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- 2025-12-25 15:34:14
- Company
- Ono's BTK inhibitor Velexbru was approved for sale
- by Nov 10, 2021 05:55am
- Onopharm (CEO Choi Ho-jin) announced on the 9th that it has received approval from the MFDS to sell BTK inhibitor Velexbrew as a monotherapy for patients with B cell-induced PCNSL. The first BTK inhibitor has emerged as a PCNSL treatment that has not yet been established. The basis for approval is the results of phase 1/2 clinical trials (ONO-4059-02) evaluating the efficacy and stability of Velexbrew in patients with recurrent or refractory PCNSL in Japan. The first efficacy evaluation index was ORR according to BICR. In this study, the ORR of the Velexbrew administered group was 52.9% (9/17 patients). The main side effects of grades 3 and 4 included neutropenia, leukopenia, and hyperneutral lipidemia, respectively, and 11.8% (2/17 patients).
- Company
- Non-reimbursed prescriptions for migraine drug Ajovy begin
- by Eo, Yun-Ho Nov 09, 2021 05:55am
- The new migraine drug ‘Ajovy’ is now being administered without reimbursement in Korea. According to industry sources, Teva-Handok Pharma’s Calcitonin gene-related peptide (CGRP) targeting migraine drug, Ajovy (fremanezumab), which was released in Korea on the 18th of last month, is now available for prescriptions at several medical institutions, including the Shinchon Severance Hospital. However, the drug has only passed a few drug committee (DC) reviews at general hospitals yet. Instead, the company had set a pre-order system for the drug for supply due to a flood of inquiries from patients whose symptoms recurred after taking Lilly's Emgality (galcanezumab)', another migraine drug that was released before Ajovy, also without reimbursement. Patients with severe migraines have shown expectations that Ajovy will bring different results based on the fact that the two migraine drugs have different dosages and methods of administration, although the two are from the same class. Emgality can currently be prescribed in medical institutions nationwide, in the ‘Big 5’ that includes the Seoul National University Hospital and Sinchon Severance Hospital, as well as other institutions nationwide, such as the Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. Ajovy is administered two ways: 225 mg monthly, or 675 mg every 3 months (where 3 subcutaneous injections of 225mg are injected consecutively). The drug demonstrated its efficacy in the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 patients with episodic migraines (EM) and chronic migraines (CM). In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to a placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both of the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. 44.4% of subjects in the monthly dosing, 47.7% of subjects in the quarterly dosing group, and 27.9% in the placebo group showed a 50% or more reduction in migraine days. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and 4.3±03 days in the quarterly dosing Ajovy group, both were significant compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive therapies that had to be taken every day, patients may manage their migraines with once-a-month injection with CGRP targeted antibody drugs. The treatment cost remains an issue, however, we have high expectations for the drug because the more the patient receives the targeted therapy, the easier it is to treat."
- Company
- Will Ildong sell Nexium with annual sales of 50 billion won?
- by Kim, Jin-Gu Nov 09, 2021 05:54am
- Daewoong and AstraZeneca will terminate a joint sales contract for Nexium, a PPI-based gastroesophageal reflux disease treatment. The new joint sales partner of the large item, which generated about 50 billion won in sales last year, is said to be likely to be Ildong. According to the pharmaceutical industry on the 9th, Daewoong and AstraZeneca agreed to terminate the joint sales contract of Nexium last month. The contract is until December 31 this year. Nexium is a PPI-based gastroesophageal reflux disease treatment launched in Korea in 2000. Daewoong has been jointly selling with AstraZeneca since 2008. Sales have steadily increased over the next 14 years, making it the No. 1 item in the same ingredient market. According to the two companies, Nexium's sales reached 49.4 billion won last year. Instead of breaking up with Nexium, Daewoong plans to focus on sales and marketing of Fexuprazan, which is expected to be released next year. Daewoong is developing Fexuprazan, a P-CAB-based gastroesophageal reflux disease treatment. It is a drug of the same family as K-CAB of HK inno.N, which is rapidly growing in the market. Phase 3 clinical trials in 2019 have been completed. Currently, it has applied for item permission from the MFDS. It is also expected to be available as early as the end of this year. Daewoong Pharmaceutical has already been approved for generics with components such as Nexium in 2019. Starting next year, it is expected to sell Nexierd containing esomephrazole along with Fexuprazan. Ildong is said to be the most likely new co-selling partner of Nexium. Ildong is already jointly selling diabetes treatments such as Onglyza, Kombiglyze, and Qtern with AstraZeneca. On top of that, it is expected to further strengthen the combined front with AstraZeneca by jointly selling Nexus from next year. An official from Daewoong said, "The joint sales contract of Nexium will end at the end of this year," adding, "We decided not to extend the contract to focus on Fexuprazan, which is expected to be released next year." An official from the pharmaceutical industry said, "As far as I know, Ildong is likely to be the new partner of AstraZeneca, which will jointly sell Nexium," adding, "Unless there is a major change, the contract is expected to be signed soon."
