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- 2026-04-07 09:51:39
- Opinion
- [Reporter’s View] 'all-comers' with strict criteria
- by Eo, Yun-Ho Jul 02, 2024 05:48am
- Drugs that are intended for use regardless of any conditions are strictly regulated. In the pharmaceutical industry, 'all-comers' refers to a drug indication that can be prescribed at any treatment stage, regardless of conditions. Drugs with all-comers indications have demonstrated their efficacy regardless of receptors or genetic mutations. This is appealing and interesting. Yet, the Korean government has a firm stance towards these all-comers’ indications. It is certainly reasonable. Drugs with many uses, in other words, mean an increased volume of use, which then leads to financial consideration. However, the government’s discretion towards a drug seems to suggest another hurdle besides finance. Drugs with all-comers indication have proven records and gained the Ministry of Food and Drug Safety (MFDS) approval, yet a difference in efficacy exists. When reviewing reimbursement of all-comers that target particular genes, considering the mechanisms of drugs, but the basis of concluding effectiveness is irrelevant to those genes, the government stands by the guideline, 'limiting to originally targeted genetic mutations.' Such discretion is considered reasonable and to be considered with time. However, time hasn’t been helpful when we consider past cases. In the case of the PD-L1 inhibitor 'Optivo (nivolumab),' an immunotherapy medication for the treatment of non-small cell lung cancer (NSCLC) that was approved for all-comers indication, experts at the time agreed that 'PD-L1 expression rate' was not a marker. However, due to untimeliness of the drug’s release, Optivo was granted reimbursement in 2017 with a conditional criteria. Since then, numerous new drugs with all-comers indications have been released. Yet, these drugs are still applied with limited reimbursement criteria during the review for reimbursement listing. It suggests that the government must consider patients and propose a compromise along with carefulness. If pharmaceutical companies make unreasonable requests during the reimbursement discussion of a drug with approval, the government cannot accept them, especially since even the physicians oppose them due to financial issues. However, the government must provide reasons rather than just saying "difficult." Instead, the government must continue the discussion based on data evidence.
- Policy
- GSK will discontinue supply of Infanrix IPV
- by Lee, Tak-Sun Jul 02, 2024 05:48am
- GlaxoSmithKline has decided to discontinue supply of its ‘Infanrix IPV’ vaccine, which protects against diphtheria, tetanus, pertussis, and polio in children, in South Korea. Infanrix IPV and Sanofi Pasteur's ‘Tetraxim’ are the only DTaP-IPV vaccines used in the National Immunization Program (NIP), raising concerns about the shortage of vaccines and the shortage of vaccinations that will follow. GSK reported to the MFDS that it will discontinue the supply of Infanrix IPV Prefilled Syringe as of July 1. The reason for the suspension is low domestic demand. The company said, "It is difficult to import additional supply, and it will not be possible for the company to participate in future NIPs after the stock is exhausted. The remaining stock is expected to run out in January next year. In fact, sales of Infanrix IPV on IQVIA last year were not captured. Tetraxim, on the other hand, generated sales of $3.1 billion. The vaccine is used to prevent diphtheria, tetanus, pertussis (whooping cough), and polio in infants and children from 2 months of age. It is administered as 3 intramuscular injections of 0.5 mL at 2, 4, and 6 months of age, followed by a booster dose of 0.5 mL at 4 to 6 years of age. Infanrix IPV has experienced pediatric immunization shortages in the past. In 2016, the global DTaP vaccine shortage disrupted pediatric immunizations due to domestic supply disruptions. In 2016, a global shortage of the DTaP vaccine disrupted pediatric immunization schedules, and when the domestic supply of Infanrix IPV was temporarily suspended, Tetraxim’s stock also ran out due to high demand. In 2021, GSK’s vaccine was also suspended due to a paperwork error, and the MFDS allowed cross-immunization with an alternative vaccine. Such history suggests that the discontinuation of Infanrix IPV in the Korean market will inevitably cause disruptions on-site. A fundamental solution for this is localizing pediatric vaccines. Recently, LG Chem has begun localizing a hexavalent combination vaccine for infants and young children, but it will take time for the product to be commercialized in Korea. An industry official said, “Vaccines for nationally mandated vaccinations such as DTaP are entirely imported from foreign countries. Localization of vaccines required for nationally mandated vaccinations is urgently needed to protect people's health and improve national competitivity as seen during the COVID-19 crisis." .
