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- 2025-12-22 21:27:42
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- Growing DME market…new drugs clinical trials·biosimilars
- by Son, Hyung-Min May 31, 2024 05:52am
- Korean pharmaceutical companies are challenging the market for diabetic macular edema treatments with oral formulations. Handok and Curacle confirmed effects in clinical trials for oral diabetic macular edema treatments. Because only injectables are available in the market, oral formulations can have a competitive edge because of their convenience of administration. Furthermore, Korean pharmaceutical companies are set to compete in the market with biosimilars to Eyelia. According to industry sources on May 29th, positive results were secured from novel candidate product RZ402’s Phase 2 trials for diabetic macular edema conducted by Rezolute, Handok’s related company. This novel candidate drug works by inhibiting the overexpression of plasma kallikrein, which participates in blood coagulation. Handok owns RZ402’s marketing rights in South Korea. Diabetic macular edema (DME) is a diabetes complication that affects the central area of the retina, leading to vision deterioration and disorder. DME is a disease with damaged retinal vasculature due to increased blood glucose levels, resulting in macular fluid leaking. Conventional DME treatments are vascular endothelial growth factor (VEGFR) inhibitors, including Eylea, Lucentis, Beovu, and Vabysmo. Treatments offering the convenience of administrarion are leading the market. The intervals of administration of Eylea, the top-selling drug in the market, have been extended from once every two months to up to five months, and that of Vabysmo, an emerging competitor, can be administered once every four months. RZ402 is being developed as an oral formulation, and therefore, it has the advantage of differentiating from other treatments. This novel candidate product secured positive results from recently disclosed phase 2a trials, increasing its potential for commercialization. This research evaluated the efficacy and safety of RZ402 monotherapy (50 mg, 200 mg, 400 mg) and enrolled 94 patients with DME patients who had no prior experience with injectables or had limited therapies. The clinical results demonstrated that the RZ404 200 mg treatment group had the most improved edema, while there was no change across dosages. For the safety profile, no significant adverse reactions compared to the placebo were observed. Since the AZ402 200 mg treatment group had the most significant effect, this dosage will serve as the reference for future clinical 2b trials. Curacle, a Korea-based bioventure company, is developing an oral DME treatment CU06. The top-line results of clinical Phase 2a trials demonstrated no significant changes regarding the central subfield thickness, measured as CU06’s primary endpoint. However, significant improvements were observed in baseline in best-corrected visual acuity (BCVA), which was the secondary endpoint. In clinical trials, CU06 improved the patients’ word reading assessments within three months of administration. At 12 weeks, CU06 100, 200, and 300mg administration improved BCVA by up to 1.9, 2.5, and 2.2 letters, respectively. Notably, 300 mg treatment in the vision below 0.5 patient group improved BCVA by up to 6.6 letters at 16 weeks. Curacle signed a technology transfer licensing of CU06, excluding Asia, with Théa Open Innovation in October 2021. However, the company recently was notified of the return. Despite having the license returned, Curacle plans to continue the follow-up development since CU06 demonstrated clinical potential. Biosimilars are expected to be released…competition intensifies A significant number of Eyelia biosimilars are expected to be released. A significant number of Eyelia biosimilars are expected to be released in addition to novel oral formulations. Consequently, the competition in the market for DME is expected to intensify. Samsung Bioepis and Samil Pharmaceutical launched Afilivu, an Eyelia biosimilar, in the Korean market earlier this month. Afilivu was approved in February and completed reimbursement listing last month. In addition to these two companies, Sam Chun Dang Pharm successfully developed an Eyelia biosimilar, and Celltrion and Alteogen are also conducting clinical trials. Roche’s novel drug Vabysmo has been covered by insurance since last October and launched in the market. Vabysmo inhibits VEGF and inhibits angiopoietin-2 (Ang-2) to recover vasculature stabilization. It has the advantage of an extended effect. Vabysmo can be administered once every four months. Vabysmo’s global market sales closely match Eyelia’s. In two years of its launch, Vabysmo generated KRW 3.56 trillion in sales in the global market last year, which is over half of Eyelia’s KRW 7.8 trillion. Bayer, Eyelia’s developer, also recently introduced a high-dose formulation to defend the market. Bayer launched a product four times higher in dose than the previous 2 mg and extended the injection interval up to once every five months. Since Novartis’ Lucentis, Beovu, and Lucentis biosimilar are also seeking opportunities to expand sales, the competition in the market is expected to intensify.
