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- 2025-12-27 12:03:48
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- Hana secured copyright for anesthetic drugs in 6 countries
- by Lee, Seok-Jun Jan 13, 2020 06:26am
- Hana Pharm Co. announced on the 9th that it signed an exclusive contract with six countries in Southeast Asia for anesthetic drug, Remimazolam. Remimazolam is a new anesthetic drug that is considered to be a Propofol alternative. After finishing phases III in each country, they are getting global approval for Japan, USA and Europe. The original developer is Paion by Germany, and Hana has acquired the rights of six Southeast Asian countries following Korea. According to the disclosure, Southeast Asian countries are Vietnam, Indonesia, Thailand, Philippines, Singapore and Malaysia. The other party is Paion and the contract is €1.5 million (about ₩2 billion). Phased permits, launches, and sales-linked milestones will be paid separately. Remimazolam has a global license ahead. Depending on the country partner, Japan's Mundipharma issued a permit application in December 2018, Cosmo Pharmaceutical U.S.A., 2019, and European Paion in November. In Korea, Hana completed the application for approval on December 30 last year. It is likely to be the first to be approved in Japan. If the permit is granted, it will have a positive effect on domestic approval. OEM Europe and Japan Export Challenge Hana is setting export targets for Europe and Japan in addition to the Remimazolam copyright contract. The region plans to advance to Paion's 2nd Vendor OEM. There are only four Remimazolam producers in the world, including Hana. Hana's strategy is to establish a global market base through Southeast Asian copyright and European and Japanese consignment production. Hana is also expanding its facilities to meet the demand for Remimazolam. Hana decided to invest ₩58.5 billion in November to construct a new injection plant and introduce facilities. The new plant's production capacity is estimated at ₩200 billion for injection. Operation is expected in 2022. In last February, the facility invested. In order to secure the site for the new factory, the company purchased the sale of the Pyeongtaek Dreamtech General Industrial Complex. Kepa has not been decided yet, but the new plant will be completed by 2025. An official of the company explained, "Remimazolam can be produced in existing factories, but is investing in facilities to meet the growing demand".
- Company
- Sanofi recruits 4943 patients in three clinical trials
- by Chon, Seung-Hyun Jan 13, 2020 06:22am
- Hanmi Pharmaceutical's new technology, "Efpeglenatide", exported to Sanofi, continues commercializing smoothly.. Three cases were recruited out of five phase III trials. In three clinical trials, a total of 4943 patients were recruited, accumulating the scientific evidence to prove the competitiveness of Efpeglenatide. The whole view of Hanmi Pharmaceutical HeadquartersAccording to Clinical Trials, a clinical information site run by the National Institutes of Health (NIH), Sanofi recently completed a recruitment of one of the Phase III trials of Efpeglenatide. This is a Phase III clinical trial comparing the combination of Efpeglenatide and Metformin with the competing drug Trulicity ( Dulaglutide). Sanofi began the trial in September 2018 and after enrolling 481 subjects, changed the clinical stage to “Active, not recruiting” on the 7th.. The target completion date is next February. Sanofi has completed three of the five trials of Efpeglenatide in Phase III trials. Efpeglenatide is a GLP-1-based diabetic drug that extends daily injections from once a week to up to once a month. It is based on Hanmi’s 'Lapscovery' technology. Lapscovery is a platform technology that increases the short half-life of biopharmaceuticals and reduces the number of doses and dosages to reduce side effects and improve efficacy. Hanmi signed a technical export contract with Sanofi’s Efpeglenatide in November 2015, and holds the record of the largest contract ever for four years. In November 2015, Hanmi signed a contract with Sanofi to export technology for a total of €3.9 billion in quantum projects (Efpeglenatide·sustained insulin· Efpeglenatide·sustained insulin). The down payment is €400 million. In December 2016, Hanmi signed an amendment agreement with Sanofi to return one of its technology transfer projects. Hanmi returned €196 million to Sanofi out of the €400 million received from Sanofi. Sanofi announced a detailed development plan at the end of 2017, two years after taking the rights of Efpeglenatide. Sanofi began five clinical trials in late 2017 after the first phase III trial comparing Efpeglenatide to placebo. In last June, 4076 people were enrolled in the AMPLITUDE-O, which is considered the core clinical trial of Efpeglenatide. In last October, the recruitment of AMPLITUDE-M compared to placebo was completed. A total of 4943 patients were enrolled in the three clinical trials that were completed. It is accumulating scientific evidence to secure market competitiveness while demonstrating the safety and effectiveness of Efpeglenatide in large patients. Efpeglenatide survived the reorganization of Sanofi's harsh R&D pipeline. Efpeglenatide is the only diabetic drug among the five R&D pipelines that Sanofi has set for NDA within two years. Sanofi suddenly stopped developing GLP-1 based triple agents (SAR441255) last year. It also returned the rights of the SGLT-1/2 double inhibitor ‘Zynquista(Sotagliflozin)’, which was introduced in 2015. Sanofi announced in last December that Sanofi increased its investment in four areas: cancer, blood disease, rare disease, and nervous system disease and stopped research into cardiovascular disease. Efpeglenatide is in a position to complete development and search for a new vendor.