- Company
- GLP-1 uses↑…targets MASH, diabetes, and obesity
- by Son, Hyung-Min Jul 01, 2024 05:48am
- New drug candidates of the GLP-1 class target metabolic dysfunction-associated steatohepatitis (MASH) in addition to diabetes and obesity. Global pharmaceutical companies, such as Novo Nordisk, Eli Lily, Boehringer Ingelheim, and Korean pharmaceutical companies, including Dong-A ST and D&D pharmatech, are developing GLP-1 agents for the treatment of MASH. GLP-1 can aid weight loss by increasing fullness and can enhance blood glucose control by increasing insulin secretion and sensitivity. Weight loss can have a positive impact on patients, as MASH occurs when fat saturates in the liver of individuals who have had low or no alcohol consumption. Nonetheless, pharmaceutical companies are working on the potential of GLP-1 for the treatment of MASH in addition to diabetes and obesity. New drug development for MASH by multinational pharmaceuticals companies. (from the top) Madrigal Pharmaceuticals’ Rezdiffra, Intercept Pharmaceuticals’ Ocaliva, Galmed Pharmaceuticals’ Aramchol, Novo Nordisk’s semaglutide, akero’s efrixiferm, Regeneron Pharmaceuticals and Alnylam Pharmaceuticals’ ALN-HSD, Viking Therapeutics’ VK2809, and others. According to industry sources on June 12th, Boehringer Ingelheim’s 'survodutide' and Lily’s 'Tirzepatide' demonstrated the effectiveness in Phase 2 clinical trials. These two new drug candidates are a type of glucagon-like peptide 1 (GLP-1). In a Phase 2 trial, survodutide, targeting both GLP-1 and glucagon, showed effects in the percentage of symptom worsening at 48 weeks compared to the placebo. This trial assessed the Survodutide’s effectiveness in 295 adults with MASH and liver fibrosis regardless of having type 2 diabetes. Based on recent clinical results, the percentange of patients who significantly improved in MASH-associated liver diseases withought worseninig of fibrosis stage was 83% in the survodutide treatment group, whereas 18.2% in the placebo group. The survodutide treatment group also had a higher percentage of patients with decreased liver fat over 30%, compared to the placebo. Eli Lily also confirmed the effectiveness of tirzepatide in a phase 2 trial for MASH. Tirzepatide is a GLP-1·GIP dual targeting agent with the same ingredient as Lily’s type 2 diabetes drug Mounjaro and obesity drug Zepbound. The SYNERGY-NASH Phase 2 trial, evaluating the effectiveness of tirzepatide, involved 190 MASH patients who have biopsy-confirmed moderate-to-severe fibrosis. At 52 weeks, established as the primary endpoint, the percentage of symptom improvement without worsening fibrosis was 43.6%, 55.5%, and 62.4% for tirzepatide 5 mg, 10 mg, and 15 mg, respectively. Korean companies show progress in MASH clinical trials New drug development for MASH by pharmaceutical companies based in South Korea. (from the top) Hanmi Pharm’s efocipegtrutide, Dong-A ST’s DA-1241 and DA-1726, HK inno. N’s FM-101, D&D pharmatech’s DD01, Yuhan’s YH25724, Ildong Pharmaceutical’s ID119031166, LG Chem’s LG303174 and LG203003. Korean companies are also focusing on the potential of GLP-1. Dong-A ST is developing DA-1241 with an underlying mechanism of GPR119, a receptor on beta cells in the pancreas, and is also considering the potential for combination therapy with a GLP-1 agent. Neurobo, Dong-A ST’s subsidiary, recently confirmed the effect of semaglutide in combination with a MASH novel drug candidate, DA-1241. Dong-A ST is exploring the potential of semaglutide, a GLP-1 agent, as a combination therapy in addition to its phase 2 trial for DA-1241 monotherapy. The trial evaluated the efficacy and safety of administering DA-1241 in combination with semaglutide in a metabolically altered MASH mouse model. The clinical results showed that mice treated with combination therapy improved NAS (liver fat activity score) by greater than a score of 1. Furthermore, the genetic analysis of liver tissue showed that the combination therapy significantly improved the expression of genes related to inflammation and fibrosis. Dong-A ST plans to make clinical entry for the combination therapy and present global phase 2 trial results on DA-1241 monotherapy. D&D pharmatech is conducting a phase 2 trial in the United States. The company recently received IND approval from the U.S. Food and Drug Administration (FDA). In preclinical trials, D&D pharmatech’s DD01, an agent targeting both GLP-1 and glucagon, has shown a significant decrease in liver fat and a weigh loss effect. In a phase 1 trial, the four-week treatment of DD01 reduced the liver fat by 50%. DD01’s phase 2 trial will be conducted across 10 institutes in the United States, enrolling 68 patients with MASH-accompanying overweight and obesity. 