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- 2025-12-23 00:36:55
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- Samsung Bioepis confirms efficacy of its Eylea biosimilar
- by Nho, Byung Chul Feb 27, 2024 05:45am
- Samsung Bioepis (CEO Hansung Ko) announced today that the company had presented the follow-up results from its Phase III clinical trial on SB15 (Korean brand name: Afilivu/Eylea biosimilar/Aflibercept) at the Annual Asia-Pacific Academy of Ophthalmology (APAO) Congress that was held in Indonesia from the 22nd to the 25th this month, SB15 is a biosimilar of Eylea, the eye diseases treatment for diseases such as macular degeneration that was developed by the U.S. company Regeneron in the U.S. It works by binding to the vascular endothelial growth factor (VEGF) and inhibiting the formation of new blood vessels. Macular degeneration is an ocular disease caused by aging and inflammation of the retinal macula, the nerve tissue in the center of the retina of the eye. In severe cases, it can cause blindness, resulting in high patient costs due to continuous treatment. In the abstract presented at the congress, Samsung Bioepis disclosed the results of a subgroup analysis of 103 patients (82 patients in Korea and 21 in Japan) with neovascular age-related macular degeneration (nAMD) in Asia who participated in a Phase III clinical trial for SB15. The company conducted a global Phase III clinical trial on SB15 from June 2020 to March 2022, recruiting 449 patients from 10 countries across Asia, Europe, and the U.S. The data from the Asian region was selected for the follow-up analysis. In the Asian subgroup analysis, the efficacy, safety, and immunogenicity, including best corrected visual acuity (BCVA), of patients randomized at Week 0 to receive SB15 through Week 56 (SB15 arm, 52 patients) versus the original drug product (original drug product arm, 24 patients) versus patients randomized at Week 0 to first use the original drug product then switch to SB15 from Week 32 (switch arm, 26 patients) were analyzed. Results showed that the patients' best-corrected visual acuity improved similarly in all 3 arms at Week 56 compared to Week 0: 8.3 letters in the SB15 arm, 7.0 letters in the original drug’s arm, and 6.8 letters in the switching arm. The type and frequency of adverse events were also comparable in the SB15, original, and switching arms, with no new safety signals identified in any of the 3 arms and no detection of anti-drug antibodies, an indication of the drug's immunogenicity. Hejin Kim, Vice President of the Medical Team at Samsung Bioepis, said, “We were able to reaffirm the efficacy of SB15 through the Asian subgroup analysis. The drug demonstrated bioequivalence to the original drug in the Asian subgroup just as it had in the global clinical trial.” Samsung Bioepis currently owns a total of 11 biosimilar products in its pipelines, and SB15 is the second ophthalmic treatment developed by the company after SB11 (Amelivu in Korea, Byooviz in the U.S. and Europe, and Lucentis biosimilar/ ranibizumab). Samsung Bioepis plans to work with Samil Pharm on the sales of SB15 and SB11 in Korea to boost the development and sales synergies of both companies. The 2 companies launched SB11 in January 2023, and in February this year, they signed an additional sales agreement for SB15, establishing a cooperation system for the 2 ophthalmic drugs.
