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- 2026-03-14 07:19:22
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- Forxiga expands its benefit through heart failure
- by Jung, Sae-Im Jul 04, 2023 05:36am
- Domestic and foreign cardiac societies recommend SGLT-2 for preserving exudation rates Forxiga, a blockbuster treatment with an annual prescription of 90 billion won, has expanded its scope to the entire heart failure. AstraZeneca Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 3rd to commemorate the expansion of chronic heart failure indications, including preservation of SGLT-2 inhibitor Forxiga ejection rate. At the meeting, Yoon Jong-chan, a professor of cardiology at Catholic University Seoul St. Mary's Hospital, and Oh Jae-won, a professor of cardiology at Yonsei University Severance Hospital, led by Kang Seok-min, chairman of the Korean Heart Failure Association (Cardiology at Severance Hospital). Heart failure is divided into reduction, mild reduction, and preservation according to the heart rate. Usually, less than 40% of the ejection rate is regarded as HFrEF, 41-49% as HFmrEF, and 50% or more as HFpEF. Unlike heart failure, which reduces the rate of exudation, there has been no suitable treatment for mild reduction and preservation of exudation. Many new drugs have challenged this area but failed clinical trials. SGLT-2 inhibitors have succeeded in advancing into exudate conservation heart failure. Following last year's SGLT-2 inhibitor Jardiance, Forxiga also secured the indication this year. With the expansion of this indication, Forxiga can be used in all chronic heart failure patients, including heart failure conservation at the rate of exudation. Phase 3 DELIVER study conducted by the company is a global phase 3 clinical trial that evaluates the effectiveness of Forxiga compared to placebo in heart failure patients with a withdrawal rate of more than 40% (hardness reduction-preservation) regardless of type 2 diabetes. Professor Oh Jae-won said, "About half of the patients without a history of type 2 diabetes were included, and relatively high-risk patients were included in the clinical trial, such as those who were hospitalized or have been hospitalized for heart failure. In addition, most of the patients were using various drugs, and at the time of registration of the study, patients with an improved exudation rate of more than 40% were also registered. " As a result of clinical trials, Forxiga reduced the risk of developing complex evaluation variables evaluated as cardiovascular death or worsening heart failure (unscheduled hospitalization and hospital visits due to heart failure) by 18% compared to the placebo group. Forxiga was 23% lower than the placebo group in overall heart failure exacerbation and cardiovascular death risk, and the symptom evaluation score also improved by an average of 2.4 points over the placebo group. In a sub-analysis according to the ejection rate, Forxiga also confirmed a consistent improvement trend in the patient groups of 49% or less, 50-59%, and 60% or more. Professor Oh explained, "The results of the DELIVER study are an important basis for patients and actual clinical trials as Dapagliflozin can be considered for patients with heart failure who can be prescribed by working regardless of the exudation rate." With the performance of Jardiance and Forxiga, guidelines for treating CHF have also changed. In the 2022 revised heart failure guidelines jointly published by ACC, AHA, and HFSA, the three major cardiac societies in the United States, SGLT-2 inhibitors such as Fosiga were recommended as HFmrEF·preserved heart failure treatments (recommended level 2a). The Korean Heart Failure Society also recommended SGLT-2 inhibitors to reduce hospitalization or cardiovascular death from heart failure in patients with preserving exudation rates, with or without diabetes (recommended grade 1). Professor Yoon explained, "Furthermore, this year's ACC recommended that all patients with preserving exudation rates start treatment with SGLT-2 inhibitors in the amendment to the Expert Consensus Decision Pathway." Professor Yoon said, "Half of the patients died within five years of diagnosis, so active treatment is needed from an early stage to improve the prognosis, and SGLT-2 inhibitors have provided the basis for their role." From the left, Professor Kang Seok-min, Professor Oh Jae-won, and Professor Yoon Jong-chan Professor Kang, who headed the team, explained, "It is very meaningful that the DELIVER study confirmed the effectiveness and safety of SGLT-2 inhibitors in patients who take other drugs as well as the entire ejection rate spectrum of chronic heart failure." He added, "In the meantime, new treatment options have been limited in patients with preservation and mild reduction of exudation rates, so we hope that many patients will benefit by registering their benefits as soon as possible."
