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- Pfizer's Novasc 10mg packaging will change to 28 tablets
- by Jung, Hye-Jin Jan 16, 2020 06:07am
- Pfizer's Novasc 10mg packaging unit will change from 30 tablets to 28 tablets. In addition, many drugs, including Bayer's antibiotic Avelox and Samjin Pharm's Gelma suspension, were sold out. According to the wholesale industry on the 14th, 30 tablets of Novask tablet 10mg tablet of Korean Pfizer will be discontinued and 28 tablets packaging will be supplied. The only discontinued item is 30 tablets of 10mg, and 30 tablets of 2.5mg, 5mg tablets and 500 tablets of 5mg tablets are supplied unchanged. Due to the delay in global production and supply, 30 tablets packaging of Bayer's Avelox Tablet 400mg is in short supply. Chong Kun Dang, which distributes Avelox, said it will be available by April 20. Samjin Pharmaceutical announced on the 14th that 125 pouch packaging products (25 pouches*5EA) of Gelma Suspension 10g were sold out. The reason for the absence of stock and the timing of resupply were not disclosed. Pfizer's psychoactive drug, Halcion 0.125mg, is also sold out due to a shortage of supplies. The cause is a delay in the supply schedule, which Pfizer expects to be available from March. Allergy medications Montelukast 10mg and Montelukast Chew 5mg and 4mg from Dongkwang Pharm are also in imbalance between supply & demand, and will be supplied again at the end of next month. It will be resupply in mid-March due to the delay. Jeil's 30-pack package of Bondube 60mg for osteoporosis treatment will be resupplyed in mid-March due to delays in product improvement. The packaging of 30 tubes of Ganfort UD 0.4ml, an eye drop solution by Allergan, is also temporarily sold out due to delays in import schedules. It will be resupplyed on February 14.
- Policy
- IMD-generic drug price differential regulation is revised
- by Lee, Jeong-Hwan Jan 16, 2020 06:07am
- Expectations are growing in the news that the Ministry of Health and Welfare is announcing the reform of the generic drug price regulation, which recognizes the value of IMD and maintains the premium pricing clause. In particular, the revised plan will postpone the regulation of IMD next year instead of this year, and if there are not many new drugs of the same class released, it is likely to include a plan to maintain the current drug price. There is an evaluation that the Ministry of Health and Welfare has signaled that it will implement a policy based on advanced IMD. According to the industry on the 13th, the reform of the drug price regulation of the Ministry of Welfare will not stop at simply easing the price regulation of IMD. Some experts believe that it can also be seen as a ‘game changer’ that will stop the current bitter generic competition and serve as a cash generator to lead the pharmaceutical industry ahead of new drug development. The Ministry of Health and Welfare is expected to proceed with some revised administrative notices of the Amendment and Adjustment Criteria. It contains the Ministry of Welfare's policy to adjust the price of IMD, unlike simple generics, to exempt regulations. The Welfare Ministry will release it as early as this week. In this case, the basic framework of some amendments announced by the government last year is likely to be implemented in July of this year, and the revised parts will be implemented afterwards through administrative procedures. The industry's proposed amendment is to revise the revised synthetic and biopharmaceutical adder system to guarantee the addition maintenance period of IMD. This means that they will be differentiated from generics in recognition of their efforts to develop IMD. This is due to the consensus that the government, the pharmaceutical industry, and the National Assembly's Health and Welfare Committee created a consensus on maintaining IMD’s premium pricing policy. There are two additional scenarios that the industry anticipates: delaying the implementation of IMD price regulations and premium pricing policy demonstrating progress. As a kind of methodology, the postponement of implementation is intended to give a period of preparation for IMD development capabilities for generic pharmaceutical companies. Demonstrating progression In the case of advanced IMD, if