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- 2026-05-20 13:47:38
- Company
- Pfizer launches Vyndaqel followed by Vyndamax in Korea
- by Eo, Yun-Ho May 18, 2020 06:16am
- Pfizer is expecting to introduce 'Vyndamax' following 'Vyndaqel'. According to the related industry, Pfizer is in the process of approving for Vyndamax (Tafamidis meglumine) by the MFDS, a treatment for cardiomyopathy caused by hereditary transthyretin amyloid polyneuropathy (hATTR-PN) and transthyretin mediated amyloidosis (ATTR-CM). It is expected in the second half of the year. Vyndaqel (Tafamidis meglumine) and Vyndamax have the same active ingredients but differ in indication and dosage. In the case of Vyndaqel, it was already approved in Korea in 2015, and it is currently undergoing an expanded indication for cardiomyopathy indications by ATTR-CM. Both drugs added an indication for cardiomyopathy caused by ATTR-CM following hATTR-PN from the US FDA last year. The efficacy of ATTR-CM has been demonstrated in a phase III study. The primary endpoint of the study was a comprehensive assessment of mortality for all causes and frequency of hospitalization for cardiovascular disease, and the secondary endpoint was a Kansas City survey of 6-minute walking distance tests and quality of life for patients with heart failure. As a result of the study, the two drugs showed statistically significant results in both the mortality rate according to all causes and the hospitalization period due to heart disease compared to the placebo. On the other hand, hATTR-PN is a genetic disease, whereas ATTR-CM is not the only cause. There is a non-genetic factor, and it is more common in men than in women as age increases. The incidence of non-genotype hATTR-CM is higher than that of PN. It is estimated that there are more patients in the world.
- Opinion
- [Reporter’s View] COVID-19 and vaccine self-sufficiency
- by An, Kyung-Jin May 18, 2020 06:15am
- The U.S. and Europe have sparked a conflict over COVID-19 vaccine still in development. The tension arose when a multinational pharmaceutical company Sanofi announced its intention to prioritize the distribution of the vaccine to the U.S., in case the company successfully completes the development. During an interview with Bloomberg, Sanofi’s British CEO Paul Hudson who newly took over the office in last September said, “The U.S. government has the right to the largest pre-order because it’s invested in taking the risk,” so “the Americans will likely get Sanofi’s COVID-19 vaccine before the rest of the world.” Along with its competitor GlaxoSmithKline (GSK), the French-based multinational company has initiated COVID-19 vaccine co-development project. And apparently, the U.S. Biomedical Advanced Research and Development Authority (BARDA) has provided USD 30 million (approximately 36.8 billion won) for the project Immediately after the news was released, the whole of Europe was shaken. Particularly, the reaction from France, where Sanofi’s headquarters and manufacturing plants are housed, was rough. The French government was infuriated by the pharmaceutical company’s public comment as the country and the EU have been often giving direct and indirect support for the company’s R&D programs. French Prime Minister Édouard Philippe reproached by twitting “A #COVID19 vaccine should be a global public good. And the equal access to the vaccine is not negotiable.” The European Commission official also published a statement insisting that “The vaccine against COVID-19 should be a global public good and its access needs to be equitable and universal.” The pharmaceutical industry experts are claiming the international cooperation has worsened as the EU intervened the U.S. and China’s race for the COVID-19 vaccine. Some are concerned that a war on exclusive pre-ordering of the vaccine in development may break out. Eventually, CEO Hudson took back his words, as his ‘America-first’ comment has inflicted a firestorm. When the vaccine is fully developed, he said all countries around the world would have an equal access to the vaccine. But the CEO also urged “the European countries should also assertively take risks on the vaccine development like the U.S.” He pointed out how the U.S. is taking a risk even before scientifically confirming the success of the vaccine development, whereas the European countries have not. The CEO also argued the risk should be shared among European countries and the U.S. Sanofi CEO’s comment also rings in a grave tone in Korea as well, where the country has not yet fully resolved the vaccine self-sufficiency issue. When Green Cross established the Hwasun vaccine plant in 2009, South Korea has become the 12th country in the world to locally procure flu vaccine. The locally made vaccine is viewed as the top contributor in overcoming the 2010 flu pandemic. Although it has been a decade since then, Korea’s self-sufficiency rate in vaccine has not improved much. Out of 19 National Immunization Program (NIP) vaccine types, only six types—hepatitis B