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- 2026-05-04 19:44:17
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- "Trodelvy gives new hope for triple-negative breast cancer"
- by Son, Hyung-Min Jul 23, 2024 05:48am
- Triple-negative breast cancer refers to a breast cancer that is negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). It is a rare cancer that accounts for about 12-15% of all breast cancer. This cancer tends to be aggressive and has a high risk of metastasis and recurrence, leading to poor diagnosis. However, patients with this type of cancer have relied on cytotoxic anticancer medicines, the first-generation cancer treatment. They were unable to benefit from the latest cancer treatments, such as antihormone therapies and targeted cancer therapies, because all the receptors that could be targeted were negative. Trodelvy, a Trop-2 protein targeting antibody-drug conjugate (ADC), has opened a road for a new treatment for patients with metastatic triple-negative breast cancer. Trop-2 protein is a cell membrane antigen that is highly expressed in breast cancer and overexpressed in over 90% of triple-negative breast cancer. Trodelvy binds with Trop-2 protein and releases cytotoxic agents inside the cancer cells. It has the advantage of minimizing damage to healthy cells while maintaining the beneficial effects of targeted cancer therapies and cytotoxic anticancer medicines. In the multinational phase 3 clinical study, Trodelvy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). In May, Trodelvy obtained approval from the Ministry of Food and Drug Safety (MFDS) and launched in South Korea. (From the left) Dr. Sohn, Joo Hyuk, Professor in the Department of Internal Medicine at Yonsei Cancer Hospital·Dr. Aditya Bardia, Professor in the Department of Medicine at UCLA Health Jonsson Comprehensive Cancer Center. Daily Pharm met with Dr. Aditya Bardia, the first author of 'ASCENT' clinical study and Director of Translational Research Integration and Professor in the Department of Medicine at UCLA Health Jonsson Comprehensive Cancer Center, and Dr. Sohn, Joo Hyuk, Professor in the Department of Internal Medicine at Yonsei Cancer Hospital and Korean Cancer Study Group (KCSG)'s Head of Breast Cancer Committee, to look at recent therapy trends for triple-negative breast cancer and clinical use of Trodelvy. Q. For a long time, there has been a high demand for new treatment options for triple-negative breast cancer. What is the reason for the difficulty in developing treatments? [Dr. Bardia] Triple-negative breast cancer shows the most aggressive characteristic among breast cancers, and it occurs in relatively young patients. Cytotoxic anticancer medicines are mainly used for the treatment because it is difficult to use targeted therapies due to potential therapeutic targets such as ER, PR, and HER are all negative. The problem is anticancer agents do not work efficiently in patients with metastatic cancer. Such difficulties contributed to high unmet needs for new drugs among breast cancers. [Dr. Sohn] Triple-negative breast cancer can be categorized as a diagnosis of exclusion. It refers to all breast cancer types that do not test positive for hormone receptor or HER2. Within the type, subtypes also exist. Therefore, the cancer does not exhibit consistent characteristics, posing difficulty in developing a generalized drug to be used for triple-negative breast cancer. The number of patients is relatively small, and a biologically verified target has not been identified; therefore, a treatment has not been developed. The disease itself shows aggressiveness, and patients tend to have poor diagnoses because anticancer chemotherapy that was developed decades ago is used. Q. What are the advantages Trodelvy for treating triple-negative breast cancer, where new drug development has been slow? Dr. Sohn, Joo Hyuk, Professor in the Department of Internal Medicine at Yonsei Cancer Hospital. [Dr. Bardia] Triple-negative breast cancer is negative for three receptors, ER, PR, and HER, but it does not entail that there are no receptors. Trodelvy is a treatment that targets Trop-2 protein, which is known to be overexpressed in over 90% of triple-negative breast cancer. Trodelvy can target cancer cells more efficiently than conventional standard therapies, showing superior effects. It has been designed to affect less on healthy cells, lowering toxicity and side effects that patients experience. [Dr. Sohn] Targeted therapies to date have used oncogenes that affect the progression and expansion of cancer as a target. However, Trop-2, which Trodelvy targets, is only a receptor expressed on the cell surface. Trodelvy is the first medicine to demonstrate the concept that a therapy targeting receptor expressed on cancer cell surface instead of an oncogene can be used to destroy cancer cells. In other words, it is meaningful that we have confirmed that identifying a receptor expressed on a cancer cell surface can lead to the development of a therapy. Q. According to the phase 3 ASCENT study, Trodelvy improved OS, PFS, and ORR statistically significantly compared to anticancer chemotherapies. What do these results indicate? [Dr. Bardia] Trodelvy had twofold longer OS than anticancer chemotherapy, extending patients' life expectancy. It also improved symptoms that affected patients' quality of life due to cancer, such as pain, thereby improving the quality of life during survival. The result gives patients hope to live a longer and better quality of life. [Dr. Sohn] The last drug to demonstrate the benefit of OS in triple-negative breast cancer was Halaven, released 10-20 years ago. New drugs, such as immunotherapy for cancer and PARP inhibitors, have been introduced. However, they are designed to target particular patient groups, such as PD-L1-positive patients and BRCA-mutation patients. Other than these, cytotoxic anticancer medicines are the only treatment that can be used in all patient groups with triple-negative breast cancer. Therefore, the recent data showing extended OS is historically meaningful. Patients are the only ones who can understand the differences in the number of months. Q. Has there been any change in clinical settings, including breast cancer treatment guidelines, since Trodelvy was introduced? Dr. Aditya Bardia, Professor in the Department of Medicine at UCLA Health Jonsson Comprehensive Cancer Center.