- LOGIN
- MemberShip
- 2025-12-24 05:38:50
- Company
- Practice manual issued for COVID-19 treatments in Korea
- by Jan 30, 2023 05:54am
- Doctors have issued a ‘Practice Manual’ to provide an understanding of how to use the COVID-19 treatment in one glance. The manual was prepared to directly address difficulties HCPs experienced prescribing COVID-19 treatments in the field due to a large number of contraindicated drugs. The Korean Society for Antimicrobial Therapy (KSAT) recently distributed a manual for the actual prescription of Paxlovid, Pfizer's oral COVID-19 treatment. The manual was designed to allow easier understanding for HCPs on whether to refrain prescription of Paxlovid or make dosage adjustments according to a patient's medication status. Paxlovid is the first oral COVID-19 treatment that was approved in Korea. The drug was granted Emergency Use Authorization in December 2021 and was indicated for moderate-to-severe COVID-19 patients at high risk of progressing to severe disease. At the time the authorities initiated the supply of Paxlovid, the authorities had also issued treatment prescription guidelines, however, the guidelines issued then were more than 100 pages long and were not easy to use in the field. un-Joo Choo, Professor of Infection, Soonchunhyang University College of Medicine, The Guidelines on Paxlovid use that was recently announced by KSAT is a practice manual that addresses such difficulties experienced in the field. The KSAT collected the main areas of consideration of up to 100 drugs that require attention so that they could be applied to practice right away. The manual summarized the cautions that do not appear in the Drug Utilization Review (DUR) program. The guidelines also contain, a list of over-the-counter drug products that contain ingredients that require special attention. In an interview with Daily Pharm, Eun-Joo Choo, Director of the Insurance Committee at KSAT and Professor of Soonchunhyang University College of Medicine, who contributed to the preparation of the guidelines for Paxlovid, said, “The existing guidelines were too detailed to identify what precautions apply for each patient's medication. We hope that the guideline can contribute to increasing the practical prescription rate of oral COVID-19 treatments that lower disease severity rate,” stressing the importance of prescribing the COVID-19 treatment. The full interview transcript of Daily Pharm’s interview with Professor Choo is as follows. - A Paxlovid prescription guideline that the government issued already exists. Why did KSAT see a need to prepare a separate guideline?? =KSAT’s practice guideline is more of a ‘practical manual' that allows healthcare professionals to understand contraindicated drugs and dose adjustment at a glance in the field during prescriptions. The Paxlovid prescription guidelines issued by the government are over 100 pages long. It contains too much detail for HCPs to immediately absorb and apply in the field. This is why HCPs had difficulty prescribing the drug in the field, being an unfamiliar drug that is difficult to use. Paxlovid KDCA’s guideline categorizes the list of drug-drug interactions as ▲ 7 contraindicated drugs ▲21 drugs that can be temporarily discontinued or substituted to a different drug during Paxlovid use, ▲List of OTC drugs that contain the ‘St. John’s Wort’ substances that are contraindicated, ▲drugs that require use with caution when co-administered, etc. In particular, the drug substances that require caution in the use and key recommendations were summarized in a table format so that they can be applied immediately in practice. -I first thought the contraindicated drugs will be easy to identify as they immediately show up in the DUR database, but it seems that I was wrong. In particular, it seems that it would have been difficult to identify all the products that contain St. John’s Wort, as the substance is commonly used in OTC drugs and health functional foods. =That’s right. Only the 7 contraindicated drugs that must not be prescribed together pop up on the DUR, which includes epilepsy substances such as St. John's Wort. Substances commonly used by patients for hyperlipidemia, heart failure, gout, etc., that can be temporarily discontinued or substituted to administer Paxlovid, but such information is not reflected in the DUR. In addition, there are about 100 drugs that require attention, such as dose reductions, etc. It's not easy for doctors to know all this during prescriptions. In particular, the St. John's Wort substance is contraindicated, regardless of whether it is a prescription drug, general OTC drug, or health functional food. Since doctors need to check directly with the patient on whether or not they use the substance, a list of the OTC drugs was prepared that specifies the product and company names. The self-checklist also asks patients once more to confirm whether they are taking OTCs or health functional foods. Fortunately, St. John's Wort is mainly used in women, but the rate of those taking it at the age of over 60 is not that high. Patient self survey to identify patient -The prescription rate of oral COVID-19 treatments has remained in the 30% range for several weeks. What do you believe is the reason behind this? = During our webinar, one of the most common concerns that the doctors had was ‘Whether they should use COVID-19 treatments in mild COVID-19 patients with few symptoms.’ Being a drug that the doctor hasn’t used before, in addition to the fact that the drug has many drug-drug interactions, and the treatments for COVID-19 are mainly conducted non-face-to-face, it is natural that doctors may be hesitant in using such unfamiliar drugs. The part I want to emphasize is that oral COVID-19 treatments prevent patients with mild symptoms from progressing to severe diseases. Patients may have minor symptoms at first, but if they do not take the right medicine at the right period, their disease can progress to severe disease, in particular in patients that are over the age of 60 or have underlying diseases. In fact, quite a lot of inpatients who had COVID-19 were sent to the intensive care unit when there were no available vaccines or treatments. However, this number decreased significantly after the introduction of COVID-19 vaccines and oral treatments. Real-world data also showed that the rate of progressing to severe disease was reduced by about 50% with the prescription of Paxlovid. I believe prescriptions will naturally increase after such data on Paxlovid’s actual effect and HCP prescriptions increase and accumulate. -The majority of Korean people have been vaccinated several times. Also, with so many having a history of COVID-19 infections, not many are concerned about reinfections. Do you believe these people also should receive vaccinations with booster shots? If they are high-risk groups, would they need to be prescribed oral COVID-19 treatments when reinfected? If you look at the government’s reinfection rate data, the age-standardized risk of death in case of reinfection is 1.58 times higher than that at initial infection. Just as people receive vaccination for the flu every year and then use Tamiflu when infected, COVID-19 also requires regular vaccination and treatment. In fact, COVID-19 requires more caution as it has a higher rate of complications and disease progression than the flu. Patients who have pneumonia due to COVID-19 suffer complications such as difficulty in breathing due to pulmonary fibrosis even after completing treatment. Some people describe COVID-19 as a 'highly contagious cold', but I do not agree, as no one dies of a simple cold. Also, the experience of the patient that receives the treatment is as important as the HCP that prescribes Paxlovid. There is little positive feedback yet because not many patients have experienced the treatment. However, the treatment has been proven to be effective, and in particular, it is more beneficial for patients that opt for at-home treatments. Because of the definite benefits, I hope that patients do not worry too much and take their prescribed oral COVID-19 treatment as indicated.
- Company
- HK inno.N introduces biosimilar for Prolia & Xgeva
- by Lee, Seok-Jun Jan 27, 2023 05:51am
- HK inno.N announced on the 25th that it has signed an exclusive license contract for Denosumab biosimilar, a treatment for preventing osteoporosis and cancer-related skeletal complications in Mabxience, Spain. HK inno.N will receive an exclusive supply of two Denosumab biosimilars from Mabxience to apply for and sell domestic licenses. Denosumab is an antibody treatment that targets the RANKL protein, which is key to the survival and function of osteoblasts and exhibits a strong bone absorption inhibitory effect. The original is Prolia60mg, a cancer osteoporosis treatment, and Xgeva 120mg, which is used to prevent skeletal complications in patients with metastatic cancer and treat osteoporosis. Both products were released in Korea in 2016. Based on IQVIA, it recorded a total of 120 billion won in sales from October 2021 to September 2022 and is about to expire in 2025. HK inno.N aims to obtain a domestic license for Denosumab biosimilar in 2025, the expiration date of the original patent. Mabxience, which signed a contract with HK Innoen, was acquired by Fresenius Kabi in Germany last year as a company specializing in the development, production, and commercialization of biopharmaceuticals based in Spain. Mabxience is currently undergoing an original equivalence confirmation clinical trial with a Denosumab biosimilar.
