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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.”
Company
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.
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