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- Adtralza becomes the 2nd reimbursed biological drug for AD
- by Son, Hyung-Min May 31, 2024 05:52am
- Jiyoung Ahn, Professor of Dermatology at the National Medical Center LEO Pharma Korea has launched Adtralza (tralokinumab) as the 2nd biologic drug in the atopic dermatitis market and is on its way to take on Dupixent. LEO Pharma has been emphasizing that Adtralza has a longer dosing interval after 16 weeks compared to existing therapies and is relatively cheaper, reducing the cost burden for patients. On March 30, LEO Pharma held a press conference at the Grand Hyatt Hotel in Seoul to celebrate the reimbursed launch of Adtralza. Adtralza is a biological drug that selectively targets interleukin-13 (IL-13). The drug is being reimbursed for the treatment of chronic severe atopic dermatitis in adults and adolescents from the 1st of this month. IL-13 is a key cytokine that causes signs and symptoms of atopic dermatitis, including immune dysregulation and skin barrier dysfunction, and is overexpressed in affected skin and is known to be correlated with the severity of the disease. The launch of Adtralza adds a biologic treatment option for atopic dermatitis alongside Sanofi's Dupixent, which inhibits IL-4 and IL-13. Adtralza is reimbursable for the treatment of chronic severe atopic dermatitis in adults (18 years and older) and adolescent patients (12 years to 17 years of age) whose condition has remained symptomatic for at least 3 years and meets one of the following conditions: ▲patient received at least 4 weeks of topical therapy (at least moderate-potency corticosteroids or calcineurin inhibitors) as a first-line treatment but was unable to adequately control their condition, followed by at least 3 months of systemic immunosuppressive agents (cyclosporine or methotrexate) that did not result in a 50% or greater reduction in Eczema Area and Severity Index (EASI) or was unable to continue their use due to side effects’ or ▲Patients has an EASI of 23 or greater prior to Adtralza use. Adtralza’s clinical efficacy and safety were confirmed through four Phase III ECZTRA 3 and ECZTEND trials. The ECZTRA 3 trial compared Adtralza to placebo in patients 18 years of age and older with moderate-to-severe atopic dermatitis who had not responded adequately to prior topical therapy or requires systemic therapy. The primary endpoint of the trial was the Investigators' Global assessment score of 0 (clear) or 1 (almost clear) and EASI 75 (75% improvement in Eczema Area and Severity Index)at week 16. Trial results showed that the rate of patients who achieved EASI 75 at Week 16 was 56.0% in the Adtralza group, which is a clinically significant improvement compared with the 35.7% in the placebo group. Also, 38.9% in the Adtralza group achieved IGA (Investigator’s Global Assessment) 0/1 at week 16, compared with 26.2% in the placebo group. Results from the ECZTEND study, which evaluated the long-term efficacy of Adtralza, showed that 84.5% of patients had an EASI-75 at 4 years of Adtralza treatment. Adtralza was also effective in patients with difficult-to-treat head and neck atopic dermatitis. In particular, Adtralza had the advantage of being dosed once every 4 weeks after week 16, ensuring ease of administration for the patients. Jiyoung Ahn, Professor of Dermatology at the National Medical Center, said, “Although the symptoms of atopic dermatitis may not seem serious, the itching and pain that patients experience can interfere with sleep and other daily life activities. Although there are many treatment options available on the market, the number of patients with atopic flare-ups continues to increase, so various treatment options are necessary, We are excited about the increased treatment options that the launch of Adtralza brings to us healthcare providers and patients." Dong Hun Lee, Professor of Dermatology at Seoul National University Hospital, said, “Adtralza is convenient because it can be administered every 4 weeks at the discretion of the physician for patients with clear or nearly clear skin after 16 weeks of treatment. Also, its reimbursed price is lower than its competitors, which will reduce the financial burden borne by the patients."
- Company
- Delay after delay…When will Phesgo be reimb in Korea?
- by Eo, Yun-Ho May 31, 2024 05:51am
- The biobetter breast cancer treatment ‘Phesgo’ is facing a tough road to insurance coverage in Korea. Roche Korea’s subcutaneous fixed-dose combination injection Phesgo (pertuzumab, trastuzumab) that combined ‘Perjeta’ and ‘Herceptin’ has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in August last year. After reporting to the Drug Reimbursement Evaluation Committee review, Roche started negotiations with the National Health Insurance Service regarding the supply and quality control obligations for Phesgo but had made no progress. The 60-day deadline for negotiations has already passed, and no agreement has been reached in the extended negotiation period. It has now been 10 months since the CDDC review. As a biobetter that is an improved version of an existing drug, Phesgo’s drug price negotiations were expected to go smoothly at first, but the government was more concerned about its fiscal impact than expected and made additional demands to Roche. The good news is that both the government and the pharmaceutical company are willing to reimburse the drug, so it is possible that the parties will reach a negotiation in the future. In the case of ‘Nexviazyme (avalglucosidase alfa),’ which was the first case of preferential pricing granted to a biobetter drug, the process to its reimbursement listing took 5 months. It remains to be seen how long the tug-of-war between the government and Roche, which began last year, will continue. Phesgo was recognized for its innovation in improving patient convenience and reducing treatment time by changing the IV-injected Herceptin and Perjeta into a fixed-dose subcutaneous injection and was named the first biobetter approved for cancer in Korea. Metastatic HER2-positive breast cancer patients who had received maintenance therapy with IV Herceptin and Perjeta injections every three weeks may reduce their administration and monitoring time by 90% from the 270 minutes (90min+180min) to 20 minutes (5min+15min) when switching to Phesgo. Also, as Phesgo is a subcutaneous formulation injected in the thigh rather than into the veins, it can reduce blood vessel and nerve damage that can be caused by repeated intravenous injections. These benefits of Phesgo could prove to be useful amid the current healthcare disruptions. However, delays in the process, which could have been listed as early as the end of last year, have left Phesgo a pie in the sky. The NCCN guidelines state that Phesgo can be used in the place of Perjeta and Herceptin, In fact, in the UK, 90% of patients treated with Herceptin and Perjeta switched to Phesgo within a year after its launch. Therefore. If listed, a significant number of patients receiving Herceptin-Perjeta treatment are expected to switch to Phesgo as well. In 2016, the government announced a plan to provide preferential pricing for biosimilars and biobetters, which are improved versions of already approved biopharmaceuticals, that have contributed to the improvement of Korea’s healthcare. In the case of biobetters (chemical drugs), considering the difficulty in developing compared to improved new drugs (synthetic drugs), it was decided to calculate it at 100-120% of the drug price of the development target product (original, etc.), and Nexviazyme became the first drug to benefit.