'Rezdiffra,' the only commercially available MASH treatment has an underlying mechanism of targeting thyroid hormone receptor The only drug commercialized for MASH treatment is Rezdiffra from the U.S.-based Madrigal Pharmaceuticals. The drug targets the thyroid hormone receptor (THR)-β. The U.S.-based Viking Therapeutics also conducted a phase 2b trial for a pharmaceutical with a similar mechanism to Rezdiffra and recently secured a positive result. In the clinical trial, Viking Therapeutics’ MASH candidate, known as VK2809, has significantly reduced liver fat. In the clinical trial VOYAGE, up to 75% of VK2809 treatment group had a MASH response, compared to 29% of the place group. The adverse reactions associated with the VK2809 treatment were mostly mild or moderate.
- Company
- Companies to focus on developing trispecific antibodies
- by Son, Hyung-Min Jul 01, 2024 05:48am
- The pharmaceutical industry in South Korea and overseas has begun developing trispecific antibodies that bind three targets. Previously, these companies focused on bispecific antibodies, which can bind simultaneously to two different antigens or two antigenic epitopes on a single antigen. Crossing the blood-brain barrier (BBB) can increase the drug permeability, especially for anticancer drugs. Multi-targeted antibodies have the advantage of crossing the BBB by target binding to receptors on the BBB surface. Recently, more companies have begun developing multi-targeted antibodies by matching antibodies that bind to both antigens regulating immune cell activity and specific antigens on tumor cells. Korean biotech companies, such as Shaperon, Celltrion, and ISU Abxis, and global pharmaceutical companies, including Gilead Sciences and Sanofi, have begun developing these. Korean biopharmas are developing trispecific antibodies According to industry sources on June 28th, Shaperon recently signed a memorandum of understanding (MOU) with Dong-A ST to develop trispecific antibodies as part of a new drug development. Through this collaboration, Shaperon will be responsible for nanobody development and Dong-A ST will use its antibody commercialization technology to focus on new global drug development. Since 2021, two companies have collaborated on developing trispecific nanobody antibodies for the treatment of cancer. This technology uses nanoantibodies to bring T cells and cancer cells closer together. Using nanobody advantages, Shaperon is developing nanobody-based various protein pharmaceuticals, including antibody-drug conjugates (ADC) and radiopharmaceuticals. Last year, Celltrion started developing trispecific antibodies in collaboration with Cyron Therapeutics, specializing in antibody development. These companies plan to develop new drugs using the CD3-targeting T-cell-engagers (TCE) platform. TCE multi-targeted antibodies are treatments that induce anticancer effects by effectively attacking cancer cells through T-cells. Recently, many global pharmaceutical companies are exploring the potential of TCE multi-targeted antibody development. However, no TCE-targeting multi-targeted antibodies have been commercialized. ISU Abxis is also developing immunotherapy for cancer using its trispecific antibody platform. For this research, ISU Abxis signed a substance transfer contract with Biocytogen, China’s global biotech company, and obtained a CD40 antibody in 2021. Biocytogen’s ‘YH003,’ a CD40 antibody new drug candidate, is under phase 2 clinical trial. ISU Abxis is preparing to develop a trispecific antibody using ‘YH003’ and its antibodies. Korean and global pharmaceutical companies that develop trispecific antibodies: (Korean companies) Shaperon recently signed a memorandum of understanding (MOU) with Dong-A ST, Celltrion started developing a T-cell-engagers (TCE) platform in collaboration with Cyron Therapeutics, and ISU Abxis acquired CD40 antibody from China’s Biocytogen. (Global companies) Sanofi acquired Amunix Pharmaceuticals and secured a T-cell-engagers (TCE) platform. Gilead Sciences discovered a TAA bispecific antibody in collaboration with a Dutch biotech company, Merus. MSD acquired the U.S.