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- 2026-04-04 03:20:00
- Company
- Daiichi Sankyo appoints Sunjin Lee to head Enhertu BU
- by Eo, Yun-Ho Dec 16, 2024 05:52am
- Sunjin Lee, head of Enhertu BU, Daiichi Sankyo Korea Daiichi Sankyo Korea has appointed Sunjin Lee (47), a former executive director of Takeda Pharmaceuticals Korea, as the new head of Daiichi Sankyo. According to industry sources, Daiichi Sankyo recently made the appointment. Lee will succeed Mr. Hyun-Joo Lee (48), who has left to head ZP Therapeutics Korea. After working at Baxter Korea and Boehringer Ingelheim Korea, Lee joined Takeda in 2017 as the Marketing Manager of Takeda's Hemophilia Business Unit, where she developed creative marketing strategies. At the company, Lee was recognized for her leadership skills, playing a pivotal role in improving access and awareness of Takeda's hemophilia business. Later, as the Launch & Digital Excellence Lead for the company’s Asia Pacific (APAC) region, she led product launches in the market and successfully executed projects, including providing vision and direction for the execution of digital transformation in APAC countries. Since 2022, Lee has led Takeda's Oncology Business Unit, where she has been responsible for promotional activities for anti-cancer drugs such as Zejula and Alunbrig. Meanwhile, Daiichi Sankyo's Oncology Business Unit, represented by the antibody drug conjugate (ADC) Enhertu, is an integrated business unit that involves the company’s licensing, drug pricing, and medical departments. Daiichi Sankyo seeks to become a global player in Oncology by 2025, and Enhertu is currently reimbursed in Korea.
- Policy
- HLB Pharma applies for reimb of 'Citrelin ODT' for SCD
- by Lee, Tak-Sun Dec 16, 2024 05:52am
- HLB Pharma HLB Pharma has reportedly applied to the Health Insurance Review and Assessment Service (HIRA) for reimbursement of 'Citrelin ODT,' a domestically distributed treatment for spinocerebellar degeneration. This product was approved in South Korea in 2015, but it has been distributed to the Korean market as a non-reimbursed drug. However, with the successful completion of its recent Phase 4 trial, involving Korean patients, the company may now attempt to obtain reimbursement for the drug. According to industry sources on December 16, the HIRA received an application for the reimbursement of Citrelin ODT and has begun its review. Citrelin ODT 5mg (taltirelin) received approval from the Ministry of Food and Drug Safety (MFDS) in Korea on February 6, 2015. It is orally administered twice daily after a meal to improve ataxia caused by spinocerebellar degeneration. Spinocerebellar degeneration (SCD), an inherited cerebellar disorder, is a degenerative disease affecting the cerebellum or spinal cord with an unknown cause. It accompanies degenerative symptoms, including ataxia, optic atrophy, and muscle spasm. Ataxia can lead to the loss of the capacity to control arm and leg muscles, causing gait and language dysfunction. It is reported to significantly hinder patients' quality of life. HLB has signed an exclusive agreement with Japan's Osaka Synthetic Chemical Laboratories (OSCL), the Citrelin ODT developer, and has been distributing the drug in South Korea. In 2017, the company attempted to obtain reimbursement. At the Drug Reimbursement Evaluation Committee (DREC) held in October 2017, a decision for re-evaluation was issued due to insufficient evidence for reimbursement approval, such as textbooks and guidelines. It was decided that the drug needed to be re-evaluated to see if it was necessary for medical use and meeting the reimbursement criteria when the company additionally submitted documents regarding the effectiveness of the drug. After that, the review held in January 2018 concluded that the drug is non-reimbursable due to insufficient evidence proving its clinical effectiveness and its costs being higher than that of other substitute drugs. Since the decision, the company has been focusing on proving the drug's clinical effectiveness by conducting a Phase 4 clinical trial involving Korean patients. Recent results from Phase 4 clinical trials were published in the 'Journal of Movement Disorder,' a SCI-grade international journal. The clinical trial involved a total of 160 study participants, 79 receiving the treatment drug and 81 receiving a control, randomly assigned. The results showed that the drug significantly reduced the K-SARA (Korean version of Scale for the Assessment and Rating of Ataxia), an objective evaluation index for ataxia, after 24 weeks of treatment. The company stated that they have confirmed this statistical significance. It is reported that Citrelin ODT is distributed at about KRW 12,000 per tablet. It costs about KRW 9 million annually. Confirming effectiveness in Korean patients is expected to impact reimbursement listing reviews for national health insurance positively. When the drug gets listed in the reimbursement list, patients will be able to afford the drug at a much cheaper price. Attention has been drawn to whether Citrelin ODT will be listed for reimbursement 10 years after it was approved in South Korea.
