traditional marketing activities or channels. -What do you consider most important in running your marketing department? This is no longer an era where a newborn first-in-class blockbuster dominates the market. That's how dynamic the market is. In particular, due to uncertainties in patient access in Korea, it is important to adapt quickly and modify our strategies in line with the ever-changing environment. Although the Oncology and Immunology departments are in charge of different diseases, both are facing the same situation in the pharmaceutical industry, especially in the current situation where so many new products and indications are being released. I think it is the role of our marketing department to think about in-depth strategies and prepare various scenarios in advance. -Your promotion strategies will also need to be changed with the end of the COVID-19 situation. So we plan to strengthen offline activities that have been restricted due to the COVID-19 pandemic. However, HCPs have also become familiar with digital channels for over two years in the COVID-19 pandemic, and as it also has advantages such as convenience, we are focusing on how to combine these well. We also have a digital marketing department within the company, and I know that they are actively discussing with the headquarters measures to find contact points with customers based on analyzed data. In the future, our marketing activities will evolve in the direction of delivering messages through effective channels by identifying areas with the greatest needs for HCPs based on data. -In the Korean pharmaceutical market, reimbursement became a determining factor that makes or breaks the success of drugs. Currently, Retevmo is undergoing reimbursement review, and marketing will also be conducting activities for reimbursement in addition to MA. The reimbursement listing process is always uncertain and requires discussion with authorities. Therefore, as a multinational pharmaceutical company, it is on us to facilitate smooth discussions between headquarters and regulatory authorities. Although the MA is responsible for communication with HQ, the marketing department provides opinions on how the drugs can be used for patients in Korea and to which extent the drugs can provide therapeutic benefits. -So how well do you communicate with global headquarters? Korea is one country where reimbursement is difficult, but with the environment in other countries rapidly changing as well, it seems that our global headquarters now understand Korea's situation. The company already saw through this reimbursement process with oncology drugs like Cyramza and Verzenio. However, it is true that Korea’s drug price differs greatly from other countries, and there are difficulties due to various related systems in Korea.
