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- 2026-03-17 16:20:01
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- Montelukast sales 22%↓ in 2 years and adds impurity issue
- by Kim, Jin-Gu Jan 25, 2022 05:55am
- The market for the montelukast ingredient used to treat allergic rhinitis and asthma has contracted for two consecutive years. The reduction is analyzed to be due to the combined effect of the US FDA’s side effect warning request for the ingredient in 2020 and the prolonged COVID-19 crisis. Industry eyes are on how the impurity issue that recently emerged would additionally affect the market. ◆Conflicting results by product… Singulair ↓ 32% vs Monterizine ↑ 15% According to the industry research institution UBIST on the 25th, outpatient prescription sales of the allergic rhinitis and asthma treatment market for montelukast was ₩94.8 billion last year. The market had risen from ₩76.1 billion in 2016 to 121 billion in 2019 but had seen a decline for two consecutive years since. Compared to 2019 when the market expanded to its greatest, the market had shrunk 22% over the recent 2 years. Montelukast is one of the most common drugs used to treat allergic rhinitis and asthma. The original drug is Organon Korea’s Singulair. In Korea, MSD Korea received approval for the original drug in 2000, and around a hundred domestic pharmaceutical companies are selling generic versions with the same ingredient. Most of the key products were unable to avoid the reduction in their prescription amount. Sales of the market lead Singulair shrunk 32% from ₩39.2 billion in 2019 to ₩26.5 billion last year. Other montelukast drugs also saw a double-digit reduction in sales. HK Inno.N’s ‘Lukio’ dropped 31% (₩12.8 billion→₩8.8 billion), Hanmi Pharmaceutical’s ‘Montezal’ dropped 35% (₩7.3 billion→₩4.7 billion), Hutec Korea Pharmaceutical’s ‘Singuldown’ dropped 26% (₩5.3 billion→₩3.9 billion), Daewon Pharmaceutical’s ‘Singuluka’ dropped 42%(₩3.1 billion→1.5 billion). On the other hand, prescription of some products has increased greatly. Sales of Hanmi Pharmaceutical’s ‘Monterizine’ increased 15% from ₩8 billion to ₩9.3 billion in the same period. Monterizine is a combination of montelukast and a third-generation antihistaminic agent ‘levocetirizine.’ It is the only combination drug sold in Korea. ◆ FDA’s ‘black box warning’ and ‘prolonged COVID-19 crisis’ cause combined effect Analysts believe that this was a combined effect from the prolonged COVID-19 and FDA’s side effect warning. The FDA required a ‘Black box warning’ on montelukast products in March 2020. The black box warning is the FDA's most stringent warning for drugs and medical devices in the market. In particular, the FDA strongly advised health care providers to avoid prescribing montelukast to patients with mild allergic rhinitis, as it is the FDA’s judgment that the risk outweighs the benefits for mild patients. According to the FDA, serious adverse reactions, including suicide, have been reported with the use of Singulair since 2008. Some of these side effects occurred while the patients were treated with montelukast and disappeared after discontinuing the drug. The prolonged COVID-19 incidence had also reduced the prescriptions. The pediatric clinics have been one of the areas most affected by the COVID-19 crisis. Since most patients with allergic rhinitis and asthma are children and adolescents, the prolonged COVID-19 crisis has aggravated the reduction in prescriptions of montelukast. ◆MFDS orders NDPA impurity tests…rises as a ‘new variable’ in market The industry has also been paying attention to the impurity issue that had arisen recently. The Ministry of Food and Drug Safety had recently ordered pharmaceutical companies to conduct an investigation into their montelukast ingredient and finished products for impurities and submit the reports by April 25th. This precautionary measure was issued after the ministry received safety information that N- nitrosodipropylamine (NDPA) was detected in the API montelukast. The NDPA is a new nitrosamine impurity that has been identified. Since 2018, two types of nitrosamine impurities, - ‘N-nitrosodimethylamine (NDMA)’ and ‘N-nitrosodiethylamine (NDEA)’ were detected in valsartan, ranitidine, and nizatidine. The MFDS predicts that NDPA occurred in the API manufacturing process of montelukast. Contrasting opinions have been produced on how the impurity concern may affect prescriptions in the field. Those who believe that impurity will not affect the market are focusing on the fact that such impurity issues have risen every year. After the valsartan incident in 2018, impurities were consecutively detected in ranitidine, nizatidine, metformin, losartan, varenicline, etc., building resistance among frontline clinics and hospitals regarding the issue. The government had also initially suspended the sale of all items, but recently ordered only specific lot numbers to be recalled. Others who have opposing views argue that it is too soon to predict that the impurity concern will not be significant, given that the montelukast are mainly prescribed to children and adolescents, unlike other items.
