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- 2026-04-12 02:53:19
- Policy
- Lipilouzet, which is more expensive than Atozet
- by Lee, Tak-Sun Jul 20, 2022 05:49am
- Chong Kun Dang is establishing a clear position in the market for the hyperlipidemia complex Atorvastatin-Ezetimibe complex. This is because MSD's Atozet, the original drug, has been jointly sold since 2016, and there is even a certain insurance called Lipilouzet. Lipilouzet has a higher upper limit than Atozet. According to an industry on the 18th, Lipilouzet has been selling since it was listed as the highest price in April last year. Lipilouzet is the only item that started at the same price as Atozet, which was the highest price at the time of listing. The same-active ingredients listed on the same day are consignment items produced by Chong Kun Dang, and the drug price is lower than that of Lipilouzet according to the standard requirements. Since then, in October last year, Lipilouzet has become the highest-cap item in the same system as the original Atozet has been reduced in accordance with PVA negotiations. Lipilouzet 10/10mg is priced at 1,037 won, higher than Atozet 10/10mg 1005 won. In addition, Lipilouzet 10/20mg is 1,315 won, the highest in the same content, followed by Atozet 10/20mg 1,276 won. Lipilouzet 10/40mg is priced at 1,415 won, surpassing Atozet 10/40mg 1,373 won and listed at the highest price. Since Chong Kun Dang is overwhelming the Atorvastatin-Ezetimibe combination market through strong sales power, the high upper limit is advantageous for improving performance. Since Chong Kun Dang is overwhelming the Atorvastatin-Ezetimibe market through strong sales power, the high upper limit is advantageous for improving performance. However, Chong Kun Dang is still more eager to sell Atozet than Lipilouzet. In February, it signed an extension contract with Organon Korea for joint sales of Atozet. Organon is a spin-off company from MSD and owns Atozet. Atozet raised 86.8 billion won in outpatient prescriptions based on UBIST last year. For Chong Kun Dang, even if the joint sale of Atozet is terminated, the risk can be minimized because there is Lipilouzet, which has a higher upper limit than Atozet. It is an insurance that guarantees performance. Organon is likely to continue to maintain Atozet joint sales. Chong Kun Dang is also making consignment profits by supplying products with the same ingredients to other companies through the development of Lipilouzet, so both production and sales were possible at the same time.
- Company
- Big Pharma are making all efforts to preoccupy orphan drugs
- by Jul 20, 2022 05:49am
- New drugs are emerging one after another for rare diseases such as multiple Castleman's disease, beta thalassemia, Fabri's disease, and spinal muscular dystrophy, which were not well known and had no medicine. Global pharmaceutical companies such as Johnson & Johnson, AstraZeneca, and Roche are leading new drugs for rare diseases. It was suggested that Korea should also provide institutional support and active development in the rare disease market dominated by global companies. ◆ Global company focused on rare drugs. 26% of total sales in 2026 According to the "Global Rare Disease Market Research Report" published by KIMCo, the global orphan drugs market is expected to grow by 12% annually, and sales of orphan drugs are expected to account for 20% of the total prescription drug market by 2026. Global Big Pharma is aggressively dominating the market through active technology transfer and mergers and acquisitions. In fact, the M&A case of a global pharmaceutical bio company in the first half of this year also reveals the high interest of Big Pharma in rare diseases. Pfizer acquired Biohaven, a developer specializing in treatments for rare nervous system diseases, for $11.6 billion. It is the largest deal in the first half of this year. GSK and UCB also spent $1.9 billion each to buy biotechs that developed treatments for rare cancers and rare epilepsy. Last year, AstraZeneca spent $39 billion to acquire Biotech Alexion, which specializes in treating rare diseases. It is predicted that 79% of the global new drug pipeline currently being developed is rare drugs, and the trend of global new drug development in the future will focus on more rare drugs. It is predicted that sales of rare drugs will reach an average of 26% of Big Pharma's total sales in 2026. ◆"Korea Has Less Development