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- 2026-05-02 13:47:59
- Company
- Novartis’s operating income grew 123% in Q3 with Entresto
- by Son, Hyung Min Nov 01, 2024 05:50am
- The Swiss global pharmaceutical giant Novartis' sales increased slightly compared to the previous year. Novartis showed even sales growth in various therapeutic areas, including cardiovascular, anticancer, and immunosuppressive agents. According to industry sources, Novartis reported a revenue of USD 12.823 billion in Q3 last year, up 10% YoY. The company’s operating income was approximately USD 3.627 billion, a 123% increase YoY. The largest revenue generator in Q3 was the heart failure drug Entresto. Entresto generated USD 1.865 billion in revenue, up 26% YoY. Entresto is an angiotensin receptor-neprilysin inhibitor (ARNI) class heart failure drug and is the only innovative drug that works directly on the heart. Its strength lies in its ability to be used as a first-line treatment for heart failure in combination with other medicines, including SGLT-2 inhibitors. Entresto’s sales have continuously increased with additional indications. Entresto was initially approved for use in heart failure patients with reduced ejection fraction, defined as a left ventricular ejection fraction of 40% or less. Through clinical trials, Novartis has been successful in expanding the indication of Entresto to patients with heart failure with preserved ejection fraction. Novartis' biologic treatment Cosentyx generated the second-largest revenue. Cosentyx generated sales of USD 1.693 billion, up 28% YoY. Cosentyx, which targets anti-interleukin (IL)-17, is effective in a wide range of inflammatory diseases and has emerged as a competitor to tumor necrosis factor alpha (TNF-α) inhibitors such as Humira and Remicade. The highest sales growth rate was seen in the PCSK9 inhibitor Leqvio. Leqvio’s sales totaled $198 million, a 119% year-over-year increase. Leqvio is a first-in-class siRNA drug approved in Korea, the U.S., and Europe. Leqvio uses naturally occurring siRNA to reduce LDL-C in the blood by inhibiting the production of the PCSK9 protein, which raises LDL-cholesterol (LDL-C). Leqvio has been shown to reduce LDL-C by up to 57% with twice-yearly dosing. The rise in sales of the prostate cancer drug Pluvicto was also notable. The company reported Q3 sales of USD 386 million, a 50% YoY increase. Pluvicto is a radiopharmaceutical Notavis acquired through the acquisition of US-based Endocytein in 2018. Sales of Pluvicto, which was introduced to the market in 2022, surpassed USD 200 million (KRW 260 billion) the same year. Since then, it has continued to grow, reaching nearly USD 1 billion (about KRW 1.3 trillion) in sales last year. Sales of the breast cancer drug Kisqali increased 43% year-on-year. Kisqali is a CDK4/6 inhibitor that targets HR+/HER2- breast cancer. The fact that it was the first CDK4/6 inhibitor to be prescribed to premenopausal women contributed to its rapid market growth. According to the National Comprehensive Cancer Network (NCCN) guidelines, Kisqali is recommended as a Category 1 in the first-line treatment of HR+/HER2- peri-menopausal breast cancer patients. In addition to its strong cardiovascular, oncology, and immunosuppressive pipeline, Novartis is also actively pursuing radiopharmaceuticals and cell therapies to reinforce its portfolio. Earlier this year, Novartis acquired the Dutch immunotherapy company Calypso Biotech for USD 425 million (about KRW 560 billion). Calypso owns a cell therapy candidate, ‘CALY-002,’ with other monoclonal antibodies in development for various immune disorders.