- Company
- K-biopharma starts trials with bispecific antibodies
- by Son, Hyung-Min Feb 27, 2024 05:45am
- Major global pharmaceutical companies have accomplished successful marketing of bispecific antibodies. Now, the Korean biopharmaceutical industry is also joining this challenge. Current bispecific antibodies include Roche’s Lunsumio and Columvi, Abbvie’s Epkinly, and Janssen’s Tecvayli. Korean companies are planning to evaluate the possibility of developing bispecific antibodies in an area of immunotherapy. According to industry sources on the 26th, Hanmi Pharm, ABL Bio, and ImmuneOncia joined the race to develop bispecific antibodies. Bispecific antibodies are known to have clinical advantages as they have additional specific antigen-binding sites compared to monoclonal antibodies. Korean biopharmaceutical companies have started developing anticancer therapy with bispecific antibodies. Hanmi Pharm’s immunotherapy candidate product BH3120 has recently entered Phase 1 clinical trials. BH3120 simultaneously targets 4-1BB and PD-L1. PD-L1 is a target that immunotherapies, such as Keytruda and Opdivo, have demonstrated effectiveness. Hanmi plans to expand the antibody’s efficacy by also targeting 4-1BB protein. Hanmi’s bispecific antibody platform technology, Pentambody, was applied to developing BH3120. Pentambody is a next generation bispecific antibody platform technology that stimulates immune cells while attacking target cancer cells simultaneously. BH3120 is designed to activate 4-1BB specifically in the immune cells near PD-L1-expressing cancer cells. This design minimizes toxicity while demonstrating anti-cancer efficacy in preventing late recurrence. ABL Bio has the most bispecific antibodies of any pharmaceutical companies in Korea. ABL Bio has more than seven pipelines including ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), and ABL503(PD-L1x4-1BB). ABL Bio is also developing ABL001 jointly with Handok. Handok has entered into a licensing agreement with ABL Bio, securing the rights of the drug in Korea and the company has been focusing on biliary tract cancer since February 2021 and conducting Korean Phase 2 clinical trial of ABL001(HDB001A). Handok’s Korean Phase 2 clinical trial, which enrolled patients with biliary tract cancer, demonstrated drug’s efficacy. Therefore, Handok has established a foundation for expanding into multinational clinical studies. In the clinical trial, ABL001 was administered in combination with Paclitaxel to patients who had received their first or second systemic anticancer therapies. The combination therapy demonstrated an objective response rate (ORR) of 37.5%. The median overall survival (OS) was reported to be 12.5 months, with an estimated median duration of response rate (DOR) of 9.4 months. The company is planning to enter later stage clinical trials. ABL Bio announced the interim analysis of Phase 3 for ABL111 last year. The company aims to secure indications for solid cancer by simultaneously targeting Claudin18.2 and 4-1BB. ABL111 did not show any serious adeverse reactions of greater than level4, with an index of 4-1BB-specific toxicity side-effects, according to the company. Additionally, ABL503 is a cancer immunotherapy that simultaneously targets PD-1 and 4-1BB, similar to Hanmi’s BH3120. According to the Phase 1 clinical trial result, one instance of complete response (CR) and three instances of partial remission (PR) were confirmed in ovarian cancer patients administered with ABL503. The Phase 1 clinical trial of ABL503 is currently being conducted at six institutions in the United States and three institutions domestically, focusing on dose escalation and expansion parts. Once the optimal dosage is determined, the plan involves identifying the most suitable target among solid tumors. ImmuneOncia’s IMC-201 is an independently developed bispecific antibody utilizing CD47 and PD-L1. In the preclinical study, IMC-201 binds strongly to solid cancer cells or blood cancer cells expressing CD47/PD-L1 and selectively binds to cancer cells even when cancer cells and red blood cells are co-cultured. In addition, IMC-201 exhibited higher macrophage-dependent phagocytosis than monoclonal antibody IMC-002. Particularly in a mouse tumor model of triple-negative breast cancer, IMC-201 showed more substantial tumor suppression than the combination of monoclonal antibodies IMC-002 and IMC-001. ImmuneOncia is developing cancer immunotherapy candidate IMC-002. IMC-002 blocks the signal between CD47 on cancer cells and macrophages. The result of IMC-002 administration to 12 patients demonstrated no drug toxicity in each dose. 6 out of 12 patients showed stable disease (SD). The company will determine the recommended dose based on Phase 1 clinical study results.
- Company
- Reimbursement for novel CMV drug Livtencity imminent in KOR
- by Eo, Yun-Ho Feb 27, 2024 05:45am
- The novel cytomegalovirus drug Livtencity will soon receive reimbursement in Korea. According to industry sources, Takeda Pharmaceutical Company of Korea recently completed drug pricing negotiations with the National Health Insurance Service for its cytomegalovirus (CMV) drug Livtencity (maribavir). The drug is expected to be approved in April if no issues arise. When reimbursed, the drug will provide a new treatment option for patients who are resistant to existing drugs. The company submitted an application for Livtencity’s reimbursement in Q3 last year, and the agenda the passed Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in December of the same year. Cytomegalovirus (CMV) is a type of herpes virus that's extremely common worldwide. Over 60% of all adults are infected with CMV within their lifetime and typically develops in patients who use immunosuppressants after hematopoietic stem cell transplantation (HSCT). Around 30-70% of HSCT patients experience CMV viremia. In HSCT patients, CMV causes multisystemic diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, pneumonia’s mortality rate is near 60%. Because CMV in immunocompromised patients is fatal, patients had generally received preemptive treatment mainly with ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization had been essential. Additionally, because these drugs have similar mechanisms of action if resistance to one drug develops, it is highly likely that the patient will not respond to other treatments as well. However, the introduction of Livtencity will bring hope to these patients. Livtencity has almost no side effects compared to existing drugs and can become an alternative if patients develop resistance to the existing drugs. Livtencity’s antiviral activity inhibits CMV multiplication and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells, but also interferes with viral DNA replication, encapsidation, and nuclear egress. Meanwhile, Livtencity was first approved in November 2021 by the US FDA as the first treatment for patients with post-transplant CMV infection/disease and was approved in Korea in December 2022.
