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- 2025-12-27 05:14:55
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- Outpatient Rx amount for major chronic diseases decreased
- by Chon, Seung-Hyun Jun 22, 2020 06:08am
- Prescriptions for chronic diseases such as hyperlipidemia, hypertension, and diabetes, which have the largest sales due to COVID-19, have been reduced by half. According to UBIST, a drug research agency on the 17th, the outpatient prescription size was ₩2,360 billion in April and May, a 9.0% decrease from the same period last year. In April, the outpatient prescription amount fell 8.7% from the same period last year, and the prescription amount decreased 9.4% last month. Prescriptions for major chronic diseases that form a large market have declined. The prescription amount for statin drugs used in the treatment of dyslipidemia was April and May, at 1618 billion won, a 4.0% decrease from the same period last year. Considering that the prescription amount of statins in April and May rose 7.1% year-on-year, the decline was large. In the first quarter, the outpatient prescription for statin drugs in the first quarter was ₩247 billion, an increase of 3.0% compared to the same period last year, but turned downward from April. The prescription amount for statin drugs in April was ₩82 billion, a 2.8% decrease from the previous year, and decreased by 5.1% in May. The prescription amount for hyperlipidemic drugs in the first quarter was ₩120 billion, up 26.0% from the previous year, but the prescription amount in April and May increased by 15.2%. Recently, Rosuvastatin or Atorvastatin and Ezetimibe combined drugs increased explosively as the preference increased, but growth has been slow since April. Monthly outpatient Rx Amount for major chronic disease treatments (Unit: ₩100 million, Source: UBIST) It is analyzed that a full-scale prescription difference occurred in the second quarter as patients with chronic diseases received long-term prescriptions in advance in February and March when the number of COVID-19 infected patients surged. In fact, when the number of COVID-19 infected patients surged, it was reported that the number of patients receiving prescriptions for 3 to 6 months in advance increased significantly. The large chronic disease prescription market, such as hypertension or diabetes, has a similar pattern. The April/May prescription for 'ARB+CCB' combination, the most commonly used hypertension drug, increased 2.3% compared to the same period last year. Compared to last year's April and May prescriptions, an increase of 7.1% over the previous year, growth has slowed. In the first quarter, the prescription size of outpatients was ₩198 billion, an increase of 10.0% from the same period last year. ‘ARB+CCB' is a combination drug of calcium channel blocker (CCB) and angiotensin II receptor blocker (ARB). The prescription amount of 'ARB+CCB' combination in the first quarter of last year was ₩180 billion, an increase of 9.2% over the previous year. However, the growth rates in April and May were reduced to 3.2% and 1.4%, respectively. In April and May, prescription amount for ARB-based drugs were ₩64.1 billion, a 3.3% decrease from the same period last year. The prescription amount in April and May last year increased by 7.2% from the previous year, but this year it decreased. Prescription amount for ARB-based drugs decreased in April and May by 2.8% and 4.9% YoY, respectively. The size of the April/May prescription for the 'DPP4-inhibitor + Metformin' combination, which is the most widely used diabetes treatment, was ₩30.7 billion, a 1.4% decrease from last April & May (₩30.5 billion). The prescription amount of 'DPP4-inhibitor + Metformin' in the first quarter rose 6.9% from last year. Monthly outpatient Rx amount for major antibiotics (Unit: ₩100 million, Source: UBIST) The amount of antibiotic prescription was significantly reduced in the major prescription market. The prescription amount of Cephalosporins in April and May was ₩29.6 billion, a 39.2% decrease from the same period last year. Prescriptions for oral Cephalosporins fell 1.3% year-on-year, but fell sharply after April. It decreased by 41.2% in April compared to the same period last year, and decreased by 37.1% in May. Prescription amount of oral Penicillins decreased 11.9% in the first quarter compared to the previous year, but fell 57.0% in April and May. It is analyzed that the decrease in antibiotic prescription is closely related to the decrease in the number of patients. This is because after the spread of COVID-19, external activities contracted and personal hygiene management, such as washing hands and wearing a mask, strengthened, and the incidence of infectious diseases such as cold decreased. According to statistics released by UBcare last month, prescriptions for acute nasopharyngitis in April were 71% less than in the same period last year. In April, the amount of prescriptions for children and adolescents decreased by 52% from the previous year, and the number of prescriptions dropped by 76%.