- Company
- It is expected that the SGLT-2 combination will be activated
- by Eo, Yun-Ho Nov 08, 2021 05:52am
- Domestic approved SGLT-2 inhibitorsExpectations are also rising for revitalization of the combination drug market along with the expansion of combined benefits for the drug SGLT-inhibitors. According to related industries, pharmaceutical companies with SGLT-2 inhibitors and DPP-4 inhibitors, such as Beringer Ingelheim, AstraZeneca, and MSD, will go through the registration process of the complex when discussions on expanding the combined diabetes benefits are completed. However, it is expected that there will be differences in the actual registration speed due to the expiration of patents. ◆Esglito, co-developed by Beringer Ingelheim =Beringer Ingelheim and Lilly, is a combination of SGLT-2 inhibitor Jardiance and DPP-4 inhibitor Trajenta. Esglito was originally approved in Korea under the product name Glyxambi in 2017, but changed its product name at the beginning of this year. Currently, Jardiance has applied for an increase in benefit and is waiting for the HIRA's action. Beringer Ingelheim and Lilly's diabetes pipelines have been led by domestic promotion partners Yuhan Corporation. It remains to be seen whether Esglito will join Yuhan Corporation after the benefit issue has been resolved. ◆ AstraZeneca's Qtern= Unlike other complex, Qtern, combination of Forxiga (Dapagliflozin) and Onglyza (Saxagliptin) was launched in about four years. Ildong Pharmaceutical signed a domestic exclusive sales contract with AstraZeneca and began marketing and supply it in earnest from the 1st. Ildong Pharmaceutical is also expected to make decisions on Qtern if Forxiga's benefit is expanded. ◆MSD's Stegluzan=Stegluzan, combination of Steglatro and Januvia was released in October last year. MSD has also submitted an application for the expansion of Steglatro's combined benefits and is waiting for the HIRA's review. MSD plans to switch Stegluzan to release as soon as Stegluzan's benefit expansion is decided. A meeting of diabetes experts convened by the HIRA in September concluded in the direction of integrating and recognizing the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors. At the meeting, TZD-related drugs, which had cardiovascular side effects, were required to be judged by drug. Accordingly, prescription restrictions are expected to continue only for the combination of TZD. The HIRA is currently discussing the schedule for formal procedures, including the introduction of the Drug Reimbursement Evaluation Committee.
- Company
- K-Rare Disease Drug Hunterase that is more popular overseas
- by Chon, Seung-Hyun Nov 08, 2021 05:51am
- Hunterase, developed by GC Pharma, is speeding up its efforts to target global markets. It is successful as a treatment for rare diseases developed in Korea, generating more than three times more sales than domestic demand in overseas markets. According to GC Pharma on the 4th, Hunterase's sales rose 77.7% year-on-year to 23.1 billion won in the third quarter. It more than doubled from 11 billion won in the previous quarter. In the third quarter of this year, cumulative sales jumped 63.9% year-on-year to 47.2 billion won. Sales exceeded 46.2 billion won recorded over the past year. Hunterase, which was approved in Korea in 2012, is the world's second treatment for Hunter syndrome. Hunter syndrome, called Mucopolysaccharidosis type II, is a rare disease known to occur in the remaining 100,000 to 150,000 people. Hunter syndrome, a congenital metabolic abnormality disease, is a genetic disease that shows unpredictable symptoms such as skeletal abnormalities and decreased intelligence, but dies early around the age of 15 in severe cases. The number of patients in Korea is only about 70 to 80. Hunterase's recent steep growth is based on a high rise in overseas markets. Hunterase's export performance in the third quarter was 17.4 billion won, more than doubling from 7.8 billion won in the same period last year. It tripled in one quarter from 5.8 billion won in the previous quarter. Hunterase's domestic sales in the third quarter rose 9.6% year-on-year to 5.7 billion won, which means that it has realized a significant growth in overseas markets. Exports accounted for 75.3% of Hunterase's third-quarter sales. The company explained, "The use of Hunterase abroad has increased significantly and demand has soared in Russia." Hunterase is on sale in 14 foreign countries, including Russia, Egypt, Turkey, and Brazil. It is analyzed that Hunterase's competitive drugs are not many, and that it is recording stable sales growth due to the characteristics of rare disease treatments that are expensive