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- 2025-12-24 13:49:19
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- Heart failure drug Entresto makes KRW 10 bil in Q3
- by Kim, Jin-Gu Nov 14, 2022 06:07am
- Pic of Entresto Novartis’ chronic heart failure treatment ‘Entresto’ is growing rapidly. Its quarterly sales first exceeded KRW 10 billion in 5 years since its release in Q3 this year. The analysis is that its rapid growth was due to its de facto domination of the market. However, with the nearing entry of ▲SGLT-2 class diabetes treatments, ▲new chronic heart failure treatments, ▲Entresto generics, various prospects are being raised on whether Entresto will be able to maintain its growth rate. ◆Quarterly prescriptions of Entresto exceed KRW 10 billion…2.6 time growth in 3 years According to the market research institution UBIST on the 12th, Entresto’s Q3 prescriptions amounted to KRW 10.5 billion. This is a 21% increase from KRW 8.6 billion in Q3 last year and a 2.6-time increase from the same period 3 years ago in Q3 2019. Entresto is a drug used to reduce the risk of death and hospitalization in patients with left ventricular (LV) dysfunction. As a combination of neprilysin inhibitor sacubitril and an angiotensin receptor blocker (ARB) valsartan, it has a double mechanism of action. where sacubitril works on the neurohormonal system and reinforces the heart protection effect and valsartan blocks the angiotensin II receptor. Novartis received approval for the drug in Q2 2016 and released the drug with reimbursement in Q4 2017. Until now, no suitable treatment existed for chronic heart failure before Entresto. ACE or ARB inhibitors were mainly prescribed with not much effect. Quarterly prescriptions of Entresto (Unit: KRW 100 million, Data: UBIST) Entresto’s sales rose rapidly based on its sole lead in the field of chronic heart failure. After recording KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then to KRW 32.3 billion in 2021. Its cumulative sales recorded KRW 29.2 billion in Q3 this year. At this pace, its sales are expected to reach nearly KRW 40 billion by the end of the year. ◆SGLT-2 inhibitors, new treatments, and generics knock to enter the heart failure treatment market However, varying prospects are being made on how long this growth will last. The biggest variable is that the SGLT-2 class antidiabetics were approved for the heart failure indication. The Korean Society of Heart Failure (KSHF) published a newly revised Heart Failure Clinical Practice Guidelines and recommended SGLT-2 inhibitors as a main treatment regardless of the patient’s diabetic status in all areas of chronic heart failure. The SGLT-2 inhibitors specified in the guidelines are limited to 'Jardiance (empagliflozin)' and ‘Forxiga (dapagliflozin).’ If reimbursement is also extended to chronic heart failure after the amendment of the guidelines, the market is expected to grow further. Pic of Forxiga(left), Jardiance (right) SGLT-2 inhibitors have a larger scope of indication than Entresto. Entresto can be used in patients with heart failure with reduced ejection fraction, heart failure with mildly reduced EF, and heart failure with preserved ejection fraction. On the other hand, Entresto cannot be used for HFpEF. Therefore, if Jardiance and Forxiga are reimbursed, they will compete with Entresto in the heart failure market. On the other hand, there is also a prospect on the possibility of combined prescription using SGLT-2 inhibitors and Enhertu based on study results that showed improved prognosis with combined use. In that case, sales of Entresto and Jardiance/Forxiga will all rise in synergy. Pic of VerquvoAnother variable is the introduction of new chronic heart failure treatments with a new mechanism of action. Currently, Bayer has announced the release of ‘Verquvo (vericiguat).’ Bayer received approval for Verquvo in Korea in December last year and submitted an application for reimbursement in August this year. Verquvo is a drug with a new mechanism of action. Entresto blocks the harmful effects from the natural neurohormonal system activated by myocardial and vascular dysfunction. Verquvo improves myocardial and vascular function by stimulating the synthesis of intracellular cyclic guanosine monophosphate (cGMP) that regulates vascular tone, cardiac contractility, and cardiac remodeling. Also, the possible entry of Entresto’s generics can also act as a big variable in Entresto’s sales growth. 13 Korean pharmaceutical companies have won the first trial against Novartis on Entresto’s patent and were qualified to release Entresto generics. If the companies succeed in releasing Entresto generics, their price will automatically be discounted by 30%. One year after its release, the price will be further reduced to 53.55% from the existing price.