-based Harpoon Therapeutics and secured a trispecific T-cell engagers (TCE) platform. Global pharmaceutical companies are also developing…still in the early phases of clinical trials Global pharmaceutical companies are also developing trispecific antibodies, superior to bispecific antibodies. However, these companies’ R&D of multi-targeted antibodies is still in the early phases. Most new drug candidates remain in the early phases of clinical trials. Sanofi is developing a multi-targeted antibody that targets HER2. In 2021, Sanofi acquired Amunix Pharmaceuticals, a U.S.-based biotech company, for US$1 billion (approximately KRW 1.2 trillion). Amunix Pharmaceuticals is developing ‘AMX-818,’ a HER-2-targeting TEC that activates immune responses and attacks cancer cells. Gilead Sciences began developing trispecific antibody for cancer in March in collaboration with a Dutch biotech company, Merus. These companies will conduct joint research to discover novel tumor-associated antigen (TAA) bispecific antibodies. Merus owns a trispecific antibody platform called Triclonics, which is analyzed to have the potential for developing antibodies that bind three targets simultaneously. MSD is developing trispecific antibodies through the U.S.-based Harpoon Therapeutics, which MSD acquired in January. Harpoon Therapeutics owns the trispecific TCE platform, bispecific antibody, and cell therapy technology. SystImmune is conducting three cases of a phase 1 trial for a trispecific antibody in collaboration with China’s biotech company.
- Company
- Various treatment options introduced for multiple myeloma
- by Eo, Yun-Ho Jul 01, 2024 05:48am
- New treatment options for multiple myeloma treatment are emerging one after another. According to industry sources on the 28th, drugs such as Pfizer’s ‘Elrexfio (elranatamab)’ and GSK’s ‘Blenrep((belantamab mafodotin)’ are receiving attention as promising candidates in the field of multiple myeloma. In the case of Elrexfio, the drug was recently approved in Korea. Elrexfio has been designated as the 4th GIFT (Global Innovative products on Fast Track) drug by the Ministry of Food and Drug Safety. Elrexfio’s efficacy was demonstrated through the Phase II MagnetisMM-3 trial, an open-label, multicenter, non-randomized study that was conducted on 123 who had not received prior BCMA-directed therapy (ie, BCMA-naïve patients). The study evaluated the efficacy and safety of elranatamab monotherapy in patients with relapsed or refractory multiple myeloma (RRMM) who had previously received at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 antibody. Results showed that the overall response rate (ORR), the primary endpoint, of adult patients with RRMM who have received three or more lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody but had not received prior BCMA-directed therapy was 61.0% for the Elrexfio arm, 56.1% of which showed very good partial response (VGPR). Elrexfio is expected to compete with Janssen's bispecific antibody Tecvayli (teclistamab). Like Elrexfio, Tecvayli targets both the BCMA and the CD3 receptor. GSK recently presented data from the DREAMM-8 study on Blenrep at the American Society of Clinical Oncology Annual Meeting (ASCO 2024). The DREAMM-8 study compared the existing treatment for multiple myeloma, pomalidomide plus bortezomib and dexamethasone (PVd), with Blenrep with pomalidomide and dexamethasone (BPd). The study enrolled 300 patients who had failed at least one first-line treatment for multiple myeloma. According to the presented results, 71% of the patients who received BPd survived without disease progression at 1 year. This is approximately 48% higher than that of the PVd combination arm (51%). This translates to a reduction in the risk of further disease progression or death at 1 year after treatment from 49% to 29%, which translates to a nearly half reduction. In 2022, GSK decided to withdraw approval of its BPd therapy determining that it did not improve outcomes for patients with multiple myeloma. However, GSK has since continued to test the efficacy of Blenrep in late-stage clinical studies. Meanwhile, Janssen's CAR-T drug Carvykti (ciltacabtagene autoleucel) also recently unveiled an additional study on multiple myeloma at ASCO. The study showed that Carvykti improved survival compared to the existing second-line standard of care of pomalidomide plus bortezomib plus dexamethasone (PVd) or daratumumab plus pomalidomide plus dexamethasone (DPd) in patients with functionally high-risk (FHR) multiple myeloma.
