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- 2026-04-17 15:11:30
- Policy
- Mothers joins competition to develop Orlistat tablets
- by Lee, Tak-Sun Jan 21, 2020 06:24am
- Original Product, XenicalOrlistat, generic for Xenical, a fat absorption inhibitor used in the treatment of obesity, is being actively developed to change the product from capsules to tablets. CMG & Motherspharm are accelerating product commercialization. The Ministry of Food and Drug Safety approved the Phase III trial plan of ZEROfat tablets on Motherspharm. ZEROfat tablets were developed after the development of fat absorption inhibitors, Orlistat. Motherspharm has ZEROfat capsules with the same ingredients. Currently all 24 Orlistat formulations approved in Korea are capsules. The reason Motherspharm develops a formulation change is that tablets are more convenient to store and higher medication compliance than capsules. Capsules contain gelatin, which can cause digestive problems, making patients less compliant with the medication. In addition, tablets are known to be resistant to higher temperatures and humidity than capsules, and have the advantage of being easy to store and carry. Tablets can also be divided. Orlistat is widely prescribed in the domestic obesity drug market, so if tablets with increased medication compliance are expected, the demand will be high. The domestic Orlistat market is estimated to be about ₩25 billion. Orlistat, unlike other psychotropic obesity drugs that stimulate the central nervous system and suppress appetite, inhibits the function of lipolytic enzyme lipase to reduce the body's absorption of fat. CMG Pharm is also developing Orlistat tablets. In last September, the company received a phase III trial plan for CMG Orlistat tablets 120mg and is working on commercializing products. Both CMG and Mothers are likely to have success in commercialization as they have entered phase III clinical trials with formulation changes. Of the two companies, it is noted who will receive the product license first.
- Company
- The Rx rate of Lipitor and Plavix is high
- by Chon, Seung-Hyun Jan 20, 2020 06:27am
- Last year, the strength of patent expiration drugs stood out in the top domestic outpatient drug market. Lipitor, a hyperlipidemia treatment drug, continued to rise and remained No.1 in the prescription market for two consecutive years. The antithrombotic drug Plavix has grown by about 50% in five years. 'Twynsta', 'Crestor', and 'Aricept' also increased the amount of prescriptions despite the generics. Among the products developed by domestic companies, 'Gliatamin' and 'Rosuzet' showed a remarkable progress. Last year, Lipitor took the lead in outpatient Rxs of ₩176.2 billion, according to drug research agency UBIST. It was 8.4% higher than the previous year, winning the Rx market for two consecutive years. In 2017, Gilead's hepatitis B treatment, Viread, ranked first. Outpatient Rx Performance Rank by item in 2019 (Unit: ₩100 million,%, Source: UBIST) Lipitor is clearly ranked first in the outpatient Rx market with a gap of ₩69.4 billion from the second-largest Viread. Hyperlipidemia drug Lipitor by Pfizer Lipitor, which was released in Korea in 1999, is exceptional. More than 100 generic products have entered since 2009, and insurance prices have fallen by half compared to before patent expiration. Pfizer recently received a series of large-scale clinical studies on Koreans, engaged in a variety of social contribution activities, and is said to have concentrated on Lipitor. Last year, the prescription market showed the most notable increase in patent expired drugs. .Sanofi's Plavix last year recorded prescription results of ₩88.9 billion, up 17.3% from the previous year .Rx amount of Plavix increased 28.1% in two years from ₩69.4 billion in 2017 .Prescription performance of Plavix has risen by 48.2% in five years from ₩60 billion in 2014 .The patent expired in 2007 and has entered more than 120 generics .The accompanying rise in patent expired drugs is a very unusual phenomenon .In general, the market share drops rapidly after the release of drugs such as generics or salt-changed generics .In the domestic market, the market share is increasing .Prescriptions also increased last year, compared to last year's generic competition, including Boehringer Ingelheim's Twynsta, Eisai's Aricept and Novartis' Exforge .Due to the domestic drug price system, original drugs are said to be favorable for market share expansion .In Korea, when generics are released, the drug price of original drugs drops to the