- Company
- United to complete P2T enrollment for its inhaled Covid drug
- by Lee, Seok-Jun Jan 25, 2022 05:55am
- Korea United Pharm will complete patient enrollment of its Phase II trial for the world’s first inhaled COVID-19 treatment ‘Corobin Activair (budesonide+ arformoterol).’ According to the company on the 24th, Korea United Pharm had been enrolling patients for its trial at specialized COVID-19 hospitals in Seoul to assess the safety and efficacy of Corobin Activair in patients with moderate-to-severe COVID-19 since last year. Korea United Pharm aims to receive conditional approval for its drug within the first half of this year after demonstrating its efficacy and safety in the Phase II trial. The company had completed manufacturing investigational Corobin Activair for the clinical trial last year. Its Sejong plant 2 is equipped with cGMP manufacturing facilities that can produce several million courses of Corobin Activair per year according to domestic and global demand immediately upon approval. A company official said, “With the COVID-19 virus continuing to prevail around the globe with variants such as the Omicron variant, Korea United Pharm will work with various institutions and focus all its capabilities on developing the world's first inhaled COVID-19 treatment.”
- Company
- Hanmi & Celltrion are producing generic COVID tx
- by Chon, Seung-Hyun Jan 25, 2022 05:55am
- Hanmi and Celltrion produce oral COVID-19 treatments developed by MSD and supply them to underdeveloped countries. According to the industry on the 20th, Hanmi and Celltrion have completed a license-in contract with the MPP for the production of generic drugs for Molnupiravir (Lagevrio) treatment for COVID-19. The license contract is based on the granting of a non-exclusive license by MSD, the original developer of "Molnupiravir," that allows the sale of mid- to low-income countries through MPP, an international institution, to expand access to COVID-19 treatments. A number of pharmaceutical companies around the world submitted letters of intent to select licensees, and only 27 companies were given licenses. Hanmi Pharmaceutical and Celltrion will receive know-how in manufacturing Largevrio from Merck, and patent fees will be exempted until the WHO declares the end of the pandemic. Among domestic companies, DongbangFTL, a raw material company, was also selected. Under this contract, Hanmi Fine Chemical, a raw material drug company of Hanmi Pharmaceutical Group, will start producing raw materials for Largevrio. The produced raw materials will be transferred to Hanmi Pharmaceutical's smart plant located in Paltan, Gyeonggi-do, and put into the production of finished drugs. In the case of Celltrion, the development and production of Molnupiravir generic finished products will be handled by its affiliate Celltrion Pharmaceutical and supplied overseas by Celltrion. Celltrion Pharmaceutical has launched a formulation study with the aim of completing product development by the end of this year. Celltrion and Hanmi Pharmaceutical plan to produce generic for Largevrio and supply and sell them to some of the 105 underdeveloped countries. MPP is a UN-supported non-profit medical organization that signed an agreement with MSD in October last year on the provision of patent licenses for Molnupiravir. The contract between Hanmi Pharmaceutical and MPP was made in a surprise move in line with the aim of adding strength to the world's efforts to end COVID-19 by greatly increasing accessibility to underdeveloped countries. Largevrio is RNA analog and is a drug that is inserted instead of normal ribonucleic acid necessary for the virus replication process to induce virus death. Largevrio received EUA in the UK in November last year and was approved in the United States in December last year to administer it to patients who were unable to use "other approved COVID-19 treatments." Currently, the screening is being conducted in Korea. The "COVID-19 Treatment/Vaccine Development Pan-Government Support Committee" under the MOHW began behind-the-scenes support for the selection of Korean pharmaceutical companies by conducting prior consultations with MPP for the domestic production of oral COVID-19 treatments since November last year. In this regard, the government said it plans to continue to support the domestic production and global expansion of oral COVID treatments through corporate meetings. An official from Hanmi Pharmaceutical said, "Hanmi's decision has begun to end the COVID-19 pandemic." He said, "We will do our best to start production as soon as possible in close consultation with MPP and MSD and quickly supply high-quality medicines to the world based on Korea and the United States' excellent drug manufacturing technology and production capabilities." An official from Celltrion Group said, "Through this license acquisition process, we were able to reaffirm that Celltrion Group's chemical drug production capacity and technology met global demand and standards, and at the same time were competitive."
