- LOGIN
- MemberShip
- 2026-05-03 21:03:09
- 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.
- Company
- Another anticancer drug 'Augtyro' set to be launched in KOR
- by Eo, Yun-Ho Jun 26, 2024 05:46am
- Augtyro (repotrectinib), an anticancer drug effective regardless of cancer types. A ROS-1 targeting lung cancer treatment called 'Augtyro' is entering the Korean market. According to the industry sources, Bristol Myers Squibb (BMS) Korea has recently applied for market approval from the Ministry of Food and Drug Safety (MFDS) for its Augtyro (repotrectinib), an anticancer drug effective regardless of cancer types. This drug has been designated as an orphan drug by the MFDS in early June. Augtyro is specifically indicated for ▲the treatment of patients with ROS-1 positive topical advanced or metastatic non-small cell lung cancer (NSCLC) ▲the treatment of patients with NTRK(Neurotrophic tyrosine receptor kinase) fusions in topical advanced, metastatic solid cancer or who have a high likelihood of severe morbidity upon surgical removals. Augtyro initially received U.S. FDA approval for the treatment of NSCLC in November of last year. Its indication for the treatment of solid cancer accompanying NTRK fusions is being processed for approval after having been designated for expedited review in February. The drug’s efficacy was confirmed through multinational Phase 1/2 TRIDENT-1 studies. The results showed that 71 patients who had not previously received TK1 treatments had an objective response rate (ORR), which was the primary endpoint, of 79% after Augtyro treatment. Progression-free survival (PFS) doubled compared to conventional targeted therapy. The ORR was defined by the percentage of patients showing decreased tumor sizes (partial response) or no more cancer symptoms (complete response) during the specified treatment period. The median duration of response (DOR) was 34.1 months. 56 patients who had previously undergone ROS1 TK1 therapy and no chemotherapy had an ORR of 38% and a median DOR of 14.8 months. The study also demonstrated the drug’s effectiveness in patients who had developed drug tolerance to previously administered targeted therapies. 56 patients with drug tolerance had an ORR of 38% and a PFS of 9 months. Notably, 17 patients who acquired G2032R mutation had an ORR of 59% and a PFS of 9.2 months. TRIDENT-1 study was published in the New England Journal of Medicine (NEJM, IF 176.082) with Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital) as the corresponding author. Meanwhile, lung cancers with ROS1 mutation account for 2% of all lung cancers. Conventional therapy includes targeted anticancer therapies that target the mutated gene. The common drugs are 'crizotinib' and 'entrectinib.' 'Repotrectinib' is gaining attention as the next-generation drug.
- Policy
- ‘Hypertension·hyperlipidemia generics are pricier in KOR'
- by Lee, Jeong-Hwan Jun 26, 2024 05:46am
- According to a government study, generic drugs for some indications, such as those for the gastrointestinal system, hypertension, and hyperlipidemia, are more expensive in Korea than in major overseas countries other than the United States, such as the United Kingdom, Switzerland, and Japan. As of 2022, Korean generic hyperlipidemia drugs were more than 10 times more expensive than those in the UK and 3 times more expensive than those in Japan, while those for hypertension were 2 times more expensive than those in the UK and 3 times more expensive than those in Japan. Based on such findings, the study concluded that the government may directly reduce the price of hypertension and hyperlipidemia drugs with more than 20 generic listings. The researchers proposed the government consider a policy that collectively reduces the price of hypertension and hyperlipidemia drugs to 85% of the lowest price when 20 or more items are listed at the same time. In addition, it was suggested that the domestic generic drug price system should be converted to an indirect price reduction structure, in which the drug price is reduced when the number of listed items increases above a certain level. "Domestic generic drugs for gastrointestinal system-hypertension-hyperlipidemia are more expensive than in overseas" The Ministry of Health and Welfare compared the generic drug prices in South Korea with the "A8" countries (the United States, the United Kingdom, Germany, France, Japan, Italy, Canada, and Switzerland) for 323 ingredient-dose drugs that contain 160 ingredients in 5 efficacy groups Specifically, the study compared the Price-to-Consumer (PTC) price rather than the Price-to-Pharmacists (PTP) price as PTPs in countries abroad include pharmacy dispensing fees and are not comparable to domestic prices. When comparing the PTC price based on the buying power index, the A8 countries' drug price index in 2022 ranged between 0.52 to 0.86 and