[Dr. Bardia] The breast cancer guidelines of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) foremost recommend Trodelvy as a second-line treatment for metastatic triple-negative breast cancer. In particular, Trodelvy has received a score of 5 on the ESMO-MCBS, a value-evaluation tool for anticancer medicines. Out of 37 approved treatments for metastatic breast cancer, there have been only two medicines that received a score of 5 (Trodelvy and HER+/HER2- medicine, Ribociclib). [Dr. Sohn] Previously, the effect of standard therapies for the treatment of triple-negative breast cancer was not good. When a first-line anticancer treatment had failed, the survival expectancy was only 7 months. It is a great hope to introduce a new treatment with verified survival effects to patients. Patients are welcoming treatments even if they are yet non-reimbursable. Until now, clinical settings for triple-negative breast cancer have been challenging, but this medication is likely to resolve a long-standing issue. Q. What resources are most needed to improve treatment settings for triple-negative breast cancer in South Korea? [Dr. Bardia] What we need most is to introduce the most effective new drugs regardless of the situation. We hope to enhance patients' survival duration and quality of life. I know that due to non-reimbursement, patients have limited access to Trodelvy in South Korea. I hope that National Health Insurance will be quickly applied and that access to Trodelvy in combination with other medicines will be granted. [Dr. Sohn] Patients who have private insurance or have financial well-being always choose Trodelvy. Considering the clinical data, it is a must. However, it is unfortunate that patients cannot use the medicine for economic reasons despite of the clinical evidence. I hope that healthcare financing will be allocated to those in need so that no patients are left without access to life-saving medicines. By reducing unnecessary medical spending and increasing resources for essential healthcare, South Korea can become a society that provides hope and easy access to new drugs for desperate patients. Q. What do you envision as the future approach to treating metastatic triple-negative breast cancer? [Dr. Bardia] I was once interested in AKT and PI3CA mutations and conducted two accounts of phase 3 clinical studies. However, I did not achieve fruitful outcomes. We guessed that because triple-negative breast cancer is further characterized into many subtypes, targeting AKT and PI3K3CA mutations was not effective for triple-negative breast cancer. Currently, treatments that target genetic mutations are limited to PARP inhibitors, which are offered as a first-line or second-line treatment to patients with BRCA mutations. [Dr. Sohn] Since recent studies to find new targets to treat triple-negative breast cancer are failing to demonstrate effectiveness, the remaining solution is likely to be the development of medicines targeting oncogene addiction. I heard that 350 ADCs are currently under development. New drug development is anticipated through studies about antibodies targeting cell surface receptors, cytotoxic agents, and linkers. I hope there will be more research related to combination therapies of ADCs and cytotoxic anticancer agents.
- Company
- Eisai reports degrowth for 3 consecutive years
- by Hwang, Byung-woo Jul 23, 2024 05:47am
- Eisai Korea has recorded a decline in sales of its flagship products, including its anti-cancer drug Lenvima (lenvatinib), for 3 consecutive years since 2020. The company has not seen a clear rebound since experiencing a significant drop in sales in 2022. The company’s JAK inhibitor Jyseleca (filgotinib), which was listed for reimbursement late last year, and the dementia drug Leqembi (lecanemab-irmb), which is expected to be launched by the end of the year, are gaining interest as potential drivers of the company’s performance growth. 