- Company
- Atopic dermatitis drug Ebglyss to enter Korea next year
- by Whang, byung-woo Oct 31, 2024 05:55am
- The atopic dermatitis drug Ebglyss (lebrikizumab), which is set to soon be released in Korea, has added competitivity by securing rationale for switching between biologics. The company plans to receive reimbursement after launching the drug without reimbursement early next year. Pic of EbglyssAt the recent Fall Clinical Dermatology conference that was held in the U.S., Lilly presented results from the ADapt Phase IIIb study, which confirmed the effectiveness of Ebglyss in patients with moderate-to-severe atopic dermatitis who were previously treated with Dupixent (dupilumab). Patients in the ADapt study were those who discontinued Dupixent due to insufficient response, intolerance, adverse events, or other reasons (e.g., burden of cost, loss of access to treatment). Results showed that among patients treated with dupilumab, the proportion of patients achieving an Eczema Area and Severity Index (EASI) of 75 after treatment with Ebglyss was 57% at Week 16 and 60% at Week 24. In addition, among patients who had an inadequate response to sarilumab, 46% achieved an EASI-75 at Week 16 on Ebglyss. These results were similar to those observed in two Phase III studies (ADvocate 1 and ADvocate 2) which evaluated the clinical utility of Ebglyss monotherapy in dupilumab-naïve patients. This confirms its competitive advantage, particularly as an alternative option for atopic dermatitis patients who have not responded to Dupixent, which owns the largest share of the atopic dermatitis treatment market. According to the drug research institution IQVIA, Dupixent generated KRW 105.2 billion in sales in 2022, but last year's pediatric reimbursement expansion led to a significant increase in sales to KRW 143.2 billion. In Q1 this year, the drug generated KRW 40.5 billion in sales, with further sales growth expected. Currently, Lilly Korea has applied for Ebglyss’s reimbursement in Korea. However, due to the time required to review its reimbursement, the drug will first be launched without reimbursement early next year. However, it is expected that the drug’s reimbursement approval will be a top priority for Lilly to enter the market even after the launch of Ebglyss, as it is difficult to penetrate the market due to the fact that several therapies, including Dupixent and JAK inhibitors, have received reimbursement. What Lilly is looking forward to is the possibility of allowing switching between treatments in severe atopic dermatitis. According to industry sources, HIRA established the standards for switching between biologics and JAK inhibitors through expert discussions in September. Although the follow-up procedures such as negotiations with the NHIS are scheduled, the fact that discussions have been initiated is receiving positive evaluations. “Due to the nature of severe atopic dermatitis, there are patients who cannot see an effect with currently available treatments, so I think there will be a demand to use Ebglyss,” said a professor of dermatology at University A Hospital. ”There is a positive trend for switching, but Ebglyss is not yet reimbursed, so it will be important to see whether it will be reimbursed in the future.”
- Company
- Oral ALS drug 'Radicava' likely to land in KOR
- by Eo, Yun-Ho Oct 31, 2024 05:55am
- Product photo of Radicava. 'Radicava,' an oral drug for the treatment of amyotrophic lateral sclerosis (ALS), is expected to be commercialized in South Korea. Sources said that Mitsubishi Tanabe Pharma Korea's Radicava (edaravone) is under consideration for domestic approval. The drug is a treatment for ALS, formerly known as Lou Gehrig's disease. Radicava is an oral suspension. It can reduce patient burden by lowering the number of hospital visits and pain compared to conventional drugs designed for intravenous (IV) injection. Radicava received accelerated approval designation from the U.S. Food and Drug Administration (FDA) in October 2019. The drug was approved in May 2022. It has significantly reduced the administration time compared to IV injection. Unlike IV injection administered as a single daily dose as a 60-minute intravenous drip infusion after 2 ampules (edaravone 60 mg) diluted in saline, 'Radicava ORS' takes only a few minutes to administer. Mitsubishi Tanabe Pharma has conducted a comprehensive clinical development program for 'edaravone' IV injection and oral formulation for over 10 years. The basis of 'Radicava ORS' approval was the Phase 3 MCI186-19 study, which involved 137 patients with ALS, in addition to several research data. In the MCI186-19 study, the ALS Functional Rating Scale-Revised (ALSFRS-R) was used to monitor the disease at 24 weeks. ALSFRS-R is a verified assessment tool. The results showed that the 'edaravone'-treated group had a 33% reduction in the loss of body function compared to the placebo group. Additionally, the company conducted seven Phase 1 clinical pharmacological studies. They have investigated the pharmacokinetics, safety, drug-to-drug interaction, dosage, bioavailability, and biological equivalence of 'Radicava ORS' in healthy patients or in patients with ALS who have or do not have percutaneous endoscopic gastrostomy (PEG) tube or NG tube. Also, its Phase 3 clinical study demonstrated the safety and drug tolerance profile of 'Radicava ORS' treatment at 24 weeks in 185 patients with ALS. The company is conducting a Phase 3 study evaluating the long-term safety and drug tolerance over 96 weeks. Meanwhile, Radicava received domestic approval as 'Radicut' oral formulation in December 2015. Currently, it is approved as 'Fra-Cut Inj' in South Korea.
