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- 2026-05-16 04:04:18
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- Lipitor won the market in the 2010s
- by An, Kyung-Jin Feb 12, 2020 06:27am
- In the past decade, Lipitor, the hyperlipidemia drug, recorded the most outpatient prescriptions. Lipitor has been prescribed a total of ₩1.31 trillion since 2010. After the patent expiration in 2009, even in the offensive of generic drugs, Lipitor showed that it never fell below the second place in prescriptions. The hepatitis B drug 'Baraclude' has been priscribed an average of more than ₩100 billion per year from 2010 to last year and has been at the leading position for the longest time. In 2010, hepatitis B treatment drug Viread and hyperlipidemia medicine Crestor had accumulated over ₩800 billion in prescriptions. Pfizer's Lipitor(Atorvastatin), ranked first in 2010-2019 with a total prescription of ₩1.31 trillion. Pfizer Korea introduced Lipitor to the domestic market in 1999. In the 20 years since its launch, more than 130 generic products have poured into the market for Atorvastatin-based hyperlipidemia. The drug price of Lipitor 10mg was cut in half from ₩1,241 in 2007 to ₩644. Nevertheless, Lipitor's outpatient prescriptions increased by nearly 80% from 2010's ₩98.3 billion. In the past decade, the overall prescription drug ranking has never fallen below second place. Pfizer Pharmaceuticals has self-diagnosed that the prescription amount could be continuously increased by conducting a large-scale clinical study of Koreans and carrying out active marketing activities such as social contribution activities. It is also analyzed that co-selling with Jeil, which has been established for a long time, has generated synergies. Outpatient prescription performance by year for the top three products in 2010-2019 (Unit: ₩100 million, Source: UBIST) BMS's Baraclude has accumulated over ₩1.23 trillion in the past 10 years. This means that the company has recorded more than ₩100 billion in prescriptions over the past 10 years. There are only two products, Lipitor and Baraclude, that have recorded prescriptions worth ₩ one trillion over 10 years. Baraclude has been the leader in prescriptions for the longest period of 2010, with outpatient prescriptions soaring from ₩ 88.8 billion in 2010 to ₩193.1 billion in 2014. However, after the emergence of competitive drugs and generic patent expiration, it fell to ₩71.4 billion in 2019 due to the entry of generics. Outpatient prescriptions decreased 63% QoQ. The rival drug Viread has been ranked 3rd in terms of cumulative prescriptions, with prescriptions worth ₩847 billion for the past 10 years. Viread, which appeared in the domestic market in 2013, led the year with a record of ₩166 billion in 2017, but fell to ₩106.8 billion last year. Since the entry into the generics market, drug prices have dropped sharply. Baraclude and Viread, along with Lipitor, dominated the prescription drug market in the 2010s, but suffered the upswing in generics after the patent expiration. During the decade of the 2010s, the top spot for prescriptions was granted to only three items: Lipitor, Baraclude, and Viread. After Lipitor took the top spot in 2010, Baraclude took the lead for five years from 2011 to 2015. In 2016, Lipitor recaptured the first place in six years, but in 2017, gave the lead. Since then, due to drug price cuts and the general offensive, Viread's prescription performance has slowed down. In 2018, Lipitor returned to the top position and remained the number one for two consecutive years until last year. AstraZeneca's hyperlipidemia treatment, Crestor recorded a total prescription amount of ₩803.3 billion over the last 10 years. Sanofi's anti-thrombotic drug Plavix has accumulated cumulative prescriptions of ₩721.9 billion since 2010. Boehringer Ingelheim's Twynstar (Telmisartan/Amlodipine) has been prescribed for ₩711.8 billion over the last 10 years. Antihypertensive drugs, Exforge & Amosartan, Norvasc, and prostatic hyperplasia treatment, Harnal have been listed in the top 10 items with the highest prescription rates in the last decade. Over the past decade, the trend in prescription drug sales has been clear. Multinational pharmaceutical companies with patent-expired drugs implemented their market defense strategy by strengthening their sales force through joint sales agreements with domestic pharmaceutical companies. Crestor's outpatient prescriptions peaked at ₩100.8 billion in 2014 from ₩66.8 billion in 2010 and then turned downward. However, the company has