렌비마 제품사진 Eisai’s sales last year recorded KRW139.3 billion... backsliding every year since 2021's KRW 221.9 billion In 2023, Eisai Korea’s sales in Korea totaled KRW 139.3 billion, down -0.8% from KRW 140.4 billion in 2022. This is the third consecutive year the company saw a decline since 2020. Eisai’s sales peaked at KRW 221.9 billion in 2020 before declining to KRW 212.9 billion in 2021. The company's revenue then fell to KRW 140.4 billion in 2022, a 34% year-on-year decline. During the same period, operating profit was KRW 23.2 billion in 2020, KRW 22.8 billion in 2021, and KRW 5.1 billion in 2022. However, operating profit rebounded to KRW 9.3 billion last year, largely due to a decrease in the cost of goods sold (KRW 77 billion to KRW 73.3 billion) and selling, general and administrative expenses (KRW 58.2 billion to KRW 56.6 billion). The decline in growth is attributed to the company’s decline in sales of Lenvima, which is used to treat liver and thyroid cancer, along with a decline in sales of its existing product portfolio. According to IQVIA, Lenvima’s sales have declined from KRW 15.8 billion in 2021 to KRW 13.6 billion in 2022, then to KRW 10.3 billion in 2023. In addition, the fact that Lenvima is facing patent challenges from generic companies is also discouraging news for Eisai in the long term. Currently, Boryung is challenging Lenvima’s patents from multiple directions. Eisai is raising its barriers by registering new patents, but Boryung is also actively responding, reaffirming its determination to launch its generic early. In addition, sales of Pariet, a GERD drug, were KRW 14.6 billion last year, down slightly from the KRW 15.1 billion the previous year. Equfina’s sales grow after reimbursement...Aricept’s sales exceeded KRW 70 billion for the third consecutive year Although Eisai’s sales declined for the third consecutive year, there is room for its rebound. Its Aricept, its key product, showed solid sales, and Equfina’s sales growth and the introduction of new drugs are expected to also work in favor of the company. First, sales of its Parkinson's disease treatment Equfina (safinamide mesilate) have grown every year since its reimbursement in February 2021. Equfina, which generated KRW 800 million in sales in its first year of coverage, has grown at an average annual rate of about KRW 2 billion, reaching KRW 4.8 billion in sales last year. It is also positive that Aricept (donepezil hydrochloride), a dementia treatment, has shown solid sales for 3 consecutive years since posting sales of KRW 70.4 billion in 2021. ArIcept sold KRW 73.8 billion last year, up 1% from KRW 72.9 billion in 2022 A particularly promising part of Eisai’s dementia portfolio is its dementia drug Leqembi, which is expected to launch by the end of the year. Leqembi, which was approved by the MFDS in May, is said to have utilized the ‘approval-reimbursement linkage system’ for the drug’s reimbursement. The system allows for a drug to apply for reimbursement approval to the Health Insurance based on the results of the MFDS’s safety and efficacy review before approval. This reduces the insurance drug price review period and enables faster market entry. In addition, Jyseleca, which entered the reimbursement system in November last year and passed the drug committee (DC) of major hospitals including tertiary hospitals, is also a promising item. Jyseleca was initially approved for rheumatoid arthritis and moderate-to-severe active ulcerative disease, and while several JAK inhibitors are competing with the same indications, Jyseleca is priced competitively at less than 90% of the weighted average price, which is expected to drive sales growth.
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- Atopic dermatitis drugs get expanded indication for infants
- by Eo, Yun-Ho Jul 23, 2024 05:47am
- Dupixent and Adtralza. New atopic dermatitis drugs are currently being considered for expanded use in infants and young children. First, Sanofi Korea's 'Dupixent (dupilumab)' will be reimbursed for treating infants aged 6 months beginning next month. The company has recently concluded the drug price negotiation, and on July 19th, Dupixent was incorporated into the Ministry of Health and Welfare (MOHW)'s revised regulations on the criteria and scope of National Health Insurance. Dupixent's expanded reimbursement for young children was in high demand. Previously, the Severe Atopic Dermatitis Association (SADA) issued a statement urging the coverage of Dupixent for young children aged 6 months to younger than 6 years with severe atopic dermatitis. 85-90% of atopic dermatitis manifests symptoms at the age of five, and for severe cases, the disease persists until adulthood and relapses. However, treatments approved for children under the age of five are limited to topical treatments, and the patients with symptoms uncontrolled with topical treatments have limited treatment options due to long-term skin retractions and infection risks. Leo Pharma Korea is preparing to secure an indication for its 'Adtralza (tralokinumab),' which became reimbursement-listed in May, to treat young children. On July 1st, Leo Pharma was approved for phase 3 clinical trials to evaluate the safety and effectiveness of Adtralza in combination with a topical corticosteroid in patients with moderate-to-severe atopic dermatitis aged 2-12 years and 6 months to younger than 2 years. Adtralza can be reimbursed when prescribed for treating adult patients (18 years or older) and adolescent patients (12-17 years) with chronic severe atopic dermatitis whose symptoms persisted for over three years. Meanwhile, the phase 3 ECZTRA3 and ECZTEND studies demonstrated the efficacy and safety of Adtralza. The ECZTRA3 study compared Adtralza to placebo in patients aged 18 years and older with moderate-to-severe atopic dermatitis who had an inadequate response to previous topical therapy or require systemic therapy. Dupixent's efficacy in young children was demonstrated in the LIBERTY AD PRESCHOOL Phase 3 trial. The results confirmed that Dupixent significantly improved skin pathology. At 16 weeks, 28% of patients treated with Dupixent in combination with topical corticosteroids (TCS) showed a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S), demonstrating a significant improvement in atopic dermatitis compared to 4% of the placebo group. Consequently, it met the primary efficacy endpoint.