- Policy
- Otezla generics enter negotiations for reimb
- by Lee, Tak-Sun Dec 13, 2024 05:52am
- Dong-A STGeneric to Otezla (apremilast, Amgen), which is used to treat psoriatic arthritis and psoriasis, is being considered for reimbursement negotiations with the National Health Insurance Service (NHIS). Attention has been drawn to whether a generic drug will be listed for reimbursement, the process in which a company with the original drug gave up. According to industry sources on December 11, the NHIS has recently included five products containing apremilast to the list of drugs for price negotiations. These medicines include 5 products: Dong-A ST's 'Otelia,' Daeowoong Pharmaceutical's 'Apsola,' Chong Kun Dang's 'Otebell,' Dongkoo Bio's 'Otemila,' and Hanlim Pharm's 'Psopre Tab.' Otezla received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea in November 2017. However, the company withdrew from the Korean market due to difficulty listing the drug for reimbursement. Amgen voluntarily withdrew approval in June 2022. However, Otezla's sales have been skyrocketing in the overseas market. It recorded no.1 among oral psoriatic treatments in global sales last year. It is reported that Otezla recorded sales of US$3.984 billion (about KRW 5.5 trillion) last year worldwide. Recognizing Otezla's superior effectiveness and marketability, Korean pharmaceutical companies have been putting efforts into registering the drug in the reimbursement market ahead of the original drug. Pharmaceutical companies with generics successfully avoided two cases of active ingredient patents registered in South Korea. They have successfully overcome the patent challenge by signing an agreement with Amgen for the remaining usage patent. Based on these outcomes, they received approval from the MFDS in April. Generics have entered the market that the original drugs withdrew. For instance, Dong-A ST launched the Otelia tab in July as non-reimbursed. The Drug Reimbursement Evaluation Committee (DREC) review held in October ruled that medicines would be appropriate for reimbursement coverage if the company accepted the drug price below the evaluated amount. Analysis suggests that relevant pharmaceutical companies have accepted the drug price below the evaluated amount and proceeded with the negotiation phase with the NHIS. Because most companies tend to accept a drug price negotiation exemption criterion when they accept the drug price below the evaluated amount, they are likely to proceed with the negotiations for the expected claim amount. Then, they could conclude the negotiation early and be more likely to reach an agreement. Meanwhile, besides the current discussions for apremilast, the NHIS has started negotiating with the reimbursement expansion for Darzalex. Janssen, which owns Darzalex, is proceeding with getting reimbursement for DVTd therapy (Darzalex+bortezomib+thalidomide+dexamethasone) as a first-line treatment for multiple myeloma.