- Company
- Sales of SGLT-2 diabetes drugs surpassed 150 billion won
- by Ji Yong Jun Jan 24, 2022 05:56am
- Sales of SGLT-2 inhibitor-based diabetes treatments exceeded 150 billion won for the first time last year. The SGLT-2 inhibitor market, including Forxiga and Jardiance, continues to grow at double digits every year. ◆ Sales of SGLT-2 inhibitors have increased five times in the past five years According to UBIST, a pharmaceutical market research firm on the 21st, the total amount of outpatient prescriptions for SGLT-2 inhibitors last year was 150.1 billion won, up 17.2% from the previous year. Sales of SGLT-2 inhibitors in Korea, which amounted to 28.6 billion won in 2016, have more than tripled in the past five years. The market size of SGLT-2 inhibitors has grown year by year. It rose from 50.1 billion won in 2017 to 70.3 billion won (40%) in 2018, followed by 96.9 billion won (37.8%) in 2019. The following year, it achieved 127.9 billion won (32%) in 2020. This growth is expected to continue for the time being. Both Forxiga and Jardiance, SGLT-2 inhibitors, are likely to increase their prescription performance in the future as their indications expand to patients with full heart failure in addition to diabetes treatment. SGLT-2 plays a role in reabsorbing glucose from urine into blood. SGLT-2 inhibitors are mechanisms that inhibit this reabsorption action to prevent glucose from entering the bloodstream and release it into urine. ◆SGLT-2 inhibitors such as Forxiga and Jardiance lead the growth The leading items in the domestic SGLT-2 inhibitor market are AstraZeneca's Forxiga and Jardiance. Last year, Sales of AstraZeneca's Forxiga and Xigduo recorded 79.5 billion won. The domestic market share alone is 52.9%. By product, Forxiga's outpatient prescription amount was 42.6 billion won, up 12% from the previous year. During the same period, Xigduo recorded 36.9 billion won, up 21.3%. It is analyzed that AstraZeneca got the preemptive effect when it first introduced Forxiga in Korea in 2014. The joint sale with domestic companies from the beginning of entering the market is also believed to have affected the increase in performance. AstraZeneca started co-selling with CJ Healthcare (currently HK inno.N) from the beginning of its launch. Since March 2018, it has been jointly selling with Daewoong Pharmaceutical. Jardiance and Jardiance Duo of Beringer Ingelheim and Lilly are closely chasing Forxiga. Last year, Jardiance achieved 40.9 billion won in outpatient prescription performance, up 10.8%. During the same period, Jardiance Duo also rose 46.7% to 24.5 billion won. The performance of these two items is 65.3 billion won, with 43.5% market share. Jardiance was released in 2016, two years later than Forxiga in the domestic SGLT-2 inhibitor market. Although it is generic, it is evaluated that it is acting as a positive factor in expanding prescription performance by proving the effect of reducing cardiovascular mortality through clinical trials. Astellas' Suglat and MSD's Steglatro's prescription performance was poor. Suglat's outpatient prescription amount stood at 3.5 billion won last year, similar to the previous year. Suglat has been in charge of distribution, marketing, and sales since April 2018. At that time, a synergy effect was expected when Handok, which had diabetes treatments such as Tenelia, introduced Suglat, but its performance was not good. MSD's Steglatro rather reduced prescription performance. Last year, Steglatro's outpatient prescriptions fell 21.8% from the previous year.