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- The market is recovering for the first time in two years
- by Kim, Jin-Gu Nov 14, 2022 06:07am
- The size of outpatient prescriptions of Montelukast for asthma and allergic rhinitis has increased by 21% in a year. The market, which had been stagnant for the past two years due to the COVID-19 incident and side effect issues, seems to be recovering from its previous year's prescription performance this year. It was found that the impurity negative factor that occurred at the beginning of the year also did not have a significant impact on the market recovery. According to UBIST, a pharmaceutical market research institute on the 9th, the outpatient RX in the Montelukast asthma treatment market in the third quarter of this year was 80.5 billion won. It increased by 18% compared to 68 billion won in the same period last year. Compared to the cumulative prescription amount (75.3 billion won) in the third quarter of 2020, two years ago, it increased by 7%. Montelukast is a common drug for allergic rhinitis and asthma. The original is Singulair by Oganon, Korea. MSD Korea received domestic approval in 2000. More than 100 domestic pharmaceutical companies are selling generics with the same ingredients. The market for this ingredient treatment has grown steadily until 2019. However, due to the COVID-19 crisis in 2020, visits to hospitals for children and adolescents who are mainly prescribed this drug have decreased significantly. At the same time, the U.S. Food and Drug Administration (FDA) attached a black box warning, adding to the issue of side effects. The market suffered a slump for more than two years until the end of last year. The market size, which expanded to 123.9 billion won in 2019, shrunk to 101.8 billion won in 2020 and 96.3 billion won in 2021. It seems to be rebounding this year. It recovered to 92% of the cumulative prescription amount (88 billion won) in the third quarter of 2019 before the COVID-19 incident and side effect issues occurred. If the current trend continues, it is expected to expand to more than 110 billion won by the end of the year. ◆ Most of the major products have increased prescription amount Analysts say that the risk of impurities that occurred earlier this year did not lead to a decrease in prescription performance. In January of this year, the Ministry of Food and Drug Safety decided to introduce pharmaceutical companies Impurities tests have been ordered for montelukast ingredients and finished drugs. It was a precautionary measure according to safety information that NDPA was detected in Montelukast-based raw material drugs. Pharmaceutical companies submitted the results of the impurity test to the Ministry of Food and Drug Safety in April. However, it is reported that NDPA impurities were not detected in domestic products, including the original Singulair. In the case of Montelukas preparation, unlike Valsartan and Ranitidine, large-scale sales prohibition or recovery did not proceed. In fact, most of the major products' prescription performance increased compared to the same period last year-on-year. Hanmi Pharmaceutical's Monterizine recorded a cumulative prescription performance of 8.3 billion won in the third quarter of this year. It increased by 25% compared to 6.7 billion won in the same period last year. Compared to the cumulative 5.7 billion won in the third quarter of 2019, before the outbreak of COVID-19, it increased by 1.5 times. This year, for the first time, the annual prescription amount is expected to surpass 10 billion won. Montezal, another montelukas formulation of Hanmi Pharmaceutical, also saw its cumulative prescription increase by 20% from 3.3 billion won to 3.9 billion won in the third quarter. Monterizine is a combination that combines Montelukas with Levocetirizine, a third-generation antihistamine. During the same period, HK inno. N Lukio increased by 5% from 6.4 billion won to 6.7 billion won. Boryung Asluka rose 199% from 1.3 billion won to 4 billion won, Hutex Pharmaceutical's Singuldown rose 15% from 2.7 billion won to 3.2 billion won, Singulmon rose 7% from 2.6 billion won to 2.8 billion won, and Daewoong Bio's Dawoong Montelukast rose 85% from 1 billion won to 1.9 billion won. The original product, Singulair, saw its cumulative prescription amount fall 4% from 24.5 billion won last year to 23.4 billion won this year. Singulair is being sold by Oganon Korea. Oganon Korea was spun off from MSD Korea early last year. During the spin-off process, Singulair's copyright was transferred to Organon Korea.