continued its uptrend for the second straight year, reaching ₩74.1 billion in 2018 and ₩84 billion in 2019. AstraZeneca has been co-selling Crestor with Daewoong Pharmaceutical since 2016. Last year, prescription sales for Plavix increased by 17.3% year-on-year to ₩88.9 billion. In 2013, it fell to ₩46.4 billion in 2013 from ₩95.8 billion in 2010, but recovered ₩60 billion in the following year, up 48.2% in five years. Two years after launching joint sales with Dong-wha in 2017, the prescription performance jumped 28.1%, which is considered to be an effective defense against the generic offensive. More than 100 generic products for Twynsta have been poured to the market since its patent expiration in 2013, but there has been no change in prescription performance. After peaking at ₩97.7 billion in 2016, the market faltered to ₩81.2 billion in 2017 and ₩80.3 billion in 2018, but rebounded to ₩84.7 billion last year. Twynsta is co-sold by Yuhan. (Clockwise from top left) Lipitor, Baraclude, Viread, Albis, Stillen, & Hepsera The top prescriptions in 2010 and 2019 were also changed significantly. Dong-A ST's gastritis treatment Stillen, which was ranked fourth in 2010 with a prescription amount of ₩88.3 billion, disappeared from the top of 2019. In 2011, the prescription amount of Stillen, jumped to ₩93.3 billion, but its market position has declined significantly since the emergence of generics. In 2017, the reimbursement for prevention of gastritis was deleted, and even reimbursement benefit was cut in half. Last year, outpatient prescriptions amounted to ₩9.3 billion, which was only about one tenth of 2010. Chong Kun Dang's high blood pressure treatment, Dilatrend, Pfizer's Norvasc, Daewoong's brain function improver Gliatilin, and MSD's asthma treatment, Singulair disappeared from the top of 2019. On the other hand, Daewoong Bio's brain function improver Gliatamin, Boehringer Ingelheim's Twynsta, Hanmi's Rosuzet, Eisai's brain function improver Aricept, Hanmi’s Amosartan have newly ranked at the top.Top 10 Outpatient Prescription Products in 2010 and 2019 (Unit: ₩100 million, Source: UBIST)
- Company
- JAK-inhibiting oral antirheumatic drug market getting fuller
- by Eo, Yun-Ho Feb 11, 2020 06:31am
- Orally taken antirheumatic treatment, JAK inhibitor drug market in Korea would be soon led by four competitors. According to pharmaceutical industry, the close competition between Pfizer’s Xeljanz (tofacitinib) and Lilly’s Olumiant (baricitinib) would get even intensified as Astellas Pharma’s Smyraf (peficitinib) entered the competition last month and AbbVie’s upadacitinib is awaiting Ministry of Food and Drug Safety’s nod at the moment. Janus kinase (JAK) inhibitor has gotten the industry’s attention since its release, because it was first oral therapeutic option for autoimmune disease with equivalent treatment level as anti-TNF medicine. However, its position in the market is not as influential as other biologics. While anti-TNF drug and anti-interleukin drug have consolidated their positions in the market, JAK inhibitors’ indications have been too narrow except for rheumatoid arthritis. Global Sales Volume of Anti-TNF Drugs and JAK Inhibitor Drugs (Unit: KRW 100 million) In other words, JAK inhibitor still has much more potential. The first JAK inhibitor, Xeljanz was additionally indicated for treating ulcerative colitis and psoriatic arthritis, and other following drugs have ongoing trials to expand indications treating autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylsoing spondylitis. Once Smyraf and upadacitinib enter the market, and Gilead Sciences’ filgotinib, currently under review in the U.S. and Europe, is commercialized in Korea, JAK inhibitor market with convenience of oral administration option would naturally grow. But also there is a drawback. JAK inhibitor recently had an adverse reaction issue regarding cardiovascular system safety when administering high dose. Although direct relationship of cause-and-effect has not been fully confirmed, warning has been labeled on the high-dose prescription of the three drugs. High-dose of the drugs is prescribed for rheumatoid arthritis and other major indications. JAK inhibitors block inflammatory cytokine cell’s family of Janus kinase enzymes (JAK1, JAK2, JAK3, and TYK2). Different kinds of JAK inhibitors share the same mechanism of actions but with some intricate differences. Xeljanz inhibits JAK1 and JAK3, Olumiant blocks JAK1 and JAK2, whereas Smyraf blocks JAK1, JAK2, JAK3 and TYK2. Upadacitinib and filgotinib interferes activity of JAK1.
