- LOGIN
- MemberShip
- 2026-04-07 09:51:38
- Company
- KOD will service platform for epilepsy patients next year
- by Lee, Tak-Sun Jun 28, 2024 04:33am
- A platform for epilepsy patients and healthcare professionals will soon be launched in Korea. Japan's Knock on the Door (KOD) announced in May that it has established its branch in Seoul and is preparing to launch the service next year. KOD was established in Tokyo, Japan, in 2018 with the goal of "Realizing a society where patients with intractable diseases and their families can shine and always stay true to themselves.” Hiroomi Hayashi, Representative Director of KOD, said, “To achieve this goal, we provide a platform where we work with patients with intractable diseases and their families to improve their medical care, life, and quality of life.” Specifically, KOD has built a platform for Japanese patients with intractable epilepsy. The platform includes "nanacara," an application that allows patients to record symptoms such as seizures and medication information, "nanacara for Dr.," which allows specialists to check the information recorded by patients and their families during medical visits, and "nana-medi," an online medical consultation and medication guidance service that allows patients to connect with specialists and pharmacists anywhere in the country. Director Hayashi explained, "By leveraging our accumulated data and network of patients, families, and doctors that use Nanacara, we provide solutions to pharmaceutical companies to help improve the quality of medical care for intractable diseases. We strive to create a society where high-quality medical care can be quickly accessed anywhere in Japan." Currently, there are approximately 1 million people with epilepsy in Japan. Approximately 300,000 are intractable epilepsy patients and approximately 100,000 are pediatric intractable epilepsy patients. There are about 900 epilepsy specialists in Japan, affiliated with 450 medical institutions. Currently, about 30,000 people in Japan have downloaded and used Nanacara, mainly pediatric intractable epilepsy patients and their families. This is around 30% of the affected patients in Japan. In addition, 265 of the approximately 450 medical institutions with epilepsy specialists have adopted Nanacara for Dr., which represents a 60% share. Director Hayashi said, “Through these platforms, we can now more easily and accurately measure the patients' seizure records and facilitate smoother communication with healthcare professionals in their institutions. Many patients and their families have also gained physical and mental relief with the use of our platform.” KOD began communicating with epilepsy patients and families in Korea last year. During the discussions, the company identified the need to document seizure records and rapid delivery of information amongst Korean patients as well. To address the need, KOD established a branch office in Seoul in May and is preparing to launch the service in 2025. In Korea, Nanacara will be rebranded as 'Borabora.’ Director Hayashi added, "We want to create an environment in Korea where more people can support people with epilepsy, and where people with epilepsy can live true to themselves. We hope that many people in Korea will use the platform and contribute to establishing an environment where patients can continue living a rewarding and valuable life.” KOD also participated in the International Epilepsy Congress that was held in Seoul from the 21st to the 22nd and held a booth presentation for Nanacara. During the exhibition, we received many opinions from Korean epileptologists. Building on the input, we will begin preparations to make Nanacara for Dr. available to Korean epileptologists as well. "We will also actively promote cooperation with related pharmaceutical companies that develop and provide anti-epileptic drugs in Korea. We hope our collective efforts will contribute to the development of medical care for epilepsy in Korea."