- Company
- The popular Daewoong's Nabota
- by Nov 14, 2022 06:06am
- EvolusDaewoong Pharmaceutical's botulinum toxin drug Nabota exceeded $100 million in cumulative sales in North America this year. This is an increase of 61% compared to the previous year. According to the earnings report of Daewoong Pharmaceutical partner Evolus on the 9th (local time), Jeuveau, which is sold by the company, recorded cumulative sales of $13.6 million (14.3 billion won) in the third quarter of this year, up 61.1% from a year earlier. Jeuveau is the North American product name of Nabota, a botulinum toxin formulation exported by Daewoong Pharmaceutical. Sales in the third quarter were $33.21 million (45.6 billion won), the lowest this year, but increased by 24.5% compared to the same period last year. Evolus is a global copyright partner of Nabota developed by Daewoong Pharmaceutical. Since the approval of the U.S. Food and Drug Administration (FDA) in February 2019, Nabota has been actively sold in North America. Early last year, the ITC dispute with Allergan and Medytox was terminated to resolve the negative factors. Nabota has recorded more than $30 million in sales for the fourth consecutive quarter as active marketing for Nabota and demand that had slowed down due to COVID-19 have increased. In the second quarter of last year, it broke its biggest quarterly sales of $37.16 million (51 billion won). Evolus predicted that growth momentum will continue in the fourth quarter with the recently launched large-scale campaign "Switch Your Tox." The campaign added 650 new customer accounts in the third quarter, securing more than 8,800 customers so far. The rate of reordering remains above 70%. The number of consumers who wrote the Evolus Reward loyalty program reached nearly 450,000. "The large-scale campaign has kept demand for Nabota strong," said David Moatazedi, CEO of Evolus. "Evolus will be able to reach the top of this year's revenue guidance range of 143 million to 150 million dollars, which is about 50% annual growth." This is about three times the expected growth rate of the toxin market, he said. Evolus also started selling Nabota in the UK in October. Nabota, which was officially released under the name Nuceiva, delivered its first order last month. Evolus will also launch Nabota in other countries in Europe next year.
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- Daewoong obtained an item license for Fexuclu
- by Nov 11, 2022 05:52am
- FexuclueDaewoong Pharmaceutical announced on the 10th that Fexuclu, a new drug for gastroesophageal reflux disease, obtained an item license from the Philippines FDA on the 3rd. The approval was made about eight months after submitting an application for item permission (NDA) at the end of February. It takes about three years to obtain an item license in the Philippines, and Daewoong Pharmaceutical explained that it has greatly shortened the period based on its know-how. Daewoong Pharmaceutical will invite KOLs, including the chairman of the Philippine Gastroenterological Society, to hold a Fexuclu symposium on the 24th and share directions and opinions on entering the Philippine market. Starting from the Philippines, the company will accelerate its overseas expansion of Fexuclu. It plans to submit NDA to 10 countries around the world by the end of this year. So far, a total of eight countries have applied for item permits, including the Philippines, Brazil, Indonesia, Thailand, Mexico, Chile, Ecuador, and Peru. Fexuclu is a new drug for gastroesophageal reflux disease in the P-CAB series officially launched in Korea by Daewoong in July. By improving the shortcomings of existing PPI preparations, it is characterized by fast and stable suppression of gastric acid secretion by combining with a proton pump without the need for activation by gastric acid. There are a total of two indications of Fexuclu: ▲ treatment of erosive gastroesophageal reflux disease (40 mg) ▲ improvement of gastric mucosal lesions of acute gastritis, and chronic gastritis (10 mg). In particular, Fexuclu is the only P-CAB drug in Korea for gastritis indication, and the 2022 European Gastroenterology Association recently published the results of Fexuclu's gastritis adaptation study. Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "It is very encouraging that Fexuclu received approval for the first time overseas by drastically shortening the license period in the Philippines, one of Daewoong Pharmaceutical's branch offices, and this is a proven case of Daewoong Pharmaceutical's global business capabilities."