- Company
- Flu activity rises...revives Tamiflu market
- by Jan 27, 2023 05:51am
- The influenza treatment market, which had virtually disappeared after the spread of COVID-19, has revived for the first time in 3 years. With the number of flu patients surging due to the flu epidemic, the number of quarterly prescriptions soared from less than KRW 100 million to KRW 10 billion. According to the market research institution UBIST on the 26th, outpatient prescriptions of oseltamivir in A4 last year had recorded KRW 10 billion. Oseltamivir is the most commonly used substance to treat influenza, and the original product is Roche's 'Tamiflu'. This is the first time since Q4 2018 that quarterly prescriptions of the substance recorded KRW 10 billion. By product, Roche Korea’s ‘Tamiflu’ occupied over half of the market, recording KRW 6 billion in sales. Hanmi Pharmaceutical’s ‘Hanmiflu’ followed, raising KRW 1.7 billion in sales. The flu treatment market had been dissolved after the spread of COVID-19 in 2020. With the breakout of the pandemic, personal hygiene management such as social distancing, the mandatory wearing of masks, and hand washing have been strengthened, resulting in a significant decrease in the incidence of infectious diseases, including the flu. The market, which raised prescriptions of KRW 7.8 billion in Q4 2019 and KRW 8.7 billion in Q1 2020, plunged 99.7% YoY to KRW 27 million in Q4 of 2020 after Corona 19 became prevalent. Since then, the market recorded less than KRW 100 million won in quarterly prescriptions for 9 consecutive quarters and then showed signs of a rebound in Q3 last year. The first flu epidemic warning in 12 years since 2010 was issued in Q3 last year. The Korea Disease Control and Prevention Agency issued a flu epidemic warning earlier than in previous years with the fraction of flu-like patients (patients with suspected flu symptoms) meeting the epidemic standards of 5.1 per 1,000 people from September 4 to 10 last year. Data: KDCA Weekly Report on Infectious Disease Sample Surveillance The number of flu patients really started to surge rapidly in the winter. The fraction of suspected patients, which was 13.2 in the 46th week of last year (November 6-12), increased by 130% to 30.3 a month later. In the 53rd week, the last week of last year, the fraction peaked to 60.7. This was a higher rate than that in the 2019-2020 season. Due to the surge in the number of patients and the limited quantity of treatments, a treatment shortage issue had also risen last year. In addition to the original oseltamivir, many generic versions have been approved for manufacture, but their manufacture was limited. Even before COVID-19, the majority of drugs other than Hanmi Pharmaceutical’s ‘Hanmiflu’, Yuhan Corp’s ‘Yuhan N Flu’, Kolon Pharmaceutical’s ‘Comyflu,’ and Vivozon Pharm’s ‘Seltaflu Flu,’ etc sold less than KRW 100 million per quarter. Also, many products withdrew their licenses in the aftermath of COVID-19. According to the Ministry of Food and Drug Safety, licenses of ▲Dong-A ST’s ‘Newraflu,’ ▲Ahngook New Pharm’s ‘New Flu,’ ▲Dongkoo Bio Pharm’s ‘Dongkoo Oseltamivir,’ ▲Samsung Pharm’s ‘Samsung Oselta,’ ▲Dae Han New Pharm’s ‘Enphiflu Cap,’ ▲Seoul Pharma’s ‘ OD Flu,’ ▲Yuyu Pharm’s ‘Yuyu Tami,’ ▲Inist ST’s ‘Inist ST Oseltamivir,’ ▲CTC Bio’s ‘Easy Flu Cap,’ ▲Genu Pharma’s ‘Genupharma Tamiro,’ ▲Kolon Pharmaceutical’s ‘Comiflu Suspension Powder,’ ▲GC Corp’s ‘Taminewra,’ ▲Hawon Pharm’s ‘Tami-One,’ ▲Roche Korea’s ‘Tamiflu Suspension Powder,’ ▲Aprogen Biologics ‘Tamflu,’ ▲Kwang-dong Pharm’s ‘Phenflu,’ ▲HK Inno,N’s ‘Flucle Cap,’ ▲Han Lim Pharm’s ‘Hanlim Oseltamivir,’ ▲ Hanmi Pharmaceutical’s ‘Hanmi Flu-S’ had automatically expired or voluntarily withdrawn during the COVID-19 pandemic. With many of the approved drugs not in circulation in the market, a shortage of flu treatments had risen last month. To address the shortage, the KDCA supplied 780,000 courses of flu treatments from the government stockpile to the market on the 9th. With the flu epidemic subsiding this year, the number of prescriptions is also expected to decrease slightly. According to KDCA, the fraction of suspected patients in the second week of January (8th to 14th) was 40.2, a 12.3 (23.4%) person decrease from 52.5 in the previous week.