- Company
- Lagevrio was voluntarily withdrawn from Europe
- by Kim, Jin-Gu Jul 03, 2023 05:47am
- Merck has voluntarily withdrawn its European approval application for Lagevrio, an oral COVID-19 treatment. The pharmaceutical industry is paying close attention to whether the global supply of this drug will continue. Celltrion and Hanmi Pharmaceutical, which had already decided to produce and supply Lagevrio generics to developing countries, have withdrawn their plans. Foreign media including Reuters reported on the 28th (local time) that Merck voluntarily withdrew its application for permission from the European Union (EU) for Lagevrio, an oral COVID-19 treatment. It is an analysis that Europe is in fact stepping out of the process. The EMA-affiliated CHMP recommended banning Lagevrio approval in February this year. At the recommendation of the CHMP, Merck eventually voluntarily withdrew its application for authorization in the EU. In the pharmaceutical industry, attention is focused on whether Lagevrio's exit will spread to other countries, including the United States. Lagevrio is being supplied as a corona treatment in more than 25 countries, including Korea, the US, Japan, the UK, Australia, and China. Regarding this, Merck drew a line, saying, "This decision will not affect the use of Lagevrio in countries where licensing or approval has already been completed." Lagevrio appeared in 2022, in the midst of the Corona-19 crisis. Together with Pfizer Paxlovid, it was widely used as an oral corona treatment. However, this year, the global pandemic situation has ended and its use has declined significantly. In the pharmaceutical industry, there is an analysis that Merck has decided to withdraw from the European market due to declining marketability. It is analyzed that the lower effect compared to Paxlovid also influenced the decision to withdraw voluntarily. Lagevrio is a mechanism that inhibits viral replication. Unlike Paxlovid, which lowered the risk of hospitalization and death due to corona by 89%, Lagevrio only reduced the risk of hospitalization and death by 30%, as shown in phase 3 clinical trials. It is said that the treatment effect is low and the marketability is greatly reduced, and global demand is said to have decreased significantly. After generating $5.684 billion in global sales last year, Lagevrio's sales have plummeted this year. As a result, domestic biopharmaceutical companies that were trying to produce and supply Lagevrio generics to low- and middle-developed countries are also stepping back. Celltrion Pharmaceuticals recently passed the bill to terminate the license agreement for Lagevrio generic production at the board of directors' meeting. The company originally planned to produce Lagevrio generics at its Cheongju plant but decided to terminate the contract as the COVID-19 situation eased compared to the time of the contract. Hanmi also signed a contract to produce Lagevrio generics last year but canceled it earlier this year. Likewise, Hanmi Pharm explained that this is because demand has significantly decreased as the corona crisis turned endemic. In the pharmaceutical industry, attention is focused on alternatives to Lagevrio, which is in the process of being virtually phased out. Potential alternative drugs include Xocova, developed by Japan's Shionogi Pharmaceutical, and Xafty, which is being developed by Hyundai Bioscience. Xocova is an oral COVID-19 treatment developed by Japan's Shionogi Pharmaceuticals. Xocova is currently being supplied only in Japan with EUA. Xocova recorded sales of close to 1 trillion won in Japan for four months from November last year to March this year. The Japanese government purchased 2 million doses of Xocova for 104.7 billion yen under a supply contract with Shionogi. In Korea, Ildong Pharmaceutical started the joint development of Xocova with Shionogi Pharmaceutical. Earlier this year, Ildong Pharmaceutical applied for product approval of Xocova to the Ministry of Food and Drug Safety. The review is still ongoing after 6 months. Hyundai Bioscience is developing niclosamide, which was previously used as an insect repellent in Korea, as an oral corona treatment through drug re-creation clinical trials. In phase 2 clinical trials, it was found that the time taken for improvement of corona symptoms was shortened by 4 days. Hyundai Bioscience plans to proceed with EUA and product approval to the Ministry of Food and Drug Safety.
