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- 2026-04-16 11:26:58
- Policy
- Development of generic for Pelubi is active
- by Lee, Tak-Sun Aug 18, 2020 06:03am
- Daewon Pharm’s anti-inflammatory generics for Pelubi, which recorded an outpatient prescription of ₩28.9 billion last year, is actively developing. In July, the first application for permission of generic for Pelubi was received, and nine bioequivalence test plans were approved this year. Generic companies are now developing not only Pelubi, but also Pelubi SR. However, additional indications acquired late through a clinical trial by Daewon Pharm are expected to be protected as long as the PMS expires. According to the industry and the MFDS on the 17th, Mothers Pharm received approval of two bioequivalence test protocols for the generics of Pelubi SR on July 29 and July 31. The first approved bioequivalence test is conducted on an empty stomach, and the second approved test is to determine the equivalence with Pelubi after meals. Earlier in May, generic by Huons was approved for the same bioequivalence test. Daewon Pharm's Pelubi SR is a drug approved in March 2015 and is administered orally after meals twice a day. Pelubi which was approved as a new drug made in Korea in April 2007, is a drug that is administered orally after meals three times a day. Generics for Pelubi by Mothers Pharm and Huons were also approved for bioequivalence tests in March, and are currently ended. In addition, Yungjin Pharm, Nexpharm, and Hutecs were also approved. However, in order for them to obtain and release generic for Pelubi, they must overcome the patent first. Formulation patent for Pelubi is scheduled to expire on November 12, 2028. Starting with Yungjin Pharm at the beginning of this year, Mothers Pharm, Hutecs, Huons, Nexpharm Korea, and Chong Kun Dang in turn requested a trial to confirm the scope of their rights for patent evasion, but a trial decision has not been made yet. In addition, the composition patent of Pelubi SR is listed on the patent list of the MFDS in the. The composition patent is scheduled to expire on October 17, 2033, but there is no patent challenge from generic companies. At the end of July, the first application for Pelubi’s generic was received, but if the patent cannot be overcome even after the product permission, it cannot enter the market for the duration. However, generic companies are confident in the success of the patent challenge and are highly likely to release early. Even so, it is difficult to secure and release all indications of Pelubi and Pelubi SR. In the case of Pelubi, there are antipyretic indications for acute upper respiratory tract infection along with osteoarthritis, rheumatoid arthritis, and low back pain (low back pain). Among them, PMS will expire on September 18, 2021 for antipyretic indications. Generic companies can apply for permission after the PMS expires. In addition, Pelubi SR has indications for osteoarthritis, rheumatoid arthritis, low back pain (low back pain) and post-traumatic pain. Pelubi's antipyretic effect and Pelubi SR's indication for pain were obtained through additional clinical trials after the marketing of Daewon Pharm. The indications for post-traumatic pain in Felubiceron will only expire on June 16, 2024. generic companies are developing generics, excluding additional indications. In the case of Pelubi’s generic, which applied for permission at the end of July, the antipyretic indication for acute upper respiratory tract infection was omitted. In addition, generic for Pelubi SR, which is currently being developed, is expected to exclude the indication for nervous tension post traumatic pain. The recent development of Pelubi's generics shows that its popularity in the market is rising rapidly. Pelubi, which recorded ₩28.9 billion in outpatient prescriptions last year, surpassed ₩10 billion for the first time in 2017. It was only eight years after launch. As PMS already ends in April 2013, it is an analysis that generic companies have confirmed marketability and started developing generics. Pelubi, which did not meet expectations at the beginning of its release, gradually expanded its market share. This also affected the part in which Daewon Pharm acquired the indications sequentially through subsequent clinical trials. When it was approved, Pelubi's only indication was osteoarthritis. Even if another generic is released through the success of the patent challenge, the indications for acute upper respiratory tract fever and post-traumatic pain can be valid.