- Company
- Will the 3 asthma biodrugs finally be reimbursed this year?
- by Eo, Yun-Ho Jan 27, 2023 05:50am
- Whether the 3 new biologics for asthma will be listed for insurance reimbursement in Korea is receiving attention. According to industry sources, treatments for severe asthma including GSK Korea’s Nucala (mepolizumab), Teva-Handok’s Cinqair (reslizumab), and AstraZeneca Korea’s Fasenra (benralizumab) are undergoing processes for reimbursement in Korea. As interleukin-5 antagonists, the drugs reduce levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. At the time of their approval, the drugs received attention for being an effective treatment option that had not been available before. All 3 drugs have been approved for over 3 years in Korea. However, no other drug has been reimbursed since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020. At the time, the companies had foregone the listing process as they deemed it would be difficult to narrow the differences in opinion on setting the drug price with the government. However, at the end of last year, GSK, Teva-Handok, and AstraZeneca started discussing reimbursement listing again at about the same time. However, it remains to be seen whether the pharmaceutical companies will be able to derive positive results from cost-effectiveness discussions with the Health Insurance Review and Assessment Service under different their different situations. One of the main purposes of asthma management is to reduce the risk of asthma exacerbations Nucala, Cinqair, and Fasenra directly bind to the alpha subunit of the interleukin-5 receptor (IL-5Rα) to induce apoptosis. The drugs demonstrated efficacy in reducing asthma exacerbation and improving lung function.
- Company
- JAKi Cibinqo attempts reimb in both adolescents and adults
- by Eo, Yun-Ho Jan 26, 2023 06:06am
- Pfizer is attempting to receive approval to reimburse its JAK inhibitor ‘Cibinqo’ in atopic dermatitis (AD) for both adults and adolescents in Korea. According to industry sources, Pfizer Korea resubmitted an application for the reimbursement approval of its new janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib)’ at the end of last year. After the drug passed the review of the National Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee in August last year, no news had been heard of its deliberation by the Drug Reimbursement Evaluation Committee. This time, the company is attempting to receive reimbursement approval for the drug in adolescents aged 12 years or older as well as adults that the company had previously applied for. As a latecomer, Pfizer is seemingly attempting to receive reimbursement for its combined indication as its competitors, Lilly Korea’s ‘Olumiant (baricitinib),’ ‘Abbvie’s ‘Rinvoq (upadacitinib),’ has already been receiving reimbursement for the atopic dermatitis indication since May and Rinvoq is also attempting to extend its reimbursement to adolescents. As a result, competition among JAK inhibitors is expected to widen from the adult atopic dermatitis market to the adolescent market as well. Sanofi-Aventis Korea’s ‘Dupixent (dupilumab),’ which is of a different class, has also been receiving attention after its pediatric-adolescent AD indication passed DREC review. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at Week 12 and demonstrated improvement in itch relief 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy vs placebo in randomly assigned patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than that in the placebo group.