- Company
- Pfizer's Q3 sales 31%↑amid increased demand for COVID-19
- by Son, Hyung Min Oct 31, 2024 05:55am
- The global pharmaceutical company Pfizer's sales are increasing compared to the previous year. Pfizer's growth has been driven by the sales of COVID-19 vaccines and treatments such as Paxlovid and Comirnaty. According to industry sources on October 30, Pfizer's sales in Q3 recorded US$17.72 billion (about KRW 24.48 trillion), up 31.2% year-over-year (YoY). Pfizer's combined sales from Q1 to Q3 were US$45.864 billion (about KRW 63.47 trillion), up 2.0% from the same period last year. Pfizer's sales growth in Q3 has been driven by COVID-19 medications. Paxlovid, a COVID-19 treatment, generated US$ 2.73 billion in Q3, up 1,238.1% YoY. Sales performances of Paxlovid (dark blue) and Comirnaty (light blue) (unit: US$ 1 million) in 2023 and 2024. The changes in the demand for COVID-19 medications significantly impacted Pfizer's sales. After recording US$4.069 billion in Q1 of 2023, Paxlovid generated US$143 million in Q2, down 96.4%. This is due to the decreased demand for COVID-19 medications in line with the time of the endemic announcement. However, many countries have recently focused on securing treatments as COVID-19 patients are on the rise due to new variants such as JN.1. The Korean government has listed Paxlovid for insurance reimbursement this month as part of its effort to secure treatments. The COVID-19 vaccine, Comirnaty, has recorded US$1.422 billion in Q3 of 2024, up 8.9% from the previous year. As the demand for the Comirnaty vaccine significantly dropped, the sales dropped to US$195 million in Q2. Pfizer released Comirnaty JN.1 this year to prepare against new mutations. The company also launched 'Comirnaty JN.1 0.033,' a COVID-19 vaccine for infants, and is expecting a sales turnaround. Besides the COVID-19 medications, Vyndaqel products significantly drove sales growth. Vyndaqel products generated sales in Q3 of US$1.447 billion, up 62.2% from the previous year. Vyndaqel products include 'Vyndaqel,' 'VYNDAMAX,' and 'VYNMAX,' which are used to treat amyloid multiple sclerosis and cardiomyopathy. Pfizer has expanded indications for these products to increase their use in countries worldwide. Pfizer expects growth of new drugs secured from acquiring Seagen. In March 2023, Pfizer acquired Seagen, a company specializing in antibody-drug conjugate (ADC), for US$43 billion (about KRW 55 trillion). Seagen developed various ADC cancer drugs, including Adcetris, Padcev, and Tukysa. Padcev, a drug approved to treat urothelial cancer, generated sales in Q3 of US$409 million, and Tukysa, a breast cancer treatment, recorded US$124 million. Adcentris, which is used for blood cancers, raised US$268 million, contributing to Pfizer's sales growth. As a mid-to-long-term strategy to foster growth, Pfizer has set a goal to strengthen its presence in the anticancer drug field by developing eight new drugs with sales of over US$1 billion (KRW 1.3 trillion) by 2023. Pfizer plans to establish a new blockbuster drug portfolio around Seagen's ADC, in addition to its targeted anticancer agents, such as Ibrance for treating breast cancer and Lorviqua for treating lung cancer. Additionally, Pfizer aims to reduce its expense by US$4 billion (about KRW 5.2 trillion) by the end of this year through the Cost Realignment Program. Pfizer announced that it plans to save an additional US$1.5 billion by 2027. Pfizer's Headquarters is also discussing restructuring. This month, the company dismissed employees from its Sanford, North Carolina, U.S. manufacturing plant.