- Company
- Samsung Bioepis targets Stelara market
- by Hwang, Byung-woo Jul 01, 2024 05:47am
- Samsung Bioepis is seeking to target the Stelara (Ustekinumab) market by directly marketing its Stelara biosimilar Epyztek in Korea. The company is adding Epyztek to the list of autoimmune disease treatments it has been selling directly since March, a strategy that is expected to strengthen its marketing capabilities while increasing profitability. A view of the Samsung Bioepis building in Songdo.Samsung Bioepis will launch Epyztek, an autoimmune disease treatment, in the Korean market in July. Epyztek is a biosimilar of Stelara, Janssen’s treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Epyztek was approved by the Ministry of Food and Drug Safety in April. Stelara inhibits interleukin (IL)-12/23 activity, a class of inflammatory cytokines (signal transmitters). As of 2023, its annual global product was around KRW 1.4 trillion, and domestic market sales were around KRW 41.6 billion. According to the ‘Drug Reimbursement List and Reimbursement Ceiling Table' announced by the Health Insurance Review and Assessment Service as of July 1, Epyztek is priced at KRW 1,298,290 per 45mg/0.5ml prefilled syringe. This is about 40% lower than the price of the existing original drug. Although Stelara’s price will also be reduced following the launch of the biosimilar, Epyztek still has a price advantage. Professor A, Department of Gastroenterology at a tertiary hospital in Seoul, Korea, said, "There seems to be little doubt about the effectiveness of biosimilars as prescriptions have accumulated. The financial burden of Stelara’s initial intravenous infusion may serve to lower the threshold for the introduction of its biosimilars." The biggest characteristic of biosimilars is in their lower cost compared to the original. However, in Korea, the price difference is not large due to the low patient copayment rate applied through Korea’s insurance reimbursement system, but Stelara’s characteristics may still provide competitivity for the biosimilars. Another characteristic of Epyztek is that the company sells the product directly. Since March, Samsung Bioepis has switched to direct sales of 3 autoimmune disease drugs that it had been selling in partnership with Yuhan Corp. With the exception of anticancer and ophthalmic drugs, the company’s decision to switch to direct sales is interpreted as the company’s attempt to increase the profitability of the drugs. Currently, Samsung Bioepis has about 20 domestic sales personnel for direct sales, and in March, it secured a distribution network in the domestic market by signing a pharmaceutical third-party logistics contract (3PL) with Geo-Young. In the field, the prospect is that Epyztek’ssales will depend on Samsung Bioepis' marketing capabilities and how quickly it can land in the market. An industry official said, "It is true that the marketing capabilities cannot be ignored due to the nature of biosimilars. However, given how Samsung Bioepis already has experience in selling biosimilars for autoimmune diseases, we expect sales to be directly related to how quickly the drug can land in each hospital." A Samsung Bioepis official said, “We are able to offer various treatment opportunities for patients with autoimmune diseases with the launch of Epyztek. Based on the reasonable drug price, we expect the drug to address the unmet demand in the field and contribute to saving national health insurance finances."