- Company
- “Safe, effective and convenient Zejula for ‘all-comers'"
- by Eo, Yun-Ho Aug 18, 2020 06:03am
- Professor Park Jeong-yeol Different drugs in a same class can have different indications. It could be a development strategy by pharmaceutical companies or a Columbus’ egg. But clearly, the respective companies would try to appeal for different indications in different prescription area and relevant benefit proven from safety and efficacy data. Two poly ADP-ribose polymerase (PARP)-inhibiting targeted therapies, introduced recently with the heightened anticipation from the ovarian cancer treatment scene, are the examples of the said strategy. Takeda Pharmaceuticals’ Zejula (niraparib), in fact, has been indicated for treating ‘all-comers’ in all approved lines of treatment, regardless of mutation in the targeted BRCA genes. AstraZeneca’s Lynparza (olaparib), approved before Zejula, has a limited indication to only treat ovarian cancer patients with BRCA mutation, except for the second-line treatment. It is not the matter of choosing a superior treatment, but about an option. But having an all-comer targeted therapy is an interesting factor to consider. Daily Pharm interviewed Professor Park Jeong-yeol of gynecology department at Asan Medical Center on the use of PARP inhibitor and Zejula in ovarian cancer treatment. -What are the realistic expectations of medical professionals on Zejula indicated for all-comers in all lines of treatment? Considering the largely unmet medical needs, their expectations are obviously high. Besides as a standard therapy, Zejula could be used as a treatment on all patients diagnosed with ovarian cancer regardless of the line of treatment. In the NOVA study, PARP-inhibiting Zeula confirmed its efficacy in all patient groups regardless of biomarkers statuses like germline BRCA (gBRCA) mutation or homologous recombination deficiency (HRd). The study confirmed the Zejula-treated patient group carrying germline BRCA mutation achieved the median progression-free survival (mPFS) four times longer than that of the control group, and also their risk of disease progression or death was reduced by 74 percent. And Zejula doubled the mPFS in a gBRCA mutation-negative group, and also significantly improved mPFS in a HRd-negative, gBRCA mutation-negative patient group. -Zejula is not the sole option for PARP inhibitor. What would be the reason for treatments with specific targeted gene showing such efficacy? The academia is still discussing which class shows treatment efficacy in all patients. Nevertheless, Zejula is the only proven treatment for all-comers so far, so it would be versatile. -Compared to its competitor Lynparza, Zejula user has to take frequent blood test to confirm hematological adverse reaction. Isn’t it inconvenient for the patients? The complete blood counts (CBC) monitoring is conducted once-weekly for the first month, once-monthly for the next 11 months, and once every two to three months after a year. The ovarian cancer patients generally visit hospital to get a blood test a week after their chemotherapy. Additional treatments would be provided, in case of discovering an adverse reaction in blood test, and the patient has to come in the next week to confirm the status again. So, none of the patients complained of inconvenience in visiting hospitals weekly after administering Zejula. On the contrary, there are more patients satisfied with orally administering Zejula, two to three pills a day. Also from a doctor’s perspective, conducting a weekly CBC monitoring for the first month of administering Zejula does not seem like a problem. -Going back to the NOVA study, the dose of Zejula was controlled depending on the individual tolerance. How do you adjust the dose? For a patient weighing less than 77 kg or showing platelet counts less than 150,000/ μL would start with 200 mg dose, but it would be lowered to 100 mg, if need be, and the administration would be halted for the second reduction of dose. Most of the patients in Korea start the treatment with 200 mg dose. Other patients weighing more than 77 kg and showing platelet counts over 150,000/ μL initiate the therapy with 300 mg, and the dose can go down to 200 mg and 100 mg for first and second reduction, respectively. After reducing the dose down to 100 mg, the administration has to be haltered if the dose needs further reduction. But most of the patients only reduce the dose once. Not many of them actual halt the therapy. In the NOVA study, only 4 percent of the patients exited the therapy due to hematological adverse reaction. Generally, patients lowering the dose down from 200 mg to 100 mg stabilize their adverse reaction and maintain the recovered status. Most of the patients subjectively do not feel the adverse reaction when taking 200 mg. An exploratory data analysis on the NOVA study actually found the efficacy of the treatment was maintained at the optimum dose for individual patients. -The Korean government is conservative about Zejula being effective in patients ‘regardless of BRCA mutation,’ although it has been indicated for all-comers. The clinical evidence demonstrated its efficacy, but the efficacy level differed in HRd-negative patients with BRCA mutation. Would you say the insurance coverage is needed for the all-comer indication? Indeed, it is. Generally, only 15 percent of epithelial