- Company
- Leclaza and Tagrisso compete for reimb in the first line
- by Jung, Sae-Im Jul 03, 2023 05:47am
- (From the left) Pic of Leclaza and Tagrisso Yuhan Corp’s EGFR-targeted anticancer drug ‘Leclaza (lasertinib)’ has been approved as a first-line treatment in Korea and is competing for reimbursement with its competitor ‘Tagrisso (osimertinib).’ As reimbursement review for Tagrisso’s first-line indication is already in progress, Yuhan is also expected to hasten its steps to receive reimbursement for its Leclaza. On June 30th, the Ministry of Food and Drug Safety approved the change in Leclaza’s indication to ‘the treatment of patients with advanced or metastatic non-small-cell lung cancer harboring EGFR mutation exon 19 deletions or exon 21 substitution.’ With the approval, Leclaza, which had been used as a second-line treatment until now, is now available as a first-line treatment in Korea. As a result, 2 third-generation TKIs – Tagrisso and Leclaza – are now available for the treatment of EGFR-mutated NSCLC in the first line. However, as the first-line indication for the drugs is yet to be reimbursed in Korea, the drugs are mainly used as subsequent therapy following initial treatment with first and second-generation drugs. Leclaza PFS data(Data: ESMO Asia) Results of the Phase III LASER301 trial that was presented in December last year showed that Leclaza achieved its primary endpoint and improved progression-free survival (PFS) over its comparator (gefitinib) by 9.7 months. Also, Leclaza reduced the risk of disease progression and death by 55% compared to the control group (HR=0.45). Also, its benefit was consistently observed in ▲patients with brain metastasis, ▲patients with L858R mutation, and▲ Asians. Although a uniquely high incidence of paresthesia was observed in the Leclaza-treated group, most were mild and manageable. ◆Tagrisso and Leclaza compete for first-line reimbursement With the approval, Leclaza is now on a level playing field with Tagrisso. Leclaza quickly closed the gap during the 4 years Tagrisso struggled and failed to pass its first step to receiving reimbursement in the first line. Therefore, how the competition will end will now depend on which drug becomes reimbursed in the first line. In the case of Tagrisso, its adequacy for reimbursement in the first line was finally recognized in March by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) after 5 attempts. AstraZeneca had attempted to pass CDDC review with its global FLAURA trial data that was the basis of Tagrisso’s fist-line indication and the FLAURA China trial data that confirmed an improvement in overall survival (OS) in Asians, to no avail. The CDDC had deemed that the data was not sufficient to recognize the drug’s effect on Asians. The company had strategically narrowed its reimbursement standards, but that attempt was also turned down by the CDDC. The situation turned in favor of Tagrisso at the end of 2022 after large-scale real-world data on Tagrisso’s effect as a first-line treatment in Asia and Europe was released. Analysis of the real-world data of 660 Japanese patients confirmed a progression-free survival of 20.0 months and overall survival of more than 3 years (40.9 months), which was longer than that found in its Phase III clinical trial. Based on the data, the company put an end to Tagrisso’s efficacy controversy in Asia. However, the problem is that the company has only now passed the first step to its reimbursement. Tagrisso’s reimbursement agenda needs to pass HIRA’s Drug Reimbursement Evaluation Committee (DREC) review, drug pricing negotiations with the National Health Insurance Service, and the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee (HIPDC) to complete the reimbursement process in Korea. As a risk-sharing agreement (RSA) drug, Tagrisso must also pass pharmacoeconomic evaluations. HIRA’s statuary evaluation period is set at 120 days or less, but it is common for HIRA to exceed the set deadline if the company is required to submit supplementary data. In fact, 3 months have passed since Tagrisso passed the CDDC review, but no schedule for the subcommittee for its pharmacoeconomic evaluation has been set yet. Although the statutory period set for the reimbursement process sets the timing for Tagrisso's reimbursement extension at the end of this year, there is a strong