previous 70% level .After one year, the price will drop to 53.55% before patent expiration .The upper limit of the generic drug can be up to 59% of the original drug before the patent expires, and after one year, the price goes down to 53.55% like the original .After the patent expiration of new drugs, drug prices were similar to those of generics, and it is analyzed that the prescription of the original drug has increased in the prescription field .It is estimated that the market defense of patent expired drugs is firmly established by strengthening sales activities of domestic pharmaceutical companies .Lipitor is sold jointly by Jeil Pharm, while Plavix and Twynsta are sold by Dong-wha and Yuhan .Domestic patented new drug products such as Crestor (Daewoong), Aricept(Chong Kun Dang), and Harnal(Boryeong) also joined the business .Viread, which ranked No .1 in prescription drugs in 2017, fell outpatient prescriptions at ₩106.4 billion last year, down 30.5% YoY .The gap with leading Lipitors widened sharply due to drug price cuts and a decline in market share .Daewoong Bio's “Gliatamin,” a brain function improving agent of “Choline Alfoscerate”, recorded the most of ₩91.6 billion of outpatient prescriptions last year .It is up 19.5% from ₩76.7 billion in 2018 .Chong Kun Dang's “CKD Gliatilin Soft Cap” of the same ingredient also posted a prescription of ₩72.3 billion, up 14.9% from the previous year .Last year, the effectiveness of choline alfoscerate was debated, but it still rose sharply .'Rosuzet', launched by Hanmi in late 2015, recorded ₩77.3 billion, up 36.4% from last year .Rosuzet is a hyperlipidemic complex consisting of Rosuvastatin and Ezetimibe .Hanmi entered the market earlier than its competitors by securing the right to use Ezetimibe from the patent holder MSD and ranks first in the same ingredient market .Hanmi's hypertension complex, Amosartan, was listed at the top of last year with a prescription of ₩74.1 billion .Amosaltan, released in 2009, is a hypertensive complex that combines calcium channel blocker (CCB) 'Amlodipine' and angiotensin II receptor blocker (ARB) 'Losartan'.
- Company
- Novartis holds the most number of drug patents in Korea
- by Kim, Jin-Gu Jan 20, 2020 06:26am
- Sources confirm a pharmaceutical company with the highest number of pharmaceutical patent in Korea is Novartis Korea. The company owns the rights of 153 patents related to total of 29 drug items. While multinational drug companies are mostly dominating the top ten list of patent holders, Hanmi Pharmaceutical with incrementally modified drug (IMD) patents is the only Korean company in the list. On Jan. 17, Daily Pharm analyzed Ministry of Food and Drug Safety’s (MFDS) statistics on patents and found there are overall 1,881 drug patents in effect as of January 2020. The patents affect 1,093 drug items. Top 30 drug patent-holding companies in Korea Currently, 116 companies own at least one or more patents. Novartis Korea own the most with 153 patents related to 79 items. The company’s major line-up consists of Galvus, Galvus Met, Tasigna, Cosentyx, Jakavi, Glivec, Entresto, Afinitor, Stalevo, Exjade, Xolair and more. And recently, patents on Galvus and Galvus Met had been challenged fiercely by Korean pharmaceutical companies. Centering Hanmi Pharmaceutical and Ahn-gook Pharmaceutical, the Norvatis’ patent has been challenged by Korean companies’ defensive confirmation trial for the scope of patent right. The industry expects to see the original’s generics launched by August 2021 at earliest. Janssen Korea takes the second place, but has a significant gap with Novartis. Janssen holds 83 patents for 47 items, including Darzalex, Stelara, Prezista and more. Hanmi Pharmaceutical follows next on the list with 66 patents registered for 43 items. Most of them are IMDs like Amodipin, Amosartan, and Hanmi Flu. The rest of the list includes MSD Korea, GSK Korea, Takeda Pharmaceuticals Korea, Pfizer Pharmaceutical Korea, Korea Boehringer Ingelheim Korea, AstraZeneca Korea, and Bayer Korea. Hanmi Pharmaceutical is the only Korean company in the top-ten list. Expanding out the list down to top 20, there are total seven Korean pharmaceutical companies. LG Chem (27 patents), Chong Kun Dang Pharmaceutical (27 patents), Dong-A ST (24 patents), JW Pharmaceutical (22 patents), Daewoong Pharmaceutical (20 patents), and SK Chemicals (19 patents) have their places in the top 20 list. Interestingly, the top sales revenue list and the top patent-holders list do not match. As of 2018, Yuhan is the top selling Korean pharmaceutical company, but