- Company
- SK Biopharm’s Q3 sales rise 270% with rise in Xcopri sales
- by Nov 11, 2022 05:51am
- SK Biopharmaceutical’s sales rose greatly in Q3 with the rising sales of its new anti-epileptic drug ‘Xcopri (cenobamate)’ in the US. On the 10th, SK Biopharmaceutical announced sales of KRW 88.8 billion in Q3 this year, a 270.9% on-year increase. The company also reported an operating loss of KRW 9.2 billion in the same period. Almost half of its sales were driven by Xcopri. Xcopri generated sales of KRW 47.4 billion in the US in Q3 this year. This is over a twofold increase on-year from the KRW 19.9 billion it had generated in Q3 last year. Xcopri’s sales have been driving the performance of the company after getting on track this year. After recording KRW 10 billion in sales in Q1 2021, Xcopri’s sales exceeded KRW 20 billion by Q4 last year. Only a half year later, its sales exceeded KRW 40 billion. Xcopri’s cumulative sales this year reached KRW 119.4 billion. Xcopri’s amount of prescriptions in the US has also been rising continuously. Its prescriptions in Q3 this year rose 12% compared to those in Q2. Xcopri’s monthly prescriptions exceeded 15,000 in August. The company explained that this is a 1.8-time increase compared to the average prescription amount of its competitors at 29 months. SK Biopharmaceutical attributed the rise in US sales to the active online and digital marketing it had relayed in the US. To strengthen its sales capabilities for Xcopri in the US, the company carried out active marketing activities to HCPs and patients. Also, in line with the improvement seen in the face-to-face sales environment, the company reorganized its US local sales and marketing organization and maximized sales efficiency. The company’s analysis is that the activities led to the improvement of relevant indicators, including the total number of calls, rate of face-to-face sales activities, new prescription amount, etc. The company also actively embraced the use of social media and delivered various experiences of patients using Xcopri on the company’s official YouTube channel and sent Direct Messages to patients and their caregivers. Also, the company reserved a large booth at the American Epilepsy Society Annual Meeting that will be held in Q4 to further raise Xcopri’s brand awareness. The company plans to attend various academic conferences and focus on promoting and marketing its drug to epilepsy specialists. Also, a TV commercial for epilepsy patients is planned for the next year. SK Biopharmaceuticals predicted that this year's global sales of Xcopri will exceed its target of KRW 185 billion, with the product’s accelerated entry into new markets in Europe and Latin America. Xcopriis scheduled to be released in Finland, Switzerland, Spain, and France through its European partner Angelini Pharma within the year. The company’s operating loss was reduced by KRW 40.7 billion on-year to record KRW 9.2 billion. However, the cumulative operating loss amounted to KRW 86.5 billion due to its investments in clinical trials for follow-up drugs and promotional activity in the US in the first half of the year.
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- Impinzi's indication is expected to be approved in Korea
- by Eo, Yun-Ho Nov 10, 2022 05:46am
- Impinzi is also expected to have options for treating immuno-cancer drugs in the area of biliary tract cancer. According to related industries, the Ministry of Food and Drug Safety is reviewing the expansion of biliary tract cancer indications of Imfinzi, an immuno-cancer drug before PD-L1 inhibition mechanism. Permission is possible as early as this year. Impinzi is drawing more attention in Korea as researcher-led clinical trials conducted by Oh Do-yeon, a professor of oncology at Seoul National University Hospital, played a leading role in adding indications. Impinzi's specific biliary tract cancer indication was validated through a TOPAZ-1 study with "conventional chemotherapy (Gemcitabine·Cisplatin, GemCis) in the primary treatment of local progressive or metastatic biliary tract cancer" and obtained approval from the U.S. FDA in September. The TOPAZ-1 study is a multinational, randomized, double-blind, and placebo-controlled phase 3 clinical trial in 685 patients with progressive biliary tract cancer that compared and evaluated the combination of Impinzi, which is added to the existing standard treatment "GemCis." It is also worth noting that in the TOPAZ-1 study, patient recruitment was conducted in 17 countries, including the United States, Europe, and South America, and about 55% of the total was registered in Asian countries including Korea, Thailand, Japan, and China. As a result of the study, the Impinzi combined group had a 20% lower risk of death than the placebo combined group. However, the extension of the median value of the total survival period was only 1.3 months compared to the control group. The most commonly reported side effects were anemia (48.2%), neutropenia (31.7%), and zones (40.2%). Potentially serious side effects were 62.7% in the Impinge combined group and 64.9% in the placebo combined group, suggesting that most side effects were due to chemotherapy in both groups. Impinzi's expansion of biliary tract cancer indication was made under Project Orbis, priority screening, and designation of rare drugs. AstraZeneca, a developer, is currently in the process of expanding its indication in many countries, including Korea, Europe, and Japan.
