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- 2026-03-17 16:20:01
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- Sales of Statin/Ezetimibe have surpassed ₩600 billion
- by Chon, Seung-Hyun Feb 03, 2022 05:57am
- In the dyslipidemia treatment market, a combination of Statin + Ezetimibe is gaining explosive popularity. The annual prescription market has more than quadrupled over the past five years, exceeding 600 billion won. Rosuvastatin +Ezetimibe is leading the market growth. According to UBIST, a pharmaceutical research institute, the amount of outpatient prescriptions for Statin +Ezetimibe was 609.9 billion won, up 23.1% from the previous year. It increased 52.3% in two years from 40.4 billion won in 2019. It showed rapid growth every year from 136.9 billion won in 2016 to 345.4% in five years. Sales of Rosuvastatin and Ezetimibe are forming the largest market. Last year, the prescription amount of Rosuvastatin and Ezetimibe was 436.3 billion won, up 18.8% from the previous year. The market size has more than tripled in five years from 56 billion won in 2016. Rosuvastatin and Ezetimibe account for 71.5% of Statin and Ezetimibe market. The market for Rosuvastatin and Ezetimibe began in 2015 when Hanmi Pharmaceutical launched Rosuzet. Rosuzet recorded a prescription performance of 123.2 billion won last year, up 17.4% from the previous year, contributing the most to the expansion of Statin and Ezetimibe markets. Hanmi Pharmaceutical has secured the right to use Ezetimibe from MSD and has recorded high growth rates since entering the market before its competitors, ranking first in the same ingredient market. Rosuzet ranked second among all medicines. For the first time in 2020, it exceeded 100 billion won in prescriptions and was named the "100 billion won club" for the second consecutive year. Last year, it ranked second in prescription amount after Lipitor among all medicines. A total of 10 companies recorded more than 10 billion won in prescriptions last year, playing a role as a cash cow. Yuhan Corporation's Rosuvamibe rose 7.8% from the previous year to 62 billion won in prescriptions last year. HK inno.N, GC Pharma, Daewoong, Huons, Jeil, Kyung Dong, Hutechs, and Myungmoon recorded more than 10 billion won in prescription amount in the Rosuvastatin and Ezetimibe market last year. Last year, Atorvastatin-Ezetimibe market showed great growth. The prescription amount of Atorvastatin-Ezetimibe was 128.8 billion won, up 55.6% in a year from 82.8 billion won in 2020. With the release of a huge number of Atozet's generics, the market size expanded in a short period of time. MSD's Atozet was the only one generic until 2020. Since last year, the size of the market has risen significantly as more than 100 domestic companies have joined at the same time. In October 2020, Chong Kun Dang's Lipilouzet went through a clinical trial in October last year and was approved. At this time, 22 companies' generics for Lipilouzet were approved and were listed from April last year. Since February last year, 88 additional pharmaceutical companies' generic for Atozet have started to be approved. Since January 22, when Atozet's review period expired, it has been approved for sale simultaneously since applying for permission and registered in May, a month later than generic for Lipilouzet. As Korus Pharm and Mirae Pharm were approved for generics for Atozet in June last year, the number of domestic companies that have entered the Atozet market over the past year has increased to 113. Sales of Simvastatin+Ezetimibe slowed down. Last year, the prescription amount of the Simvastatin+Ezetimibe was 43 billion won, down 5.3% from the previous year. It is down 23.6% from five years ago. Simvastatin+Ezetimibe, the original product of MSD's Vytorin, was first released in Statin-Etimibe market, but its growth is stagnant. Amount of outpatient prescriptions for Statin + Ezetimibe by year (unit: 100 million won, data: UBIST)
- Company
- Hepatitis C market in decline due to superior treatment
- by Ji Yong Jun Feb 03, 2022 05:56am
- The hepatitis C treatment market had contracted for two consecutive years since 2020. The annual decline in the number of hepatitis C patients and the introduction of effective drugs is analyzed to have caused the contraction. According to the market research institution UBIST on the 29th, outpatient prescription of hepatitis C treatments recorded ₩35.1 billion last year, which was a 26.1% decline from the previous year. This is one-fourth the ₩135.2 billion that was made in outpatient prescriptions in 2017. The market had been declining for the past 4 years, reducing 45.5% to ₩73.7 billion in 2018, then to ₩65 billion in 2019, and to ₩47.4 billion in 2020. (DATA=UBIST)The overall market contraction was due to the reduced prescription of the market’s lead product, Abbvie’s ‘Mavyret.’ Mavyret sold ₩26.3 billion last year, a 26.4% reduction from the 26.3 billion in the previous year. Mavyret is a direct-acting antiviral (DAA) that was introduced in the market in the fourth quarter of 2018 that may be prescribed to all hepatitis C genotypes and has a cure rate of 99%. The drug can be taken once daily in 3 tablets with food, and its administration period is 8 weeks, 4 weeks shorter than other treatments. Mavyret had stood out in the market due to this differentiated effect at the time of its release, and sold ₩7.5 billion in prescriptions in only three months after its release. In 2019, prescriptions soared to ₩44.5 billion, transforming the market. However, since 2020, its prescription amount recorded ₩35.7 billion and fell 21.8% from the previous year. This is due to the characteristic of hepatitis C treatments. Hepatitis C is transmitted through exposure to an infected person’s blood. Many are asymptomatic and patients find out their condition after disease progression, 80% of which develops chronic hepatitis C, and 20% to cirrhosis of the liver or liver cancer. Also, the number of Hepatitis C patients has been decreasing every year. According to the National Health Insurance Services, 8.647 new patients have been diagnosed with hepatitis C in 2020. This is an 11.5% annual decrease in average from the 14,087 diagnosed in 2016. With the number of patients reducing every year as such, the industry interprets that the market had to contract due to the introduction of a novel new drug that can fully cure the condition. Also, other drugs have seen a decline in sales or withdrew from the market due to the introduction of Mavyret. Gilead Science’s ‘Sovaldi’ sold 77% less than the previous year to record ₩210 million last year. Sovaldi had been the lead product in the hepatitis C treatment market before the introduction of Mavyret. Just in 2017, outpatient prescription of Sovaldi recorded ₩84.3 billion. For example, sales of Abbvie's ‘Viekreia’ and ‘Exviera’ dropped sharply to reach an uncountable amount from 2020. However, outpatient prescriptions of Sovaldi fell over half to ₩37.7 billion the next year. In 2019, it once again dropped 89.7% from the previous year to record ₩3.9 billion. Prescription of Gilead’s other hepatitis C treatment ‘Harvoni’ decreased 14.7% from the previous year to ₩8.1 billion. This is over a half reduction from the ₩17.6 billion in 2017. Another hepatitis C treatment, MSD’s ‘Zepatier’ was released in the second quarter of 2017, and recorded ₩30 billion in outpatient sales by 2018. However, its demand fell sharply from the following year, losing the competition to Mavyret and Sovladi. Last year, outpatient prescriptions for Zepatier recorded ₩430 million, a 61% drop the previous year. BMS’s ‘Daklinza’ and ‘Sunvepra’ withdrew from the Korean market. The two products had recorded a 15% share in the Hepatitis C treatment market in 2017, then continued to lose their share to Mavyret and Sovladi. The products were discontinued supply in 2020, and BMS voluntarily withdrew the marketing authorization of the two products in March last year.
- Company
- Competition in the narcolepsy tx market is expected
- by Eo, Yun-Ho Feb 03, 2022 05:56am
- Competition for prescription of drugs that prevent sleepiness and manage so-called narcolepsy has begun. According to related industries, competition with Teva Handok's Nuvigil (Armodafinil) is expected as Wakix (Pitolisant) of Mitsubishi Tanabe Pharma will be applied from next month (February). Wakix is a counteractive and antagonist that selectively binds to histamine H3 receptors and is a new mechanism for increasing histamine concentration in the brain. Nuvigil, an active isomer of the sleep attack treatment Provigil, is a drug that promotes awakening by activating dopamine in the brain and improves the duration of existing drugs. Mitsubishi Tanabe Pharma is currently undergoing prescription procedures at major medical institutions nationwide, including the Big 5 hospitals, ahead of the launch of the benefit. Nuvigil, listed in September 2018, can be prescribed at medical institutions nationwide, including Seoul National University Hospital, Sinchon Severance Hospital, and Samsung Medical Center. Narcolepsy is currently included in a rare and intractable disease, and 10% of patients' coverage is applied. Meanwhile, narcolepsy is a sleep disorder disease characterized by abnormal expression of sleep-wake cycle confusion and rapid eye movement (REM) sleep due to the loss of neurons that produce a neurotransmitter called Hypocretin in the brain. Representative symptoms include Excessive Daytime Sleepiness (EDS) and cataplexy, in which REM sleep is expressed in an awakening state.