- Company
- “Immunotherapy Tecentriq, a crucial turning point for TNBC"
- by Eo, Yun-Ho Jun 19, 2020 06:20am
- Professor Im Seock-ah “The release of immunotherapy makes a significant difference in treating triple-negative breast cancer with limited treatment options.” To this date, treating the triple-negative breast cancer (TNBC), reacting negatively on all receptors (estrogen, progesterone and HER2), has not been struggling with high unmet medical need. Programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq (atezolizumab) is now getting the limelight as it has been newly indicated to treat patients with TNBC. Roche Korea (President Nic Horridge) convened a press conference on June 17 at the Westin Chosun Seoul regarding the shift in TNBC treatment paradigm. On Jan. 30, Korea’s Ministry of Food and Drug Safety (MFDS) approved Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, to treat patients with PD-L1 positive, unresectable, locally advanced or metastatic TNBC. The indication made Tecentriq to be the first and only immunotherapy to treat patients with TNBC in Korea. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy marked the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.”
- Company
- KRPIA-KPBMA welcome MOHW revising stepped pricing reduction
- by Eo, Yun-Ho Jun 18, 2020 06:28am
- “We sincerely welcome the Ministry of Health and Welfare’s reasonable decision.” The pharmaceutical industry, especially the companies preparing an ownership change in drug item, seemed to be relieved with the latest decision by the Korean government. On June 17, Ministry of Health and Welfare (MOHW) preannounced the revised Standard of Pharmaceutical Decision and Adjustment that ultimately exempted stepped drug pricing reduction on transferred drugs. So far, the pharmaceutical industry has been greatly concerned of the government possibly applying stepped drug pricing reduction on the drug products transferred due to corporate restructuring. The controversial Section ‘Ba’ revised The issue of pricing reduction on the transferred drug was first raised when the Standard of Pharmaceutical Decision and Adjustment was revised in February. The Section Ba (바) in the February revision, according to the Pharmaceutical Affairs Act Paragraph 2 of Article 89, stipulates a product transferred by a change in the ownership would be priced at a lower pricing between the final upper limit pricing and calculated pricing. In other words, an item’s pricing could be brought down depending on the number of listed generics and the revised drug pricing conditions the item qualifies for. Pfizer Pharmaceutical Korea (with Pfizer Upjohn Korea) and MSD (with Organon), for instance, are preparing to transfer a number of originals for their split and they were initially expecting significant damage. Also Takeda Pharmaceuticals that recently transferred its antidiabetic pipeline to Celltrion was not completely free from the issue. In case of Pfizer Pharmaceutical Korea transferring Lipitor (atorvastatin) to Pfizer Upjohn Korea, healthcare reimbursement on the first-in-class item would be removed at first. And when the item reapplies for the reimbursement listing, the original would be considered as a generic with over 20 other generics already listed, and Lipitor would be priced at 85 percent of the lowest pricing of other same substance drug. But the newly revised Section Ba stipulates when a same company re-applies for reimbursement listing of an already-listed but removed item, its pricing would be set to a lower pricing either by the final upper limit pricing or by the pricing calculated by the Article 2. Basically, the government newly established a separate regulation to maintain the original pricing of an item transferred to another company due to corporate merger or acquisition. Industry against the February revision, urged the government to revisit the change After the preannouncement of the first revision in February, Korean Research-based Pharmaceutical Industry Association (KRPIA), as well as Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), have conveyed their official statement and urged the government to exclude the items transferred by corporate restructuring from the pricing reduction. KRPIA, representing the global pharmaceutical companies in Korea, has been demanding the government to make an exception in the revised drug pricing system via an authoritative interpretation. The organization claimed the revision did not agree with the initial objective of the regulation to follow the principle of differentiating the drug pricing by recognizing the endeavor to develop a novel drug. KPBMA also supported KRPIA’s argument by demanding the government to assure the status of a first-in-class drug (mostly a novel drug), and by questioning the government’s negative intention to ‘prevent unfair listing of a generic.’ However, the industry’s complain is seemingly subsiding fast as MOHW even set down a separate regulation instead of the demanded authoritative interpretation. KRPIA official said, “The issue could have gravely impacted the novel drug business. We sincerely welcome the government’s decision to prevent making an innocent victim while agreeing with the original objective of the regulation.” KPBMA official also commented, “The decision to sustain the pricing of transferred original drug was appropriate and well reflected the reality of the industry. By exempting the stepped pricing reduction on the transferred item, pharmaceutical companies would feel less burdened when diversifying the business model and collaborating with other partners.”
