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- 2026-05-06 09:54:43
- Company
- Orion bids KRW 548.5 bil to enter the pharma industry
- by Kim, Jin-Gu Jan 17, 2024 05:29am
- The Orion Group has become the largest shareholder of LegoChem Biosciences, a prime new drug developer. With the acquisition of LegoChem, Orion is expected to jump into the pharmaceutical bio-industry in earnest, breaking away from its previous passive activities such as signing a memorandum of understandings, making indirect investments, and establishing joint ventures. According to industry sources on the 16th, Orion announced on the 15th that it will acquire 9.36 million and 3,283 shares of LegoChem Biosciences for KRW 54.85 billion. After the acquisition, Orion will possess a 25.73% stake in the company, making it the largest shareholder of LegoChem Biosciences. Orion will acquire 7,963,282 million new shares via a third-party allocated capital increase at an additional KRW 469.8 billion. It will also purchase 1.4 million existing stocks from Orion’s largest stakeholders, CEO Yong-Zu Kim (1.2 million shares) and President Se-jin Park (0.2 million shares). Orion’s subsidiary, Pan Orion Corp., which is located in Hong Kong, will take charge of the acquisition procedure. After Pan Orion, which is a holding company for 7 corporations finalizes the acquisition, a holding company for seven entities in China, completes the acquisition process, Orion will incorporate LegoChem Biosciences as its affiliate. Orion is expected to enter the pharma-bio industry in earnest with the acquisition of the new drug developer LegoChem Biosciences. Orion announced its entry into three new businesses in 2020 and pointed to the pharmaceutical bio industry as one of them. However, before the acquisition of LegoChem Biosciences. However, as the company had only shown activity in the diagnostics business and mainly focused on laying the foundation for overseas businesses before the acquisition, the industry’s evaluation was that the company had sought to indirectly enter the market through joint ventures, etc., taking a step back from making direct investments. In 2020, Orion signed an MOU with diagnostic kit maker Sugentech, and in 2021, it signed a license-out agreement with Genomictree for its early diagnosis technology for colorectal cancer. The same year, it formed a joint venture in China with Shandong Lukang Pharmaceutical. In 2022, the company signed a joint development agreement with Quratis to jointly develop a vaccine for tuberculosis. In December 2022, the company established Orion Biologics. Orion Biologics is a 6:4 joint venture between Orion Holdings, the group's holding company, and Hysense Bio, a dental disease treatment venture company. However still, Orion Biologics is considered to be focusing on supporting the company’s diagnostic and vaccine business in China rather than Korea’s pharma-bio industry. But with the acquisition of LegoChem Biosciences, Orion is seemingly making entry into the pharma-bio industry in earnest. The company seems to be focusing the group's pharmaceutical bio business capabilities on LegoChem Biosciences while maintaining the existing management and operating system for the rest of its businesses. The pharmaceutical industry is paying attention to the potential of LegoChem Biosciences that Orion seeks to acquire. LegoChem Biosciences specializes in the development of antibody-drug conjugates (ADCs), which have recently attracted great interest from global big pharmas. LegoChem Biosciences has signed more than 10 technology transfer agreements in the ADC field since 2015. Starting with the technology transfer to China's Fosun Pharma in 2015, the company has made 13 known technology transfers. Of these, 4 candidates have entered the clinical stage. In addition to the upfront payment, the company is expected to receive additional milestone payments upon achievement of commercial milestones. The most recent deal was signed in December last year. The company signed a technology export agreement with the multinational pharmaceutical company Janssen for its ADC drug candidate 'LCB84'. LCB84 is an ADC candidate drug that can target various solid tumors, including triple-negative breast cancer and non-small cell lung cancer. LegoChem Biosciences has a proprietary ConjuAll linker. An ADC consists of a linker, a payload (drug), and an antibody. The ConjuAll linker is believed to be able to overcome the release of cytotoxic drugs in the blood and attack normal cells. Based on this potential, the company has a market capitalization of more than KRW 1.5 trillion on the KOSDAQ market as of the closing price on the 15th. It ranks 28th in market capitalization on the KOSDAQ market. It ranks 7th among pharma-bio companies listed on KOSDAQ.