possibility that the period will be delayed somewhat. Unlike Tagrisso, Leclaza’s reimbursement agenda is expected to pass CDDC review without difficulty as the drug demonstrated its effectiveness in the Asian subgroup with a hazard ratio of 0.46. The fact that it is the only homegrown new drug is also expected to work in favor of Leclaza. Therefore, if Leclaza passes the CDDC review in July or August, the drug may also be deliberated by DREC with Tagrisso. Yuhan Corp plans to apply for reimbursement in the first line as soon as possible. Also, the company has also prepared an Early Access Program (EAP) that provides Leclaza free of charge until the drug is granted reimbursement. The move shows Yuhan Corp’s confidence that it will be able to rapidly receive reimbursement. Yuhan Corp said, “With Leclaza’s approval, we are pleased to be able to provide a new treatment option for patients with EGFR mutation-positive NSCLC, which is highly prevalent in Korea. We are preparing to apply for the reimbursement extension for Leclaza in the first line and provide our drug for free to the patients until it is reimbursed through our Early Access Program (EAP).”
- Company
- Pfizer, Lilly, AbbVie engage in JAKi battle in KOR
- by Nho, Byung Chul Jul 03, 2023 05:47am
- Pfizer's Xeljanz and Lilly's Olumiant are engaged in an intense competition for sales in the JAK inhibitor market. According to the distribution data of pharmaceuticals, Xeljanz (including Xeljanz XR) recorded sales of KRW 15.5 billion won last year, while Olumiant recorded KRW 15.4 billion. Although Xeljanz maintained a slight lead, Olumiant has shown a faster infiltration rate in terms of growth. Olumiant's sales in 2019, 2020, 2021, and 2022 were KRW 2.2 billion, 9 billion, 12.6 billion, and 15.4 billion, respectively, representing a 600% increase over four years. During the same period, Xeljanz recorded sales of KRW 14.6 billion, 16.2 billion, 15.1 billion, and 13.7 billion, with an additional sales increase of approximately KRW 2 billion in 2021 with the launch of Xeljanz XR. AbbVie's Rinvoq has also established its position in the market quite quickly. Its sales in 2020, 2021, and 2022 were approximately KRW 55 million, 2.6 billion, and 11.4 billion, respectively. Although the representative JAK product Xeljanz has maintained its lead so far, the drug's prospects are unpredictable from this year onwards. Already in Q1 2023, Xeljanz, Olumiant, and Rinvoq recorded sales of KRW 3.3 billion, 3.7 billion, and 3.5 billion, respectively, engaging in fierce competition. The total market size of major JAK inhibitors has risen from KRW 16.8 billion, 25.3 billion, 31.1 billion, to 42.4 billion, demonstrating a growth close to KRW 10 billion each year and is being recognized as a blue ocean market. The indications for Xeljanz Tab. (tofacitinib) include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The indications for Rinvoq PR Tab. (upadacitinib) include atopic dermatitis, in addition to the indications of Xeljanz Tab. Olumiant (baricitinib) has shown efficacy in rheumatoid arthritis, atopic dermatitis, and alopecia areata. Xeljanz XR Tab. is prescribed for the treatment of moderate-to-severe active rheumatoid arthritis in adults who do not respond adequately to or cannot tolerate methotrexate. Furthermore, Pfizer has expanded its market share by launching the JAK1 inhibitor Cibinqo in November 2021, after receiving approval from the Ministry of Food and Drug Safety. This is the fourth JAK inhibitor that has been introduced to the Korean market, and the second JAK class drug to be introduced by Pfizer, following Xeljanz. Cibinqo is expected to compete with Dupixent and Rinvoq as the treatment of severe atopic dermatitis. Olumiant is a JAK inhibitor that has gained attention as a new treatment option for alopecia areata, a condition where therapies for autoimmune disease have shown limited effectiveness. Olumiant has demonstrated significant improvements, 6-10 times more than placebo, through two large-scale clinical trials. While Rinvoq was previously reimbursed only for the treatment of moderate to severe atopic dermatitis in adults, starting from April this year, reimbursement for adolescents aged 12 and above has been approved. As a result, it is anticipated that adolescent patients with atopic dermatitis will have improved accessibility to treatment.
