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- 2025-12-22 07:38:28
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- Will Imfinzi and Imjudo be reimbursed in Korea?
- by Eo, Yun-Ho Nov 26, 2024 05:54am
- Whether the immuno-oncology drug combination of Imfinzi and Imjudo will gain a place as a treatment option for liver cancer in Korea is gaining attention. AstraZeneca Korea's combination therapy of PD-L1 inhibitor Imfinzi (durvalumab) and CTLA-4 inhibitor Imjudo (tremelimumab) recently passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review and is headed towards a Drug Reimbursement Evaluation Committee review. Given that the application was submitted in June, this is a relatively fast track reaching coverage in Korea, which is why the industry’s eyes are on how quickly the combination therapy will be approved for reimbursement. The immunotherapy combo will first target liver cancer, as the combination was approved as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (liver cancer). More specifically, the approved STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab) includes an initial single dose of Imjudo 300mg added to Imfinzi 1500mg, followed by Imfinzi every 4 weeks. At the recent European Society for Medical Oncology (ESMO) Congress 2024, the 5-year overall survival data from the Phase III HIMALAYA trial that demonstrated the efficacy of the Imfinzi and Imjudo combination in hepatocellular carcinoma was presented. In the HIMALAYA trial, patients with inoperable HCC were treated with STRIDE (single dose of Imjudo followed by Imfinzi maintenance therapy), Imfinzi monotherapy, and sorafenib monotherapy. When comparing the results of the Imfinzi and Imjudo combination with sorafenib combination therapy in patients with unresectable HCC, patients who received the STRIDE regimen had a 5-year overall survival (OS) rate of 19.6%, compared with the 9.4% for patients who received sorafenib. The median overall survival was 16.43 months and 13.77 months, respectively, showing a 24% lower risk of death in the Imfinzi-Imjudo combination arm. “ The Imfinzi-Imjudo combination therapy has significant advantages in that it has a much lower risk of bleeding than conventional therapies and does not worsen liver function," said Hong Jae Chon, Professor of Hemato-Oncology at CHA Bundang Medical Center. “In particular, the combination shows potential for longer survival than existing therapies."
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- ‘Oral drugs can address the unmet PNH treatment needs’
- by Son, Hyung Min Nov 26, 2024 05:54am
- Dr. Jun Ho Jang, Professor of Medicine, Department of Hematology-Oncology, Samsung Medical Center The paroxysmal nocturnal hemoglobinuria (PNH) market, which has been dominated by AstraZeneca's Soliris and Ultomiris, has seen the introduction of the oral drug Fabhalta. Experts believe that Fabhalta’s use will increase in the future as it has been shown to reduce anemia and blood transfusions compared to existing treatments. On the 25th, Novartis Korea held a press conference for specialized journalists in Samseong-dong, Seoul, to celebrate the approval of Fabhalta in Korea. Fabhalta was approved in August as the first oral treatment for PNH. PNH is a rare and life-threatening disease caused by the destruction of red blood cells in the blood vessels, leading to symptoms of bloody urine and complications such as acute kidney failure. The disease is estimated to affect approximately 1.5 people per million worldwide. Its incidence is higher in East Asian countries such as Korea, China, and Japan than in Western countries. The number of PNH patients in Korea is expected to have approximately doubled from 260 in 2010 to 504 in 2023, with the number still on the rise. Fabhalta is a factor B inhibitor that acts proximally in the immune system's alternative complement pathway and has a comprehensive mechanism of action that controls red blood cell destruction. Previously, PNH has been treated with C5 inhibitor drugs, including Soliris and Ultomiris. However, while C5 inhibitors reduce the risk of thromboembolism by controlling intravascular hemolysis, they may not completely inhibit extravascular hemolysis. Up to 50% of patients on C5 inhibitors experience extravascular hemolysis, which is a major contributor to the development of persistent anemia. In addition, approximately 80% of PNH patients treated with C5 inhibitors have had an incomplete response to treatment, to the extent that they required transfusions or experienced anemia. Fabhalta has been shown to be effective in patients both on and off C5 inhibitors. The drug’s efficacy was confirmed through the Phase III APPLY-PNH trial in patients with residual anemia despite prior anti-C5 treatment who switched to Fabhalta and the Phase III APPOINT-PNH study in complement inhibitor-naïve patients. Trial results showed that 82.3% of anti-C5-experienced Fabhalta patients, 0% of anti-C5-treated patients, and 77.5% of complement inhibitor-naïve patients showed a sustained increase of hemoglobin levels of 2 g/dLa or higher from baseline in the absence of transfusions. The patients’ hemoglobin level was maintained in the 48-week extension study. The study showed that patients who continued to take C5 inhibitors had hemoglobin levels similar to those of the initial switch group when they switched to Fabhalta at Week 24, and the fatigue score returned to those of healthy individuals in the Fabhalta arm. In terms of safety, there were no treatment-related