- Company
- An unexpected story by Organon and Viatris
- by Jan 28, 2022 05:58am
- Organon and Viatris' patent expired drugs remain powerful. Although questions have been raised about the growth engines of the two independent corporations after receiving "old drugs" from MSD and Pfizer, it is evaluated that it is as good as in Korea. ◆Organon's Atozet and Cozaar's outpatient prescription is 250 billion won According to UBIST, a drug research institute, on the 28th, Organon, which was launched in June last year, exerted the power of patent-expired drugs. Last year, Organon's outpatient prescription estimate was 252.4 billion won. This is the sum of the outpatient prescriptions for items transferred to Organon among MSD products. It accounts for 58% of the 437.5 billion won prescription for MSD. The amount of outpatient prescriptions for Organon products grew 5.4% compared to 239.4 billion won in 2016. Organon is a company spun off from MSD. It took over Atozet, Cozaar, Singulair, and Nasonex, which are "Old Drugs." Most of Organon's products showed growth even though they were patented expired drugs that compete with generic products. Atozet is a large item that recorded 86.8 billion won in outpatient prescriptions last year. The number of prescriptions more than tripled over the past six years from 24.7 billion won in 2016. Due to the expiration of patents in January last year, the release of more than 100 generics also rose 4.9% from the previous year. Cozaar is an old drug that has been 25 years since its launch, and when generic was released in 2008, sales of 70 billion won collapsed. However, sales of prescriptions have been on the rise again recently. It increased 15.8% from 25.7 billion won in 2016 to 29.7 billion won last year. In particular, Cozaar is one of the products that did not exceed the standard value during the Losartan impurity crisis last year. The amount of prescriptions surged in December last year as demand flocked to the original due to concerns over impurities.Organone also has Propesia, a hair loss treatment. It is widely used not only for prostate hypertrophy treatment but also for hair loss treatment as a non- reimbursed drug. It is estimated that it generates more than 40 billion won in sales in Korea. ◆Lipitor, 22 years since its launch, 200 billion won in sales Founded in November 2020, Viatris posted the largest number of outpatient prescriptions among multinational pharmaceutical companies last year. Viartris' outpatient prescription amount last year was 463.9 billion won, up 15.8% from 40.5 billion won in 2016. Although it decreased 0.3% from the previous year, it is good compared to the 2 to 7% drop in prescriptions by many multinational pharmaceutical companies amid prolonged Corona. Viatris is a company merged with Pfizer Upjohn and Mylan, a Pfizer patent expiration business. Lipitor, Novasc, Lyrica, Cerebrex, and Viagra have been transferred to Viartris. Lipitor has been 22 years since its launch, but it has been recorded as the most prescribed drug for the fourth consecutive year. Lipitor recorded 205.2 billion won, an increase of 0.7% last year, after surpassing 200 billion won in outpatient prescriptions in 2020. The scale has increased 23.4% from 2016. Celebrex, a COX-2 inhibitor, also recorded 46.3 billion won in outpatient prescriptions, up 3.6% from the previous year. At one time, the prescription amount fell to 36.5 billion won due to the launch of generic and the subsequent drop in drug prices, but has recovered to around 40 billion won since 2018. Lyrica and Norvasc, which were released in 2006 and 1991, are still paying nearly 70 billion won in outpatient prescriptions. The two products, worth 60.1 billion won and 62.6 billion won in 2016, respectively, grew 16.3% and 10.3% over six years. ◆ Price competitiveness and domestic business network When generics such as salt change items are released, the market share of original drugs drops rapidly. However, in the domestic market, despite the intensive check of generics, original drugs that expire patents are showing off their robustness. Due to the nature of the drug price system in Korea, generic's price competitiveness is low, so the original is advantageous for expanding its market share. Market sales of patent-expired drugs have been established more firmly due to the sales price of domestic pharmaceutical companies. Viatris' Lipitor, Lyrica, and Celebrex are jointly sold by Jeil. Organon's Atozet is co-sold by Chong Kun Dang.