- Company
- Shingrix leads shingles vaccine mkt…occupies 44% of mkt
- by Chon, Seung-Hyun Feb 26, 2024 05:24am
- The new shingles vaccine, Shingrix, has risen to lead the market in its first year of sales. It quickly gained 44% of the market share with its strong shingles prevention effect despite its high price. Since the addition of Shingrix, the market has doubled in size. According to the drug research institution IQVIA, the shingles vaccine market was worth KRW 87 billion last year, expanding 105.8% from the previous year. The domestic shingles vaccine market has been declining every year after reaching KRW 89.9 billion in 2019. In 2022, the market size was KRW 42.3 billion, less than half of what it was 3 years ago. The analysis is that the pandemic has caused the premium vaccine market to shrink. Annual size of shingles vaccine market (Unit: KRW 100 million, Data: IQVIA) However, the introduction of the new Shingrix has revitalized the shingles vaccine market. In last year’s shingles vaccine market, Shingrix posted the most sales, posting KRW 38.5 billion in sales. The vaccine, which has been available since December 2022, began to exert its presence in Q1 last year with sales of KRW 6 billion, occupying a 28.9% share. In Q2 last year, it quickly became the leading shingles vaccine, posting KRW 11.1 billion, and continued to lead in Q3 and Q4, posting KRW 9.9 billion and KRW 11.1 billion, respectively. Shingrix’s share of the shingles vaccine market last year reached 44.2%. In other words, the vaccine took the market by storm, occupying nearly half of the total market in its 1st year of release. In Q4 last year, the company's market share rose to 50.2%, further solidifying its lead. The greatest benefit of Shignrix is its strong shingles-prevention effect. In a Phase III clinical trial (ZOE-50) that was conducted on adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group at 3.2 years of follow-up, and in another Phase III clinical trial (ZOE-70) conducted on adults aged 70 years and above, Shingrix showed an 89.8% efficacy at 3.7 years of follow up. This is superior to the 5% protection in adults aged over 50 years of age and 41% in adults aged 70 years and above demonstrated with the use of Zostavax. The prevention rate of SKYZoster is also known to be comparable to Zostavax. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or those with solid cancer, blood cancer, or solid organ transplant patients who have an increased risk of shingles are also eligible to receive vaccination with Shingrix. At the time of its release, Shingrix's significantly higher price than existing vaccines was pointed to as an obstacle to the vaccine’s early settlement into the market. vaccines. The price of Shingrix, which is administered two times in total, is set at around KRW 500,000 to 600,000. This is more than twice as high as the existing vaccine, which costs KRW 150,000 to 200,000. However, Shingrix rapidly increased its market share in the market supported by its superior efficacy despite the high price. Also, the sales support from 2 domestic pharmaceutical companies contributed to Shingrix’s rapid market penetration. GSK started domestic sales of Shingrix in partnership with two companies, GC Biopharma and Kwangdong Pharmaceutical. Sales of shingles vaccines (Unit: KRW 100 million, Data: IQVIA) Existing shingles vaccine products such as SKYZoster and Zostavax saw sales increase from the previous year, but their market share declined due to Shingrix. SK Bioscience’s SKYZoster’s sales had risen 33.3% YoY to record KRW 26.2 billion last year. SKYZoster is a live attenuated vaccine for the prevention of shingles that was developed by SK Bioscience with its proprietary technology. The vaccine has proven its non-inferiority compared to its competitor (Zostavax) in adults aged 50 or older in 8 domestic clinical institutions. In October 2017, the company obtained approval for SKYZoster from the Ministry of Food and Drug Safety for 'preventing shingles in adults over the age of 50'. Before its approval, MSD's Zostavax was the only vaccine in the market, and the introduction of SKYZoster had sparked market competition. SKYZoster's growth slowed during the pandemic after posting KRW 34.1 billion in sales in 2019. In 2021, sales fell to 18.2 billion won, a 46.7% drop in two years. SKYZoster rebounded in 2022 with 19.7 billion won in sales and grew even more last year. However, its market share fell from 46.5% in 2022 to 30.1% in one year due to the rise of Shingrix. In the case of Zostavax, it posted sales of KRW 22.4 billion last year, up 0.5% YoY. In 2019, Zostavax posted KRW 55.9 billion in sales, occupying 62.1% of the market share. However, its sales have been on a downward trend since then, and its share shrank to 25.7% last year.