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- Over 50,000 ppl signed 2nd petition for Trodelvy’s reimb
- by Eo, Yun-Ho May 30, 2024 05:50am
- The second petition calling for the insurance reimbursement of the breast cancer drug 'Troldelvy (sacituzumab govitecan-hziy)' has again garnered over 50,000 signatures. This is the second petition filed after the first in January that garnered 50,000 signatures. Patients are growing increasingly desperate, as 3 months have passed with little news heard on Troldelvy’s reimbursement progress. Unfortunately, with the 22nd National Assembly currently in session, it is unlikely that the agenda will be reviewed by the relevant committee. The petitioner, who described herself as a Stage IV triple-negative breast cancer (TNBC) patient on the petition board, wrote, "My tumor is growing too fast. I'm stage IV, and I beg the government to give me the chance to live," she wrote, stressing the need for Trodelvy’s reimbursement. However, no news has been heard of on its review at the DrugReimbursement Evaluation Committee stage since it passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in November last year. Gilead Sciences' triple-negative breast cancer drug Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May last year to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second or higher line of treatment for the entire TNBC patient population that has demonstrated an improvement in overall survival, but the cost-effectiveness evaluation remains a major hurdle to reimbursement. However, there is hope as another ADC, ‘Enhertu (trastuzumab deruxtecan),’ which was reimbursed in April, was recognized for innovativeness and applied a beneficial ICER from the government. Therefore, it will be interesting to see whether any progress will be made in Trodelvy's reimbursement amid the growing patients’s requests. Meanwhile, Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57% improvement in progression-free survival (PFS). These effects were observed regardless of the patient’s brain metastasis status.
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- 11 years since global entry…K-biosimilars
- by Chon, Seung-Hyun May 29, 2024 05:45am
- The biosimilar products developed by Korean companies are actively tapping into the global market. Celltrion received approval for Remsima in Europe in 2013. Since then, Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years. Celltrion secured 11 approvals in Europe and the United States, and Samsung Bioepis accomplished 14 approvals. According to industry sources on May 27th, Celltrion and Samsung Bioepis’ biosimilars received three approvals from Europe and the United States. On May 24th, Celltrion received the European Commission (EC) approval for its Omlyclo, a biosimilar to Xolair. The official approval was granted in two months, after the company received an approval recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in March. Omlyclo is the first Xolair biosimilar to receive European approval. Xolair is a biosimilar antibody used for persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. It recorded KRW 5 trillion in global sales last year. In Omlyclo’s global Phase 3 trials, which enrolled 619 patients with chronic spontaneous urticaria across six European countries, Celltrion demonstrated Omlyclo’s equivalent efficacy to the original medicine and confirmed a similar safety profile. In two years since receiving approval for Vegzelma, a biosimilar to Avastin, in 2022, Celltrion established an additional biosimilar pipeline. This year, Samsung Bioepis received approval for its biosimilar both in Europe and the United States. Samsung Bioepis received EC approval for Pyzchiva, Stelara’s biosimilar. The company received the final approval for Pyzchiva two months after receiving a positive review for approval from the EMA’s CHMP in February. Stelara, developed by Janssen, is prescribed for treating autoimmune diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It inhibits the activities of the immune response-associated inflammatory cytokine called interleukin (IL)-12 and 23. The annual global sales amount to approximately KRW 1.4 trillion. Samsung Bioepis added the product to its portfolio after receiving approval