adverse events with Fabhalta that required treatment discontinuation. The incidence of clinical breakthrough hemolysis was significantly lower with Fabhalta compared to C5 inhibitors, and headache, nausea, and diarrhea occurred but were resolved within 1 week. An advantage of Fabhalta is its formulation. As an oral formulation, the drug offers better dosing convenience over existing intravenous formulations like Soliris and Ultomiris. Currently, Soliris (a 4-hour infusion once every 2 weeks) and Ultomiris (a 5.5-hour visit once every 8 weeks) require an in-person visit for their administration in the hospital. The introduction of C5 inhibitors has significantly improved the treatment of PNH, but there is an unmet need amongst patients who are unable to benefit from the use of C5 inhibitors or experience side effects,” said Dr. Jun Ho Jang, Professor of Medicine, Department of Hematology-Oncology, Samsung Medical Center. ”Up to 82% of patients do not achieve normal hemoglobin levels with C5 inhibitors, which can lead to anemia and blood clots. “ “Fabhalta targets both intravascular and extravascular hemolysis. Its strength lies in its ability to normalize hemoglobin and LDH levels,” added Jang. “In addition, switching from existing therapies to Fabhalta can improve patients’ quality of life by reducing fatigue, and can help patients overcome transfusion dependency.”
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- "Pharmaceutical companies using CSOs must renew contracts
- by Kim, Jin-Gu Nov 26, 2024 05:53am
- Based on the Contract Sales Organization (CSO) reporting system implemented last month, pharmaceutical companies must be aware of potential legal risks. Pharmaceutical companies using CSOs must sign contracts with companies that have completed registration and renew existing contracts to align with the timeline following reporting. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) hosted the On November 22, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) hosted the 'Ethical Management Workshop for the Second Half of 2024' at the Mondrian Seoul Itaewon. During the workshop, Attorney Park Jong-cheol from the law firm Hwawoo advised as such. Over 300 compliance officers (CP) from the pharmaceutical industry, in-person and online, have participated. Park presented strategies for minimizing legal risks for pharmaceutical companies using CSOs. According to him, these companies face various legal risks, including violations related to illegal rebates, labor laws, fair trade laws, and pharmaceutical laws. To minimize risks, Park emphasized the necessity of continuous management and oversight of CSOs and maintaining detailed records as evidence. Park also advised that promotional activities conducted by in-house sales teams and those belonging to CSOs should not overlap. To minimize risks, He said, "Companies must select larger, established firms capable of independently fulfilling contractual obligations." Park gave examples of practices that could constitute violations of the Fair Trade Act. He explained that these include cases where a CSO provides excessively high or low compensation to healthcare professionals, guarantees fixed margins, or continues transactions despite repeated unfair practices. Park also emphasized the importance of compliance with the CSO Reporting System, which has been effective since October 19. Under this system, pharmaceutical companies are permitted to contract only with CSO companies that have completed registration with local governments. Any existing contracts must be renewed following the registration date to ensure compliance. Contracts must include the following details: ▲The name of the pharmaceutical promotion agent ▲The name of the representative, the location of the business office, registration number, and business registration number ▲Details of the promotional activities entrusted, including the names of the delegated pharmaceutical products and the commission rates for each item ▲Duration of the contract ▲Obligations and compliance requirements for the entrusted party, including training provisions. The mandatory retention period for these contracts is five years, and they must be submitted to the MOHW upon request. Park advised, "If an existing contracted company fails to register, the termination of the contract should be considered." He added, "During subcontracting, oversight may become less stringent. It is advisable to diversify CSO transactions and standardize transaction terms to better align with industry standards." "Increasingly rigorous tax audits on pharmaceutical companies…must prepare by conducting diagnostics assessment" Suseok Ryu, an accountant at KPMG Samjong Accounting, explained ways to respond to the high-intensity investigation of the pharmaceutical industry by the National Tax Service. Ryu said the pharmaceutical and biotech industries have faced increasingly rigorous tax audits. These audits are characterized by extended or suspended timelines and comprehensive requests for access to companies’ IT systems. Both planned and unplanned investigations have become more frequent, while the intensity of regular audits has also increased. The documents requested during these audits cover a wide range, including internal company policies on sales incentives, discounts, and employee welfare expenses, domestic and international bank account details showing cash and cash-equivalent assets, expenditure reports and corporate card usage records, gift card purchase records, distributor