- Company
- The NOAC market with ₩230 billion is fluctuating
- by Kim, Jin-Gu Jan 27, 2022 05:44am
- Lixiana, Pradaxa, Xarelto, Eliquis (clockwise from the top left)The NOAC market, which has grown to 230 billion won, has fluctuated due to generic drugs. After the Supreme Court ruling, Eliquis enjoyed reflective benefits as generics were withdrawn altogether. On the other hand, in the case of Xarelto, as generic products were released one after another due to the expiration of material patents, it seems to have slowed down somewhat. Lixiana maintained its No. 1 position in the market last year by repeating rapid growth. It was found that prescription performance decreased for the fourth consecutive year due to the prolonged slump in Pradaxa. ◆ Lixiana's annual prescription amount of increased by 16% year-on-year According to UBIST, the size of NOAC's external prescription market last year is estimated at 231.9 billion won. It increased by 10% from 211.1 billion won in 2020. NOAC is attracting attention as a drug with a lower risk of bleeding side effects and a greater thrombus prevention effect than Warfarin, a conventional anticoagulant. Sales have been rising since the early 2010s, replacing Warfarin. Market growth was led by Daiichi Sankyo's Lixiana and BMS' Elliquis. Sales of Lixiana recorded 84.8 billion won last year. It increased 16% from 72.9 billion won in 2020. Lixiana was the last NOAC to enter the market. While other NOACs were licensed in Korea from 2009 to 2011, Lixiana was licensed in 2015. It was then released in January 2016. Although it is generics, synergy with domestic partners is one of the reasons why it was able to quickly settle down as the No. 1 market. Daiichi Sankyo has joined with Daewoong Pharmaceutical since the launch of Lixiana. Lixiana quickly settled in the NOAC market due to the joint sales strategy of the two companies, and has topped the market since 2019, three years after its launch. Lixiana's annual prescriptions amounted to 4.8 billion won in 2016, 20.9 billion won in 2017, 39.5 billion won in 2018, 61.9 billion won in 2019, 72.9 billion won in 2020, and 84.8 billion won in 2021. Considering the current upward trend, it may exceed 100 billion won at the end of this year. ◆This is due to a 19% increase in the prescription amount of Eliquis, and generic withdrawal after the Supreme Court ruling Eliquis then ranked second in the NOAC market. Eliquis' prescription amount last year was 65.2 billion won, up 19% from 55 billion won in 2020. It is analyzed that the withdrawal of generic had a significant impact on the nearly 20% increase in Eliquis' prescription performance. In April last year, the Supreme Court overturned the previous first and second trials in a patent lawsuit surrounding Eliquis and sided with BMS, the original company. Shortly after the ruling, generics withdrew from the market. This is because BMS announced a claim for damages due to patent infringement. Generic companies won Eliquis' material patent trial in February 2018. It also won the second trial in March of the following year. Based on this ruling, Chong Kun Dang and Yuhan Corporation have launched a series of generics since June 2019. Generics posted a prescription of 1.2 billion won in 2019. In 2020, generic prescriptions increased to 9.4 billion won. However, due to last year's Supreme Court ruling, the prescription amount shrank to 5.4 billion won. Inventory supplied to retailers and others is also believed to have been completely exhausted. ◆Generic for Xarelto was released due to the expiration of the patent Last year, Xarelto's prescription amounted to 59.6 billion won. It increased by 4% from 57.3 billion won in 2020. Although it has increased slightly. In the case of Xarelto, it recorded an average annual growth rate of 14% for four years from 2016 to 2020. One of the reasons why Xarelto's prescription performance has slowed down is the launch of the generic. Many generics have been released around the expiration of Xarelto material patents (October 2020). Since then, a total of 1.6 billion won has been paid by the end of last year. Chong Kun Dang's strategy to preoccupy the market is drawing attention. Chong Kun Dang launched the generic in May 2020, before the Xarelto material license expired. Prior to this, Xarelto's material patent was requested for a passive trial to confirm the scope of rights. It launched the generic on the premise of winning Xarelto's material patent trial. Analysts say Chong Kun Dang has made a winning move to preoccupy the market. It is analyzed that Chong Kun Dang's winning strategy worked to some extent. Last year, the prescription amount