and must be administered for a lifetime. Prior to the appearance of Hunterase, Eleapase was the only treatment. GC Pharma is also speeding up Hunterase's entry into the Asian market. In October last year, it obtained an item license for Hunterase from the NMPA. Earlier this year, it received permission for Hunterase ICV items from the MHLW. Hunterase ICV is a new formulation that inserts a device into the head and administers the drug directly to the ventricle. It has the advantage of overcoming the limitations of existing intravenous formulations that do not improve symptoms of intelligence degradation because drugs cannot penetrate the cerebrovascular barrier (BBB). China's licensed item is a Hunterase intravenous injection (IV) formulation, and the market preoccupation effect is expected in that there was no previously approved Mucopolysaccharidosis type II treatment in China. It is predicted that it will serve as a catalyst for overseas sales growth as it starts selling to China and Japan, which have large markets.
- Company
- Reimbursement for Olumiant in AD is being discussed
- by Eo, Yun-Ho Nov 05, 2021 05:24am
- Discussions on increasing coverage for atopic dermatitis treatments continue. According to industry sources, the authorities have completed collecting expert opinions on Lilly’s JAK inhibitor ‘Olumiant (baricitinib)’ Sanofi’s ‘Dupixent (dupilumab)’ and is awaiting deliberation by the Health Insurance Review and Assessment Service’s Insurance Benefit Standard Subcommittee. The progress comes 5 months after the company submitted its application in May. Discussions for another JAK inhibitor, Dupixent, had also started in earnest 7 months after its application. In this context, whether the addition of Olumiant will spur discussions on expanding coverage in atopic dermatitis remains to be seen. Olumiant is a new drug for moderate-to-severe atopic dermatitis that applied for reimbursement at a more economical price than the recently-listed new atopic dermatitis treatment, ‘Dupixent (dupilumab).’ The drug t selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and shows an overall anti-inflammatory effect. The efficacy and safety of Olumiant was identified in the three clinical trials - BREEZE-AD1, BREEZE-AD2, BREEZE-AD7 – as a monotherapy and combination therapy with a topical corticosteroid (TCS) in adult patients with moderate to severe AD. In particular, Olumiant rapidly improved itching that severely deteriorates the quality of life from Day 2 in the three clinical trials. Chang-Wook Park, Professor of Dermatology at Severance Hospital said, “Olumiant can bring hope to AD patients in Korea who have had limited treatment options, as the drug showed rapid symptom improvement in patient-reported outcomes from Day 2 of treatment.” Also, one other JAK inhibitor is attempting to expand its reimbursement to atopic dermatitis. Last month, Abbvie applied to expand reimbursement of its ‘Rinvoq (upadacitinib)’ to atopic dermatitis. Discussion for Rinvoq has not started yet, but its efficacy was verified through the Phase IIIb Heads Up study, a head-to-head trial between Rinvoq and Dupixent.
- Company
- LG Chem, developing a new drug that has never existed before
- by Lee, Seok-Jun Nov 05, 2021 05:24am
- LG Chem has started clinical development to develop next-generation osteoarthritis treatments that have not existed before. Osteoarthritis is a degenerative disease that causes pain and gait disorders due to inflammation in the joints and cartilage wear. LG Chem announced on the 4th that it has been approved for phase 1b/2 clinical trials of LG34053, a new drug candidate for osteoarthritis treatment. The company will conduct a study at SMC to evaluate indicators such as safety and drug resistance, pharmacokinetics (drug absorption, distribution, metabolism, and elimination) and select optimal doses for patients with mild and moderate knee osteoarthritis (K&L 2-3). LG34053 is an injection-type new drug that blocks inflammatory pathways of new mechanisms and inhibits cartilage cell death. Preclinical results have improved pain relief effects, as well as cartilage damage, the root cause of arthritis. LG Chem is planning to expand its region to Australia and conduct phase 1b/2 clinical trials to secure global clinical data. Since then, it plans to carry out Phase III global commercialization in the U.S. and other regions and start global commercialization from 2028. According to global market research data, the osteoarthritis market in seven major countries with large medical markets, including the United States, Japan, Germany, France, the United Kingdom, Italy and Spain, is expected to form KRW 2 trillion by 2028.