- Company
- NIP inclusion of HPV vaccines on the horizon
- by Whang, byung-woo Oct 31, 2024 05:55am
- Amid high interest in the expansion of the National Immunization Program (NIP) to include HPV vaccines, the possibility of its inclusion in 2026 has arisen in Korea. Although the agenda is yet in the planning stage, attention is being paid to whether it can gain substance in line with the NA budget deliberation discussions next month. The NA Audit by the Health and Welfare Committee made 12 written inquiries related to HPV or the HPV vaccine this year. The inclusion of the HPV vaccine was mentioned in the last NA audits in 2022 and 2023, but interest in this year's audit was particularly high due to the interest of the ruling and opposition parties as the issue was included in the government's major national agenda. In response to the NA Audit inquiry, the Korea Disease Control and Prevention Agency answered that it had prepared the grounds for the introduction through cost-effectiveness analysis, and secured the feasibility of its introduction through priority assessment. In fact, in the study 'Establishing a Mid- to Long-term Plan for the Introduction of NIP,' including Gardasil 9 in the NIP for 12-year-old girls was ranked third in the overall priorities, and the vaccination of 12-year-old boys with Gardasil 9 was ranked sixth. However, regarding its future expansion plans, the KCDA provided a cautious response, saying that expanding subjects and introducing vaccines in the NIP requires a cautious approach due to the large budget investment required. The KDCA said, “We will closely discuss the introduction plan within the government while comprehensively considering age and gender characteristics, disease burden, vaccine availability, and the budget requirements.” However, the KCDA also provided direction on the timing of the expansion of HPV vaccination for boys in response to a written inquiry from NA Rep. Jin-sook Jeon (Democratic Party of Korea). According to the KDCA’s “Achievements and Plans for Expanding HPV Vaccination to Boys,” the KDCA plans to secure funding for expanding the target population and introducing a new vaccine in 2025 and consider introducing a new vaccine from 2026. If the agency secures the required funding, it is analyzed that NIP vaccination of boys for HPV may be possible in 2026. As HPV vaccination is on the government's agenda, the KCDA agrees on the need to introduce the vaccine, and academics and experts have emphasized the effectiveness of its addition to NIP, the industry expects that there will be no major hurdles once the budget issue is resolved. The budget issue is also likely to be resolved as the National Assembly plans to rediscuss the agency's budget cuts. Lawmakers on the National Assembly's Health and Welfare Committee are expected to discuss increasing the budget for NIPs during their budget review in November. According to the KCDA's 2025 budget and fund management proposal that it submitted in August, next year's NIP budget is 24.9% lower than this year's, but if this budget is increased, the inclusion of the HPV vaccine in NIP is likely to be discussed actively. However, it is unclear which vaccine will take center stage even if the budget is increased, as there are currently a number of vaccines that are in need of expansion to NIP, including the shingles vaccine. MSD Korea, which currently owns Gardasil 9, an HPV vaccine, said it will continue discussions with the government about expanding the NIP. “We will actively engage in discussions with the government, including the KDCA, on expanding NIP for HPV vaccines,” said an MSD representative.
- Policy
- Seretide withdraws from Korea due to poor performance
- by Lee, Tak-Sun Oct 31, 2024 05:55am
- GSK's asthma inhaler 'Seretide' is withdrawing from the domestic market. Once the market leader in the market, it seems that the company is reorganizing the product line as its performance has recently declined due to the entry of new products. According to industry sources on the 30th, GSK recently sent letters to long-term care organizations and distributors to notify them of the withdrawal of 6 seretide items and the removal of their reimbursement listing. The 6 currently licensed Seretide products are Seretide 100 Diskus, Seretide 250 Diskus, Seretide 500 Diskus, Seretide 50 Evohaler, Seretide 125 Evohaler, and Seretide 250 Evohaler. Among those, 3 of the Seretide Evohaler formulations have already withdrawn from the market as of April 29th. The remaining 3 Discus formulations have also applied for withdrawal and are expected to be removed in the near future. “We have carefully considered the fact that sufficient alternatives to the Seretide product line already exist in the Korean market and have decided to withdraw the Seretide product line in Korea to simplify and concentrate our respiratory portfolio,” said GSK. The company said the expected date of the items’ reimbursement withdrawal is Dec. 1, with prescribing and reimbursement available for approximately 6 months until the end of May 2025. Seretide was once the leading asthma inhaler in South Korea, but it has been on a downward spiral in recent years due to the entry of its generics and new drugs. Sales of Seretide Diskus have fallen to KRW 12.2 billion in 2019, KRW 11.7 billion in 2020, KRW 9.1 billion in 2021, KRW 7.6 billion in 2022, then to KRW 1.7 billion last year, according to IQVIA. Seretide Evohaler also generated only KRW 800 million in sales last year. In addition to Seretide, GSK has other asthma-COPD inhaler products such as Arnuity, Anoro, Flixotide, Relvar, and Trelegy. In particular, sales of Relvar Elipta was KRW 36.2 billion and Trelegy Elipta was KRW 8.1 billion last year.
