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- 2025-12-27 12:03:48
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- Pfizer's EGFR TKI to compete against Iressa and Giotrif
- by Eo, Yun-Ho Jan 17, 2020 06:27am
- Pfizer Pharmaceutical Korea is stepping into the lung cancer-treating EGFR TKI market. Industry sources reported, Korean health authority is expected to grant approval on Pfizer’s epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) within the first quarter of the year. Last year, the global company has submitted a marketing approval application. Vizimpro won approvals from the U.S. Food and Drug Administration (FDA) and European Commission in October 2018 and April 2019, respectively. The drug is a first-line target therapy treating patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutations. It is categorized as a second generation therapy like Giotrif (afatinib) by Boehringer Ingel Heim. EGFR TKI products approved in Korea Currently, first generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (Erlotinib), second generation Giotrif, and third generation AstraZeneca’s Tagrisso (osimertinib) are available for prescription. When the company releases Vizimpro, it would directly compete against Iressa, Tarceva and Giotrif. But the competitor line up would change when Tagrisso is listed as a reimbursed first-line treatment. Considering Vizimpro is a follow-on drug, Pfizer would price the drug comparatively lower and rather aim to receive reimbursement fast. Vizimpro’s efficacy was confirmed in a Phase 3 study, ARCHER 1050. The clinical study compared arms each treated with dacomitinib and AstraZeneca’s first generation medicine Iressa, and observed overall 425 patients with NSCLC. As a result, Vizimpro lowered patients’ hazard ratio 41 percent more than Iressa, whereas median progression-free survival (PFS) in the Vizimpro arm was 14.7 months compared to 9.2 months in the Iressa arm. However, Vizimpro group had more adverse reaction reported. The most common third-level and higher serious adverse reactions were acne (14 percent) and diarrhea (eight percent) in Vizimpro group, and abnormal liver enzyme level (eight percent) in Iressa group. 60 percent of Vizimpro-treated patients had to adjust treatment dose due to the side effects.
- Company
- Nexava’s patent expired, Why generics not released yet?
- by Kim, Jin-Gu Jan 17, 2020 06:24am
- Generics have not appeared even though the patent for hepatocellular carcinoma 'Nexava' (Sorafenib) has expired. Hanmi is reportedly having difficulty in generic development even though it has actively solved the patent problem. In some industries, abandonment is raised. Hanmi is poised to bring it to market as soon as the bioequivalence test and licensing process is completed. According to the pharmaceutical industry on the 14th, Hanmi Pharmaceutical has challenged to develop Nexava alone. The item went to the Supreme Court and worked hard enough to pass the patent. There are three patents on Nexava. Bayer, the original company, has registered patents for materials, crystalline patents, and formulations and uses. Among these, Hanmi has succeeded in overcoming the crystalline patent and the formulation and use patent. In 2015, Hanmi Pharm claimed a negative jurisdiction for judging crystalline patents and an invalidity trial for formulation and use patents. The patent dispute was fierce enough to go to the Supreme Court. In the end, the Supreme Court concluded the dispute over two years on the side of Hanmi Pharm in both patent disputes in 2017. As a result, Nexava-related patents were left with only one patent. The patent even expired this month. The hurdles for generic releases are gone. Nevertheless, the launch of generics for Nexava are still uncertain. As of the 14th, the generics aren’t be identified in the drug product authorization list of the agency. This is an unusual interpretation given that generics are generally released in accordance with the expiration of material patents. It did not pass the bioequivalence test. Hanmi conducted bioequivalence test in August 2015 named Hanmi Sorafenib. As a result, it failed to confirm bioequivalence test. With this, some have raised doubts about whether Hanmi has abandoned its development. Hanmi made it clear that it was not true about abandonment. Hanmi has been on the verge of reviving since March last year. It is reported that the recent recruitment of patients is over. An official from Hanmi said, "We will proceed with the application for approval as the bioequivalence test is completed". According to IQVIA, a pharmaceutical market analyst firm, Nexava's annual sales are ₩26.3 billion (as of 2018). If Hanmi succeeds in launching the generics as planned, it is expected that it will be able to secure a significant portion of Nexava's sales, as it is under exclusive development. So far, only Hanmi has succeeded in avoiding Nexava patents. Yuhan Corporation, JW pharmaceutical, and Ahn-gook Pharmaceutical challenged the patent, but withdrew the patent trial request.