- Company
- New PAH drug Winrevair to land in KOR next year
- by Eo, Yun-Ho Dec 13, 2024 05:52am
- The new pulmonary arterial hypertension drug ‘Winrevair’ is expected to be commercialized in Korea soon. According to industry sources, MSD Korea's Winrevair (sotatercept), the world's first symptomatic treatment for pulmonary arterial hypertension, recently passed the second approval-reimbursement linkage evaluations. The drug’s formal approval is expected in 2025. Winrevair had been designated as an orphan drug by the Ministry of Food and Drug Safety in January, then designated as a Global Innovative products on Fast Track (GIFT) in April this year. In March, the US FDA approved Winrevair for the treatment of pulmonary arterial hypertension as a subcutaneous injection administered once every three weeks. Winrevair is a combination of the protein complex activin with the transforming growth factor TGF-β. It works by blocking abnormal signaling between pulmonary vascular cells to reverse disease progression. Pulmonary arterial hypertension is a condition in which the blood vessels in the lungs narrow, causing high pulmonary blood pressure, which leads to heart failure. In Korea, about half of patients die within 5 years. More than 10 drugs have been approved in the area, including phosphodiesterase-5 inhibitors and endothelin receptor antagonists, but many patients suffer from severe symptoms despite using 2 to 3 drug combinations. In Phase III STELLAR study, sotatercept demonstrated efficacy over placebo. In the trial, patients were randomized 1:1 to sotatercept or placebo to assess the efficacy and safety of the drug. Results showed that sotatercept increased the 6-minute walk distance (6MWD), the primary endpoint, by 40.1 meters compared to a 1.4-meter decrease found with placebo over the same period. 38.9% of patients that used sotatercept met the secondary composite endpoint, which included an improvement of 30 meters or more in the 6-minute walking test. This was 4 times longer than that of the 10.1% in the placebo group.
- Opinion
- [Reporter's view] What corporates expect from entering pharm
- by Dec 13, 2024 05:52am
- Denmark's Novo Nordisk, the maker of the obesity drug 'Wegovy,' became Europe's No.1 in market capitalization in September last year. It topped France's luxury goods group LVMH Moët Hennessy Louis Vuitton SE (LVMH). At that time, Novo Nordisk's market cap was approximately KRW 790 trillion, exceeding Denmark's gross domestic product (GDP) last year. In other words, 'a well-brought-up new drug' is feeding the country. Because the pharmaceutical industry is difficult to enter, it could be a source of stable economic growth. Based on 'The Fortune 500,' American business magazine Fortune's annual ranking of the world's 500 largest companies, a big difference exits between the top 20s in the 2000s and those in the 2020s. In contrast, there is no change between the top 20 ranking of the big pharma in the 2000s and 2020s. It means that well-established pharmaceutical business is likely to be a key business that could be a foundation of the country's economy. A government provides significant support for the country's future income source. However, government-led support is not enough for the pharmaceutical business. New drug development has uncertainty in nature. This area requires concentrated investment, but it is challenging for a government or a public authority to concentrate funds on a particular company. The pharmaceutical industry is different from the government's strategically supported electronics·heavy·chemistry·steel manufacture· ·auto industries. Therefore, it is good news that Korean conglomerates are entering the pharmaceutical industry. As HD Hyundai jumps into launching a new drug development business, eight out of 10 top Korean companies have entered the pharmaceutical business, excluding Hyundai Motor Company and Posco. In addition to early starters, Samsung, SK Corp, LG Corp, Lotte Corp, GS Corp, and CJ Corp have joined the industry lately. Besides these companies, Orion Corp and OCI Company have selected the pharmaceutical business as their new growth engines. Conglomerates have the advantage in running a pharmaceutical business in their cash power. Conglomerates can initiate a large-scale investment based on their proprietary cash source. A parent company with a stable financial structure can act as a supplier of liquidity to its subsidiary running a pharmaceutical business. For instance, Lotte Biologics procured KRW 900 billion at once through utilizing a debt guarantee from Lotte proprietor. Of course, success in the pharmaceutical industry cannot be achieved merely through funding. The numerous failures encountered by Korean conglomerates in the past support this claim. Hanwha Group and Amorepacific Corporation had jumped into the medicine business but withdrew from the market after failures. Lotte and CJ, who recently entered the biotech industry, have already experienced bitterness. However, a different approach can be observed by looking into the paths of conglomerates entering the pharmaceutical industry lately. In the past, conglomerates focusing on short-term accomplishments were pointed out as one of the reasons for their failure. Analysis suggests that the market entry strategy became more precise. For instance, HD Hyundai is reported to have prepared for a new drug business under the water after establishing AMC Bio three years ago. Group owners leading the pharmaceutical business are drawing attention. SK Corp, Lotte Corp, Orion, HD Hyundai, and GS Corp have positioned their owners who are undergoing owner business takeover to the pharmaceutical business. Given the high risk of the field and the difficulty in achieving short-term results, strong ownership is expected to influence ongoing investment in the business positively. It has been reported that South Korea will no longer depend on the semiconductor market. The pharmaceutical industry may be a new growth power to the country's growth. Besides being rationed for saving humankind, the pharmaceutical industry is practically a nationwide project that must succeed for the country's future. We wish the best for Korean conglomerates that have experienced multiple failures to achieve success shortly.