ovarian cancer patients have been known to have mutated BRCA 1/2 gene. And it means, 85 percent or the majority of the patients do not express BRCA-mutated gene. So at the moment, the majority of the ovarian cancer patients do not receive coverage on using an effective PARP inhibitor. The academia is still urging for the coverage. As you may know, Lynparza initially had reimbursement limitation of covering only up to 15 months. The academia raised the voice on it to remove the limitation and they a good end result. Recently, the academia is pressing on the government to grant the insurance benefit regardless of biomarker status. Apparently they have requested the government to expand the current insurance standard. -Have you contemplated on the order of therapies, now that the variety of ovarian cancer treatment including PARP inhibitors and Avastin combination therapy is available? Many of the researchers are also interested in the topic. Currently, there has not been a clinical study head-to-head comparing the efficacy of PARP inhibitor and Avastin (bavacizumab). A real-world research would be possible, when both are approved for the first-line maintenance therapy in ovarian cancer treatment and the related cases are collected. When choosing a medication, adverse reaction from the treatment addressed in a study is considered as crucial as the confirmed efficacy. Moreover, patients’ opinions are definitely a factor to consider. But when it comes down to the order of treatment, using more effective drug seems to be better. All drugs demonstrate better efficacy when used in the first-line treatment.
- Company
- Competition of Humira biosimilars intensifies
- by Kim, Jin-Gu Aug 18, 2020 06:03am
- HumiraCelltrion and LG Chem compete in earnest in the biosimilar market of Humira (Adalimumab). Both companies have completed phase III clinical trials and are currently working on preliminary work to apply for product approval. If Samsung Bioepis, which has already obtained approval for the product, releases its product early next year, competition in the Humira biosimilar market with annual sales approaching ₩100 billion will intensify. According to the pharmaceutical industry on the 12th, Celltrion is in the process of preliminary work to apply for an item license for CT-P17. CT-P17 is a Humira biosimilar being developed by Celltrion. Celltrion has conducted phase I and III clinical trials simultaneously in the United States, Europe, and Korea since March last year. It applied for an item license in Europe in this March. According to industry officials, the application for a domestic item license is also imminent along this extension. An official from Celltrion said, "After the clinical trial was completed at the end of last year, we are currently in the process of preliminary work for domestic item license application, but we have not yet determined the exact time to apply for approval." According to Celltrion, CT-P17 is the first high-concentration formulation among Humira biosimilars. The dose was reduced from the previous 4 times to 2 tims. It is evaluated for improving patient convenience by removing citrate, which may cause pain during self-injection. LG Chem is also preparing to apply for a Humira biosimilar product license. LG Chem is developing a Humira biosimilar named LBAL. Since 2016, it has conducted phase III clinical trials simultaneously in Korea and Japan with Japanese pharmaceutical company, Mochida. The clinical end point is in the first half of 2018, ahead of Celltrion. LG Chem is preparing for product approval based on the clinical results. An official at LG Chem said, "We are preparing additional data for product approval after the 3rd phase of clinical trials is completed." LG Chem's LBAL is characterized by changing the composition of the protein formulation by different combinations of various additives so that it can be stored more stably than existing products for a long time. LG Chem has applied for a related patent earlier this month. Prior to the two companies, Samsung Bioepis has obtained product approval from Humira Biosimilar. In September 2017, Samsung obtained a license for 'Adaloche' in the form of a injection. Pen-type injections was approved in July of this year. However, this product has not been released in earnest yet. The official release is scheduled for early next year due to a license agreement with the original company, AbbVie. If Celltrion and LG Chem succeed in obtaining product licenses for Humira biosimilars, three companies are expected to form a competitive structure in the domestic market together with Samsung Bioepis. In particular, Humira is expected to intensify competition as it is the item that generates the most sales among various autoimmune disease treatments. According to IQVIA, Humira's domestic sales last year were ₩96.2 billion. In Europe, where competition for the Humira biosimilar market began before Korea, biosimilars are targeting the original very quickly. In Europe, Samsung Bioepis, Amgen, Boehringer Ingelheim, Sandoz, Pfizer, and Mylan have each released Humira biosimilars. An official from the pharmaceutical industry predicted that "Celltrion will be able to obtain a license as early as the first half of next year. If LG Chem adds to this, competition in the domestic Humira biosimilar market will begin in earnest from next year."