- Company
- Samsung Bioepis’s Eylea biosimilar Afilivu approved in KOR
- by Son, Hyung-Min Feb 26, 2024 05:24am
- Samsung Bioepis announced on the 23rd that it has obtained domestic approval for its Eylea biosimilar ‘Afilivu.’ The approval marks the 2nd ophthalmic disease treatment Samsung Bioepis has received approval for after being granted approval for its Lucentis biosimilar Amelivu. Eylea is a macular degeneration treatment developed by the multinational pharmaceutical companies Regeneron and Bayer. Samsung Bioepis plans to comarket both Amelivu and Afilivu with Samil Pharm. The companies released Amelivu last year and signed an agreement for Afilivu in February this year. Samsung Bioepis conducted a Phase III clinical trial for its Eylea biosimilar in 449 patients with wet age-related macular degeneration from June 2020 to March 2022 in 10 countries, including the U.S. and South Korea. In the clinical trial, Afilivu demonstrated bioequivalence in terms of efficacy and safety with Eylea. "With the approval of Afilivu, we have once again demonstrated our biopharmaceutical research and development capabilities. We will continue to strive to contribute to addressing unmet medical needs in the field of ophthalmic diseases in Korea."
- Company
- Eylea continues to lead AMD mkt despite new competition
- by Son, Hyung-Min Feb 26, 2024 05:24am
- The entry of new drugs in the macular degeneration treatment market made little impact on Eylea’s sales. Eylea continued to top the macular degeneration treatment market last year, posting sales of KRW 96.7 billion. The Eylea biosimilars Vabysmo and Lucentis, which were released last year, have shown little presence in the market yet. According to the market research institution IQVIA on Thursday, Eylea’s revenue last year was KRW 96.7 billion, up 20.2% from the KRW 80.4 billion it had made in 2022. Eylea is a vascular endothelial growth factor-A (VEGF-A) inhibitor for macular degeneration that was developed by Bayer and Regeneron. The drug was approved in Korea in 2013 and entered the market in earnest the following year after receiving reimbursement approval. Although Eylea’s sales were lower than that of its competitor Lucentis until 2015, the market demographic changed in Q3 2016. Since then, Eylea’s sales have continued to grow, reaching KRW 46.8 billion in 2019, and then KRW 60.3 billion in 2020. In 2022, it surpassed the KRW 80 billion mark and reached the KRW 100 billion mark the last year. However, Eylea now has to fend off an onslaught of biosimilar competitors due to the expiration of its patent last month. Celltrion, Samsung Bioepis, and Sam Chun Dang Pharm have all made a bid with their Eylea biosimilars. The original developers, Bayer and Regeneron, are preparing to develop a higher-dose version of Eylea in preparation for the entry of biosimilars. The companies plan to launch a higher-dose formulation to increase the dosing interval. The two companies plan to seek approval for the higher-dose Eylea for all of their approved indications, including diabetic macular edema (DME), wet age-related macular degeneration (wAMD), and retinal vein occlusion. Novartis’s Lucentis posted sales of KRW19.8 billion last year, down 20.2% from the previous year. Lucentis’s sales have declined steadily since 2020, when it generated KRW 37 billion in sales. In 2022, the company reported sales of KRW 29.4 billion, and even less, to record sales of less than KRW 20 billion last year. Lucentis uses the same mechanism of action to inhibit VEGF-A as Eylea but has a shorter dosing interval. Lucentis must be administered once a month, compared to Eylea, which can be administered once every two months. Eylea’s efficacy had demonstrated superior vision improvement to Lucentis in patients with severe vision loss due to diabetic macular edema. Therefore, Novartis plans to focus on marketing its next macular degeneration drug, Beovu. Like Eylea, Beovu can be dosed once every 2 months. Beovu, which was released in Korea in Q3 2021, generated sales of KRW 8.6 billion in the same year. Since then, its sales have continued to grow, generating sales of KRW 16.5 billion in 2022 and KRW 21.3 billion last year. Total sales of new drugs and biosimilars that entered the