- Company
- Pfizer recalling Lipitor and Caduet in defective packaging
- by Jung, Hye-Jin Feb 11, 2020 06:29am
- Pfizer Korea is recalling some of Lipitor and Caduet stocks, not because of the drug itself but because of defective packaging. On Feb. 6, Pfizer Korea disseminated official notice to vendors and requested them to suspend shipping of Lipitor and Caduet. The shipping is halted for Lipitor 10 mg in 90-tablet packaging with manufacturer’s serial number DA1448 (expired by Apr. 15, 2022), CY0992 (expired by Apr. 15, 2022), and DA0505 (expired by Oct. 24, 2021), and Caduet 5/ 20 mg in 30-tablet packaging with serial number CR4181 (expired by Aug. 5, 2022). Pfizer Korea explained the company has found potential risk on product quality, and said it would voluntarily recall the products. The official notice stated, “Any healthcare institute or distributor with the said packaging in the stock should suspend shipping, and return the products to supplier when the recall is initiated.” Currently, Pfizer is discussing about the recall with Ministry of Food and Drug Safety (MFDS), and is also planning to notify related vendors and healthcare institutes about the recall method as soon as possible when it is decided. Pfizer Upjohn Korea official said, “The shipping suspension has been decided, because we found some bottled products with a crack on the rim of bottle opening. However, the ratio of products with the crack among the to-be-recalled products is estimated to quite low.” The company elaborated the potential risk on patient is low, but the preemptive steps are taken voluntarily to ensure safety of the patients.” Lipitor is hypertension-treating drug with atorvastatin that made 176.2 billion won in Korea last year. Caduet is a combination drug treating hypertension and dyslipidemia with atorvastatin and amlodipine. It has raised 24.1 billion won last year from prescription.
- Company
- MSD’s Spin off completes within this year
- by An, Kyung-Jin Feb 10, 2020 06:31am
- Employees of Korean subsidiaries had begun to stir as Merck (US MSD) declares a division of business. Anxiety over future behaviors is heightening as the company announces the launch of an independent corporation to manage women's health-related products, patent expired drugs, and biosimilars within the year. #Decision to split MSD business, Transfer women's health and biosimilar products to a new corporation MSD held a conference call on the 5th and formulated a spin-off plan. The company plans to split the existing pharmaceutical division into two and set up a separate independent corporation (tentatively named NewCo) to focus on women's health-related products, cardiovascular diseases, respiratory and pain products, and biosimilar products. MSD has decided to focus its research and development (R&D) capabilities on remaining drugs, including anticancer drugs, vaccines, specialty products, and animal health. By item, About 90 patent-expired drugs such as ▲Biosimilars distributed by MSD headquarters such as Renflexis, Brenzys and Ontruzant through a contract with Samsung Bioepis ▲Etonogestrel implant Nexplanon franchise, birth control pills, maternity products, etc. ▲Hyperlipidemia drug, Zetia, Vytorin, respiratory disease drug Singulair, skin disease drugs, pain medicine, etc. will be transferred to the new corporation. Business split plan announced by MSD (Source: Merck Conference Call) Ken Frazier, CEO of Merck, said he decided to split the company to build a business model that fits the portfolio and expects both companies