lists and related contracts, employee travel logs, and VAT non-deductible purchase details and data backups. In particular, the National Tax Service primarily focuses on illegal rebates, activities related to the Fair Competition Code, such as product briefings·academic conferences, costs incurred from returns or complaints by healthcare providers, sales discounts, sales incentives, and business travel expenses. "For pharmaceutical companies, tax audits heavily focus on identifying a history of rebates. Therefore, they must identify potential issues and prepare accordingly through tax diagnostics assessments," Ryu emphasized. "As tax investigators are authorized to review financial transactions without the taxpayer's consent, it is crucial to meticulously prepare supporting documentation to account for cash flow and ensure compliance." "For expenses related to academic conference funds, it is essential to secure documentation that can prove the advertising effects, such as booth operation photos and journal advertisement placement records." Ryu added, "Returns of unsellable pharmaceutical inventory should also be justified with detailed evidence, as they could otherwise be misconstrued as entertainment expenses." "Expenditure report will be disclosed at the end of year…must be thoroughly cross-checked for omission·errors" Han-Cheol Kang, an attorney at Kim & Chang's Corporate Compliance, introduced strategies to respond to potential disputes before releasing the first expenditure report at the end of the year. According to the revised Pharmaceutical Affairs Act, the government will disclose expenditure reports submitted by pharmaceutical companies and CSOs for the first time at the end of the year. Kang stressed the importance of accurate data entry. "Even in the U.S., which implemented its disclosure system after years of preparation, 31% of transaction records contained errors," Kang said. "The American Medical Association's findings attributed these issues to a lack of review opportunities and data inaccuracies." "Once expenditure reports are disclosed, they are difficult to amend and may lead to violations of the Pharmaceutical Affairs Act. Therefore, it is crucial to ensure no omissions or errors, such as incorrect attendee records," Kang stated. "It is also essential to cross-check the provided amounts and categories with supporting documentation to ensure accuracy." "Companies must prepare for potential disputes by securing evidence, establishing systems to verify facts, and implementing error-checking procedures," Kang emphasized. "The persistent practices of providing unjust economic benefits, practical challenges due to excessive regulations, and negative public opinion present significant risk factors both within and outside the industry," Jae-Kook Lee, Senior Vice President of KPBMA, said. "The pharmaceutical and biotech industries must not forget their responsibility to meet the era's·public's expectations. In collaboration with its 297 member companies, the KPBMA will continue to make every effort to promote ethical management practices."
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- K-Bio to showcase at the ASH 2024
- by Son, Hyung Min Nov 25, 2024 05:54am
- Development accomplishments of the Korean pharmaceutical industry's blood cancer treatments will be showcased at an international conference. Hanmi Pharmaceutical, PharosiBio, LigaChem Biosciences, and Aptamer Sciences will present their promising clinical study results, and they are set to join the global stage. PharosiBio and Hanmi Pharmaceutical will present their clinical accomplishment of new drug candidates for acute myeloid leukemia (AML). Aptamer Sciences and LigaChem Biosciences will unveil the competitiveness of their antibody-drug candidate (ADC) platforms. Clinical results of AML will be showcased…new drug discovery platform competitiveness ↑ According to sources on November 23, the American Society of Hematology Annual Meeting and Exposition (ASH 2024) will take place from December 7 to 10 in San Diego, U.S. The American Society of Hematology, the world's largest blood cancer-related academic conference, commences its 66th meeting this year. Hanmi Pharmaceutical will showcase the clinical result of its innovative new drug candidate for AML, 'tuspetinib,' confirming the potential of the drug as a triple combination drug therapy at the ASH 2024. The results will be presented by Hanmi Pharmaceutical's U.S. partnering company, Aptose Biosciences. In 2021, Hanmi Pharmaceutical outlicensed tuspetinib to Canadian pharmaceutical company Aptose Biosciences. Tuspetinib is a new innovative drug targeting key kinases involved in myeloid malignancies. Tuspetinib works in a differentiated pattern. It has been developed as a once-daily administration. It received the fast-track designation pharmaceutical from the U.S. Food and Drug Administration (FDA) last year. Aptose Biosciences is currently investigating the potential of tuspetinib in combination with hypomethylating agents such as BCL2 inhibitor Venetoclax (product name: Venclexta) and azacitidine. Previously, Aptose Biosciences has reported that the combination therapy of tuspetinib and venetoclax in patients with relapsed or refractory AML demonstrated favorable safety profiles and positive drug responses, regardless of prior venetoclax treatment experience. In particular, with tuspetinib administration, no noticeable side effects or typical toxicity responses were observed in medications of the same class. It