- Company
- BI-Boryung concludes copromotion deal for NOAC ‘Pradaxa’
- by Kim, Jin-Gu Jan 24, 2022 05:56am
- Boehringer Ingelheim and Boryung Pharmaceuticals have concluded its co-promotion deal for Boehringer Ingelheim’s non-vitamin K antagonist oral anticoagulant (NOAC) therapy ‘Pradaxa (dabigatran).’ Boehringer Ingelheim plans to directly sell Pradaxa starting this year. According to industry sources on the 21st, Boehringer Ingelheim and Boryung Pharmaceuticals concluded their co-promotion deal for Pradaxa at the end of last year. Rather than find a new partner company to sell its product, Boehringer Ingelheim decided to sell Pradaxa directly. An official from Boehringer Ingelheim said, “The two companies agreed to terminate the copromotion deal at the end of last year. The company will be directly selling the product starting this year.” Pradaxa is a dabigatran NOAC anticoagulant that received attention for having a better effect in preventing blood clots with fewer bleeding side effects compared to the anticoagulant warfarin. Pradaxa has started replacing warfarin in the early 2010s, increasing its influence in the prescription field. Boehringer Ingelheim received approval for the drug in Korea in 2011 and released the drug the next year. A the time of release, the company joined forces with Yuhan Corp for its sale, Boehringer Ingelheim taking charge of hospital-level institutions, and Yuhan of private clinics. Then for 4 years from 2018 to the previous year, Boehringer Ingelheim worked with Boryung Pharmaceuticals for the copromotion of Pradaxa. However, the drug’s sales performance was less impressive than its competitors in the Korean market. Compared to Daiichi Sankyo’s ‘Lixiana,’ Bayer’s ‘Xarelto,’ BMS’s ‘Eliquis’ that grossed ₩50-₩60 billion per year in outpatient prescriptions, Pradaxa made less than ₩15 billion. Also, the drug’s substance patent expired in July last year. Intro Biopharma, Aju Pharm, Jinyang Pharm, and Huons had invalidated Pradaxa’s salt and composition patent and was granted generic exclusivity.
- Company
- The growth rate of the DPP-4i market increased slightly
- by Ji Yong Jun Jan 24, 2022 05:55am
- The domestic DPP-4i diabetes treatment market, which is formed at 600 billion won a year, slowed down last year. It recorded the lowest growth rate in the last seven years. In the DPP-4 inhibitor market, where growth has slowed, the position of domestic companies has also expanded significantly. Rx sales for foreign company products fell. ◆DPP-4 inhibitor, growth rate of 1% in 7 years According to UBIST, a pharmaceutical market research firm, on the 19th, the total market for DPP-4 inhibitors last year was 611.3 billion won, up 1.3% from a year earlier. The growth rate of the DPP-4 inhibitor market is the lowest since 2014. In the past seven years, the market for DPP-4 inhibitors has grown rapidly. It increased 21.5% from 299.5 billion won in 2014 to 363.9 billion won in 2015. Since then, it has surpassed 600 billion won for the first time, recording 437.6 billion won in 2016, 468.6 billion won in 2017, 502.3 billion won (7.1%) in 2018, 569.1 billion won (13.2%) in 2019, and 602.9 billion won (5.9%) in 2020. Since MSD's Januvia was released in 2007, it has become a trend by replacing existing diabetes drugs. Since then, nine active ingredients have been released in the DPP-4 inhibitor market and are fiercely competing. ◆LG Chem, Dong-A ST, and Handok's expansion of influence in the DPP-4i market It was confirmed that domestic companies made strides in the DPP-4i market last year. The prescription amount of all three domestic pharmaceutical companies, LG Chem, Dong-A ST, and Handok, has increased. LG Chem's three types of Zemiglo prescriptions, Zemiglo, Zemimet, and Zemiro, totaled 130.3 billion won, up 8.8% from the previous year. The market share also expanded 2.1%p from 19.2% in 2020 to 21.3% last year. Despite the slowing growth of Zemiglo , the combination drug has