- Company
- “RSA expansion, a foundation to expedite new drug listing"
- by Eo, Yun-Ho Jan 10, 2020 06:26am
- A ‘new drug’ holds the foremost value of the pharmaceutical industry. And global pharmaceutical companies’ eyes are currently fixated on the ‘adequate value of new drug’ than ever before. As the era of high-cost drug has come, government and pharmaceutical industry’s gap in views of drug pricing has never been so apart. Korea Research-based Pharmaceutical Industry Association (KRPIA), representing the voices of global pharmaceutical companies in Korea, is stepping forward seeking the middle ground of the two. A consensus between them does exist. For an instance in last year, the Korean health authority expanded scope for risk sharing agreement (RSA) and announced a plan to apply RSA on follow-on drug and to expand pharmacoeconomic evaluation (PE) exemption system. The year 2020, the time of changes and expectations, marks Chair Avi Benshoshan’s third year serving KRPIA. And Daily Pharm interviewed him for this year’s plan of the organization. Chair Avi Benshoshan#- New Year’s greetings and message for the member companies. As you may be aware, this year would be another year of economic recession and sluggish growth as predicted by major economic indicators. However, we hope to create a regulatory environment that recognizes value of innovation to maintain the growth engine of pharmaceutical and bio industry this year as well. And I wish everyone has a year full of keen wisdom to seek an opportunity in crisis, like a small but bright mouse. - KRPIA member companies share a common theme of ‘new drug.’ But each of them has diverse field of expertise in anticancer, rare disease, chronic disease and off-patent treatments, which comes with different interest groups. Respective member companies have their own specialized field, but in a bigger frame, they are all heading for the same goal of improving patient’s health. In the same sense, KRPIA is planning to present more concrete basis for new drug to strengthen the ‘patient-centered healthcare policy,’ and to reinforce the organization’s role as a communicator between government and healthcare sector stakeholders. The organization ultimately aims for a mutual growth through raising awareness of social value in new drug and improving policy. We think the government, global pharmaceutical companies and the organization also share a same goal of adequately providing new drug to patients in urgent need and lowering barrier of new drug access to prevent disheartening catastrophe of patients giving up on treatment for financial reasons. - It could be considered quite limited, but the organization’s long-awaited drug pricing system revision is in process. The organization sees it as a positive change as RSA scope expansion and PE-exemption system amendment are all part of regulatory reform to improve patient’s access to new drug. We fully understand the government’s contemplation on soaring medical expense. However, considering on how ‘Korea Passing’ phenomenon was a prevalent issue throughout the pharmaceutical industry, decision on new drug reimbursement has reached a difficult point in time as it has to take account of other countries as well. We have a great anticipation on the government’s decision to expand scope of RSA as it was their solution balancing between stable National Health Insurance (NHI) finance and patient’s access to new drug. And also it could be a starting point of regulatory reform to adopt fast-track listing. Although the government has not unveiled any specifics, yet, the organization plans to cooperate with the government to deliver the complete effect of regulatory change to the patients. -Last year, the government presented a research outcome on new drug review period. What do you suggest is needed to enhance the review system? The last year’s research holds a significant meaning to it as it investigated, for the first time in Korea, the actual time taken for new drugs to be reviewed and approved in Korea.” The average time taken for review and approval on 115 investigational new drugs in Korea was approximately 300 days, similar to that in other advanced countries. Unlike other countries with already set predictability of the review system, however, Korea’s approval period showed large gaps between different items and in different years. Predictability is a crucial factor for a business, therefore, the government should consider including additional supplementary material submission period as part of the review processing period to raise regulatory predictability like the other countries. And for rare disease treatment with urgent and highly unmet medical need, the government should activate preferential review system, differentiated from general approval procedure and implement practical policies for better effectiveness. - Regarding regulations, in which part does KRPIA