was lower than Korea's index except for diabetes drugs and antibiotics which were 1.66 times and 1.81 times higher, respectively. Excluding diabetes drugs and antibiotics, generics for gastrointestinal drugs, hypertension drugs, and hyperlipidemia drugs were about 14% to 48% more expensive in Korea than in the A8 countries. In particular, the study looked at the drug prices of the 7 individual countries other than the U.S., given that the U.S. has a relatively high drug price among the A8 countries. Results showed that generics in 3 out of 5 therapeutic classes in Canada were more expensive than in South Korea, while in Germany antibiotics, in Switzerland antibiotics, and UK gastrointestinal drugs and antibiotics were more expensive than in South Korea. Except for these, the price of hyperlipidemia drugs in most countries was 0.09 to 0.41 times less expensive than those in Korea. This means that hyperlipidemia drugs were priced at 9% to 41% of the price of the same in Korea. In addition, the ratio of original to generic drug prices was below 0.5 in most countries, whereas it was closer to 1 in Korea. "20 product criteria for differential pricing of generic drugs is adequate" The study analyzed the market share of the top products by drug market segment and found that the top 20 products accounted for more than 90% of the market in most cases, and 60% in the lowest cases, indicating that the top 20 products dominate the market. This means that the current threshold of 20 products set for differential pricing of generics is sufficient to motivate companies to enter the generic market and to maintain the generic market within an ingredient. In addition, the researchers added that the market share of the top 10 products ranges from 50% to 80%, which accounts for a significant portion of the market but is not considered sufficient to maintain the market. Therefore, according to market logic, the price of ingredients with multiple products should be allowed to be reduced, and policy mechanisms should be put in place to compensate for the market failure of ingredients that no longer enter the market. "For drugs that have 20 or more generics listed simultaneously, setting its price at 85% of the lowest drug price should be reviewed" The study concluded that the comparison of domestic generic prices with those of A8 countries showed price differences by drug class and ingredient and that there are limitations to applying a one-size-fits-all approach. Since the domestic generic drug price level is not unilaterally higher or lower than foreign countries across all efficacy groups and varies by efficacy group, the research diagnosed that the generic policy currently in place should be observed so it could show effect, then be reviewed again and modified. Nevertheless, in terms of maintaining the appropriateness of the generic drugs’ price level, the study suggested the government introduce price-reducing measures for multiple listed ingredients. In particular, the study pointed out that hypertension and hyperlipidemia drugs have many products listed and are expensive compared to foreign countries, so the price of items with more than 20 listed products can be directly reduced. The study suggested the government consider a policy that unilaterally reduces the price of hypertension and hyperlipidemia drugs to 85% of the lowest price when “20 or more products are listed at the same time.”
- Company
- Returned license-outs for new drugs one after another
- by Kim, Jin-Gu Jun 26, 2024 05:46am
- Korean biopharmaceutical companies have been receiving termination notifications from their partnering companies for their licensed-out new drug candidates one after another. Olix Pharmaceuticals and Curacle recently received notifications of contract terminations from France’s Thea Open Innovation. Voronoi’s license-out agreement for its new anticancer candidate was terminated in April. In the past two months, three accounts of license-out of new drug candidates were returned. The industry views this as a result of changes in the development strategies of contracting companies. Companies that had their rights returned rights are planning to change their strategies to in-house development. Olix Pharmaceuticals, Curacle, and Voronoi received termination notifications of their license-out agreements in the past two months Olix Pharmaceuticals announced that they received termination notifications of their licensed-out agreement for 'OLX301A,' which was under development for the treatment of dry and wet age-related macular degeneration, on June 24th. In March 2019, Olix Pharmaceuticals signed a license-out agreement with France’s Thea Open Innovation for its OLX301A. In October 2020, the company expanded the contract for OLX301A and added a license-out agreement for 'OLX301D,' a candidate for the treatment of wet age-related