- InterView
- ‘New start at a law firm…will become a trusted expert’
- by Kim, Jin-Gu Dec 13, 2024 05:52am
- Expert Advisors Jung-Eun Kim (left) and Sol Kim (right) recently joined Shin & Kim The role of law firms has greatly expanded in the pharmaceutical bio and healthcare sectors recently. Whereas law firms used to provide piecemeal legal services in the past, law firms have now been providing comprehensive services over a long period of time, covering the whole course of a drug’s journey from pre-approval to reimbursement. As such, many talents in the pharma and biotech industry have been heading to law firms. This is the case with Sol Kim(35) and Jung-Eun Kim (34), who joined Shin & Kim's Healthcare team this year. “I want to become a trusted expert for the clients,” they said. Expert advisors from pharmaceutical companies and HIRA joint Shin&Kim Healthcare Team Sol Kim and Jung-Eun Kim Kim joined Shin & Kim's Healthcare Team in June and September of this year, respectively. Sol Kim was previously in charge of insurance drug pricing at the Korean subsidiaries of multinational pharmaceutical companies such as Pfizer Korea, AstraZeneca Korea, and BMS Korea. Before joining the firm, Jung-Eun Kim worked for over 6 years at the Health Insurance Review and Assessment Service, where she was responsible for evaluating drug reimbursement adequacy. The two pointed to the scope of their work as the biggest difference between their new jobs at the law firm. Whereas in their previous jobs, they were able to delve deeply into a relatively narrow scope of work, they said, their work at law firms requires them to be creative across a much wider range of areas. “The scope of collaboration is much larger at the firm, so you can be creative without being limited to a specific area,” says Sol Kim. ”In the past, when working in government affairs, I used to wonder about the government’s perspective. Here, there are many lawyers, advisors, and expert advisors from government and public organizations, which is very helpful.” For Jung-Eun Kim, a former HIRA member, the change is even greater. “When I was in HIRA, I only looked at the drugs I was in charge of. Here, I experience everything that happens before a drug enters the insurance landscape. I didn't realize how much work goes into the process, and it has broadened my perspective.” Deciding to join a law firm took a lot of thought...“The value of working for the patients remains constant” Both advisors had many concerns before joining the law firm. They explained how they contemplated the role of law firms in the pharma-bio-healthcare sector, why they wanted to join a law firm, and what they could do at a law firm. “No matter where you work, you work for patients,” was the conclusion made by both advisors. In addition, having the opportunity to be more proactively involved in pharmaceutical affairs in a much broader scope at a law firm was attractive. “I thought a lot about what I could do in a law firm,” said Sol Kim. ”After thinking about it, I concluded that it doesn't matter where you work, in drug pricing or others, as you’re still working for patients, and I think there's a lot more you can do in a law firm as Korea’s reimbursement regulations are becoming more and more demanding.” Jung-Eun Kim also said, “At HIRA, I was in charge of objectively looking at drug prices based on pharmacoeconomic evaluation results. Rather than just imposing price cuts, I had been reviewing the appropriate price. The same is true here. As the drugs come into our country the exchange rate changes. The same applies here, in that we want to make sure that these drugs come into Korea and are available to patients at the right price.” “Will become an ‘expert’ who trusts clients...will grow together with Shin & Kim's Healthcare Team” Both members emphasized their desire to grow with Shin & Kim’s Healthcare Team. With the addition of the 2 members, Shin & Kim's Healthcare Team has grown to over 30 people. The team is led by Sung Tae Kim, a former lawyer at the Ministry of Health and Welfare, and includes a number of people who have worked at the Ministry of Health Welfare, Ministry of Food and Drug Safety, Health Insurance Review and Assessment Service, and pharmaceutical and biotech companies. Jung-Eun Kim said, “Not only HIRA, but MOHW is also in charge of drug pricing based on the enforcement and implementation rules stipulated by law. This means that interpreting the law is a very important point. It is very helpful to have lawyers in the same space. In addition, the other experts and advisors provide different perspectives.” “I joined here as an expert advisor,” said Jung-Eun Kim, ”so I want to be true to my position and serve as an expert that clients can trust.” “I think the role of law firms is becoming more important as regulations related to drug prices are becoming more and more stringent,” said Sol Kim. ”As a former pharmaceutical industry member, I aim to become an expert who can better understand the needs of pharmaceutical companies and act as a bridge between pharmaceutical companies and law firms.”