try to improve or recommend? To enhance Korea’s medical and bio companies’ capacity and support their global market expansion, KRPIA has been operating ‘Global Pharmaceutical Company-Startup Co-incubating Platform’ with KOTRA since March 2018, targeting about 100 medical and bio startups. And in 2019, we have organized ‘Global Open Innovation Korea’ with KOTRA, Ministry of SMEs and Startups and Korea Institute of Startups & Entrepreneurship Development (KISED) as an effort to meet the government’s biohealth industry fostering policy. We highly appreciate the government's commitment designating the biohealth industry as one of top key emerging industries and also their aggressive investment on the industry. Nevertheless, it is unfortunate to see multiple government bodies executing different biohealth industry fostering policies resulting in overlapped actions and inefficient communication in between the policies. Based on other cases in overseas, the massive scale of government’s investment, determined to assertively support the bio industry, is as important, but also we believe focusing investment efficiently among various government policies would bring a success to the policy. As Korea already has an outstanding infrastructure in basic science, life science and clinical study for development of biohealth industry, it would be wise to fine tune policies between government bodies to maximize the investment effect. –How about a word of determination and ambition for the New Year’s? For the year 2020, KRPIA plans to provide even more concrete basis for new drug to strengthen ‘patient-centered healthcare policy’, and to raise awareness of social value in new drug. Also, the organization would engage with government and healthcare sector interest groups better to improve existing policies. And we would endeavor to grow deeper mutual relationship between Korean and global pharmaceutical companies in various fields like technology co-development and overseas market co-marketing. Last but not least, the organization would fully support Korea to become a pharmaceutical powerhouse by hosting more clinical trials and increasing R&D investment. We hope the pharmaceutical industry could bring better health to the people and result in fruitful outcome to contribute improving the people’s happiness.
- Company
- The controversy of Eliquis' fluctuating price
- by Jung, Hye-Jin Jan 10, 2020 06:25am
- The price of Eliquis, an anticoagulant drug, Apixaban, has fluctuated several times. Wholesalers and pharmacies dealing with dispensing and distribution are also confused. In particular, as the most recent provisional disposal application that Korea BMS applied for was accepted earlier than expected, some pharmacies and wholesalers had to pay the difference, but Korea BMS showed a negative attitude toward settlement. Initially, the Ministry of Health and Welfare announced that as of January 1 this year, the Eliquis insurance price, which is ₩1185, will be reduced to ₩830 , a 30% reduction. Accordingly, Korea BMS has proceeded with the original lawsuit to prevent the price cut, and has defended the price cut right now by applying for suspension of execution. The BMS filed an application for disposition shortly after the suspension of drug price reduction was lifted after the first trial decision by the Ministry of Health and Welfare. As the court accepted it, the drug price, which was lowered on January 1, recovered to ₩1185 from two days later. The problem is that the provisional decision was unexpectedly fast and was shipped at a reduced price on the first two days of January. There was no time for wholesalers and pharmacies to cope. January 1 2020 was a public holiday, but during the two-day weekday, wholesalers and pharmacies nationwide charged Eliquis at ₩830. Even though pharmaceutical companies need to settle balances on shipments made during the day, Korea BMS has been controversial, stating that it will only settle for prescription quantities. Personal information such as the patient's prescription is required to check the quantity of the prescription. But, wholesalers or pharmacies cannot provide the personal information to pharmaceutical companies under the Personal Information Protection Act. A wholesaler said, “As the result of the application for disposable treatment on the afternoon of January 3, we had a hard time reprocessing all the shipments that were shipped on the morning of the day at the original medicine price, and if a drug company wants to settle the balance only for the prescription of a hospital, it is like evading settlement”. The official pointed out that BMS is the first Korean pharmaceutical company to announce such a settlement method. A BMS official explained, “The company anticipates the problems that may arise as the price of medicines has been reduced, and has countermeasures, and will confirm the specific details and answer”.