- Company
- MSD seeks to expand NIP subjects for Gardasil
- by Hwang, Byung-woo Jun 28, 2024 04:33am
- With the aim of expanding coverage of its human papillomavirus (HPV) vaccine within the National Immunization Program (NIP), MSD Korea has been working to improve its vaccine awareness. Expanding NIP coverage of the HPV vaccine is one of the hot topics on the government's agenda. In fact, it was ranked the third-most important task in the 'Establishing a Mid- to Long-term Plan for the National Immunization Program' study. MSD KoreaHowever, the fact that the government has set limits on the cost and subject is acting as an obstacle. According to the study, the issues discussed expanding NIP coverage to 'vaccination of girls under 12 years of age with Gardasil 9' and 'vaccination of boys under 12 years of age'. In the study, expanding vaccination of Gardasil 9 to 12-year-old girls ranked third in the overall priority list. However, vaccinating 12-year-old boys with Gardasil 9 was set as the sixth priority. The researchers differentiated the priority for the same vaccine by subject. Against this backdrop, MSD Korea has been emphasizing the need for HPV vaccination in both boys and girls At a conference held in late May, MSD Korea mentioned that 33 out of the 38 Organization for Economic Co-operation and Development (OECD) countries (as of April 24, 2014) have introduced NIP for male HPV vaccinations. Sei-Young Lee, Professor of Otolaryngology and Head-and-Neck Surgery at Chung-Ang University Hospital, said, "In men, HPV-related cancers and diseases on the rise globally, and their effect in increasing disease burden and reducing the quality of life are being undermined. Korea's male HPV vaccination rate is in the single digits, which is far below that of Australia and the United Kingdom, which have been actively carrying out HPV prevention programs." In this situation, MSD Korea is trying to build awareness of the need through social media activities. In addition to the top-down approach of emphasizing the need for HPV vaccination through pharmaceutical companies and academic communities, MSD is also working on a bottom-up approach, increasing awareness of the need for Garadsil’s coverage through NIP amongst vaccine recipients. The company has been promoting the need for HPV vaccination through social media outlets that are occupied by young people during the back-to-school season, coming-of-age day, etc. The key message is that both men and women need to be vaccinated. Pic of Gardasil 9An industry official said, "The ultimate aim for most vaccines is to be included in the NIP, so MSD Korea is constantly knocking on the door for expanded NIP coverage for Gardasil 9. Awareness-raising activities can be cumbersome as even social media posts are subject to advertising review, but the company seems to have recognized the need to increase awareness." According to the drug research institution IQVIA, Gardasil 9’s sales grew to KRW 72.6 billion in 2021, and to KRW 117 billion in 2022, then fell to KRW 106.4 billion last year. If the NIP is only applied to HPV vaccines vaccinated to women, and the product is switched to Gardasil 9, its sales could further decrease due to lowered supply prices. In other words, apart from including male HPV vaccinations in the NIP, the company would need to build awareness of its needs. An industry insider said, "If Gardasil 9 is included in the NIP, the government’s supply price will have to be lower than the current market price. If the NIP vaccination covers boys, the reduced price will be offset by the increased coverage. Even if MSD's best-case scenario of expanding coverage to both genders does not become realized, improving awareness would be essential for sales."
- Company
- Spinraza tops Q1 revenue in SMA mkt with KRW 17.7 billion
- by Nho, Byung Chul Jun 28, 2024 04:32am
- (From the left) Spinraxa Inj, Zolgensma Inj, and Evrysdi for spinal muscular atrophy Biogen Korea's Spinraza remains the No. 1 drug for spinal muscular atrophy (SMA) in the KRW 80 billion market. However, its performance has been somewhat sluggish due to the launch of competitors such as Roche Korea’s Evrysdi and Novartis’s Zolgensma. In terms of drug distribution performance, Spinraza's sales in Q1 of this year were KRW 17.7 billion, 9 to 14 times higher than that of Zolgensma (KRW 1.8 billion) and Evrysdi (KRW 1.2 billion). Sales of Spinraza (nusinersen sodium) were in the range of KRW 72.2 billion, KRW 61.2 billion, KRW 62.3 billion, and KRW 58.9 billion, in 2020, 2021, 2022, and 2023, respectively. Zolgensma (onasemnogene abeparvovec), which was approved in Korea in 2021 sold KRW 16.2 billion and KRW 14.4 billion in 2022 and 2023, respectively. Evrysdi (risdiplam), which was approved by the MFDS in 2020 generated KRW 600 million and KRW 1.123 billion during the same period. What is unusual is that Zolgensma exceeded last year's sales in just the first quarter of this year, while Evrysdi’s sales tend to be somewhat sluggish in terms of quarterly results alone. Spinraza (5m), Evrysdi (80ml), and Zolgensma (1 kit) are all ultra-high-priced orphan drugs and are priced at KRW 92.35 million, KRW 9.52 million, and KRW 1.98172 billion, respectively. . Spinraza can be administered directly to the central nervous system, where motor neurons are located, through intrathecal injection to deliver the treatment at the source of the disease. It can also be administered in multiple doses, making it easier to monitor clinical outcomes. Based on clinical study data and real-world evidence (RWE) accumulated over up to 8 years of treatment, the treatment has confirmed sustained efficacy and safety profile across all ages and types of patients. In addition, its reimbursement extension to patients with Type 3 SMA who have developed symptoms after the age of 3 is working in favor of the drug. As a one-shot treatment, Zolgensma works by inserting a functional replacement copy of the SMN1 gene into a carrier called a vector and delivering it to motor neuron cells in the body via intravenous infusion. The disadvantage is that it is difficult to administer multiple doses to patients who cannot be treated with a single dose.