- Company
- Illaris for 13 pts, re-challenge to enter insurance benefit
- by Eo, Yun-Ho Jul 03, 2023 05:45am
- Illaris, a treatment for vulva diseases with only 13 patients in Korea, will try again to enter the insurance benefit zone. According to related industries, Novartis Korea submitted an application for Ilaris' benefit in April and is under discussion. However, the registration process is still expected to be difficult. The drug has already undergone two pay procedures but has not achieved its purpose. Ilaris, licensed in Korea in 2015, is a treatment for hereditary recurrence syndrome, and detailed diseases are divided according to abnormal genes. Specifically, Ilaris can be prescribed for ▲CAPS, TRAPS, HIDS/MKD, and FMF ▲ Systemic JIA in Korea. Among them, CAPS is classified again as ▲FCAS/FCU ▲MWS▲NOMID/CINCA. As there are so few target patients and the indications are complicated, it is not easy to discuss the benefits. The number of patients corresponding to various indications of Ilaris is extremely small. Some indications of Illaris do not even have a disease code or have been recently registered. In the case of CAPS, a drug called Kineret is used through the KODC. It is a drug that comes through the center rather than officially approved by the MFDS in Korea, and there are some disruptions in supply, but the communication channel is unclear and there is a limit to supply improvement. In addition, in the case of FMF, colchicine is recommended as the primary treatment, but this drug is not available in Korea. Ilaris is licensed for use in FMFs where colchicine is contraindicated or does not show an appropriate response to the highest drug dose of colchicine. However, since colchicine has not been introduced in Korea, it is difficult to use Illaris if the permission and salary problems of Kolkisin are not resolved even if the benefit is applied later. In order to solve this problem, the association is known to have applied for an increase in the salary of the drug. Since the HIRA regulations define alternative drugs as drugs included in the same treatment range in terms of permission and salary standards, it is not expected that Illaris will be able to devise a reimbursed strategy by viewing Kineret, an unlicensed emergency drug currently used only for CINCA. "There are many difficulties in many ways because the target diseases that require treatment for Illaris are detailed and the number of patients is too small," said Jeong Dae-Chul, chairman of the KCPCI (Pediatric and Adolescent Department at Seoul St. Mary's Hospital). "It is a pity for the medical staff that there are patients who are considering immigration to countries where Ilaris can be prescribed." It remains to be seen whether the drug "Ilaris" for very few patients will achieve good results this time. Ilaris is an IL-1 inhibitor recommended by international guidelines for the treatment of hereditary recurrence syndrome and is the only approved treatment in both domestic and U.S. FDA and European EMA. Ilaris is used as a benefit in a total of 30 countries based on the therapeutic effect and safety confirmed through clinical research. In Italy, Switzerland, and the United Kingdom, patients have benefited from the treatment of Illaris since 2009 in Canada and 2011 in Japan. In the UK and Canada, where Health Technology Assessment (HTA) is carried out to register new drugs like Korea, Illaris excludes cost-effectiveness evaluation and applies salaries only for PFS (CAPS, TRAPS, HIDS/MKD, FMF) indications.