showed broad activity in all patients with AML who have genetic mutations. Aptose Biosciences will decide on the volume of the triple combination therapy and finish the pilot study by presenting it in the European Hematology Association (EHA) meeting next year. PharosiBio will showcase the Phase 1 trial results of its new drug candidate, 'PHI-101,' for AML. Along with the clinical Phase1b results conducted with PHI-101 160 mg monotherapy, this company is expected to unveil comprehensive clinical data after completing the recruitment of patients. PHI-101 is a targeted cancer agent being developed for treating patients with AML not responding to previous medications or who relapsed due to FLT3 mutation. This new drug candidate product targets the FLT3 gene mutation that occurs in 35% of all patients with AML, inhibiting the growth of cancer cells. In addition to the study of PHI-101 monotherapy, PharosiBio is also conducting clinical trials of combination therapy. The company confirmed the effects of triple combination drug therapy containing PHI-101, Venetoclax, and azacytidine. Venetoclax and azacytidine are used as a first-line treatment for adult patients with AML. In a xenograft animal model, PHI-101 showed a 95% tumor growth inhibition (TGI) when used in combination with Venetoclax. Additionally, when azacitidine was added to the PHI-101+Venetoclax combination therapy, the reported survival period was 53 days. This figure is longer than the 30 days of the control group. PharosiBio plans to investigate the potential of both monotherapy and combination therapy and aim to target all treatment phases. ASH 2023 photo (source=ASH). Development of ADC for blood cancer is actively conducted LigaChem Biosciences and Aptamer Sciences will report on competitiveness of their ADC platform. ADC is a novel anticancer drug that connects an antibody, which binds to specific antigens on the surface of cancer cells, with a cytotoxic drug linked by a linker. ADCs take advantage of antibodies' selectivity for their targets and the drug's cytotoxic activity to selectively target cancer cells, thereby increasing therapeutic efficacy while minimizing side effects. LigaChem Biosciences will unveil Phase 1 results of CS5001, an ROR1 targeting ADC candidate product under co-development with ABL. ROR1 is a protein that is strongly expressed during fetal development. The clinical trial analyzed the efficacy, pharmacokinetics (PK), and antitumor activity of CS5001 in patients with solid cancer and lymphoma. Based on the presented clinical results, in the first eight dose groups of CS5001, no dose-limiting toxicities (DLT) were observed. Superior safety and expected pharmacokinetics properties were reported, with the maximum tolerated dose (MTD) not being reached. Aptamer Sciences will showcase the study data of 'AST-202,' a new drug candidate product that was selected from utilizing ApDC (Aptamer-Drug Conjugates) in patients with blood cancer. ApDC is a next-generation ADC new drug development platform with its proprietary branched linker-payload technology. Aptamer Sciences has conducted a comparison study comparing ACD Adcetris and AST-202, which are used as conventional blood cancer treatment, and acquired a significant result in tumor-suppressing effects. In a lymphoma model, AST-202 demonstrated superior tumor-suppressing effects than Adcetris, and more than 80% of the AST-202-treated group survived.
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- 'Altuviiio' for hemophilia A expected to be marketed in KOR
- by Eo, Yun-Ho Nov 25, 2024 05:53am
- 'Altuviiio,' a new once-weekly administered hemophilia A drug, is expected to be marketed in South Korea. According to industry sources, Sanofi-Aventis has recently submitted an application for approval of Altuviiio (efanesoctocog alfa). The Ministry of Food and Drug Safety (MFDS) granted this drug an Orphan Drug Designation (ODD) in May. Altuviiio recently received the 'Global Innovative products on Fast Track (GIFT)' designation. Altuviiio is the first hemophilia therapy to receive an orphan drug designation from the MFDS in South Korea other than a non-factor agent, which received the designation three years ago. Altuviiio is a first-in-class high sustained factor (HSF) therapy for hemophilia A. With once-weekly treatment, Altuviiio keeps hemophilia factor activity levels at over 40% and helps provide patients with a near to normal life. Following approval in the United States and Japan last year, it was approved in Europe this year. Benefits such as accelerated approval review and exemption from GMP facility inspection are granted when designated as an orphan drug. Additionally, drugs designated as a GIFT item undergo rolling review and receive an expert consulting through 1:1 support between the reviewer and the developer, allowing them to be marketed more quickly. Meanwhile, the efficacy of Altuviiio was demonstrated through the XTEND-1 global Phase 3 study. The study results demonstrated that the Altuviiio-administered group had a significant reduction of 77% in annualized bleeding rates (ABR) compared to a group with prior factor VIII prophylaxis. The average weekly factor VIII activity for the Altuviiio-administered group was over 40 IU/dL and they had shown levels of 15 IU/dL at 7 days. Also, Altuviiio demonstrated superior drug tolerance and antibody occurrence was not reported in the Altuviiio-administered group. The most common side effects of Altuviiio were headache, arthralgia, falling, and backache.