- Policy
- Gov't releases generic drug price comparison study results
- by Lee, Tak-Sun Jun 27, 2024 05:47am
- The government's decision to fully disclose the 'Study on Measures to Improve the Generic Drug Pricing System,' which ended in April, ahead of the final meeting for the external reference pricing reevaluations, is being analyzed as a sign that the authorities intend to push ahead its plan to cut generic drug price through reevaluations. In particular, the industry believes the government is using media to publicize the study findings that the generic drug price is up to 10 times more expensive in Korea than in other countries, excluding the U.S., as a means to justify the reevaluation. According to industry sources on the 25th, the 10th meeting on the external reference pricing reevaluations is scheduled for the 27th. The government is reportedly planning to finalize the process of collecting opinions from the pharmaceutical industry within this month. Therefore, the 10th meeting is expected to be the final meeting between the government and the industry. In this situation, there are voices that the recently released study on how to improve the generic drug pricing system is just the government’s means to justify its plan for external reference pricing reevaluations. The study compared drug prices with the A7 countries (Canada, France, Germany, Italy, Japan, Switzerland, and the United Kingdom), excluding the United States, where generic prices are relatively high. As a result, as of 2022, the price of hyperlipidemia generics in most countries was 0.09 to 0.41 times cheaper than those in Korea. However, the study concluded that the comparison of Korean generic drug prices with those of A8 countries showed differences by efficacy group and API and that there is a limit to unilaterally applying price cuts to generic drugs. The pharmaceutical industry analyzes that the comparison of drug prices excluding the U.S. used in the study is similar to the recent government's proposed external reference pricing reevaluation, which suggested using an adjusted average price that excludes the highest and lowest prices among the A8 countries. This is because excluding the highest price removes the U.S. price, which has the highest generic drug prices, from the comparison. As shown in the study, excluding the U.S. price will lead to Korea having relatively high prices for hyperlipidemia drugs, and domestic pharmaceutical companies are concerned that the performance of related generic drugs will suffer from the price cuts that may follow. An industry official said, "Off-patent drugs can become cheaper abroad than in Korea over time. In foreign countries, generics occupy a higher market share than the original over time, so they can maintain sales even at the lowered price." On the other hand, the industry official explained that there is no difference between Korea and the A8 countries when comparing generics that newly entered the market upon patent expiry. "It is problematic to compare overall prices based on only one aspect when generic prices vary depending on the time of launch or disease. We should be giving incentives to increase the generic drugs’ market share and grow the market pie like foreign countries." The study also proposed the creation of a market structure that allows generic drugs to gain competitiveness. For example, in order to create a drug pricing structure where drug prices can be reduced over time after generics enter the market, it is necessary to strengthen not only the pricing policies used at the time of drug listing but also policies to encourage the use of low-priced products in the field. However, the government will likely first focus on lowering domestic generic prices through external reference pricing system.