- Company
- It will be Fulcare & Dermatix to communicate more
- by Eo, Yun-Ho Jun 17, 2020 06:21am
- Managing Director, Jaeyoung Lee 'Consumer Healthcare' now represents the OTC business. In the pharmacy market, the management relying on the profits of pharmaceuticals is limiting, and the interest in improving profits through OTC sales is increasing. In this situation, multinational pharmaceutical companies are attracting attention as long as they are promoting the strategy of catching both pharmacists and consumers. A treatment for nail athlete’s foot, Fulcare launched by Menarini in 2013, quickly became the top 10 OTC product in Korea. This year, Menarini is strengthening pharmacy communication through signing exclusive sales contracts with Kwangdong, while reaching out to consumers with TV advertisements for Fulcare and Dermatix Ultra The reporter of Dailypharm met with Jae-Young Lee (45), head of the consumer health care division of Menarini Korea, and heard about the company's strategy and direction. -You have a lot of experience in the consumer goods business. Briefly introduce yourself I started as a salesperson in Yuhan Kimberly. Since then, through various job experiences such as marketing and global marketing at Kimberly-Clark Headquarters, I have been able to experience sales and marketing in general for about 16 years. In the meantime, I thought to expand my capabilities for a healthy life for consumers, and started a new challenge at the Menarini Korea Consumer Business Division from December 2019. At that time, the company's consumer health division was making changes as various talents such as consumer goods channel experts, OTC channel experts, and digital e-commerce experts joined. Synergy effects are expected in the future. -The generic drug and consumer goods business are clearly different. Was there anything difficult? My previous career helped me a lot in common terms. On other aspects such as pharmacy communication and institutional restrictions, I am learning with the help of my colleagues. -The recently launched Fulcare & Dermatix TV advertisments have the strategy and will of the reorganized Menarini Consumer Healthcare. First, let's hear about Fulcare. Basically, both products aim to become a friendly brand that can communicate more closely with consumers and empathize with them. Among them, Fulcare chose an approach to understand the way and style of consumers' lives and focus on providing solutions that products can support in support, and to reach more meaningful brands. In the advertisement, full nail care restores the health of the nails and expresses our appearance of enjoying our own 'clear again' with confidence, and wanted to draw consumers' sympathy not only through clear product information but also emotionally. The message of 'clear again' can be said to contain the wishes of all of us in the COVID-19 outbreak. The goal is to get true empathy through the connection with the current era, beyond the framework of the existing generic drug advertisements, where certain models come out and describe the features of the product. TV advertisements for the newly launched Fulcare & Dermatix Ultra-What about Dermatix Ultra? Dermatix also focused on forming a consensus that brands could share in everyday life of consumers beyond simply delivering information on products. Since it is a medical device specialized in scar management, it focused on the differentiation points from other products for correct scar management, and expressed Jang Yoon-jung and Do Yeon-woo as models to express the hearts of families who care about each other. Dermatix Ultra Kids for children was also released last year. I think the safety of Dermatix, which can be used from 3 months of age and has clinical data supporting it, is a clear advantage. In order to highlight the friendly image of 'Kids' products, it is approached by using various contents such as digital marketing and consumer events using dinosaur characters. In fact, it is a pity that Menarini does not have any other products besides the two representative items. I agree. The first thing I did as soon as I joined Menarini was to set a vision for the next five years, one of which was strengthening the portfolio. What I felt in the COVID_29 was that national issues could occur anytime in the future. It's important how prepared we are for what happens. I think strengthening the portfolio is also essential in this dimension. This issue is currently being considered at the regional headquarters level as well as at Menarini Korea Corporation. Currently, two products that are recognized for brand power are being prepared to be introduced in various ways to create synergies when the next product is added. In particular, consumer health is now considering the concept of 'prevention'. This is in line with the release of 'Flucare plus cream'. We are constantly conducting studies on new products other than derivative products. -Then let's talk about pharmacy communication this time. There was a big change in Menarini, which was an item wholesale system From January of this year, through the new Co-Promotion partnership with Guangdong Pharmaceutical, we expect the results of mutual win-win by adding the product power of Menarini Korea and the sales force of Kwangdong As mentioned earlier, I had a lot of experience in the consumer goods business, so there are still some unfamiliar parts of the OTC industry and pharmacy channels. Through partnerships with Kwangdong, we continue to increase our competitiveness in the pharmacy channel, continue to provide a portfolio of products that can secure competitiveness in various channels, as well as communication to draw closer to consumers experienced in the consumer goods industry. Also, we paid much attention to the production of brochures for pharmacies. We provide brochures with rich clinical and academic data and details of the product. We plan to continue communication through media channels such as online symposiums and dailypharm.