- Company
- "Confirmed long-term Tx effects of Camzyos…new oHCM Tx"
- by Son, Hyung Min Dec 13, 2024 05:51am
- Dr. Neal K. Lakdawala, Professor at Brigham and Women "In a clinical study spanning three years, Camzyos has demonstrated consistent patient symptom management and safety in many patients with obstructive hypertrophic cardiomyopathy (oHCM). Given its proven efficacy in long-term treatment, it is expected that many patients with oHCM can significantly improve their quality of life through this treatment without the need for surgical treatment." During a recent meeting with Daily Pharm, Dr. Neal K. Lakdawala, Professor at Brigham and Women's Hospital in the United States, remarked on 'Camzyos,' a first-in-class targeted treatment option for obstructive hypertrophic cardiomyopathy (oHCM), as above oHCM is a type of hypertrophic cardiomyopathy (HCM) characterized by abnormal heart muscle thickening, primarily in the left ventricle. This condition obstructs blood flow and impairs heart function. Common symptoms include shortness of breath, chest pain, and fainting, and it can lead to complications such as heart failure, atrial fibrillation, and even sudden cardiac death. Until now, treatment methods besides surgical treatment because no treatments could directly target pathophysiological causes of oHCM. While unmet needs for oHCM have been high, the introduction of Camzyos as the first treatment targeting the pathophysiology of the disease has opened the gate for new treatment options. Camzyos is a treatment for oHCM that reduces excessive cross-bridge formation between actin and myosin in the heart muscle, which is the underlying cause of the condition. This mechanism helps relax the overly contracted heart muscle. Additionally, the therapy has demonstrated myocardial remodeling effects, improving not only the function of the heart but also its structural integrity. Camzyos can be reimbursed with the national health insurance starting this month in South Korea. Now, Korean patients with oHCM can use targeted treatment options besides the option of surgical treatment. Dr. Lakdawala remarked that Camzyos could change the treatment paradigm for oHCM since the drug's efficacy and safety were demonstrated not only in clinical trials for approval but also in long-term administration studies. Camzyos demonstrates consistent effectiveness in long-term administration studies In the EXPLORER-HCM trial, which was the basis for approval, Camzyos demonstrated significant improvement in the primary endpoint, which assessed both symptom severity (NYHA class) and exercise capacity (pVO2), compared to the placebo group. Camzyos continues to establish additional evidence for its long-term safety and efficacy. At the European Society of Cardiology annual congress (ESC 2024) in September, results from the MAVA-LTE clinical study evaluating Camzyos' long-term effects and safety were unveiled. Interim results showed that at week 180 of treatment, 66.3% of patients achieved NYHA Class I, with 46.8% demonstrating a complete response (NYHA Class I+Valsalva LVOT pressure gradient of ≤30 mmHg). The NYHA classification system, established by the New York Heart Association, evaluates the extent of symptoms and activity limitations in patients. Additionally, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels decreased by 81% from baseline at week 180, with 53.8% of patients reaching normal NT-proBNP levels. NT-proBNP serves as a biomarker for assessing heart failure severity and prognosis, often elevated under conditions of excessive myocardial stress or stretch in heart failure patients. The EQ-5D-5L score, which assesses health-related quality of life, showed improvement, indicating better subjective health perceptions among patients. "Camzyos' long-term