virus, hemorrhagic fever with renal syndrome (HFRS), varicella, influenza, tetanus, diphtheria, and pertussis (Td), Haemophilus influenzae type b (Hib)—are locally produced without importing the vaccine strain. Other three vaccine types are locally produced with imported strain, and the rest of the nine types are imported as finished products. In case of a pandemic or biologic terrorism, Korea has to unavoidably rely on other countries for vaccine. When the country cannot even self-procure vaccines long demanded, it is skeptical if Korea would be able to promptly produce vaccine during a novel infectious disease outbreak. According to the World Health Organization’s (WHO) update, total eight cases of clinical studies in COVID-19 vaccine have started their global trial phase. Four of them are funded by Chinese government and corporations. Partnered with a biotechnology company Moderna, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), associated under the National Institute of Health (NIH), has started a clinical trial for a vaccine against COVID-19 from last month. The U.S. government body aims to report the immunological reaction in around coming July or August. In Korea, a number of pharmaceutical companies like SK Bioscience, GC Pharma and Genexine are seeking for a vaccine against COVID-19, but the progress is far behind compared to the U.S. or China. The country was able to put the limelight on its promising global level biotechnology as the world highly evaluated Korea’s ability to test the disease. To maintain the outstanding disease control capacity, the Korean government would need to invest and support the vaccine and treatment development, bottomlessly. Korea should let the latest pandemic be the reminder of the necessity of ‘vaccine self-sufficiency.’
- Policy
- The mechanism by SGLT2 inhibitors was first identified
- by Lee, Hye-Kyung May 18, 2020 06:15am
- Research has shown that the 'diabetes treatment agent' SGLT2 inhibitor lowers the risk of cardiovascular disease by inhibiting inflammatory cytokine secretion. Jung-Sun Kim, Professor of cardiology, Yong-ho Lee Professor of endocrinology, and Sang-Guk Lee Professor of laboratory medicine at Severance Hospital and So Ra Kim, Professor of hospital medicine at Yongin Severance Hospital said on the 14th that SGLT2 inhibitors significantly reduced inflammatory cytokine secretion in macrophages. This is the first study to show that SGLT2 inhibitors reduce cytokine secretion in the human body, and was published in the latest issue from Nature Communications, a world-renowned international academic journal. Diabetes is closely related to abnormal metabolic conditions, including inflammation, dyslipidemia, and insulin resistance. Among these, inflammatory cytokines involved in inflammatory reactions are being identified as causes of various cardiovascular disease (CVD) such as myocardial infarction, heart failure, and angina. Inflammatory cytokines are secreted from NLRP3 inflammasomes present in macrophages. SGLT2 inhibitors are known to reduce cardiovascular disease or mortality in diabetic patients by inhibiting reuptake of glucose from the kidneys. The American Heart Association, the ESC, and the EASD recommends that SGLT2 inhibitors be given priority to other medications for diabetics at high risk of cardiovascular disease. However, the mechanism by which SGLT2 inhibitors lower the risk of cardiovascular disease has not been determined. The research team randomly selected type II diabetes patients admitted to Severance Hospital from November 2016 to July 2017, and divided them into groups A and B. Group A (29 patients) assigned to treatment with SGLT2 inhibitors and group B (32 patients) received a sulfone urea drug, a diabetes drug that promotes insulin secretion. As a result of analyzing macrophages isolated from blood after 1 month, group A significantly decreased secretion of inflammatory cytokines than group B. SGLT2 inhibitors inhibited NLRP3 inflammasome activity by 83% more than group B by lowering blood sugar and reducing uric acid and insulin hormone. Particularly, in group A, NLRP3 inflammasome activity and inflammatory cytokine secretion were decreased in the body compared to before administration of the drug, but group B had no such effect. In the group A taking the SGLT2 inhibitor, the blood ketone body (β-hydroxybutyric acid) also increased from 0.06 mM to 0.20 mM. Increased blood ketone bodies inhibited the activity of NLRP3 inflammasomes, resulting in decreased secretion of inflammatory cytokines. Professor Yong-ho Lee said, "While large-scale studies have been reported that SGLT2 inhibitors reduce cardiovascular disease, researchers around the world are very interested because the mechanism by which cardiovascular disease is reduced is not yet clear." Professor Lee said that this is the first study that revealed that SGLT2 inhibitors reduce NLRP3 inflammasome activity and inflammatory cytokine secretion in the human body, and further studies will be conducted in the future.