and Poor Support. Development strategies for orphan drugs" Behind the global big Pharma's rush to turn to rare diseases is the policies of major countries that give strong benefits to the development of orphan drugs. The U.S. Food and Drug Administration (FDA) provides up to 50% of tax benefits for R&D costs for new drugs designated as orphan drugs. It also advises on the design of subsidies and protocols for clinical development and exempts for orphan drugs for application for examination. If a new drug is commercialized, the exclusive right period will also be given seven years, two years longer than five years of general new drugs. This year, it also established a priority review for orphan drugs. Europe also has tax benefits for orphan drugs, exemption from examination application fees, and priority review systems. Monopoly rights can be granted up to 10 years from the date of marketing authorization, and the monopoly period is set through re-evaluation five years after marketing. Tax benefits are given from the development stage and various incentives such as priority review, post-marketing monopoly rights, and extension of item permits can help pharmaceutical companies secure growth engines in the long run. Global Big Pharma is taking a strategy to maximize drug sales by continuously expanding the indication of non-rare diseases after entering the market after phase 2 with an orphan drug designation and rapid screening program. Korea has implemented the Rare Disease Control Act since 2017, relatively late, and has prepared a legal basis for incentives for orphan drugs. Under this law, orphan drugs are given a 10-year validity period. In addition, the priority review system can be applied to orphan drugs, and fees will be reduced. The exclusive right shall be granted for four years from the date of marketing authorization. Some point out that the domestic benefit policy for orphan drugs, which are relatively expensive, is still insufficient. At the "policy debate to improve the environment of pediatric rare diseases" held at the National Assembly on the 13th, Professor Lee Bum-hee of AMC argued that orphan drugs designated by the Ministry of Food and Drug Safety and rare disease treatments are separated. Professor Lee Bum-hee pointed out that even if a new drug is developed successfully, the market will not be able to be activated unless an environment that can be used properly is supported.
- Company
- Maximizing JW Pharma's platform technology
- by Chon, Seung-Hyun Jul 20, 2022 05:48am
- JW Group is implementing an active open innovation strategy to maximize R&D capabilities. In order to boost the potential of two core platform technologies developed by themselves, they are mobilizing all resources that can be utilized from domestic bio ventures to overseas investment institutions. According to industries on the 13th, JW Group signed a business agreement with ARCH Venture Partners, a U.S. venture capital (VC). ARCH Venture Partners is the largest venture capital in the United States that invests in companies with early innovative technologies in the healthcare field. It is recognized for commercializing technologies developed by academic institutions, corporate research institutes, and national research institutes, and is investing in companies jointly established by major scientists and entrepreneurs to showcase innovations in life and physical science to the market. JW Group will be provided with the ARCH technical service program under this business agreement. ATS provides promising biotech and technical information selected by ARCH Venture Partners to strategic investors interested in business cooperation with venture companies around the world. This is the first time for a domestic pharmaceutical company to work together with a VC specializing in bio and healthcare in the U.S. for open innovation in the field of discovery stage. The reason why JW Group joined hands with ARCH Venture Partners is to maximize its own platform technology. JW Group is currently operating a new drug development program using two platform technologies, JWELRY and CLOVER. Its goal is to discover new targets that can increase the utilization of these platform technologies by utilizing ARCH Venture Partners' ATS program. Both JWELRY and CLOVER are big data platforms based on chemical and bioinformatics built by JW Pharmaceutical. JWELRY is a platform that distinguishes between activity and inhibition