- Policy
- Expenses for the major four severe diseases tops KRW 7T
- by Lee, Tak-Sun Jul 01, 2024 05:47am
- Pharmaceutical expenses for the four major severe diseases exceeded KRW 7 trillion last year. The four major severe diseases refer to cancer diseases, cerebrovascular disease, and rare·severe incurable diseases. Pharmaceutical expenses for this category have risen due to high-cost pharamceuticals. Consequently, an analysis suggests that managing pharmaceuticals in this category is crucial for continuing the National Health Insurance. The Health Insurance Review and Assessment Service (HIRA) published the '2023 Report on Reimbursement Claims for Pharmaceuticals Expenses' on June 27th. It indicates that the claim amount for the four major severe diseases last year was KRW 7.348 trillion, a 20% increase from KRW 5.8495 trillion in 2022. Pharmaceutical expenses for the four major severe diseases (unit: 1,000 cases, KRW 1 million). Notably, pharmaceutical expenses for cancer disease and rare·severe incurable diseases are increasing rapidly. Anticancer drug expenses have reached KRW 4 trillion. Last year’s expense was KRW 3.8506 trillion, up 23.5% Year-over-Year (YOY). Pharmaceutical expenses for rare·severe incurable diseases topped KRW 3 trillion. It was KRW 3.337 trillion for 2023, up 16.2% YoY. Pharmaceutical expenses for cerebrovascular and cardiac diseases were KRW 803.5 billion and KRW 700.5 billion, respectively, and they have maintained an increasing trend. In contrast, the percentage of pharmaceutical expenses out of the total medical fees for the National Health Insurance has remained at 23% for the past two years. Last year’s figure was 23.86%, an increase from 23.34% in 2022 but still at around 23%. From 2019 to 2021, pharmaceutical expense was at around 24%. However, last year’s rate of increase in pharmaceutical expenses showed the highest figure in the past five years. The rate of increase for pharmaceutical expenses was 12%, recording a double-digit figure. This seems to be relevant to the rapid increase in pharmaceutical expenses for the four major severe diseases. Last year’s total pharmaceutical expense was KRW 25.6446 trillion. The percentage of pharmaceutical expense for the major four severe diseases out of the total expense amounted to 27.4%. The government is in the process of improving the post-management system and re-assessment for pharmaceutical expense management. Specifically, it plans to establish a system to post-manage high-cost pharmaceuticals after reimbursement and re-assess the pricing, such as lowering the pricing after comparing to foreign drugs or patent-expired drug costs.
- Company
- Ilaris’s reimbursement imminent in Korea
- by Eo, Yun-Ho Jul 01, 2024 05:47am
- The ultra-rare disease treatment Ilaris has finally passed the final hurdle to its reimbursement in Korea. Novartis Korea recently completed drug price negotiations with the National Health Insurance Service for Ilaris (canakinumab), a treatment for hereditary periodic fever syndrome. The company was quick to accept the conditional benefit decision from the National Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in April, and quickly finalized what was expected to be a difficult drug price negotiation process. Novartis' determination for reimbursement is notable. The company resubmitted the application and received a re-deliberation from DREC on the 4th after receiving a conditional reimbursement decision in February, but received the same results. However, the reduced scope of data requested by the government opened up the possibility of reimbursement. In February, Novartis was unable to accept the condition proposed by DREC. However, during this round of review, DREC likely requested less additional supplemental data with the conditional reimbursement approval decision, which Novartis was able to accept this time. It is also notable how the government swiftly responded to the first claim and reduced the scope of the evidence that was required for submission. Ilrais’s reimbursement agenda will be passed along to the Health Insurance Policy Deliberation Committee, after which the company anticipates that the drug will be reimbursed starting in August. Ilrais is indicated for the following diseases in Korea: ▲Periodic fever syndromes (PFS), cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial mediterranean fever (FMF) ▲Active systemic juvenile idiopathic arthritis (Systemic JIA). For CAPS, the indication can be further categorized into the following symptoms: ▲Familial cold autoinflammatory syndrome (FCAS)/ familial cold urticaria (FCU) ▲Muckle-Wells syndrome (MWS) ▲Neonatal onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous and articular syndrome (CINCA).