data, confirmed through the MAVA-LTE study, shows the positive potential of the drug. Patients' symptoms have been consistently maintained well during 3 years of long-term study, and the safety profile has also been consistent," Dr. Lakdawala emphasized. "In fact, the number of patients choosing to undergo surgical treatments is declining after the introduction of Camzyos. The Real-World Data of Camzyos confirmed in clinical practices show an equivalent level of effectiveness and safety profile to results demonstrated in previous clinical studies," Dr. Lakdawala added. "Although the outcomes may vary depending on individual's pathophysiology, most patients undergone Camzyos treatments also have significantly improved symptoms or show much improved responses." "Camzyos' myocardial remodeling effect, which improves cardiac function and structure, has gained most attention since the early EXPLORER-HCM study," Dr. Lakdawala stated. "The study results showed significant reductions in key indicators of cardiac hypertrophy in HCM, such as left ventricular wall thickness and left ventricular mass, following Camzyos treatment. These changes were observed as early as 24 to 30 weeks into the treatment and were sustained over the long-term treatment period," he added. Despite the introduction of targeted treatment option..undiagnozed patients↑ Despite the recent introduction of targeted treatment option, diagnosing oHCM is still challenging. According to Dr. Lakdawala, many cardiomyopathy patients often adapt to their long-standing symptoms, and they fail to recognize their condition. Typically, as symptoms gradually restrict physical activity, patients adjust to a limited lifestyle and forget that their health status is not normal. Dr. Lakdawala explained that many patients only realize that HCM caused their past symptoms after receiving a diagnosis and experiencing improvement following treatment. "The issue of undiagnosed HCM is one of the major global challenges today. To address this issue, it is crucial to educate cardiology healthcare providers through multiple channels to help them understand that patients’ symptoms may be associated with this condition," Dr. Lakdawala emphasized. "When there is a thickening of the left ventricular wall, it is important not to simply attribute it to secondary effects of hypertension or overlook the severity of the condition. Additionally, the lack of appropriate imaging diagnostics, which often leads to missed diagnoses of HCM, is another critical issue that must be resolved," he stressed. With the introduction of Camzyos, patients' left ventricular outflow obstruction and related symptoms can be improved by taking an oral drug once a day. While surgical treatment is still necessary for some patients, most are expressing satisfaction that their symptoms can be effectively managed through oral medication alone, according to Dr. Lakdawala. "Recent guidelines for HCM in the United States and Europe prioritize a patient-centered approach above all," he stated. "These guidelines focus on symptom management as the primary goal and emphasize expanding treatment options to improve symptoms. Previously, surgical treatments like septal reduction therapy (SRT) had been the primary option. Introducing Camzyos in the guidelines provided a new option, expanding patients' treatment choices." Dr. Lakdawala added, "In the past, HCM patients were often prohibited or restricted from engaging in physical activity. However, recent studies have confirmed that appropriate levels of exercise are safe for these patients. Based on this evidence, we are gradually relaxing guidelines to permit regular exercise and moderate physical activity, while continually seeking ways to enhance the quality of life for patients with HCM."