- Company
- Valsartan's third payment deadline has expired
- by Chon, Seung-Hyun Jan 10, 2020 06:24am
- The third payment deadline for the Valsartan damages claim urged by health authorities has ended. Most of the companies that did not pay the compensation were refused to pay. The health authorities say they will continue to incentivize payments, but a lawsuit filed by pharmaceutical companies will conclude the legitimacy of government action. According to the industry on the 7th, the third payment deadline for the Valsartan indemnity claims by the National Health Insurance service has expired on December 31 last year. In October last year, the NHIS asked for 69 drug companies to pay ₩2030 million in compensation. It is a follow-up in accordance with the Ministry of Health and Welfare's decision to return the amount of money invested in pharmacies since the outbreak of the impurity Valsartan issue in 2018 for the remainder of the prescription. The NHIS sent the first reminder to the pharmaceutical companies that did not pay the compensation, by last October 31. Again, due to low payment rates, the NHIS sent a second reminder last December. In order to increase the collection rate, three payment deadlines were given. However, most companies that did not pay the initial deadline were reportedly refused to pay. According to data submitted to the Democratic Party's lawmakers by In-soon Nam last November, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. Pharmaceutical companies refused to pay about 80% of the proceeds. The company has already entered a lawsuit with the NHIS, especially those with large amounts of compensation. Pharmaceutical companies filed a lawsuit to confirm the absence of debt against the National Health Insurance Service on November 27 of last year. It preemptively filed a lawsuit stating that it was not responsible for Valsartan damages claimed by the NHIS. Companies involved in litigation include JW PHARMACEUTICAL CORPORATION , JW SHINYAK CORPORATION, SK Chemicals, Khunil Pharmaceutical, Kwang Dong Pharmaceutical , Guju Pharmaceutical, Kukje Pharmaceutical, Nexpharm Korea, Dasan Pharmaceutical, Daewoo Pharmaceutical, Daewon Pharmaceutical, DAE HWA Pharmaceutical Co., Ltd., DongKoo Bio Pharmaceutical, Mother's Pharmaceutical, MyungMoon Pharm. Co., Ltd., BINEX.CO.LTD, Samik Pharmaceutical Co., Ltd., SAMIL PHARMACEUTICAL CO.,LTD , CMG Pharm, Ajou Pharm, Unimed Pharm, Inist Bio Pharm, Eden Pharma, Reyon Pharm, Chong Kun Dang, Jinyang Pharm, Terragen Etex, Hana Pharm, Korea Kolmar, Hutecs, Hanlim Pharmaceuticals, Hanwha Pharmaceuticals, Whanin Pharmaceuticals, Huons, Huons Medicare, etc. Most companies with large amounts of compensation were involved in litigation. LG Chemical did not participate in the lawsuit among six companies, including Daewon Pharm, Hutecs, LG Chemical, Hanlim Pharm, JW SHINYAK CORPORATION, and Korea Kolmar. Pharmaceutical companies are claiming that they are not responsible for Valsartan claims claimed by the government. Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity Valsartan. Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan issue, is a hazardous substance in the Valsartan raw material that has no standard. Neither governments nor pharmaceutical companies were aware of the risk of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that a defect was not found at the level of science and technology at the time the manufacturer supplied the product, it would be liable for damages.