- Policy
- Patients suffer from quarrels between companies & the HIRA
- by Lee, Jeong-Hwan May 18, 2020 06:15am
- Patients urged Ono Pharma Korea, BMS Korea, and MSD Korea to come up with a reasonable burden-sharing plan that the health authorities could accept. Patients have been urging to expand the health benefits of Opdivo (Nivolumab) and Keytruda (Pembrolizumab), which have various therapeutic indications, such as lung cancer and kidney cancer. It is a request to urgently improve the reality that Opdivo and Keytruda have failed in the HIRA’s Cancer Drug Review Committee due to controversy over the financial burden of health insurance due to high prices. On the 14th, at 10 am, the Korea Alliance of Patients Organization held a press conference in front of Ono Pharma Korea, urging the expansion of health benefit for immune cancer drugs. At 1 pm on the same day, the Korea Alliance of Patients Organization will hold a press conference with the same purpose at the Seoul Women's Plaza. The Korea Alliance of Patients Organization was scheduled to hold an interview in front of Ono Pharma Korea and MSD Korea, the developer of Opdivo and Keytruda respectively. Changes in place were inevitable as meetings and interviews became impossible due to the occurrence of COVID-19 confirmed patients in Seoul Square, where MSD resides. The patient's demand is that the developer & the HIRA should stop negotiating drug prices and prepare a reasonable level of financial sharing that the financial authorities will accept. The domestically approved immune anticancer drugs include Ono Pharma·BMS' Opdivo, MSD's Keytruda, Roche's Tecentriq (Atezolizumab), AstraZeneca's Imfinzi (Durvalumab), and BMS' Yervoy (Ipilimumab). Indications are rapidly expanding from non-small cell lung cancer, Hodgkin's lymphoma, head and neck cancer, kidney cancer, bladder cancer, gastric cancer, esophageal cancer, breast cancer, etc., Looking at the health insurance coverage, Opdivo, Keytruda and Tecentriq were reimbursed as non-small cell lung cancer, Opdivo and Keytruda as melanoma, and Tecentriq as bladder cancer. In order to receive treatment with immunosuppressive drugs for indications other than the indications is reimbursed, it costs from ₩ tens of millions to more than ₩100 million. The Korea Alliance of Patients Organization said to improve this reality. "The quality of life of terminally ill cancer patients living in the era of targeted anti-cancer drugs, followed by targeted anti-cancer drugs, has improved in a different dimension than when the first chemotherapy was administered," the organization said. "It is an urgent reason to increase the supply of immuno-cancer drugs." The organization said, “Pharmaceutical companies seeking to get high drug prices and financial authorities trying to save money on health insurance are not making any concession over the expansion of the benefits of anti-cancer drugs.” "We only accepted two indications for head and neck cancer and eliminated indications for kidney and stomach cancer." The organization said that Keytruda’s company also did not accept the expansion of the primary treatment reimbursement standard for non-small cell lung cancer. The HIRA’s Cancer Drug Review Committee asked pharmaceutical companies to prepare a rational financial sharing plan. The organization criticized the patient for dying of life-sustaining or cure-out opportunities while governments and pharmaceutical companies struggled with the price of drugs, such as a proverb saying when elephants fight, it is the grass that suffers. The Korea Kidneycancer association also issued a statement saying that the HIRA’s Cancer Drug Review Committee would speed up the registration of Opdivo for disqualification due to the financial burden. The organization also said that it was difficult to understand that Opdivo did not get kidney cancer benefits from the HIRA’s Cancer Drug Review Committee. According to the organization, the cost of the immuno-cancer drug is close to ₩6 million to ₩10 million per month, but it is also important for the health and financial benefits of the health insurance company, but the most important thing is patient’s life. The organization said that it is necessary to extend the patient's life by using the resources used in the patient support program that is conducted before the reimbursement to reduce the price.