- Policy
- Zolgensma was added to target diseases
- by Lee, Tak-Sun Aug 18, 2020 06:02am
- The minutes of the Central Pharmaceutical Affairs Review Committee were released in connection with the expansion of the target age of the expensive drug 'Zolgensma' of ₩2.5 billion, and it was revealed that the target disease was added on the 3rd. The committee presented a negative opinion on the expansion of the age group, but Orphan drug designation change announcement revealed that the age group has expanded. At the beginning of this year, Novartis Korea, a sales company of this drug, applied for a formal approval, and it is noteworthy how the indications will be determined when the product is approved. This is because, as this drug is an ultra-high-priced drug with a price of ₩2.5 billion by the manufacturer, the difference in the amount of benefits in the future increases depending on the difference in the number of patients. According to the industry on the 13th, the MFDS has further expanded the target disease of Zolgensma, currently designated as an orphan drug on the 3rd. Zolgensma was designated as an orphan drug in December 2018 in Korea. When designated as an orphan drug, approval screening is accelerated, and purchases are facilitated through the KOEDC. It was designated as the first orphan drug, the target disease was announced as 'spinal muscular dystrophy (Type 1)'. However, the target diseases announced this time have been changed to ▲if there is a clinical diagnosis of type 1, and ▲the number of copies of the Survival Motor Neuron 2 (SMN2) gene is 3 or less Survival Motor Neuron 1 (SMN1)' in patients with Spinal Muscular Atrophy (SMA) with a double allelic mutation in the gene. Spinal muscular dystrophy is all about patients with mutations in the SMN1 gene that act on the motor nerves. However, it is divided into 3 types according to symptoms. Type 1, which was previously a target disease, dies within 2 years of age from 2/3 or more, and type 2 can survive until elementary school entrance, but there are many cases of using a wheelchair due to muscle disorder, and type 3 appears normal in the neonatal period, but progresses slowly. In particular, type 1 is mostly diagnosed in infants under 6 months. Zolgensma can be administered to children under the age of 2 in the United States and Japan, and to children under 21 kg of body weight, regardless of age, approved earlier this year in Europe. On the other hand, since the use of TYPE 1 for orphan drugs designated in Korea is limited to infants under 6 months, Novartis tried to expand the patient group by adding diseases for orphan drugs before official approval. However, at the committee held in May, it was desirable to further restrict the target age, type, etc., and presented a negative opinion on the contents of Novartis' application. However, the 'survival motor neuron 2 (SMN2) gene's copy number of 3 or less' is also included in the target disease, resulting in an expanded age group. This is because many patients with type 2 and type 3 SMA diagnosed after 6 months have 3 to 4 SMN2 genes. Patients with type 1 have only one or two SMN2 genes. Currently, 60% of SMA patients are in type 1, 30% in type 2, and 10% in type 3. It means that Zolgensma can be used in types 2 and 3 regardless of age. However, it is difficult to predict the final indication as this drug has not yet been officially approved in Korea. However, there is a high possibility that the designation of orphan drugs will be reflected in the official approval. From a manufacturer's point of view, sales can be expected to increase due to the expansion of the age group. On the contrary, it seems that the insurance authorities' concerns will increase in the phase of applying for benefits after formal approval. This is because even if the number of patients used increases by just one or two, the size of the health insurance premium differs by several billion won(₩). Currently, about 17 SMA patients under the age of 2 in Korea are known to have been diagnosed annually. When the manufacturer's suggested amount is applied to the domestic patient group, the size of the treatment will reach ₩42.5 billion per year.
