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- 2026-05-21 08:54:56
- Company
- The NHIS again urged to pay Valsartan damages by this month
- by Chon, Seung-Hyun Dec 24, 2019 06:10am
- Health authorities urged pharmaceutical companies to pay Valsartan claims. 36 pharmaceutical companies have already filed a lawsuit that they are not liable to pay preemptively, but have reaffirmed their willingness to collect the money. According to the industry on the 20th, the National Health Insurance Service recently issued a reminder to pharmaceutical companies to pay Valsartan compensation claims. The National Health Insurance Service requested to pay ₩2.03 billion in compensation to 69 pharmaceutical companies. After last year's outbreak of the impurity Valsartan’s issue, it is follow up by the Ministry of Health and Welfare that they will get back the amount of money invested in the drug to the patients for the remainder of the existing prescription. The National Health Insurance Service sent out a notice to pharmacy companies that did not pay the compensation and urged them to pay by October 31. But the payment rate was low, so they sent a second reminder this time. In fact, most large companies have refused to pay. According to the data submitted to In-sun Nam, a member of the Democratic Party of Korea, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. The drugmakers refused to pay about 80% of the recourse amount. The industry believes that companies that have not paid the bill so far are unlikely to pay. A legal battle with the health authorities has already become a reality. Pharmaceutical companies filed a debt existence verification lawsuit against the National Health Insurance Service in Seoul Central District Court on Nov 27th. It preemptively filed a lawsuit stating that it was not responsible for the Valsartan damages claimed by the National Health Insurance Service. Thirty-six pharmaceuticlas of the claims were filed. Originally, pharmaceutical companies considered ways to co-operate if the National Health Insurance Service filed a lawsuit for damages. However, they agreed to take a hard-line response by preemptively bringing up class action. Pharmaceutical companies are claiming that they are not responsible for Valsartan damages 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 that has no standard in the Valsartan raw material. Neither governments nor pharmaceutical companies were aware of the risks of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that the defect was not found at the level of science and technology at the time the manufacturer supplied the product, he would be liable for damages. After the Valsartan issue, the MFDS derived a test method for detecting NDMA from Valsartan raw materials and set new standards. The MFDS reviewed the guidelines recommended by the International Pharmaceutical Regulatory Harmonization Committee (ICH M7), domestic and international data, and expert advice to set the NDMA standard for Valsartan to 0.3 ppm or less. Pharmaceutical companies also hold the position that compensation claims made by the National Health Insurance Service are not included in liability. Pharmaceutical companies insist that there is no liability under the Product Liability Act for Valsartan consultation fee or dispensing fee.
- Policy
- Korea’s Drug expense management to settle on ‘trade-off’
- by Lee, Hye-Kyung Dec 24, 2019 06:10am
- Apparently, the government is to redirect finance saved by dropping drug with unproven clinical efficacy from reimbursement listing and adjusting drug price to provide coverage on new drugs for treating severe and rare disease. It would mean that the ‘trade-off’ strategy kept mentioned by Korea’s Ministry of Health and Welfare (MOHW), as a part of the National Health Insurance Comprehensive Plan, would be implemented soon. The technicality of the trade-off strategy and the tentatively named ‘Severe Disease Drug Expense Account’ would be included in the ‘Pharmaceutical Listing and Adjustment Standard’ MOHW is to publicly notify soon after the pre-announcement period started from September. Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW reiterated the notion of ‘money pot’ when describing the trade-off strategy at a policy seminar convened on Dec. 19 about insurance coverage on immunotherapy by Lawmaker Kim Kwang-soo. The deputy director pointed out, “England has Cancer Drugs Fund (CDF) that sets a road map to manage National Health Service (NHS)-covered drug and its annual action plan, but it has a limitation on the ‘money pot’”. The government official indirectly mentioned of the Korean ministry planning to reallocate saved drug reimbursement to cover severe disease drug expense as a trade-off. Deputy Director Choi stated, “Whether it be a household or a state, they need to get an access to money when need be. But there are not many pots of money available, realistically. We need to reevaluate drugs to sort out drug underperforming and ineffective than expected and even considered valueless in other countries”. Recently, Health Insurance Review and Assessment Service (HIRA) held a public hearing on pharmaceutical reimbursement reevaluation standard and procedure, and stated it would conduct a post-marketing review on high-cost anticancer and rare disease