- Company
- 54 billion won ⟵ 3.7 billion won in four years
- by Kim, Jin-Gu Jan 26, 2023 06:06am
- In the high blood pressure and hyperlipidemia complex market, the pace of generational replacement between the second and third complexes is accelerating. The size of outpatient prescriptions for the third-party complex of the ARB+CCB+statin combination has tripled in the past three years, expanding to the market of more than 50 billion won a year. The ARB+statin combination's second-generation complex market has been on the decline since its peak in 2021. In the case of last year, the market size fell below 90 billion won, down 7% year-on-year. ◆ Three-drug complex last year's prescription amount was 54 billion won, 3.4 times in three years According to UBIST, a pharmaceutical market research institute on the 25th, the outpatient prescription amount of the three-drug combination of hypertension and hyperlipidemia last year was 54 billion won. This market has exploded recently. The market size expanded from 3.7 billion won in 2018 to 15.7 billion won in 2019, 34.9 billion won in 2020, and 50.8 billion won in 2021. In other words, the size of the market has expanded 3.4 times in the past three years. The market was formed in October 2017 when Hanmi Pharmaceutical launched "AmosartanQ" in a combination of Amlodipine + Losartan + Rosuvastatin. The following year, Ildong Pharmaceutical, Jeil Pharmaceutical, Daewon Pharmaceutical, Celltrion Pharmaceutical, and Samjin Pharmaceutical introduced the third-generation complex to the market. In 2019, Yuhan, Hana, Daewoong, Ahngook Pharmaceutical, and HK inno.N launched their products, and in 2020, Boryeong, Myungmoon, Kyungdong Pharmaceutical, and Unimmed Pharmaceutical launched their products. Most of them are products that have improved their second-order composite. The market leader is Boryung Dukaro. Dukaro made a soft landing in the market with a prescription performance of 6.4 billion won in the first year of its launch in 2020. In 2021, it doubled to 12.7 billion won. At the same time, it surpassed Hanmi Pharmaceutical's AmosartanQ, which is the No. 1 product in the existing market, and took the lead in the market. Last year, prescription performance increased further to 14.1 billion won. Hanmi Pharmaceutical's "AmosartanQ" steadily increased to 2.7 billion won in 2018, 6.8 billion won in 2019, 10.5 billion won in 2020, and 11.4 billion won in 2021. Still, its growth seems to have slowed to 11.3 billion won last year. In addition, Daewoong Pharmaceutical's Ollomax (8.7 billion won), Ildong Pharmaceutical's Telostop Plus (4 billion won), Yuhan Duowell A (2.8 billion won), and HKinno.N Exone-R (2.8 billion won) produced more than 2 billion won last year. Since the success of the third-party complex, competition for the fourth-party complex is also in full swing. Likewise, Hanmi Pharmaceutical first pioneered the market and other companies entered the competition with drugs from the same combination of ingredients. Hanmi Pharmaceutical was approved for Amozaltan XQ in November 2020. The prescription amount of Amozaltan XQ increased 2.7 times from 2.3 billion won in 2021 to 6.4 billion won last year. Following Hanmi Pharmaceutical's Amozaltan XQ, Yuhan Duowell A Plus, GC Pharma Rozetelpine, Jeil Pharmaceutical's Telmican-Q, and Chong Kun Dang Nuvorozet were approved one after another. The pharmaceutical industry predicts that competition for the fourth-generation complex will take place in earnest this year. ◆2nd Compound Market Decreases to Less than 90 Billion won As the 3rd and 4th composite markets grow explosively, the pace of generational replacement with the existing 2nd composite is also accelerating. Last year, the market size of the ARB+Statin combination's second-generation complex was 89.6 billion won, down 7% from 2021. The second complex market has steadily expanded to 86.9 billion won in 2018, 90.4 billion won in 2019, 94.5 billion won in 2020, and 96.5 billion won in 2021, but it has been reduced for the first time last year. Most of the major products are also on the decline. Yuhan Duowell's prescription amount increased to 20 billion won in 2018 but has steadily decreased since then. Last year, prescriptions fell to 16.5 billion won. Hanmi Pharmaceutical's Rovelito also peaked at 22.7 billion won in 2018 and steadily decreased to 15 billion won last year. JW Pharmaceutical's Livaro V, LG Chem's Rovatitan, and Ildong Telostop also saw their prescriptions fall more than 10% year-on-year last year. The prescription performance of Akarb and Tuvero in Boryung increased. Akarb recorded a prescription amount of 7.4 billion won last year. It increased by 14% compared to 6.5 billion won in 2020. Tuvero, which combines fimasartan with Rosuvastatin, increased slightly from 6.4 billion won to 6.5 billion won.