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- "Korean pharma draws attention, open innovation will heat up
- by Son, Hyung Min Nov 22, 2024 05:56am
- The Ministry of Health and Welfare (MOHW) and the Korea Health Industry Development Institute (KHIDI) held the Global pharmaceutical companies continue to invest in research & development (R&D) to overcome patent expiration. Industry experts have said that open innovation between global pharmaceutical companies and Korean pharmaceutical companies will be fired up, enabling collaborations in various diseases. According to industry sources on November 21, the Ministry of Health and Welfare (MOHW) and the Korea Health Industry Development Institute (KHIDI) held the '2024 Global Open Innovation Week' on November 20 at El Tower, Seoul. Representatives from various global pharmaceutical companies, including BMS, Novo Nordisk, and Takeda, attended the event and presented about R&D approaches and collaboration opportunities for open innovation. Aiming new diseases…BMS develops ADC·radiopharmaceutical·neuroscience-drug BMS is one of the companies actively involved in open innovation and merger & acquisitions (M&A) deals. The company's patents for new drugs, coagulant agent 'Eliquis,' and multiple myeloma drug 'Revlimid,' have expired. Due to the introduction of generics, BMS is facing a reduction in sales. The immune checkpoint inhibitor, 'Opdivo,' which emerged as a global blockbuster drug, is also set to expire. In the past year and this year, BMS has invested in Karuna Therapeutics (US$14 billion), RayzeBio (US$4.1 billion), Mirati Therapeutics (US$4.8 billion), and SystImmune (US$8.4 billion), expanding its pipeline. BMS developed a new schizophrenia drug, Cobenfy, by acquiring Karuna Therapeutics. It also jumped into the radiopharmaceutical market by acquiring RayzeBio, and the company plans to develop new drugs for cancer through Mirati Therapeutics and SystImmune. Additionally, BMS signed a technology transfer agreement with Orum Therapeutics last year, which was the first collaboration on open innovation with a Korean company. BMS paid Orum Therapeutics US$180 million last year, successfully securing antibody-drug conjugate (ADC) technology. Mariko Hiramatsu, BMS "Until now, the company has significantly been relying on Opdivo. Not only focusing on immune checkpoint inhibitors, but we also plan to secure new pipelines in various diseases," Mariko Hiramatsu, BMS' Head of Japan in Business Development and Asia Search, stated. "BMS is interested in collaborating with global companies and partnering with Asian companies, including those in South Korea, for new drug candidates. For example, gastric and pancreatic cancers have high incidence rates in the Asia-Pacific region, and collaborating with Asian companies can enhance the potential for new drug development. Such strategies often consider regional disease prevalence to tailor drug development approaches," Hiramatsu said. "When evaluating the introduction of new drug candidates, we consider how quickly milestones can be achieved and the associated investment costs, which are also key factors." "The contract with Orum Therapeutics is one of the important contracts for BMS. We aim to bolster innovation in South Korea and focus on developing new drugs for global patients," Hiramatsu emphasized. Continue to invest in fields where they have strengths…Novo Nordisk searches new drug candidates for treating diabetes·obesity·MASH Novo Nordisk said the company will continue investing in areas where they have strengths. The company has drugs that belong to a class of GLP-1 and obesity treatments, including Saxenda, Wegovy, Ozempic, and Victoza. The company's chief focus is developing new drug candidates for metabolic diseases, such as MASH treatments. To bolster its pipeline, Novo Nordisk pulled off M&A deals one after another. In August 2023, Novo Nordisk acquired Inversago Pharma, a company specializing in developing new drug candidates for obesity, at US$1.1 billion (about KRW 1.5 trillion), strengthening their obesity pipeline. Inversago Pharma is developing INV-202, a CB1 receptor-based novel drug candidate for diabetes·obesity. According to Phase 1 clinical trial results, INV-202 has demonstrated tolerability and safety in adult patients showing signs of metabolic syndrome. After that, Novo Nordisk acquired the Danish biotechnology company Embark Biotech. Embark is a spinout company from the Novo Nordisk Foundation in 2017. Embark Biotech is developing 'EMB1,' a novel obesity treatment candidate targeting the G-protein-coupled receptor on fat cells. Calvin Chen, Associate Director of Global Search & Evaluation at Novo Nordisk "Novo Nordisk remains open to various possibilities and is not solely focused on late-stage drug candidates in Phase 3 clinical trials. We are interested in all competitive drug candidates in our key areas of expertise, including obesity, diabetes, and MASH," Calvin Chen, Associate Director of Global Search & Evaluation at Novo Nordisk, stated. Chen added, "Our focus is on sustainability. We are seeking an open innovation partner who is responsible for various aspects, such as societal and environmental aspects."