for Soliris biosimilar, Epysqli, in Europe in May last year. Samsung Bioepis received approval from the U.S. FDA for its Opuviz, a biosimilar to the macular degeneration drug Eylea. Eylea, developed by Regeneron Pharmaceuticals in the United States, is indicated for the treatment of wet (neovascular) age-related macular degeneration (AMD). Eylea’s global sales last year amounted to approximately KRW 1.3 trillion. This marks the approval of Samsung Bioepis’ biosimilar in three years, following the approval of Byooviz, a biosimilar to Lucentis, in 2021. Korean biosimilar products granted approvals in Europe and the United States. Celltrion’s Remsima, a biosimilar to Remicade, and others. Samsung Bioepis’ Benepali, a biosimilar to the autoimmune disease treatment Enbrel, and others. The current list of global entries by companies show that Celltrion has received six approvals in Europe and five approvals in the United States. Celltrion received the marketing authorization in Europe for its Remsima, titled ‘world’s first biosimilar antibody,‘ in August 2013. Subsequently, Celltrion received European approval for Truxima, a biosimilar to Mabthera, in 2017 and Herzuma, a biosimilar to Herceptin, in 2018. These drugs are immunotherapy for cancer. In November 2019, Celltrion received European approval for Remsima SC, a subcutaneous injection formulation of Remicade, and entered the market. Remsima SC is a biosimilar developed by Celltrion by changing the formulation of Remicade from intravenous (IV) to subcutaneous (SC) injection. In February 2021, Celltrion obtained European approval for its Yuflyma, a biosimilar to Humira. In August 2022, Celltrion obtained European marketing authorization for its Vegzelma, a biosimilar to Vystin. In 2016, Celltrion's Inflectra, a biosimilar to Remicade, became the first to pass the FDA approval gateway in the United States. In 2018, Truxima and Herzuma received FDA approval. In September 2022, Celltrion obtained marketing authorization for Vegzelma, a biosimilar to Avastin, from the FDA, and last year, Yuflyma, a biosimilar to Humira, also received FDA approval. In August last year, Celltrion received marketing authorization for Zymfentra, a subcutaneous (SC) formulation of the biosimilar antibody Remsima, as a novel drug. Samsung Bioepis accomplished eight approvals in Europe and six approvals in the United States. In January 2016, Samsung Bioepis began its global market expansion by obtaining approval for its Benepali, a biosimilar to the autoimmune disease treatment Enbrel, in Europe. In May of the same year, Samsung Bioepis also obtained marketing authorization in Europe for its biosimilar Flixabi, a biosimilar to the autoimmune disease treatment Remicade. In 2017, Samsung Bioepis received European approvals for its biosimilars to Herceptin, an immunotherapy for cancer, and Humira, an autoimmune disease medication. In 2020, the company successfully acquired European approval for its biosimilar to Avastin, and in 2021, it also received a marketing authorization for a biosimilar to Lucentis, an eye disease medication, in Europe. In May last year, Samsung Bioepis obtained marketing authorization from the EC for ’Episcli,’ a biosimilar to the orphan drug ’Soliris.’ Episcli is the first biosimilar developed by Samsung Bioepis in hematology. Soliris, developed by Alexion Pharmaceuticals, is a high-cost medication for refractory rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In April 2017, Samsung Bioepis received the first FDA approval in the United States for its Renflexis, a biosimilar to Remicade. In 2019, Samsung Bioepis received FDA approval for three biosimilars to Herceptin, Enbrel, and Humira. In January 2019, Ontruzant, a biosimilar to Herceptin, received marketing authorization in the United States, followed by Eticovo and Hadlima, biosimilars to Enbrel and Humira, in April and July of the same year, respectively. Samsung Bioepis obtained FDA approval for its Byooviz, a biosimilar to Lucentis, in the United States in September 2021. Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years, following Celltrion’s European approval for Remsima in 2013. The companies strengthened global targeting, entering over two products annually into the United States and Europe.