treatments with uncertainty in clinical efficacy based on foreign government insurance listing status, usage frequency, and ratio of claimed reimbursement. In short, the government is to revisit pharmaceutical expense increase rate and reimbursement claim cost. Deputy Director Choi stressed, “The ministry is trying to create a pot of money, or an account, by reevaluating listed drugs and reusing saved finance on anticancer or rare disease treatment. Only when we save money from the reevaluation, we would be able to use it as resource to cover anticancer or rare disease treatment”. A so-called trade-off or money pot is a tentatively named Severe Disease Pharmaceutical Expense Account as stated the National Health Insurance (NHI) action plan. The action plan aims to generate an account from adjusted and saved NHI expense according to pharmaceutical reevaluation to utilize it on enhancing coverage over high-cost severe disease treatments. The government is considering various means to operate the Severe Disease Pharmaceutical Expense Account without revising statute, but by having National Health Insurance Service (NHIS) to manage the account separately like the National Health Promotion Fund. In September, Song Young-Jin from the Pharmaceutical Benefits Division published an article in the September issue of HIRA Policy Report and also stated “The government plans to differentiate evaluation style or gradually apply evaluation model, taking in account of unique pharmaceutical quality, on selectively reimbursed drug, high-cost severe disease treatment, conditionally approved drug, evaluation-exempted drug or drug underperforming than expected.” The government official also has mentioned of establishing future reevaluation initiative by reviewing past pharmaceutical reevaluation cases and similar cosigned research, and also set pilot program for year 2020 to expand reevaluation system gradually.
- Company
- BMS loses the trial to revoke Eliquis’ 30% price cut
- by Kim, Jin-Gu Dec 24, 2019 06:09am
- Bristol-Myers Squibb (BMS) filed an administrative litigation to appeal against the government’s decision to lower pricing of new oral anticoagulant (NOAC) Eliquis (apixaban), but lost the case regardless. At a trial to revoke the Maximum Drug Reimbursement Price Adjustment order by the Minister of Health and Welfare on Dec. 19, Seoul Administrative Court has decided to dismiss the plaintiff, BMS’ appeal. The court also ordered the plaintiff to pay for the litigation cost. According to the court ruling, the Eliquis price reduction already postponed twice would be enforced soon. However, BMS has not confirmed their intention to file another appeal. The legal dispute between BMS and MOHW over lowering price of Eliquis actually started from a patent dispute. The Eliquis patent dispute began since March of 2015. Huons and other companies challenged Eliquis’ patent to invalidate it. The Patent Court, as a first trial, had decided that the drug patent is invalidated in February, 2018. The Korean companies won preferential sales approval by Ministry of Food and Drug Safety (MFDS) based on the invalidation ruling. Accordingly, apixaban generic was launched this June. With the generic entering the market, MOHW notified it would lower the maximum reimbursement price of the original Eliquis by 30 percent. The administrative measure was made based on the regulation stating the original’s maximum reimbursement price should be lowered, due to commercialization of its generic, by 30 percent in the first year and to 53.55 percent of the initial price from the following year. Therefore, the price of Eliquis was supposed to be lowered by 30 percent from 1,185 won per tablet to 830 won per tablet. However, BMS requested the Administrative Court to suspend the execution urging the ministry’s decision to lower the price was unfair. Simultaneously, the company officially filed for litigation against the administrative action to drop the drug pricing. The Seoul Administrative Court allowed BMS’ request on suspending the execution. The court stated the patent dispute over Eliquis has not been settled, yet, and the litigation to revoke drug price reduction is still ongoing, so the drug pricing reduction should be deferred until the final decision is made. While the BMS’ litigation was in process, price reduction on Eliquis has been postponed twice. MOHW then has decided to maintain the original’s initial pricing until Dec. 31 this year. Finally the last decision on the litigation has been made. But the Seoul Administrative Court that previously accepted BMS’ request to suspend the execution made a contrasting decision during the litigation case. Experts see that the Supreme Court invalidating Elquis’ patent in October has played the key role in the decision. The Supreme Court reaffirmed the first and second trial ruling by the Intellectual Property Trial and Appeal Board and the Patent Court, respectively, and ruled for the generic manufacturers. A legal expert elaborated, “The judge made a polarizing decision for the litigation case than for the suspension of execution trial. Whether or not the judge would quote the suspension of execution trial is not to base on the legality of the plaintiff’s claim, but on the predicted loss and the grounds of litigation.”