market last year amount to KRW 19 billion The Lucentis biosimilars and Roche's Vabysmo, which were newly launched last year, did not make much of an impact in the market the past year. Chong Kun Dang’s LucenBS, which was the first Lucentis biosimilar to enter the market, sold KRW 500 million, and Amelivu, which is comarketed by Samsung Bioepis and Samil Pharm, sold KRW 800 million last year. Chong Kun Dang sought to turn the atmosphere around with a price cut. The company cut the price of Lucentis from KRW 300,000 to KRW 150,000 this month. The original Lucentis costs KRW 580,000 per vial and Samsung Bioepis' Amelivu costs KRW 350,000 per vial. Because its competitor has significantly reduced the price of its drug, attention is rising to what Samsung Bioepis will do in the next as well. Vabysmo, which had gained great attention even before its launch, generated KRW 600 million in sales last year. However, the real competition is expected to start this year, as Vabysmo was granted reimbursement in October last year. Vabysmo is a macular degeneration treatment that was developed by Roche. The drug not only inhibits VEGF but also blocks the angiopoietin-2 (Ang-2) pathway to inhibit neovascularization. Blocking both pathways independently has been shown to be more effective than blocking VEGF alone in reducing inflammation, leakage, and abnormal blood vessel growth. In particular, in clinical trials, Vabysmo improved visual acuity at a level non-inferior to that of Eylea in the TENAYA and LUCERNE trials that compared its safety and efficacy with Eylea. Its duration of response lasted 24 months. In other words, Vabysmo achieved comparable efficacy to other treatments with once every 4 months dosing compared to the once every 1-2 month dosing required for other treatments. In the global market, Vabysmo’s sales are already closing in on that of Eylea. Vabysmo generated approximately USD 3.56 trillion in global sales last year, more than half of Eylea’s $7.8 trillion, in just 2 years after its launch.
- Company
- Kay Bae appointed as KRPIA chair, also overseeing NZ, AUS
- by Eo, Yun-Ho Feb 26, 2024 05:24am
- Kay Bae, KRPIA Chair Kay Bae (53), Sanofi-Aventis Korea Country Lead, literally has become the ‘center’ of the pharmaceutical company. Bae, who was recently appointed as a Country Lead to manage subsidiaries including Korea, New Zealand, and Australia of the Sanofi Group, is appointed as a new Chair of the Korean Research-based Pharmaceutical Industry Association (KRPIA). As the head of the organization representing Korean multinational companies and big pharma Sanofi’s major Asian-Pacific countries, Bae emerged as a key player in multifaceted communication. Bae’s KRPIA appointment was a surprise because Bae declined an offer for the position multiple times when the KRPIA chair position became vacant. Bae’s interests and Korean-like modesty may likely have influenced her previous decisions, but the analysis suggests that Bae may have declined offers previously because of her commitment to her primary appointment (Sanofi-Aventis Korea Country Lead). This time, Bae may have been in a situation where she could no longer decline KRPIA’s offer. KRPIA’s board of directors (BOD) list shows that new members have joined the board following many CEO transfers within the multinational pharmaceutical companies in one to two years. Rumor has it that Sang Kyung Noh (61), Amgen Korea’s CEO, was the only other candidate besides the previous Chairman Oh Dong-Wook (54), Pfizer Korea’s CEO, for the head of KRPIA. The KRPIA board of directors 2024 (Member companies in alphabetical order): Soyoung Kang of AbbVie Korea, Sang Kyung Noh of Amgen Korea, Junil Kim of Astellas Pharma Korea, JinA Lee of Bayer Korea, Hye Young Lee of BMS Pharmaceutical Korea, Jaeyeon Choi of Gilead Sciences Korea, Maurizio Borgatta of GSK Korea. Christoph Hamann of Merck Korea, Ji-young Sohn of Moderna Korea, Albert Kim of MSD Korea, Jae (Byungjae) Yoo of Novartis Korea, Dong-Wook Oh of Pfizer Korea, Kay Bae of Sanofi-aventis Korea.Although her business responsibilities have expanded, Bae has taken on the role of the chair. Sanofi has recently undergone a restructuring that combines Korean, New Zealand, and Australian corporations. In