- Company
- The Galvus patent dispute continues
- by Kim, Jin-Gu Nov 03, 2021 05:47am
- Although the Supreme Court had made its ruling on the ‘Galvus (vildagliptin)’ patent dispute, it seems that the fierce battle is yet far from being over. The case will now again be dealt by Intellectual Property Trial and Appeal Board, and depending on its result, there remains the possibility that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s patent duration. ◆The battle continues… will be again dealt at IPTAB On October 28th, the Supreme Court dismissed Novartis’ appeal against Hanmi Pharmaceutical and Ahngook Pharmaceutical over the Galvus patent dispute. The written judgment showed that the court ‘found no profit in appeal for Novartis.’ As Novartis had already won the second trial and achieved its purpose, the court decided that there was no need to file an appeal in the first place. Even if Novartis was dissatisfied with the judgment from the 2nd trial, the court decided that appealing this to the Supreme Court was procedurally right. As a result, the case will again be dealt by IPTAB. The industry expects a decision will be made early next year, which will finally conclude the 4-year patent dispute over Galvus’s patent term. ◆Novartis extends substance patent duration by 2 years, of which Ahngook claims187 days invalid On the surface, the Supreme Court’s ruling is in favor of the generic companies, as the court dismissed Novartis’ appeal against the 2nd trial ruling. However, the key point of the case lies elsewhere. Domestic pharmaceutical companies are raising the concern that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s substant patent duration, depending on the ruling that will be made by IPTAB. The key issue in the 4-year long dispute was how much of the ‘extended patent duration’ of a drug’s substance patent should be considered invalid. Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and for regulatory approval is added onto the term as companies cannot release their product immediately after applying for a patent. Depending on how much of this period is recognized, patent protection for a drug can be extended to last 21 years or even 22 years. Novartis had succeeded in extending Galvus’ substance patent for 2 years, 2months, and 23 days (813 days). With the extension, the patent, which was to originally expire on December 9, 2019, was extended to expire on March 4, 2022. ◆Mixed rulings at the 1st and 2nd trial regarding the ‘132 days’ extended for overseas clinical trials of Galvus Ahn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid. Ahn-Gook claimed that Novartis did not do its due care during the ‘132 days,’ from the completion of the bridging trial on Koreans to the submission of API report, and the ’55 days’ from receiving the MFDS’ notice to supplement its data to the data submission, rendering the 187 days invalid. The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial. The Patent Court of Korea accepted Ahn-Gook’s claim and ruled all of the 187 days invalid. With the ruling, the substance patent expiry date of Galvus was shortened to August 30th, 2021. In the second trial, the IPTAB partially accepted Novartis’ claim and ruled only 55 days of the 187 days invalid, making the substance patent expiry date of Galvus January 9th, 2022. Acceptance of Novartis’ claims on the 132 days that the company conducted clinical trials overseas was what made the difference between the rulings The claim, which was not accepted at the 1st trial, was then accepted at the 2nd. In other words, the overseas trial that was deemed irrelevant to the drug’s domestic approval in the 1st trial was deemed necessary in the 2nd trial. ◆Dispute continues for no real benefit on either side Novartis, discontent with the 132-day extension recognized at the 2nd trial, appealed to the Supreme Court to receive acceptance for the remaining 55 days. However, the Supreme Court returned the case to IPTAB. Right now, how hard the two parties will continue to fight this battle remains unclear as both parties - the original developer and generic companies – have little to earn from the continued battle. On Novartis’ part, it is now difficult to implement a strategy to delay the entry of latecomer drugs through litigations, as its substance patent is likely to expire while the case is reassigned to IPTAB and again reviewed. Novartis can always file a claim for damages after winning the dispute and being recognized for patent infringement. However, even so, the period of infringement will only be around 2 months, and not be very profitable. The cost of litigation may be greater than the profit earned from the suit for damages. Also, on the generic companies’ part, the companies have already succeeded in moving up the release of their latecomer drugs by 2 months and have no need to actively continue the dispute. ◆Original developers may ‘abuse’ the system to extend the duration of their substance patent The issue arises when the IPTAB follows the existing ruling of its higher court, the Patent Court of Korea. If the companies do not actively engage in the legal dispute, the IPTAB will highly likely follow the existing ruling made by the Patent Court. If the dispute ends this way, Novartis’ claim of ‘132 days of follow-up trial overseas’ will also be recognized for the extension. This has been raising concern among domestic pharmaceutical companies that it may be abused as a basis for original developers in extending their substance patents in the future. Until now, no period for overseas follow-up trials was accepted for extension of substance patents. Until now, the Korean Intellectual Property Office and the Ministry of Food and Drug Safety both had deemed follow-up trials that were only conducted overseas irrelevant, unlike global trials that include Koreans or bridging studies on Koreans. The Patent Act stipulates that the patent duration may be extended to 5 years at most. If overseas follow-up trials are included in the term of patent duration, original developers may abuse the system to extend their patent’s duration to the maximum 5 years. In other words, the concern is that the existing substance patent duration of ‘20+2 years’ may be prolonged to ‘20+5 years.’