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- Industry eyes myelofibrosis drug Ojjaara’s reimb progress
- by Eo, Yun-Ho Nov 22, 2024 05:55am
- Interest is gathering on the insurance reimbursement of Omjjara, a targeted therapy for myelofibrosis. According to industry sources, GSK Korea is preparing to submit a reimbursement application for its myelofibrosis drug, Ojjaara (momelotinib) in Korea. The company is expected to submit its application next month (December). Specifically, the indication the company will apply for reimbursement is for the “treatment of myelofibrosis in intermediate- or high-risk adults with anemia.” The drug’s approved indication includes both primary myelofibrosis and myelofibrosis post-polycythemia vera (PV) and post-essential thrombocythemia (ET). Unlike existing drugs that act on a single target, Ojjaara is a multi-target drug that blocks all three major signaling pathways that lead to the disease, providing a potent treatment effect. The drug blocks three key signaling pathways, including the JAK1 and JAK2 proteins that were inhibited by existing therapies, and the ACVR1 (activin A receptor type). The recommended dose is 200 mg orally once daily and can be taken with or without food. Myelofibrosis is a rare blood cancer in which the bone marrow becomes fibrotic, causing symptoms such as anemia, thrombocytopenia, and spleen and liver enlargement. It affects about 1 in 100,000 people worldwide, and in Korea, about 2,292 patients were confirmed to have received inpatient and outpatient treatment for the condition as of 2023. Patients with anemia symptoms in particular have a poor prognosis, and the problem is that the majority of patients experience anemia. In one study, 87% of patients with myelofibrosis were anemic at the time of referral, and in another study, 46% of patients required a blood transfusion more than a year after diagnosis. In general, the development of anemia in myelofibrosis patients doubles the risk of death compared to other prognostic factors such as age, leukocytosis, and systemic symptoms. In 2 global Phase III clinical trials - the SIMPLIFY-1 study and the MOMENTUM study - Ojjaara confirmed the clinical efficacy and safety profile of anemia in adult myelofibrosis patients, including the treatment of key symptoms such as improved splenomegaly and reduced transfusion dependency in patients with anemia. The SIMPLIFY-1 study directly compared Ojjaara to ruxolitinib in 432 adult myelofibrosis patients who had not previously received JAK inhibitor therapy, with a post hoc analysis in the anemia subgroup. The results demonstrated non-inferiority of Ojjaara to ruxolitinib for the primary efficacy endpoint of spleen volume response (>35% reduction) at 24 weeks of treatment but did not show non-inferiority in terms of total symptom score improvement. The proportion of patients in each arm who were transfusion-free was 66.5% in the Ojjaara arm and 49.3% in the ruxolitinib arm, with significantly lower transfusion dependence (better transfusion independence) in the Ojjaara arm. In the MOMENTUM study, another pivotal trial, which evaluated the efficacy and safety of Ojjaara versus danazol in 195 adult patients with myelofibrosis who were previously treated with a JAK inhibitor and had symptoms and anemia. All subjects enrolled in the study had previously received ruxolitinib, and 4.6% had received fedratinib. The co-primary efficacy endpoints were the proportion of patients with a 50% or greater reduction in Total Symptom Score (TSS) at 24 weeks of treatment and transfusion independence. Key secondary endpoints included spleen volume response.