- Company
- Medytox in legal dispute with its Chinese partner
- by Kim, Jin-Gu Jan 25, 2023 06:08am
- Medytox has been embroiled in a 120 billion won legal dispute with its Chinese botulinum toxin partner. Medytox officially announced on the 20th that Gentix Ltd., a subsidiary of the Chinese company Bloomage Biotechnology, had filed a claim for damages against Medytox to the Singapore International Arbitration Centre (SIAC). Gentix had claimed that Medytox violated the contracted terms of their Chinese joint venture. In addition, Gentix requested SIAC to confirm the company’s right to terminate the agreement. The amount claimed for damages is HKD 750 million (approximately KRW 118.8 billion). Based on the end of the third quarter of last year, this is equivalent to 26.4% of Medytox's total capital of KRW 449.2 billion. Medytox established Medybloom China with Bloomage Biotechnology in 2015 to prepare for entry into the Chinese market. Medytox had planned to sell its botulinum toxin product to the Chinese market through the newly established company. However, the plan was put to a halt in July last year with Bloomage announcing intentions to terminate its cooperative relationship with Medytox. At the time, Bloomage is said to have pointed to how Medytox did not supply products for sale as the reason for termination. On this, Medytox said, "We believe that no violations of such that have been claimed by the other party has been made, and plan to actively respond with our legal representatives.”
- Company
- LG Chem completes acquisition of US bio-company AVEO
- by Kim, Jin-Gu Jan 20, 2023 06:07am
- Executives and employees including LG Chem Vice Chairman Hak Cheol Shin (first row, fourth from the left), AVEO CEO Michael Bailey (next to VC Shin), LG Chem Life Sciences President Jeewoong Son (first row, far left) met to take a celebratory photo LG Chem has completed the acquisition of the US bio-company AVEO Pharmaceuticals and plans to make the leap to become one of the 'global top 30 pharmaceutical companies focusing on the oncology business. On the 19th, LG Chem announced that it had invested KRW 707.2 billion (USD 571 million) in its U.S. affiliate, ‘LG Chem Life Science Innovation Center,’ to acquire AVEO Pharmaceuticals on the 18th. The company plans to complete the M&A process by the 20th. LG Chem received approval for the HSR filing on December 1, 2022. Afterward, the merger passed the shareholders’ meeting and was approved by the Committee on Foreign Investment in the United States (CFIUS) on the 17th. After the acquisition, AVEO will be integrated as a subsidiary of LG Chem. However, the company will be operated independently as before based on its oncology business capabilities. AVEO Pharmaceuticals, which was established in Boston, MA in 2002, owns full capabilities ranging from clinical development, approval, sales to marketing in oncology. The company received FDA approval for its targeted therapy Fotivda for the treatment of renal cell carcinoma in 2021. In only 2 years since the release of the new drug, the company raised KRW 130 billion last year, and sales are expected to grow over 60% and achieve KRW 210 billion this year. The US securities companies expect sales of Fotivda to reach KRW 450 billion by 2027. Through the acquisition, LG Chem aspires to grow as a global pharmaceutical company in the field of oncology. In the mid-to-long term, the company will transfer the company’s new anticancer drug pipeline to AVEO and accelerate the commercialization of new oncology drugs in the US. LG Chem is currently developing cell therapies and immune checkpoint inhibitors in the preclinical