expanded its influence. Zemiglo's prescription amount last year was 38.9 billion won, up 2.6% from the previous year. Sales of Zemimet reached 90.8 billion won over the same period, up 11.6% from the previous year. Dong-A ST's self-developed new drug Suganon series also saw its prescription amount rise. Last year, the total amount of prescriptions, including Suganon and Sugamet, surpassed 30 billion won for the first time with 32.6 billion won. The market share was 5.3%, an increase of 1.3%p from the previous year. Suganon's outpatient prescriptions last year amounted to 13 billion won, up 23.51% from a year earlier. During the same period, Sugamet also increased 39.72% to 19.6 billion won. Handok's Tenelia series recorded 46.2 billion won in prescriptions last year. Tenelia's prescription amount was 21.4 billion won, up 83% from the previous year. During the same period, Tenelia M (Tenerigliptin + Metformin) increased by 9% to 24.8 billion won. ◆ Multinational corporation DPP-4 inhibitor, slowing prescription performance The prescription performance of items from multinational companies has fallen. Last year, the total amount of prescriptions for the MSD Januvia products was 171 billion won, down 2.9% from a year earlier. Among the Januvia products, the decrease in prescriptions for Januvia was the largest at 5.8%. Sales of Janumet fell 3.8% from the previous year to 76.2 billion won, while Janumet XR's sales rose 1.8% to 50.4 billion won. Sales of the Trajenta prodcuts also slowed down. It decreased by 1.5% from 61.6 billion won to 60.7 billion won. Trajenta Duo's sales recorded 65.5 billion won, down 2.6%. Sales of Novartis' Galvus products decreased by 0.8% from 47 billion won to 46.6 billion won, and Sales of Takeda's Nesina fell 3.7% from 32.1 billion won to 30.9 billion won. In 2020, Takeda sold its rights to Celltrion in the Asia-Pacific region of 18 Rx drugs and OTC drugs. It was found that Nesina's transfer process has not yet been completed. Sales of AstraZeneca's Onglyza and Kombiglyze also fell 1.2% from 27.6 billion won in 2020 to 27.3 billion won last year.
- Company
- Avastin biosimilar "Onbevezy" can be prescribed in earnest
- by Eo, Yun-Ho Jan 21, 2022 05:56am
- Samsung Bioepis' Avastin biosimilar Onbevezy has become possible to be prescribed in earnest. According to related industries, Onbevezy, a biosimilar of the blockbuster anticancer drug Avastin, passed DC of medical institutions such as Chilgok Kyungpook National University Hospital and Hwasun Chonnam National University Hospital, including Samsung Medical Center, Seoul National University Hospital, and Asan Medical Center. It has been entering the market quickly since insurance benefits were registered in September last year. Onbevezy's price was set at 208,144 won for 0.1g/4ml and 677,471 won for 0.4g/16ml. Compared to the original Avastin, it is 69% and 63%, respectively. Boryung Pharmaceutical, which has signed a domestic exclusive copyright agreement between Onbevezy 100mg and Onbevezy 400mg since May last year, is expected to actively carry out promotions. Avastin is a targeted anticancer drug with various indications. According to IQVIA, a pharmaceutical market research firm, Avastin's domestic sales reached 118.1 billion won in 2020. It is also a product that recorded sales of 7.73 billion Swiss franc (about 8.8 trillion won, as of 2019) in the global market. Competition for Avastin biosimilars is expected to expand further. In May last year, Pfizer's 'Jairabeve was approved in Korea, and Alvogen Korea's product was also approved on the 19th. Celltrion's biosimilar is also in the process of licensing in September last year. If it expands its scope to markets around the world, more companies are competing. Mvasi, co-developed by Amgen and Allergan, is already competing with Avastin. In addition, Beringer Ingelheim, Biocon, AstraZeneca, Kyowa Kirin Korea, Celltrion, and Prestige BioPharma are developing biosimilars.