- Company
- PPC signs co-marketing partnership with Biosuntek
- by Eo, Yun-Ho Jan 10, 2020 06:23am
- From left; CEO Kim Sanghee, CEO Michael Stibilj, President Cho Joon-sang and Senior Director Suh Young-hwan PPC Korea and Biosuntek Laboratory (“Biosuntek”) have agreed to co-market pharmaceutical clinical development. PPC Korea, a contract research organization (CRO) providing service in Asian region, has invested in a bioequivalence test analyst institute, Biosuntek Laboratory and signed a strategic partnership agreement on Jan. 8. The signing event had PPC Group CEO Michael Stibilj, PPC Korea CEO Kim Sanghee, President of Biosuntek Cho Joon-sang and many other related company personnel. With the partnership agreement, Biosuntek and PPC Korea would offer one-stop service covering early clinical development to last phase clinical trial by respectively providing bioequivalence test analysis and early clinical trial services and post-clinical trial service. Together, two companies are now able to provide services ranging from project management, regulatory affairs, clinical monitoring, data management, biostatistics, medical writing, pharmacovigilance, and also bioequivalence study based on pharmacokinetic analysis and protein analysis. Established in 2010, PPC Korea is PPC Group’s offshoot in Korea and it has been a leading CRO conducting clinical trials not only for synthetic drug, but also for innovative investigation medicine like cell therapy, biosimilars and anticancer treatments for global and Korean companies. The parent company, PPC Group has conducted over 600 clinical trials for investigation drugs and over 2,000 bioequivalence studies in Korea, China and Taiwan since 1997. In China and Taiwan, the company owns four clinical pharmacology units to conduct Phase I study, three bioanalytical labs and a central lab. In 2019, the company was listed as APAC Top 10 CROs by Pharma Tech Outlook with its leading position in Asian CRO market. Founded in 2008, Biosuntek has been offering services, such as analytic methodology development, analytic validation and sample analysis, biosimilars and proteins including antibody protein analysis, bioequivalence test, PK, DDI and related clinical trial. And as of 2019, the laboratory has been an industry leader with over 200 ingredient analytic methodologies. PPC Korea CEO Kim Sanghee stated, “We are very pleased to now provide more valuable service to clients by investing on an outstanding analytic laboratory, Biosuntek, and agreeing on strategic partnership and co-marketed clinical study.” President of Biosuntek Cho Joon-sang commented, “As PPC Korea became a shareholder of Biosuntek, we have constructed a strong foundation to offer global-level one-stop new drug development solution based on the optimal synergy created from two companies’ technology and capacity.”
- Company
- Big Pharmas butting heads over Faslodex combination
- by Eo, Yun-Ho Jan 09, 2020 09:06am
- Three investigational drugs are busy preparing for applying reimbursement on a combination therapy with Faslodex. The competing three investigational drugs are cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor treatment—Pfzier’s Ibrance (palbociclib), Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib). The three global pharmaceutical companies are expected to intensely compete against each other over reimbursement on an indication of second-line combination therapy with AstraZeneca’s Faslodex (fulvestrant) to treat patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2) breast cancers. According to industry sources, Ibrance and Verzenio have simultaneously entered a negotiation with Risk Sharing Agreement Subcommittee in the end of last year, and Kisqali, approved for marketing in Korea the last in November, would be deliberated by Cancer Disease Deliberation Committee soon. The close race may continue with only Ibrance and Verzenio starting a Drug Reimbursement Evaluation Committee (DREC) deliberation first, or all three of them undergoing reimbursement feasibility review at the same time. Nevertheless, the three drugs have different circumstances. Ibrance, as first-line therapy (combination with letrozole), has already been listed for reimbursement through refund type risk sharing agreement, but it is now applying for reimbursement on the additional indication. Ibrance had applied for reimbursement on the expanded indication several times before, but the talks fell through as Faslodex as a monotherapy was not listed for reimbursement at the time. Meanwhile, Verzenio was approved for the Korean market in May, when monotherapy Faslodex was listed for reimbursement, and applied for reimbursement immediately. So far, the drug could take the RSA procedure as no other drug has received reimbursement for a combination therapy with Faslodex, yet. As for Kisqali, speed would unlock the door to the final race. Regardless of the Cancer Disease Deliberation Committee passing the drug in January, Kisqali can be deliberated by DREC only after getting passed by Pharmacoeconomic Evaluation Subcommittee and RSA Subcommittee.