- Company
- Hanmi on legal action against Sanofi returning efpeglenatide
- by Chon, Seung-Hyun May 18, 2020 06:14am
- A multinational pharmaceutical company Sanofi has decided to return the rights on antidiabetic candidate medicine efpeglenatide back to Hanmi Pharmaceutical. Apparently, the French-based company is putting an abrupt brake on the development of efpeglenatide, licensed out as the biggest Korean-developed pipeline in 2015. Hanmi Pharmaceutical explains “The decision was solely made by Sanofi with their shift in business plan,” and stated it would review taking a legal response. A view over Hanmi Pharmaceutical headquarters On May 14, Hanmi Pharmaceutical released news that Sanofi has notified the intention to return the licensed out efpeglenatide, currently undergoing a series of phase 3 clinical trials. According to the contract terms, the two companies are to finalize the decision on the retuning of the rights after 120 days of negotiation. Even if the French company returns the right, the Korean company is not subjected to return EUR 200 million (approximately 260 billion won) already received from the partner company. Hanmi Pharmaceutical official elaborated, “We have decided to negotiate with Sanofi to complete the ongoing phase 3 global study on efpeglenatide as it is close to the end,” and said the company “plans to seek for a new global partner company.” A glucagon-like peptide-1 (GLP-1) receptor agonist, efpeglenatide is an innovative bio drug candidate to treat patients with diabetes by administering the drug once-weekly or once-monthly at most. The candidate drug is based on Hanmi Pharmaceutical’s core platform technology ‘Labscovery,’ which prolongs the short half-life period of biologics and reduces administration frequency and dose to lessen the adverse reaction and improve effect. In November 2015, Hanmi Pharmaceutical and Sanofi had signed a license-out deal valued at 390 million euros on the Quantum Project (efpeglenatide, long-acting insulin, efpeglenatide plus long-acting insulin combination). Although the contract terms have been revised twice since then, the deal is still the biggest license out deal a Korean pharmaceutical company holds to the date. Hanmi Pharmaceutical claims Sanofi’s decision to return their rights over efpeglenatide were unreasonable, because the global company is dropping the already agreed upon phase 3 clinical study. Intending to take a legal action, Hanmi Pharmaceutical official said, “Sanofi’s decision was made without discussing with Hanmi Pharmaceutical.” After a new CEO took over the office in last September, Sanofi has unveiled a widely reformed R&D plan to halt diabetes and cardiovascular related research but to strategically concentrate on four main sectors including oncology, hematology, rare disease and neurology. When the announcement was made, Sanofi officially noted the multinational company would give up the rights to commercialize and distribute the antidiabetic pipeline efpeglenatide and search for a new partner, however, the ongoing phase 3 clinical trials would be completed with the company. At the moment, Sanofi is conducting five global phase 3 clinical trials related to efpeglenatide. Hanmi Pharmaceutical stressed Sanofi giving up on the efpeglenatide rights is unrelated to the medicine’s efficacy and safety. Hanmi Pharmaceutical official stated, “As Sanofi has publicly promised affected patients, investigators and Hanmi Pharmaceutical that the global phase 3 clinical trials would be fully conducted, we would demand Sanofi to keep their word,” and “Further legal actions pursuing litigation would be reviewed, if need be.” The Korean company official stressed, “Efpeglenatide is a promising pipeline, as the global GLP-1 receptor agonist market would be worth approximately USD 10 billion by the time the candidate medicine is commercialized,” and “the biologic would be able to find a new global partner at around the end of the year or the beginning of next year, when the outcomes of the superiority trial against efpeglenatide’s competitor Trulicity would be released.”