- Company
- 'Increased' competitiveness in autoimmune diseases
- by Son, Hyung-Min Jun 27, 2024 05:47am
- The Korean biopharmaceutical industry is successfully signing license agreements of drugs for autoimmune diseases. HK inno. N, IMBiologics, and Y-Biologics have signed license agreements for their jointly developed novel drug candidates. AprilBio has also signed a license agreement for a novel drug candidate that has shown efficacy in a phase 1 trial. This is not the first time Korean companies have successfully entered into license agreements for novel drugs for autoimmune diseases. LG Chem, Voronoi, Hanall Biopharma, and Daewoong have also completed technology transfers overseas. Even after out-licensing, these treatments have demonstrated efficacy, confirming South Korea’s R&D capacity. Autoimmune diseases occur when the body’s immune system attacks healthy cells after mistakenly recognizing them as antigens rather than exterior antigens, such as germs and viruses. Since the cause of these diseases is still unknown, targeted treatments are not available. As a result, there is an unmet need for more new treatment options. According to industry sources on June 25th, HK inno. N signed a license agreement with Navigator Medicines, a U.S. new drug development company, for 'IMB-101,' a novel drug candidate for the treatment of autoimmune diseases. The contract totaled US$940 million (approximately KRW 1.3 trillion), including an up-front payment of US$20 million (KRW 27.6 billion). Navigator Medicines secured global development and sales rights through this agreement, excluding Asia. IMB-101 was jointly developed by HK inno. N and Y-Biologics in 2016, and it was transferred to IM Biologics in 2020. The current agreement was led by IM Biologics, a bioventure company established by people who worked at HK inno.N. IMB-101 is a novel bispecific antibody candidate that is designed to target both OX40L and TNF, simultaneously modulating adaptive and innate immune responses. OX40L pathway is involved in activating T cells, and TNF is a cell signaling protein involved in immune responses. Until now, no novel drugs have targeted both OX40L and TNF. IBM-101 and Sanofi’s SAR442970, in a phase 2 trial, are the only two novel drug candidates that have entered clinical trials. IM Biologics received approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 1 trials for 'IMB-101' in August of last year. The company is currently conducting a Phase 1 trial. Phase 1 trial will evaluate the safety and drug tolerance of the drug in healthy adults and in patients with autoimmune diseases. AprilBio has also successfully signed a license agreement with Evommune, a novel drug development company in the United States, for 'APB-R3,' a novel drug candidate for the treatment of autoimmune diseases. The deal was valued at a total amount of up to US$475 million (approximately KRW 655 billion), including a non-refundable up-front payment of US$15 million (KRW 20.7 billion). The sales royalty will be paid separately. APB-R3 is a biologics candidate targeting interleukin (IL)-18. So far, there are no commercialized products with similar mechanisms of action. Once APB-R3 is commercialized, it will become the first-in-class. AprilBio has confirmed the drug tolerance and safety of APB-R3 in a phase 1 trial. Evommune plans to conduct a phase 2 trial of APB-R3 in the first half of next year. This marks the second time AprilBio has signed a license agreement for novel drug candidates for treating autoimmune diseases. In 2021, it out-licensed APB-A1 to Danish pharmaceutical company Lundbeck for US$448 million (approximately KRW 540 billion). APB-A1 is a novel drug candidate that inhibits CD40L.. CD40L is commonly expressed in activated T-cells due to inflammations. When T Cells’ CD40L binds to CD40 of natural killer cells, large quantities of cytokines are released. APB-A1 works by targeting CD40, inhibiting the formation of cytokine-releasing antibodies through B cells and natural killer cells. Now, UCB’s dapirolizumab and the U.S. biotech company Horizon Therapeutics’ Dazodalibep are under development with mechanisms of action similar to APB-A1. Increased out-licensing of novel drugs for autoimmune diseases…clinical trials are making good progress Clinical trials conducted by companies that have developed novel drug candidates for autoimmune diseases are going well. Hanall Biopharma is developing a subcutaneous formulation of a drug candidate for FcRn antibody therapy batoclimab (HL161). In 2017, Hanall Biopharma out-licensed HL161, a drug candidate for the treatment of autoimmune diseases, to Roivant Sciences, a Swiss company that also owns Immunovant. The company is investigating the potential of batoclimab for treating various autoimmune diseases, including myasthenia gravis (MG), thyroid eye disease (TED), immune thrombocytopenic purpura (ITP), neuromyelitis optica (NMO), and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The efficacy of batoclimab has been confirmed in a phase 2 trial, and it is currently undergoing multinational phase 3 trials. Hanall Biopharma plans to present its top-line results within this year. LG Chem is developing an autoimmune disease pipeline, ‘LC510255.’ In 2021, the company successfully out-licensed the pipeline to China’s TransThera Biosciences. The drug is undergoing a phase 2 trial involving patients with ulcerative colitis and atopic dermatitis. The drug tolerance and satey of LC510255 have been confirmed in a phase 1 trial. Daewoong Pharmaceutical is developing a novel drug called 'DWP213388' for the treatment of autoimmune diseases. DWP213388 has a bispecific mechanism of inhibiting both BTK and ITK, which are involved in activating immune cells such as B cells and T Cells. The phase 1 trial is being conducted in the United States. Daewoong Pharmaceutical has proven its potential by signing a global license agreement with Vitalli Bio of the United States for DWP213388 at the Korea-U.S. Digital and Bio-Health Business Forum, which was held in Boston, U.S., last year. The agreement amounted to US$477 million, including an up-front payment of US$11 million, excluding a royalty payment.