stage. With the merger, the Life Science Innovation Center, which owns strengths in early-stage research and manufacturing process development, will be in charge of ▲discovering promising anticancer candidate substances, ▲preclinical and early-stage clinical trials, and the ▲commercialization process development, and AVEO, which owns know-how in clinical development and sales in the US market, will be in charge of ▲later stage research of the company’s oncology pipeline, and ▲commercialization. In addition, the company plans to continue reinforcing its anticancer product portfolio by promoting the introduction of oncology tasks in late-stage clinical trials near commercialization. LG Chem plans to invest KRW 2 trillion in its bio-business by 2027 and release 4 or more new drugs in the fields of oncology and metabolic diseases in the global market by 2030. Also, the company plans to achieve sales of KRW 2 trillion by 2027 by expanding sales in existing businesses such as diabetes, vaccines, growth hormones, and oncology. After sales of new drugs currently under development begin in earnest in 2030, LG Chem expects sales to continue to grow by hundreds of billions of won each year. Hak Cheol Shin, Vice Chairman & Chief Executive Officer at LG Chem, said, “We will focus on fostering Aveo as a future bio hub that can drive the growth of our oncology business and combine and maximize synergies of our business to make the leap forward and become one of the 'global top 30 pharmaceutical companies focusing on the oncology business.’ Michael Bailey, CEO of AVEO, said, “The merger has brought AVEO one step closer to its vision of ‘improving the lives of cancer patients.’ By combining the capabilities of the two companies, we will grow to another level and become a company that continues to release new drugs
- Company
- Anti-depressant Brintellix generic for exclusivity succeeded
- by Jan 20, 2023 06:07am
- Myungin Pharmaceutical (CEO Lee Dong-myung) and Unimmed Pharmaceutical (CEO Kim Gun-nam) announced on the 18th that they succeeded in invalidating the patent for the antidepressant Brintellix. The Korean Intellectual Property Tribunal recently made a decision to cite the claim on Brintellix purpose patents filed by both companies against Lundbeck Korea. Lundbeck Korea has a total of two material patents that expire in May 2027 and usage patents that expire in November 2028 related patents that expire in November 2028. Myeongin Pharmaceutical and UniMed Pharmaceutical have filed invalid and passive claims for patents for use. The decision also outlined generic for exclusivity for Brintellix's generics. Myungin Pharmaceutical and Unimed met the requirements for "first trial request" and "first item permit application" by filing a series of requests for judgment in March last year. In June, the Ministry of Food and Drug Safety applied for the first simultaneous generic item license. As both companies win the patent invalidation trial, only the two pharmaceutical companies are expected to acquire generic for exclusivity use of Brintelix. Brintellix was approved domestically in August 2014 as a multi-acting antidepressant through direct regulation of serotonin receptors involved in depression and inhibition of serotonin reabsorption. According to IQVIA, a pharmaceutical market research firm, Brintelix's annual sales continued to grow by double digits every year to 8.7 billion won in 2020, 9.7 billion won in 2021, and 10.4 billion won in 2022. Myungin Pharmaceutical and Unimed Pharmaceutical will be able to sell generic products exclusively for nine months after May 10, 2027, when the substance patent expires.