- Policy
- Xeljanz was rejected for the uninsured benefit
- by Lee, Hye-Kyung May 18, 2020 06:14am
- The application to use 'Xeljanz (Tofacitinib citrate)' from Pfizer Korea, which has been approved for rheumatoid arthritis and ulcerative colitis, was rejected for the uninsured benefit for patients with dermatomyositis or severe alopecia. The HIRA is applying in advance for the uninsured benefit that is not approved by the MFDS in order to prevent the use of drugs that lack medical basis or are concerned about safety. According to the details of the 'disapproval of the uninsured benefit' recently released by the HIRA, 10 new cases of disapproval, including Xeljanz, have been added, resulting in a total of 183 cases of disapproval of the uninsured benefit. First of all, in the case of Xeljanz, a medical institution applied to prescribe 5mg twice a day for 6 months to refractory dermatomyositis patients, but was rejected due to insufficient medical evidence. Another medical institution has requested that Xeljanz be used in patients with severe alopecia areata who have failed to continue treatment with systemic steroids or Cyclosporine for 3 months or cannot continue treatment due to side effects (alopecia over 80% of the entire scalp area). This institution evaluated the area of hair loss every 6 months and compared to the first time, if the area of hair loss decreased by more than 50% (SALT 50), it will be administered continuously, and the drug will be discontinued if hair loss improves with an SALT score of 10 or less. However, due to insufficient evidence, it was rejected. In this case, 'Olumiant (Baricitinib)', a treatment for rheumatoid arthritis in Lilly Korea, has been newly added. A medical institution said that it would administer Olumiant once a day to patients in 2019-nCoV acute respiratory disease, among patients undergoing inpatient treatment, fever, elevated inflammatory values, pneumonia findings and hypoxia in chest radiographs not improving or worsening. However, the HIRA said, "The data presented suggests the theoretical possibilities screened by artificial intelligence, and medical evidence is insufficient to support clinical use." In addition, it is not permitted to use the uninsured benefit because there are warnings that infection patients should not be used, and that the infection rate will be increased.” In addition, 'Botox', Carmine Injection 0.8%, Tuberculin PPD RT , Diabex XR, Luphere Depot, Enbrel, Enbrel Myclic Pen 50mg, Eucept Prefilled Syringe, Eucept autoinjector which have been applied for the uninsured benefit, were also not approved for use due to insufficient medical evidence of the submitted data.