to focus on investment and growth in the first half of 2021. The company announced that it will proceed with the process of establishing a new corporation in the coming months. Based on the contraceptive and infertility related products currently owned by MSD, the goal is to foster new corporations as global leaders in women's health. The company also said it would seek opportunities for active partnerships with other pharmaceutical bio companies to maximize the value of cardiovascular and skin diseases, respiratory diseases, pain, and biosimilar products and to increase patient access. MSD plans to split the company within this fourth quarter, reorganization is imminent According to the headquarters policy, reorganization is inevitable even for a Korean corporation with 700 employees. MSD Korea held a town hall meeting for all employees on the 6th afternoon to share information on corporate division and had a Q&A time. According to officials who attended the Town Hall meeting, the management of the Korea MSD on the day set the standard that the employee's affiliation will follow the business unit to which the dedicated product portfolio belongs. Of the four divisions under the MSD of Korea, more than 100 employees from the DB (Diverse Brand) division dealing with respiratory and skin diseases such as Propecia and Singulair and some employees in the PC(Primary Care) with diabetes and cardiovascular diseases are influential. Since the new corporation is a completely independent company, the office will be operated separately after the spin-off. For example, sales marketing staff currently in charge of vaccine products such as Gardasil work at MSD, while sales marketing staff dedicated to DB business products such as Singulare are moved to a new corporation. The distribution criteria for employees who were in charge of both company's products or internal departments other than sales marketing department have not been specified yet. Since the company's affiliation may vary depending on the division's operating model, the company said that it would provide individual guidance on whether or not it belongs to the third quarter. The management of Korea MSD said, “It is expected that it will complete the spin-off within the fourth quarter of this year, regardless of the schedule of the headquarters. It is difficult to predict the number of employees who will be moving to a new corporation, except for clinical departments. Next week's departmental session will provide details”. Korean subsidiary's confusion aggravated, "no ERP implementation plan" by company Sudden decision adds confusion among employees. Employees attending the town hall are said to have asked questions about the succession of consecutive years of service and salary, benefits, and conditions of succession when they move to a new corporation. There is also anxiety that the ERP(Early Retirement Program) may be activated if the service years are not inherited or if the settlement of severance pay in the middle of business split. In this regard, a Korean MSD official said, “the company does not currently plan to settle interim severance pay or implement ERP. Years of service remain the same. Since the establishment of the new corporation, the company has not received any information from the headquarters regarding the sale and merger and acquisition plan”. He stressed, "It is not a cost reduction but a decision for long-term growth, so we plan to actively support the growth and career development of our employees after the division".