a number of IMD of the same type are not developed and released, there is a possibility that a policy will be prepared to maintain the current price advantage. If a IMD can't be released by anyone, it is determined that it is a medicine that has proven to be somewhat progressive. Source: Korea Pharmaceutical Bio Association Specifically, experts in the pharmaceutical industry classify the criteria for the IMD into ▲the improvement of patient medication convenience through the change of administration route, ▲the improvement of patient medication compliance through the change of dosage forms such as sustained-release tablets, and ▲the improvement of dosage and usage through the change of salt. For example, the famous antivirals, Tenofovir by Gillead Science replaces the existing TDF (Tenofovir disoproxyl fumarate, Viread) with TAF (Tenofovir alafenamide fumarate, Vemlidy). This proved progressive. TAF with altered TDF salt improves renal and bone cell side effects and is equally effective with a 10% dose of TDF. It is estimated that 90% of the drug used to obtain the drug is reduced, and the size of the pill is smaller, improving patient safety and medication convenience. The industry understands that the policy of the Ministry of Health and Welfare is to ease the drug price restrictions on the IMD. The pharmaceutical industry is in full agreement with this view. A pharmaceutical company official in Korea said, “IMD proves to be progressive will in some way inspire the development of pharmaceutical companies and encourage the advancement of the entire industry, in particular, the Ministry of Health and Welfare was convinced of the exception of the regulation on the price of IMD, and it seemed to signal the generic developer to turn to overseas market by turning to IMD”. A official said, “But at present, no specific proposals are disclosed, so we cannot expect too much IMD price regulation positively, and The Ministry of Health and Welfare will need to be unveiled on which price exceptions will apply”. Another B Pharmaceutical official said, “We believe that the Ministry of Health and Welfare has largely embraced the claims of the pharmaceutical industry. Both probation and preferential treatment are more than expected, and we wonder how the IMD standards will be proven and many pharmaceuticals will go ahead and improve the constitution”. The official said, “When the government's drug price regulation was first released, it was burdened with the licensing and restriction of the addition system, and the biggest meaning is that the Ministry of Health and Welfare agrees that the IMD is more valuable than generics”.
- Policy
- Atozet generic’s gold rush unaffected by new regulation
- by Lee, Tak-Sun Jan 16, 2020 06:07am
- The Korean pharmaceutical industry is keeping a close eye on a series of generics following MSD Korea’s blockbuster combination drug for hyperlipidemia, Atozet (ezetimibe/atorvastatin calcium hydrate), in development with individual bioequivalence test, as the government has enforced new regulation on joint bioequivalence test. Despite the already-saturated statin-ezetimibe combination drug market and increased cost of developing generic with individual bioequivalence test, the industry experts analyze the industry’s needs for the hyperlipidemia treatment generic is still high. According to Ministry of Food and Drug Safety (MFDS) on Jan 13, total 21 cases of bioequivalence test protocols have been cleared for Atozet generics. 18 cases were approved last year alone, and additional two cases were approved this year. Expecting Atozet’s post-marketing surveillance (PMS) period to expire on Jan. 22 next year, Korean pharmaceutical companies are in a hurry to develop follow-on drugs. The industry has expected many generics would be developed after the blockbuster Atozet generating accumulated prescription sales of 44.8 billion won (according to UBIST) as of third quarter in 2019. 