- Policy
- Some Akynzeo products recalled due to insufficient API
- by Lee, Hye-Kyung Jun 27, 2024 05:47am
- The Ministry of Food and Drug Safety (MFDS) recalled some lot numbers of HK Inno.N's antiemetic ‘Akynzeo Cap’ after confirming the possibility that the drug may not contain enough active pharmaceutical ingredient (API). On the 21st, the MFDS issued a recall order for Akynzeo batch number '43000563 [2026-11-30].’ The reason for the recall was the possibility of the drug lacking some of its API (palonosetron hydrochloride). HK Inno.N also informed wholesalers of the voluntary recall of Akynzeo and asked them to send the drug back to the warehouses of companies that have the affected product. HK Inno.N imported Akynzeo from the Swiss pharmaceutical company Helsinn. It is indicated for the prevention of initial nausea and vomiting or the prevention of acute and delayed nausea and vomiting induced by repeated treatment in adults receiving moderate emetogenic cancer chemotherapy. It contains fosnetupitant (as chloride hydrochloride) and palonosetron hydrochloride, which work by inhibiting neural pathways involved in nausea and vomiting. Both ingredients have a long plasma half-life, making them effective antiemetic agents.
- Company
- New drug 'Mylotarg' for AML makes another attempt at reimb
- by Eo, Yun-Ho Jun 27, 2024 05:47am
- Pfizer Korea’s Mylotarg (gemtuzumab ozogamicin), a treatment for acute myeloid leukemia (AML). A new drug 'Mylotarg' for the treatment of acute myeloid leukemia (AML) is making another attempt to obtain insurance reimbursement listing. According to industry sources, Pfizer Korea has recently reapplied for reimbursement review for Mylotarg (gemtuzumab ozogamicin), a treatment for acute myeloid leukemia (AML). In May 2022, Mylotarg was considered for review by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA). However, it received a decision of unestablished reimbursement criteria. It passed the Cancer Disease Review Committee review in October last year, but the subsequent decision was canceled. It is to be watched whether Mylotarg, which previously failed, will successfully acquire the listing this round. This drug is an antibody-drug conjugate (ADC) that can be used for the first-line treatment of newly diagnosed adult patients with CD33-positive AML. Mylotarg received approval in South Korea in December 2021. It is an ADC made of a CD33-targeting monoclonal antibody and calicheamicin. Mylotarg works in CD33-antigen-expressing cells found in 90% of all AML patients. The drug blocks the cancer cell growth and induces cell death through this mechanism. The basis of Mylotarg was a clinical trial involving 271 AML patients, aged between 50 and 70 years, who had not received any treatment before and were newly diagnosed. ALFA-0701 clinical trial of Mylotarg was conducted as an open-label, randomized, multi-center Phase 3 trial. The trial compared the conventional chemotherapy of daunorubicin plus cytarabine to the combination therapy of Mylotarg plus daunorubicin plus cytarabine. The result showed that the Mylotarg plus daunorubicin plus cytarabine combination therapy group had a median event-free survival (EFS) of 17.3 months, which was 7.8 months longer than 9.5 months of the daunorubicin plus cytarabine combination therapy group. It also reduced the risks of induction failure, relapse, or death by approximately 44%. The Mylotarg plus daunorubicin plus cytarabine combination therapy group had a median relapse-free survival (RFS) of 28.0 months, whereas the daunorubicin plus cytarabine combination therapy group had an RFS of 11.4 months, showing a significant difference of approximately 16.6 months. Furthermore, the Mylotarg plus daunorubicin plus cytarabine combination therapy group had an overall survival (OS) of 27.5 months, whereas the daunorubicin plus cytarabine combination therapy group had an OS of 21.8 months, indicating no statistical significance.