the company sits on the 13th place on the top Korean patent-holding companies’ list. The second top selling company GC Pharma is on the 21st place on the patent-holder’s list. Whereas the top selling global pharmaceutical company Pfizer is actually on the sixth place on the top patent holder’s list. Janssen is within the top ten selling pharmaceutical companies’ list, but it is on the second place for the patent holder’s list. Top 20 patent-holding multinational companies 50 multinational pharmaceutical companies’ patents affect 63.6 percent of drugs in the Korean market. The global companies hold 72.8 percent of all drug patents in Korea, which means each global company owns average of 13.9 patented drugs. Among 66 Korean companies, each one holds average of six patented drugs. However, most of the Korean companies (46 companies) own less than five patented items. 21 companies have only one item patented. Patent-holding ratio of multinational and Korean pharmaceutical companies in Korea As far as patented substance goes, metformin hydrochloride had the most number of related patented drugs with 47 items. Following the list, rosuvastatin calcium (29 drugs), amlodipine besylate (25 drugs), hydrochlorothiazide (20 drugs), losartan potassium (16 drugs), telmisartan (16 drugs), amlodipine camsylate (15 drugs), and pregabalin (15 drugs) have the most number of related patented drugs. Mostly, the patented drugs treat chronic diseases like hypertension and diabetes.
- Company
- Takeda's Kynteles indicated for first-line treatment
- by Eo, Yun-Ho Jan 20, 2020 06:26am
- Kynteles would be rubbing shoulders with tumor necrosis factor-alpha (TNFα)-antagonist in treating ulcerative colitis and Crohn’s disease. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated on Jan. 15, ulcerative colitis and Crohn’s disease treatment Kynteles (vedolizumab) won Korean Ministry of Food and Drug Safety’s (MFDS) approval on an indication for a first-line treatment. According to the approval, Kynteles would be available from Jan. 15 for prescription on treating patients with ulcerative colitis and Crohn’s Disease after having to fail in remission by conventional treatment (with corticosteroid or immune therapy). This means the treatment can be used, on the same treatment level as TNFα-antagonist and other biological drugs, to treat patients with inflammatory bowel diseases. The two most common forms of inflammatory bowel diseases, ulcerative colitis and Crohn’s disease, tend to relapse and remit repetitively. Studies found half of patients with inflammatory bowel diseases faced limits to their treatment so far having chronic, relapsed or worsened symptoms, damaged digestive systems and induced complications. Besides clinical remission, intestinal mucosal healing is globally emerging as a new treatment target for inflammatory bowel disease. Kynteles is a gut-selective treatment designed to specifically antagonize the α4β7 integrin, a cause of intestinal inflammation, and to inhibit the binding of α4β7 integrin. Unlike existing treatments possibly increasing risk of tuberculosis and infection, Kyntelels’ efficacy as systemic immunosuppressant has not been confirmed. According to GEMINI LTS study result, the vedolizumab drug demonstrated long-term effectiveness and safety profile in patients with ulcerative colitis and Crohn’s disease, observing clinical remission maintained up to 152 weeks. And in Phase 3b VERSIFY study testing the treatment’s efficacy in 101 patients with severe Crohn’s disease, 15 percent and 12 percent of patients treated with Kynteles showed complete mucosal healing and endoscopic remission, respectively. In a recent study, Kynteles demonstrated statistically superior clinical remission compared to conventional TNF-α antagonist. Comparing patient groups either intravenously injected with Kynteles or subcutaneously injected with Humira (adalimumab), VARSITY study found 31.3 percent of Kynteles group reached clinical remission at week 52, but only 22.5 percent of Humira group did. President of Korean Association of the Study of Intestinal Diseases (KASID), Kim Joo Sung claimed, “In Korea as of 2018, over 40,000 people were diagnosed with ulcerative colitis and 20,000 people with Crohn’s disease, and their prevalence rates have been soaring fast lately in Asian region including Korea. As the diseases require long-term treatment, alleviating symptoms are not sufficient, but rather the patients should also improve mucosal healing and treat their inflammatory bowel diseases considering safety profile of drugs.”