- Company
- Roche’s Tecentriq is preparing to enter the Korean market
- by Eo, Yun-Ho Jun 17, 2020 06:21am
- Immune anticancer drugs are expected in the first line of hepatocellular carcinoma in Korea. According to the related industry, Roche Korea has recently expanded its indications for the combination therapy of Tecentriq (Atezolizumab) in combination with Avastin (Bevacizumab) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Considering that it was approved by the US FDA on the 29th of last month, it is preparing to enter the Korean market quickly. If combination therapy with Tecentriq and Avastin is approved, it will be the third option as a first-line drug and the first as an anti-cancer drug. The combination therapy of the two drugs was confirmed by the IMbrave150 study released in last December. Tecentriq in combination with Avastin reduced the risk of death (OS) by 42% and reduced the risk of disease worsening or death (PFS) by 41%, compared with Nexavar (Sorafenib). With median follow-up of 8.6 months, median OS with Atezolizumab combination was not estimable (NE) compared to 13.2 months with Sorafenib. Median PFS with the combination was 6.8 months versus 4.5 with Sorafenib. The ORR with the respective treatments was 27% versus 12% with Sorafenib. Do-young Kim, Professor of Severance Hospital Said, "With the exception of OS verification, improvement in response rate and PFS is encouraging. Immune anticancer drug options has been added to the treatment of liver cancer that had no treatment other than Nexavar, and utilization is expected to increase in the future."
- Company
- Hanmi Science commenced development of oral COVID-19 vaccine
- by Jun 17, 2020 06:21am
- Hanmi Science, a holding company of Hanmi Pharm Group, is developing 'COVID-19 vaccine for oral use'. In addition, a research center of ₩300 billion is established in Pohang, and an unprecedented personnel system, such as a 100% increase in salary for outstanding talent, is introduced. Hanmi Science unveiled 'The Six Visions for the Post COVID-19 Era' on the 15th According to the company, the six visions imply 'education','digital','oral','city','green', and 'ocean'. Each item contains ▲Cyber Education ▲Green Bio ▲Oral Bio ▲City Bio ▲Green Bio ▲Marine Bio. It was named 'Cydio Cigma' after the two letters in front of the English letter. The conditions were unprecedented for executives who presented concrete results for the six visions. CEO Jong-Yoon Lim emphasized, "It will destroy the HR system of the existing salary system by raising 100% of annual salary and giving the rank to talented people who perform well in the six vision projects." Specifically, the group plans to establish K-Bio and K-Med Graduate Schools for the 'Cyber Education' project and attract over 5,000 foreign experts. Hanmi Science decided to cooperate with Gyeongsangbuk-do, Pohang-si and Postech to develop new drugs and foster experts in the biotechnology field, human exchange, joint research and technical information exchange, and joint use of research facilities. For the'City Bio' project, a memorandum of understanding was signed on the 15th to build a smart healthcare infrastructure by spending ₩300 billion in Pohang, Gyeongbuk. By 2030, it plans to build a smart healthcare clinical center, a bio open innovation research and development center, and a prototype production facility in 51,846㎡ of the Pohang Free Economic Zone. The'Oral Bio' project is a new oral coronavirus infection (corona19) vaccine research. Applying Hanmi’s Orascovery technology, the company will develop a non-injection vaccine 'Covid MDT'. It is currently preclinical. In addition, Hanmi Science decided to start marine microbiology research (Marine Bio) using Pohang's original 4th generation accelerator. The goal is to uncover the underlying biological mechanisms, such as genomic studies before and after evolution, understanding of inter-microbial ecosystems including viruses, and the origin of human cell function through marine bioresearch. Plant biotechnology will also be applied to expand external appearance. Hanmi Science has promised global joint development and marketing of bio-based venture companies and plant-based bio products called 'green vaccines'. The two companies have decided to establish a joint venture for overseas sales of the world's first plant-based swine fever marker vaccine product commercialized by BioApp. In the near future, a joint venture will be established and product registration will begin in China. In particular, the two companies plan to jointly develop green vaccines against various diseases including COVID-19. Recently, Hanmi signed a technology transfer contract with a professor of Chinese Academy of Agricultural Sciences for a new drug candidate related to metabolic disease, and started developing a new green drug.