- Company
- New ATTR-CM drug Vyndamax to be prescribed at GHs
- by Eo, Yun-Ho Nov 02, 2021 05:54am
- Vyndamax, a new drug for transthyretin amyloid cardiomyopathy (ATTR-CM), is now available for prescription at general hospitals. According to industry sources, Pfizer Korea’s ATTR-CM drug, 'Vyndamax (tafamidis 61mg),' passed the review of drug committees (DCs) at various medical institutions including Samsung Medical Center, Seoul Asan Medical Center, Hanyang University Medical Center, etc. However still, the landing may not directly translate to active prescriptions, as Vyndamax is being prescribed to certain patients without reimbursement. After the company failed to receive designation as an essential drug earlier this year, the company had applied for reimbursement once again after conducting the PE assessment for the Risk Sharing Agreement (RSA) scheme. Being deemed inappropriate even after submitting data for PE evaluation, reimbursement of Vyndamax is at a standstill. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. Vyndamax is the only drug that demonstrated its survival benefit in patients with ATTR-CM (ATTR amyloidosis with cardiomyopathy) and is virtually the only drug available, as there are no alternatives. Vyndamax's efficacy was demonstrated through the Phase III ATTR-ACT and a long-term extension study. Analysis of the results of the Phase III ATTR-ACT study and its long-term extension study that was presented recently demonstrated a 30% relative reduction in the risk of death among patients with ATTR-CM who transitioned to Vyndamax 61mg after being initially treated with Vyndaqel 80 mg versus patients who transitioned to Vyndamax 61 mg after being initially treated with Vyndaqel 20 mg. When adjusting for covariates, including age, biomarkers, and functional capacity, the risk reduction was increased to 43% for Vyndaqel 80 mg/Vyndamax 61 mg versus Vyndaqel 20 mg. Both Vyndaqel 80 mg/Vyndamax 61 mg and Vyndaqel 20 mg were associated with safety profiles similar to placebo.
- Company
- AstraZeneca co-sells Qtern with Ildong Pharmaceutical
- by Eo, Yun-Ho Nov 01, 2021 05:56am
- According to related industries, AstraZeneca Korea and Ildong Pharmaceutical have decided to jointly promote Qtern, which combines DPP-4 inhibitor Onglyza (Saxagliptin) and SGLT-2 inhibitor Forxiga(Dapagliflozin), which will be released today (1st). Since March 2014, the two companies have already been conducting co-marketing on diabetes treatments such as Onglyza and Kombiglyze XR(Metformin·Saxagliptin). Qtern jointly conducts sales and marketing of the product at general hospitals and Ildong Pharmaceutical alone at clinics. With the official launch of Qtern, the market for diabetes combination drugs is expected to change. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito(Linagliptin+Empagliflozin) and MSD's Stegluzan(Ertugliflozin+Sitagliptin). It has been confirmed that they are also preparing to launch along with resolving benefit issues. GC Pharma received approval from the MFDS on the 25th for the biological equivalence test plan of GC2123A. The active ingredient of this product candidate is known as Empaglipozin+Linaglipin. Meanwhile, Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of combined diabetes insurance benefits was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. Not long ago, a meeting of diabetes experts convened by the HIRA is trying to integrate and recognize the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors.