- Company
- Dong-A ST finished Abbvie’s ₩48 billion down payment
- by Lee, Seok-Jun Jan 17, 2020 06:24am
- Dong-A ST completed a 36-month split recognition of the Abbvie technology export contract of $40 million (about ₩48 billion). The 36 months is a period in which the two companies are considering the selection of pipelines. In other words, the preclinical study has countdown on the assumption that the pipeline has been successfully derived. Dong-A ST transferred the technology of MertaK inhibitor DA-4501 in the process of pipelines to Abbvie in December 2016. MerTK inhibitors are a new mechanism of immunological anticancer drugs that inhibit the activity of MerTK (MerTyrosine Kinase) protein and help the immune system. According to the industry on the 15th, Dong-A ST completed the 36-month split recognition of the Abbvie technology export contract by November last year. In the meantime, the $40 million contract has been booked at $ 1.11 million (about ₩1.3 billion) monthly and $3.33 million (about ₩3.8 billion) quarterly. Dong-A ST lost fixed profits after the split recognition. However, additional milestones can be expected as clinical progress Dong-A ST's Abbvie technology export maximum milestone is $ 485 million, excluding the $ 40 million contract. As clinical progress progresses, the inflow of royalties increases. According to the company, there are no milestones for receiving pipelines. After the down payment, the following fees are based on preclinical results. Since then, the milestones will increase in size. An official of Dong-A ST explained, "The Abbvie’s split-up recognition period is the period in which the pipeline is derived, and the pipeline is expected to be derived soon. If successful, it will enter the pre-clinical". The two companies, on the other hand, are obliged to carry out joint development until pre-clinical. For this, Dong-A ST and Abbvie formed Joint Research Committee. Steps after pre-clinical will be carried out by Abbvie alone.
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- BTX market new comers not bothered by legal dispute
- by Kim, Jin-Gu Jan 17, 2020 06:22am
- The Korean botulinum toxin market competition is reaching the peak. While the toxin strain related legal dispute has not yet been fully resolved, more and more companies are latching on to the market. Bio ventures, on top of the large and small-and-medium companies, have announced their plan to join the over-heated competition. On Jan. 13, Ministry of Food and Drug Safety (MFDS) cleared two botulinum toxin items, ‘Bienox’ and ‘Hitox,’ respectively from BNC Korea and BMI Korea. Founded in 2007, BNC Korea specializes in aesthetic plastic surgery medical devices like dermal filler and hyaluronic acid filler. Established in 2005, BMI Korea is the only pharmaceutical company to base in Jeju Island. It has been mainly manufacturing injections for anesthesia and pain. It seems their strategy is to first receive approval as an export product, and to win sales approval in Korea after conducting clinical trial in the future. With the export approval, the companies may export the products overseas without marketing approval in Korea. The strategy has worked for Huons, when its botulinum toxin product first got cleared for export under the name of ‘Hutox’, and received approval for Korean market later under the name of ‘Liztox.’ Including BNS Korea and BMI Korea, now 12 pharmaceutical companies have Korean government-approved botulinum toxin products. The number goes down to eight, excluding importers like Allergan, Merz and Ipsen. The rest of the list consists of Medytox, Hugel, Daewoong Pharmaceutical, Huons, Pharma Research Bio, Chong Kun Dang Pharmaceutical, BNC Korea and BMI Korea, in the order of approval date. Botulinum toxin products approved by MFDS The list expands to 18 companies if companies with botulinum toxin in development are added. All the latecomers are new bio companies, such as Jetema, Protox, Kanzen, Eubiologics, and Inibio. According to sources, Jetema has recently applied for MFDS’ export approval. The company has been approved as a pharmaceutical manufacturing company in January 2019. The purpose of the company seems to be clear and focused on manufacturing botulinum toxin products. On the other hand, Protox completed the construction of its botulinum toxin production facility in Hyangnam Pharmaceutical Industry Cluster in Hwaseong, Gyeonggi Province. The facility has a capacity to manufacture approximately 2.7 million vials a year. The company plans to conduct Phase 1 trial this year on its independently developed product, ‘Protoxin.’ Eubiologics and Inibio had their clinical trial protocols passed in March and December last year, respectively. Kanzen has registered botulinum toxin strain discovered on a snow mountain. Botulinum toxin products in development As a result, an unprecedentedly intense competition is expected to unfold in Korea. Currently, there are about three to seven global pharmaceutical companies supplying botulinum toxin products. Starting from Allergan, Ipsen and Merz, other global companies like Galderma, US WorldMeds, Revance Therapeutics and Lanzhou Bioengineering are in the game. In around 2022 and 2023, at least 14 companies would be competing against each other with 16 items according to the companies’ development plans. As blunt as it is, the competition would inevitably do more damage. The market, once led by Medytox and Hugel, has gotten saturated with Daewoong Pharmaceutical and Huons joining the market. Sources confirmed Medytox and Hugel have stopped growing already. Also the unresolved legal dispute over the source of botulinum toxin strain could be a burden for the new challengers. At the moment, Medytox and Daewoong Pharmaceutical are preceding astronomically expensive litigation on the source of botulinum toxin strain. The litigation would get close the final decision in around June. An insider of the industry commented, “Depending on the final decision, the two companies may proceed with next litigation.”
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- Mabthera anticipating indication on pediatric polyangiitis
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- MabtheraPharmaceutical industry is expecting anticancer treatment Mabthera to get indicated for treating pediatric patients in Korea. The industry source reported Roche Korea has submitted an indication expansion application to Ministry of Food and Drug Safety (MFDS) for Mabthera (rituximab) to treat 2-year-old and older pediatric patient with granulomatosis with polyangiitis (GPA) and microscopic plyangiitis (MPA). The application was for intravenous administration of Mabthera, and it is expected to get cleared within this year considering general processing period. The two diseases are rare angiitis that flares up inflammation in small vessels and significantly decreases blood volume, resulting in damaging major organs like lung and kidney and affecting skin. In September last year, the U.S. Food and Drug Administration (FDA) has approved the pediatric indication for Mabthera under a priority review with orphan drug designation. The approval was based on Phase 3 study that consisted of 25 patients aged from six to 17 years with the diseases. The clinical trial observed 14 patients achieving remission after six months of Mabthera treatment, and every patient achieving remission after 18 months. During the study, infections, infusion-related reactions and nausea were the most common side effects reported. And also, patients participating in the study with pediatric GPA and MPA have been observed with hypogammaglobulinemia. Indicated not only for treating hematologic cancer, but also for autoimmune conditions like rheumarthritis, Mabthera has formed an approximately five-trillion-won market (according to IQVIA data from 2018) in the U.S. alone. Currently, the treatment has an emerging competition in the U.S. as Pfizer and Korean company Celltrion’s co-marketed biosimilar with expanding indications.
