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- 2026-05-10 23:37:47
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- “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.
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- 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."
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- 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.
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- 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.”
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- 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.
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- 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.
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- Kynteles is added in the revision of the domestic guidelines
- by Eo, Yun-Ho Aug 13, 2020 06:25am
- Kynteles is expected to be recommended as the first line therapy in the domestic IBD guidelines. Kim Joo-sung, president of the KASID( Department of Gastroenterology, SNUH), guided domestically at a press conference to commemorate the expansion of insurance coverage for the first-line treatment of Inflammatory Bowel Disease (IBD) of Takeda's 'Kynteles (Vedolizumab)' held on the 12th. Until now, in Korea, it had to be used secondarily only to patients who failed the TNF-α inhibitor according to the requirements. However, as the indications were expanded as the first-line treatment at the beginning of this year and the reimbursement was obtained On the 1st, it can be used as a first-line treatment in Korea, regardless of using TNF-α inhibitors. Kynteles, the only anti-integrin drug among the first-line treatments for IBD licensed in Korea, blocks inflammatory cells entering the intestine by a mechanism that specifically binds to α4β7 integrin of white blood cells that induce intestinal inflammation. In other words, the risk of tuberculosis or infection is lower than that of conventional treatments because there is no confirmed systemic immune suppression effect and only works in the intestine. Global guidelines also reflect this. In February, the guidelines published by the American Gastrointestinal Association (AGA) suggested strategies for inducing remission in outpatients with moderate or severe ulcerative colitis, depending on whether or not treated with biological agents. For patients without biologic treatment experience, conditional recommendations were given to Kynteles or Remicade (Infliximab) rather than Humira (Adalimumab) for remission induction. Kim Joo-seong said, "The more available treatments, the more likely the medical staff will treat patients safely and effectively. The domestic guidelines have also been revised. As Kynteles can be prescribed with benefits for first-line therapy in Korea, This will be actively reflected in the new guidelines. Meanwhile, Kynteles proved its effectiveness through a VARSITY study that directly compared with Humira. According to the results of the study, the clinical remission† rate of patients treated with Kynteles was 31.3% at 52 weeks, and the clinical remission rate of Humira was 22.5%. In addition, 39.7% of the patients treated with Kynteles showed the effect of healing the intestinal mucosa, whereas only 27.7% showed the effect in the control group.
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- Quadrivalent Flu Vaccine for NIP, failed in bidding
- by Aug 13, 2020 06:25am
- The procurement of a tetravalent vaccine for influenza for NIP failed bidding three times due to an excessively low unit price. According to related industries on the 10th, two bids for the '2020-2021 season influenza vaccine purchase' conducted by the KCDC were failed on the 28th of last month. Initially, New Medipharm and PharmWorld (NIP, local government project, AI response, etc.) and Seojun Pharm (children, pregnant women) were each successful bidder, but both failed to submit a supply confirmation and gave up delivery. The government's low unit price setting is blamed as the reason for abandoning delivery. The government set the estimated unit price for a quadrivalent flu vaccine at ₩8,790. This is only 60% of the usual supply price of ₩14,000 to ₩15,000 for tetravalent vaccines. Even this is also somewhat increased due to the failure in bidding. At the time of the first bidding on the 2nd of last month, the estimated unit price suggested by the KCDC is ₩8,490. Wholesalers who did not receive a supply agreement from the manufacturer at an excessively low price eventually gave up supply. Accordingly, the government slightly increased the unit price to ₩8,610, but it was sold as a single bid. In the third bid, ₩8,790 was offered, but the final successful bid was not achieved. It is in danger of delaying the government's plan to complete the contract in July and begin purchasing in August with subsequent reservations to begin full-fledged vaccination from October. The government plans to conduct an urgent bid to purchase an influenza vaccine on the 13th, but the possibility of failing in bidding remains as it is applying the same unit price as the last bid. An official from the flu vaccine manufacturing industry said, "The government’s proposed tetravalent vaccine supply price is almost no difference compared to the trivalent vaccine price, which has a low production cost." Also, as the NIP supply price decreases, the difference between the supply price in the private market widens, which is a burden for manufacturers. This is because the greater the gap, the stronger the demand for price cuts in the private market will increase.