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- CKD Bio & Cutia Therapeutics signed a supply contract
- by Chon, Seung-Hyun Jan 21, 2022 05:55am
- CKD Bio is targeting overseas markets for botulinum toxin drugs under development. CKD Bio announced on the 19th that it has signed a supply contract with Cutia Therapeutics for Tyemvers, a botulinum toxin. The size of the contract is 8.3 billion won, which supplies the product to China, Hong Kong, Macau, and Taiwan for 15 years after licensing Chinese products. The step-by-step milestone is a condition that receives $2.5 million when applying for a clinical trial plan in China and $1 million and $1.5 million when approving product licenses in Korea and China, respectively. Tyemvers is the product name of a botulinum toxin drug under development by CKD Bio. This contract is the first overseas expansion signed by CKD Bio since it started developing botulinum toxin drugs. In June 2019, CKD Bio signed a contract with a European-based research institute to introduce a license for commercialization of botulinum strains and prepared to enter the botulinum toxin market. The completion ceremony of the CKD Bio Osong plant held at Osong Life Science Complex in December last year. (From the right), Korea Bio Chairman Ko Han-seung, KPBMA Chairman Won Hee-mok, Cheongju City Vice Mayor Lim Taek-soo, CKD Bio CEO Lee Jung-jin, CEO of Chong Kun Dang Holdings Kim Tae-young, Director of Economic and Trade Bureau Shin Hyung-geun, and CEO of Bell E&C Lee Hwan-young CKD Bio completed the construction of the Osong plant, a production facility exclusively for botulinum toxin, at Osong Life Science Complex in Cheongju, North Chungcheong Province, in December last year. CKD Bio Osong Plant is a production plant dedicated to botulinum toxin drugs at the level of cGMP in the United States. It was completed two years after the construction began in June 2019. It was built with a total floor area of 13,716㎡ on 21,501㎡ of land with an investment of about 45.7 billion won. It has an annual production capacity of 6 million vials of botulinum toxin and plans to expand its production to 16 million vials in the future. CKD Bio went through a full-time trial of botulinum toxin and received approval from the MFDS on the 18th and entered the full-fledged development stage. In a clinical trial conducted at Chung-Ang University Hospital, the safety and effectiveness of CKDB-501A are compared with Botox in adults who need to improve middle or severe wrinkles. CKD Bio said, "CKDB-501A does not use animal-derived ingredients, so higher safety can be expected. Through phase 1 clinical trials, we can expect the economic effects of the country through import substitution and export in the botulinum toxin market, which aims to improve wrinkles between our eyes."
- Company
- 60 billion won worth of neutropenia market fluctuates
- by Kim, Jin-Gu Jan 20, 2022 05:55am
- The market for neutropenia treatments worth 60 billion won a year is expected to fluctuate significantly. The copyright of the No. 1 and No. 2 items in the second-generation neutropenia treatment market has shifted in succession, and new drugs have joined the competition in six years, signaling a upheaval. ◆Boryung and Jeil will change the top 2 items in the market and announce competition According to the pharmaceutical industry on the 20th, Boryung Pharmaceutical recently signed a co-promotion contract for Neulasta (Pegfilgrastim) with Kyowa Kirin Korea. Boryung Pharmaceutical will start selling Neurastar in earnest starting this year. GC Pharma's Neulapeg (Pegteograstim)' contract, which had been jointly sold until last year, ended. With the end of the business with Boryung, Jeil will jointly sell it with GC Pharma from this year. Neutrophilia refers to an abnormally low neutrophil level in the blood. If neutrophils decrease, they become vulnerable to bacterial and viral infections. Cancer patients' neutrophil levels decrease during chemotherapy, and neutrophil reduction drugs prevent this. The first-generation treatment was administered four to six times per cycle of chemotherapy. The second-generation treatment can be effective only with one administration per cycle. Neulasta and Neulapeg are the No. 1 & No. 2 items in the second-generation neutropenia treatment market. According to IQVIA, a pharmaceutical market research firm, Neulasta posted sales of 18.9 billion won and Neulapeg posted sales of 16.5 billion won until the third quarter of last year. Sales in 2020 are 25.1 billion won for Neulasta and 15 billion won for Neulapeg. Interestingly, Boryung and Jeil's reversed position. Jeil, Neulapeg's new partner, has co-sold Neulasta from 2014 to 2017. Boryung Pharmaceutical co-sold