- Company
- Imfinzi+Imjudo combo approved for liver cancer in KOR
- by Eo, Yun-Ho Jul 03, 2023 05:45am
- The immuno-oncology drug ‘Imfinzi’ added an indication in Korea and can be used in combination with ‘Imjudo’ in Korea. According to industry sources, AstraZeneca received approval for the combined use of Imfinzi+Imjudo from the Ministry of Food and Drug Safety on June 30th, immediately after receiving approval for its CTLA-4 inhibiting cancer immunotherapy Imjudo (tremelimumab) in Korea. The immunotherapy combo will first target liver cancer, as the combination was approved as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (liver cancer). More specifically, the approved STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab) includes an initial single dose of Imjudo 300mg added to Imfinzi 1500mg, followed by Imfinzi every four weeks. The Phase III HIMALAYA trial that confirmed the efficacy of Imjudo+Imfinzi showed that patients treated with the Imjudo+Imfinzi STRIDE regimen achieved a median overall survival (mOS) of 16.4 months, reducing the risk of death by 22% compared to the current standard-of-care Nexavar. At 36 months of follow-up, the OS rate of Imfinzi+tremelimumab(Imjudo) and Nexavar was 30.7% and 20.2%, respectively, demonstrating the long-term survival benefit of the combination. The benefit of the combination therapy In the Asian subgroup analysis was also consistent with the global results. The Imjudo+Imfinzi combination is also being studied for various other types of cancer, including locoregional hepatocellular carcinoma (EMERALD-3), small cell lung cancer (ADRIATIC) and bladder cancer (VOLGA and NILE).
- Company
- Oral AML drug Onureg can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 30, 2023 06:01am
- The oral acute myeloid leukemia (AML) treatment ‘Onureg’ can now be prescribed at general hospitals in Korea. According to industry sources, BMS Korea’s new AML drug Onureg tablet (azacytidine) has passed the drug committees of Asan Medical Center and Seoul National University Bundang Hospital and is also undergoing landing processes at major general hospitals in Korea. As the company is currently negotiating drug prices with the National Health Insurance Service for reimbursement listing, preparations are in full swing to create an appropriate prescription environment. Onureg was approved in Korea in March 2022 and passed the NHIS’s Cancer Disease Deliberation Committee review in December of the same year, and then the Drug REimbrusement Evaluation Committee in April this year. The listing process took place relatively quickly since Onureg’s marketing authorization in Korea. Onureg, the only oral maintenance therapy in AML, can be prescribed to adult patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT) The drug demonstrated its efficacy through the Phase III QUAZAR AML-001 trial that was conducted on AML 472 patients. In the trial, Onureg prolonged survival by 10 months, showing a median overall survival (OS) of 24.7 months vs 14.8 months for patients receiving a placebo, reducing the risk of death by 31%. The percentage of patients who survived in the Onureg-treated group at 1 year and 2 years of treatment was 73% (56% in the placebo group) and 51% (37% in the placebo group), respectively, both of which higher than those in the placebo group. Also, in terms of relapse-free survival (RFS), the median RFS was 10.2 months for Onureg, 5.3 months longer than that of the placebo group, confirming its effect in reducing the risk of relapse. Meanwhile, AML is the most common but also the most fatal type of leukemia. If left untreated, 90% of the patients die within a year. Even patients that went into complete remission are at risk of relapse due to the 100 million residual leukemia cells that may remain at most. If appropriate treatment is not accompanied after complete remission, the relapse rate reaches up to 50% within 1 year, and the median overall survival (OS) after relapse is only 8 months.