- Policy
- The MFDS releases Metformin’s NDMA test
- by Lee, Tak-Sun Jan 20, 2020 06:26am
- The MFDS has prepared a test method to properly detect NDMA (N-nitrosodimethylamine), which is a carcinogen, in the diabetes drug 'Metformin'. Unlike Ranitidine or Nizatidine, the test conditions are GC (Gas Chromatography) -MS/MS. This is the same test used by Singapore health authorities that detected NDMA in Metformin. The MFDS unveiled the test method, saying that it is also collecting drugs for sale on the market. The MFDS released its NDMA test method for Metformin using GC-MS / MS on its website on the 15th. As publicly available test methods are released, pharmaceutical companies can conduct their own tests with the test method. An official of the MFDS said, "We have prepared a test method in consideration of the test method and material properties conducted in Singapore". However, a pharmaceutical's own tests, subject to LC (Liquid Chromatography), before the test release, are expected to be re-validated. The MFDS official said that in this case, he will look at whether the LC condition test is appropriate, but it is necessary to retest as the official test method is GC. The MFDS added that it is also conducting inspections of commercial distribution items with the release of the test method. An official from the MFDS said, "We started the inspection of the distribution items on the market as we proceeded with the system investigation last month and prepared the test method, and specific test subjects and results will be disclosed later". The industry believes that NDMA has been collected and inspected for products made from the same raw materials as those for Singapore. It is observed that the source of raw materials and finished products were collected after the systematic investigation was confirmed. This is due to the fact that it takes a long time to conduct a full survey as there are 640 approved Metformin products in Korea. As the MFDS has started a full-scale investigation, the tension in the pharmaceutical industry is expected to increase. However, there are many cases where NDMA has not been detected in its own investigation, and there is no detection case outside of Singapore, so it is optimistic that there will be no problem in Korea.
- Company
- Samsung BioLogics opens new CDO lab in San Francisco
- by Lee, Seok-Jun Jan 20, 2020 06:25am
- Samsung BioLogics will establish a CDO R&D Lab in San Francisco in the first half of this year. The company is the first US corporation. Samsung BioLogics plans to further expand to other regions of the US and Europe. Samsung Biologics President Tae-han Kim and Vice President John Lim announced the plan at the JP Morgan Biohealth Conference in San Francisco. Tae-han Kim, President & CEO, Samsung BioLogics (left) & Vice President John Lim(Right) President Tae-han Kim shared the business status. President Tae-han Kim said, "We are currently conducting 35 CMO products, 47 product approvals, 42 CDO projects and 10 CRO projects, & expanding our global business with 47 product approvals". As the project accumulates, the plant utilization rate is rising. Kim said, “The first plant is nearing its maximum utilization rate and the second plant is currently in full operation, the third plant has 35% of its production capacity and will raise it to 60% this year”. Vice President John Lim announced the entry into the CDO R&D Lab in San Francisco, USA in 2020. This is to create synergy with customer satisfaction and production base in Korea through overseas expansion. "We are looking into the CDO R&D lab in San Francisco in 2020 and further expansion in other parts of the United States and Europe," said John Lim. He said, “Samsung BioLogics began expanding its value chain to CDO/CRO in 2017, and established a one-stop service from cell line development to clinical material production through sCMO, quality control/analysis, and commercial mass production. Biotech and Big Pharma have more than 9,000 locations".