- Policy
- Martial law impacts the launch of the Pharma-Bio Committee
- by Lee, Jeong-Hwan Dec 13, 2024 05:51am
- The National Bio Committee directly under the President, which was scheduled to be launched this month, has been disrupted by President Suk-Yeol Yoon’s declaration of emergency martial law. As the National Assembly is in the early stages of voting on an impeachment bill against President Suk-Yeol Yoon, who was supposed to chair the committee, the establishment of the National Pharmaceutical and Biotech Control Tower is at risk of being canceled. According to the Ministry of Health and Welfare on the 10th, the first meeting of the National Bio Committee, originally scheduled for sometime this month, has been postponed indefinitely. The MOHW explained that it has not received a specific date for the launch of the committee nor a date for its future launch. The National Bio Committee, a body directly under the president, is responsible for deliberating on policies such as R&D and approval in the pharmaceutical and biotech sectors. The Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Trade, Industry, and Energy, all of which are related to the industry, have been jointly preparing for its launch. Sang-Yeop Lee, Vice President of the Korea Advanced Institute of Science and Technology (KAIST), was internally designated as the Civilian Vice Chairman, and more than 20 bio experts in the field of biotechnology, including Bit-nae-ri Kim, Director at the Institute for Basic Science, Han-Seung Ko, head of Samsung Electronics' Future Business Planning Division, and Young-Tae Kim, President of Seoul National University Hospital, were scheduled to participate as civilian committee members. In particular, the controversial inclusion of a global pharmaceutical company executive among the civilian members has stirred up controversy, and the confusion surrounding the Bio Committee grew greater with the rise of the impeachment situation due to President Yoon's declaration of martial law. The government's plans to become one of the top five global bio powerhouses and create blockbuster national drugs have been compromised. In the midst of the state of impeachment, President Yoon has stated that he will leave his term and stabilization plan to his party, and the opposition party has stated that they will repeat the impeachment vote every Saturday, virtually halting all schedules for the National Bio Committee. The pharma and biotech industry has expressed regret that the martial law and impeachment aftermath has unexpectedly shaken the establishment of the Bio Committee. “There were concerns that the National Bio Committee, directly under the president, would overlap with the Bio Health Innovation Committee, an organization directly under the prime minister, but the pharmaceutical industry still had high expectations,” said a pharmaceutical industry official. ”We do not expect the Bio Committee, chaired by the president, to be able to play its role in the situation where the impeachment bill is presented in the National Assembly.” “We have effectively lost one window to directly appeal to the president for policies to strengthen state support for domestic pharmaceutical companies aiming to develop global new drugs,” the official said, adding, ”It is the hope of the pharmaceutical industry to wait for the political turmoil to be cleared up quickly and for the committee's launch and operation plan to materialize.
- Company
- NeuroBiogen enters into Binding Term Sheet with US Company
- by Lee, Seok-Jun Dec 12, 2024 05:50am
- Scilex Holding Company, a Nasdaq-listed company, announced that d a binding Term Sheet had been signed between NeuroBiogen, a Korean company specializing in innovative new drugs, and Scilex Bio, a controlling interest of joint venture by Scilex Holding Company on December 10th, local time. Under the terms of the agreement, Scilex Bio will be granted an exclusive worldwide license to develop and commercialize tisolagiline (KDS2010), an oral treatment for Alzheimer's disease and obesity that is in clinical development by NeuroBiogen. The collaboration will leverage NeuroBiogen’s R&D capabilities for KDS2010 and Scilex’s commercialization expertise in the central nervous system and first-line therapy. “We are currently in the process of finalizing a term sheet with Scilex for the formal agreement, and are currently negotiating the details of the agreement,” said a NeuroBiogen representative. NeuroBiogen has successfully completed a Phase I clinical trial on KDS2010 for Alzheimer's disease and obesity and is conducting a Phase II trial. Meanwhile, Scilex, which was founded in 2011, is a leading research and development company for CNS-related therapies, including FDA-approved treatments for gout, migraine, and non-opioid painkillers.