- Company
- Pharmaceutical industry focuses on Spread of COVID-19 again
- by An, Kyung-Jin May 15, 2020 06:05am
- Pharmaceutical companies are also nervous again as the spread of COVID-19 from Itaewon Club in Seoul. Pharmaceutical companies seem to be cautious about unexpected situations when they tried to earnestly engage in sales marketing activities with the government's distancing in daily life. According to the industry on the 13th, a domestic pharmaceutical company e-mailed to all employees to inform the personnel team that they have visited a entertainment area in Itaewon, Seoul, and Gyeonggi Province, or immediately contact a personnel team after the visit to the entertainment district, individuals with personal health problems were notified immediately to contact the human resources team. Most companies recommend self-isolation for 2 weeks after self-examination to employees who have visited Itaewon entertainment store or suspected of symptoms related to corona19 such as fever, cough, sore throat. Samsung Bioepis asked to check the visit to Itaewon through a mobile interview last weekend. During this period, employees who visited nearby Itaewon also made strong preventive measures, such as recommending self-examination. Korean corporations of some multinational pharmaceutical companies such as AstraZeneca Korea and Janssen Korea plan to continue working for a long time with flexible operation of autonomous hours, such as every other day. Panoramic view of an office building lobby in Jung-gu, Seoul with a lot of floating Pharmaceutical companies are keen on the further spread of COVID-19 by employees who recently visited the Itaewon Club. If the spread of COVID-19 was concentrated in Daegu, Gyeongbuk 3 month ago, it is concentrated on young people in the metropolitan areas such as Seoul and Incheon, which intensifies the anxiety in the industry. In the case of COVID-19 confirmed patients in departments with high proportions of young employees, such as production facilities, research institutes, and sales departments, it is fatal to the operation of the company. In particular, in buildings where it is not possible to work from home, such as production facilities and research institutes, pharmaceutical companies become more nervous in that they have to stop operating for a while if there is one confirmed patient. In fact, a bio company that has a production facility in the metropolitan area said that employees who visited the area near Itaewon were suspicious until they received a negative result for COVID-19. The two companies in Seoul Square building where corona19 confirmed patients visited Itaewon were also nervous. MSD Korea and Mundipharma entered emergency telecommuting on the 11th after receiving a notice that Pernod Ricard Korea’s employee was confirmed on the 10th floor of the same building after visiting a local area near Itaewon in Seoul. Both companies seemed to be confused after ending their three-month telecommuting job and trying to approach work normalization. MSD Korea only started working at the office for only two weeks, but decided to switch to telecommuting and watch the trend. On the evening of the 11th, a management meeting decided to extend telecommuting until the 13th, and instructed employees not to stay in the office. Mundipharma also banned working at the office. Although building disinfection has been completed, it maintains a conservative position to set the time for resumption of work while paying close attention to the guidelines of the quarantine authorities. Companies are strengthening their guidelines to refrain from entering enclosed spaces The Yonsei Severance Building, where Boeringer Ingelheim of Korea resided, suffered a tumult on the news that the employee on the 11th was in close contact with COVID-19 confirmed patient. It turned out that Hyundai Shell Base Oil executive, the resident of the 7th floor of Yonsei Severance Building, ate with COVID-19 confirmed patient last weekend. Some of the companies in the same building immediately noticed the news and immediately left the company to work and urgent telecommuting was conducted for a day on the 12th, and Boeringer Ingelheim, who resided on the 16th floor, continued normal work. Although the close contact employee finally ended in happening after receiving a negative result, Boeringer Ingelheim, which resumed normal work from the 11th, passed the crisis of returning to home work in one day. An official from the pharmaceutical industry said, "The companies that tried to normalize the management after social distance was relieved by distancing in daily life was again in state of emergency and worried because there were a lot of young employees. but it is also not easy to recommend. The greater the psychological anxiety, the more the business disruption will continue. ”
- Company
- Sanofi Pasteur GM Baptiste de Clarens to leave Korean office
- by Eo, Yun-Ho May 15, 2020 06:04am
- The General Manager at Sanofi Pasteur Korean office, Baptiste de Clarens is to leave the office at the end of May. According to pharmaceutical industry sources, the resignation of General Manager Baptiste de Clarens has been decided by the headquarter. The decision was apparently made as his term in Korea is ending and a new general manager would be take charge of the Korean office from July. Like the other previous general managers of Sanofi Pasteur Korean office, the new general manager has reportedly led the Asian-Pacific regional office. After leaving the Korean office, General Manager Baptiste de Clarens would be appointed at the Sanofi Pasteur headquarter in Lyon, France to oversee the vaccine business. Since joining the French-based company in 2006, the general manager has worked on enhancing efficiency in general marketing and sales at the Lyon headquarter office and developed his global expertise. He has also supervised the company’s business operation in Asia in Singapore, before he was appointed as a general manager in offices in Malaysia, Singapore, Brunei, and in South Korea from July 2017. Currently, Sanofi Pasteur supplies various vaccines to Korea, including influenza vaccine, diphtheria plus tetanus plus pertussis vaccine, DTaP-IPV Combo vaccine, meningococcal vaccine, live attenuated virus vaccine against Japanese encephalitis, hepatitis A vaccine, and yellow fever vaccine.