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- Big 5 pass Qsymia powered by Alvogen-CKD co-marketing
- by Eo, Yun-Ho Aug 12, 2020 06:00am
- The Big Five general hospitals have cleared the prescription of Qsymia speedily widening its brand awareness within the obesity treatment market. According to pharmaceutical industry sources, the drug committees at Big Five hospitals like Seoul National University Hospital, Severance Hospital, Samsung Seoul Medical Center and Seoul Asan Medical Center have reviewed and approved the prescription of Qsymia supplied by Alvogen and its Korean co-marketing partner Chong Kun Dang. Seoul St. Mary's Hospital is also in the process of reviewing the drug. The prescription code has been landed in Korea University Anam Hospital, Ajou University Hospital and other major hospitals around the country. Qsymia can be prescribed in four different doses—3.75 mg/ 23 mg, 7.5 mg/ 46 mg, 11.25 mg/ 69 mg and 15 mg/ 92 mg—and their pricing have been fixed to 4,000 won per tablet. Belviq, Contrave and Qsymia’s cost per day are about the same in Korea and the U.S. A clinical study on Qsymia found the drug demonstrates the most superior effect in weight loss among the Food and Drug Administration (FDA)-approved long-term obesity treatments, and shows better safety than Saxenda or Contrave. The retrospective meta-analysis study comparing five drugs have reviewed 28 randomized clinical studies on 29,018 patients. Qsymia showed the best weight loss effect in losing over five percent of body weight, and Saxenda, Contrave, Belviq and Xenical followed in the order. The distribution of the drug effect in patients who have lost over 10 percent was also led by Qsymia (54 percent) and followed Saxenda (34 percent), Contrave (30 percent), Belviq (25 percent) and Xenical (20 percent). Saxenda and Contrave had the highest risk of halting the administration due to adverse reaction, whereas Belviq had the lowest. Qsymia’s level of risk was around the mid-way between Saxenda and Belviq. In just three months after the release, Qsymia generated 4.3 billion won in a quarter and seconded the obesity treatment market in Korea. The sales gap between Qsymia and Saxenda are only 1.6 billion won. The drug has already doubled the sales of Daewoong Pharmaceutical’s Dietamin, which has been tailgating after Saxenda until the fourth quarter last year. Qsymia is a phentermine plus topiramate combination drug developed by the U.S.-based Vivus, and Alvogen signed a deal in 2017 to supply the drug to Korea. Alvogen then inked a co-marketing deal with Chong Kun Dang in last year, and fully initiated the sales and marketing activities from early this year. Alvogen, with experience in obesity treatment sales like Furing and Furimin, have generated a synergy effect with Chong Kun Dang’s sales power for the obesity treatment to quickly take up the market. A pharmaceutical market research firm UBIST found Qsymia has made 310 million won and 614 million won in last January and February, respectively, and placed itself on the leader board following Saxenda (875 million won), Dietamin (847 million won) and Hutermin (780 million won) as of February.
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- Sayana and Gonal-F shortage may last longer than expected
- by Aug 12, 2020 05:59am
- Shortages in various drug products are reportedly caused by manufacturing facility changes and unstable supply of pharmaceutical substances. According to pharmaceutical distribution industry sources on Aug. 10, Pfizer Pharmaceutical Korea, Merck Korea, Dalim Biotech and other companies have recently informed of shortages in some products. Pfizer Pharmaceutical Korea notified of halting supply of an injected female contraception Sayana (104 mg/ 0.65 mL) from coming October. The subcutaneous injection is currently indicated for contraception or pain from endometriosis in female patients. The global company explained the unstable production delay in the manufacturing facility would prolong the shortage. The final batches of supply are to be expired on May 31, 2023. Merck Korea’s self-injected fertility treatment Gonal-F Pen (300/ 450/ 900 IU) would also experience temporary shortage due to delay in supply. Apparently, the QC schedule in Korea was postponed. Merck Korea stated, “The supply would be ceased around Aug. 10,” but “It would resume around second or third week of September. And more accurate schedule would be notified again in late August or early September.” The importation schedule for Menarini Korea’s diuretic Torem 2.5 mg tablet has been pushed, because the company is changing the overseas manufacturing facility. The supply is expected to resume from Sept. 4. Regardless, Torem 5 mg or 10 mg tablets would be supplied normally. Dalim Biotech issued a notice on temporary shortage in Norpin 20 mL injection due to reevaluation on the transferred manufacturing facility. Dalim Biotech official noted, “As the company moved its manufacturing factory, the health authority has also been changed from Gyeongin Regional Office of Food and Drug Safety to Seoul Regional Office of Food and Drug Safety. And the health authority requested reevaluation on Norpin,” accordingly, “The product would likely to experience temporary shortage until the Ministry of Food and Drug Safety (MFDS) completes the evaluation.” The shortage is expected to last about a month, and the normalized supply would resume from late August to early September. With the manufacturing factory transfer, Dalim Biotech is also having a temporary shortage in a diabetic nephropathy treatment Lipo-A tablet 30T. However, Lipo-A tablet 500T is in supply. Meanwhile, Ildong Pharmaceutical’s OTC digestive Soxinase Triple tablet 300T and Korea United Pharm’s hypertriglyceridemia treatment Omethyl QTlet 2 g soft capsule are also out of stock at the moment as the companies are dealing with problems in substance supply. Currently, the two companies do not have specific dates for the resumption of the product supply.