- Company
- AstraZeneca, decided to withdrawal from the KDPU
- by Kim, Jin-Gu Feb 10, 2020 06:31am
- AstraZeneca Korea decided to withdraw from the KDPU(Korea Democratic Pharmaceutical Union). The branches of the KDPU have been reduced to 18, including 17 multinationals and 1 domestic. According to the pharmaceutical industry on the 6th, the Branch of AstraZeneca Korea under the KDPU has voted for members whether or not to withdraw from the end of this January. As a result of the voting, More members were in favor of the withdrawal. After the withdrawal process, the union of AstraZeneka Korea will conduct collective bargaining with the company as an industrial union. AstraZeneca Korea's withdrawal from the KDPU is the third after Janssen Korea and Novonordisk. Prior to AstraZeneca Korea, the majority of members withdrew from the MSD Branch of Korea, but it did not lead to a complete withdrawal yet. At the end of last year, MSD Korea withdrew 300 members out of 380 members of the KDPU. There are currently two unions in the MSD Korea. Reasons for withdrawal include unequal voting rights and an increase in union costs. The KDPU are currently entitled to one vote per company regardless of the number of members. As a result, large companies continue to complain. It is reported that the union's executive department recently decided to raise union costs. In the case of large companies, the right to vote is limited and union costs have increased, which is a double burden. After the withdrawal of Jansen Korea, AstraZeneca Korea was the second largest after Novartis Korea. The KDPU was launched in 2012 by multinational companies under the Federation of Korean chemical Workers’ Unions. At the time, 8 companies including ▲Novartis Korea ▲Takeda Korea▲Sanofi-Pasteur ▲AstraZeneca Korea ▲Wyeth Korea ▲Zuellig Pharma Korea ▲ Bristol-Myers Squibb Korea and ▲Janssen Korea participated as founding members. Since then, ▲Baxter Korea ▲Merck KGaA ▲Ferring Pharmaceuticals, Korea ▲Allergan Korea ▲Fresenius Kabi Korea ▲Fresenius Medical Care ▲Abbvie Korea ▲Astellas ▲MDS Korea ▲Mundipharma Korea ▲Galderma Korea ▲Zuelligpharma services Korea joined as a new union branch. Among domestic companies, Kolon pharma has attracted attention by joining the union. Among them, Janssen Korea, Novonordisk and AstraZeneca Korea withdrew, and currently, there are 18 branches under the KDPU.
- Company
- Ilyang's Supect, good effect on leukemia cells reduction
- by Jung, Hye-Jin Feb 10, 2020 06:30am
- Ilyang announced that its phase III clinical trial of 'Supect', a leukemia treatment drug developed by the company, outperformed than Glivec. Ilyang Pharmaceutical (President Kim Dong-yeon) announced on the 6th that the clinical results were published in British journal of Hematology. In this trial, 241 patients with chronic myelogenous leukemia were administered to 24 hospitals in Asia (Korea, Thailand, Philippines, and Indonesia) for four years, and the results were followed by the administration of Supect, brand for Radotinib and the first generation of anticancer drugs 'Glivec'. According to the results, 86% of Supect administration group & 75% of Glivec administration group were the patients who received the major gene response who estimated to have reduced leukemia cells by more than 1000 times, and The complete gene response rate was 58% in the Supect-treated group and 49% in the Glivec group. According to Ilyang Pharmaceuticals, the treatment failure rate was 6% in the 300mg twice daily dose of SUPECT, more than three times less and 19% in the Glivec group. Kim Dong-Wook, Hematology Professor of Seoul St. Mary's Hospital, who led the clinical study and participated in the paper, said, “At 3 months after treatment, predicted long-term good genetic response rate was 86% in the Supect group and 71% in the Glivec group. The use of Supect is expected to result in a long-term treatment effect in a larger number of patients faster and significantly increase the number of patients who can stop drug treatment after using SUPECT for a period of time. Targeted anticancer drugs prescribed for patients with chronic myelogenous leukemia for the first time were Glivec, a first-generation anticancer drug, and a second-generation target anticancer drug, such as Supect from Ilyang Pharmaceutical, Tasigna by Novartis Switzerland, and Sprycel by Bristol Myers Squibb. Ilyang said, “The first diagnosis of chronic myelogenous leukemia patients showed faster and higher gene response rates in the 'Supect' group, and there was no new serious adverse reaction even after long-term follow-up, It was confirmed that the repair treatment could increase the possibility of Treatment Free Remission. And, the second generation of targeted anticancer drugs has been selected as the first treatment in many countries because of its superior efficacy than Glivec". In addition, "Supect, the second-generation targeted anticancer drug, is the inexpensive treatment cost, which can reduce the financial burden on patients and contribute greatly to the financial stability of national health insurance". A total of 20 researchers participated in the trial, including Professor Do Young-rok (first author), Department of Hematology and Oncology, Keimyung University Dongsan Medical Center and Professor, Dong-Wook Kim(corresponding author), Seoul St. Mary's Hospital.