of Wnt signals. Wnt signaling pathways are preserved across all species, from nematodes and fruit flies to mammals, and play an essential role in cell proliferation or differentiation, animal organ development, and morphogenesis. Although the Wnt signaling pathway is involved in many diseases, there are no new drugs involved in this pathway so far. It is developing a treatment for hair loss (JW0061). The blood cancer and stomach cancer treatment (CWP291), developed based on the Wnt platform, is undergoing phase 1 clinical trials worldwide. New drugs are also being developed in the field of immune disease and tissue regeneration. CLOVER is a big data platform that accumulates cancer cell lines, tissues, genetic information and compounds, as well as pharmacological efficacy prediction data. CLOVER, which is capable of deriving low-molecular substances that inhibit or activate STAT signals, is evaluated as a platform capable of overall performance of mechanical and biomarker studies. STAT is an essential signaling system that regulates cell growth, mutation, proliferation, differentiation, and apoptosis. Abnormal STAT signals can cause various diseases affecting the skin, cancer, and immune system. JW Pharma has discovered more than 10 species through CLOVER so far. Among them, atopic dermatitis treatment (JW1601), gout treatment (URC102), and solid cancer treatment (JW2286) have entered the clinical stage. In addition, atopic dermatitis treatment and gout treatment were exported to global companies, respectively. JW Pharma signed a technology export contract with Leo Pharma in August 2018 for JW1601, an atopic dermatitis treatment. The total amount of contracts, including 17 million dollars in down payment, is 402 million dollars. In August 2019, Nanjing Simcere Dongyuan Pharmaceutical signed a technology export contract for the gout treatment URC102. The down payment is $5 million and the total down payment is $70 million. JW Pharma is expanding joint research with domestic bio companies to maximize the potential of its own new drug development technology. JW Pharma signed a joint research contract with bio-venture ILIAS Biologics last month. It is about developing a target type exosome treatment equipped with a low-molecular anticancer drug. The contract aims to develop a global innovative new drug that applies ILIAS's own exosome platform technology to low-molecular anticancer new drug candidates secured by JW Pharmaceutical. Earlier, JW Pharmaceutical also signed a joint research cooperation contract with Voronoi, SyntekaBio, Oncocross, and Organoidscience. The study with Voronoi is a method of applying Voronoi's (PROTAC; Proteolysis-targeting chimera) technology to JW Pharm's STAT3 target low-molecular anticancer drug candidates. PROTAC is a new drug development platform that removes target proteins using the in vivo proteolysis system. During the development process, Voronoi is in charge of designing compounds, synthesizing them, and deriving clinical candidate materials, while JW Pharm is in charge of intermediate clinical research including candidate material evaluation. SyntekaBio and Oncocross are pushing to develop new drugs using AI. JW Pharma has been discovering candidate materials for innovative new drugs for SyntekaBio and specific protein targets since last year. It is jointly planning innovative new drug tasks that work on specific proteins and speeding up the discovery of innovative new drug candidates with DeepMatcher, an AI platform owned by SyntekaBio, and drug 3D simulation technology. Since March, JW Pharma has been exploring new indications of new drug candidates and existing drugs with Oncocross and verifying the possibility of development. Oncocross has a RAPTOR AI platform. RAPTOR AI is an R&D platform that screens for optimal indications for new drug candidates or previously developed drugs, increasing the probability of clinical success and shortening the development period. In May, it signed a joint research contract with Organoids. It builds an R&D platform that makes Organoid's genomic information into DB. Organoid develops an organoid model using tissue samples from patients, and JW Pharma is responsible for decoding the genes of the organoid model and building a platform that accumulates the information. JW Pharma's R&D investment is also increasing. JW Pharma estimated this year's R&D investment cost at 85 billion won, up 65.7% from last year.