- Company
- Takeda's partners relieved their worries
- by An, Kyung-Jin Jun 17, 2020 06:20am
- Domestic partner companies are nervous as Takeda officially sells its business units. As Celltrion decided to maintain a co-sales contract for 18 items that take over copyrights, immediate changes were avoided, but it may be difficult to maintain copyrights after changing partners. According to the industry on the 15th, Celltrion is expected to maintain joint sales cooperation with domestic partners for the time being even after Takeda's acquisition of the Primary Care Division (PC BU) in Asia Pacific. Celltrion has agreed to take over all rights, including patents, trademarks, licenses, and sales rights from 18 brands, including Rx drugs and over-the-counter drugs, from Takeda, and to take over the rights to co-promotion (co-sales). The 18 types that Celltrion will take over are 12 Rx items including 'Nesina', ‘Actos', ' Edarbi', ' Madipine', 'Basen', 'Ubretid', 'Condilin', 'Gutron', 'Zafatek’, ‘Blopress’, ‘Rozerem’, and ‘ Doribax’ and 6 OTC such as ‘Whituben’, ‘Whituben Nasal spray’, ‘Albothyl’, ‘Majesto’, ‘Nebramine’, and ‘Calcichew’ In Korean subsidiaries, five specialized medicines such as 'Nesina', 'Actos', 'Bason', 'Edarbi', and 'Madipine' in distribution in Korea and OTC items such as ‘Whituben’, ‘Whituben Nasal spray’, ‘Albothyl’, are included in the scope of this contract. All are products that are entangled in a co-promotional relationship with other domestic companies such as Jeil Pharm, Dong-A ST, Green Cross, andHK Inno.N in the domestic distribution and sales process. (Clockwise from top left) Actos, Nesina, Edarbi, Whituben & Madipine Jeil Pharm is in charge of sales for 'Nesina', the diabetes treatment drug with the largest sales. The two companies have maintained a cooperative relationship for 7 years since they were renewed once after the first contract in 2013. 'Nesina' product line, such as 'Nesina', a single drug of the DPP-4 inhibitor, 'Nesina act', and 'Nesinamet', is a large-scale product that combines outpatient prescriptions of ₩35.1 billion based on UBIST last year. Dong-A ST has been jointly selling ARB-based hypertension treatment 'Edarbi' and 'Edarbyclor' as a combination drug since August 2017. Outpatient prescriptions amount for 'Idalbi' and 'Idalbiclo' last year were ₩8.8 billion. Green Cross is in charge of domestic sales and distribution of 'Whituben', a cold medicine, which is highly recognized among consumers, and 'Albothyl', a canker sore treatment. In the case of 'Bason' for diabetes treatment and 'Madipine' for hypertension treatment, the outpatient prescription amount was ₩4 billion and ₩2 billion, respectively, as of last year. It is somewhat complicated. For these partners, they have no choice but to pay attention to the news of the drug sale. In fact, since the sale of the Takeda Pharmaceuticals PC division in Korea in the second half of last year, the inquiries from partners to confirm its authenticity have been reported. After Celltrion's merger and acquisition (M&A) contract, the partners were tense, saying that Takeda retained the existing contract relationship. The immediate change to the copyright agreement was avoided. However, it may be difficult to re-contract after the contract expires. In the pharmaceutical industry, there are also cases where the co-promotional contract relationship, which usually takes place every 5 years, ends prematurely. An official from Celltrion said, “For 18 items, Takeda will also take over all the rights related to co-promotion. After the contract expires, they will decide whether to re-contract by reviewing the use of marketing organization.” An official from a partner company in Korea said, "We received a notice that even a co-promotional contract is included in the M&A terms, and since the terms and conditions of the contract are all the same, there will be no immediate impact, but we believe that the long-term changes will have to be watched." Another domestic partner said, "It is difficult to judge the specific impact right away because the specific conditions between the contracting parties are unknown. The situation is carefully monitored until the acquisition procedure is completed."