- Company
- Samjin-Pin to co-develop new targeted protein degrader
- by Lee, Seok-Jun Nov 10, 2022 05:46am
- Samjin Pharm announced on the 9th that it had signed a strategic Memorandum of Understanding (MOU) with the new drug developer Pin Therapeutics to develop a radical and improved treatment for cancer and fibrosis. Under the MOU, Samjin Pharm will conduct a comprehensive study on the targeted protein degrader (TPD) candidate to assess its efficacy, toxicity, formulation, and CMC. Pin Therapeutics will study its structural design and conduct screening on the drug. Pin Therapeutics is a new TPD drug developer that was established in 2017. Through collaboration with ‘PinUS,’ its 100% US subsidiary, the company has been conducting research and development at a global level. In addition to individual pipelines that degrade specific proteins, the company is also securing platform technology to overcome technical limitations in the field of TPD. New TPD therapies are a next-generation new drug development platform that can specifically degrade target proteins using the Ubiquitin-Proteasome system (UPS), which is one of the natural protein degradation systems in cells. TPD drugs fundamentally degrade and remove the pathogenic proteins whose function had been only inhibited with conventional small molecule inhibitors. It is a superior therapeutic modality compared to existing small molecule inhibitors in terms of efficacy and target selectivity. Sumin Lee, head of Samjin Pharmaceutical’s research center, said, “The TPD technology is expected to become a game changer in the field of new drug development as it can target more than 80% of the pathogenic proteins that could not be controlled by existing small molecule compounds.”
- Company
- The number of reimbursed drugs is the lowest in 33 months
- by Chon, Seung-Hyun Nov 09, 2022 05:47am
- The number of medicines listed on the health insurance benefit list is the smallest in about three years. New-entry drugs have decreased significantly due to the price reorganization of generic drugs and joint development regulations. The size of the reimbursed drug has been greatly reduced due to the reorganization of items such as microbial or unclaimed deletion of drug benefits. Prior to the reorganization of the drug price system, reimbursed drugs exploded, but they are rapidly recovering to the previous level. According to the HIRA on the 8th, a total of 23,604 drugs were registered as of the 1st of this month. It decreased by 1,057 in a month from 24,661 in the previous month. The health authorities delete drugs that have not claimed insurance benefits in the past two years or have not reported production or import performance for three years from the payroll list. The number of medicines has been on a steady decline since it hit 26,527 in October 2020. It has decreased by 2,923 in the past two years and one month. This means that there have been 2,923 more withdrawals or exits from the market than new entries into health insurance benefits over the past two years. In November 2018, the number of reimbursed drugs was recorded at 26,689, but in October 2020, the number increased by 5,838 in a year and 11 months to 26,527. During this period, new entries overwhelmed the number of withdrawals from the market, with the size of salary-listed drugs expanding by 28.2%. In the 22 months from November 2018 to October 2020, the number of salary-listed drugs decreased compared to the previous month only once on November 8 and December 2019. In other words, the remaining 21 months have all increased the size of salary-listed drugs compared to the previous month. During this period, the average number of unproduced and unclaimed drug benefits was deleted twice a year, but the number of new entries was higher. The number of times listed drugs has decreased from the previous month 16 times in 25 months from October 2020 to this month. Since August last year, the number of drugs listed has decreased for six consecutive months. Currently, the number of drugs listed has fallen to 25,694 in February 2020, the lowest in 33 months. It is analyzed that the overall number of listed drugs has continued to decline as the speed of the health authorities' continuous arrangement of reimbursed drug items has advanced to the new entry. Recently, the