- Opinion
- [Reporter’s View] No innovation without failure
- by Son, Hyung-Min Jul 01, 2024 05:47am
- Korean biopharmaceutical companies are exchanging joy and sorrow over out-licensing agreements. Last month, three companies, including HK inno.N, have successfully signed agreements to out-licensing of their new drug candidates in addition to AprilBio and ISU Abxis. In contrast, there are instances where new drug candidates that have been successfully out-licensing are later returned. GC Cell announced that a collaborative R&D agreement with Artiva Biotherapeutic, its U.S. subsidiary, for three treatments for CAR-NK solid tumors in 2021 has terminated. Furthermore, Olix Pharmaceuticals and Curacle received notifications of contract terminations from France’s Thea Open Innovation last month. In April, Voronoi terminated the out-licensing agreement made in 2022 with METiS Therapeutics, a biotech company in the United States, for its solid tumor treatment VRN14. Yet, it is too early to be disappointed about the termination of out-licensing agreements. There are instances where companies can succeed by developing drugs for new indications. For instance, last year, Hanmi Pharmaceutical confirmed the potential of Poseltinib for the treatment for recurrent or diffuse large B-cell lymphoma (DLBCL). The licensing of Poseltinib, a BTK inhibitor under development by Hanmi Pharmaceutical, was returned from Lily in January 2019 because the efficacy of the drug was not confirmed in a phase 2 trial involving patients with rheumatoid arthritis. Additionally, Hanmi Pharmaceutical is showing a process in clinical trials for efpeglenatide, a new drug candidate for obesity. Efpeglenatide is a product that initially struck a licensing agreement with Sanofi in 2015 to treat diabetes and later returned to Hanmi Pharmaceutical. Then, Hanmi Pharmaceutical changed its development strategy for this drug to a Korean-focused obesity treatment. Based on recent clinical results, Efpeglenatide demonstrated weight loss effects. During the new drug development process, selecting and focusing are necessary steps. The company’s R&D strategy can be changed, and instances of new drug candidates that fail to demonstrate efficacy can occur. Out-licensing returns are common practice in the pharmaceutical industry. Fortunately, none of the four returned new drug candidates had significant issues regarding their efficacy. Companies with returned technologies plan to proceed with later phases of clinical trials without delays. Now is the time for companies to clearly announce their potential development directions to seek future investment opportunities. When clear directions are suggested, they could seek opportunities to out-license their new drug candidates again. There is no innovation without failure. If a company firmly believes in a pipeline item (new drug candidate), it may not worry about each case of returned licensing or the success of out-licensing. Only the companies that are not discouraged or give up are poised to survive.
- Company
- GC Cell-Artiva-MSD’s 'CAR-NK' co-R&D deal terminated
- by Kim, Jin-Gu Jun 28, 2024 04:33am
- Despite the recent termination of the collaborative R&D agreement with MSD, GC Cell and Artiva will continue their collaborative research on ‘CAR-NK solid tumor treatment.’ GC Cell and Artiva Biotherapeutic’s collaborative research and development (R&D) agreement with MSD for ‘CAR-NK solid tumor treatment’ has been terminated. MSD informed Artiva Biotherapeutic, GC Cell’s U.S. subsidiary, of the contract termination. As a result, Artiva Biotherapeutic and GC Cell’s research agreement has been automatically ended. On June 25th, GC Cell announced a collaborative R&D agreement with Artiva Biotherapeutic for three treatments for CAR-NK solid tumors has terminated. In January 2021, GC Cell signed a collaborative R&D agreement with Artiva for CAR-NK cell treatment targeting solid tumors. GC Cell received an upfront payment of US$15 million (approximately KRW 17 billion) and was to receive milestone payments of up to US$966.75 million (approximately KRW 1.34 trillion). At that time, MSD joined the agreement as well. Artiva was responsible for R&D, with MSD participating as the main sponsor. GC Cell was responsible for the research aspect of Artiva’s R&D. Then, GC Cell completed the research requested by Artiva and delivered the results. However, despite this effort, MSD recently informed Artiva of the contract termination due to an internal decision. As a result, the agreement between Artiva and GC Cell was also terminated. GC Cell stated that despite the termination of the collaborative R&D agreement, with MSD participating as the main sponsor, the CAR-NK platform research conducted by GC Cell and Artiva as a collaborative effort will continue. GC Cell is collaborating with Artiva to conduct research on three candidate products, including AB-101, AB-201, and AB-202. Specifically, AB-101 is in a phase 1/2a trial in the United States. AB-201 has received IND approval for its phase 1 trial in the United States. The company is preparing to enter the U.S. clinical trial for AB-202. “The 2021 agreement was primarily led by Artiva. After the contract between Artiva and MSD was terminated, the agreement between GC Cell and Artiva automatically ended,” GC Cell’s official said. “Consequently, we are not obligated to return the upfront payment of US$15 million.“ The GC Cell official explained, “This does not mean the end of collaborative R&D of the CAR-NK platform with Artiva. GC Cell will primarily continue the R&D of the CAR-NK platform.”