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- Six pharmaceutical companies challenge the 'Esgliteo' patent
- by Kim, Jin-Gu May 29, 2024 05:45am
- Generic companies have claimed patent challenges against Boehringer Ingelheim’s combination therapy for diabetes, 'Esgliteo (empagliflozin+linagliptin).' It is the strategy of six companies, including Boryung, to launch their generics early by avoiding or nullifying the patent of this combination therapy, which contains SGLT-2 inhibitor and DPP-4 inhibitor ingredients. According to pharmaceutical industry on May 28th, the six companies, including Boryung, Dongkook Pharm, Aprogen, Korea Prime Pharm, and Daehwa, filed claims for passive trials to confirm the scope of a right involving the Esgliteo patent. These companies also filed a claim for a nullification trial for the same patent. In the case of a nullification trial, Genuonesciences has already filed a claim for a trial last month. Consequently, generic companies are challenging both avoidance and nullification of a single patent. Esgliteo is protected by the patent titled 'A pharmaceutical composition including glucopyranosyl-substituted benzene derivatives' until August 2028. However, this patent is not listed on the Ministry of Food and Drug Safety (MFDS) list. This strategy is similar to that of Boehringer Ingelheim, where Jardiance (empagliflozin) and Trajenta (linagliptin) were not patented. The companies challenging patents aim to launch their generics after either avoiding or nullifying the Esgliteo patent. Since they are challenging a single patent with two approaches simultaneously, the analysis indicates that they are eager to overcome the patent. The generic version of linagliptin is expected to launch after the Trajenta substance patent expires next month. If the companies successfully challenge Esgliteo patent, they can expand their portfolio of linagliptin-based combination therapy. The remaining hurdle is the possibility of an unregistered patent. Similar to the cases of Jardiance and Trajenta, there may be unregistered patents. The analysis suggests that the product approval is not affected by the remaining unregistered patent challenge, but there may be a patent infringement possibility when products are launched. Meanwhile, Esgliteo has the highest prescription sales among combination therapies, consisting of SGLT-2 inhibitor and DPP-4 inhibitor, for diabetes. According to market research firm UBIST, Esgliteo a generated prescription amount of KRW 2.7 billion. This is higher than KRW 2.2 billion of LG Chem’s 'Zemidapa (dapagliflozin+gemigliptin),' KRW 2.1 billion of AstraZeneca’s 'Qtern (dapagliflozin+saxagliptin),' KRW 600 million of CKD Pharm’s 'Exiglu S (dapagliflozin+sitagliptin),' and KRW 500 million of Dong-A ST’s 'Sugadapa (dapagliflozin+evogliptin).' Esgliteo generated KRW 2.5 billion this year in the first quarter, similar to last year’s annual prescription performance. The pharmaceutical industry anticipates that other generic companies may challenge the patent additionally because Esgliteo sales are rapidly increasing.
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- High-dose Eylea is approved in KOR
- by Son, Hyung-Min May 29, 2024 05:45am
- Dr. Jae Hui Kim, Director of Future Planning of the Korean Retina Society (Kim’s Eye Hospital) The higher-dose version of Eylea, which more than doubles the dosing interval, has been approved in Korea. With the approval, Eylea now owns the longest duration of effect among its competitors. Bayer held a press conference in Yeouido, Seoul, on the 28th to celebrate the approval of Eylea High Dose (8mg) in Korea. Eylea is a treatment for age-related macular degeneration and diabetic macular edema developed by Bayer and Regeneron. The higher dose was approved in April of this year, nearly a decade after the lower dose (2 mg) was approved in 2013 Eylea binds to the vascular endothelial growth factor (VEGF)-A and B and growth factors in the retina, inhibiting VEGF from binding to its native receptor and activating it. Bayer sought to receive approval for the higher dose of Eylea due to its extended dosing interval. While the current lower dose Eylea requires dosing every two months, the higher dose Eylea will extend the dosing interval to up to 5 months. The approval of the high-dose Eylea was based on the PULSAR study in patients with macular degeneration and the PHOTON study in patients with diabetic macular edema. The PULSAR trial, which was conducted on 1,009 patients with nAMD, compared the efficacy of high dose and low dose Eylea. Trial results showed that Eylea 8mg administered every 12 and 16 weeks were non-inferior to Eylea 2mg administered every 8 weeks in terms of best corrected visual acuity (BCVA) changes. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 6.7 letters from baseline for its 12-week dosing regimen and 6.2 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 7.6 letters Eylea 2mg achieved at a fixed 8-week treatment interval. The high dose Eylea also demonstrated noninferiority to low dose Eylea in the PHOTON study that was conducted on 658 patients with DME. Results showed that Eylea 8 mg achieved comparable visual improvement to Eylea 2 mg every 8 weeks. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 8.8 letters from baseline for its 12-week dosing regimen and 7.9 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 9.2 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In terms of dosing intervals, 93% of patients receiving Eylea 8 mg maintained a dosing interval of 12 weeks or longer at Week 48. The high dose Eylea is expected to compete with Roche's Vabysmo in the market. Vabysmo had demonstrated non-inferiority to the lower dose of Eylea at a dosing interval of once every 4 months. "The high dose will be highly useful for patients whose symptoms are not controlled with the low dose Eylea," said Dr. Jae Hui Kim, Director of Future Planning of the Korean Retina Society (Kim’s Eye Hospital). "As Eylea is a well-verified drug, we expect the higher dose to bring similar results as well.” "Among the many available treatment options, I would first prescribe high dose Eylea to patients who have not responded to lower doses. Also, if given the choice between the low and high doses of Aylia, I think most patients will want to start with the high dose because of the dosing interval benefit."