- InterView
- "Recruiting a company to co-develop pitavastatin+ezetimibe"
- by Kim, Jin-Gu Oct 30, 2024 05:54am
- Seung Hee Baek, Shinil Pharmaceutical Shinil Pharmaceutical will collaborate with other biopharmaceutical company to co-develop a generic 'pitavastatin+ezetimibe' combination drug for treating hyperlipidemia. Through joint-collaboration, Shinil Pharmaceutical plans to improve not only the contract manufacturing of medicines but also cost savings and productivity. In the meantime, the company plans to teach its construction technology for active ingredients and production know-how to companies participating in joint development in addition to out-licensing. "The pitavastatin+ezetimibe combination drug is set to enter the generics market in 2027," Seung Hee Baek (52), Shinil Pharmaceutical's Executive Director who is directing the co-development·out licensing project, said. "We started to prepare for the current project amid searching for a new sales approach following the implementation of 1+3 bioequivalence regulation." 'pitavastatin+ezetimibe' combination drug sales are skyrocketing…Sinil has completed the bioequivalence test for its generic drug, set to enter the market The company's pitavastatin+ezetimibe combination drug for treating hyperlipidemia received approval under the name Livalozet (JW Pharmaceutical). Livalozet sales are skyrocketing in the prescription market. According to the pharmaceutical market research firm UBIST, Livalozet generated sales of KRW 70.4 billion in prescription sales, more than twice the previous year's growth. Up to September 2024, it generated KRW 66.8 billion in sales. It is expected to surpass last year's prescription record. It seems that Korean pharmaceutical companies have started to show interest in these generics, as Livalozet has shown strong sales in the prescription market. During 2020-2021, many generics containing pitavastatin+ezetimibe received approvals. Livalozet generics are currently subjected to reconsideration. When the reconsideration period ends after 2027, product launch is possible. Sinil Pharmaceutical focused on pitavastatin's low statin side effects and significant treatment effects. The company has already completed a bioequivalence test and is set to enter the market. "The advantage of pitavastatin is that it lowers the risk of diabetes than other statin agents," Baek said. "Sinil Pharmaceutical had selected the pitavastatin+ezetimibe combination as an in-house project. In April 2024, the company demonstrated the bioequivalence of the drug to the control drug through a bioequivalence test." "Searching for a company to co-develop…we will make a technology transfer, including active agent designing·production know-how" Sinil Pharmaceutical will begin technology marketing based on its completed bioequivalence demonstration. The company plans to secure a co-development company and make a technology transfer to the partner, including active agent designing·production know-how·how-to prepare documents for approval. Baek anticipated that such a co-development·technology transfer strategy would be a win-win for both Sinil Pharmaceutical and its partnering company. Baek explained that Sinil Pharmaceutical could benefit from improving its profitability by sharing the development cost. A co-development company can learn various know-how during the technology transfer process. In addition, a co-development company can appoint a CMO company. "Sinil Pharmaceutical conducts the process of product development·approval·production in-house. We can make a technology transfer of necessary technology for each stage up to launching a product," Baek emphasized. "Partnering company can secure various know-how, including the production technology needed in a plant and CTD documentation for applying for approval, in addition to active ingredient designing that made Sinil Pharmaceutical successfully complete the bioequivalence test." Baek emphasized that 'timing is a key to generics development.' Baek explained that the timely development of drugs secures high drug pricing and establishment in the market. Additionally, a company has to consider the cost-effectiveness of the development for an agent that is difficult to demonstrate bioequivalence. "Sinil Pharmaceutical has already demonstrated a bioequivalence of its pitavastatin+ezetimibe combination," Baek emphasized. "Considering cost-effectiveness, joining one of the three co-development companies will provide benefits." Changes occurred following the 1+3 bioequivalence regulatory policy…"It's our new sales strategy" Sinil Pharmaceutical strategized this approach following the 1+3 bioequivalence regulatory policy, which the government implemented in July 2021. The policy requires that a bioequivalence document can be used up to three times when a manufacturing plant produces a pharmaceutical that is equivalent to one for which a pharmaceutical company conducted a bioequivalence test. Only four generics can receive approval based on a single bioequivalence test. After the implementation of the policy, CMO companies faced significant changes, Sinil Pharmaceutical likewise. Concerns have risen in the company that profitability could be lowered because the company can appoint only three CMOs companies. "Sinil Pharmaceutical has been actively developing first-generics," Baek said. "After the implementation of the 1+3 policy, the company had to find a different sales approach for its CMO business." Baek explained, "Recruiting only three CMO companies can hinder development, but on the bright side, expanding to technology sales can be a win-win strategy for both CMO and consignment companies." Sinil Pharmaceutical plans to expand its business field based on the current joint development·technology transfer experience. "We have tried technology transfer of previously manufactured products after the implementation of the 1+3 policy. However, we had difficulty starting a business because too much information had already been shared," Baek said. "For a new product, it is different. We plan to pursue technology transfer sales for a new product actively."