number of new generics has decreased significantly. According to the Ministry of Food and Drug Safety, the number of Rx drugs licensed from January to October this year was 942, an average of 94 per month. Last year, 1,603 Rx drugs were licensed, recording an average of 134 per month, down 41.2% in a year. Compared to the 2,616 Rx drug licenses (218 per month on average) in 2020, it has fallen to less than half in two years. The number of Rx drug permits was 1,562 in 2018, recording an average of 130 per month, but in 2019, it soared to an average of 350 per month. Since then, it has been gradually decreasing. It is analyzed that the number of permits for generic drugs, which account for the largest proportion of Rx drugs, has decreased. The reorganization drug price system, which took effect in July 2020, focuses on maintaining the 53.55% upper limit of the current original drug before the expiration of the patent only when generic products meet both the direct performance of BA Test and the use of registered raw materials. The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the registration period is delayed. If more than 20 generics are listed in the specific ingredient market, the upper limit of newly listed items will be up to 85% of the existing lowest price. It is analyzed that the approval of the manufacturing consignment generic for the entire process has decreased significantly due to the structure in which the drug price drops significantly if pharmaceutical companies do not develop the generic themselves and perform BA tests. Some say that the regulation on joint drug development, which took effect in July last year, has promoted the decline in generic permits. The revised Pharmaceutical Act, which was passed at the plenary session of the National Assembly in May last year, limits the number of IMDs and generics that can be approved as a single clinical trial. If all manufacturing processes are manufactured the same with the same prescription and manufacturing method at the same manufacturer as the pharmaceutical company that directly conducted the BA test, the use of BA data will be limited to three times. This means that only four generics can be licensed with one BA test. Clinical trial data can also be agreed on up to three items other than medicines by direct pharmaceutical companies. In the past, when certain pharmaceutical companies received generic permits through BA test, dozens of pharmaceutical companies often received consignment generic permits with the same data, but joint development regulations made it impossible to "unlimited generic replication." It is analyzed that pharmaceutical companies received generic permits indiscriminately regardless of marketability before tightening regulations, and there are many cases that lead to market withdrawal without sales performance.
- Company
- Atozet market ↑40% in 1 year...Lipitor Plus leads generics
- by Kim, Jin-Gu Nov 09, 2022 05:47am
- The atorvastatin and ezetimibe combination market has grown 40% in a single year. The cumulative prescription amount of related generics increased over twofold and drove the market growth. In particular, Jeil Pharmaceutical and Viatris Korea’s Lipitor Plus is rapidly increasing its influence in the market. Prescription sales of Lipitor Plus rose 4.6 times in one year and became the highest-performing product among all generics. ◆Prescipriton of Atozet generics rise 96% in a year…market share increases to 56% According to the market research institution UBIST on the 7th, the outpatient prescription sales of the atorvastatin and ezetimibe combination had reached KRW 51.1 billion in Q3 this year. This is a 39.8% increase from the KRW 36.6 billion made in Q3 last year. The original product in the market is MSD’s Atozet. Atozet’s prescriptions in Q3 this year were KRW 22.5 billion, rising 2.3% in one year. With sales of the original drug slowing down, the market growth is being evaluated to have been driven by the generics. Prescription of Atozet generics rose around twofold (96%) in one year, from KRW 14.6 billion in Q3 last year to KRW 28.6 billion in Q3 this year. The market share of atorvastatin and ezetimibe combination generics has been growing rapidly since their release in Q2 last year. Their prescriptions, which had amounted to