- Company
- MFDS to clear Forxiga’s heart failure indication soon
- by Eo, Yun-Ho Feb 10, 2020 12:17am
- Anti-diabetic treatment Forxiga is ready to be reintroduced as a heart failure drug in Korean market as well. According to pharmaceutical industry on Feb. 7, AstraZeneca’s sodium-glucose cotransporter 2 (SGLT-2) inhibitor Forxiga (dapagliflozin) would be soon indicated for reducing the risk of hospitalization by heart failure in patients with type 2 diabetes. Korea’s Ministry of Food and Drug Safety (MFDS) is expected to conclude the review within this month at earliest. AstraZeneca started the additional indication approval procedure immediately after the U.S. Food and Drug Administration (FDA) has cleared of the indication in back October 2019. The company also aims to quickly process expanding an indication to reduce the risk of heart failure in patients with reduced ejection fraction, with and without type 2 diabetes, the FDA has processed under Priority Review. Forxiga’s efficacy to reduce the risk of hospitalization of diabetic patients with heart failure was confirmed during Phase III DECLARE-TIMI 58 trial. The large-scale trial observed 17,000 patients around the world with co-morbid type 2 diabetes and either cardiovascular-related risk or heart failure to study the effect of the SGLT-2 inhibitor on cardiovascular conditions. The outcome found Forxiga lowering the risk of hospitalization or death from heart failure by 17 percent and, specifically, the risk of hospitalization was lowered by 27 percent. The tendency of reduced risk of hospitalization by heart failure or death by cardio vascular disease was consistently prevalent in patient groups with cardiovascular risk factors (hypertension, dyslipidemia, smoking), and previous record of cardiovascular disease. Executive Director Chae In Ho of Korean Society of Interventional Cardiology (Professor at Seoul National University Bundang Hospital) stated, “Although heart failure treatment options are available, its medical need is still highly unmet. The use of SGLT-2 inhibitor for treating heart failure would be significantly popular in Korea.” Another SGLT-2 inhibitor, Boehringer Ingelheim’s Jardiance (empagliflozin) also has ongoing clinical trials to test indication to treat heart failure. The drug is simultaneously conducting EMPEROR-Preserved trial on patients with preserved ejection fraction and EMPEROR-Reduced trial on patients with reduced ejection fraction. Based on EMPEROR and EMPERIAL studies particularly testing efficacy on heart failure, FDA has reportedly granted fast track status on Jardiance’ heart failure indication.
- Company
- Opdivo retries expanding reimbursement without NSCLC
- by Eo, Yun-Ho Feb 06, 2020 06:31am
- Seemingly have given up on expanding reimbursement, Opdivo has turned around and started taking actions again. Nevertheless, its health coverage application excluded indication for lung cancer. According to industry sources, Ono Pharmaceutical and BMS have recently applied for expanding reimbursement on PD-1 inhibitor-based immunotherapy Opdivo (nivolumab). The application is for the use as second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN), and second-line treatment for typical Hodgkin’s disease. The issue-making indication treating non-small cell lung cancer (NSCLC) regardless of expressed PD-L1 was dropped from the new application. Although the companies may have left the NSCLC indication behind, they are determined to continue improving access to Opdivo. Since early 2019, the government has been negotiating with respective pharmaceutical companies on Opdivo, Roche’s Tecentriq (atezolizumab), and MSD’s Keytruda (pembrolizumab) all together for expanded reimbursement. In the process, Ministry of Health and Welfare (MOHW) engaged in preliminary negotiation with the companies and laid a condition to limit reimbursement only to patients showing response and the ‘trade-off’ initiative, which would reduce off-patent drug’s pricing as a compensation for recognizing value of new drug. The preliminary negotiation is a type of special procedure, not a part of regular deliberation process for reimbursement expansion, such as Cancer Disease