- Company
- Difficulty expanding indications for antibody-drug conjugate
- by Moon, sung-ho Oct 30, 2024 05:54am
- Drug candidates that received much expectation as next-generation antibody-drug conjugates (ADCs) based on the success of Enhertu are on a struggling path to reimbursement in Korea. Although the companies aimed to expand the scope of coverage of their drugs based on their effectiveness in specific cancer types, the expectations damped somewhat due to the disappointing clinical research results. Nevertheless, the domestic and international pharmaceutical and bio industries are attempting to develop new drugs by starting clinical research on the combined use of ADCs and immuno-oncology drugs. The TROP-2 class of drugs has been receiving the most attention as the next generation of ADCs in the global pharmaceutical and biotechnology industries and clinical sites. The leading products in the market include TRODELVY® (sacituzumab govitecan-hziy, Gilead), and datopotamab deruxtecan (AstraZeneca, Daiichi Sankyo). However, these candidates have recently struggled to expand their indications. According to industry sources on the 25th, Gilead recently formalized the ‘abandonment’ of its application to expand Trodelvy’s indication to urothelial cancer in consultation with the US Food and Drug Administration (FDA). Troldelvy binds to the Trop-2 protein, which is highly expressed in a variety of cancers including breast cancer, and releases the drug inside the tumor cells, destroying not only the tumor cells but also the tumor microenvironment, with minimal impact on healthy cells. Currently, it has demonstrated efficacy in advanced triple-negative breast cancer (TNBC) and HR+/HER- breast cancer. However, the company abandoned its other promising indication - urothelial carcinoma. The company failed to demonstrate overall survival (OS) in the TROPiCS-04 study, a Phase III confirmatory trial that was part of the conditional approval. The Keytruda (pembrolizumab, MSD) and Padcev (enfortumab vedotin, Astellas) combination therapy, which has been introduced in Korea as a first-line treatment option for urothelial carcinoma, stood out in the trial, demonstrating its relative effect. Another TROP-2 class ADC, datopotamab deruxtecan, Dato-DXd, is also facing difficulties. The final OS analysis HR+/HER2 low- or negative-expressing breast cancer did not show a statistically significant improvement over chemotherapy. At the same time, it failed to achieve statistical significance in OS compared to docetaxel in advanced/metastatic NSCLC. Following the failure of Trodelvy in demonstrating survival benefits in metastatic stage IV NSCLC, datopotamab deruxtecan is also struggling to gain traction in the lung cancer space. However, AstraZeneca and Daiichi Sankyo have applied to the FDA for the approval of datopotamab deruxtecan for advanced/metastatic non-squamous NSCLC, as they believe it could be a new treatment option. As such, the FDA is expected to make a decision on whether to approve datopotamab deruxtecan for NSCLC by December 20th. Dr. Min-Hee Hong, professor of Medical Oncology at Severance Hospital, said, “If you think about the role of ADCs in NSCLC, nothing has been approved so far. “However, if you look at Trop-2-targeted ADC studies, there is some talk that some subgroup analysis results were good. But whether the company can get FDA approval with the data remains in question, as it didn't meet its primary endpoint.” “I think it shows what we call “cherry picking” in the medical community, where they're really cherry-picking the data that they want to show, so I think it's fair to say that there's no approved drug and no role for the drug at this point. But we'll have to wait and see because the FDA’s decision hasn't been announced yet.” While global pharmaceutical companies' next-generation ADC candidates are struggling to expand their scope, the domestic pharmaceutical and biotech industry's presence in ADC development has been growing. The Korean pharmaceutical and biotechnology industries are attempting various clinical trials with the combination of ADCs and immuno-oncology drugs, which are being actively conducted around the world and are leading to actual technology export results. Gilead, AstraZeneca, and Daiichi Sankyo are already attempting clinical studies with immuno-oncology drugs such as Keytruda or Imfinzi (durvalumab) in combination with Trodelvy and datopotamab deruxtecan. One representative domestic company is LigaChem Biosciences. LigaChem Biosciences is a company specializing in ADC development that has signed a total of 10 technology transfer agreements. Starting with the technology transfer to China's Fosun Pharma in 2015, the company successfully exported its LCB84 technology to Janssen in December last year. LCB84 is an ADC candidate that can target various solid cancers, including triple-negative breast cancer and non-small cell lung cancer. LigaChem Biosciences also recently announced that it has signed 2 technology transfer agreements with Japan's Ono Pharmaceutical Industries, including LCB97, which targets