- Company
- No more patent-evading IMD, needs new strategies
- by Kim, Jin-Gu Dec 23, 2019 06:29am
- Technically, the days of Korean pharmaceutical companies evading drug patent infringement by modifying the original’s salt base are over. The Supreme Court’s ruling on the solifenacin (trade name: Vesicare) case in the beginning of the year first showed the signs of ending drug patent infringement with incrementally modified drug (IMD). And it was reaffirmed on Dec. 20 with the Patent Court’s ruling for varenicline (trade name: Champix). As for Korean companies, the time has come to seek for other strategy to challenge patent. Experts say it would be more difficult than the old IMD strategy, but it is not say there isn’t any other way to challenge patent. The other feasible strategy is to file an invalidation trial for each item to challenge the accusation of patent infringement. Popular IMD strategy has become a thing of the past Pharmaceutical industry and legal experts say the Champix ruling was actually “expected”. The majority of the experts predicted the solifenacin case would set a new precedent. Only a handful of experts claimed the Supreme Court left a room for interpretation on the patent’s ‘practical equivalence’ and ‘technical obviousness of Person Having Ordinary Skill in the Art (PHOSITA)’. Ultimately, judges made same decisions on following Januvia, Pradaxa, and Champix cases and reaffirmed the Supreme Court’s decision. In August and September, the Patent Court ruled favorably for the original patentee of Pradaxa and Januvia, respectively, against IMDs. Even in last year, IMD with switch in saline base has been the most common strategy for Korean companies to evade patent infringement and launch their generic early. Hanmi Pharmaceutical’s Amodipin is a typical case. By incrementally modifying Pfizer’s Norvasc in 2004, Hanmi Pharmaceutical has been generating tens of billions of won annually after commercializing the antihypertensive amlodipine generic. The first alert went off when the original manufacturer, Astellas Pharma had requested litigation for cancellation of a trial decision on solifenacin IMD to the Patent Court in 2016. Korean companies switched out succinate of the original solifenacin drug with fumarate. The Patent Court recognized two combinations as different substances, and decided that solifenacin fumarate does not infringe the extended patent period. However, the Supreme Court said the otherwise. Following the court’s ruling, lower courts made a series of similar decisions and put the IMD strategy on shaky ground. Pipeline strategy to change inevitably, then how about the originals? Experts predict about 150 IMDs challenging respective patents would end up with similar ruling as the precedents. Accordingly, Korean companies now have no choice but to shift pipeline strategy. The time has come to let go of IMD, the relatively convenient option of evading patent infringement. Considering medium-sized pharmaceutical companies challenged patents with IMDs, the intangible loss for giving up on IMD is expected to be significant. Moreover, the original’s companies could start a domino of litigations. Based on the precedents, the original companies are highly likely to file damage suit against IMDs for infringing their patents. Since the overruling the previous solifenacin decision, Pfizer has requested for an injunction to ban sales of incrementally modified solifenacin, and the court has accepted the request. Other original companies have not been reported to have requested the injunction. The industry is keenly paying an attention on whether or not Pfizer would file the damage suit. The legal experts see that the case would probably be favorable to Pfizer quoting the Supreme and Patent Courts’ decisions and Seoul Central District Court’s injunction. Seeking for other options to challenge drug patent The industry-changing court ruling aside, it’s not to say Korean companies’ patent challenge is absolutely impossible from now on. The patent system can be bypassed. The Patent Court’s ruling on Betmiga (mirabegron) made a day before Champix case is a good example. At the Patent Court on Dec. 18, 11 Korean companies, including Hanmi Pharmaceutical, Chong Kun Dang Pharmaceutical, JW Pharmaceutical, Ildong Pharmaceutical, Intro Biopharma, Alvogen Korea, Kyung Dong Pharm, Shinil Pharmaceutical, Han Wha Pharma and Shin Poong Pharmaceutical won the patent dispute against original company Astellas Pharma. Meanwhile, Korean pharmaceutical companies are apparently trying new patent challenge strategies. The existing IMD strategy was based on defensive confirmation trial for scope of a patent, which means it was challenging a small part of a whole patent. Incremental modification of saline base was meant to challenge a part of extended period of drug patent. On the other hand, the Korean companies filed an invalidation trial instead to challenge the patent. If they win, the trial would nullify not partial, but the whole patent. However, the trial is not to challenge drug patent, but to challenge novel use patent. In other cases, some have challenged the extended period of drug patent with invalidation trial. Hanmi Pharmaceutical and Ahn-gook Pharmaceutical won the invalidation trial against Novartis’ DPP-4 class diabetic treatment Galvus in last February. The two companies have successfully revoked validity of the extend patent on Galvus. A legal expert commented, “More than the Champix’ case, Betmiga’s trial attracted more attention as it was unpredictable. Invalidation trial is surely complicated, but it is not impossible”. “Defensively confirming the scope of a patent is now useless only for IMD, but other option could be used to challenge drug patents”, the legal expert added.