- Company
- 'Effective in Asian patients' Leclaza vs Tagrisso comb
- by Son, Hyung Min Dec 12, 2024 05:49am
- Leclaza plus Rybrevant and Tagrisso plus platinum-based chemotherapy have shown consistent effects in Asian patients. The effects of the combination therapy of Leclaza and Tagrisso, which are non-small cell lung cancer (NSCLC) treatments, have been unveiled at the European Society for Medical Oncology (ESMO) Asia Congress 2024. ESMO Asia Congress 2024 took place over three days, starting on December 6, in Singapore. The concurrent use of Leclaza with Rybrevant subcutaneous (SC) formulation showed non-inferior results compared to the conventional Rybrevant intravenous (IV) injection. Tagrisso plus platinum-based chemotherapy has consistently improved overall survival compared to Tagrisso monotherapy in Asian patients. Leclaza plus Rybrevant SC formulation, injection-related adverse reactions sixfold↓in the PALOMA-3 study Combination therapy of YuhanAccording to industry sources on December 10, Janssen unveiled the result of the PALOMA-3 clinical trial, which was to investigate the potential of Leclaza plus Rybrevant SC formulation, treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Previously, in this clinical study, Leclaza plus Rybrevant SC showed non-inferiority compared to Leclaza plus Rybrevant IV. Leclaza plus SC Rybrevant combination therapy had an objective response rate (ORR) of 30.1%, whereas Leclaza plus IV Rybrevant combination therapy had an ORR of 32.5%, meeting the non-inferiority requirement. Leclaza plus SC Rybrevant combination therapy showed a positive trend regarding progression-free survival (PFS). PFS refers to a duration during which a patient's disease does not worsen. Unlike the oral formulation of Leclaza, Rybrevant was developed as an IV injection. For Rybrevant IV inj, patients have the inconvenience of visiting the hospital once every 2-3 weeks, and the administration takes more than an hour. Janssen plans to develop an SC formulation to offer ease of administration and reduce concern regarding adverse reactions related to injection. SC formulation is expected to improve patient convenience since it can significantly reduce the administration duration to within 10 minutes. The latest presentation is a follow-up clinical result where the efficacy and safety of the drug were evaluated in 255 Asian patients out of the total 418 study participants. Patients had previous treatment history of receiving AstraZeneca's targeted therapy Tagrisso and platinum-based chemotherapy. During the first 4 months of the treatment, 74% of the Leclaza+Rybrevant SC group and 75% of the Leclaza+Rybrevant IV group received anticoagulant agents to prevent venous thromboembolism (VTE). The key endpoints included disease control rate (DCR), duration of response (DOR), PFS, overall survival (OS), and safety. Clinical results showed that the Leclaza+Rybrevant SC group had a DCR of 80.2%, and the Leclaza+Rybrevant IV group had a DCR of 72.9%. DCR refers to a percentage of delaying the disease progression to extend patient survival. For PFS, Leclaza+Rybrevant SC group showed a favorable trend. At 12 months, 77% of the patients treated with Leclaza+Rybrevant SC survived. It was 61% for those treated with Leclaza+Rybrevant IV. DOR and PFS could not be estimated. For injection-related response (IRR), the Leclaza+Rybrevant SC group had an IRR sixfold less than the Leclaza+Rybrevant IV group. Most responses were mild, Grade 1-2. For the VTE occurrence rate, 11% of the Leclaza+Rybrevant SC group treated with anticoagulant had VTE, and it was 12% for the Leclaza+Rybrevant IV group. It was 18% and 22% for those who did not receive anticoagulants, respectively. The safety profile of Asian patients corresponded to those in other countries. The effectiveness of Tagrisso+platinum-based chemotherapy as a first-line treatment has been reconfirmed AstraZenecaAstraZeneca unveiled the study results of the FLAURA2 cohort study, which involved Tagrisso+platinum-based chemotherapy in Asian patients. Previous results of this clinical study showed that Tagrisso+platinum-based chemotherapy demonstrates a statistically significant improvement in PFS compared to Tagrisso monotherapy. Patients had not previously received treatment, and they were randomly assigned 1:1 to Tagrisso plus pemetrexed (product name: Alimta) plus cisplatin/carboplatin group and Tagrisso monotherapy group. Participants were categorized into Chinese Asian/non-Chinese Asian/non-Asian. The primary endpoint included PFS, and the secondary endpoints included OS, ORR, DOR, and safety. The clinical results showed that the PFS of the Tagrisso combination therapy group was 25.5 months, which was over six months older than the 19.4 months in the Tagrisso monotherapy group. The median OS was 40.5 months for the Tagrisso combination therapy group and 38.3 months for the Tagrisso monotherapy group. The safety profile showed that the adverse event rates over Grade 3 in the Tagrisso combination therapy group were 67%, higher than in the Tagrisso monotherapy group. The adverse event rates due to discontinued use of Tagrisso were 10% for the Tagrisso combination group and 7% for the monotherapy group. "Tagrisso+platinum-based chemotherapy showed consistent benefits in Asian patients similar to the previous clinical results. Such clinical results demonstrate the potential of the therapy as a first-line treatment of Asian patients with EGFR-positive advanced NSCLC," a researcher remarked.