of Chong Kun Dang's Riroxia was 1.2 billion won. Considering that the total amount of generic prescriptions from the remaining 16 companies was only 400 million won, the strategy of launching generic about five months earlier than other companies won. There is a possibility of losing the patent lawsuit. If Chong Kun Dang finally loses the patent suit against Bayer, patent infringement is recognized. At this time, large-scale compensation for damages is inevitable. Currently, Chong Kun Dang is waiting for the second trial ruling after losing the first trial. ◆Pradaxa prescription sales declined for the fourth consecutive year, and copromotion with Boryung ended Another NOAC, Pradaxa, is prolonged sluggishness. Pradaxa's prescription amount last year was 15.2 billion won, down 8% from 2020. If the scope is expanded, it has been steadily decreasing since 2017. It includes KRW 21.6 billion in 2017 to KRW 19.6 billion in 2018, KRW 18.7 billion in 2019, and KRW 16.5 billion in 2020. Beringer Ingelheim selected Boryung Pharmaceutical as a partner to make up for the slump. The two companies launched a joint sale of Pradaxa in 2018. However, Pradaxa's performance did not rise despite the addition of Boryung Pharmaceutical. Eventually, at the end of last year, Beringer Ingelheim and Boryung Pharmaceutical terminated the co-promotion contract under mutual agreement.
- Company
- Celltrion completes transfer of Takeda-acquired products
- by Ji Yong Jun Jan 27, 2022 05:43am
- (Clockwise from the left) Nesina, Actos, Edarbi, Albothyl, Whituben, Nesina Met (Pic=MFDS) The transfer of rights for Takeda Pharmaceutical’s products that Celltrion acquired is now complete. The license of OTCs and diabetes drugs that were sold under Takeda Pharmaceutical’s name has been changed to Celltrion Pharm. According to the industry on the 26th, the ownership of the license for Nesina Act Tab 12.5/30mg has been changed from Takeda Pharmaceutical to Celltrion recently. With the change, the company completed changing the license rights for drugs acquired from Takeda Pharmaceutical. This completion comes in around a year since Celltrion acquired the rights for some Takeda pharmaceutical products in the Asia Pacific region. In December 2020, Celltrion acquired the rights of 18 prescription drugs and OTCs in the Asia Pacific region for a total of $278.3 million (₩307.4 billion). Under the deal, Celltrion Healthcare will own the license and be in charge of distribution and sales overseas, and Celltrion Pharm of distribution and sales in Korea. Under the deal, Celltrion Pharm had been sequentially transferring the rights of Takeda products sold in Korea. The DPP-4 inhibitor class ‘Nesina (alogliptin) series’ and TZD class ‘Actos (pioglitazone) series,’ and ARB class hypertension treatment ‘Edarbi (azilsartan)’ are some of the key products that have been acquired by Celltrion. Also, the company is acquiring permits and rights for Takeda’s OTCs such as the cold remedy ‘Whituben’ and the stomatitis treatment ‘Albothyl.’ Celltrion Pharm secured the license rights of all acquired drugs other than Nesina Act 25/15mg·25/30mg, Actos Met, and Albothyl. The company had sped up the transfer process since then and completed the acquisition of all the rights recently. However, the diabetes treatment Basen and hypertension treatment ‘Madipine‘ were excluded from the transfer of rights. Both products are developed by Takeda and the domestic licensing and manufacture of the products are handled by HK Inno.N in Korea. The sales performance of the key products that were transferred to Celltrion is reflected as Celltrion Pharm’s performance. Last year's performance of such products was estimated to be around ₩700 billion. Data= UBIST Based on UBIST results, the outpatient prescription of products that were transferred to Celltrion from Takeda Pharmaceutical last year amounted to ₩67.9 billion. In detail, its Nesina series sold ₩30.9 billion last year, a 3.7% drop from the ₩32.1 billion of the previous year. In the same period, sales of its Actos series also dropped 8.1% from ₩28.4 billion to ₩26.1 billion. Last year, the Edarbi series maintained sales at a level comparable to the previous year with ₩10.9 billion. Last year’s sales of OTCs like Whituben and Albothyl were not counted yet, but the prolonged COVID-19 crisis and the resulting contraction of the OTC market are expected to have slowed down the performance of the drugs as well. An official from Celltrion Pharm said, “We have completed the transfer of rights for major products that we acquired from Takeda, and is planning to focus on expanding prescription sales in earnest from this year.”