- Company
- KRPIA's new BOD is full of Korean members
- by Eo, Yun-Ho Jan 17, 2024 05:29am
- KRPIA has launched its new board of directors for the 2024 New Year. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has recently announced its new board of directors (BOD). The new BOD stands out as it is primarily made up of Korean members. Among the 13 BOD members, which includes KRPIA chairman Dong-Wook Oh (CEO of Pfizer Korea), only two are foreign nationals, making up 85% of the board as Korean members. Because multinational pharmaceutical companies appointing Koreans as CEOs of their Korean branch instead of foreign nationals, it has likely led to the BOD members consisting primarily of Korean members. CEO of Astellas Pharma Korea, Junil Kim, CEO of Bayer Korea, JinA Lee, and CEO of MSD Korea, Albert Kim, are Koreans who were newly appointed last year. Of note, Albert Kim holds Canadian nationality. New foreign members of the BOD include Maurizio Borgatta, CEO of GSK Korea, and Christoph Hanman, CEO of Merck Korea. Meanwhile, KRPIA is facing substantial changes in the coming years. The association has recently appointed Choi In-Hwa, an executive at Roche Korea, to oversee the association's policy business following the retirement of Kim Min-Young (currently the Director of Market Access at Gilead Sciences Korea), who left the position in February of last year. This appointment fills the vacancy after a year. Additionally, the current chairman of the association is also nearing the end of the term. Chairman Oh Dong-Wook's term is set to expire this month (January), and it is expected that a new chairman will be appointed in February. Chairman Oh has been leading the association since his appointment as chairman in 2021.
- Policy
- High-priced drugs receive reimb in the new year
- by Lee, Tak-Sun Jan 17, 2024 05:29am
- Ultra-high-priced drugs whose costs exceed KRW 100 million are being listed for reimbursement one after another in the new year. Following Koselugo’s reimbursement this month, Luxturna, which will cost KRW 1 billion, is expected to be reimbursed next month. With such ultra-high-priced drugs being listed one after another, voices have been rising on the need to strengthen post-listing management to efficiently manage the financial expenditures of Korea’s national health insurance. According to industry sources on the 16th, ‘Luxturna Inj,' an ultra-expensive drug that costs KRW 950 million, has completed drug pricing negotiations with the NHIS and is set to be reported to the Health Insurance Policy Deliberation Committee this month. The drug is a ‘one-shot treatment’ that shows an effect after a single dose, similar to previously listed drugs like Kymriah and Zolgensma. Luxturna is indicated for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. It is estimated that there are about 50 patients who are eligible to receive LUXTERNA in Korea. The issue is its high price. The drug costs about USD 710,000 per single dose in the US, which roughly translates to KRW 950 million in Korean won. Feeling burdened by the high price, patients have been awaiting the drug’s reimbursement listing since it was approved by the Ministry of Food and Drug Safety in September 2021. However, a sense of anxiety filled the air when Luxturna’s pricing negotiations, which began in September, failed to finish within the set deadline and extended the deadline. Fortunately, the two sides quickly reached an agreement during the extended negotiation period. The company and the government reportedly shared the price burden at a reasonable level through the risk-sharing agreement system. Since this drug is an ultra-high-priced one-shot treatment like Kymriah and Zolgensma, it is likely to raise follow-up management issues even after listing. Ultra-high-priced KRW 950 million Luxturna awaiting to be reimbursed in Korea The neurofibromatosis treatment Koselugo Cap (selumetinib, AstraZeneca) has been reimbursed from the 1st of this month. The drug has succeeded in receiving reimbursement listing for 2 years and 6 after filing an application in June 2021. The expanded scope of subjects eligible for waiving submission of pharmacoeconomic evaluation data (PE exemption drugs) that was implemented in January last year played a decisive role in its reimbursement listing. The company agreed upon three risk-sharing types of RSA – the refund type, expenditure cap type, and initial treatment cost refund type – with the NHIS reducing the burden of health expenditures on the government’s part. With the reimbursement listing, patients only need to a copayment rate of 10% of the annual cost of KRW 200 million required for its use, reducing the burden to a KRW 10 million range. The cost of new drugs being listed recently is well over KRW 100 million. Zolgensma, which was listed for reimbursement in 2022, is currently the most expensive drug on the reimbursement list, at a price of KRW 1.98173 billion per kit. With these high-price drugs increasing healthcare expenditures, health authorities are also focusing on the post-listing management of these high-priced drugs. With