KRW 6.9 billion in Q2, had risen to KRW 14.6 billion in Q3, and KRW 19.3 billion in Q4. In Q1 this year, the generics made KRW 22.1 billion, exceeding sales of the original version (KRW 21.4 billion). Its growth continued on since then to occupy 56.0% of the market in Q3. In Korea, 112 companies were approved to manufacture atorvastatin and ezetimibe combination generics. Chong Kun Dang first received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet in October 2020. In January of the following year, 21 companies received approval for their authorized generics of Lipilouzet. Authorized generics refer to already approved generic products with different packaging. The drugs were listed for reimbursement in April last year. Latecomer generics joined the competition in February. 88 companies received approval for Atozet generics then, which were listed for reimbursement in May last year, one year later than the authorized generics of Lipilouzet. Among the companies, 83 are currently selling atorvastatin and ezetimibe combination drugs. ◆Lipitor Plus rises as the leading generic in the market despite low price Among the selling atorvastatin and ezetimibe combination generics, Lipitor Plus’s rapid growth is gathering attention. Pic of Lipitor PlusLipitor Plus’s Q3 prescription amount was KRW 3.7 billion, a 4.6 times rise from the KRW 0.8 billion it had made in Q3 last year. At the same time, the drug recorded the highest prescription performance among all atorvastatin and ezetimibe combination generics. Its cumulative prescription amount by Q3 this year is KRW 8.6 billion, and the analysis is that its annual prescription is highly likely to exceed KRW 10 billion this year. Lipitor Plus was released as an Atozet generic, not an authorized generic of Lipilouzet. Being listed a month later than the authorized generics of Lipilouzet, its price was set at a lower price than other generics. Based on the 10/10mg dose, the insured ceiling price of Lipilouzet is KRW 1,037, whereas the price of authorized generics of Lipilouzet is 85% of that at KRW 881, and Atozet generics 30% of that at KRW 637. In accordance with the reform of the drug pricing system in July 2020, the price ceiling of 20 of the 21 authorized generics that were listed at the same time as Lipilouzet was set at 85% of the highest price. This is because the drugs did not meet the requirement of “directly conducting a bioequivalence test”, one of the two requirements that need to be met to receive the highest ceiling price among generics. As the number listed identical products exceeded 20 by the time the Atozet generics were listed a month later, their price was set as the lower of the two - '85% of the price of the drug that did not meet the two requirements' or '85% of the previous lowest price’ - regardless of whether or not the two requirements were met. As a result, the price ceiling of Atozet generics was set around 30% lower than the authorized generics of Lipilouzet. Due to its low price, the sales performance of Lipitor Plus had not been good earlier in its release. In Q3 last year, its prescriptions had been lower than that of its competitors, such as Daewoong Pharmaceutical’s Litorvazet (KRW 1.7 billion), Boryung Pharmaceutical’s L50 (KRW 1.6 billion), Yuhan Corp’s Atovamibe (KRW 1.4 billion), HK Inno.N’s Zepitor (KRW 1 billion). Q3 prescription sales of major atorvastatin+ezetimibe generics However, Viatris and Jeil Pharmaceutical made a joint promotion agreement and rapidly increased prescriptions of Lipitor Plus. For Lipitor Plus, Viatris will be supplying the API of Lipitor, atorvastatin to Jeil Pharmaceutical, and the final product will be manufactured and produced by Jeil Pharmaceutical. The two companies will manage and jointly promote sales of the drug. The fact that Lipitor (atorvastatin), one of the main ingredients in Lipitor Plus, is still exerting much influence in the prescription field, positively influencing the sales performance of its follow-on, Lipitor Plus. Following Lipitor Plus, Daewoong’s Litorvazet sold KRW 3.6 billion, Boryung’s L50 sold KRW 2.4 billion, Yuhan Corp’s Atovamibe KRW 2.2 billion, HK.Inno.N’s Zepitor KRW 2 billion, and Ahngook’s Lipozet KRW 1.5 billion in Q3 this year. Quarterly sales of other products in the market were less than KRW 1 billion.