addition, Sanofi will integrate business divisions previously operated independently into a unified business system. In other words, Bae will have greater decision-making power and expanded roles within the company. There will be many overseas business trips as well. There are concerns regarding whether Bae can commit to the organization since she has additional business in the busiest period. On the other hand, Bae is expected to do well, considering her role as a control tower. In an era of high drug prices, KRPIA works diligently for drug pricing of new drugs. The KRPIA plays a critical role in the organization, suggesting reform in drug pricing system and communicating with the government. Amid this situation, Bae will be responsible for determining the core message of the organization representing pharmaceutical companies in Korea while also overseeing New Zealand and Australia, which are Korea’s drug pricing reference counties. After a long period of vacancy, the primary positions of KRPIA are now filled, indicating vitality. New wheels are turning. It is to be watched whether the executive team under Bae's leadership can achieve more than just protecting drug prices. They need to negotiate with health authorities using sound reasoning and judgement, resulting in an agreement that prioritizes 'improving patient accessibility.' “Global pharmaceutical companies face a rapid healthcare and medical atmosphere. Based on KRPIA’s patient-centered vision, we will engage in various efforts to provide patients in Korea with rapid and broadened treatment benefits of innovative new drugs,” Bae stated as she was appointed as KRPIA’s chair. Meanwhile, Bae became the longest-serving CEO of a multinational company last year when Kim Dae-jung (64), former CEO of Daiichi Sankyo, retired. Bae was appointed as the CEO of Genzyme Korea in 2010 and has served as the Country Lead of the Sanofi-Aventis Korea and Sanofi integration management committee (then Sanofi-Aventis, Sanofi Pasteur, Genzyme, Merial) for over ten years since 2013. Bae represents a female CEO in a multinational pharmaceutical company. Bae started her business career at Novartis and later joined Genzyme. Bae led the integration process when Genzyme was fully acquired by Sanofi in 2019.
- Company
- New Alzheimer’s drug Leqembi closer to drug marketing
- by Eo, Yun-Ho Feb 26, 2024 05:24am
- Leqembi (lecanemab), a drug jointly developed by Eisai and Biogen. A new Alzheimer’s treatment ‘Leqembi’ is expected to receive approval for marketing in Korea. The Ministry of Food and Drug Safety (MFDS) is conducting a final assessment of Leqembi (lecanemab), a drug jointly developed by Eisai and Biogen, for marketing approval. Leqembi’s application for approval was submitted last year, indicating an expected approval date in the first half of the year. The drug will be indicated as a treatment of ‘Mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.’ Leqembi has been shown to reduce the rate of disease progression and to slow cognitive and functional decline through selectively binding to β-amyloid (βA), which is known as an agent that causes Alzheimer’s disease. This drug achieved statistically significant results in both the primary endpoint and secondary endpoint in the Clarity AD study. Notably, Leqembi-treatment group had reduced functional decline of the brain by 27% compared to the placebo group during the 18 months. Although Leqembi is recognized for its effectiveness in delaying dementia in the market for Amyloid-targeted therapy, the characteristic side effects associated with the treatments have remained a recurring issue. Leqembi-associated ARIA side effects refer to brain swelling and small spots of bleeding detected in magnetic resonance imaging (MRI) scans. Depending on how side effects appear, the side effects are further categorized as ‘ARIA-E,’ defined by vasogenic edema of the brain and sulcal effusion, and ‘ARIA-H,’ defined as microhemorrhage and hemosiderosis. It remains to be watched whether Leqembi can overcome side-effects associated with amyloid-targeting new drugs and make a mark in the Alzheimer’s market. Leqembi was approved in China last January, following the United States (July 2023) and Japan (September 2023).