21 bioequivalence test protocols have been approved so far proves the drug’s height of popularity. However, some industry insiders once predicted the popularity of Atozet generic development would subside soon as Ministry of Health and Welfare (MOHW) has announced March last year of a plan to lower pricing of generics developed with joint bioequivalence test from July at earliest. The insiders also hinted the ezetimibe-statin combination drug market being excessively saturated with 202 items approved including Atozet, would affect companies developing follow-on drugs. But it turns out those predictions have completely missed the mark. The number of joint bioequivalence tests has dropped due to the revised pricing regulation, but individual companies seem to be conducting their own tests to develop their generics. After nine companies—Medica Korea, Daewoong Bio, Samik Pharm, Ahn-gook Pharmaceutical, Union Korea Pharm, Intro Bio Pharma, Korea Prime Pharm, Hawon Pharm, Youngil Pharm and Wooridul Pharmaceutical—have been approved for joint bioequivalence test on passed Jan. 30, no other joint test protocol has been approved. The sudden fall in joint bioequivalence test approval is because Atozet generic can apply for approval listing from Jan. 22, 2021 when the original’s PMS expires. But generic based on the joint test would probably take the reduced pricing. Although Wooridul Pharmaceutical and Korea Prime Pharm initially planned to conduct a joint test, they respectively received approval for individual tests on Sept. 20 and Jan. 10 last year. Individually conducted bioequivalence test is more financially burdening for each company, compare to co-conducted test with two or more companies. Nevertheless, the companies are jumping on to take individual tests with no hesitance as they are running out of the list of potential generic development. A pharmaceutical industry personnel noted, “The number of new generics would descend with the healthcare authority regulating joint bioequivalence test, but markets with popular original would be affected far less. A ten-billion-won worth original with soon expiring exclusivity is getting even rarer these days. So it is not surprising Atozet is attracting many companies to develop follow-on drugs.” Meanwhile, some criticizes Korean pharmaceutical companies blindly developing profitable original’s generic, despite the super-saturated market.
- Company
- Zejula indicated for late-line therapy on ovarian cancer
- by Eo, Yun-Ho Jan 16, 2020 06:06am
- Anticancer treatment Zejula is now available for a monotherapy prescription on patient with ovarian cancer, who has been treated with fourth-line or later treatment. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated Ministry of Food and Drug Safety (MFDS) has additionally indicated Zejula’s (niraparib) on Dec. 24 for treating patient with relapsed ovarian cancer, who has been treated for more than third-line treatment. From March last year Zejula, the first poly ADP ribose polymerase (PARP) inhibitor used regardless of BRCA mutation, has been approved in Korea for maintenance treatment of adult patients with recurrent epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer), who are in a complete or partial response to platinum-based chemotherapy. And in December last year, the government granted healthcare reimbursement on the indication. However, the first reimbursed indication was limited to patients with BRCA mutation. By expanding the indication, Zejula is now the only PARP inhibitor in Korea indicated for BRCA mutation-positive patient regardless of platinum sensitivity, or hormone recombination deficiency (HRD)-positive adult patients, who have been treated with third-line plus chemotherapy. The indication expansion was based on an open-label multi-center QUADRA study evaluating the safety and efficacy of Zejula treating adult ovarian cancer patients with a record of third-line plus treatment. Treating HRD-positive platinum-sensitive patient group demonstrated objective response rate (ORR), a primary endpoint of the study, of 24 percent, whereas BRCA mutation-positive platinum-sensitive patient group, BRCA mutation-positive platinum-resistant patient group and BRCA mutation-positive platinum-refractory patient group demonstrated 39 percent, 29 percent and 19 percent, respectively, which confirmed the clinically meaningful benefit of the treatment. The secondary endpoint of the study, median duration of response (mDOR) of 8.3 months was observed in HRD-positive platinum-sensitive patient group. The finding confirmed the treatment’s safety profile can be managed by controlling the treatment dose.