- Policy
- Moon Jae-in Care needs speed control
- by Lee, Hye-Kyung Dec 23, 2019 06:29am
- There were voices of concern that the government's policy to strengthen health insurance guarantees could weaken domestic economic growth potential and national competitiveness. The Korea Employers Federation (Chairman of KEF, Kyung-sik Sohn) held a session on the 19th to evaluate the 1st National Health Insurance Comprehensive Plan (2019 ~ 2023) under the theme of 'National Health Insurance, Sustainable?'. The debate was held in the public's concern about the financial crisis of health insurance due to the overlap of policy factors such as increased measures to the medical use due to aging. In the past 10 years (2008 ~ 2018), Korea's medical expenses growth rate is 6.9% per year, three times the OECD average of 2.3%, and the fastest rate among 36 member countries. In the case of National Health Insurance, which accounts for the largest proportion of medical expenditures, which have increased by 8% every year for the past five years (2014 ~ 2018), are expected to increase by more than 13% this year. Yong-geun Kim, the Vice President of the KEF, said, “Recently, medical expenditures are rapidly increasing, which raises the public's concern about the financial crisis of health insurance, at the current rate of increase in medical expenses, it will soon become a factor that weakens growth potential and national competitiveness as excessive national resources are put into the medical sector”. Mr. Kim said, “Expansive radical guarantees will entail excessive insurance premiums, which will eventually lead to a vicious cycle of lowering private investment and consumption and reducing economic vitality, and it needed to adjust the speed of security measures”. The government plans to raise the rate of health insurance premiums by 3.2% annually to cover the cost of expanding the coverage, but this also means that in the era of low growth with an economic growth rate of around 2%, the burden on the people and businesses is beyond. Mr. Kim said, “Companies paying 43% of the total health insurance income cannot afford to pay premiums anymore due to the deteriorated business environment and poor performance, we need to focus on improving fiscal soundness by rationally improving health care spending while minimizing premium rate hikes”. He also called for a full reform of the health insurance system to make more efficient use of limited resources, and he cited the resolution of moral hazards in the medical field, revitalization of private insurance subscribers, the introduction of incentives for reducing medical expenses, the expansion of comprehensive budget system, the reduction of drug costs, and the introduction of the primary doctor's system. In addition, he urged a preemptive reform of the committee's operating system so that the opinions of companies (labor-management) and community members who are responsible for health insurance can be reflected in a greater proportion. Professor Hee-kyun Yang, Kyung Hee University, who was in charge of the first presentation, predicted that the burden of subscribers would increase because there is no way to solve the overuse of medical services due to the expansion of the guarantee coverage. Therefore, in case of excessive anticipated medical use (MRI, ultrasound, anticancer drugs, treatment materials, etc.) and services (elderly outpatient’s flat sum system, copayment limit, long-term hospitals, upper ward benefits) The government said that it is necessary to prepare a management plan for discounts and surcharges. As a plan to alleviate the phenomena of large hospitals, it was required to establish a four-stage medical delivery system (clinics-hospitals-advanced hospitals-nationalwide hospitals), including the establishment of a nationwide hospital using the total contract method. The second speaker, Seong-in Chang, a professor at Yonsei University, predicted that the cumulative reserves, which amounted to ₩20.8 trillion in 2017, will be exhausted in 2022. Professor Chang said, “To secure financial health of health insurance, we must break away from the stereotype of solving all things with one health insurance and establish a hybrid medical security system that properly connects social security and market economy principles, we need to consider introducing a lifetime health account that manages parts as an individual account”. Seok-yong Chang, a professor of Eulji University, the third speaker, pointed out that despite the establishment of the 1st National Health Insurance Comprehensive Plan, there is still no high-level health development plan. Professor Chang said, “As the rules of the game need to be carefully reviewed, we need a social consensus on strengthening the representation and professionalism of members and the formation of public interest committees in decision governance such as the Health Insurance Policy Review Committee and the Financial Steering Committee, and considering the enormous amount of financial operations, it is necessary to establish a pre-control mechanism of the National Assembly”.