- InterView
- ‘Leqembi enables prevention of Alzheimer's disease’
- by Son, Hyung-Min Jun 27, 2024 05:47am
- Duk Lyul Na, Director of the Happymind Clinic (former Professor of Neurology at Samsung Medical Center,), "Now that there is a treatment for Alzheimer's disease, we can prevent dementia by 90% if it is detected early. With better drugs expected to be developed in the future, we should provide timely treatment for the patients so they can live to grasp that new opportunity." Duk Lyul Na, Director of the Happymind Clinic (former Professor of Neurology at Samsung Medical Center,), stressed the importance of treating Alzheimer's disease early during a meeting with Dailypharm. Alzheimer's disease has been one of the unexplored areas of treatment. Since the hypothesis that Alzheimer's disease is caused by amyloid beta emerged, drugs targeting amyloid beta were developed, to no effect. One such drug was Eisai’s Aduhelm (aducanumab). Because the amyloid beta hypothesis was first received with doubt at the time, there was not much trust in the drug, but it showed an effect. However, Aduhelm was withdrawn from the market due to its high price and concerns about side effects. Then came Leqembi (lecanemab-irmb). Developed by Eisai and Biogen, Leqembi has shown efficacy in early-stage Alzheimer's disease in clinical trials and has cleared the regulatory hurdles in South Korea, the United States, Japan, and China. The introduction of Leqembi has raised hopes of conquering dementia by allowing a more fundamental treatment that goes beyond symptom relief. Director Na emphasized that treatments that target amyloid beta are more likely to make a difference than those that do not, and that starting treatment at the earliest stages of dementia is key to maximizing the treatment effect. Leqembi delays disease progression by 27% in phase III trial Leqembi, the first drug approved in Korea, was shown to delay the rate of Alzheimer's disease progression by 27% compared to placebo in the Phase 3 Clarity AD study. The study compared the efficacy and safety of Leqembi versus placebo in 1,795 patients aged 50 to 90 years with early Alzheimer's disease who had evidence of brain amyloid accumulation on positron emission tomography (PET) or cerebrospinal fluid tests. Study results showed that the primary endpoint, the Clinical. Dementia Rating Sum of Boxes (CDR-SB) score at 18 months post-dose, was 1.21 in the Leqembi arm. This was lower than the 1.66 recorded by the placebo group. Higher scores indicate worse symptoms. One of the secondary endpoints, change in amyloid deposition via PET, was also reduced in the Leqembi arm starting at 3 months after administration. "In other diseases, such as diabetes and cancer, patients often get better with treatment, but in brain diseases, stopping disease progression is near a miracle. The 27% effect in slowing disease progression compared to placebo includes patients with mild cognitive impairment and early Alzheimer’s type dementia. If treatment is started at an earlier stage, we expect the effect to be greater.” But there are concerns about side effects. In the trial, Leqembi’s incidence of ARIA-E with cerebral edema was 12.6%, and ARIA-H with cerebral hemorrhage was 17.3%. "Aducanumab, which was introduced before Leqembi, had a reported ARIA-E rate in the 40% range, but in the real world, the rate was about 19%, not as high as in clinical studies. In the field, the dose was increased more slowly than standard and patients were monitored via MRI every month, so we were able to respond early to side effects " "Therefore, Leqembi’s side effects can also be managed by closely monitoring patients and proactive management. For reference, the high cost of MRI in the U.S. makes it difficult to perform frequent MRI tests, but Korea has a relatively favorable environment for frequent testing." "First new drug for Alzheimer’s in Korea...Early Alzheimer's patients should be treated aggressively with the drug” Director Na stressed how patients should be aggressively treated with the introduction of the first new drug for Alzheimer's disease. According to Dr. Na, the treatment effect for Alzheimer's disease is not high if it is detected and treated at the middle or early to mid-stage of the disease. "If there is even a small amount of brain atrophy found via MRI, there is a high probability that the amyloid PET test will be positive. Therefore, if you can afford it, I recommend taking the APOE gene test. Depending on the results, you can confirm Alzheimer's lesions with an amyloid PET test. The best option is to remove amyloid beta from the brain while the patient’s cognitive function is still normal." "The earlier we can treat the disease, the less financial and disease burden it can cause. Also, if we can maintain the disease without progression, another opportunity may come for the patients to be treated when new therapies become available." In particular, Na noted that if the disease is left untreated in the early stages, it can become more costly and distressing for the patients and their families. Treatment with lecanemab is expected to cost KRW 20 to 30 million annually. If the patient starts treatment in the early stages of Alzheimer's disease when there are no symptoms and the amyloid beta is cleared, the cost spent will be enough to cure