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- 'Camzyos' anticipated for the DREC review consideration
- by Eo, Yun-Ho May 29, 2024 05:45am
- The industry is awaiting the progress on whether 'Camzyos,' the first novel drug for obstructive hypertrophic cardiomyopathy (oHCM), will receive an insurance reimbursement listing. According to industry sources, BMS Korea’s novel drug Camzyos (mavacamten) has cleared the review by the Economic Evaluation Committee of Health Insurance Review and Assessment Service (HIRA). It is now being scheduled for the Drug Reimbursement Evaluation Committee (DREC) review. It is expected that Camzyos will be considered for the DREC review in June. Because Camzyos is the first treatment option for the particular disease to receive a review, it is to be watched what outcome will be yielded from the first attempt. Camzyos is the only drug that selectively inhibits cardiac myosin-actin cross-bridge formation, which is the cause of oHCM. Its underlying mechanism involves dissociating myosin from actin, relaxing overstimulated heart muscle, and thereby improving left ventricular outflow tract (LVOT) structure and LVOT outflow obstruction. Because no treatments have been available to treat oHCM for a long time, Off-label medications were used to manage symptoms. Because of Camzyos, the European Society of Cardiology (ESC) updated its guidelines for managing cardiomyopathy for the first time in about nine years. Previously, the guidelines for HCM were based on evidence limited to small-scale monitoring data, retrospective analysis results, and consensus opinion. However, Camzyos has completely changed this situation. Two large-scale, phase 3 clinical trials conducted as randomized controlled trial (RCT) have confirmed the significant effect of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. American College of Cardiology (ACC) and the American Heart Association (AHA) are preparing to update their guidelines. Furthermore, based on this phase 3 trial evidence, the U.S. FDA granted Camzyos Breakthrough Therapy Designation (BTD) and approval. Considering these factors, Camzyos appears to have met the criteria of an innovative new drug, announced by the government last year: ▲There are no alternative products, therapeutically equivalent products, or therapies available ▲Extending the survival period significantly and showing clinically meaningful improvements ▲Has been approved for MFDS’ GIFT (priority review designation), U.S. FDA’s BTD, or Europe’s EMA expedited review (PRIME). Meanwhile, Camzyos demonstrated efficacy through Phase 3 EXPLORER-HCM trials. In this trial, Camzyos improved primary endpoints, the patient’s symptoms (NYHA classification) and exercise capacity measured with peak oxygen uptake (pVO2), by more than twofold compared to the placebo. 20% of the Caymzyos treatment group met NYHA classification and pVO2 improvements. It also reduced the LVOT outflow obstruction index by fourfold after exercise. 10 out of 7 patients who received Camzyos treatment had improved indexes and ended up not considering surgery, and they maintained the effect for 30 weeks. Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital, said, "On the surface, the reimbursement listing of Camzyos may seem like a burden to the National Health Insurance finance, but if we expand our view, it’s the opposite. If we neglect oHCM patients without offering the treatment, there will be an increased risk of cardiovascular episodes, which will, in turn increase medical spending directly and indirectly."
- Company
- Multinational pharmaceutical companies post mixed results
- by Son, Hyung-Min May 28, 2024 01:31pm
- The Korean subsidiaries of multinational pharmaceutical companies posted mixed performances last year. Sales of Pfizer Korea, MSD Korea, and Gilead Sciences Korea, which developed COVID-19 vaccines and treatments, plummeted due to the base effect of the pandemic. On the other hand, GlaxoSmithKline (GSK) and Amgen Korea saw sales increase thanks to the growth in sales of their innovative new drugs. According to the Financial Supervisory Service on Saturday, the sales of 36 major multinational pharmaceutical companies in Korea fell 12.5% to KRW 10.37 trillion last year from KRW 11.84 trillion in 2022. Of the 36 MNCs, 12 companies, including Pfizer, MSD, Janssen, Gilead, Bayer, Alcon, Lilly, MundiPharma, Ipsen, Teva-Handok, and Biogen, saw a sales decline. The company that saw the largest decline was Pfizer. Last year, the company's revenue fell 50.3% YoY to KRW 1.60 trillion. The company's sales surged from 2021 supplying the COVID-19 vaccine Comirnaty and the treatment Paxlovid. The company's sales soared to KRW 391.9 billion in 2020, KRW 1.70 trillion