- Company
- Ulcerative colitis added to Stelara's domestic indications
- by Eo, Yun-Ho Dec 23, 2019 06:29am
- Janssen's interleukin-12/23 (IL-12/23) inhibitor 'Stelara' can be prescribed for ulcerative colitis. According to the industry, the KFDS recently approved Janssen's Stelara (Ustekinumab) as a treatment for moderate to severe adult active ulcerative colitis. As a result, Stelara has acquired four indications in Korea, including ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn's disease. The expansion of Stelara's ulcerative colitis indications was based on the UNIFI program, Phase III. The program consisted of one maintenance therapy with subcutaneous injection every 8 weeks for 44 weeks after one initial induction study with a single intravenous injection of Stelara. The study found that 19% of Stellar dose groups reached clinical remission in 8 weeks and 58% of patients responded. In maintenance studies, 44% showed improved tissue endoscopic mucosal membranes after one year. Meanwhile, starting with Stelara in the interleukin therapeutic market, four items are approved including ▲IL-17's Cosentynx (Secukinumab) by Novartis, ▲Lilly's Taltz (Ixekizumab), ▲IL-23 Inhibitor, Tremfya (Guselkumab). In addition, Boehringer Ingelheim is conducting a global phase III study comparing the IL-23 inhibitor 'BI655066' with Stelara, and Brodalumab, developed by AstraZeneca, has also been shown to be effective in direct comparison with Stelara and has been approved in Europe.
- Policy
- Who holds the key to end financial toxicity?
- by Lee, Hye-Kyung Dec 22, 2019 09:52pm
- (From left) Professor Kim Hee-jun of Chung-Ang University Hospital, Professor Lee Dae-Ho of Seoul Asan Medical Center Department of Oncology, Professor Park Ji-hyun of Konkuk University Medical Center Department of Hemato-oncology, Professor Suh Dong-Churl of Chung Ang University College of Pharmacy, Baek Jin-young Korea Kidney Cancer Association, and Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW Doctor: “Although it’s non-reimbursed, the immunotherapy option is recommended for kidney cancer. But it’s expensive” Patient: “How much is it?” Doctor: “It’s about 10 million won per month”. Patient: “Can I get fully recovered”. Doctor: “It’s not guaranteed”. Patient: “It’s too expensive”. Doctor: “Discuss and decide with your family after checking the price, if you have a private insurance.” At a policy seminar convened on Dec. 19 about enhancing coverage for immunotherapy, President Baek Jin-young Korea Kidney Cancer Association enacted a common conversation between a doctor and kidney cancer patient. The seminar was organized by Lawmaker Kim Kwang-soo at a seminar room in the National Assembly Member’s Office Building. President Baek said, “During the three-minute counseling time, cancer patients have to listen to a doctor talk about financial toxicity first than the severity of their own health. It happens quite often.” Professor Kim Hee-jun of Chung-Ang University Hospital and Professor Park Ji-hyun of Konkuk University Medical Center Department of Hemato-oncology nodded their heads at President Baek’s story. Professor Kim stated, “It’s dishearteningly relatable. Once when a colleague visited and listened to a conversation between my patient and me, she commented it sounded like I was selling a private insurance. I have to ask patients about their private insurance status and limits. And even if I show a survival rate graph after the talk, I know they are not paying an attention anymore.” She added, “When Obdivo announced its launch in Korea in 2015, I was excited. But it’s disheartening that I cannot use it for all patients.” President Baek and Professor Kim proposed that the special case benefit applying five percent patient copayment rate from first-line therapy could be raised. President Baek claimed “Cancer patients should also stop being stubborn about the five percent copayment rate, but embrace the opportunity to choose different options with higher copayment rate. It is also crucial for pharmaceutical company, patient and government to share the initial risk of uncertainty in treatment efficacy, and to establish reasonable standard of reimbursement.” Professor Kim also added, “At first, I was grateful for the five-percent copayment