- Company
- Pfizer's EGFR TKI to compete against Iressa and Giotrif
- by Eo, Yun-Ho Jan 17, 2020 06:27am
- Pfizer Pharmaceutical Korea is stepping into the lung cancer-treating EGFR TKI market. Industry sources reported, Korean health authority is expected to grant approval on Pfizer’s epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) within the first quarter of the year. Last year, the global company has submitted a marketing approval application. Vizimpro won approvals from the U.S. Food and Drug Administration (FDA) and European Commission in October 2018 and April 2019, respectively. The drug is a first-line target therapy treating patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutations. It is categorized as a second generation therapy like Giotrif (afatinib) by Boehringer Ingel Heim. EGFR TKI products approved in Korea Currently, first generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (Erlotinib), second generation Giotrif, and third generation AstraZeneca’s Tagrisso (osimertinib) are available for prescription. When the company releases Vizimpro, it would directly compete against Iressa, Tarceva and Giotrif. But the competitor line up would change when Tagrisso is listed as a reimbursed first-line treatment. Considering Vizimpro is a follow-on drug, Pfizer would price the drug comparatively lower and rather aim to receive reimbursement fast. Vizimpro’s efficacy was confirmed in a Phase 3 study, ARCHER 1050. The clinical study compared arms each treated with dacomitinib and AstraZeneca’s first generation medicine Iressa, and observed overall 425 patients with NSCLC. As a result, Vizimpro lowered patients’ hazard ratio 41 percent more than Iressa, whereas median progression-free survival (PFS) in the Vizimpro arm was 14.7 months compared to 9.2 months in the Iressa arm. However, Vizimpro group had more adverse reaction reported. The most common third-level and higher serious adverse reactions were acne (14 percent) and diarrhea (eight percent) in Vizimpro group, and abnormal liver enzyme level (eight percent) in Iressa group. 60 percent of Vizimpro-treated patients had to adjust treatment dose due to the side effects.
- Company
- Nexava’s patent expired, Why generics not released yet?
- by Kim, Jin-Gu Jan 17, 2020 06:24am
- Generics have not appeared even though the patent for hepatocellular carcinoma 'Nexava' (Sorafenib) has expired. Hanmi is reportedly having difficulty in generic development even though it has actively solved the patent problem. In some industries, abandonment is raised. Hanmi is poised to bring it to market as soon as the bioequivalence test and licensing process is completed. According to the pharmaceutical industry on the 14th, Hanmi Pharmaceutical has challenged to develop Nexava alone. The item went to the Supreme Court and worked hard enough to pass the patent. There are three patents on Nexava. Bayer, the original company, has registered patents for materials, crystalline patents, and formulations and uses. Among these, Hanmi has succeeded in overcoming the crystalline patent and the formulation and use patent. In 2015, Hanmi Pharm claimed a negative jurisdiction for judging crystalline patents and an invalidity trial for formulation and use patents. The patent dispute was fierce enough to go to the Supreme Court. In the end, the Supreme Court concluded the dispute over two years on the side of Hanmi Pharm in both patent disputes in 2017. As a result, Nexava-related patents were left with only one patent. The patent even expired this month. The hurdles for generic releases are gone. Nevertheless, the launch of generics for Nexava are still uncertain. As of the 14th, the generics aren’t be identified in the drug product authorization list of the agency. This is an unusual interpretation given that generics are generally released in accordance with the expiration of material patents. It did not pass the bioequivalence test. Hanmi conducted bioequivalence test in August 2015 named Hanmi Sorafenib. As a result, it failed to confirm bioequivalence test. With this, some have raised doubts about whether Hanmi has abandoned its development. Hanmi made it clear that it was not true about abandonment. Hanmi has been on the verge of reviving since March last year. It is reported that the recent recruitment of patients is over. An official from Hanmi said, "We will proceed with the application for approval as the bioequivalence test is completed". According to IQVIA, a pharmaceutical market analyst firm, Nexava's annual sales are ₩26.3 billion (as of 2018). If Hanmi succeeds in launching the generics as planned, it is expected that it will be able to secure a significant portion of Nexava's sales, as it is under exclusive development. So far, only Hanmi has succeeded in avoiding Nexava patents. Yuhan Corporation, JW pharmaceutical, and Ahn-gook Pharmaceutical challenged the patent, but withdrew the patent trial request.