macular degeneration and subretinal fibrosis. Both contracts amounted to 166.95 million euros (approximately KRW 230 billion). In 2019, Olix Pharmaceuticals received an upfront payment of 2 million euros (approximately KRW 3 billion). In 2020, the upfront payment from the company expanded to 5.3 million euros (approximately KRW 7.9 billion). Then, the company additionally received milestone technology fees in 2022 and 2023, amounting to 1.33 million euros (approximately KRW 2 billion) and 400,000 euros (approximately KRW 600 million), respectively. The total amount that Olix Pharmaceutical received from the contract with Thea Open Innovation amounts to 7.03 million euros (approximately KRW 10.4 billion). This amount is non-refundable. Olix Pharmaceuticals, Curacle, and Voronoi received termination notifications of their license-out agreements in the past two months. Last month, Curacle was notified of the licensing return. Curacle announced that the company received notification of the return of the license for 'CU06,' which was under development for the treatment of diabetic macular edema and wet age-related macular degeneration. Curacle received the return of the rights from France’s Thea Open Innovation, just like Olix Pharmaceutical. In October 2021, Curacle had signed a licensing agreement with Thea Open Innovation for a contract totaling US$163.50 million (approximately KRW 190 billion). As part of the agreement, Curacle received a non-refundable upfront payment of US$6 million (approximately KRW 7 billion). In April, Voronoi also received notification of the return of the technology from METiS Therapeutics, a biotech company in the United States. In September 2022, Voronoi entered into a contract to transfer its technology of a pan-RAF inhibitor targeting solid cancers. The total contract amount was up to US$482.2 million (approximately KRW 670 billion), and Voronoi received US$1.7 million (approximately KRW 2.4 billion) cash up front, including the research milestone. Licenses were returned…K-bio will overcome via an in-house development strategy Companies that have had their license-outs returned are aiming to overcome this through in-house developments. These companies have explained that the return of licensed-out products is a result of the partnering companies' shift in development strategies, rather than a failure to demonstrate the efficacy of these candidates. Therefore, the companies are considering either continuing the development in-house or seeking another licensing opportunity. Olix Pharmaceutical said, “We will internally develop technology and conduct clinical trials in the future.” OLX301A obtained U.S. FDA approval for an IND for a phase 1 trial in August 2022. OLX301D is currently in the preclinical phase. Curacle also stated, “We will regain all the rights of CU06’s global licensing and clinical trial development in the future.” They explained, “Regardless of the licensing returns, we plan to conduct further clinical trials without delays.” Curacle explained, “We confirmed the vision improvement effects and safety of the drug through our recently completed CU06 Phase 2a trials.” And added, “During the researchers meeting at the ‘Association for Research in Vision and Ophthalmology (ARVO)’ conference in the United States, we received a lot of advice regarding the vision improvement effects. As a result, we plan to conduct further develop CU06 without any delays.” Voronoi stated, “We will review the development data and decide on future development.”
- Policy
- Fasenra·Idelvion, Ajovy·Emgality receive reimb in KOR
- by Lee, Jeong-Hwan Jun 25, 2024 05:47am
- AstraZeneca's severe eosinophilic asthma treatment Fasenra (benralizumab) and CSL Behring's hemophilia B drug Idelvion (albutrepenonacog alfa) will be reimbursed by the national health insurance starting on the 1st of next month. Also, the anti-malignant tumor agent rituximab (original brand name: MabThera) and the migraine drug Ajovy (fremanezumab) and Emgality(galcanezumab) will receive expanded reimbursement coverage. In addition, the reimbursement standards for psoriasis and macular degeneration treatments will be improved. The Ministry of Health and Welfare recently issued a pre-announcement of an administrative notice on the ’Partial Amendment of Details Regarding the Standards and Methods for Applying Medical Care Benefits (drugs)’ that contained the details stated above. The MOHW plans to collect opinions until the 25th and implement the amended standards from the 1st of next month. New reimbursement standards set for Fasenra·Idelvion Fasenra, a severe eosinophilic asthma drug that contains benralizumab, and Idelvion, a hemophilia B treatment that contains albutrepenonacog alfa, will be newly granted reimbursement in July. Fasenra will be granted reimbursement for use in adult patients with severe eosinophilic asthma