the introduction of Kymriah and Zolgensma, a performance evaluation system that applies reimbursement through post-evaluations has been introduced. HIRA is seeking to broaden the scope of the system to manage PE exemption drugs and has been also promoting the reevaluation of existing drugs. From this year, it also established the 'Pharmaceutical Performance Evaluation Department, which will be responsible for the post-listing management of listed high-priced drugs. The NHIS plans to secure the financial soundness of its system by advancing the risk-sharing agreement system. To this end, it plans to minimize financial uncertainties by applying a performance-based risk-sharing system at the patient level and strengthening follow-up management of drugs using systems including the price-volume agreement system. The government’s plan for managing high-priced drugs is also expected to be included in the 2nd Comprehensive National Health Insurance Plan that is expected to be announced this month.
- Company
- Whan In has exclusive distribution rights for Sanofi's Arava
- by Kim, Jin-Gu Jan 16, 2024 06:09am
- On the 10th, Whan In Pharm had signed an exclusive promotion & distribution agreement with Sanofi-Aventis Korea for Arava tablet in Korea. On the 10th, Whan In Pharm announced that the company signed an exclusive promotion and distribution agreement with Sanofi-Aventis for Arava Tablet, a rheumatoid arthritis treatment containing the active ingredient leflunomide, in Korea. Whan In Pharm is recognized for its business specialization in the central nervous system (CNS) field. Through this agreement, Whan In Pharm plans to expand its business focus into areas beyond the CNS. Arava Tablet is a drug for alleviating rheumatoid arthritis symptoms, active psoriatic arthritis symptoms, and others. The drug is steadily generating sales of around 6 billion won every year. “We are pleased to announce our first partnership in the non-CNS field with Sanofi,” Lee Wonbum, CEO of Whan In Pharm, stated. “We anticipate that our collaboration with Sanofi will drive mutual growth and enhance our market competitiveness in the rheumatology field. “We are thrilled to establish a strategic alliance with Whan In Pharm, a company with a proven track of success in the CNS field. Through this partnership, we anticipate that we will be able to steadily supply Arava, an important treatment for Rheumatoid Arthritis, to patients in need,” Suk Sang Kyu, Foundation Business Unit Head at Sanofi-Aventis Korea stated.
- Policy
- Caution required for use of ADHD drug methylphenidate
- by Lee, Hye-Kyung Jan 16, 2024 06:09am
- The warnings and precaution section of the attention deficit hyperactivity disorder (ADHD) treatment ‘methylphenidate’ is expected to add warnings for increased intraocular pressure and glaucoma. The Ministry of Food and Drug Safety (MFDS) prepared a change to the label of drugs that contain methylphenidate based on a review of the safety information on methylphenidate products by the U.S. Food and Drug Administration (FDA) and is conducting an opinion inquiry until the 26th. 14 methylphenidate products are currently approved in Korea, including Janssen Korea’s ‘Concerta OROS Er Tab,’ Whan In Pharm’s ‘Penid Tab,’ and Myung-In Pharm’s ‘Perospin Tab.’ The labeling change will be made separately, for ‘delayed release capsule’ products ‘film-coated extended-release tablets,’ and ‘uncoated immediate release tablets.’ The updated general warnings and precautions for delayed-release capsule products will include increased intraocular pressure and glaucoma. Due to reports of increased intraocular pressure (IOP) associated with methylphenidate treatment, the warning and precautions section will be changed to state that patients with abnormally elevated IOP should only be prescribed treatment if the benefits outweigh the risks. Patients with a history of abnormal IOP elevation or open-angle glaucoma should have their IOP monitored closely during treatment. For the extended-release film-coated tablets, ‘very rare motor and verbal tics’ will be added to the post-marketing surveillance data as an adverse event, and the general warnings and precautions will specify that patients should be monitored periodically for the onset and worsening of tics during methylphenidate therapy in addition to conditions such as IOP elevation and glaucoma and that treatment should be discontinued when clinically appropriate. The general warnings and precautions section for uncoated immediate-release tablets will include ‘Clinical evaluation of tics should be performed prior to use as well as family history,’ in addition to IOP elevation and glaucoma. During treatment with methylphenidate, patients should be regularly monitored for the onset and worsening of tics or Tourette syndrome, and treatment should be discontinued when clinically appropriate.’ Meanwhile, the treatment efficacy of methylphenidate ADHD has been demonstrated in clinical trials in children and adolescents aged 6 to 17 years of age and adult ADHD patients aged 18 to 65 years who meet the who meet the DSM-IV criteria.