- Company
- Sales of flu treatments have decreased significantly
- by Chon, Seung-Hyun Jan 27, 2022 05:42am
- The outpatient prescription market also fluctuated two years after the landing of COVID-19. Sales in the pharmaceutical market, which is mainly used for infectious diseases such as influenza (flu) treatments, antibiotics, and expectorants, have decreased significantly. The flu treatment market has virtually disappeared. According to UBIST on the 24th, the amount of outpatient prescriptions for flu treatments last year was only 46 million won. It decreased 99.5% in a year from 8.8 billion won in 2020. Compared to 22.5 billion won in 2019, two years ago, the market size decreased by 99.8%. Flu treatment is the market where the most dramatic change has occurred since the spread of COVID-19. After the spread of COVID-19, the flu treatment market has virtually disappeared as the number of flu patients has plummeted due to strengthening personal hygiene management such as washing hands and wearing masks. According to The KCDA, since March 2020, when COVID-19 began to spread in earnest, the number of suspected patients per 1,000 outpatients has never exceeded the epidemic standard of 5.8 patients. Since recording 6.3 in the first week of March 2020, it has recorded less than five in nearly two years. This year, only 2.1 and 1.8 suspected flu patients per 1,000 outpatients in the first to third weeks of January. The flu treatment market has recorded less than 100 million won for six consecutive quarters since the market size recorded 1.8 billion won in the second quarter of 2020. In the fourth quarter of last year, the market size was less than 10 million won even though it was the flu season. In the case of Tamiflu, a leading flu treatment, the prescription amount reached 37.4 billion won in 2016, but only 40 million won last year. The antibiotic market was also damaged by the COVID-19 incident Last year, the amount of outpatient prescriptions for oral cephalosporin drugs was KRW 1.6.6 billion, down 8.0% from the previous year. It fell 28.2% from 27.1 billion won in 2020. Cephalosporin drugs are widely used antibiotics for pneumonia, sore throat, tonsillitis, and bronchitis. It is analyzed that the prolonged COVID-19 flu or a sharp drop in cold patients also affected the antibiotic market. In the case of other antibiotics, the damage is even greater. Last year, the prescription size of oral PCN drugs was 105.2 billion won, down 15.7% from the previous year. It decreased 40.8% in two years from 182.2 billion won in 2019 before COVID-19 hit. The situation was similar in the prescription market for other antibiotics such as Macrolides and similar drugs. Last year's prescriptions for Macrolides and others amounted to 86 billion won, down 6.6% from the previous year. Compared to two years ago, it fell 35.5%. The market size of expectorants used for phlegm and coughs in patients with colds and flu has also been greatly reduced. In 2019, the size of the prescription for expectorants recorded 182.2 billion won, down 29.8% to 127.8 billion won in 2020. Last year, it fell 15.7% again to 107.8 billion won. Last year, the prescription amount of expectorants shrank 40.8% from two years ago. Last year, the prescription performance of expectorants was 55.1 billion won, down 28.1% from the previous year. It was reduced 53.5% from 118.3 billion won in 2019. Prescriptions for last year fell 57.1% and 50.5%, respectively, from two years ago.