- Company
- Ezetimibe combo drug market grows steeply amid COVID-19
- by Chon, Seung-Hyun Aug 18, 2020 06:02am
- In the dyslipidemia treatment market, the volume of ezetimibe combination drug prescription is expanding rapidly. Preference in prescribing ezetimibe combined with rosuvastatin or atorvasutatin is growing fast. Hanmi Pharmaceutical’s Rosuzet and MSD’s Atozet seem to be leading the steep increase in the use of ezetimibe combination therapy. According to the pharmaceutical market research institute UBIST on Aug. 12, the outpatient prescription of ezetimibe plus statin combination drug for dyslipidemia treatment has grown by 19.5 percent from the second quarter last year at 95.4 billion by reaching 114.0 billion won in the second quarter this year. The combination drug has also shown an impressive growth of 23.3 percent in last first quarter as well. Quarterly outpatient prescription volume in statin plus ezetimibe combination drugs (Unit: KRW 1 million) Source: UBIST In the second quarter, the chronic disease treatment market stagnated amid COVID-19 pandemic, but the ‘statin plus ezetimibe’ combination drug showed an exceptional growth. The statin plus ezetimibe combination drug’s prescription volume only reached 55 billion won in the second quarter of 2017, but it almost doubled in three years. Compared to 29.6 billion won in the second quarter 2016, the market has tripled in just four years. The industry experts analyzed the preference in the combination drug has been surging as the drug demonstrate improved efficacy in lowering low-density lipoprotein cholesterol (LDL-C) level and also the products are reasonably priced. Currently, the available products are a combination of simvastatin, rosuvastatin or atorvastatin with ezetimibe. But rosuvastatin plus ezetimibe drug’s prescription volume has leapt with Korean pharmaceutical companies intensely driving the growth. Outpatient prescription volume in different ezetimibe combination drugs (Unit: KRW 1 million) Source: UBIST Compared to last year at 85.1 billion won, the rosuvastatin plus ezetimibe combination drug prescription volume in last second quarter grew by 23.8 percent. The figure tripled from 31.5 billion won in 2017. As of last second quarter, rosuvastatin plus ezetimibe combination drug dominates 74.7 percent of the statin plus ezetimibe drug market. Basically the combination drug is leveraging the growth in the entire combination drug market. Hanmi Pharmaceutical’s Rosuzet has been leading the boom of rosuvastatin plus ezetimibe combination drugs as it entered the market the first in late 2015. Rosuzet’s second quarter prescription volume hit 24.1 billion won and grew by 21.6 percent from last year. The rosuvastatin plus ezetimibe combination drug broke the record of the largest prescription volume, among all Korean-developed combination drugs. Hanmi Pharmaceutical was able to enter the market first and won the opportunity to monopolize the market, as the company licensed the use of ezetimibe patent from the patent owner MSD. Rosuzet’s 2017 third quarter prescription volume exceeded 10 billion won, and its consistent growth has never been crippled. Another rosuvastatin plus ezetimibe drug, Yuhan’s Rosuvamibe also grew by 17.1 percent from last year second quarter by generating 13.2 billion won this year. HK inno.N’s Rovazet has generated 6.1 billion won in the second quarter and showed a significant growth of 20.3 percent from last year. Quarterly outpatient prescription volume in Rosuzet and Atozet (Unit: KRW 100 million) Source: UBIST Moreover, atorvastatin plus ezetimibe drug also had a consistent growth. Currently, MSD’s Atozet is the only atorvastatin plus ezetimibe drug available. In the second quarter, Atozet generated 18.4 billion won and grew by 14.5 percent from last year. In just two years since the second quarter of 2018, its prescription volume grew by 67.4 percent from 11 billion won. MSD has a co-marketing partnership with Chong Kun Dang over Atozet. The combination drug’s overall growth would expand in the future as another atorvastatin plus ezetimibe drug is soon to be launched. In April last year, Chong Kun Dang completed a clinical trial on atorvastatin plus ezetimibe drug ‘CKD-391’ and submitted an item approval application to the Ministry of Food and Drug Safety (MFDS). Currently, about 20 Korean companies have started bioequivalence test for their Atozet generics. On the contrary, the prescription growth in simvastatin plus ezetimibe combination drug has been sluggish. In the second quarter, the combination drug only made 10.4 billion and the prescription volume was brought down by 0.9 percent from last year. The combination seems to have been affected by the rapid growth of other rosuvastatin plus ezetimibe drugs.