- Company
- Near miss, tension in the Middle East
- by Kim, Jin-Gu Jan 08, 2020 06:18am
- Amid rising military tensions between the United States and Iran, there is also concern about bad influence on trade between Korea and Iran. In the case of drugs, exports have already been blocked since last year. There is also concern that the resumption of exports will be postponed indefinitely. According to the Korea Customs Service's import and export statistics on the 7th, pharmaceutical products exported from Korea to Iran for the past five years (January 2015-November 2019) totaled $90 million. The annual average is $18 million. Earnings are $20,000 over five years, virtually zero. Compared to Korea's total exports of pharmaceuticals ($ 36.24 million, provisional in 2019), the proportion is small at 0.5%. Imports and Exports of Pharmaceuticals to Iran by Year, Data: Korea Customs Service Exports to Iran steadily increased to $ 13.78 million in 2015, $ 17.9 million in 2016, $ 22.89 million in 2017, and $ 24.5 million in 2018, but dropped sharply to $ 10.95 million last year. Considering that last year's statistics are up to November, a significant decrease is observed. The sharp drop in exports last year was due to US sanctions against Iran. The United States has sanctioned trade with Iran since 2010. However, medicines were classified as 'humanitarian trade items' and recognized as an exception. In 2018, pharmaceutical exports were at an all-time high as sanctions eased. But in last May, the United States raised sanctions. At the same time, it refused to recognize even humanitarian trade items. In fact, the export of medicines to Iran has been blocked. Last October, the International Court of Justice decided that "sanctions could not be imposed on humanitarian trade," but the US still does not follow. Korea is in the same situation. In this situation, the military tension between the United States and Iran is at its peak, and the resumption of humanitarian trade is indefinitely postponed. If the situation prolongs, the pharmaceutical industry will inevitably lose ₩21 billion annually. .A pharmaceutical industry official said, “In recent years, more and more pharmaceutical companies have entered or are advancing into the Middle East .However, the situation has raised concerns not only in Iran but also in the Middle East”.
- Company
- Tension on impurity diabetic drugs is for a month
- by Chon, Seung-Hyun Jan 08, 2020 06:17am
- The whole view of the MFDS It's been a month since concerns of impurity Metformin were triggered overseas, but there are still no clear conclusions. Expectations are raised in the pharmaceutical industry that there is no recovery country other than Singapore and that it can only be a surprise. However, there is still a lot of tension that if there is a recovery from the excess of impurities from overseas, there will be an instant spark in Korea. According to the industry on the 5th, no further follow-up measures have been taken at home and abroad for a month after some Metformin recovery measures have been taken in Singapore. Molecular structure of MetforminOn December 4, last year, the Singapore Health Sciences (HSA) surveyed 46 Metformin products sold locally and recovered three products. This is because NDMA above the daily allowance was detected. Shortly after Singapore's recovery, Metformin impurities were investigated in the US and Europe. The US Food and Drug Administration (FDA) has begun investigating the detection of NDMA in Metformin products in the United States. The European Medicines Agency (EMA) has also ordered companies to investigate Metformin's NDMA detection. Japan's Ministry of Health, Labor and Welfare also instructed manufacturers and distributors of Metformin-containing preparations to conduct risk analysis on NDMA incorporation of ingredients and drug products and report the results. A month has passed since then, but no conclusions have been made regarding the recovery of Metformin in countries other than Singapore. No follow-up has been made in Korea yet. This is not the same as the case of Valsartan and Ranitidine. The biggest difference is that both Valsartan and Ranitidine have been preempted in Europe and the United States. Valsartan immediately suspended the sale of products using the drug substance when recovery news came from Europe. Ranitidine began collecting inspections in the country after cases of discontinuation in the United States, and secondly suspended all products after announcing "no problem." In Korea, the MFDS has already submitted the usage data of Metformin preparations from pharmaceutical companies. Last month, the MFDS instructed pharmaceutical companies to submit the production history of the drug containing 'Methformin HCl' and the system for investigation of the active drug substance by the 17th. Pharmaceutical companies submitted the total number of drugs containing Metformin-containing products, items and number of production