- Company
- Gov't will reduce fines for companies that adopt CPs
- by Kang, Shin-Kook Jan 16, 2024 06:08am
- A revised Fair Trade Act that grants benefits, such as reduced penalty surcharges to companies that have adopted and excellently operated a Fair Trade Compliance Program (CP), will be enforced on June 21st this year. On the 15th, the Fair Trade Commission announced that it would prepare sub-statutes, including the Enforcement Decree and Notification of the revised Fair Trade Act , to stipulate standards and procedures for the implementation of the system in February for the timely enforcement of the revised Fair Trade Act CP is an internal compliance system that companies establish and operate independently to comply with fair trade-related laws and regulations. The system, which includes training and supervision, was introduced proactively by the private sector in 2001. The FTC has been providing various benefits to companies that introduced and operated CPs to activate the CP system since its introduction, and has been operating a CP rating system since 2006 to grant differentiated benefits based on operational performance to induce the sound operation of the system. However, as the CP system is based on established rules rather than the law, the government had difficulty preparing incentives to actively induce and operate the CP. To address these issues, the FTC amended the Fair Trade Act in June last year to legislate the CP system, and CP operation rating system, and prepare a legal basis to provide support such as fine reductions or rewards to companies that have excellently operated their CP. Also, to promote the implementation of CP in companies, the FTC plans to minimize the burden on companies by reducing the cost of introducing and operating CP and making it easier and simpler to apply for rating evaluations, and providing more substantial benefits to excellent CP companies, such as reducing penalty surcharges, lowering the Korea Credit Guarantee Fund fee rate, and award premiums when assessing implementation of the fair trade agreement with franchisees and agents. An FTC official said, "We expect the number of companies introducing and operating CP to increase with the establishment of a legal basis for the CP system and support, such as penalty fine reductions. The number of companies that applied for CP rating evaluations had increased to 28 companies in 2023 when the legal basis for the CP system had been prepared. This is a 1.75-time increase from the 16 companies that applied in 2022.”
- In-Hwa Choi will become KRPIA's new Policy Director
- by Eo, Yun-Ho Jan 16, 2024 06:08am
- KRPIA's head of policy position, which had remained vacant for about a year, is soon set to be filled. According to industry sources, the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently named In-Hwa Choi (60), current Access and Policy Head at Roche, to oversee the association's policy business. Choi will succeeding the former Director Min-Young Kim (53, current Director of Market Access at Gilead Sciences Korea) who resigned in February last year. The new Director Choi will retire from her role as Access & Policy Cluster Lead at Roche this month (January). KRPIA has been operating without a policy lead for about a year after its former Director Min-Young Kim left to work as the Head of Market Access (MA) at Gilead Sciences Korea. Therefore, Choi's appointment is expected to strengthen the association's capability to engage in policy-related external activities. Director Choi graduated from Ewha Womans University College of Pharmacy and started her career as a public pharmacist for the Central Pharmaceutical Affairs Council. After working at Boryuong Pharmaceutical and Taejoon Pharmaceutical, she joined Roche in 2001, where she has been in charge of policy-related businesses such as market access (MA) and regulatory affairs (RA) for over 2 decades.