- Company
- Unlisted Trajenta patents hinder early release of generics
- by Kim, Jin-Gu Jun 29, 2023 05:56am
- The patent challenges made for the early release of antidiabetic ‘Trajenta (linagliptin)’ is going through a rough patch. The patents that the original company registered with KIPO but not with the MFDS are acting as obstacles. For the generics companies that filed patent challenges, a prolonged dispute is now inevitable as they would have to overcome all of Trajenta's unlisted patents, which may be up to 10 or more, in order to release their generics. Number of claims have been filed against Trajenta’s unlisted patents... 8 in total in 9 months Pic of TrajentaAccording to industry sources on the 28th, Genuone Sciences filed a trial against Boehringer Ingelheim to invalidate Trajenta’s use patent (10-2427380). The use patent was not listed on the Ministry of Food and Drug Safety’s Green List. Genuone Sciences had previously filed claims to has also requested a trial on 5 other unlisted patents of Trajenta. In September last year, the company filed a claim to confirm the passive scope of rights on Trajenta’s substance patent 10-2051281, and invalidation trials on 3 use patents (1558938/10-1655754/10-1806786) and 1 manufacturing method patent (10-1541791) in October last year. In addition, two other challenges are being made to Trajenta’s unlisted patents. In addition to Genuone Sciences, Sinil Pharmaceutical, Korea United Pharm, Hutecs Korea Pharmaceutical, Korea Biochem, and Hallim Pharmaceutical are also challenging Trajenta’s patent. In April this year, the companies requested a passive trial to confirm the scope of rights on two Trajenta formulation patents (10-1710881/10-1855323). This means that 8 of Trajenta’s unlisted patents have been targeted by generic companies in about 9 months from last September. Generic companies have no problem obtaining authorization as latecomer drugs even without overcoming unlisted patents. However, the situation is different when the companies actually release their generic products. Without overcoming all of the patents, the companies become embroiled in patent infringement lawsuits with the original company. If the original drug’s company files a petition for a preliminary injunction to block the release of the product when it files the patent infringement lawsuit, the release date of the generic company’s product may be delayed. In addition, if the company loses the patent infringement lawsuit, it may lead to additional lawsuits for damages. Trajenta’s last listed patent expires in June next year... Unlisted patents remain barriers The generic companies have succeeded in avoiding or invalidating most of Trajenta’s unexpired and listed patents on MFDS’s Green List. Boehringer Ingelheim, the original company, listed 6 patents for Trajenta in the Green List. Among them, one substance patent 1 (10-1150449) expired in September last year. Use patents 1 (10-1111101) and 2 (10-0926247) also expired in August and September last year, respectively. In 2016, the generic companies succeeded in evading or invalidating Trajenta’s substance patent (10-1478983) and crystalline patent (10-1452915) which were set to expire in April 2027. Therefore, the only listed patent that has a term remaining is Trajenta’s substance patent 2 (10-0883277), which is set to expire in June next year. Therefore, on the surface, the early release of generics seems possible after June next year. In fact, generic companies have originally planned to release their generic versions early, in line with the expiration of the second substance patent in June next year. However, the patents that were not listed on the Green List are acting as obstacles to the early release of their generics. Since releasing generic drugs without overcoming the unlisted patents will lead to patent infringement, the generic companies must overcome all of the patents before launching their generic drugs. "There may be up to or over 10 unlisted Trajenta patents”... increases the burden of dispute on generic companies↑ The problem is that Trajenta has too many unlisted patents. The industry expects that there may be a total of more than 10 unlisted patents, including those for which claims are yet to be filed. This means that there are more than 10 trials that generic companies would need to win additionally for the early release of their Trajenta generics. From the perspective of generic companies, the burden of concurrently ongoing patent disputes is not small. In particular, since they are not listed on the Green List, generic companies have to search for the patent information and individually request trials, which is also a hassle. Given this situation, the industry predicts there is a high possibility that the patent dispute related to Trajenta will continue in the long-term. An industry official said, “Because they are not listed on the Green List, generic companies have to find hidden patents one by one and request a trial. Moreover, when the original drug’s company applies to register a patent to the KIPO, the company does not enter the product or brand name in its inventions, therefore, finding the patents is in itself very cumbersome, and there is always the possibility that they may miss some patents.”