the L1CAM protein. The total value of the two agreements is worth over USD 700 million (KRW 943.5 billion), with the specific upfront payment amount undisclosed as per the parties' agreement. LCB97 targets L1CAM, a protein expressed in several solid tumors, including lung, pancreatic, and colorectal cancers. In February of last year, LigaChem Biosciences entered into a research and development agreement with Elthera AG in Switzerland for the L1CAM antibody, securing worldwide rights, including for ADC use. In addition, various domestic biotech companies such as NeoImmuneTech and TXINNO Bioscience are attempting clinical research with the concept of ADC and immuno-oncology combination therapy. A domestic pharmaceutical and biotech industry official said, “The success of the Padcev+Keytruda combination attracted much attention to the combination of ADCs and immuno-oncology drugs. And the combination’s reimbursement is gaining great interest in Korea. Although it has no commercialized items yet, LigaChem Biosciences gained attention for signing licensing agreements with global big pharma companies such as Ono Pharmaceutical, Janssen, and Amgen. This is because ADCs are being regarded as the next cash cow in the global market.”
- Policy
- Gvnt agrees on the need for dispensing substitute drugs
- by Lee, Jeong-Hwan Oct 30, 2024 05:54am
- In this year's NA Audit, the Minister of Health and Welfare Kyoo-Hong Cho said that he would prioritize the ‘dispensing of substitute drugs’ as a solution to the problem of unstable supply of medicines such as cold medicines that are often out of stock. Two bills related to alternative dispensing were submitted to the National Assembly on the 28th, including a bill to amend the Pharmaceutical Affairs Act, which was introduced as representative by Rep. Byung-Duk Kim and Rep. Soo-Jin Lee of the Democratic Party of Korea. The bills aim to enable pharmacy pharmacists to substitute prescribed drugs with other generic versions that have undergone bioequivalence tests certified by the head of the Ministry of Food and Drug Safety as having the same ingredients, formulation, and dosage as the drug listed in the doctor's prescription. By clarifying whether or not a pharmacist should notify the doctor of the substitution, the bill is intended to promote information sharing among pharmacists and improve convenience in prescribing and dispensing medicines. Specifically, Rep. Byung-Duk Kim's bill expands the post-notification subject for the pharmacists’ dispensing of substitute drugs to the Health Insurance Review and Assessment Service, while Rep. Soo-Jin’s bill expands the notification to HIRA and changes to the term from “dispensing of substitute drugs” to “international nonproprietary name prescriptions.” The 22nd National Assembly is regarded as being more proactive in addressing the issue of the unstable supply of drugs by changing the substitute dispensing method, as it has introduced 2 bills to activate the practice early in its term, compared to the 1 bill submitted during the 21st National Assembly. In addition, Rep. Young-Seok Seo and Rep. Yoon Kim of the Democratic Party of Korea are also considering legislation to streamline the dispensing of substitute drugs and international nonproprietary name prescriptions, so there is a possibility that more related legislation will be introduced in the future. In addition, Minister Cho is expected to actively participate in the parliamentary review of relevant legislation, as he had cited the promotion of dispensing substitute drugs as a solution to the unstable supply and demand of drugs after the COVID-19 pandemic. However, opposition from the medical community is one barrier that must be overcome. Doctors argue that increasing substitute dispensing could adversely affect patient health, as different products with the same ingredients, whether original or generic, can have different clinical effects when taken by patients. Nevertheless, lawmakers who agree with the need to promote dispensing substitute drugs say that the legislation is essential to overcome the 5-year-long problem of unstable drug supply. Some doctors find it difficult to understand why the government would consider promoting dispensing substitute drugs, which can hinder public health when it is already operating an incentive system that provides incentives to pharmacies for dispensing low-cost substitute drugs. “We shouldn't have another case of stalled legislation due to inter-functional differences among professionals about dispensing substitute drugs,’ said an official from the Health and Welfare Committee, adding, “The problem of unstable drug supply and demand has been infringing on the public's access to medicines for several years now, deteriorating public health.” “Many Health and Welfare committee members are in agreement with the need for legislation, and some are considering expanding the scope of INN prescriptions,” said the official, “As Minister Cho answered in the NA Audit that he will prioritize INN prescriptions, we plan to focus on passing the legislation together with the MOHW.”