- Company
- The safety of Statin therapy has been proven
- by Nho, Byung Chul Aug 14, 2020 03:17pm
- As the Cerebral Cardiovascular Disease Control Act was revised in April, dyslipidemia was included in the range of cerebrovascular diseases under the current law, along with hypertension and diabetes. It is explained that the severity and risk of dyslipidemia have been recognized at the national level and the willingness to support is indicated. Accordingly, the importance of dyslipidemia management is expected to become more prominent in clinical settings. In fact, in a large-scale prospective cohort study in Korea in 2014, dyslipidemia was identified as one of the four risk factors that have the greatest impact on the occurrence of cerebrovascular disease in Koreans, along with hypertension, diabetes, and smoking. In addition, dyslipidemia is a chronic disease that is increasing the most in Korea. According to the current status and issues of chronic diseases of the KCDC, the prevalence of dyslipidemia in adults in Korea as of 2017 was 21.5%, more than doubled from 10.7% in 2007. Hypertension increased by 2.4% to 24.5% in 2007 and 26.9% in 2017, while diabetes increased by 0.9% to 9.5% in 2007 and 10.4% in 2017. Dyslipidemia is a major underlying condition of cardiovascular disease, which is a major cause of death in Korea, and active lipid management from an early stage is important for the prevention and management of cardiovascular disease. If long-term treatment is left without lipid management, cholesterol accumulates on the walls of blood vessels, resulting in atherosclerosis, and such atherosclerosis narrows the blood vessels, leading to cerebral cardiovascular diseases such as angina, myocardial infarction, and stroke, which can lead to death. It is noteworthy that Statin therapy is recommended in major domestic and international medical guidelines as the primary treatment for cardiovascular disease prevention for patients with dyslipidemia and high risk of cardiovascular disease. Cholesterol Guidelines of the U.S. 2018 AHA/ACC Multisociety and treatment guidelines of the Korean Society of Lipids and Arteriosclerosis recommend Statin therapy as the first line treatment for cardiovascular disease prevention for high-risk groups such as dyslipidemia patients. As Statins have long-term therapeutic effects and safety profiles confirmed through clinical and actual patient treatment, high-risk patients need to maintain Statin therapy continuously and stably in order to effectively prevent cardiovascular disease. Statins have been introduced and used in various ingredients, and according to Cholesterol Guidelines of 2018 U.S. AHA/ACC Multisociety, 7 Statin treatments are included. The ACC/AHA cholesterol treatment guideline suggests statin suitable for high-intensity/medium-intensity/low-intensity therapy according to the LDL-C control target. Atorvastatin 10-20mg, Pitavastatin 1-4mg, Simvastatin 20-40mg, etc. are recommended for medium-intensity therapy that should lower LDL-cholesterol to 30-49% of baseline. In addition, only Atorvastatin (40mg, 80mg) such as Lipitor or Rosuvastatin (20mg, 40mg) are recommended for high-intensity therapy that requires lowering LDL-cholesterol by 50% or more. Among many Statins, Atorvastatin is by far a drug that has proven excellent cardiovascular disease management, prevention, and safety over a long period of time through large-scale clinical studies around the world. Atorvastatin also has a number of clinical data for domestic patients. According to the related clinical trial, AT-GOAL, Atorvastatin 10mg, 20mg, and 40mg were administered according to LDL-cholesterol level and cardiovascular risk, and the study was conducted by weighing the dose according to the LDL-cholesterol level at 4 weeks of administration. The proportion of patients who reached the LDL-cholesterol target level at 4 and 8 weeks of administration were 81.9% (95% CI, 77.9-85.5) and 86% (95% CI, 82.3-89.2), respectively. According to the results of a meta-analysis of 11 clinical studies conducted in Korea, Japan, and China related to medium-intensity therapy, patients taking Atorvastatin 10-20mg showed more effective effect of reducing LDL-C compared to patients taking Pitavastatin 1-4mg. (Mean difference of 2.51, 95% confidence interval 1.17–3.86, P=0.0003), and no significant difference was found in relation to the elevation of glycated hemoglobin (HbA1C) (mean difference -0.14, 95% confidence interval-1.44–1.15). , P=0.83) In the case of high-intensity therapy, Atorvastatin was found to significantly reduce the risk of major cardiovascular events by 22% when administered at a high dose (80 mg/day) and compared to a low dose (10 mg/day) through a clinical trial for patients with safe coronary heart disease. It has been shown to have secondary prevention indications for coronary heart disease, which lowers the risk of myocardial infarction (non-fatal), stroke (fatal and non-fatal), angina pectoris and congestive heart failure, and revascularization. Professor Park Deok-Woo of the Department of Cardiology of Asan Medical Center said, "As with Atorvastatin, the efficacy and safety of the drug have been proven and widely used in various clinical studies targeting various patient groups ranging from low-risk groups to high-risk groups over the past 20 years. He advised that if a patient has received Statins therapy, he or she should actively manage lipids and prevent primary and secondary cardiovascular diseases.”