- Company
- Novartis nears reimb for its 2 ultra-high-priced new drugs
- by Eo, Yun-Ho Jul 19, 2022 05:16am
- With Novartis Korea nearing reimbursement listing for its 2 ultra high-priced drugs, how the two drugs will progress is receiving attention. The two Novartis drugs that have continuously raised issues since its domestic approval are ‘Kymriah (tisagenlecleucel) and Zolgensma (onasemnogene abeparvovec-xioi). Among the two drugs, Kymirah was first listed for reimbursement in April, and the drug pricing negotiations with the National Health Insurance Service for Zolgensma were also completed recently. When Zolgensma passes deliberation by the Health Insurance Policy Deliberation Committee (HIPDC), the drug will also be applied the prior approval system like Kymriah. If approved, it will be the first time in the history of Korea’s insurance reimbursement system that two drugs were consecutively applied the prior approval system for reimbursement benefit. The reimbursement process for the drugs was far from smooth. And when considering the long wait endured by the patients, it wasn’t even that ‘quick.’ However still, given the unprecedented cost of administration and the immense fiscal investment required, as well as its ‘one-shot’ concept, the results achieved by the two drugs are quite encouraging. The gov't and pharmaceutical companies’ rapid response shone through for Kymriah The reimbursement of the ultra-high-priced one-shot CAR-T new drug Kymirah was made possible through the combined efforts of the government, pharmaceutical companies, and patients. Kymriah is indicated for the treatment of ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲pediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse. The company had submitted a reimbursement application for both indications. The drug started its reimbursement listing process after it was approved by the Ministry of Food and Drug Safety in March last year through the ‘approval-reimbursement review linkage system.’ Six months later, Kymriah was first put up as an agenda for NHIS’s Cancer Disease Deliberation Committee (CDDC) review, but the committee deferred its decision. Immediately upon news of the deferral, the Korea Leukemia Patients Organization among others strongly criticized the government and the pharmaceutical company. The KLPO had before criticized the authorities over the delay in Kymriah’s agenda being put up for deliberation by the CDDC. In the end, Kymriah’s reimbursement agenda passed the CDDC review in October of the same year. This was also the first day HIRA disclosed the results of CDDC deliberations to the public. Also, Kymriah's reimbursement agenda passed the first Drug Reimbursement Evaluation Committee (DREC) meeting held in 2022. After then, the company successfully completed drug pricing negotiations and officially listed Kymriah for insurance benefit in April. Slower but fast enough results derived for 'Zolgensma' reimbursement The progress made for Zolgensma was slower than that of Kymriah. Although both drugs are high-priced one-shot treatments developed by the same company, Zolgensma is a rare disease treatment. Novartis submitted its reimbursement application for the spinal muscular atrophy (SMA) treatment Zolgensma in May last year, but the agenda was put up for deliberations a year later, in May of this year. As Zolgensma is a rare disease drug, the pharmaceutical reimbursement standard subcommittee must first set a reimbursement guideline for the drug before undergoing DREC review. However, discussions were delayed due to repeated requests for data supplements made by the government and their submission by the pharmaceutical company. As a result, the reimbursement progress for Zolgensma progressed at a much slower speed than Kymirah, which had applied for reimbursement approximately a month before Zolgensma. However, the process sped up after DREC deliberations. After passing DREC deliberations on May 12th, Zolgensma entered drug pricing negotiations in the same month and reached a drug pricing agreement without period extensions before the 60-day negotiation period expired. As a result, Zolgensma will likely be reimbursed as early as next month (August), or in September at the latest given HIPDC’s schedule. Zolgensma is a gene therapy that contains genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved the drug as the second advanced biopharmaceutical after Zolgensma. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients.