- Opinion
- [Reporter's view] ‘Generic exclusivity' must be improved
- by Lee, Tak-Sun May 15, 2020 06:04am
- As the proposed regulation of the co-biological equivalence test was stopped by the Regulatory Reform Committee, The consigned generics business has revived. On the other hand, companies producing single generics that have claimed to regulate co-biological equivalence testing are concerned. They point out that there are many competitors in the market due to the activation of consigned generics, so there is no advantage of single-developed generics. Since the pharmaceutical industry was divided in half with respect to this regulation, it seems that everyone cannot be satisfied unless a new system is introduced. To this end, the generic exclusivity needs to be improved so that everyone can be satisfied. The generic exclusivity, which was introduced as the Korea-US FTA in 2013, has been collecting opinions from all over the recent improvement plan, but has not progressed. However, it is unlikely that any improvement measures that have been significantly changed . The biggest problem with the current generic exclusivity is that marketing exclusivity has no great benefit. The 9-month monopoly period is also a short period for generics to settle down, and there are many items that receive the generic exclusivity, so it is more than just satisfied with entering the market rather than being a monopoly. Some predicted that if the regulation is enforced, many companies will lose their generic exclusivity. However, with the withdrawal of co-regulation, the consignment system for entering the market is unlikely to be different. Through this regulation, it is predicted that the generic exclusivity will be acquired by a number of contractors with pharmaceutical companies that have successfully developed generics. As competition increases, marketing exclusivity becomes meaningless. In this regard, a plan should be devised so that generic exclusivity can be given only to companies that have overcome patents and developed generic drugs. In order to do that, even if the consignment company does not make a consignment production to the majority, it must create a structure that can benefit from the generic exclusivity to copyright. For example, it is necessary to find a way to extend the period of the right to copyright much more than 9 months a year, or to give preferential prices to the generics. If the ₩10 billion is secured during the period of generic exclusivity, there will be no other company to give profits to others. However, it is difficult for the generic to get ₩1 billion for 9 months. It is necessary to inform the medical institutions the generic exclusivity is the only generics that confronts the original through export preferential support, various tax benefits, and brand support. The MFDS has recently formed a public-private council aimed at strengthening international competitiveness of domestic generics to seek ways to support them. However, it is more difficult for generics that are not treated in the domestic market to have competitiveness overseas. Rather, it is better to grow it in the domestic market so that pharmaceutical companies can make global new drugs with that money. It is difficult to create a competitive generic with a system that cannot take advantage of generics as it is now. It seems that a more innovative support plan is needed.