- Company
- KRPIA presidents will meet with Lee Joon-seok
- by Eo, Yun-Ho Jan 26, 2022 05:57am
- Ahead of the presidential election, KRPIA and multinational pharmaceutical presidents will meet with the leader of the main opposition party. According to the Dailypharm's confirmation, the presidents of the KRPIA will hold a meeting with Lee Joon-seok, CEO of People's Power, tomorrow morning (27th). The meeting will be attended by Oh Dong-wook , CEO of Pfizer Korea, Lee Young-shin, full-time vice chairman of KRPIA, Kim Sang-pyo, CEO of AstraZeneca Korea, and Kevin Peters, CEO of MSD Korea. It has been confirmed that Rep. Seo Jung-sook (pharmacist), a member of the National Assembly's Health and Welfare Committee, and Rep. Lee Jong-sung will be present along with Lee Joon-seok . Through the meeting, the presidents of KRPIA are expected to deliver grievances, policies, and pledges from the perspective of pharmaceutical companies with the agenda of "expanding new drug coverage." Lee JunSuk Meanwhile, at the end of last year, KRPIA presidents agreed on the need to expand access to treatments for rare diseases in relation to the current government's plan to expand health insurance coverage called "Moon Care" and submitted a PE expansion opinion to the government. According to the opinion, many rare diseases do not meet the "serious disease conditions of threatening survival (less than two years of life expectancy)," which are conditions that can utilize the current special system (RSA and PE systems), but have a great impact on families, including direct medical expenses of patients. The association argues that evaluating the clinical need of these diseases only as life expectancy does not take into account the characteristics of rare diseases, and that even if the clinical need does not meet the criteria for less than two years of life expectancy, it should be added to the PE targets.
- Company
- Outpatient prescriptions slow for MNCs...Viatris in the lead
- by Jan 26, 2022 05:57am
- Outpatient prescription sales of multinational pharmaceutical companies in Korea had slowed down in general last year. Viatris held the lead among multinational pharmaceutical companies for two consecutive years, but its amount of prescriptions also decreased 0.3% compared to the previous year. The top prescription drug companies such as MSD (Organon), AstraZeneca, Novartis, Astellas, all saw a decline in sales. According to the market research institution UBIST on the 26th, Viatris Korea held the lead in outprescription sales with ₩463.9 billion among multinational manufacturing companies last year. The total prescription amount of the company had fallen 0.3% compared to the ₩465.4 billion in 2020. Lipitor and Celebrex sold ₩205.2 billion and ₩46.3 billion respectively, increasing 0.7% and 3.6%, but Lyrica and Norvasc’s sales fell 3.6% and 1.7% respectively to record ₩69.9 billion and ₩69 billion, respectively. Viatris is a spin-off of Pfizer that was established in 2020 after merging with Mylan in 2020. At the time of the spin-off, the company received Pfizer’s off-patent drugs. With key products such as ‘Lipitor (dyslipidemia treatment),’ ‘Lyrica (neuropathic pain),’ ‘Norvasc (hypertension),’ the company has maintained the lead in outpatient prescriptions ever since its establishment. The outpatient prescription performance of large multinational pharmaceutical companies had decreased in general. MSD (including Organon) recorded ₩437.5 billion in prescriptions last year, which was a 2.4% decrease from the previous year. For MSD, its off-patent drugs and women’s health products are in the process of being transferred to its spin-off Organon. If the product transfers become complete, over half of MSD’s off-patent drugs will be recorded as Organon’s products. These future Organon products account for approximately 58% of the ₩437.5 billion that was sold last year as MSD’s prescriptions. ‘Atozet,’ one of the key products that will be transferred to Organon, had recorded ₩86.8 billion in sales last year, which is a 4.9% increase from the previous year. On the other hand, MSD’s DPP-4 inhibitor ‘Januvia family (Januvia, Janumet, Janumet XR)’ did not perform so well. Sales of Janumet fell 4.1% to ₩78.7 billion, Januvia fell 5.7% to ₩45.9 billion. Only sales of Janumet XR rose 2% to ₩51.8 billion. AstraZeneca, which recorded the 3rd most in sales, recorded 424.7 billion last year, a 6.4% decrease from the previous year. The sales drop was affected by the drop in sales of its lead product, the cholesterol drug ‘Crestor,’ falling 3.4% (₩90.8 billion). Fortunately, the outpatient prescription sales of its SGLT-2 inhibitor ‘Forxiga’ and combo ‘Xigduo’ had driven the outpatient prescription sales of