- Company
- Korean drug trade in May makes first surplus amid COVID-19
- by Kim, Jin-Gu Jun 16, 2020 06:20am
- In May, the Korean pharmaceutical export volume has hit the historic high. It also was the first month to make pharmaceutical trade surplus in Korea. Europe, where the COVID-19 started spreading later than in Korea, had a sharp surge of demand on essential drug that boosted the drug trade in Korea. ◆New historic high trade volume in two months, topping 700 billion won in a month According to the Korea Customs Service (KCS) trade statistics published on June 16, Korean-made pharmaceuticals generated USD 589.47 million (716.2 billion won) in May alone. Compared to May 2019 (265.49 dollars), the figure multiplied by 2.2 times. The data only accounted for pharmaceutical export volume, excluding the COVID-19 testing kit export. Even against April 2020 (470.44 million dollars), the May export volume increased by 25.3 percent. The record high monthly export volume reached in March 2020 (537.39 million dollars) was outdone in only two months. The total pharmaceutical import volume in May reached 548.02 million dollars (approximately 665.8 billion won). As the export volume exceeded the import volume, Korea had its first pharmaceutical trade surplus of 41.46 million dollars (approximately 50.4 billion won). Monthly pharmaceutical export volume in May 2020 reached another record high in two months (Unit: USD 1,000) Source: Korea Customs Service Korea’s pharmaceutical trade has never made surplus since 2000. The yearly trade deficit marked 324.76 million dollars in 2000 and reached 1.21 billion dollars, 2.45 billion dollars and 2.63 billion dollar in 2005, 2010 and 2015, respectively. Korea made trade deficit of 2.98 billion dollars last year. Korea has made first pharmaceutical trade surplus in May 2020 (Unit: USD 1,000) Source: Korea Customs Service The good news in the Korean pharmaceutical industry contrasts with other general industries struggling in trade. In May, the overall export volume in Korea marked 34.9 billion dollars, dipping sharply by 24 percent against last year same month and by 4 percent against last April. ◆Ildong, Daewon and Hana urgently export essential drugs to Europe in distress Some analyze the COVID-19 pandemic has taken a rather positively effect on Korean drug manufacturing and export. The U.S. and Europe have experienced pharmaceutical shortage due to the pandemic continuing on, and Korean pharmaceutical companies have been swiftly answering those countries requesting for drug supplies. In fact, Ildong Pharmaceutical announced on May 13 that an infection treating Cycin injection was exported to Luxembourg. Daewon Pharmaceutical urgently exported intravenous anesthetic Freepol-MCT injection (propofol), Hana Pharm exported muscle relaxant Atra injection, heart stimulant Hana Dobutamine HCl injection, and anesthesia Vascam injection in April and May. Although not included in May statistics, Bukwang Pharm has exported midazolam injection to France on May 6 as emergency drugs. The industry experts also evaluate supply setback from China and India has also affected the increase in Korean pharmaceutical export. First, the Chinese pharmaceutical supply was impeded, and India banned export of some domestically made drugs. Eventually, other countries turned to Korea for drug supplies. Reviewing the export volume by countries in May, the Korean drug export volumes to Germany, Spain, Italy and France have gone up rapidly. The export volume to Germany reached 177.52 million dollars, showing 429 percent increase from last year same time. The export volumes to Italy (867 percent), France (353 percent) and Spain (163 percent) have also soared. Moreover, the export volume to the U.S. has increased by 587 percent. An official from the Korean company that urgently exported drugs to Luxembourg noted, “The use of essential drug in other countries centering Europe has skyrocketed amid COVID-19 pandemic. European-made drug supplies are insufficient to meet their demand,” and “besides Luxembourg, the company is currently in talks with other countries like Sweden and Israel for their emergency request for pharmaceutical supply exports.”