Neulapeg from October 2018 to last year. In other words, Jeil Pharmaceutical, which used to sell Neulapeg in the past, and Boryung, which sold Neulapeg, took charge of Neulasta. ◆ Neulasta with new engine vs Neulapeg with replaced power The key is whether Neulapeg's growth will continue. Neulapeg was somewhat sluggish until Boryung joined. In 2018, the fourth year of its launch, sales were only 4 billion won. It more than doubled to 8.9 billion won in 2019 when Boryung joined in earnest. In 2020, it rose 69 percent again to 15 billion won.Last year, Neulapeg almost caught up with Neulasta. Quarterly sales of Neulasta and Neulapeg differed by about five times from 6.2 billion won to 1.3 billion won in the first quarter of 2019, but narrowed the gap to 6.5 billion won to 6.3 billion won in the third quarter of 2021. In this situation, Boryㅕng Pharmaceutical's contract, which was evaluated as the biggest driving force behind Neulapeg's rise, was terminated. Jeil, which took over Neulapeg from Boryung, was burdened with maintaining the existing upward trend. Boryung, which has market-leading products, is also inevitable to establish a new strategy. If a sales and marketing strategy has been established from the perspective of a chaser until last year, a new strategy should be established to shake off such pursuit from this year. ◆ Rolontis, the first new drug in 6 years Another variable is Hanmi Pharmaceutical's Rolontis(Eflapegrastim). Hanmi Pharmaceutical received domestic approval for its own new drug Rolontis in March last year. It is the first new drug in six years as a treatment for neutropenia. Rolontis is a long-term persistent drug that is applied with Hanmi Pharmaceutical's own platform technology "Labscovery (once a month)." It is administered once per anticancer cycle. It was on the health insurance benefit list in November last year. Hanmi Pharmaceutical plans to start selling Rolontis in earnest starting this year. Although it is a newly released drug, the patient's economic burden is the lowest. The insurance price of Rolontis is 489,796 won. It is the lowest price among the second-generation neutropenia treatments. Neulasta's price is 785,525 won, Neulapeg 576,230 won, Dulastin 586,643 won, and Lonquex 594,429 won. It remains to be seen whether Dulastin and Lonquex, which were pushed back by Neulasta and Neulapeg, will rebound. Dong-AST's Dulastin, licensed in 2014, generated 2.7 billion won in sales in 2020. Teva-Handok's Lonquex, licensed in 2015, recorded 3.3 billion won in sales in the same year. Accumulated sales in the third quarter of last year were 2.4 billion won in Dulastin and 2.3 billion won in Lonquex.
- Company
- Second new migraine drug ‘Ajovy’ aims at reimbursement
- by Eo, Yun-Ho Jan 20, 2022 05:55am
- ‘Ajovy’ is also following the steps of ‘Emgality’ and seeks health insurance benefits in Korea. According to industry sources, Teva-Handok Pharma applied for the reimbursement of its calcitonin gene-related peptide (CGRP) targeting migraine drug Ajovy (fremanezumab). The company quickly applied for reimbursement since launching the drug without reimbursement in October last year. With slow progress being made for the reimbursement of Lilly's Emgality (galcanezumab),’ which applied for reimbursement in April last year, whether the addition of Ajovy to the game will create a synergistic effect remains a point of focus. Both drugs are currently prescribed without reimbursement. Although Emgality and Ajovy are same class drugs, they differ in dosage and administration, allowing patients to be prescribed the drugs according to their characteristics. Emgality is administered in a loading dose of 240mg (two consecutive subcutaneous injections of 120 mg each) followed by monthly doses of 120mg injected subcutaneously. Ajovy is administered in a monthly dosage of one 225 mg subcutaneous injection each month or a quarterly dosage of 675mg subcutaneous injection (three consecutive 225mg injections) every 3 months. Meanwhile, Ajovy demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to the placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both of the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. The proportion of subjects that showed a 50% or more reduction in migraine days was 44.4% in the monthly Ajovy and 47.7% in the quarterly Ajovy group compared to the 27.9% of the placebo group. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and the quarterly dosing Ajovy group was 4.3±03 days, a significant reduction compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive drugs that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the more the patient receives the targeted therapy, the easier it is to treat.”