- Company
- Reimbursed drugs hit four-year low amid regulatory changes
- by Chon, Seung-Hyun Jan 16, 2024 06:08am
- The number of drugs on the health insurance reimbursement list has reached its lowest point in four and a half years. Due to pricing revisions for generic drugs and regulations related to joint development, the introduction of new drugs is significantly reduced. The number of approvals has decreased by more than 70% compared to the figures from four years ago. According to the Health Insurance Review and Assessment Service (HIRA) report on the 16th, the total number of drugs listed on the reimbursement listing as of January 1st was 22,889. This represents a decrease of 754 drugs compared to 23,643 drugs listed in January of the previous year. Furthermore, the number of reimbursed drugs has reached its smallest in four years and four months, compared to 22,912 drugs reimbursed in September 2019. The number of drugs listed for reimbursement peaked at 26,527 in October 2020 and has been steadily decreasing. Over the course of three years and three months, there has been a decrease of 3,638 drugs. In other words, 3,638 more drugs have been either withdrawn from or forced to exit the market compared to new drug entries into health insurance reimbursements in the past three years. The number of listed drugs for reimbursement was 20,689 in November 2018, and it increased to 26,527 in October 2020, increasing by 5838 in just a year and eleven months. Over this period, the volume of listed drugs for reimbursement expanded by 28.2%, demonstrating that new drug entries exceeded market exits. Out of the 22 months from November 2018 to October 2020, December 2019 witnessed a decrease in the number of listed drugs compared to the previous year. In other words, for the remaining 21 months, the scale of listed drugs was larger compared to previous months. In contrast, the number of listed drugs for reimbursement has consistently declined. While there was an increase of 497 more drugs listed over the two months from October to November 2023, this increase is a temporary phenomenon attributable to the opening of the generics market for diabetes drugs. During this period, as the patent for the diabetes treatment ‘sitagliptin’ expired, a significant number of generic products entered the reimbursement listing. Sitagliptin is an active ingredient in the DPP-4 inhibitor-class diabetes treatment ‘Januvia.’ The number of currently listed drugs reached its lowest point in 33 months, following a total of 25,694 in February 2020. The number of listed drugs for reimbursement has significantly decreased as a result of the revision to the drug pricing system. The decrease in the number of reimbursed drugs since 2020 was primarily initiated by the revised drug pricing system. The revised drug pricing system, implemented in July 2020, requires generic products to meet both bioequivalence testing and the use of registered raw materials to maintain a maximum reimbursement price of 53.55% compared to the current patent-expired original drugs. The revised drug pricing system includes a stepped pricing system, which involves a lower maximum reimbursement price for drugs that are newly listed for reimbursement. If there are twenty or more generic versions available for a specific active ingredient in the market, the maximum reimbursement price for newly listed items can be set at up to 85% of the previous lowest price. Because the drug pricing significantly decreases when a pharmaceutical company does not develop the drug itself or undergo bioequivalence testing, generics produced by Contract Manufacturing Organizations (CMOs) have seen a more substantial decline in approval. Recently, the number of approvals for prescription drugs has significantly declined. Last year, the number of approvals for prescription drugs was 1,046, showing a decrease of 6.4% compared to the previous year. Compared to 2021, which had 1,600 approvals, there was a 34.6% decrease in approvals over two years. Since 2019, when there were 4,195 approvals, the scale of approvals for prescription drugs has shrunk by 75.1% over four years. Compared to four years ago, the number of approvals for prescription drugs decreased by 3,149. The number of approvals for prescription drugs was 1,562 in 2018, averaging 130 approvals per month. In 2019, this figure increased to 4,195, more than doubling to an average of 350 approvals per month. By May 2019, the monthly approvals reached 584. However, starting in 2020, it gradually declined and returned to the previous year’s level. From October 2018 to July 2020, over 100 prescription drugs were approved each month. However, in August 2020, after 23 months, the number of approvals for prescription drugs dropped to less than 100 per month. Last year, there were only two months with over 100 approvals for prescription drugs. The regulatory barriers for approvals have also been raised. Starting in July 2021, with the implementation of the revised Pharmaceutical