rate. But the more new drugs were launched, the longer patients had to fight against cancer. Back in the day, cancer patients had about less than a year to survive. But the survival period has gotten longer. We need to carefully consider raising the copayment rate a little bit for all cancer patients to benefit from the system.” Professor Lee Dae-Ho of Seoul Asan Medical Center Department of Oncology pointed out, “The root of all problem is money.” The professor elaborated, “We need to consider if the people would be happy to enhance coverage on four major severe diseases, and if they would be happy to spend their tax money on cancer patients,” and “I also don’t mean to reduce the price of drugs for those pharmaceutical companies trying to bring new drugs to Korean patients.” “It’s skeptical if profit-seeking pharmaceutical companies are truly for the patients,” because it is “unconvincing for insurer paying for the health insurance expenditure [to expand coverage on anticancer treatment], when the companies demand for improved access on new drug, but don’t put an effort to lower their drug price,” the professor added. New drug reimbursement application, it’s up to pharmaceutical companies After a series of criticisms from the panels, Ministry of Health and Welfare (MOHW) defended their position with vulnerable financial situation. Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW urged, “Besides people’s overestimation of immunotherapy as a miracle elixir, it is still an unknown territory as an insurer who has to pay for the insurance expenditure. We need at least a tool to confirm its response rate to grant insurance reimbursement”. Accordingly, Health Insurance Review and Assessment Service (HIRA) is conducting a RWD research for post-marketing evaluation, and National Health Insurance Service (NHIS) is conducting a study on expenditure efficiency for financial feasibility. Deputy Director Choi noted, “We always feel sorry for patients and their family, and we are regretful that we cannot provide the right weapon for medical profession to fight against cancer with. However, it is also regretful that all the responsibility for the unfortunate state is blamed on the government”. The government basically pointed out the public thinking the government is keeping the last key back to end the pharmaceutical company’s tug-of-war against the government, insurer and NHIS with the new drug pricing negotiation. Deputy Director Choi elaborated, “The government is not the one with the last key. MOHW, NHIS and HIRA exist to keep health insurance expenditure justifiable. As the insurance finance is not from a bottomless pot, the ministry set the drug pricing regulation for pharmaceutical companies to apply for reimbursement with according to their drug’s financial impact and patient protection measures and to have negotiation with government for the reimbursement listing.” Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW “Negotiation does not proceed with a unilateral yielding, but it is rather a process of reaching an agreement and seeking a way within the system. The government asks for new drug’s response rate, financial toxicity, and clinical data to base reimbursement decision. But some companies don’t even speak a word. We are not to name names, but the pharmaceutical companies are the ones holding back the key”, the deputy director reprehended. The government official also mentioned of a foreign financial support system, Cancer Drugs Fund. Deputy Director Choi said, “Some have suggested a sort of ‘money pot’ is needed when setting up the National Health Insurance Comprehensive Plan. So we are trying to make an individual account to cover anticancer and rare disease treatments with money saved from reevaluating drugs with low efficacy or not delivering expected effect”. Regarding the five-percent special case reimbursement rate, the official said “We are considering on expanding selective reimbursement scope.” “We are contemplating a realistic solution like preliminary pricing reduction for a limited number of cancer patients. Although monotherapy exists, also having a combination therapy makes the situation complicated. We would do our best to improve patient’s new drug accessibility,” said the deputy director.