- Company
- Dong-A ST finished Abbvie’s ₩48 billion down payment
- by Lee, Seok-Jun Jan 17, 2020 06:24am
- Dong-A ST completed a 36-month split recognition of the Abbvie technology export contract of $40 million (about ₩48 billion). The 36 months is a period in which the two companies are considering the selection of pipelines. In other words, the preclinical study has countdown on the assumption that the pipeline has been successfully derived. Dong-A ST transferred the technology of MertaK inhibitor DA-4501 in the process of pipelines to Abbvie in December 2016. MerTK inhibitors are a new mechanism of immunological anticancer drugs that inhibit the activity of MerTK (MerTyrosine Kinase) protein and help the immune system. According to the industry on the 15th, Dong-A ST completed the 36-month split recognition of the Abbvie technology export contract by November last year. In the meantime, the $40 million contract has been booked at $ 1.11 million (about ₩1.3 billion) monthly and $3.33 million (about ₩3.8 billion) quarterly. Dong-A ST lost fixed profits after the split recognition. However, additional milestones can be expected as clinical progress Dong-A ST's Abbvie technology export maximum milestone is $ 485 million, excluding the $ 40 million contract. As clinical progress progresses, the inflow of royalties increases. According to the company, there are no milestones for receiving pipelines. After the down payment, the following fees are based on preclinical results. Since then, the milestones will increase in size. An official of Dong-A ST explained, "The Abbvie’s split-up recognition period is the period in which the pipeline is derived, and the pipeline is expected to be derived soon. If successful, it will enter the pre-clinical". The two companies, on the other hand, are obliged to carry out joint development until pre-clinical. For this, Dong-A ST and Abbvie formed Joint Research Committee. Steps after pre-clinical will be carried out by Abbvie alone.
- Policy
- MFDS updates drug supply suspension list from Q2 2019
- by Lee, Tak-Sun Jan 17, 2020 06:22am
- Handok and Korea AbbVie are respectively suspending the supply of antiulcer treatment Gabet tablet (ecabet sodium), and hepatitis C treatment Viekira (paritaprevir-ritonavir-ombitasvir) and Exviera (dasaabuvir sodium) in Korea. According to the pharmaceutical industry on Jan. 15, Ministry of Food and Drug Safety (MFDS) recently disclosed a list of suspended drug supply suspension from the second quarter in 2019. To prevent pseudo demand (panic-buy) on the drugs, MFDS withheld immediate disclosure of the news and posted the list on the ministry’s pharmaceutical information website after six months. Accordingly, the website has been updating last year second-quarter’s drug supply suspension list from December last year. The updated list informed Handok is ceasing the sales of Gabet 500 mg tablet after its April stock goes out as its annual sales volume has been too low. The company explained, the supply of the medicine would be unaffected, because another product with the same agent (Jeil Pharm’s Ecat 500 mg tablet) is still available in the market. Moreover, the supply of hepatitis C treatment Viekira and Exviera imported by Korea AbbVie has been suspended since August last year. The decision was made as the company’s Mavyret with improved efficacy and better administration method has been released in September 2018. GlaxoSmithKline Korea also stopped supplying Haemophilus influenza type B (HIB) vaccine Vaxemhib from August last year. Apparently, the company has decided to shut down the manufacturing of the vaccine in Korea inevitably, due to the vaccine department’s plan to improve business efficiency and to integrate and check up production line. The company noted that even if Vaxemhib supply is suspended, an alternative option, LG Chem’s HIB vaccine Euhib, is still accessible. Jeil Pharm’s UFT-E 0.5 g granule supply has been cut as well since August last year due to the partner company’s decision to suspend supply in Korea. The company informed patient’s access to treatment would not be affected significantly as other capsule products with the same substance are available. Also, the company added it would hold on to its product license until the stock is completely out in the market and cancel it after confirming the stock-out. Supply of an original antibiotics, Finibax 0.25 g injection (doripenem monohydrate) marketed by Ildong Pharmaceutical, has been stopped from August last year. The importing company elaborated importing the product to Korea has been unfortunately ceased due to increasing deficit made by the high production cost. JW Pharmaceutical stopped importing enteral nutrition solution Encover from June last year as the Japanese manufacturer has stopped supplying the product. The Korean company has recently informed the product’s supply would resume from February. A pharmaceutical company is required to report MFDS of suspension of d any rug supply 60 days prior to the time. Apparently, the ministry is considering on disclosing the drug suspension information immediately to the public.