Affairs Act, the number of incrementally modified drugs (IMD) and generics that can be approved through a single clinical trial has been limited. This new regulation, known as the '1+3' rule, restricts the number of IMD and generics approved through a single clinical trial. When a pharmaceutical company conducts bioequivalence tests directly and manufactures the drug in the same facility using the same prescription and manufacturing method for all production processes, the utilization of bioequivalence data is restricted to three times. In other words, only four generics can be approved based on one set of bioequivalence tests. Clinical trial data is also limited to products from the pharmaceutical company that conducted the tests directly, in addition to three other products for which a clinical trial data agreement is possible. In the past, when a particular pharmaceutical company obtained approval for generics through bioequivalence testing, other pharmaceutical companies frequently used the same documentation for obtaining approvals for CMO generics. However, due to the regulation of joint development, the "unlimited copying phenomenon of generics" has become practically impossible. There are criticisms suggesting that the government may have played a role in the increase in generic drug approvals in 2019 and 2020. The government's measures at strengthening regulating generics may have resulted in this surge in generic approvals. In 2018, there was a ban on the sale of 175 pharmaceutical products containing the active ingredient valsartan, used to treat high blood pressure, due to excessive impurities. In response, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) established the "Committee for Improving Generic Drugs Policies" to formulate measures to control the excessive production of generics. However, as pharmaceutical companies attempted to secure generic products in advance, there was a temporary surge in generic approvals. Following the government’s regulatory revision, the number of generic approvals returned to previous levels.
- Company
- 'Discussing Rinvoq based on Korean RWD'
- by Eo, Yun-Ho Jan 15, 2024 05:47am
- Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center The value of Real World Data (RWD) increases in areas where the development of new treatment options has been slow, primarily due to insufficient medical field experience and limited information beyond randomized controlled trials (RCT). Atopic dermatitis is one of the fields that has seen a shortage of new drugs in the past. However, in recent years, there have been notable shifts in prescription patterns, with the inclusion of JAK inhibitors and interleukin inhibitors. Amidst ongoing developments, Korean researchers have unveiled RWD research findings related to the JAK inhibitor 'Rinvoq (upadacitinib)' in Korean patients. The study, led by Professor Ahn Ji Young from the Department of Dermatology at the National Medical Center, involved a retrospective analysis of the medical records of 85 atopic dermatitis patients who were treated with Rinvoq for a minimum of 16 weeks between Oct. 2021 and Dec. 2022 at the National Medical Center. As as result, Rinvoq demonstrated clinically significant improvements in patients with moderate to severe symptoms, as indicated by evaluation parameters including the Eczema Area and Severity Index (EASI), Pruritus numerical rating scale (pNRS), Life Quality Index (LQI), Patient-Oriented Eczema Measure (POEM). DailyPharm sat with Professor Ahn for an interview. -What was the background for conducting the RWD research in Korea? RCTs were available, but there could be disparities between RCT data and data collected from patients in real-world clinical settings. Furthermore, overseas data frequently originate from research that primarily involves Caucasian populations. While the drug dosage may be the same, variations can arise in the medical environment and conditions between Asian or Korean patients and those in other countries. There are also situations that cannot be satisfied solely through overseas clinical studies. Considering these factors, the objective was to acquire data customized for Korean patients. With this data, it will be possible to share information with medical professionals in Korea, potentially leading to more effective patient treatments in the future. -What was the research design? This research was not originally planned as part of the study but was conducted retrospectively after the data had already been collected. Once a substantial volume of patient data had been gathered, we analyzed the data from these patients, covering periods from the start of treatment up to 2, 4, and 16 weeks, in order to monitor changes in the patients' conditions. In addition, we assessed various parameters including pNRS, DLQI, POEM, ADCT, and others. Furthermore, we examined the types of side effects experienced by patients during treatment and identified which drugs had proven effective for those who showed