- Company
- Drug trade volume to hit all-time high over USD 10 bln
- by Kim, Jin-Gu Dec 22, 2019 09:51pm
- Korea’s accumulated trade volume is expected to surpass USD 10 billion for the first time. The biggest impact is from a significant surge of pharmaceutical export volume. This year’s overall pharmaceutical export volume is projected to go over 3.6 billion dollars. The number almost doubled, compared to four years ago in 2015. According to statistic data from Korea Customs Service, the accumulated pharmaceutical trade volume, as of November, reached 9.34 billion dollars (approximately 10.91 trillion won). If the trend continues, the pharmaceutical trade volume from this year alone is expected to surpass the 10 billion-dollar mark for the first time. Pharmaceutical import and export volume by year. 2019 includes projected December figure based on performance as of November. (Source: Korea Customs Service) In recent years, the trade volume grew constantly reaching 6.27 billion dollars, 7.44 billion dollars, 7.94 billion dollars, and 9.37 billion dollars in years from 2015 to 2018, respectively. The pharmaceutical export volume had the biggest surge. As of November, the pharmaceutical export volume reached 3.34 billion dollars (approximately 3.91 trillion won). Outperforming last year’s export volume at 3.27 billion dollars, this year’s volume is expected to easily make over 3.6 billion dollars by the end of the year, hitting the highest point in the history. The all-time high export volume was possible this year due to strong performance from Celltrion and Samsung Biologics’ biosimilars and Daewoong Pharmaceutical’s Nabota export. Moreover, the government building stronger ties with Southeast Asian countries have helped the increase in export to their markets. On the other hand, pharmaceutical import volume has reached 5.99 billion dollars as of November (approximately 7.32 trillion won). The trade surplus, balancing export and import volumes, is to get better by a bit. Last year’s pharmaceutical trade made a deficit of 2.83 billion dollars. This year’s deficit is expected to be around the similar level of 2.8 billion dollars. Pharmaceutical import and export volume from January to November, 2019. (Source: Korea Customs Service) Apparently, Korea’s overall trade volume has surpassed one trillion dollars this year. The trade volumes in last three years have exceeded one trillion-dollar mark since 2017. China, the U.S., Germany, Japan, the Netherlands, France, the U.K. Hong Kong and Italy as well as Korea are the only ten countries around the world to have overall trade volume over one trillion dollars.
- Company
- Astrazeneca-SK supplying Diabetics worth $100 million/year
- by Eo, Yun-Ho Dec 22, 2019 09:51pm
- President Dong-hyun Jang (left) & President Leif Johansson (right) AstraZeneca and SK announced that the drug was manufactured and produced under the partnership signed by the two companies in January 2018 and is being supplied to 3 million people with diabetes in 98 countries. The agreement contributed to SK's successful entry into the global biopharmaceutical manufacturing and production business and the growth of AstraZeneca, with a value of approximately $ 100 million annually. At the headquarters of SK Group, Leif Johansson, Chairman of AstraZeneca and Dong-hyun Jang, SK CEO exchanged commemorative plaques to celebrate the achievement of important milestones through the cooperation of the two companies. The event was attended by Swedish Foreign Minister Anna Hallberg, Minister of Trade, Industry and Energy, Jung-yeol Yoo, Director of Health and Welfare , In-taek Im, government officials, and officials from both companies. In accordance with the agreement between the two companies, SK Biotech, a wholly owned subsidiary of SK, manufactures and produces APIs (Active Pharmaceutical Ingredients) for diabetes treatments such as AstraZeneca's blockbusters, Forxiga (Dapagliflozin) and Onglyza (Saxagliptin). Raw materials manufactured and produced in Korea will be converted into pharmaceuticals at the SK Biotech Ireland plant in Swords, Ireland, which SK Group acquired in 2018. AstraZeneca is responsible for producing and supplying treatments to patients around the world using this materials. Leif Johansson, Chairman of AstraZeneca said, “SK Biotech is an important strategic partner of AstraZeneca and is a good example of Korea's high value and quality level in the manufacture of pharmaceutical products, Since 2018, the two companies have collaborated to deliver medicines that change the lives of patients and contribute to the patient and the society as well as to business growth”. Dong-Hyun Jang, president of SK, said, “We have been cooperating for common social values since 2018 through partnership with AstraZeneca to provide innovative medicines to patients. SK Pharmteco (SK CMO Integrated Subsidiary) will continue to solidify our partnerships by expanding the production of raw materials for a wider range of diseases”. On the other hand, AstraZeneca signed a memorandum of understanding (MOU) with the KOTRA, the KHIDI, the KoreaBIO and the KPBMA in the Korea-Sweden Business Summit held in Seoul on the 18th and announced that the company would strengthen cooperation to accelerate innovation in the Korean biohealth industry.