- Policy
- Daewoong-Merck faces new contender with metformin ER
- by Lee, Tak-Sun Jan 16, 2020 06:06am
- Once almost dominated by Daewoong Pharmaceutical and Merck, the high-dose (1000 mg) metformin extended-release (ER) tablet market has a new competitor. Dalim Biotech has joined the race with newly approved ER tablet. With extensive individual drug portfolio, Dalim Biotech has well-prepared for the competition, sources say. On Jan. 9, Korea’s Ministry of Food and Drug Safety (MFDS) has granted sales approval on Dalim Biotech’s Glupa XR 1000 mg tablet. This is not the first time a high-dose metformin tablet has been approved. The original’s manufacturer Merck and its co-marketing partner in Korea Daewoong Pharmaceutical had Glucophage XR 1000 mg tablet and Diabex XR 1000 mg tablet cleared, respectively, on Mar. 18, 2010. Since then Daewoong Pharmaceutical’s subsidiary Daewoong Bio and Hanall Biopharma also nabbed the approval. Currently, Daewoong Pharmaceutical and Hanall Biopharma are leading the individual metformin ER tablet market, followed by the original’s Merck. Basically, Merck and Daewoong Pharmaceutical are hogging the market. Other pharmaceutical companies have not dared to approach the high-dose metformin ER tablet market, as it requires tablet-size reduction technology. The patent for the technology was still protected until Mar. 10 last year. In July 2018, Dailm Biotech had its bioequivalence test approved and won the approval on high-dose metformin ER tablet after acquiring the drug equivalence. It was first time for a follow-on drug company to achieve the outcome, besides the Daewoong Group. Dalim Biotech actually has a fairly large share in the individual metformin drug market with Glupa tablet. According to UBIST’s data, the drug generated 4.2 billion won until the third quarter last year. Besides the immediate release tablet, Dalim Biotech now has a firm foundation to challenge the once-daily administered ER market with item approval received on ER 500 mg and 1000 mg tablets. The pharmaceutical industry is eyeing on the individual metformin drug market as GC Pharma has recently started supplying its original Glucophamage in Korea. With imminent changes approaching fast, Dalim Biotech’s high-dose ER tablet is expected to shake up the market landscape as well.
- Policy
- IMD, virtually confirmed without drug price restrictions
- by Lee, Jeong-Hwan Jan 15, 2020 06:44am
- The drug price reform plan, which excludes 'proven advancement IMD' from the scope of generic drug price regulation, has been virtually confirmed. The decision was made to maintain some of the existing provisions for drug price benefits, with the difference between IMD and general generics. According to the pharmaceutical industry and the National Assembly's Health and Welfare Committee on the 13th, Myung-seop Kwak, the head of the Insurance and Pharmaceutical Affairs Division of the Ministry of Health and Welfare, met with Hee-mok Won, the Chairman of the Korea Pharmaceutical Biotechnology Association this morning and explained the improvement of the generic drug price regulation, which is expecting in July. The Ministry of Health and Welfare is expected to re-administer the proposed drug price regulation, which contains the provisions for maintaining the premium pricing policy for incrementally modified drugs. The Ministry of Health and Welfare previously announced a partial revision of the ‘Determination and Adjustment Criteria for Pharmaceuticals’, which contains generic drug price regulations on July 2 last year. Since then, the pharmaceutical industry has repeatedly made claims that drug prices should not be regulated by treating generic drugs with equivalent IMD, which have demonstrated excellent advances in patient compliance and side effects. In particular, the National Assembly Health and Welfare Committee sympathized with the claims of the pharmaceutical industry, emphasizing the need to recognize the value of IMD in the domestic pharmaceutical industry that is targeting new drug powers. As a result, the Ministry of Health and Welfare is expected to reintroduce the revised plan of drug price regulation, which was announced last July through administrative procedures. In the re-notification notice, which conditions should be met by the IMD that will maintain the premium pricing policy and what level of premium pricing policy will be provided for the IMD that meets the criteria. An official of a large pharmaceutical company in Korea said, “I understand that the head of a pharmaceutical company met with the head of the Korea Pharmaceutical Association this morning to explain the exception of the regulation of IMD price and to obtain opinions and consent, and the government has partially acknowledged the necessity of the IMD in the pharmaceutical industry”. "In fact, unlike generics, we need a lot of resources to make advanced drugs that are proven to be progressive. We need to demonstrate proper efficacy and function through preclinical animal experiments and phase III clinical trials. “Fortunately, the government seems to have chosen a policy to encourage pharmaceutical companies' will of the IMD”.