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- Latecomer psoriasis treatment 'Bimzelx' launches
- by Whang, byung-woo Nov 22, 2024 05:55am
- UCV Korea has launched Bimzelx (ingredient: bimekizumab) for treating psoriasis and is set to challenge the market. Although existing psoriasis treatments have taken a share of the market, the company will target unmet needs based on the drug's new mechanism. Ki Heon Jeong, Professor of the Department of Dermatology at Kyung Hee University Medical CenterUCB Korea held a media session on November 20 to celebrate the launch of Bimzelx in South Korea and presented the product's competitiveness in the market. Bimzelx is the first treatment for plaque psoriasis that bi-specifically inhibits interleukin-17A and 17F (IL-17A, IL-17F). It received the Ministry of Food and Drug Safety (MFDS) approval at the end of August. IL-17A and IL-17F are cytokines that play a central role in inducing inflammatory cascade in psoriatic diseases. Bimzelx works by simultaneously selecting, directly targeting, and inhibiting both cytokines. In the Phase 3 BE READY clinical trial, which was the basis of approval, 90.8% of the Bimzelx-treated group reached 'PASI 90' at 16 weeks, and 68.2% of those reached 'PASI 100.' In a clinical trial comparing Bimzelx to different biological agents, a difference has been observed in the percentage of patients reaching 'PASI 100,' an indicator of complete skin clearance. In detail, the results have shown ▲59% for BE VIVID Bimzelx, 21% for ustekinumab (Stelara) ▲60.8% for BE SURE Bimzelx, 23.9% for adalimumab (Humira )▲61.7% for BE RADIANT Bimzelx, 48.9% for secukinumab (Cosentyx). The study results demonstrated that Bimzelx has the advantage of a higher PASI 100 score than previously launched biological agents. Due to the recurrent and remissive nature of psoriasis as a refractory disease, there remains an unmet need for effective treatments. The introduction of Bimzelx, with a novel mechanism, is being evaluated as a potential addition to the therapeutic arsenal. "Psoriasis patients seek treatment and expect rapid, strong, and lasting therapeutic effects, which are closely tied to improving their quality of life. Despite the availability of various treatment options, there has been an unmet need for safe psoriasis medications that maintain long-term efficacy," Ki Heon Jeong, Professor of the Department of Dermatology at Kyung Hee University Medical Center, explained. "Bimzelx has demonstrated superior efficacy to some existing treatments through direct comparison clinical trials. Additionally, its maintenance therapy allows administration at 8-week intervals, offering improved convenience compared to existing IL-17 inhibitors," Hojin Lee, UVB Korea's Medical Strategy Lead, said. Currently, UCB Korea has entered into a distribution agreement with Geo-Young and is actively preparing for the launch of Bimzelx. However, given the number of psoriasis treatments already available on the market and covered by national health insurance, the impact of Bimzelx remains uncertain. Regarding this Professor Jeong stated, "It has been quite some time since biological agents were introduced to the market, yet there are still patients suffering despite having tried all available biologic therapies. Introducing a new treatment option with strong efficacy for patients with severe psoriasis is highly significant." UCB Korea has emphasized that securing reimbursement is their top priority regarding Bimzelx's market entry. "Following Bimzelx's approval on August 29, we submitted a reimbursement application to the Health Insurance Review and Assessment Service (HIRA) the next day. While we are still in the early stages, including holding drug briefings, we aim to achieve reimbursement by next year," Il Shim, Executive Director of UCB Korea, stated. "Since previously approved treatments are in the market, the company is aware of the drug pricing issue. We aim to obtain reimbursement for the drug quickly," Shim added.