- Company
- Dupixent sales skyrocket with 'expanded indications'
- by Son, Hyung Min Oct 30, 2024 05:54am
- Sales for 'Dupixent,' a biological agent developed by Sanofi, continue to skyrocket. Net sales for Dupixent from Q1 to Q3 of 2024 reached 10 billion euros. The analysis suggests that Dupixent's added indications to treat various immune diseases, including atopic dermatitis, asthma, esophagitis, and chronic obstructive pulmonary disease (COPD), have contributed to its continued sales increase. According to Sanofi's performance report on October 29, Dupixent's Q3 global sales amounted to 3.476 billion euros (about KRW 5.2 trillion), up 18.1% year-over-year (YoY). Dupixent's sales for 2024 were 9.614 billion euros (about KRW 14.4 trillion), up 24.5% compared to Q3 of last year. Dupixent After recording 2.835 billion euros in Q1 2024, it surpassed 3 billion euros in Q2. Dupixent generated 3.476 billion euros in Q3, up 115.4% compared to 1.614 billion euros in Q1 2022. Dupixent is the first biological agent to target the signaling transmission of interleukin (IL)-4 and IL-13, which are the main causes of type 2 inflammation. Dupixent was developed from a global collaboration agreement between Sanofi and Regeneron Pharmaceuticals. The drug received marketing authorization as a treatment for atopic dermatitis in various countries, including South Korea, the United States, Canada, Europe, Japan, and Australia. Launched in the global market in 2018, Dupixent continues to generate sales growth. After recording 107 million euros in Q1 2018, it generated more than 1 billion euros (about KRW 1.5 trillion) in Q1 2022. Since then, Dupixent has grown into a blockbuster drug with annual sales of more than 10 billion euros (about KRW 15 trillion). Sanofi expects Dupixent's yearly sales to reach around 13 billion euros this year. Confirmed safety and efficacy…added indications contributing to sales hike Dupixent, SanofiDupixent is regarded as a biological agent that has proven extended efficacy and safety. Unlike conventional immune inhibitors, this drug reduced the number of side effects in clinical and real-world data. It has the efficacy in targeting only the inflammatory responses of Th2 cells. Biologics are medicines that are manufactured based on pathogenic microorganisms such as proteins, antibodies, nucleotides, and cells. This agent effectively targets proteins and cells to treat diseases, and it has the advantage of lowering side effects compared to chemical agents. Dupixent's other advantage is its continued addition of indications. In 2017, the U.S. Food and Drug Administration (FDA) granted approval to Dupixent for its indication to treat atopic dermatitis. The following year, it expanded prescription areas to treat patients with moderate or higher symptoms. In the United States, Dupixent is the only asthma drug to target all ages. Since then, Dupixent has expanded the scope of approval to various immune diseases, including chronic sinusitis with nasal polyps, nodular rashes, and eosinophilic esophagitis. Dupixent has recently added an indication to treat COPT. On October 27, the FDA approved Dupixent for the treatment of COPD. Dupixent is the first biological agent to secure a COPD indication. Dupixent has shown strength in diseases triggered by type 2 inflammation, from atopic dermatitis to asthma, chronic sinusitis with nasal polyps, and eosinophilic esophagitis. It is expected to add additional indications for diseases caused by similar mechanisms. Currently, Sanofi is conducting a Phase 3 clinical study of Dupixent, aiming to secure indications to treat chronic idiopathic urticaria (CSU), chronic pruritus (CPUO), and bullous pemphigus (BP).