- Company
- Alecensa prepares to solidify its lead in lung cancer mkt
- by Son, Hyung-Min Feb 23, 2024 05:49am
- Alecensa is showing a strong position in the targeted therapy market for ALK-positive lung cancer in Korea. Last year, Alecensa generated KRW 34.9 billion in sales, far outpacing the runner-up, Takeda Alunbrig's KRW 13.6 billion. As the only ALK-targeted therapy that has demonstrated efficacy in early-stage lung cancer, Alecensa is likely to continue its lead in the market for the foreseeable future. According to the market institution IQVIA on the 22nd, Alecensa sold KRW 34.9 billion last year, up 0.5% from KRW 34.7 billion in 2022. Alecensa's sales have been on a steady rise since surpassing KRW 5 billion in Q3 2019 and have posted average quarterly sales of over KRW 8 billion since 2021. Alecensa is a second-generation ALK-positive targeted therapy developed by Roche. Targeted therapies for ALK-positive cancer are classified into 3 categories: first-generation drugs like Pfizer’s Xalkori; second-generation drugs like Roche’s Alecensa and Takeda’s Alunbrig; and third-generation drugs like Pfizer’s Lorviqua. With the possibility rising for Alecensa’s use in early-stage lung cancer, the drug is expected to continue solidifying its lead in the market According to clinical data presented at last year's European Society for Medical Oncology Congress 2023 (ESMO 2023), Alecensa showed effect as adjuvant chemotherapy. In the clinical trial, Alecensa improved disease-free survival (DFS) over platinum-based chemotherapy. The Alecensa-administered group showed a 76% reduction in recurrence or death and a 78% reduction in the risk of CNS progression or death. Although Alecensa does not yet own an indication for early-stage lung cancer in Korea if it adds the indication, the drug will likely remain the market leader for some time. Takeda's Alunbrig posted sales of KRW 13.6 billion last year, up 23.6% YoY. Alunbrig's sales have been growing steadily since surpassing KRW 2 billion in Q3 2021. Alunbrig's strength is that it can be taken once daily with or without meals. In the case of Alecensa, 4 capsules need to be taken twice daily, for a total of 8 capsules per day. Also, Alunbrig is available in 3 different strengths to help patients find the right dose. Pfizer's Lorviqua generated KRW 11.7 billion in sales last year, a 216.2% increase from 2022. Lorviqua, which was released in the Korean market in Q1 2022, has posted more than KRW 3 billion in sales since Q3 2022 after a level period of KRW 200 million in sales in Q1 and Q2. Lorviqua’s sales rise started in full swing after being granted reimbursement as a second-line treatment for ALK-positive lung cancer in September 2022. Currently, Lorviqua is only available for patients who have failed with the use of Xalkori, Alunbrig, or Alecensa. Pfizer is currently seeking to expand its reimbursement to the first line. On the other hand, Pfizer's Xalkori was the only ALK-targeted therapy to see a sales decline. Xalkori generated KRW 9.9 billion in sales last year, which was a 13.1% YoY decline. After generating KRW 8 billion in sales in Q1 2019, Xalkori’s sales plummeted to KRW 4.8 billion in Q2. The decline in Xalkori sales is related to the release of second- and third-generation targeted therapies. These drugs demonstrated a higher effect with improved safety over Xalkori. Second- and third-generation targeted therapies are said to have lower drug toxicity, fewer adverse events, and better efficacy than first-generation drugs. Also, Second- and third-generation targeted therapies also have the advantage of a greater penetration rate into the central nervous system (CNS), including the brain.
- Company
- Alteogen expands license agreement with MSD
- by Kim, Jin-Gu Feb 23, 2024 05:49am
- Alteogen officially announced on the 22nd that it will receive an additional USD 20 million (approximately KRW 26.7 billion) from the multinational pharmaceutical giant MSD under the terms of their modified agreement. In June 2020, Alteogen signed a non-exclusive licensing agreement with MSD for its proprietary human hyaluronidase technology (ALT-B4). At the time, The upfront payment was USD 160 million. MSD is using the technology to develop a subcutaneous (SC) formulation of Keytruda (pembrolizumab). Alteogen explained that the original agreement had been modified into an exclusive agreement. The company will grant exclusive licensing rights to the Keytruda line of products that MSD is developing by adding ALT-B4. However, the non-exclusive agreement will continue to apply to non-KEYTRUDA development projects. As part of the modified agreement, Alteogen will receive an additional USD 20 million in payments independent of the original upfront payment. This amount represents 93% of Alteogen's consolidated sales revenue of KRW 28.8 billion last year. The additional milestone payments Alteogen could receive have also been expanded. Alteogen was previously eligible to receive up to USD 3.865 billion in milestone payments based on regulatory approval, patent extension, and cumulative net sales of the Keytruda family of subcutaneous injection formulations that are applied to the ALT-B4 technology. The modified agreement increases the maximum amount of milestones Alteogen is eligible to receive by USD 432 million to USD 4.298 billion (KRW 5.7 trillion). A condition for royalties based on commercial sales has also been added. Alteogen will receive a percentage of sales of the Keytruda product line each year as royalties even after the agreement period for the patent term, until March 2040. An official from Alteogen said, "We expect to receive the additional payment under the modified agreement on or before the 25th of next month.”