- Company
- Zejula, re-challenges 'all comer' for ovarian cancer
- by Eo, Yun-Ho Aug 14, 2020 06:23am
- The anticancer drug 'Zejula' once again challenges 'all comer' insurance benefit through the first line maintenance therapy for ovarian cancer. According to related industries, Takeda Korea recently introduced epithelial ovarian cancer or fallopian tubes that showed a complete or partial response to primary platinum-based chemotherapy regardless of the BRCA mutation of the Poly ADP-ribose Polymerase (PARP) inhibitor Zejula (Niraparib). The company submitted an application for benefits for cancer and primary peritoneal cancer monotherapy. In December of last year, Zejula was first listed for patients with BRCA mutation in the sole maintenance therapy of adult patients with platinum-sensitive recurrent highly serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who responded to platinum-based chemotherapy completely or partially. .This drug has secured indications so that it can be prescribed regardless of the BRCA mutation .Afterwards, in June of last year, Zejula was dealt with ▲Platinum-sensitive recurrent highly serous ovarian cancer that responded completely and partially to gBRCA-negative platinum-based chemotherapy, ▲Recurrence after receiving 4 or more anticancer chemotherapy Monotherapy for sexual ovarian cancer at the Cancer Disease Review Committee in June of last year .However, only 4th line therapy passed, and gBRCA negative did not pass .The government is sticking to a conservative attitude toward the indication of 'allcomer' of anticancer drugs .The efficacy of Zejula's primary maintenance therapy was based on a PRIMA clinical study in 733 adult patients with ovarian cancer .The primary efficacy evaluation variable was the progression-free survival period evaluated by the BICR, and the homologous recombination deficiency (HRd) patient group and the overall population were sequentially evaluated .In clinical studies, Zejula showed a median progression-free survival (PFS) of 21.9 months, which is more than twice as long as placebo in the homologous recombination deficiency (HRd) patient group, and reduced the risk of disease progression and death by 57% .The median PFS of the placebo group was 10.4 months .The median PFS of all patient groups was 13.8 months in the Zejula group and 8.2 months in the placebo group, reducing the risk of disease progression and death by 38% .Meanwhile, Zejula was first listed on the reimbursed list at ₩76,400 .It was judged to be more cost-effective than the alternative drug, AstraZeneca's 'Lynparza (Olaparib)' .However, since Lynparza was listed through the RSA (Risk Sharing Agreement) economic evaluation exemption track, the same type of fixed price contrac was applied.