- Company
- Daiichi Sankyo's CSR activities resumed in 3 years
- by Lee, Seok-Jun Jul 19, 2022 05:16am
- As ESG management has recently emerged as a hot topic, corporate social responsibility (CSR) activities are also drawing attention. ESG and CSR are different, but they are evaluated to be similar in large concepts. All are based on the premise that voluntary participation of CEOs and executives and employees should precede. ESG and CSR are difficult to start or continue. Daiichi Sankyo Korea resumed its Friendly CPR Day in three years, which was suspended in the aftermath of COVID-19. The campaign, which began in 2016, is a step toward developing into a long-term CSR that saved corporate identity. Analysts say that CSR will be reflected by President Kim Dae Joong (62 yrs old), the longest-serving Korean CEO of a multinational pharmaceutical company. He leads the company from 2010 to the present and serves as a supporter for continuous CSR activities as well as business expansion. A company official said, "Due to COVID-19, large-scale offline events of the campaign have been suspended over the past two years. As the pandemic situation has improved recently, it is seeking to resume in stages. Starting this year, we will hold a small-scale sincere campaign, Friendly CPR Day, which invited family members and acquaintances of employees." The Campaign is a differentiated social contribution activity in which executives and employees of Daiichi Sankyo Korea, a company specializing in cardiovascular relations, visit community elementary schools and provide CPR education. Since 2016, it has been held every year on its founding anniversary (July 16). Due to COVID-19, 2020 and 2021 were suspended. A total of 69 people participated in this year's campaign, including 12 CPR instructors from Daiichi Sankyo Korea, 46 family members and acquaintances, and 11 Observer. Considering the COVID-19 situation, the first and second education sessions were divided and shared the "general CPR process," one of the standard curriculum of the Korea Cardiopulmonary Resuscitation Association, for about 1 hour and 40 minutes each. For education, the know-how of cardiopulmonary resuscitation education of executives and employees, which has been accumulated for many years, was used. In addition to cardiopulmonary resuscitation education, practice using mannequins and automatic cardiac shock devices (AEDs) was conducted to teach how to apply CPR in emergency situations. Daiichi Sankyo Korea encourages all employees to obtain KACPR's public instructor certificate through its sincerity campaign. The company fully supports the necessary expenses for employees to obtain and maintain their licenses, and recognizes the time required as working hours. As a result, about 130 out of 220 employees currently have instructor certificates to educate the general public on CPR. Among Daiichi Sankyo Korea employees, there are cases where citizens were saved by using certificates in emergency situations that actually require CPR. Kim Dae Joong Daiichi Sankyo Korea CEO said, "The campaign is not a one-time event activity, but a long-term social contribution activity that utilizes Daiichi Sankyo Korea's vision and the identity of a cardiovascular company." The company's executives and employees are members of pharmaceutical companies that contribute to the public health, and will continue to make efforts to devote themselves to the public interest and fulfill their social responsibilities as corporate citizens." Participants in the event said, "We have gained knowledge that can be used in practice, such as cardiopulmonary resuscitation through the sincerity campaign. It was a precious time to share values about the company my parents work for and have a time to understand each other, he said. In addition to the campaign, Daiichi Sankyo Korea is carrying out various social responsibility through social contribution activities such as the "Sevikar Love Sharing Campaign" to support heart disease patients' surgery costs and the "Korean Association for Children with Leukemia and Cancer Donation."
- Company
- Samsung Bioepis announces effectiveness of Lucentis Similar
- by Kim, Jin-Gu Jul 19, 2022 05:16am
- Samsung Bioepis announced on the 18th that it has announced the results of research on the ophthalmic disease treatment "SB11 (Lucentis biosimilar, Ranibizumab)" at the ASRS conference held in New York from the 13th to the 16th (local time). Samsung Bioepis released the results of post-hoc analysis of phase 3 clinical data for macular degeneration patients through an oral presentation session at an academic conference on the 16th. The presentation was conducted by Neil M. Bressler, a professor at Johns Hopkins University who participated in phase 3 clinical trials of SB11. Samsung Bioepis has conducted phase 3 clinical trials for 705 patients in 9 countries. A comparative study based on 634 prescription data for 52 weeks has proven medical equivalence with the original drug. The primary efficacy evaluation indicators of clinical trials were how much CST decreased at the time of the 4th week and how much BCVA increased at the time of the 8th week. This study was a statistical analysis aimed at identifying the baseline factor that affects the therapeutic effect from the clinical trial data and then confirming whether the equivalence is proven even when analyzing the subgroups considering it. As a result, the company explained that the vision and anatomical measurements between SB11 and the original drug were similar. An official from Samsung Bioepis said, "We were able to further prove the medical equivalence with the original drug through post-analysis of the SB11 clinical phase 3 data." "We will focus on expanding sales so that SB11 can be the best treatment alternative for many patients," he said. SB11's original drug Lucentis is a treatment for ophthalmic diseases such as wet AMD and DME developed by Genentech. Annual sales amounted to 4.4 trillion won last year. Samsung Bioepis obtained permission to sell under the name BYOOVIZ in Europe and the United States in August and September last year, respectively. Subsequently, in June this year, the product was released by its partner Biogen in the U.S. market at a price about 40% lower than that of the original drug. In May this year, it was approved in Korea under the name 'AMELIVU'. In Korea, it signed a marketing partnership with Samil Pharmaceutical ahead of its market target.