- Company
- SK Plasma supplies 39 billion worth of blood products
- by Jun 29, 2023 05:56am
- SK Plasma announced on the 28th that it will begin full-fledged production this month after receiving product approval for blood products (albumin and immunoglobulin) from the Singapore Health Authority (HSA). The company will independently supply a total of 30 million dollars (39 billion won) worth of blood derivatives over the next six years, starting with the initial export in the fourth quarter. When the Singapore health authorities send plasma secured through their own blood source to SK Plasma, SK Plasma produces finished blood products such as albumin using the plasma as raw material at the Andong plant and sends it to Singapore. In 2022, Singapore's health authorities designated SK Plasma's blood product as a priority review target. As a result, the approval review process, which normally takes 18 months, was shortened by 5 months. Blood products are medicines that use blood as raw material, and are manufactured in the form of medicines such as albumin and immunoglobulin by fractionating and refining blood components. It is used as an essential treatment in various fields such as shock caused by excessive bleeding, congenital immunodeficiency disease, and hemophilia. In a national disaster situation, blood products such as albumin and immunoglobulin are widely needed, so they are designated and managed as essential national medicines. The Singapore government is supplying blood products to its citizens in the form of a national tender. In the 2021 blood product bidding by the health authorities, SK Plasma was selected as the first Asian country to consign production of the entire volume. SK Plasma plans to process and export approximately 20,000 liters of blood products annually to Singapore. The Singapore plasma, which has been stocked since this year, will be put into production soon. In addition, it plans to accelerate its global business by cooperating with foreign countries to introduce local raw material plasma and promote consignment production. Kim Seung-Joo, CEO of SK Plasma, said, "This toll processing of blood products is an example of SK Plasma's technological prowess being recognized as the first exclusive toll processing export of a country at the EU GMP level." We plan to continue to expand," he said. SK Plasma is promoting the construction of a blood derivatives plant in Indonesia. In March, a blood product plant near Jakarta, Indonesia, which can process 1 million liters of plasma raw material per year, is under construction with the goal of completion in 2025.
- Company
- RET-targeted Retevmo lands in Big 5 general hospitals in KOR
- by Eo, Yun-Ho Jun 29, 2023 05:56am
- The RET-targeted anticancer therapy ‘Retevmo’ may now be prescribed at the Big 5 hospitals in Korea. According to industry sources, Lilly Korea’s Retevmo (selpercatinib) passed the drug committees of all the Big 5 tertiary hospitals in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. As the drug is undergoing drug pricing negotiations with the National Health Insurance Service, the drug is expected to be readily prescribed if it passes reimbursement. Whether the first targeted RET mutation-targeted anticancer drug option will be born remains to be seen. Retevmo, which received marketing authorization in March last year, was unable to pass CDDC review for reimbursement in May of the same year but then passed review in November and finally passed deliberation by the Drug Reimbursement Evaluation Committee in May this year. The drug is indicated for the treatment of ▲adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. The drug demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. Patients with RET fusion-positive NSCLC, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer patients with or without prior treatment experience enrolled in the LIBRETTO-001 trial. The primary endpoints of the trial were the objective response rate (ORR) and duration of response (DOR) as assessed by the independent review committee. In patients with RET fusion-positive NSCLC without platinum-based treatment experience, the ORR in the Retevmo-treated group was 85%. Although the median DoR was not yet reached, 79% of the patients showed a durated response during the follow-up period (median 7.4 months). In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months. Professor Min-Hee Hong of Oncology at Yonsei Cancer Center said, “Lung cancer patients with RET mutations are twice more likely to experience CNS metastasis, but had to be treated with chemotherapy due to the lack of options until now, which is less effective and more prone to toxicity.” Hong added, “Retevmo demonstrated a significant response in the LIBRETTO-001 trial, as well as an 82% ORR in patients with CNS metastasis. 23% of these patients achieved complete response.”