- Company
- Hyperlipidemia Drug Leqvio’s nears market entry in KOR
- by Hwang, Byung-woo Jul 23, 2024 05:47am
- Novartis’s Leqvio’s (Inclisiran), is preparing to enter Korea’s market as the first siRNA therapy, armed with its convenience of twice a year administration. However, in a situation where there are already many treatments for hyperlipidemia available on the market, the high cost of Leqvio compared to existing treatments may act as a hurdle, regardless of its advantages. Pic of Leqvio Leqvio is a first-in-class siRNA therapy that was recently approved in Korea as an adjunctive therapy to diet in patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia. It utilizes a naturally occurring siRNA to reduce LDL-C in the blood by inhibiting the production of PCSK9 protein, which raises LDL-cholesterol. It is injected directly by a healthcare provider twice a year, reducing the fear and discomfort of self-injection. In the three Phase 3 studies that confirmed the effectiveness of Leqvio - ORION-9, ORION-10, and ORION-11 -Leqvio reduced the LDL-C level by 47.9%, 52.3%, and 49.9% compared to placebo at Day 510, respectively. In all 3 studies, the safety profiles of Leqvio and placebo did not show statistically significant differences. In ORION-18, which was conducted on Asian patients including 24% Korean patients, Leqvio achieved a 57.17% LDL-C reduction compared to placebo at Day 330. These results have been driving Leqvio’s rapidly growing global sales. Leqvio’s global sales in the first half of the year amounted to $333 million, prompting Novartis to raise its full-year profit forecast. The company is expected to target the market armed with its twice-a-year dosing advantage in Korea. The question is how it can compete with the other competitors that are already being reimbursed. Higher cost compared to competitors...receiving reimbursement crucial for market suceess For Novartis, its first and utmost priority will be to receive reimbursement. According to industry sources, Novartis is considering a list price of KRW 1.5 million for a single dose of Leqvio. If so, the cost of the twice-a-year treatment is expected to be in the range of KRW 2 to 3 million. Considering how it is administered 3 months after the initial dose, and then every 6 months thereafter, the drug can cost even more in the first year. Current direct competition is Amgen's Repatha (evolocumab), which has overlapping indications for hypercholesterolemia and mixed dyslipidemia. Repatha’s sales had been around KRW 4.2 billion in 2021, KRW 7 billion in 2022, and KRW 10.5 billion in 2023, according to IQVIA. Repatha is priced at KRW 121,000 per dose with reimbursement. The recommended dose is 420 mg once every two weeks or once a month (three doses). Therefore, it costs 1.42 million won based on the higher dose of 420 mg once a month. The price gap becomes even wider when compared to Viatris’ Lipitor, which has expanded its indication and is recorded as a top-selling drug in Korea every year. Lipitor is priced at KRW 640 per 10mg tablet, which means it costs KRW 233,600 when taken once a day. Based on the largest dose of 80 mg, which costs KRW 1,523 per tablet, it still costs 558,895 won a year. In the end, the therapeutic effect of Leqvio and the convenience it provides to patients who have difficulty managing their medications will be the key to its future market competitiveness. "I think Leqvio will be in demand among elderly patients who have difficulty taking drugs consistently and those with poor prognosis. However, most patients are seeing significant therapeutic effects with existing medications and exercise," said a cardiology professor from A Hospiatl in Gyeonggi-do. In some cases, patients who are well-controlled on Repatha can maintain their levels well with once-a-month Repatha injections. From a personal point of view, the cost versus convenience of dosing is a difficult decision."
- Company
- Efforts to develop a new drug for dry eye syndrome continue
- by Son, Hyung-Min Jul 22, 2024 05:51am
- The domestic and foreign pharmaceutical industry is intent on developing new drugs for dry eye syndrome, making reattempts despite the failure of their clinical trials. Hanall Biopharma is conducting its third Phase III clinical trial, and Huons has started clinical trials with a new drug candidate. In the U.S., Aldeyra is reattempting FDA approval through a new clinical trial after receiving FDA rejection for its previous clinical trial. According to industry sources on the 22nd, Hanall Biopharma recently initiated a Phase III VELOS-4 trial for its dry eye drug HL036 (tanfanercept). The company had previously failed to prove the efficacy of HL036 in two previous trials. The new trial is designed to evaluate the efficacy and safety of HL036 and will enroll 750 dry eye patients at 60 eye hospitals in the United States. HL036 works by inhibiting the tumor necrosis factor (TNF), which causes inflammation in the eye. Results from the VELOS-3 trial, which the company disclosed last year, showed that HL036 did not achieve statistical significance in the primary endpoint of Central Corneal Staining Score (CCSS) and Eye Dryness Score (EDS) at the end of treatment. Specifically, HL036 failed to achieve statistical significance with a CCSS of -0.84 compared with -0.81 in the placebo group. No statistically significant difference was found in EDS as well, being -16.9 in the HL036-treated arm and -19.79 in the placebo arm. However, HL036’s efficacy was confirmed with the Schirmer test, which measures tear volume as a secondary endpoint. Focusing on this efficacy result, Hanall Biopharma aims to secure top-line results for its VELOS-4 trial within the second half of next year. HLB Therapeutics is conducting the 4th trial for its dry eye drug candidate RGN-257 through its US subsidiary, Regentry. Amid the numerous clinical failures, the company has been tirelessly making reattempts, changing the study design again and again. RGN-257 did not meet its primary endpoint in its last published clinical results in 2021. RGN-259 owns a unique mechanism of action that inhibits and modulates pro-inflammatory chemokines and cytokines of thymosin beta 4 and promotes corneal wound healing. HLB Therapeutics plans to complete clinical trials this year and apply for approval next year. Huons recently completed patient recruitment for its Phase III clinical trial to evaluate the efficacy and safety of its HU007 eye drops. In June 2021, Huons voluntarily withdrew its marketing authorization application for HU007 after receiving a data supplemental request from the Ministry of Food and Drug Safety. Following the voluntary withdrawal, the company restarted clinical trials for HU007 in December 2022. The company is also conducting a Phase I clinical trial on HUC1-394, its other drug candidate for dry eye syndrome that has a different mechanism of action. The trial will evaluate the safety, topical tolerability, and pharmacokinetics of HUC1-394 eye drops in gradually escalating doses in 60 adults. HUC1-394 is a peptide-based eye drop that was developed using technology outlicensed from Novacell Technology. The drug candidate is believed to improve keratoconjunctivitis, repairing damaged corneas and reducing inflammation and the likelihood of side effects, which are key factors of dry eye syndrome. US Aldeyra also reattempts approval Aldeyra will restart clinical trials for its dry eye drug candidate, reproxalap. In April, the FDA placed a hold on the approval of reproxalap as a treatment for dry eye syndrome. Aldeyra previously failed to meet its primary endpoint in a Phase III trial in December 2021. Reproxalap is a dry eye drug candidate that targets reactive aldehyde species (RASP). The retrial will enroll approximately 100 patients to assess the primary endpoint of ocular discomfort. In its review, the FDA required Aldeyra to conduct additional clinical trials of dry eye and treatment effectiveness. Aldeyra aims to reapply for approval after conducting additional trials, as it believes it has confirmed the efficacy of reproxalap in improving dry eye symptoms. Based on the clinical results published to date, reproxalap met its primary endpoints of safety and efficacy in 5 clinical trials, including dry eye symptom scores, ocular hyperemia, and Schirmer's test. The company had conducted a range of activities, from within minutes of drug administration to up to 12 weeks of treatment, crossover, and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings, and has found no serious adverse events.