- Policy
- Diverse response for premium pricing policy for IMD
- by Lee, Jeong-Hwan Jan 15, 2020 06:37am
- The Ministry of Health and Welfare has virtually confirmed the premium pricing policy of excluding incrementally modified drugs(IMD) from generic drug price regulations, and since then, subtle airflow has been detected in the domestic and overseas pharmaceutical industry. The expression of the reform of the Ministry of Health's Welfare on Drug Price Regulations is mixed between multinational companies with a large proportion of original new drugs and domestic companies centered on generic and incrementally modified drugs. it tends to take domestic industry’s side. According to the pharmaceutical industry on the 14th, the direction of the reform of the premium pricing policy for incrementally modified drugs by the Ministry of Health and Welfare was quickly delivered to domestic and foreign pharmaceutical companies RA (development and licensing) and MA (pharmaceutical and loan) agents. As the scope of drug price regulation is reduced to generics, some domestic pharmaceutical companies that have been strategically focused on incrementally modified drugs become practical targets, and global companies with original drugs complain about unfair drug price management. To review directly at the background of complaints, the Ministry of Health and Welfare does not maintain the premium pricing policy for incrementally modified drugs, but rather establishes a reasonable price-listing environment for original new drugs, which are heavily invested in cutting-edge technologies and clinical trials and are the source of development of new drugs. The Ministry of Health and Welfare, which cut its original drug price as much as possible every time it is listed, is inconsistent with maintaining the premium pricing policy by overturning the regulation that the Ministry of Health and Welfare had noticed. Indeed, some foreign companies dissatisfied with the domestic drug price listing process have decided to pass in other Asian countries so called, 'Korea Passing' such as China and Japan while skipping Korea. In the end, Korea's drug price estimates are too low, which is the argument of foreign companies. Only incrementally modified drugs with overwhelming domestic market share were decided as the preferential key, which led to the dissatisfaction of domestic drug price policies. Indeed, in 2016, the Korea Multinational Pharmaceutical Industry Association (KRPIA), a group of international multinational pharmaceutical companies, criticized the government's plan to improve insurance prices for global innovative new drugs as a 'differentiated drug price premium pricing policy excluding multinational companies'. At the time of controversy, the government took out the policy that domestically developed new drugs applied 100% innovative drug price premium policy while globally introduced new drugs did not apply regardless of innovation. An official of Global A, who asked for anonymity, said, “The fair price policy for new drugs, generics, and incrementally modified drugs is a claim that foreign companies have consistently demanded. The premium pricing policy for incrementally modified drugs is not wrong, but a corresponding original drug price policy should be prepared”. A official said, “The need for drug price policy to protect its own industry is recognized, but Korea needs a new drug price policy that covers both its own and other countries to become a pharmaceutical power. The original drug price policy needs to be improved to reflect this value”. On the other hand, it is too much for the original company to try to involve the premium pricing policy for incrementally modified drugs, rather than generics. Incrementally modified drugs, which have improved administration and dosage compared to the original by changing the route of administration, dosage form, and salt, and improved the convenience of patient medication, are marked by the progress and significant cost and effort for actual development. Although it is not as difficult as a new clinical trial, the incrementally modified drugs that have advanced properties require animal studies and small-scale phase III clinical trials. In their opinions, current pricing policy is reasonable. The head of the development team of the domestic B pharmaceutical company said, “Honestly, simple salt-modified generics adopt the safety and efficacy data of the original new drug as it is, and there is no progress and it is easy to reproduce, and this is why generic drug price policy is not fair. However, it is hard to accept the opposition to the premium pricing policy for incrementally modified drugs with sufficient progress compared to the original”. The head of the development team of the domestic B pharmaceutical company said, “Korea's original drug price calculation standard is too low. Some multinationals claim that the authority to control drug costs is the responsibility of the government, not the company, the characteristics are different and individualized policies are needed”.