- Company
- The Brain disease prescription market disappears
- by Chon, Seung-Hyun Jan 19, 2023 05:59am
- Pharmaceutical companies lost 30 billion won a year due to Oxiracetam. Prescription loss became a reality as it failed to prove its efficacy in an eight-year clinical re-evaluation. Following acetyl-L-Carnitin last year, the annual prescription market worth 100 billion won has disappeared due to the failure of clinical re-evaluation of cerebrovascular-related drugs over the past year. According to the Ministry of Food and Drug Safety on the 18th, prescription and preparation were suspended because Oxiracetam failed to prove the effectiveness of "improving symptoms of vascular cognitive impairment" as a result of clinical trial reevaluation. Oxiracetam has been licensed to improve cognitive impairment due to Alzheimer's type dementia, multiple infarction dementia, and organic brain syndrome caused by brain failure. Cognitive disorders include decreased memory, attention, and concentration, speech and behavioral disorders, emotional anxiety, and lack of motivation. The Ministry of Food and Drug Safety announced the clinical re-evaluation of Oxiracetam in March 2015. According to the clinical revaluation design, indications were adjusted in 2019 due to the improvement of vascular cognitive impairment. Oxiracetam's deadline for submitting clinical re-evaluation data was set in March 2019, but the deadline for submitting the data was extended twice and finally closed in June last year. As a result of reviewing the clinical trial data, it was concluded that it failed to prove its efficacy, and decided to discontinue the prescription. As a result, Oxiracetam is expected to lead to the deletion of indications and exit from the market eight years after the announcement of clinical re-evaluation. According to UBIST, a drug research agency, the number of outpatient prescriptions for Oxiracetam last year was 21.3 billion won. Oxiracetam formed a prescription market of 30.8 billion won and 31 billion won in 2017 and 2018, respectively. Since the adjustment of indications in 2019, the prescription volume in 2020 has decreased by 26.6% from two years ago to 22.6 billion won, and the decline has continued in 2021 and last year. According to the prescription amount by item, Korea Pharmaceutical's Neuromed showed the largest prescription performance of KRW 11.8 billion last year. This clinical re-evaluation means that Korea Pharmaceutical will lose 11.8 billion won annually. Samjin Pharmaceutical's Neuracetam recorded 5.1 billion won in prescriptions last year, while Hwanin Pharmaceutical's Neuoxitam and Kwangdong Pharmaceutical's Neuropia raised 2.8 billion won and 1.5 billion won, respectively. As a result, drugs related to brain diseases will be removed from the market for the second consecutive year following acetyl-L-Carnitin last year due to failed clinical re-evaluation. Dong-A ST's Nicetile, acetyl-L-Carnitin, has been approved for use in "primary degenerative disease" or "secondary degenerative disease caused by cerebrovascular disease." In 2013, the Ministry of Food and Drug Safety ordered a clinical re-evaluation of acetyl-L-carnitine drugs. The re-evaluation clinical trial was conducted in two groups according to indication. Dong-A ST took the lead in conducting a clinical trial of "primary degenerative disease." Hanmi Pharmaceutical was in charge of clinical trials of "secondary degenerative diseases caused by cerebrovascular disease." As a result of clinical trials, the indication was deleted in July 2019 because it failed to prove the primary degenerative disease. In August last year, it was concluded that the "secondary degenerative disease caused by cerebrovascular disease" also failed to prove its effectiveness. In other words, as a result of nine years of clinical re-evaluation, all indications were not proven, leading to the exit procedure. Acetyl-L-carnitine preparations also suffered from clinical design. It is known that it took about two to three years to set up a clinical design while designing a new clinical trial reflecting the latest scientific standards. At the request of the pharmaceutical company, the deadline for clinical re-evaluation of primary degenerative diseases was extended by two years, and the submission of clinical trial data for secondary degenerative diseases was extended by four years, which resulted in failure. Acetyl-L-Carnitin drugs formed an outpatient prescription scale of 72.6 billion won in 2017 and 74.8 billion won in 2018, but fell to 64 billion won and 51.1 billion won in 2019 and 2020, respectively. With the deletion of the first indication, the market size has been reduced. Last year, the prescription record was 31.6 billion won, but it finally disappeared from the market. As of last year, Hanmi Pharmaceutical's Carnitil left 11 billion won and Dong-A ST's Nicetile left 5 billion won in prescriptions. In 2017 and 2018, Oxiracetam and acetyl-L-Carnitin collaborated on a total of 103.4 billion won and 105.9 billion won in prescriptions. The pharmaceutical industry has become inevitable to lose about 100 billion won a year due to the failure of clinical re-evaluation of oxiracetam and acetyl-L-carnitine drugs.