- Company
- NTS will provide tax support for bio companies
- by Kang, Shin-Kook Jul 19, 2022 05:15am
- NTS CommissionerBiopharmaceutical companies are set to receive tax support from the National Tax Service. The National Tax Service (Commissioner Chang-ki Kim) held a roundtable meeting at the Incheon Free Economic Zone located in Songdo, Incheon to listen to the difficulties experienced by those in the field with leaders of small-to-mid-sized enterprises that are residing in the Songdo Bio Cluster. The roundtable meeting was prepared to listen to the tax-related difficulties experienced by SMEs in high-tech industries that represent Incheon as a region and devise tax support measures for their resolution. At the meeting, Commissioner Chang-ki Kim said, “We have been providing liquidity support by extending the payment deadline and providing early refunds for SMEs that are suffering from high prices, high interest rates, and high oil prices. We also have a tax support promotion task force in place based around tax offices nationwide to continuously monitor the damages in each region and provide customized tax support measures that fit their needs.” Commissioner Kim emphasized, “We are working to foster an environment that encourages corporate growth, by expanding exempting regular tax audits for SMEs in their early stages or those that created jobs to support economic revitalization, etc.” Commissioner Kim also added, “This year, we will simplify the document requirements to enable easier use of the prior review system for tax deduction provided to research and human resource development expenses while providing consulting on tax deduction and reductions that SMEs have difficulty with, as well as the family business succession system. Commissioner Kim added, “This year, we will simplify the document requirements to enable easier use of the prior review system for the tax deduction of research and human resource development expenses while providing consulting on tax deduction and reductions that SMEs have difficulty with as well as the family business succession system." The SME leaders that attended the meeting proposed ▲improving the tax credit system for integrated investments ▲reducint the tax audit burden ▲ expanding tax reduction for consigned R&D in the bioindustry ▲expanding tax deductions for companies that increase employment, etc. To such requests, Commissioner Kim said, “We will actively discuss the suggestions that were made with relevant departments so that the voices of the field can be reflected in the tax administration process.” Meanwhile, the Songdo Bio Cluster is located in Zones 4,5 (Bio cluster, high tech industry cluster) where companies and institutions in the bio-industry including universities, research institutions, hospitals, foreign companies, etc. are located. By 2030, about 700 companies and research institutes are expected to move in to the cluster. Major residents include Samsung Biologics, Celltrion, DM Bio, and Janssen Vaccine.
- Company
- Will social distancing resume?