the condition. However, if symptoms appear and the disease progresses to dementia, it is likely to cost an additional KRW 300 to 500 million per month in care costs alone. Na explained, “I have been treating dementia patients for more than 30 years, and I have seen how dire the situation is for patients with amyloid beta accumulation in the brain. In practice, the ratio of positive and negative amyloid PET scans in patients with mild cognitive impairment is about 50 to 50. And the difference between the two patient groups increases over time. As the disease progresses, the friction between patients and their caregivers increases and the burden of care becomes significantly higher. In this sense, Leqembi is an essential treatment that can alleviate the suffering of these families." "We now live in a world where Alzheimer's can be prevented 90% of the time if it is detected in advance. If the patient’s amyloid PET test comes out negative, it is also good as they can enjoy the rest of their life without concern. I ask patients to receive testing in advance and become aware of their condition. This way they can live without vague fears and prevent dementia.”
- Company
- SGLT-2 diabetes drug Jardiance outsells mkt leader Forxiga
- by Nho, Byung Chul Jun 26, 2024 05:47am
- Boehringer Ingelheim's Jardiance and AstraZeneca's Forxiga are striving for mastery of the KRW 110 billion SGLT-2 inhibitor class single-agent diabetes drug market in Korea. In the first quarter of this year, Jardiance and Forxiga generated sales in the range of KRW 11.1 billion and KRW 8.0 billion, respectively. Notably, this is a reversal of fortune for Forxiga, which had held the lead SGLT-2 class drug market for the past 5 years. In 2020-2021-2022-2023, Forxiga was ahead of second-place Jardiance with sales of KRW 32.2 billion, KRW 38.1 billion, KRW 45.4 billion, and KRW 49.9 billion, but in the first quarter of this year, Jardiance outperformed Forxiga by nearly KRW 3 billion. This is likely due to the rumor of AstraZeneca’s market withdrawal of Forxiga in Korea. While news that AstraZeneca's diabetes combinations, including Xigduo (dapagliflozin-metformin) and Sidapvia (dapagliflozin-sitagliptin), will replace the single-agent Forxiga has been around for over 2 years, Forxiga had remained the market leader. If the anticipated withdrawal of Forxiga takes place, sales of its competitor Jardiance will rise, as well as that of less-selling dapagliflozin products. Among dapagliflozin drugs, Forxiga is followed by Boryung’s Trudapa and Hanmi Pharmaceutical's Dapalon, which generated sales of KRW 2.1 billion and KRW 1.6 billion respectively last year. The reimbursement extension granted for Jardiance is also gaining attention. If Forxiga is withdrawn from the market, Jardiance will be the only product that owns 3 indications - diabetes, heart failure, and kidney - among the original drugs. If Jardiance were to gain reimbursement for chronic kidney disease, this would further expand its share in the SGLT-2 inhibitor market. However, AstraZeneca has granted HK Inno.N Forxiga’s clinical data in chronic heart failure and chronic kidney disease. In April, the indication for HK Inno.N's Dapa N Tab was extended to include chronic heart failure and chronic kidney disease. However, the outlook for Jardiance’s performance is not so rosy. A number of domestic pharmaceutical companies are developing a generic version of Jardiance with the goal of releasing it within the first half of next year. Astellas Korea, which generated sales of about KRW 3.7 billion last year, also reported to the MFDS that it will stop supplying its drug in mid-August for business reasons. In March, MSD Korea reported to the MFDS that it would supply Steglatro Tab 5 mg (ertugliflozin L-pyroglutamic acid) until May. The decision was based on declining market demand. SGLT-2 inhibitors inhibit glucose reabsorption in the kidneys, allowing sugar to be excreted in the urine, and have the advantages of being able to control blood sugar while not stimulating the pancreas, and reducing the risk of heart failure. The downside is that as sugar is excreted in the urine, patients become more prone to hypoglycemia and urinary tract infections, both of which are less common. Clinical studies have shown that dapagliflozin-based agents like Forxiga, etc. were associated with a 39% reduction in the composite efficacy endpoint, which was defined as the risk of death from worsening renal function, cardiovascular and renal disease, compared with placebo. Dapagliflozin also reduced cardiovascular death and heart failure exacerbation in chronic heart failure patients with reduced left ventricular systolic function with or without type 2 diabetes. Chronic kidney disease is a severe and progressive disease with a high risk of heart failure and cardiovascular events, and the results above indicate the potential of dapagliflozin as a new treatment option in the area. Jardiance and other empagliflozin drugs have been shown in clinical studies to reduce the incidence of cardiovascular death and hospitalization for heart failure in patients with heart failure with preserved ejection fraction who were receiving standard of care. The study is regarded as the first to show empagliflozin’s effect in patients with heart failure with preserved ejection fraction.