Deliberation Committee, Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) or drug pricing negotiation with National Health Insurance Service (NHIS). Immunotherapy has been a game changer that shifted the paradigm of anticancer therapy. However, it is extremely expensive and its indication can expand out indefinitely. Preliminary negotiation is a unique tool the Korean government has established to discuss easing reimbursement criteria for drugs necessary for treatment but comes with significant financial burden. The purpose of the tool is to expedite the procedure with DREC and NHIS by reaching an agreement on financial issues and reimbursement criteria prior to the regular procedure. But, only Roche reached an agreement with the government. Although the second round of negotiation fell through, MSD applied for reimbursement expansion again with another indication approved at the end of last year and is now waiting for Cancer Disease Deliberation Committee’s decision. Whereas, Ono Pharmaceutical and BMS have not taken any other actions after the first negotiation ruptured last May. Many suspected the companies have basically ‘given up’ on Korean market. For now, the industry is keeping close eyes on Opdivo putting aside the discrepancy experienced last year and yet again applying for expanding reimbursement without the NSCLC indication. Initially, Opdivo was indicated ‘regardless of expressed PD-L1,’ but it was listed in August 2017 with a set expression rate of PD-L1 under refund and expenditure cap type risk sharing agreement.
- Company
- Pelubi’s indication expansion, seeking for breakthrough
- by Kim, Jin-Gu Feb 06, 2020 06:30am
- Pelubi & Pelubi CR Daewon Pharm challenges the expansion of Pelubi's patented indication. Pelubi's indication for osteoarthritis is extended to dysmenorrhea. Recently, Pelubi CR’s phase III trial plan by Daewon was approved from the Ministry of Food and Drug Safety. This is a phase III clinical trial in Korea to evaluate the efficacy and safety of DW9801 in primary dysmenorrhea patients. Currently, Pelubi has indications for osteoarthritis, rheumatoid arthritis and low back pain. There are two related patents. There are formulation patents for Pelubi and formulation patents for Pelubi CR, respectively. The attempt to expand the indication is related to the recent patent challenge. Pelubi has been patented by six pharmaceutical companies since late last year. Yungjin Pharm filed a judgement on passive confirmation of the scope on the Dec 27 last year, followed by Futecs, Huons, Chong Kun Dang, Nexpharm, and Mother’s Pharmaceutical. This is why Daewon Pharm is attempting to expand the indications to Pelubi CR rather than Pelubi. The six companies' patent challenges are headed for Pelubi. Successful overcoming this patent, which expires in November 2028, will be available after September 2021, when the PMS expires. However, even if the patent is overcome, it can be prescribed only for the treatment of osteoarthritis, rheumatoid arthritis, and low back pain, which is an indication limited to Pelubi. Under the assumption that Pelubi CR is extends the indications, it cannot be used for the treatment of dysmenorrhea. So far, no patent challenge has been confirmed for the Pelubi CR. Last year, the combined Rx amount of Pelubi & Pelubi CR amounted to ₩ 28.9 billion. Prescriptions, which amounted to ₩4.6 billion and ₩5.7 billion respectively in 2014-2015, surged to ₩8.5 billion in 2016, ₩13.5 billion in 2017, ₩23.9 billion in 2018, and ₩28.9 billion in 2019. The rapid growth of Pelubi's prescription is analyzed that to there was not a little impact on the release of Pelubi CR. Pelubi was released in 2007 as the new domestic drug No.12. Since its launch. By the first half of 2015, the half-yearly prescription performance was just around ₩2.3 billion. However, since the launch of the Pelubi CR in June 2015, the semi-annual earnings have been on the rise, and since the second half of 2017, it has grown into a blockbuster drug with full-fledged operations by Daewon Pharm. Pelubi RX results (Unit: ₩100 million, Data:UBIST) for the past six years. Since the release of Pelubi CR tablet in June 2015, it has been on the rise.