- Policy
- MFDS imposes fine on imported Nesina Met and Xeomin
- by Lee, Tak-Sun Aug 14, 2020 06:22am
- Takeda Pharmaceuticals Korea’s antidiabetic drug Nesina Met and other imported drugs have received administrative measure from Korea’s Ministry of Food and Drug Safety (MFDS). Specifically for Nesina Met, the importer would be responsible for the health authority’s 30.15 million won fine that substituted a three-month sales ban. On Aug. 13, MFDS disclosed a list of administrative measures imposed as of Aug. 7 with the said details. Besides Nesina Met, other imported botulinum toxin products were also found on the list. Takeda Pharmaceuticals Korea’s Nesina Met was fined with 30.15 million won, instead of a three-month ban, as the company neglected submission of required data for the post-marketing survey (PMS) reevaluation. The fine is due on Sept. 7. An alogliptin benzoate plus metformin hydrochloride combination antidiabetic drug, Nesina Met was approved for the Korean market in February 2015. Currently the drug is imported to Korea by Takeda Pharmaceuticals Korea. The PMS reevaluation on Nesina Me was completed as of May last year. For a new drug, the company had to submit usability investigation data like adverse reaction report to MFDS during the reevaluation period. Omitting a part of required data submission once gets a three-month sales ban, and twice gets a six-month sales ban. However, the penalty can be replaced with a fine. A dipeptidyl peptidase-4 inhibitor, Nesina Met has made 3.4 billion won in outpatient prescription from the first half of the year, according to UBIST. Administrative measures on some imported pharmaceuticals as of Aug. 7 (Source: MFDS) Two imported botulinum toxin products competing against Korean botulinum toxin products have also received administrative measure due to an omission of serial number. Merz Asia Pacific omitted serialization information when reporting supply history and shipping of ‘Xeomin injection’ and ‘Xeomin injection 50 unit’ from July through December 2019. As a result, the health authority imposed a fine of 14.85 million won due Sept. 7, substituting a month-long sales ban. Ipsen Korea has also gotten a sales ban on a botulinum toxin Dysport injection for to the same charges. From July through December 2019, the company also omitted to report Dysport serialization along with its supply record. The product sales would be banned for ten days from Aug. 21 to 30. Xeomin and Dysport have been imported to Korea for 4.6 billion won and 900 million won, respectively, in 2018. The two products together take up a small pie of 2.7 percent in the Korean botulinum toxin market. The serialization system has been enforced since January 2019. The government has mandated reporting of product serial number when a company ships out the products to improve transparency in distribution and user safety. Same administrative measures were given on Ipsen Korea with the same charges. The sales on Diphereline PR injection and Diphereline SR injection would be banned for ten days from Aug. 21 to 30.
- Company
- Bukwang, registered a patent for COVID-19 tx of Levovir
- by Aug 14, 2020 06:21am
- #Bukwang Pharm announced on the 11th that it has registered a patent of COVID-19 of antiviral drug 'Levovir' which is for “Use of L-nucleoside to treat COVID-19”. Bukwang Pharm used Remdesivir as a positive control to confirm the effect in human lung cells. And the company explained that it was also effective in a test conducted on monkey kidney cells, and that a patent was registered. The company also applied for an international patent (PCT) on the 5th and is undergoing the registration process. Levovir is an antiviral drug developed by Bukwang and is being sold as a treatment for the hepatitis B virus, the fourth in the world and the first in Asia. Levovir is a nucleic acid analog and has the effect of inhibiting the replication of viral genetic material by intervening in the process of binding of the RNA template. As an ingredient used as an antiviral agent, data on the delivery of drugs to infected cells and long-term safety values have been verified, and phase II clinical trial is in progress.
- Policy
- Bayer begins development of high-dose of Eylea
- by Lee, Tak-Sun Aug 14, 2020 06:21am
- #The competition between Bayer and Novartis for the treatment of age-related macular degeneration (AMD) is intensifying. After Novartis recently received approval in Korea for a new drug 'Beovu', which improved the number of doses, Bayer also began to develop a high-dose of Eylea that extended the dosing period. On the 11th, the MFDS approved a multinational phase III clinical trial plan for 'High-dose of Aflibercept' applied by Bayer Korea. Aflibercept is generic name for Eylea. Eyleais a product that is injected once every two months (8 weeks), and is the No. 1 item in the market, recording ₩46.8 billion based on IQVIA last year. The next ranking is Novartis' Lusentis, which recorded ₩30 billion, which has to be given an injection once every 4 weeks, which is less convenient than Eylea. However, Novartis was approved for Beovu inj and Beovu PFS in June and July, but because BioVu is injected once every 12 weeks, it is showing superiority in the number of doses per year than Eylea. If BioVu is released on reimbursed item, it is expected to compete with Eylea. Bayer is also preparing the ace in the hole against Novartis. It is reported that the high-dose of Eylea, which has been approved for phase III clinical trials this time, is being developed in a manner that is injected once every 12 weeks, like Beovu. Macular degeneration, which can cause loss of vision due to damage to the macular area of the eye, is known as the number one cause of blindness in the elderly. As such, there is a lot of demand for treatment. In particular, biosimilar products are also being developed, which is expected to intensify market competition in the future.