- Policy
- Company executives were accused of vaccine bidding bribe
- by Lee, Jeong-Hwan Jan 15, 2020 06:32am
- Foreign pharmaceutical company executives who received ₩ billions from drug wholesalers for trials of vaccine distribution such as bidding, supply, and price setting are tried. Employees of a large domestic pharmaceutical company accused of committing the same type of crime were also prosecuted. Both employees are accused of receiving payments in connection with the National Immunization Program (NIP). The prosecution is suspected that pharmaceutical companies set up wholesalers to supply vaccines to the Public Procurement Service to secure volume or price. According to the complaint filed by the Justice Department to Democratic Party of Korea's Representative's Office of Tae-Seop Geum on the 13th, the Seoul Central Prosecutor's Office recently filed employee Mr. Lee (57), a global S Pharmaceutical company and an employee Mr. An(48), a large domestic company, with dereliction of duty. Mr. Lee is accused of receiving a total of ₩1,694,400,000 from two wholesalers in return for convenience such as designation and unit pricing of pharmaceuticals and issuance of a supply letter of approval when bidding vaccines from 2004 to last August. Mr. Lee took a profit by handing a ATM card from a wholesaler and then remitting the money back and withdrawing. In addition, Mr. Lee has been receiving cash from the other wholesalers over nine rounds of cash, including the wons, euros and dollars. Mr. Ahn was charged with receiving the same purpose from 2010 to last November and gaining property benefits worth ₩262 million from a wholesaler. Mr. Ahn received a corporate credit card from a wholesale company to take advantage of his property and freely received a car worth ₩60 million. The prosecution arrested them on 17th last month and restricted them on 20th to continue the investigation. The prosecution is suspecting that pharmaceutical companies such as Korean vaccine, Yuhan, Guangdong Pharmaceutical, Boryung Pharmaceutical, and GC Green Cross will offer wholesalers as vendors to provide vaccines to the Public Procurement Service to secure volume or price. In particular, Korean vaccines were caught by the Fair Trade Commission after discontinuing the supply of intradermal BCG vaccine, also known as 'fire-injection', in order to increase sales of expensive transdermal BCG vaccines monopolistically. The prosecution is also investigating allegations of collusion and back-trade in the vaccine supply process, including tuberculosis, cervical cancer and pneumococcus, after taking over the findings from the FTC and PPS.
- Company
- Recommending ezetimibe, “The lower the LDL-C, the better”
- by Eo, Yun-Ho Jan 15, 2020 06:30am
- 김효수 교수 With robust evidences of efficacy, ezetimibe is now one of major options for treating dyslipidemia. “The lower the better.” The result of clinical trial IMPROVE-IT, with the slogan claiming the lower the low-density lipoprotein cholesterol (LDL-C) is the better the health benefit, earned its recognition when it was announced in 2015. Numerous pharmaceutical companies in Korea raced each other to release combination drugs with ezetimibe plus either atorvastatin or rosuvastatin. The products landed themselves on the market safe and sound. Given the positive response, some wondered about the unexpected recommendation addressed in Guidelines for the Management of Dyslipidemia 2018 published by Korean Society of Lipid and Atherosclerosis’ (KSoLA). While American Association of Clinical Endocrinologists (AACE) updated its guideline in 2017 with new ‘extreme risk’ category and advised medical professionals to bring the LDL-C level down to under 55 mg/dL, the KSoLA’s latest guideline maintained the target treatment level of LDL-C for ultra-high risk group at 70 mg/dL. Meanwhile, European Society of Cardiology (ESC) has recently recommended setting treatment target LDL-C level for extreme risk group at under 40 mg/dL. With an expectation of more assertive use, ezetimibe was also listed as second-line treatment option following statin treatment. Despite the release of new medicine like PCSK-9 inhibitors, the Korean guideline generally took the conservative approach. And what are the thoughts of Korean clinical doctors on dyslipidemia treatment strategy after the newest edition of the