in 2021, then to KRW 3.23 trillion in 2022, but as the number of COVID-19 patients started to decrease with the endemic, the company's sales fell by half last year. As the government took charge of the distribution and marketing of COVID-19 vaccines at the time, the company was able to generate high profits due to low SG&A costs. MSD Korea's revenue fell 7.3% from KRW 820.4 billion in 2022 to KRW 760.9 billion last year. After posting sales of KRW 471.6 billion in 2019 and KRW 541.9 billion in 2021, MSD Korea’s sales surged to exceed KRW 800 billion in 2022 but then saw a slight decline last year. According to the market research firm IQVIA, sales of its flagship product Keytruda increased 66.4% from KRW 239.6 billion in 2022 to KRW 398.7 billion last year. However, the company attributed the decline to a drop in sales of its diabetes drug Januvia and COVID-19 drug Lagevrio. Gilead posted sales of KRW 384 billion last year, down 32.1% YoY. Gilead also saw a decline in prescriptions for its COVID-19 drug Veklury, which led to a sales decline. This is due to a sharp decline in the number of patients with COVID-19 and a significant drop in the number of critically ill patients. Veklury is used for patients hospitalized with severe COVID-19 who are below 94% oxygen saturation or require supplemental oxygen therapy. Meanwhile, AstraZeneca, which was the first to develop a COVID-19 vaccine, saw a slight increase in sales. AstraZeneca Korea's sales rose 3.9% from KRW 616.1 billion in 2022 to KRW 639.3 billion last year. AstraZeneca Korea posted sales of KRW 655.3 billion in 2021, up 31.6% YoY, driven by the launch of its COVID-19 vaccine. However, the company's sales fell slightly to KRW 615.1 billion in 2022 with the introduction of vaccines by Pfizer, Moderna, and Janssen. AstraZeneca Korea’s sales rebounded last year thanks to the strong performance of its anticancer drugs. Sales of the company’s lung cancer drug Tagrisso rose 4.2% YoY to KRW 110.9 billion based on IQVIA, while the immuno-oncology drug Imfinzi generated KRW 82.7 billion in sales last year, up 57.9% from the KRW 52.4 billion in 2022. Sales of the breast cancer drug Lynparza increased 22.2% year-on-year. In addition, Alcon Korea (-21.4%), Lilly Korea (-15.8%), Sanofi Pasteur (-6.2%), Bayer Korea (-3.0%), and Janssen Korea (-2.7%) also saw a sales decline. GSK-Amgen-Sanofi post sales gains...driven by innovative new drugs GSK, Amgen, and Sanofi-Aventis posted sales increases last year, driven by sales of innovative new drugs. GSK posted sales of KRW 385.1 billion last year, up 39.6% from KRW 275.8 billion in 2022. GSK's growth was driven by its shingles vaccine, Shingrix. Last year, Shingrix was the top seller in the shingles vaccine market, with sales of KRW 38.5 billion, according to IQVIA. The fact that two domestic pharmaceutical companies joined to sell and promote Shingrix also contributed to its rapid market penetration. GSK partnered with GC Biopharma and Kwangdong Pharmaceutical to promote sales of Shingrix in Korea. Also, sales of GSK's benign prostatic hyperplasia combination drug Duodart increased 186.5% YoY. Amgen Korea posted sales of KRW 228.8 billion last year, up 33.3% YoY. Its innovative new drugs, including Prolia, Xgeva, and Repatha contributed to the sales growth. According to the market research institution IQVIA, Amgen's Prolia generated KRW 151.1 billion in sales last year, up 30.6% YoY. This is a 64.0% increase in two years from KRW 92.1 billion in 2021. Launched in Korea in November 2016, Prolia is a biologic osteoporosis treatment that targets the RANKL protein, which is essential for the formation, activation, and survival of bone-destroying osteoclasts. Sales of Repatha, a PCSK9 class dyslipidemia treatment, exceeded KRW 10 billion for the first time last year with 10.5 billion won. Sales of Xgeva, which was released as a double-dose strength of Prolia, also exceeded KRW 10 billion for the first time last year. Sanofi-Aventis Korea's sales totaled KRW 501.8 billion last year, up 3.7% YoY. The company saw steady sales growth, adding an indication for its biological agents Dupixent and Eloxatin. According to market research firm IQVIA, Dupixent generated sales of KRW 143.2 billion last year, up 36.1% YoY. Dupixent is a first-in-class drug that targets the signaling of interleukin (IL)-4 and IL-13, which are major contributors to type 2 inflammation. It has been shown to be effective in inflammatory diseases such as asthma and atopic dermatitis. Last year, Eloxatin's sales reached KRW 43.6 billion, up 2.8% YoY. Sales of Eloxatin, which was approved in Korea in 2005, have been on a slight decline since 2019, but have exceeded KRW 40 billion on average from 2020 to last year.