- by Kim, Jin-Gu Jul 19, 2022 05:15am
- As the spread of the coronavirus is intensifying again, concerns in the pharmaceutical bio industry are also growing. Front-line companies seem to be paying keen attention to whether to resume social distancing measures, while asking executives and employees to strengthen personal quarantine rules ahead of the full-fledged summer vacation season. ◆ Please strengthen personal quarantine rules. & refrain from face-to-face meetings According to the Korea Centers for Disease Control and Prevention on the 13th, as of midnight on the 11th, there were 37,360 new confirmed patients in Korea. It is the first time in more than two months that the number of new confirmed patients in Korea has exceeded 30,000 since May 17 (36,31). The quarantine authorities believe that COVID-19 will be prevalent again. The government has announced the announcement of new quarantine measures in preparation for the re-pandemic in summer. The pharmaceutical bio industry is paying keen attention to the government's announcement of quarantine measures. Social distancing measures are not expected to be implemented immediately, but various scenarios are under consideration because the possibility cannot be completely excluded depending on the spread. Most companies do not have separate internal guidelines. However, the government plans to comprehensively review the government's announcement and the spread of COVID-19 and take measures such as refraining from face-to-face meetings and recommending distributed vacations. An official from a local pharmaceutical company said, "We did not take any special measures internally. We reiterated compliance with personal quarantine rules to employees." If we resume distancing measures, guidelines such as refraining from face-to-face meetings will be issued to executives and employees accordingly," he said. An official from a multinational pharmaceutical company said, "If at least one confirmed patient is found in the company due to the recent re-proliferation of COVID-19, new guidelines are expected to be prepared, such as expanding telecommuting internally. ◆ Increasing tension in factories and research institute In particular, factories and research institutes seem nervous about the re-proliferation of COVID-19. This is because, like when COVID-19 was rampant in the past, if a COVID-19 confirmed patient occurs, all of the departments are likely to go into self-quarantine for a certain period of time. An official from a domestic pharmaceutical company said, "Unlike the early stages of the COVID-19 crisis, the entire factory will not be shut down, but if all of the departments are self-isolated, it will inevitably disrupt the operation of the line." The official said, "We are paying attention to the possibility of a sharp increase in the number of COVID-19 confirmed cases in Korea during the summer vacation scheduled for early August," adding, "We have already had a special request for factory or research institute employees regarding summer vacation. If the situation becomes serious, measures such as distributed vacation may be recommended, he explained. Pharmaceutical factories are also mindful of the possibility that supply and demand difficulties for cold medicines and antipyretics will expand again. An official from a pharmaceutical company, who operated an emergency operation system at the time of supply and demand shortage earlier this year, said, "We have secured enough inventory in preparation for the possibility of supply and demand again." ◆Marketing and sales representatives, concerned about resuming distancing A marketing officer at a domestic pharmaceutical company said, "Distancing measures are not expected to be implemented immediately, but if the situation becomes serious, there is a possibility that it will resume. It's only recently that offline events have been possible. If distance measures are resumed, marketing activities will inevitably be disrupted." "We're already full of offline marketing events for the next two or three months. Confusion is expected to be severe over whether to push ahead with the scheduled event," he added.
- Policy
- To halve the death rate from COVID-19
- by Lee, Jeong-Hwan Jul 18, 2022 06:06am
- Veru homepageAs the domestic quarantine authorities announced their plan to review and promote the purchase of Sabizabulin, a new oral treatment for severe patients in preparation for the COVID-19 re-pandemic, attention is being paid to the treatment. Sabizabulin, developed by U.S. pharmaceutical company Veru, is the first serious oral treatment for COVID-19, and is known to significantly reduce the relative risk of death compared to placebo to 55%. On the 17th, the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention reaffirmed to the National Assembly the need to introduce new oral drugs such as Paxlovid (Pfizer) and Largevrio (MSD). Sabizabulin is still a candidate drug for oral severe COVID-19. Developer Veru submitted an application for emergency use approval for Sabizabulin to the U.S. Food and Drug Administration (FDA) early last month. Developers are expected to be commercialized from August. Paxlovid and Lagevrio are for mild COVID patients. The difference is that the two oral drugs can be effective only when taken immediately after confirmation, while Sabizabulin has shown efficacy