- Company
- Antidiabetic Suganon readies clinical trial for CAVD
- by Nho, Byung Chul Jun 16, 2020 06:20am
- Diabetes treatment Suganon (evogliptin) has started a clinical trial to receive an indication to treat calcific aortic valve disease (CAVD). In North America, the number of CAVD patients is projected at 1.50 million to 11.5 million (prevalence rate ranging from 2.5 percent to 25 percent in age group over 65), and the related prosthetic valve replacement market is projected at 15 trillion won. For the disease, no other synthetic or biologic treatment options are available, yet. The pharmaceutical industry sources reported RedNVIA has been preparing for a global clinical trial from last year to confirm repurposed evogliptin’s effect in patients with CAVD. RedNVIA has licensed out evogliptin from Dong-A ST in 2019 to develop and market a CAVD treatment. In June 2019, the Korean government approved of the company’s Phase II Investigational New Drug (IND) application with a protocol to test 225 CAVD patients in Korea. And in last month, the company completed the U.S. Food and Drug Administration (FDA) Pre-IND application procedure, and plans to initiate Phase II and III global clinical trial from the third quarter when the IND application is approved. Drug repurposing is finding a new indication by redeveloping an already-commercialized drug with an initial indication or reevaluating a drug not recognized as a novel drug due to insufficient clinical efficacy. The clinical trial in preparation aims to repurpose Suganon to seek new treatment mechanism and indication. Unlike other novel drug development, the repurposing would reduce cost and time spent on candidate medicine exploration and safety confirmation, as well as the risk of clinical trial failure. RedNVIA conducted a retrospective study using hundreds of thousands of patient data in clinical setting to confirm treatment effect and safety of the drug. The study result statistically proved evogliptin-like dipeptidyl peptidase 4 (DPP-4) inhibitor is effective in treating CAVD. Cooperating with Mayo Clinic and Massachusetts General Hospital, RedNVIA constructed a clinical protocol based on ‘Seamless Adaptive Phase II/III Design’ to shorten clinical trial period and expedite commercialization. The protocol would narrow the gap between Phase II and Phase III by approximately more than ten months. In the past, global pharmaceutical company MSD has applied Seamless Adaptive Phase II/III Design on its DPP-4 inhibitor Januvia and received marketing approval earlier than the competing Novartis’ DPP-4 inhibitor Galvus, although the competitor’s development started earlier.
- Company
- Takeda to sell 18 items of diabetes & OTC to Celltrion
- by Eo, Yun-Ho Jun 16, 2020 06:19am
- The sale of some items of diabetes and OTC by Takeda was confirmed. Celltrion is the company that acquires these items. Recently, the headquarters of Takeda trademarks, for patents, trademarks, and rights to sell 18 non-core generic and OTC sold in nine countries, including Korea, Thailand, Taiwan, Hong Kong, Macau, Philippines, Singapore, Malaysia, and Australia, signed a contract to sell the rights to sales to Celltrion for ₩33.2 billion. The acquisition is through a Singapore subsidiary. The acquisition is through a Singapore subsidiary. The 18 items sold include Nesina, Actos, Edarbi, and OTC such as Whitetuben and Albothyl. The product group has generated sales of approximately $140 million as of 2018. In the industry, rumors over the sale of Takeda's items and related primary care division (PCBU) and consumer healthcare division (OTCBU) were booming, but both divisions were included. In accordance with the production and supply agreement between Takeda and Celltrion, Takeda will continue to take charge of producing assets for sale, and will supply it to Celltrion. In the future, the technology transfer process will supply the main products acquired by Celltrion Pharmaceutical's cGMP (Current Good Manufacturing Practices) facility to domestic and overseas markets. Under the terms of the agreement, Celltrion will take over the rights of the portfolio in the Asia-Pacific market through procedures such as the Fair Trade Commission. Celltrion is expected to end its business acquisition in the fourth quarter of this year after approval by local authorities, such as a business combination report. With this acquisition, Celltrion has secured the rights to patent, trademark, and sell 18 items in nine countries. Celltrion Pharmaceuticals and Celltrion Healthcare, which have sales networks in Korea, Southeast Asia, and Australia, are in charge of sales. This acquisition is also Celltrion's first major merger and acquisition (M&A). Celltrion explained that the acquisition of the chronic disease treatment market is increasing in importance, and that the company has decided to acquire it as a step toward becoming a global comprehensive pharmaceutical bio company. Celltrion said, "It is expected that Celltrion will strengthen its chemical product line with biopharmaceutical products that have maintained its global competitiveness, such as autoimmune disease treatments and anti-cancer drugs, and make it a leap forward to become a global pharmaceutical pharmaceutical company." Meanwhile, Takeda completed a deal in March to sell non-core assets in the Russia-CIS region to Stada for $660 million, and non-core assets in the Near East, Middle East and Africa were sold to Acino for $200 million. In last July, it sold Xiidra to Novartis for approximately $5.3 billion. Earlier this year, non-core assets in Latin America were $825 million for Hypera Pharma and in Europe, the sale was confirmed to the Orifarm Group for about $670 million, including two production bases located in Denmark and Poland.