- Company
- Handok strengthens global pharma partnerships
- by Kim, Jin-Gu May 28, 2024 05:52am
- Handok is strengthening its partnerships with global pharmaceutical companies. At the end of last year, Handok signed deals with the Dutch company Argenx and Swedish biopharmaceutical company Sobi for three rare disease treatments. This year, the company also launched a combination therapy for high blood pressure co-developed with Sanofi. On May 24, Handok signed a deal with India’s global pharmaceutical company Biocon for liraglutide, a GLP-1 agonist used to treat diabetes and obesity. Handok plans to fill the pipeline gap caused by patent expiration and license endings through these partnerships. Handok signs a licensing deal with India’s pharmaceutical company Biocon for a product containing the same active ingredient as Saxenda According to industry sources on May 25th, Handok signed a licensing deal with India’s global pharmaceutical company Biocon for liraglutide. Liraglutide is the same active ingredient as Novo Nordisk’s diabetes and obesity treatments, Victoza and Saxenda. Handok stated that this product has not yet been launched in the global market, but it recently received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Its global product name has not been determined. Handok signed a licensing deal with India’s pharmaceutical company Biocon for a product containing the same active ingredient as Saxenda. It is expected to be commercialized in South Korea after 2025. Saxenda and Victoza’s patents are set to expire by 2025. Saxenda is protected by two accounts of patents, each expiring in November this year and November next year. Victoza has four patents registered, and one has already expired. The expiration dates for the rest are June 2024, November 2025, and March 2037. However, the patent set to expire in 2037 is based on Liraglutide’s effect on cardiovascular diseases. Handok will not infringe on patents by launching Liraglutide after 2025 and by not commercializing it for the purpose of treating cardiovascular disease. Although new obesity drugs of the GLP-1 class, like Wegovy and Mounjaro, have not been officially launched in South Korea, the industry has a high expectation for follow-up drugs with the same active ingredient since Saxenda is practically dominating the obesity treatment market. According to a pharmaceutical market research company IQVIA, Saxenda topped KRW 66.8 billion in sales last year, up 13% YoY. The stock market response is also positive. On May 24th, Handok’s stock hit KRW 17,010, up 23.3% from the previous day. It was the highest amount in recent years, and the analysis suggests that Hadok’s announcement to introduce GLP-1 obesity and diabetes treatments has been viewed as good news. Introduced three orphan drugs consecutively…co-developed a hypertension drug with Sanofi In the second half of last year, Handok initiated partnerships with global pharmaceutical companies In September last year, Handok signed an exclusive marketing deal with Dutch Argenx for VYVGART, a treatment for myasthenia gravis. VYVGART is the first-in-class subcutaneous formulation for myasthenia gravis to be approved by the U.S. FDA. In October, Handok signed a strategic partnership deal with Sweden’s global pharmaceutical company Sobi, introducing two rare disease drugs, Empaveli and Doptelet. Empaveli targets an adult patients with paroxysmal nocturnal haemoglobinuria (PNH). It has received approvals in the United States, Europe, Australia, and Japan. Doptelet is indicated to treat adult patients with primary chronic immune thrombocytopenia (ITP). Last year, Handok introduced three rare diseas drugs, VYVGART, Empaveli, and Doptelet, to South Korea. In February, Handok launched ‘Aprovasc,‘ a combination therapy for hypertension that was co-developed with Sanofi, in South Korea. It is the first combination therapy of amlodipine and irbesartan, to receive approval in South Korea. In October 2019, Handok signed a licensing deal with Sanofi for the domestic development, manufacturing, and approval for a combination therapy to treat high blood pressure. In November, Aprovasc received the approval of the Ministry of Food and Drug Safety (MFDS). Sanofi has development and marketing rights as an original developer, and Handok will be responsible for domestic manufacturing and co-promoting Aprovasc with Sanofi. Will it fill the gap left by the patent expired 'Tenelia' and licensing retrieved 'Soliris'? Handok plans to expand cooperation with global pharmaceutical companies to fill the gap left by previous core products. Previously, Handok had Tenelia·Tenelia M, diabetes treatments of the DPP-4 inhibitor class, and Soliris and Ultomiris, rare disease treatments, as its key pipeline. However, in October 2022, Tenelia’s substance patent expired. Consequently, a many Tenelia generics were launched. In February last year, AstraZeneca Korea retrieved sales rights of Soliris and Ultomiris. Initially, Handok introduced these two drugs to South Korea from Alexion Pharmaceuticals. When AstraZeneca acquired the original developer Alexion Pharmaceuticals, the domestic sales rights transferred to AstraZeneca Korea. Handok had a sales gap from its previous core products for chronic diseases, Tenelia (left), due to patent expiration, and for rare disease area core products, Soliris (middle) and Ultomiris (right), due to sale rights retrieval. Consequently, Handok was left with no drugs related to diabetes treatment and rare disease treatment, which used to be its key pipeline. Handok plans to fill the gap in rare disease treatment area with VYVGART, Empaveli, and Doptelet. Empaveli and Doptelet are considered to be the suitable substitutes as they have indications for PNH and myasthenia gravis, as in Soliris and Ultomiris. Furthermore, Handok is expected to succeed in the novel drug market since it has already established a business network by overseeing domestic sales of Soliris and Ultomiris after these drugs received reimbursement coverage in 2018. Additionally, Handok plans to fill the gap in chronic disease treatment area with Aprovasc, a combination therapy for treating high blood pressure, and liraglutide, a treatment for diabetes and obesity. Handok aims to expand to the high blood pressure market, which was previously its weakness, with Aprovasc. And, its diabetes treatment portfolio is expected to grow with liraglutide. Handok’s diabetes portfolio includes various diabetes drugs, including the sulfonylurea (SU) class ‘Amaryl,‘ the SGLT-2 inhibitor class ‘Suglat,‘ the DPP-4 inhibitor class ‘Tenelia,‘ and medical devices, such as blood glucose monitoring device. Adding liraglutide to this list will strenghthen Handok’s completion of the diabetes portfolio.