- Boryung’s early release of its Lenvima generic unclear
- by Kim, Jin-Gu Jun 26, 2024 05:46am
- Boryung’s plan to launch a generic version of the liver cancer drug Lenvima (lenvatinib) early to coincide with the expiration of Lenvima’s product patent is facing setbacks. Despite the amount of time spent overcoming the patents, the number of remaining patents seems to be increasing rather than decreasing. With less than a year left before the expiration of the product patent, Boryung has been unable to overcome all the remaining patents. Rather, the original company filed appeals for some of the first-instance decisions that Boryung won, signaling a prolonged dispute. In addition, Boryung recently discovered an unlisted use patent and filed claims to both invalidate and evade the patent. According to industry sources on the 25th, Boryung recently filed for invalidation and passive trial on the scope of rights against Lenvima’s unregistered use patent. The unregistered patent expires in December 2035. The patent relates to the combination therapy of Keytruda and Lenvima. Lenvima is approved for 4 indications ▲locally advanced or metastatic thyroid cancer; ▲first-line treatment of hepatocellular carcinoma; ▲combination therapy with Keytruda in advanced endometrial cancer; and ▲combination therapy with Keytruda as first-line treatment of advanced renal cell carcinoma. The unlisted patents for Lenvima reportedly relate to the third and fourth indications. Lenvima is primarily used to treat liver cancer, but its use has recently been expanded in combination with Keytruda. Given the reimbursement extension potential of the Lenvima+Keytruda combination, it is in Boryung’s long-term interest to overcome the patents before launching its generic version. This explains why Boryung has filed both an invalidation and a passive trial on the scope of rights for Lenvima’s new patent. Boryung’s simultaneous filing of both trials indicates the company’s commitment to overcoming patents related to its use as combination therapy with Keytruda by any possible means. Boryung is challenging Lenvima’s patents across the board, including unregistered use patents. Lenvima was previously protected by 5 patents: a product patent, a use patent, a salt and crystalline form patent, a formulation patent, and a composition patent. Of these, Boryung’s plan was to evade and invalidate 4 patents, all but the product patent that expires in April 2025, and then launch its generic version early. However, the patent dispute over the use of patents is being prolonged, without even a first instance judgment. In November 2022, Boryung filed a request to invalidate Lenvima’s use patent, but nearly a year and a half passed without a ruling made by the Patent Trial and Appeal Board. As for the challenge to the composition patent, Boryung won the first trial, but the original’s company appealed. Boryung filed for the invalidation of the composition patent in August last year and won the first trial in March this year. However, Eisai filed a lawsuit to cancel the ruling to the Intellectual Property High Court last month, claiming that the decision was unjust. For Boryung, there are 3 patents left to overcome with less than a year to go before Lenvima’s material patent expires. Amid Lenvima’s recent sales decline, Boryung's plan to launch a generic upon the expiration of the substance patent is likely to be disrupted. According to the market research institution IQVIA, Lenvima’s sales last year were KRW 10.3 billion, down 24% from KRW 13.6 billion in 2022. Lenvima’s sales steadily increased from KRW 7.5 billion in 2019 to KRW 12.2 billion in 2020, then to KRW 15.8 billion in 2021, but have been declining ever since.