- Company
- SK Holdings reaffirms partnership with AstraZeneca
- by Lee, Seok-Jun Dec 20, 2019 06:36am
- On Dec. 19, SK Holdings CEO Jang Dong-hyun met with Chairman Leif Johansson of AstraZeneca at the SK Group Headquarters, Seoul. At the meeting, SK Biotek and AstraZeneca announced they have been supplying diabetes treatment to about hundred countries since their partnership deal signed in January 2018. The two companies stated their partnership is valued at approximately USD 100 million. After the acquisition of Bristol-Myers Squibb’s (BMS) manufacturing facility in Ireland, SK Biotek also gained a partnership with a global pharmaceutical giant, AstraZeneca. The Korean company took over the manufacturing facility and specialized human resources, as well as the supply contract with AstraZeneca. The industry evaluates the acquisition was a successful M&A that took in account of earning the extra global partnership. Reportedly, AstraZeneca last year generated 22 billion dollars (about 26 trillion). SK Holdings CEO Jang Dong-hyun (left) and AstraZeneca Chairman Leif Johansson met and briefed about performance so far at a partnership signing meeting on Dec. 19 More than half of BMS manufacturing contract in Ireland was signed by AstraZeneca SK Biotek and AstraZeneca’s relationship goes all the way back to June of 2017. SK Biotek, wholly-owned subsidiary of SK Holdings, made a decision on the acquisition of BMS manufacturing facility in Ireland (currently owned by SK Biotek Ireland). BMS’s facility in Ireland used to manufacture active pharmaceutical ingredients for anticancer, anti-diabetic and cardiovascular disease treatments. Among array of contracts, approximately 50 percent of them were signed by AstraZeneca. Accordingly, when BMS sold its manufacturing facility in Ireland, SK Biotek also took over the contracts by AstraZeneca along with the facilities and human resources. After making the final decision on the acquisition, SK Biotek immediately scheduled a meeting with the headquarters of AstraZeneca in July that year. Apparently, they talked about maintaining the contract for the future. SK Biotek not only took over BMS’ manufacturing facility, but also expanded global partnership roster. Now the company works with Pfizer and Novartis, as well as AstraZeneca. The Thursday’s meeting reaffirmed the ties between SK Biotek and AstraZeneca is still strong. A stock trading firm insider noted, “It was only natural for SK Biotek, with the complete acquisition of BMS’ manufacturing facility in Ireland, to start a business with the facility’s existing clients. The terms of SK Biotek-BMS deal stated details of transferring facility, human resources and some of synthetic ingredient manufacturing contracts”. “However, it was not so clear whether or not SK Biotek would be able to maintain the existing partnership. The new partnership signing could have been held for SK Biotek to secure global partnership with AstraZeneca, on top of the manufacturing contract in Ireland”. SK Group’s focus on pharmaceutical sector is led by a SK Holdings and SK Discovery expanding business in two different sub-sectors. SK Holdings own SK Biopharmaceuticals (drug discovery) and SK Pharmteco (CMO). SK Chemicals (pharmaceutical business), SK Plasma (blood products), and SK Bioscience (vaccine) are formed under SK Discovery. SK Holdings, following its acquisition of SK Biotek Ireland and AMPC Fine Chemicals, established SK Pharmteco as the U.S.-based holding company. SK Holdings and SK Discovery are thriving in their respective field of business while not sharing shares between them.