improvement. We evaluated various conditions to determine which aspects indicated a positive response in patients. The research findings showed that Rinvoq demonstrated a rapid onset of action during the early stages of treatment, particularly in patients with elevated eosinophil counts. This research has allowed us to identify points that could be beneficial for patients. -Can eosinophil count possibily be a biomarker? Yes. Patients with high eosinophil counts may experience positive effects from Rinvoq treatment, and we concluded that this outcome can be explained through a specific mechanism. -What were the conditions of patients? Based on the data from patients with atopic dermatitis lasting for 16 weeks or more between 2021 and 2022 at the National Medical Center, it was found that there was a slightly higher proportion of males among these patients. Typically, these patients had developed atopic dermatitis during childhood. Approximately 19% of patients developed the condition after reaching adulthood. Many patients often mention that they developed atopic dermatitis after reaching adulthood. However, upon further inquiry, it is common to find that these patients actually experienced atopic dermatitis during childhood, but it improved during that time and then worsened again after they became adults. -Any other prominent results, in addition to eosinophil counts? Based on the research results, we examined which parts of the body showed the most improvement. In terms of the body, there was overall improvement. There were concerns about the effect of interleukin inhibitors like "Dupixent (dupilumab)" on the condition of the head and neck, but Rinvoq showed improvement across various body parts. In terms of symptoms, lichenification and excoriation were more common in the acute phase, especially lichenification tended to become hardened in the chronic phase. These symptoms improved rapidly, and patients expressed high satisfaction with these improvements. -Can it be seen as the characteristics of JAK inhibitor? Rather than categorizing it as a JAK inhibitor, it is seen more as a distinctive feature of Rinvoq. Among Korean and Asian atopic dermatitis patients, lichenification is often observed, so the improvement of lichenification is a highly significant aspect. Although not yet conclusive, with more data in the future, it may be possible to say that this drug is particularly effective for Asians. However, the issue is that there was a significant occurrence of acne. While it typically appears in clinical trials at around 10%, in this research, it was observed in nearly 40% of cases. Additionally, It was observed that the incidence of acne decreased with an increase in age. -What are the benefits of Rinvoq found from the research? The key benefits include rapid onset of action and its effectiveness in improving itching. In real-world clinical practice, Rinvoq is the preferred treatment option when patients suffer from itching, -Are all JAK inhibitor and interleukin products covered by insurance? Are there any frustrations regarding the current reimbursement criteria? One of my frustrations would be the switching. Doctors affiliated with the Korean Atopic Dermatitis Association might agree to this. It's indeed a challenging situation when a patient is unable to switch to another medication, even when the initially prescribed drug proves to be ineffective. Since accurate biomarkers are not available, medical professionals often face difficulty in determining the most suitable medication for a patient right from the start. Therefore, switching should be reimbursed.
- InterView
- ‘2nd line opt for CMV is limited…should improve access'
- by Son, Hyung-Min Jan 15, 2024 05:36am
- Sung Shin, Professor of Kidney and Pancreas Transplantation at Asan Medical Center (Director of General Affairs, the Korean Society for Transplantation) An expert had suggested that we improve access to a new cytomegalovirus (CMV) treatment drug that has shown effect in patients with resistance as CMV has a major impact on transplanted organs. Sung Shin, Professor of Kidney and Pancreas Transplantation at Asan Medical Center (Director of General Affairs, the Korean Society for Transplantation) expressed so at a meeting with Dailypharm, explaining how Livtencity, which has been shown to be effective in second-line treatment, could be beneficial amid the rising number of CMV patients developing resistance to existing first-line therapies. CMV is a member of the herpesvirus family that causes infectious diseases. The risk of CMV infection is particularly high after organ transplantation when the patient’s immunity is lowered. CMV is a common complication in kidney transplant patients, to the extent that around half of the patients report infections. If not treated in time, it can lead to a variety of complications, including pneumonia and lung inflammation, but treatment options are limited for patients who develop resistance to first-line therapy, raising the need for new