- Company
- The 1st cardiomyopathy drug 'Camzyos' lands in hospitals
- by Eo, Yun-Ho Jul 22, 2024 05:50am
- Product photo of Camzyos (mavacamten). 'Camzyos,' under consideration for insurance reimbursement listing, is becoming available for prescriptions at medical centers. Industry sources said that Bristol Myers Squibb (BMS) Korea's Camzyos (mavacamten), a new drug used to treat obstructive hypertrophic cardiomyopathy (oHCM), has passed the drug committees (DC) of 'Big 5' general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital, and approximately 50 medical centers across the country, including Kangwon National University Hospital, Kyungpook National University Hospital, Keimyung University Dongsan Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, and Chonnam National University Hospital. As a result, it remains to be seen whether Camzyos will be approved for reimbursement listing and actively prescribed. Camzyos has completed the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). It is about to enter drug price negotiations with the National Health Insurance Service (NHIS). 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, 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. Last year, when Camzyos emerged, 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 trials (RCT) have confirmed the significant effects of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. The American College of Cardiology (ACC) and the American Heart Association (AHA) are also preparing to update their guidelines. Furthermore, based on the phase 3 trial evidence, Camzyos was granted a Breakthrough Therapy Designation (BTD) and approval by the U.S. FDA. 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, Phase 3 EXPLORER-HCM study confirmed the efficacy of Camzyos. In the clinical trial, Camzyos was shown to improve 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. Based on the results, 20% of the Camzyos 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.
- Company
- 'Prostate cancer market leader' Astellas eyes on KRW 300 bil
- by Hwang, Byung-woo Jul 19, 2024 05:48am
- Astellas Pharma Korea's sales rebounded within four years due to the sales growth of Xtandi (enzalutamide), a prostate cancer drug. In addition to its leading product, Prograf (tacrolimus), showing strong sales, the company is expected to continue to generate sales growth when Padcev (enfortumab vedotin), an ADC for the treatment of urothelial cancer, become reimbursable. Product photo of Xtandi After sales peaked at KRW 290 billion in 2019, Astellas Pharma Korea experienced a decline to KRW 232.2 billion in 2022 Last year, Astellas Pharma Korea's sales amounted to KRW 251. 1 billion, up 7.5% from KRW 232. 2 billion in 2022. This marks a rebound within 4 years after 2019. The company's sales peaked at KRW 290 billion in 2019, then declined every year with KRW 275.6 billion in 2020, KRW 246.4 billion in 2021, and KRW 232.2 billion in 2022. Astellas Pharma Korea's operational profit in 2019 was KRW 22.3 billion, and it declined to KRW 15.1 billion in 2022. After that, it recovered to KRW 16.7 billion in 2021 and KRW 17.5 billion in 2022. Last year, its operational profit rose to KRW 19 billion. Last year, Astellas Pharma Korea's selling and administrative expenses increased to KRW 80.9 billion from KRW 77.7 billion, up by KRW 13.2 billion. This rise included increased commission expenses (up by KRW 6 billion) and advertising and promotional expenses (up by KRW 2 billion). However, the company increased operating profit due to an overall increase in gross profit. 2019-2023 Astellas Pharma Korea Astellas Pharma Korea's sales growth was brought about by its prostate cancer drug, Xtandi. It is an oral androgen receptor inhibitor (also known as ARTA). Xtandi's sales (according to IQVIA) increased from KRW 43.2 billion in 2023 to KRW 29.1 billion in 2022. Xtandi's sales surpassed Erleada's KRW 15.9 billion and Xtandi's KRW 19 billion during the same period. Such marked growth can be attributed to expanded reimbursement. In August 2022, Xtandi was selectively reimbursed for the treatment of patients with advanced prostate cancer accompanied by distant metastasis when used in combination with androgen deprivation therapy (ADT). Since November of last year, reimbursement has been made regardless of using other androgen synthesis inhibitors. Xtandi is expected to generate further sales growth following expanded indication for the treatment of nonmetastatic, hormone-sensitive prostate cancer (nmHSPC). With this approval, Xtandi has become the only ARTA that can be applied to all stages of prostate cancer stages following biochemical recurrence, including hormone-sensitive, castration-resistant, non-metastatic, and metastatic stages. Prograf maintained KRW 90 billion range in sales for three consecutive years…sales growth expected for Xospata and Padcev While Xtandi has shown significant growth among Astellas products, Prograf, the leading product, has shown a strong presence with sales in the KRW 90 billion range for three consecutive years. Prograf is known for its indications in organ transplantation and immunosuppressive therapy. Generics were launched after the Prograf patent expired in 2005. However, Prograf still maintains over half of the market share in its ingredient segment. Prograf's sales peaked at KRW 90 billion range for the first time in 2021, at KRW 91.5 billion, and it is still maintaining sales, generating KRW 90.6 billion in 2022 and KRW 91.4 billion in 2023. In addition, it continues to expand its presence in the competitive rheumatoid arthritis market. 