when used in severe patients who have already deteriorated due to confirmation. Sabizabulin is known to reduce the mortality rate by half (55%) when taken, and is evaluated as a new weapon to fight the COVID-19 pandemic. According to the results of a phase 3 clinical study published in the international journal New England Journal of Medicine (NEJM), Sabizabulin and standard treatments were administered to 150 severe COVID-19 patients, and the standard treatment group died 45.1% after 60 days, compared to 20.2% in Sabizabulin. As a result, the relative risk of death of Sabizabulin compared to placebo was significantly reduced to 55.2%. In addition, the period of hospitalization in the intensive care unit and the period of use of the ventilator were reduced by 14 days, respectively, compared to the placebo group. Sabizabulin was originally developed as an anticancer drug. Cancer cells grow on microtubules that move between cells in the body, blocking them from growing. Researchers at the University of Tennessee in the U.S., who developed the drug in the early days of the study, began further research, believing that when the coronavirus outbreak broke out in 2020, they could block the microtubule in cells to suppress the growth of the coronavirus. In the case of existing antibody treatments, the treatment effect may decrease depending on the virus mutation, but Sabizabulin is known to have no difference in the treatment effect due to the mutation. This is because it acts in a way that directly interferes with the microtubule in cells necessary for virus proliferation, not the virus itself. Developer Veru said, "If FDA approval is completed in July, we will be able to supply 57,000 people in July and 100,000 people in August." Veru introduces itself as a bio-cancer drug pharmaceutical company targeting bladder cancer and breast cancer.
- Opinion
- [Reporter’s View] Secrecy no more in pricing negotiations
- by Eo, Yun-Ho Jul 18, 2022 06:06am
- The importance of providing a clear explanation about an administrative decision is essential in the process of handling administrative affairs. This becomes all the more important when an exception arises in the application of a regulation, which raises more questions than an introduction or abolition of a system. But the National Health Insurance Service and pharmaceutical companies have never provided an explanation on a drug that extended their drug pricing negotiation period after passing the set deadlines. This non-explanation of such events has persisted despite the increasing drug pricing negotiation extensions that are been made between the NHIS and companies to newly list or expand insurance benefits for select drugs. From the patient’s perspective, the drug pricing negotiations have become a stage of endless wait, a stage without promise. This is in part due to the fact that the negotiation expiry date, extension decision, and other matters discussed and set by the NHIS and the companies are all kept undisclosed under a confidentiality agreement. In other words, there is no way for the third party to know when the 60-day negotiation period has started or ended. This is why more and more patients and healthcare professionals are expressing feeling smothered by the increasing number of negotiation extensions. The NHIS needs to seriously contemplate why the Drug Reimbursement and Evaluation Committee and Cancer Disease Deliberation Committee decided to disclose their deliberation results. In the current “high-priced drug era,” there are plenty of very effective but expensive drugs being introduced to the market. Therefore, it can be difficult for the government and the pharmaceutical company to reach an agreement within the set period of “50 days.” However still, the emphasis needs to be laid on the word, deadline. Deadline is a kind of promise. Also, the NHIS has described the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new domestic drugs. In other words, the period is set for the final negotiation period to speed up listing and allow others to estimate the time to listing or rejection. Also, the people need to know why the negotiation fell through so that they could criticize the faulty party and find a compromise. Of course, both are to blame for the deadline extension. Negotiation extensions prevail due to a lack of a mindset to bring results within the set period as well as the vague underlying sentiment that the drug will not be listed on the first try because it is an expensive and difficult drug to negotiate. Such sentiment and mindset are what lead to the repetition of exceptional cases. Also, the companies’ time-wasting acts due to delays in communication with their HQ and the administrative department’s complacency of delaying the imminent “negotiation breakdown” due to the fear of the flood of complaints filed by patients obscure the purpose of the system itself. The HIRA’s review process, during which a drug is evaluated based on clinical efficacy and cost-effectiveness, and the drug pricing negotiations, which will directly affect fiscal spending on the authorities’ part, would have to be a sensitive issue for both parties involved. However, on how long the ‘confidentiality’ clause will be considered justifiable must be considered. Times have changed. The patients and patient families will not wait idly anymore.