- Company
- Pharmaceuticals are focusing on domestic actions for NDMA
- by Chon, Seung-Hyun Feb 06, 2020 06:30am
- Investigations have shown that Metformin's impurity content is safe in the US and EU. In Korea, the Ministry of Food and Drug Safety has also begun inspections after deriving the test method. The US Food and Drug Administration (FDA) announced on the website that some of the Metformin products sold under the FDA approval and carcinogenic substance 'N-nitrosodimethylamine (NDMA)' was detected, but the daily intake (96 ng) was not exceeded. Of the 10 products examined, NDMA was detected only in six lots of two Metformin 1000mg ER & Metformin 500mg ER products by Actavis. Detection amount was 0.01 ~ 0.02 microgram (mcg) per tablet. NDMA test results of 10 Metformin products conducted by FDA (Source: FDA) The FDA said that the test did not confirm a sample of Metformin with NDMA detected above the maximum daily intake and currently does not recommend the recovery of Metformin in the United States. In the near future, it will be posted on the website the method for detecting NDMA of Metformin used in the laboratory. On December 6, last year, the European Medicines Agency (EMA) said on its homepage, “There are very few NDMA detected in some Metformin products sold outside of the EU. Metformin products in the European Union have not yet been detected for NDMA detection". In the near future, it is expected that the results of the investigation of Metformin NDMA detection will be released in Korea. The risk of NDMA in metformin was triggered in Singapore. On December 4, last year, the Singapore Health and Science Agency (HSA) surveyed 46 metformin products sold locally, recovering three products and detecting NDMA above the daily allowance. The whole view of the MFDS The MFDS received data on the use of Metformin from pharmaceutical companies. The MFDS has received data on the production of pharmaceuticals containing Metformin hydrochloride and the systematic investigation of raw materials used until December 17 last year. Pharmaceutical companies submitted the total number of drugs containing Metformin, items and number of production records, items and quantity without production record to the MFDS. The Metformin lineage survey at the MFDS is a preliminary activity to prepare for the detection of impurities. If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company. The MFDS unveiled Metformin's NDMA test on January 15, a month and a half after the Metformin NDMA risks were raised in Singapore. It was suggested to test by Gas Chromatography (GC) method. The industry is alert on the results of Metformin's NDMA inspection in Korea. It is not easy for pharmaceutical companies to test whether they detect Metformin's NDMA. That's because there aren't enough institutions with analyzers to make self-checks. Some pharmaceutical companies are reportedly considering buying their own analyzers. However, it costs ₩300 to 500 million for each analyzer and every year, ₩ tens of millions in management costs are inevitable. Pharmaceutical companies fear that if Metformin is the case, with massive losses in Valsartan and Ranitidine, irreversible losses can occur. Metformin is overwhelmingly larger than Valsartan and Ranitidine. According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion. Ranitidine, which had been suspended from selling all its products, has formed a prescription scale of about ₩200 billion, which is more than double the market. The unit price of Metformin is less than ₩100. That's an overwhelming amount of ranitidine. Outpatient Rx performance of Metformin-containing medicines by year (Unit:₩100 million, Source: UBIST) Tensions are heightened by pharmaceuticals, as the MFDS has taken tough measures on impurities-detecting drugs. In the case of Valsartan, the MFDS discontinued the sale of drug products that used the ingredients in question at least once in January 2015. Many products are likely to be discontinued even though they did not use the raw materials in question. In the United States, only the products using the Zhejiang Huahai Pharmaceutical raw materials were recovered by manufacturing unit. No action was taken to sell the entire item. In Europe, the measure of action was similar. All ranitidine products have been discontinued in Korea. while in the US and Europe, pharmaceuticals were collected by their own lot numbers. In the case of 13 items of Nizatidine have been discontinued, but some of the products have been recalled in Japan, and no products have been ordered in the United States and Europe. An official from the MFDS said, "We are in the process of inspecting the Metformin NDMA test after deriving it".