5 Years Sales Trend of Astellas Pharma KoreaAlthough the increase in sales was modest, the sales of Xospata (gilteritinib), an acute myeloid leukemia treatment, also contributed to the sales growth. Last year, Xospata's sales amounted to KRW 4.8 billion, up 63% from KRW 2.9 billion in 2022. This year's sales are anticipated to increase further due to expanded National Health Insurance criteria in March of last year. Initially, Xospata has been reimbursed with the National Health Insurance as a monotherapy in March 2022. However, it was reimbursed only for patients eligible for allogeneic hematopoietic stem cell transplantation, with a maximum limit of four cycles. However, starting in March of this year, the limitation on eligibility for allogeneic hematopoietic stem cell transplantation and treatment duration have been lifted. As a result, Xospata is reimbursable for all adult patients with FLT3 mutation-positive relapsed/refractory acute myeloid leukemia, in accordance with domestic approval requirements. With the removal of the previous restrictive reimbursement criteria, treatment access is expected to significantly improve for elderly patients who previously could not benefit from the medication and for those who had no treatment option due to ineligibility for allogeneic hematopoietic stem cell transplantation. It is to be watched whether Astellas Pharma Korea will once again reach its previous highest sales of KRW 290 billion in 2019. The pharmaceutical industry anticipates that Padcev, the company's new ADC prostate cancer drug, will drive future growth. In February, Padcev passed the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) and has completed the economic evaluation. It remains to be seen when the drug will be considered for the Drug Reimbursement Evaluation Committee (DREC) review. Padcev's sales for last year were only KRW 900 million, but it is already expanding its presence in the global market. When it becomes available with reimbursement, it has the potential to generate steep sales growth.
- Company
- 'Adtralza' lands in general hospitals in KOR
- by Eo, Yun-Ho Jul 19, 2024 05:47am
- Product photo of LEO Pharma Korea’s Adtralza (tralokinumab). 'Adtralza,' the treatment of atopic dermatitis, is quickly establishing presence in the market. Industry sources said that LEO Pharma Korea’s Adtralza (tralokinumab), a treatment for atopic dermatitis with an underlying mechanism of neutralizing interleukin-13 (IL-13), has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Seoul St. Mary's Hospital, and other medical centers, including Korean University Ansan Hospital, Boramae Medical Center, Incheon St. Mary's Hospital, and Hanyang University Seoul Hospital. Adtralza was approved for reimbursement listing in May. The reimbursement criteria are set for treating ▲Adult patients (18 years or older) and adolescent patients (12-17 years) with chronic severe atopic dermatitis whose symptoms persisted for over three years, ▲Patients who had topical therapy (moderate corticosteroids or calcineurin inhibitors) as first-line treatment for more than 4 weeks, followed by systemic immunosuppressants for over 3 months, but have not responded well with at least a 50% reduction in Eczema Area and Severity Index (EASI) score or cannot be treated due to side effects, and ▲Patients who achieved over EASI 23 before Adtralza treatment. This drug is a biopharmaceutical that specifically targets IL-13. While Sanofi-aventis Korea’s Dupixent (dupilumab) targets both IL-4 and IL-13, it is difficult to compare the mechanism of actions of the two drugs directly. IL-13 is a crucial cytokine involved in the pathogenesis and symptoms of atopic dermatitis, such as immune response and skin barrier dysfunction. It is known to be overexpressed in atopic dermatitis skin and positively correlated with disease severity. The launch of Adtralza provides a new treatment option for treating atopic dermatitis with a biological agent, in addition to Sanofi's Dupixent, which inhibits IL-4 and 13. The phase 3 ECZTRA3 and ECZTEND studies demonstrated the efficacy and safety of Adtralza. The ECZTRA3 study compared Adtralza to placebo in patients aged 18 years and older with moderate-to-severe atopic dermatitis who had an inadequate response to previous topical therapy or require systemic therapy. The primary endpoints were the percentage of patients who improved their Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and those who achieved EASI-75 (a reduction in EASI score of over 75%) improvements. The clinical trial demonstrated a significant improvement with Adtralza, as 56.0% of patients achieved a 75% or greater reduction in EASI score, compared to 35.7% of those receiving a placebo. The results have shown that 38.9% of patients treated with Adtralza improved their IGA score of 0 or 1 at week 16, compared to 26.2% of patients treated with placebo. Dong Hun Lee, Professor in the Department of Dermatology at Seoul National Hospital, said, "Adtralza is a convenient option because patients who achieve clear or improved skin condition after week 16 can be dosed every four weeks at the physician's guidance. In particular, it will reduce the economic burden on patients because the reimbursable price is cheaper than competitors."