second-line options. Takeda's CMV therapy, Livtencity (maribavir), has demonstrated efficacy in patients who are resistant or intolerant to existing first-line therapies. In clinical trials, Livtencity demonstrated more than double the CMV viremia clearance rate compared to existing treatment options and had lower toxicity. Professor Shin welcomed the introduction of a new class of antivirals for resistant and treatment-refractory CMV and emphasized the need for its reimbursement to increase patient access to Livtencity CMV, predominantly affects organ transplant patients, and can potentially be fatal Delayed treatment of CMV can lead to the infection of various organs. Especially in the early stages of transplantation, when immunity is low, it can lead to severe pneumonia, enteritis, sepsis, and even death. CMV infection is known to be especially prevalent in kidney transplant patients. More than 2,000 patients receive kidneys in Korea every year. According to reports, more than 50% of them are infected with CMV, and more than 10% of the infected patients show infected symptoms. As much as it is difficult to receive a kidney transplant, it is also important to manage various viruses after the transplant. Professor Shin said, “CMV infection is associated with earlier loss of function in the transplanted kidneys compared to uninfected patients. Also, CMV infection is associated with a significantly higher risk of fatal pneumonia and death from severe infections.” As such, early administration of effective antiviral therapy is important for organ transplant patients susceptible to infections. However, with a reported 60% resistance rate to existing first-line antivirals such as ganciclovir and valganciclovir, only a limited range of second-line CMV treatment options exist due to toxicity issues. MSD's Prevymis (letermovir) has emerged as a prophylactic therapy for CMV infection, but can only be used up to 100 days after organ transplantation. Professor Shin explained, "The goal of CMV treatment is the achievement of complete negative viral load. We consider the treatment a failure if the virus increases after 2 weeks of treatment or does not decrease sufficiently. This could be due to the virus itself being genetically resistant to antivirals or the patient's poor medication adherence to antivirals.” "After developing a resistance, patients may use the same drug again or consider using second-line options such as foscarnet or cidofovir. However, there are limitations to the use of these agents because of their severe nephrotoxicity, which can be fatal in kidney transplant patients." Livtencity enters the scene...showing promise in patients with resistant CMV Livtencity is the drug that can address these concerns. It works by inhibiting a kinase called UL97 that allows the virus to multiply inside the cellular host. The drug’s efficacy and safety compared to existing treatment were confirmed through the Phase III SOLSTICE study. Study results showed that Livtencity demonstrated a CMV viremia clearance rate of 55.7%, more than double the 23.9% achieved with valganciclovir/ganciclovir, foscarnet, or cidofovir arms that used the drugs alone or in combinations. Also, Livtencity is associated with fewer side effects compared to existing therapies. Patients taking immunosuppressants after transplant often have poor kidney function, and Livtencity reduced their dosing burden with its low toxicity. In terms of safety, Livtencity was associated with a 1.7% incidence of neutropenia. This was 15 times lower than the 25.0% in the ganciclovir/valganiclovir arm. "The negative conversion rate was better in the Livtencity arm, and the Livtencity arm also showed a significantly higher negative conversion rate at 16 weeks of follow-up. It also showed a lower rate of adverse events such as neutropenia and nephrotoxicity, with very few discontinuations due to adverse events being reported. Livtencity’s developer Takeda’s reimbursement application for its drug had passed the Drug Reimbursement Review Committee in December last year and the company has been negotiating drug prices with the National Health Insurance Service since this month. Professor Shin stressed that insurance reimbursement is necessary for Livtencity’s broader use to benefit more patients. Professor Shin emphasized, "CMV is a virus that has a significant adverse effect on the survival rate of all transplant recipients, even among the opportunistic infections that can occur with solid organ transplant and hematopoietic stem cell transplants. Delaying its treatment increases the risk of rejection, therefore, early and effective treatment is very important." He added, "In this regard, we should welcome the introduction of a new class of antivirals for resistant and treatment-refractory CMV, as it is a blessing for transplant patients in practice. Insurance coverage for the drug is all that more important as it relieves the Livtencity’s burden of cost for healthcare providers and patients in Korea."