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- ‘Global Bio M&A Trends: Fewer New Drugs, More CDMOs’
- by Kim, Jin-Gu Nov 22, 2024 05:55am
- The global pharma-bio M&A trend is showing a distinct trend of 'risk aversion'. Due to the macroeconomic impact, investments in stable areas became more active, while investments in high-risk, high-return areas have plummeted. This explains the sharp decline in M&A related to new drug development, which is high-risk and the increase in M&A related to CDMOs, which are relatively stable. Je Sung Pyun, Director of Strategy, Risk & Transactions at Deloitte Korea, explained so at a seminar on “Global Market Entry and Intellectual Property Protection” that was held at EL Tower in Yangjae-dong, Seoul, on the 21st, hosted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association/ According to Pyun, there were 172 global M&As involving global CDMOs through the third quarter of this year. This has already surpassed the total of 153 relevant M&As that were completed last year. CDMOs are being regarded as the most active M&A area in the pharma-bio sector this year. On the other hand, M&A related to new drug development has declined significantly recently. Last year, there were 74 drug development M&As, which is less than half of the 196 completed in 2021 and 167 in 2022. This year, there have been only 72 so far through the third quarter. “While CDMO deals have been active, deals for new drug development companies have been declining,” said Pyun, “This reflects the investors’ preference for lower risk due to volatility in the financing environment driven by macroeconomic conditions.” Pyun disclosed the results of a survey on global pharma and biotech leaders. Deloitte asked pharma and biotech leaders about their outlook for biotechs in 2024 compared to 2023 and found that 85% believe the risk of biotech bankruptcies will be higher or similar to the previous year in 2024. “The risk of biotech bankruptcy is being taken more seriously,” says Pyun, ”and risk-averse investing has increased significantly. As we move through this year and into next year, we'll see the gems and pebbles be quickly distinguished among biotechs.” The decrease in investment in anticancer drugs by disease group and the increase in investment in new platforms such as ADCs and radiopharmaceuticals can also be explained in the same line of context. While anticancer drugs are high-risk investments, ADCs, and radiopharmaceuticals are less risky because they are often improvements to existing therapies. Especially in the ADC space, market demand is increasing as more effective and stable linkers are developed. The concentration of M&A on drugs in Phase III or the commercialization stage is also attributed to risk aversion. In fact, 74% of M&A in pharma & biotechs in 2023 occurred in late-stage clinical development. This is a significant increase from 60% in 2022. This is likely due to the concentration of M&A deals on targets that are less risky than those in Phase I and II trials and that can be monetized in a shorter period of time. “Partnerships are favored over deals due to the higher risk in the early clinical stage,” explained Pyun, ”Partnerships are being forged to proactively acquire technology platforms and innovative drug candidates.”
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- New CGRP antagonist 'eptinezumab' expected to be marketed
- by Eo, Yun-Ho Nov 21, 2024 05:46am
- Product photo of Lundbeck Yet another CGRP antagonist drug for migraine is expected to be marketed. Lundbeck's 'eptinezumab (Vyepti),' a CGRP antagonist for the preventive treatment of migraine, showed positive results in the global Phase 3 clinical trial in Asia involving Koreans. The drug is expected to enter South Korea quickly based on this result. Lundbeck has announced that in the Phase 3 pivotal SUNRISE trial, which was conducted to evaluate the efficacy and safety of the drug in patients with chronic migraines, eptinezumab met primary and all key secondary endpoints. Lundbeck's eptinezumab is an intravenous (IV) therapy used for preventive migraine treatment, sold in Europe and the United States. It was approved by the U.S. Food and Drug Administration (FDA) as a preventive migraine treatment in adults in February 2020. In January 2022, it received marketing authorization from the European Medicines Agency (EMA). Eptinezumab is being sold in over 30 markets worldwide in addition to the U.S. market. Ahead of its launch in Asia, Lundbeck achieved positive outcomes from the SUNRISE clinical trials. The SUNRISE clinical trial enrolled adult patients with chronic migraines who required preventive treatment. Symptoms of chronic migraine were defined as having a headache lasting more than 15 days in a month, with migraines occurring more than 8 days in a month. In a randomized, double-blind clinical trial, 983 patients were randomized and double-blinded to three treatment groups to receive eptinezumab 300 mg, 100 mg, or placebo by IV infusion. The effects were monitored for 12 weeks. The SUNRISE clinical trial results showed that eptinezumab significantly reduced monthly migraine days (MMD) compared to the placebo, meeting the primary endpoint. Measuring changes to MMD in chronic migraines during the 12-week treatment showed that the 300 mg-administered patient group had -7.5 days, the 100 mg-administered patient group had -7.2 days, whereas the placebo patient group had -4.8 days. Additionally, the eptinezumab 300 mg-or 100 mg-administered patient group had a significant MMD reduction of over 50% during the 12-week treatment compared to the placebo. In the SUNRISE clinical trial, the percentage of patients experiencing migraines the next after the eptinezumab infusion was significantly lower than the placebo, confirming that eptinezumab's preventive effects are experienced early. "In Asia, millions of people are affected by frequent and severe migraines, but only a few individuals use preventive therapy due to limitations of efficacy, safety, and drug tolerance," Johan Luthman, Executive Vice President in the R&D sector, stated. "We are very pleased with the SUNRISE clinical trial results. The current results will play a key role in Lundbeck's effort in providing eptinezumab to Asian patients who suffer from severe migraines," Luthman added. Meanwhile, Lundbeck plans to initiate the process of obtaining approval from the regulatory authority so that patients in Asia regions, including South Korea, China, and Japan, who suffer from migraines can readily use eptinezumab.