- Company
- Forxiga generics, Jardiance·Envlo, surpass original drug
- by Kim, Jin-Gu Jul 18, 2024 05:49am
- (Clockwise from upper left) Product photos of AstraZeneca The market for SGLT-2 inhibitors used to treat diabetes is shifting due to advancing generics and new drugs made in South Korea. The prescription sales of Forxiga (dapagliflozin), which is set to withdraw from South Korea, have significantly dropped. In contrast, the prescription sales of Forxiga generics quickly increased, surpassing those of the original drug in one year since its launch. Similarly, the prescription sales of the new drug in South Korea, 'Envlo (enavogliflozin),' have expanded over sixfold over a year. Analysis suggests that when Forxiga withdraws from the market in the second half of the year, Envlo will likely take second place in the market. 'Set to withdraw from KOR,' Forxiga's prescription sales↓by 26%...generics surpass the original drug According to the medicinal market research firm UBIST on July 17th, Forxiga's out-patient prescription sales in Q2 totaled KRW 10.4 billion, a 26% decrease in a year compared to KRW 14.1 billion in Q2 of last year. Analysis suggests that emerging generics after the patent expiration and the decision to withdraw from the Korean market may have affected Forxiga's prescription sales reduction. The Forxiga patent expired in April of last year. Since then, 65 generics have been launched. In December, AstraZeneca Korea has decided to withdraw Forxiga from the Korean market. The company plans to withdraw Forxiga, a monotherapy drug, and only leave 'Xigduo,' a combination therapy drug containing metformin. Currently, AstraZeneca Korea only provides the existing stock without additional imports from the global headquarters. While the Forxiga sales stalled, generics containing the same ingredient have expanded their market influences. In particular, the Q2 prescription sales of generics surpassed that of the original drug for the first time. In Q2, the prescription sales of 65 Forxiga generics totaled KRW 10.6 billion, a threefold increase from KRW 3.9 billion in Q2 last year. As Forxiga's sales declined in prescription sales, generics sales skyrocketed, resulting in generics turning around. Quarterly prescription sales of the original Forxiga and its generic version (unit: KRW 100 million, source: UBIST). Among the generics, Boryung's 'Trudapa' has recorded the highest prescription performance in Q2, with KRW 1.1 billion, followed by Hanmi Pharm's 'Dapalon (KRW 900 million),' Aju Pharm's 'Dapril (KRW 800 million),' Chong Kun Dang's 'Exiglu (KRW 600 million),' and Kyung Dong Pharma's 'Dapazin'·DongA ST's 'Dapapro'·Daewon Pharmaceutical's 'Dapaone' (KRW 500 million, respectively). The pharmaceutical industry anticipates that the prescription sales of generics will increase more rapidly in the second half of the year. Once the remaining stock of Forxiga starts to deplete, generics are likely to quickly dominate the market. On this note, the industry eyes on HK inno.N’s generic ‘Dapa N.’ Dapa N succeeded Forxiga's heart failure and kidney disease indications. In April, AstraZeneca announced that they would withdraw the BLA of Forxiga and transfer Forxiga's heart failure and kidney disease indications by granting clinical documents. As a result, Dapa N became the only generic product that gained the indication of the original drug. The industry expects the drug to start experiencing indication advantage in the second half of the year. The sales of Envlo, a new drug in South Korea, have increased 5.6 fold over a year…Jardiance has been the market leader for a year The prescription sales of Boehringer Ingelheim's Jardiance (empagliflozin) and Daewoong Pharmaceutical's Envlo have increased. It seems that the expected withdrawal of Forxiga from the Korean market may have partially influenced this trend. Jardiance has been the market leader since Q2 last year when the Forxiga patent expired. Since then, its prescription sales have been continuously increased. Jardiance's prescription sales for this Q2 totaled KRW 16.1 billion, up 10% YoY from KRW 14.6 billion. The 36th new drug in Korea, Envlo, is also quickly expanding prescription sales after its launch in May last year. The Q2 prescription sales of Envlo amounted to KRW 2.5 billion, an increase of 5.8-fold compared to KRW 400 million YoY. Summing together with HanAll Biopharma’s 'Eaglex' and Daewoong Pharmaceutical's 'Benavo,' both of which were launched at the time of Envlo, the prescription sales of these generics increased from KRW 500 million to KRW 2.8 billion over a year, an increase by 5.6-fold. Prescription sales of SGLT-2 inhibitors used to treat diabetes: Forxiga, Forxiga generics, Jardiance, Envlo, Suglat, and Steglatro (unit: KRW 100 million, source: UBIST). The industry expects Envlo's sales to continue increasing after this year. It seems that Envlo is expected to become the no.2 in the market for SGLT-2 inhibitor monotherapy, surpassing Forxiga within this year as the prescription sales of Forxiga are expected to decline quickly. Meanwhile, the sales of Astellas Pharma's 'Suglat (ipragliflozin)' and MSD's 'Steglatro (ertugliflozin)' continued to stall for a long time. Over a year, the prescription sales of Suglat declined from