- Policy
- Korea takes two-track approach on vaccine and treatment
- by Kim, Jung-Ju May 15, 2020 06:04am
- To speed up the development of Korean-made COVID-19 vaccine and treatment, the Korean government is swiftly working two most urgent regulatory changes. The revised regulation would stipulate Korean Red Cross, a non-healthcare institute, to collect blood samples integral for convalescent plasma therapy, and grant private companies to access biosafety laboratory. For a better access to needed drugs, the government has set a two-track approach to promote Korean-made medicine development and also to supply multinational pharmaceutical companies’ products. On May 8, the government officials convened a second meeting for the COVID-19 Treatment and Vaccine Development Pan-government Support Committee at the Westin Chosun Seoul to confirm COVID-19 treatment vaccine development status and strategies and to discuss regulatory revision approaches to expedite the R&D process. An image from the first meeting convened on Apr. 24 for the COVID-19 Treatment and Vaccine Development Pan-government Support Committee at the Government Complex Seoul. Besides the co-committee heads Minister of Health and Welfare Park Neung-Hoo and Minister of Science and ICT Choi Kiyoung, other related vice-ministers and Korean treatment and vaccine experts have gathered at the meeting. From Apr. 17, the government has activated the pan-government support system by weekly holding subsector meeting regarding treatment, vaccine, and disease control product and devices, and by biweekly holding meeting for the Pan-government Support Committee and working-level task force. Moreover, the government has paid attention on closely listening to and rapidly resolving complaints made by 21 companies seeking for COVID-19 treatment and vaccine through a corporate service center formed under the pan-government support committee. According to the COVID-19 treatment and vaccine development status in Korea briefed at the meeting, seven of clinical trials are in progress to expand indications on existing drug (drug repurposing). Apparently, an earliest release to the market would be feasible by the end of the year. Also there are three candidate medicines for vaccine, which are in preparation to initiate the clinical studies within this year. They are expected to be manufactured in the latter half of next year. In particular, the pan-government support committee has decided to amend two regulations urgently to expedite the treatment and vaccine development. First, the government is to offer a regulatory support for convalescent plasma therapy development. To accelerate the plasma therapy R&D, an abundant load of convalescent plasma drawn from patients cured from COVID-19 is needed. Currently, however, the blood sample collection is only possible in healthcare institute in Korea, and because Korean Red Cross is not a healthcare institute, it had difficulties in collecting R&D-purpose plasma collection. The Article 33 of the existing Medical Service Act restricts a healthcare provider without an established healthcare institute as stated in the law from practicing a medical service. But, when a leader of the state or regional government body recognizes and requests an exception, as needed for the public interest, the healthcare provider may practice a medical service within a healthcare institute. Accordingly, Ministry of Health and Welfare (MOHW) plans to interpret the statute to stipulate Korean Red Cross to collect plasma for research purposes and also to help healthcare institute lacking plasma collecting devices by renting out apheresis system to streamline plasma collection. To assist the healthcare providers, the government would publish ‘Convalescent Plasma Collection Guideline for COVID-19 Plasma Therapy Development’ and promptly set down plasma collecting standards. Furthermore, the government is to grant private corporate to access biosefaty laboratory to encourage corporate research on treatment and vaccine. A biosafety level 3 (BL3) laboratory is essential to test the effect of COVID-19 treatment and vaccine candidates, but private companies struggle to have its own BL3 lab. So their demand for the government to open the public BL3 lab for corporate use is high at the moment. So far, the government has allowed the use of facility after Korea Research Institute of Bioscience and Biotechnology (KRIBB) individually investigated each case, but the access would be expanded. Korea Centers for Disease Control and Prevention (KCDC) would list BL3 lab operating institutes on its website and link BL3 lab operating institutes with pursuing companies for more active use of public BL3 labs, after reviewing the demand of private (industry, academy, and research) use of the lab. The ‘Support Team for Private Use of Biosafety Laboratory,’ consisting of KCKC biosafety management officers and research department experts, would be newly formed and take charge of the demand and prioritization review and safety management. Meanwhile, the government is also planning to facilitate distribution of overseas pharmaceutical products to enhance patients’ access to treatment. Minister Park Neung-hoo of Health and Welfare stressed at the meeting, “We need a strategic prospective on the treatment and vaccine development support policy,” that “concentrates industrial, academic and research capacity to rapidly seek for Korean-made treatment and vaccine with assured safety and efficacy, and also that stably imports finished product or active ingredient, and essential disease control equipments. Therefore, a two-track approach should be the base of the policy.” Minister Park added, “Related ministries would cooperate together to listen to companies’ issues and resolve the issues in a streamlined manner. As each company faces unique situation, the government support varying from regulatory reform to R&D funding would be customized to meet their needs.” Minister Choi Kiyoung of Science and ICT emphasized “The fundamental key to overcome the COVID-19 outbreak is in successful development of treatment and vaccine,” and stated, “Seeking treatment and vaccine is an integral task to establish a concrete foundation for Korea to leap forward in the post-coronavirus era. The government would continue to endeavor creating reliable economic environment for the people.”