guideline was published more than a year ago? Daily Pharm interviewed Kim Hyo-soo, the then Professor at Department of Internal Medicine of Seoul National University Hospital, on the issue. At the time of publishing, he was the chairman of the society and has actively supported prescription of ezemitib at any time. - About setting 'treatment target of LDL-C level 55 mg/dL' and 'ezetimibe as first-line treatment,’ did you think it was too soon? In my opinion, ezetimibe is not in any way insufficient to be a first-line treatment. But many did not see a good reason to add ezetimibe to the first-line treatment option, when a patient can reach the target level with statin monotherapy. So the guideline recommended medical professionals to prescribe the medicine to patients struggling to manage the cholesterol level only with statin. Treatment target level of LDL-C actually differs among many clinical trials. When setting 70 mg/dL as an idealistic level, the needs for ezetimibe as a first-line treatment are low to be honest. But it’s another story when setting the level at 55 mg/dL. Usually the level is unreachable with statin monotherapy. It needs a combination therapy with ezetimibe. Personally, I prescribe statin-ezetimibe combination therapy as first-line treatment. In other words, each doctor’s level of lowest value varies, so the guideline had to take a rather careful approach. On a side note, I did suggest setting 55 mg/dL as target LDL-C level when we were updating the guideline. Now I’m looking into 35 mg/dL, even. - What had enabled ezetimibe to lower LDL-C level and to ultimately prevent cardiovascular events? LDL-C can be divided into apolipoprotein B (ApoB)-48 and ApoB-100. Previously, only ApoB-100 was considered to be accumulated as plaque, but apparently studies have found ApoB-48 also works the same. Now it’s more convincing that statin’s ApoB-100 synthesis inhibition combined with ezetimibe’s ApoB-48 absorption inhibition is lowering LDL-C level more effectively. For a long time, hyperlipidemia treatment was solely dependent on statin and the practice has prescribed a high dose of it. Combination therapy with non-statin class, previously quite unpopular, is now gaining the attention and PCSK-9 inhibitor, expensive but powerful in dropping LDL-C level, is also used more often. The time has changed, eventually. - Is there a particular patient group you would especially recommend ezetimibe combination therapy? Cholesterol absorption is accelerated in diabetic patients. With more favorable condition for cholesterol absorption than non-diabetic patient, ezetimibe could deliver more dramatic effect. Ezetimibe would also be effective for patient group with high blood sugar level, because it does not increase chance of diabetes onset when used, whereas statin does. Postprandial hyperglycemia is a vital issue for a diabetic patient, but newer studies say postprandial lipidemia is also as bad. Ezetimibe inhibits postprandial lipidemia, which would be beneficial to diabetic patients. For my clinical practice, I have often used ezetimibe to lower diabetic patients’ cholesterol level. As a matter of fact, I conducted a research on less explored area of effect of the drug on blood glucose. The researchers are currently analyzing data collected from about 200 people. - Many have mentioned of PCSK-9 inhibitor, but apparently it tends to be administered once-monthly (originally indicated for once-biweekly) as the drug use is mostly non-reimbursed, despite its outstanding efficacy. Is it alright to change the interval? For a patient, relapsed disease like acute coronary syndrome (ACS), myocardial infarction (MI) and peripheral artery disease (PAD) are critical to their condition. And those patients’ LDL-C level has to be lowered more aggressively. And if adding ezetimibe does not work, then PCSK-9 inhibitor has to be used. But, it is expensive. And that is why many of them are administered once a month, but their LDL-C level ranging from 70 mg/dL to 80 mg/dL is usually halved or more. A patient that ticks off more than two of high-risk conditions—diabetic, hypertension, age 65 and up, cigarette smoking, hypercholesterolemia—is advised to take PCSK-9 inhibitor. I personally consider using PCSK-9 inhibitor when a patient’s cholesterol level is not controlled with rosuvastatin-ezetimibe combination therapy.