who are not adequately controlled despite the use of high-dose inhaled corticosteroids-long-acting inhaled beta2-agonists (ICS-LABAs) and long-acting muscarinic antagonists (LAMA). More specifically, ▲ patients with a baseline blood eosinophil count of 300 cells/μL or greater and have experienced four or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to treatment initiation, or received continuous use of oral corticosteroids at a dose equivalent to prednisolone 5 mg/day or greater for 6 months prior to starting treatment; or ▲patients with a blood eosinophil counts of 400 cells/㎕ or greater who have experienced 3 or more acute asthma exacerbations requiring systemic corticosteroids within 12 months prior to starting treatment, will be eligible for reimbursement. Patients will be evaluated every year before and after Fasenra’s use, and those who showed overall asthma control, such as ▲ those who showed a 50% or greater reduction in the frequency of acute asthma exacerbations from baseline, and ▲those requiring ongoing oral corticosteroid therapy who showed a 50% or greater reduction in the oral corticosteroid dose from baseline while improving or maintaining asthma symptom control, that submit a doctor’s note will be eligible for continued use of Fasenra with reimbursement. However, in patients for whom the drug’s effect is deemed insufficient based on clinical symptoms, the effectiveness of the treatment can be evaluated before one year. Patients who co-administer biological agents for severe asthma will not be granted reimbursement. Also, reimbursement will not be granted for patients switching between Nucala, Fasenra, and Cinqair, or switching from Fasenra to Xolair. However, patients switching to Fasenra after Xolair may be reimbursed on a case-by-case basis if the patient has been on Xolair for at least 3-6 months and is unable to continue taking Xolair due to inadequate efficacy, side effects, or the need to improve adherence. Such patients would need to submit a doctor’s note and satisfy the Fasenra reimbursement eligibility standards to receive reimbursement. Idelvion will be granted reimbursement as a routine prophylactic therapy for the control and prevention of bleeding, pre-and post-operative management, and reduction in the frequency of bleeding episodes in patients with hemophilia B, at 23 IU/kg (30 IU/kg in children) per dose. However, for patients with moderate or severe bleeding, up to 39 IU/kg (up to 50 IU/kg for children) may be reimbursable, based on the physician's medical judgment. For patients who need to be hospitalized but receive outpatient treatment and require dose escalation, their use of the increased dose can be reimbursed with the submission of a doctor’s note. In terms of dosing interval, up to 2 doses at the first visit and 1 dose (2 doses for severe patients) at the second visit every 4 weeks will be granted reimbursement, which totals to 3 doses every 4 weeks (up to 4 doses for severe patients with a coagulation factor activity of less than 1%). If the patient's condition is stable, up to a total of 3 doses per visit every 4 weeks (4 doses for severe patients) may be reimbursed at the doctor’s discretion, and if bleeding occurs after being administered 3 doses every 4 weeks (4 doses for severe patients), up to 1 dose per visit is granted reimbursement, and a doctor's note must be attached. If the dose is administered in the hospital, the administered dose is included in the calculation of the allowable number of reimbursed doses. Reimbursement expanded for Ajovy-Emgality Reimbursement for the migraine drugs Ajovy and Emgality had been previously limited to patients who had failed treatment with three or more migraine prevention drugs within one year, but the period limit has been lifted, expanding coverage. The anti-malignant tumor agent rituximab will additionally be reimbursable as maintenance therapy for patients with severe refractory pemphigus vulgaris and pemphigus foliaceus. Two doses of 500 mg/day every 6 months, 12 months after initiation will be granted reimbursement. In addition, the reimbursement exclusion phrase for macular degeneration treatments such as abatacept (original brand name: Eylea), brolucizumab (original brand name: Beovu), faricimab (original brand name: Vabysmo), and ranibizumab (original brand name: Lucentis) has been clarified. Also, the expected adverse events in the psoriasis-specific reimbursement standards for dimethyl fumarate (original brand name: Skilarence), guselkumab (original brand name: Tremfya), ixekizumab (original brand name: Taltz), Risankizumab (original brand name: Skyrizi), secukinumab (original brand name: Cosentyx), ustekinumab (original brand name: Stelara), adalimumab(original brand name: Humira), etanercept (original brand name: Enbrel), Infliximab (original brand name: Remicade) have been further specified.