KRW 1 billion to KRW 900 million, and that of Steglatro declined from KRW 300 million to KRW 100 million. These companies have decided to withdraw from the market due to low sales. Generics' sales are increasing in the market for combination therapies…over a year, KRW 2.1 billion→KRW 6.4 billion The sales of generics are increasing in the market for combination therapies containing SGLT-2 inhibitor and metformin. In Q2, the prescription sales of 35 products that are generic versions of Xigduo (dapagliflozin+metformin) totaled KRW 6.4 billion. This figure marked an over threefold increase from KRW 2.1 billion in Q2 last year. Boryung's 'Trudapa M' and Hanmi Pharm's 'Dapalon Duo' recorded KRW 1.1 billion, followed by Aju Pharms' 'Dapril Duo'·Kyung Dong Pharma's 'Dapamet' (KRW 800 million, respectively), and Daewon Pharmaceutical's 'Dapawon-M' (KRW 500 million). However, 20 other companies manufacturing generics recorded the prescription sales below KRW 100 million in Q2. AstraZeneca's Xigduo remains the no.1 in the market for combination therapies, with KRW 10.4 billion in prescription sales. However, sales were reduced by 15% from KRW 12.2 billion in Q2 last year. The industry anticipates a significant reduction in Xigduo's prescription sales in the second half of this year due to a price reduction next month. The price reduction was delayed at AstraZeneca's request for execution suspension. The prescription sales of Boehringer Ingelheim's 'Jardiance Duo (empagliflozin+metformin)' saw a 4% increase from KRW 9.9 billion in Q2 last year to KRW 10.2 billion. 'Envlomet (enavogliflozin+metformin)' recorded KRW 400 million in prescription sales in Q2 this year. Daewoong Pharmaceutical launched Envlomet in November last year.
- Company
- GSK challenges Meningococcal serogroup B mkt with Bexsero
- by Hwang, Byung-woo Jul 18, 2024 05:49am
- GSK and Sanofi, the leading meningococcal vaccine companies in Korea, are set to face new competition with the approval of their next-generation vaccines. GSK Korea plans to gain competitivity with Bexsero, which has strengths in protecting against serogroup B, which accounts for the largest share of meningococcal infections in Korea since 2010. #1 GSK Korea held a press conference to celebrate the launch of Bexsero, the first meningococcal serogroup B vaccine in Korea, and discussed the current status of meningococcal B outbreaks and the effectiveness of its vaccine. Meningococcal infections can cause invasive meningococcal infections, meningitis, and sepsis. Invasive meningococcal infection progresses rapidly and can cause death within 24 to 48 hours of the onset of symptoms. Even with treatment, the disease is deadly, with a fatality rate of 8-15%. "Globally, meningococcal infections are most prevalent in infants under one year of age compared to other age groups,” explained Hyun-Mi Kang, Professor of Pediatrics, Seoul St.Mary’s Hospital, who made a presentation at the event, “It causes bacterial meningitis and sepsis, and one to two out of 10 survivor also experience brain damage, hearing loss, and limb loss.” Typical serogroups of meningococci that cause invasive meningococcal infections in humans include A, B, C, W, X, and Y. The most predominant meningococcal serogroup in Korea, the United States, and Europe is serogroup B, with high levels found in infancy and adolescence. From 2010 to 2016, the proportion of meningococcal B serogroup cases identified in Korea was 28%, but from 2017 to 2020, the rate increased significantly to 78%. "The prevalence of meningococcal serogroups varies across countries and time periods, so it is not easy to predict," said Professor Kang. "In Korea, the serogroup B meningococcal infection cases has increased in recent years, increasing the need for its prevention.” GSK had launched Bexsero to address this situation in Korea. "The predominance of meningococcal B in Korea has made it necessary for us to introduce a vaccine to prevent infections caused by meningococcal B," said Dr. Joon Bang, Director of Medical Affairs at GSK Korea. Meningococcal B's capsular polysaccharide is structurally similar to human tissue, which has made vaccine development challenging due to the risk of autoimmune damage. GSK developed Bexsero by applying novel technologies that employ genome sequencing. Since its initial European approval in 2013, GSK has accumulated over a decade of experience in preventing meningococcal B infections, conducting 17 studies on subjects aged 2 months to adults. The most predominant meningococcal serogroup in Korea, the United States, and Europe is serogroup B. However, meningococcal vaccines are not mandatory and are being administered without reimbursement, which means that patient opinions, pharmaceutical company strategies, and pricing influence market competition. With GSK's Menveo and Sanofi's Menactra currently available in the market, the launch price of Bexserois also an area of keen interest. "Bexsero is not intended as a replacement to Menveo; the scope of prevention offered by the two vaccines are different," said Hyunji Kwon, Head of GSK's Vaccine Business Unit in Korea. "We cannot give a specific number because the price of Bexsero is set after a comprehensive review of the vaccine's functions, efficacy, and value."