- Company
- SGLT-2 diabetes medication is on the rise
- by Kim, Jin-Gu Nov 08, 2022 05:43am
- By product, AstraZeneca Forxiga and Xigduo are chased by Beringer Ingelheim Jardiance and Jardiance DuoThe market for diabetes treatments related to SGLT-2 inhibitors has grown by 16% in a year. Analysts say that the use of this drug in the diabetes treatment market is steadily expanding and that major drugs have recently added indications for heart failure treatment, leading to the expansion of appearance. In the first half of next year, Daewoong Pharmaceutical's new SGLT-2 inhibitor-based diabetes drug is expected to launch, which is expected to intensify competition in the market in the future. ◆SGLT-2 Diabetes Treatment Market Expanded by 15% According to UBIST, a pharmaceutical market research firm, the domestic SGLT-2 inhibitor market in the third quarter of this year was 44.6 billion won. It increased by 15% compared to 38.7 billion won in the third quarter of last year. The cumulative prescription amount increased by 16% from 109.6 billion won in the third quarter of last year to 126.6 billion won in the third quarter of this year. The SGLT-2 inhibitor market was formed in 2014 when AstraZeneca released Forxiga. Astellas Suglat was added in 2015, and Beringer Ingelheim Jardiance and MSD Steglatro were added in 2016 and 2018. With the addition of new drugs, the market has grown rapidly. In the first quarter of 2017, the quarterly prescription exceeded 10 billion won for the first time. It then surpassed 20 billion won in the fourth quarter of 2018, 30 billion won in the second quarter of 2020, and 40 billion won in the fourth quarter of last year. Analysts say that the use of complex drugs at the prescription site is expanding, driving the growth of the overall market. These combinations include AstraZeneca Xigduo and Beringer Ingelheim Jardiance Duo. It is a drug that combines Metformin with SGLT-2 inhibitors. Sugar and Steglatro have no combination. In the third quarter, the number of outpatient prescriptions for the single SGLT-2 inhibitor was 25.3 billion won in total for four products. It increased by 11% compared to 22.8 billion won in the third quarter of last year. During the same period, the total amount of prescriptions for the two combination products increased by 21% from 15.9 billion won to 19.3 billion won. Although the single market is still larger, the gap is expected to gradually decrease in that the complex is rapidly increasing its influence. The expansion of the prescription area to heart failure also positively affected the market growth. In July, the Korean Society of Cardiology issued a "complete revision of the 2022 Heart Failure Treatment Guidelines" and recommended SGLT-2 inhibitors as a major drug for the treatment of chronic heart failure regardless of the presence or absence of diabetes. The SGLT-2 inhibitors specified in the guidelines are limited to Jardiance and Forxiga, which have been based on clinical research. Following the revision of the guidelines, if health insurance benefits expand to heart failure, the market is expected to grow even more. Forxiga and Xigduo's total prescription amount in the third quarter of this year was 23.7 billion won. It increased by 14% compared to 20.8 billion won in the third quarter of last year. Jardiance and Jardiance Duo increased by 19% from 16.7 billion won to 19.8 billion won during the same period. Suglat and Steglatro recorded prescription performances of 800 million won and 400 million won, respectively, in the third quarter of this year. In terms of market share, Forxiga and Xigduo decreased by 1%p from 54% in the third quarter of last year to 53% in the third quarter of this year, and Jadiang and Jadiang Duo increased by 1%p from 43% to 44%. Suglat and Steglatro are insignificant at 2% and 1% respectively. Daewoong Pharmaceutical plans to release a new self-developed SGLT-2 inhibitor in the first half of next year. I applied for an item permit in April. Daewoong Pharmaceutical is expected to receive an item license this year. As Daewoong Pharmaceutical is building strong sales power in the diabetes treatment market, competition in the SGLT-2 inhibitor market is expected to intensify with the addition of DWP16001. Daewoong Pharmaceutical is jointly selling Forxiga and Xigduo, the No. 1 product in the SGLT-2 inhibitor market. In the DPP-4 inhibitor treatment market, another diabetes drug, Daewoong Pharmaceutical is also jointly selling LG Chem's "Zemiglo Series," the No. 1 product in the market.