AstraZeneca. The two products sold ₩42.6 billion and ₩37 billion, an 11.9% and 21.1% increase, respectively. Novartis’s sales performance also slowed down, recording a 0.1% decrease from the previous year to ₩422.5 billion in sales. Products that sold over ₩10 billion in outpatient prescriptions last year fell to 8 from the 11 in 2016. All companies other than Boehringer Ingelheim among the Top 5 grossing companies among multinational pharmaceuticals saw a decline in prescription sales last year. However, companies that sold NOAC, antidiabetic, and eye drops such as Daiichi Sankyo, BMS, Janssen, Lilly, and Santen fared better in the previous year. Daiichi Sankyo recorded ₩181.7 billion in sales, a 7% increase from the previous year, benefitting from the 16% sales increase of the NOAC anticoagulant ‘Lixiana.’ Sales of BMs’s prescription drugs also increased 7.6% to record ₩181.7 billion, with sales of the NOAC ‘Eliquis’ rising 18.6%. Lilly’s sales also increased 16.1% to record ₩104.9 billion, with the even expansion in sales of GLP-1 analog ‘Trulicity’ antidepressant ‘Cymbalta,’ JAK inhibitor ‘Olumiant,’ CDK 4/6 inhibitor ‘Verzenio.’ Also, the ‘no Japan’ boycott that started in 2019 in Korea did not affect sales of Japanese pharmaceutical companies. Other than Astellas, other Japanese pharmaceutical companies saw steady growth since 2019. In particular, outpatient prescriptions of Santen Pharmaceutical rose 42.3% from ₩68.4 billion in 2018 to ₩97.3 billion last year. Sales of Santen Pharmaceutical’s eyedrop ‘Cosopt-S’ that it received the license from MSD arose significantly, and prescriptions of the eye drop ‘Cravit’ and the glaucoma treatment ‘Taflotan-S,’ as well as eye drop ‘Ikervis’ had expanded greatly.
- Company
- SK Bioscience wins 3rd EU-GMP for its vaccine plant
- by Ji Yong Jun Jan 26, 2022 05:57am
- (Picture of Andong L House=SK Bioscience)SK Bioscience, which has signed a CMO deal to manufacture the Novavax vaccine, has additional received EU-GMP certification from the European Medicines Agency. This is the third EU-GMP certification the company received. On the 25th, SK Bioscience announced that it had received additional EU-GMP certification for the manufacturing facility, process, and quality system of Andong L House that is being operated for the manufacture of the Novavax COVID-19 vaccine. SK Bioscience has been producing the drug substance of Novavax’s COVID-19 vaccine under a CMO (contract manufacturing organization) deal. With the approval, SK Bioscience’s L House received the third EU-GMP approval as a vaccine manufacturing facility. One of SK Bioscience’s vaccine manufacturing facilities for AstraZeneca’s COVID-19 vaccine and one of the three SK Bioscience’s vaccine manufacturing facilities received EU-GMP certification last year. SK Bioscience is also working for EU-GMP certification for its last facility. The company explained that it plans to receive an on-site inspection from the EMA within the first quarter at the earliest. The EU-GMP system evaluates and certifies the entire process of vaccine production, from the purchase of raw materials to manufacturing, quality control, to shipment. It is considered to be the highest level of certification in the world along with the US’s cGMP certification. SK Bioscience passed the on-site investigation and document review of the EMA that took two months since November last year. By receiving EU-GMP certification in 2 of its Novavax COVID-19 vaccine manufacturing facilities, the company will speed up the supply of its Novavax vaccine. Novavax received approval for the use of its COVID-19 vaccine from the EMA, WHO, India, Indonesia, Philippines, France, Australia, among other countries. In Korea, SK Bioscience received marketing approval for Novavax’s COVID-19 vaccine ‘Nuvaxovid’ on the 12th, and is preparing a total of 40 million doses of the vaccine. SK Bioscience plans to further expand its CMO business with global vaccine companies based on the vaccine manufacturing and quality control capabilities proven through its EU-GMP certification in the future. L House is equipped with the base technology including ▲cell culture ▲bacterial culture ▲gene recombination ▲protein conjugation and the R&D personnel necessary including the base technology to mass-produce various vaccines immediately upon development. SK bioscience CEO Jae-Yong Ahn said, “It is a great pleasure that the manufacturing facilities of the L House Plant have been recognized for its global capabilities, receiving a series of the highest-level certifications in the globe. Based on the company’s verified vaccine manufacturing and quality control capabilities, we will continue to expand our CMO business in partnership with global companies.”