- Opinion
- [FOCUS] 10 ‘global new drugs’ promised 10 years ago
- by Chon, Seung-Hyun Jan 15, 2020 06:28am
- In 2011, the government formed Korea Drug Development Fund (KDDF) to provide inter-ministerial level support for developing new drug. Ministry of Science and ICT (MSIT), Ministry of Trade, Industry and Energy (MOTIE) and Ministry of Health and Welfare (MOHW) laid down a plan to develop more than ten global-level new drugs by investing on R&D together. The initial plan was to invest 1.6 trillion won for ten years until 2020 (530 billion won by the government, 530 billion won by private investment). According to the plan, Korea should be able to release ten new drugs by the end of this year. But it seems unrealistic at the moment. Considering Korea’s pharmaceutical and bio industry’s reality, the barrier of global market was too high. When Hanmi Pharmaceutical signed a series of giant license-out deals on investigational technology in 2015, the Korean pharmaceutical and bio industry was exhilarated. Everyone celebrated the advancement Korea has achieved in pharmaceutical and bio sector. But the excitement did not last long. For a long while, no other news of notable out licensing deals was reported. And when a few of licenses were returned to Hanmi Pharmaceutical, the industry’s rosy dream subsided. In fact, many were skeptical about the exaggerated expectation on the industry. Only then, more voices spoke out about keeping the head cool. In hindsight, more realized the Korean pharmaceutical and bio industry’s landscape has not been progressing, except for the exceptional performance by Hanmi Pharmaceutical. Since then, not only traditional pharmaceutical companies, but also bio ventures, such as Dong-A ST, Yuhan, SK Chemicals, SK Biopharmaceuticals, Legochem Biosciences, BridgeBio Pharma, Alteogen, and iNtRON Biotechnology, inked out licensing deals. Global pharmaceutical giants like AbbVie, Janssen, and Boehringer Ingel Heim shook hands with Korean companies. And Celltrion and Samsung Bioepis are now leading the global biosimilar market. Now the Korean industry is yet again dreaming on about drawing level with global pharmaceutical powerhouses. But the truth is we still have a long way to go. Last year, the U.S. Food and Drug Administration (FDA) cleared two new drugs by SK Biopharmaceuticals, but only five investigational drugs developed with Korean-made technology have passed the U.S. health authority so far. None of them reached the level, what would be viewed as ‘global commercialization success.’ Finished pharmaceutical product export in 2018 generated 3.40 trillion won, which was not even 20 percent of overall manufactured volume of 18.54 trillion won. Contrastingly, 4.89 trillion won of overseas finished products, significantly higher than the export, were imported in the same year. Finished product made in Korea used in Korea has gone down lower than the previous year to 75.6 percent. Some of Korean pipelines transferred to other global companies were dropped before reaching the commercialization stage. And in the near future, more out-licensed technologies are likely to be returned than successfully made into a finished product. Recent global drug development trend has more progressive new drugs proceeding faster than Korean pipelines. In some cases, technology development partner companies have lost interest in pursuing Korean companies’ pipeline with other similar candidate medicines available. Even worse, many Korean bio companies reported disappointing news of failed pipeline and clinical trials to their investors last year. Stock market was shaken by rumors spreading with mixed facts and hopes. Share price fluctuated from maximum to minimum limit for days. Obviously, it is possible for a Korean company to soon bring surprise news of making a big global success. But even so, it would mean outstanding performance of the company and not the whole Korean corporate R&D landscape’s. For last few years, Korean pharmaceutical and bio industry has experienced a series of trial and error. The ‘world’s first gene therapy’ turned out to have switched out active ingredient in production and its approval was revoked. Such ridiculous ‘trial and error’ should not be repeated again. Hopefully, this year would be the time for the industry to grow further based on the rough experiences. This year, probably, Korean companies would hear many stories of hopes and failures. And the entire industry should not be agitated or swayed by them. Instead of heightened anticipation, what we need is keeping it calm and moving forward.