records, and items and number without production record to the MFDS. The Metformin lineage survey at the MFDS is a preliminary motion in preparation 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. In the pharmaceutical industry, anxiety continues: "Is there a problem with the drug substance used in products recovered from Singapore?" The MFDS formalized its stance on the 16th to conduct an investigation into Metformin impurities. It is known to look into the NDMA detection potential in the Metformin’s chemical structure and manufacturing environment. The industry points out that there is no standardized Metformin NDMA test, which limits the self-inspection. As soon as possible this week, the MFDS will draw up a test method for detecting N-nitrosodimethylamine (NDMA) in Metformin and present it to pharmaceutical companies. Initially, the plan was planned to be completed by the end of last year, but the schedule was delayed. Given the NDMA test method of Metformin preparation, it is expected to be actively checked in Korea. The pharmaceutical industry is expecting a final conclusion on whether or not to detect NDMA after the preparation of the test method. The possibility of preferentially conducting a collection inspection on the drug substance used in products recovered in Singapore is raised. Metformin's drug product recovered from Singapore has never been imported into Korea. In Singapore, however, it was determined that the recovery of the test results for the drug product, not the drug substance. If Metformin preparations are collected in the US or Europe, the same raw materials or finished drugs can be promptly inspected in Korea. In reality, it is impossible to conduct a full survey on Metformin preparations in Korea. Metformin is the most widely prescribed diabetic drug used as a primary treatment for glycemic control in patients with type II diabetes. There are 642 Metformin-containing products in Korea. Virtually all pharmaceutical companies have Metformin. 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, formed a prescription scale of about ₩200 billion, which is more than double the market. The unit price of Metformin is less than ₩100. In terms of usage, it is overwhelmingly higher than Ranitidine. Pharmaceutical companies are already paying attention to domestic and international measures. In the face of massive losses in Valsartan and Ranitidine, there is a strong concern that Metformin can cause irreversible loss if fire breaks out. Some pharmaceuticals are struggling to minimize the damage, saying “NDMA has not been detected by our own tests,” even though the FDA's test method was not proposed. An official of the pharmaceutical company said, “There are no test methods yet, and there are not enough organizations to check, so we did not proceed with NDMA inspection of metformin, and plan to check quickly after the preparation of test method”.
- Company
- Pfizer Korea is looking for a new office
- by Kim, Jin-Gu Jan 07, 2020 06:29am
- Pfizer Korea Myeongdong Office Pfizer Korea is pursuing the sale of its Myeong-dong office, which has stayed for the past 13 years. Location of new office is planning Yeouido, Jamsil or Pangyo. According to the pharmaceutical industry on the 6th, Pfizer Korea is considering the sale of its office and relocation of its office. Currently, Pfizer Korea is located at 110 Toegye-ro, Jung-gu, Seoul (1-11 Hoehyeon-dong 3-ga). An industry official said, “We believe that Pfizer has pursued the sale of the Myeong-dong headquarters since last year, and we have selected a real estate asset manager to manage the sale at the end of last year”. Another official said, "We were thinking about the most suitable place such as Jamsil, Pangyo, or Yeouido, and the company made an internal decision to one of the three recently considering the accessibility and the rental price." The specific sale and transfer dates are not confirmed. However, Pfizer Upjohn is expected to coincide with the launch of a joint venture with Mylan, according to the US Pfizer headquarters plan. Earlier, Pfizer signed a merger and acquisition agreement with Mylan, a generic pharmaceutical company in last July. It is the launch of a joint venture between Pfizer's business division in charge of patent expiry medicine and Mylan. The merger will be finalized this year. The new corporation was named Viatris. As it is a separate corporation, Pfizer Upjohn's Korea subsidiary is reportedly seeking a third place separately from Pfizer. Pfizer Pharmaceuticals moved to the current Myeong-dong office from Gwangjang dong, Gwangjin-gu, Seoul in June 2007. Prior to this, Myeong-dong office was purchased in June 2006. At the time, the purchase price was reported to be ₩58 billion. According to officials from the real estate industry, the price of Pfizer Korea’s Myeongdong offices is currently set at around ₩100 billion to ₩120 billion. Profits of more than ₩60 billion were generated In 13 years.