- Company
- Pfizer's Novasc 10mg packaging will change to 28 tablets
- by Jung, Hye-Jin Jan 16, 2020 06:07am
- Pfizer's Novasc 10mg packaging unit will change from 30 tablets to 28 tablets. In addition, many drugs, including Bayer's antibiotic Avelox and Samjin Pharm's Gelma suspension, were sold out. According to the wholesale industry on the 14th, 30 tablets of Novask tablet 10mg tablet of Korean Pfizer will be discontinued and 28 tablets packaging will be supplied. The only discontinued item is 30 tablets of 10mg, and 30 tablets of 2.5mg, 5mg tablets and 500 tablets of 5mg tablets are supplied unchanged. Due to the delay in global production and supply, 30 tablets packaging of Bayer's Avelox Tablet 400mg is in short supply. Chong Kun Dang, which distributes Avelox, said it will be available by April 20. Samjin Pharmaceutical announced on the 14th that 125 pouch packaging products (25 pouches*5EA) of Gelma Suspension 10g were sold out. The reason for the absence of stock and the timing of resupply were not disclosed. Pfizer's psychoactive drug, Halcion 0.125mg, is also sold out due to a shortage of supplies. The cause is a delay in the supply schedule, which Pfizer expects to be available from March. Allergy medications Montelukast 10mg and Montelukast Chew 5mg and 4mg from Dongkwang Pharm are also in imbalance between supply & demand, and will be supplied again at the end of next month. It will be resupply in mid-March due to the delay. Jeil's 30-pack package of Bondube 60mg for osteoporosis treatment will be resupplyed in mid-March due to delays in product improvement. The packaging of 30 tubes of Ganfort UD 0.4ml, an eye drop solution by Allergan, is also temporarily sold out due to delays in import schedules. It will be resupplyed on February 14.
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- Zejula indicated for late-line therapy on ovarian cancer
- by Eo, Yun-Ho Jan 16, 2020 06:06am
- Anticancer treatment Zejula is now available for a monotherapy prescription on patient with ovarian cancer, who has been treated with fourth-line or later treatment. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated Ministry of Food and Drug Safety (MFDS) has additionally indicated Zejula’s (niraparib) on Dec. 24 for treating patient with relapsed ovarian cancer, who has been treated for more than third-line treatment. From March last year Zejula, the first poly ADP ribose polymerase (PARP) inhibitor used regardless of BRCA mutation, has been approved in Korea for maintenance treatment of adult patients with recurrent epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer), who are in a complete or partial response to platinum-based chemotherapy. And in December last year, the government granted healthcare reimbursement on the indication. However, the first reimbursed indication was limited to patients with BRCA mutation. By expanding the indication, Zejula is now the only PARP inhibitor in Korea indicated for BRCA mutation-positive patient regardless of platinum sensitivity, or hormone recombination deficiency (HRD)-positive adult patients, who have been treated with third-line plus chemotherapy. The indication expansion was based on an open-label multi-center QUADRA study evaluating the safety and efficacy of Zejula treating adult ovarian cancer patients with a record of third-line plus treatment. Treating HRD-positive platinum-sensitive patient group demonstrated objective response rate (ORR), a primary endpoint of the study, of 24 percent, whereas BRCA mutation-positive platinum-sensitive patient group, BRCA mutation-positive platinum-resistant patient group and BRCA mutation-positive platinum-refractory patient group demonstrated 39 percent, 29 percent and 19 percent, respectively, which confirmed the clinically meaningful benefit of the treatment. The secondary endpoint of the study, median duration of response (mDOR) of 8.3 months was observed in HRD-positive platinum-sensitive patient group. The finding confirmed the treatment’s safety profile can be managed by controlling the treatment dose.
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- Recommending ezetimibe, “The lower the LDL-C, the better”
- by Eo, Yun-Ho Jan 15, 2020 06:30am
- 김효수 교수 With robust evidences of efficacy, ezetimibe is now one of major options for treating dyslipidemia. “The lower the better.” The result of clinical trial IMPROVE-IT, with the slogan claiming the lower the low-density lipoprotein cholesterol (LDL-C) is the better the health benefit, earned its recognition when it was announced in 2015. Numerous pharmaceutical companies in Korea raced each other to release combination drugs with ezetimibe plus either atorvastatin or rosuvastatin. The products landed themselves on the market safe and sound. Given the positive response, some wondered about the unexpected recommendation addressed in Guidelines for the Management of Dyslipidemia 2018 published by Korean Society of Lipid and Atherosclerosis’ (KSoLA). While American Association of Clinical Endocrinologists (AACE) updated its guideline in 2017 with new ‘extreme risk’ category and advised medical professionals to bring the LDL-C level down to under 55 mg/dL, the KSoLA’s latest guideline maintained the target treatment level of LDL-C for ultra-high risk group at 70 mg/dL. Meanwhile, European Society of Cardiology (ESC) has recently recommended setting treatment target LDL-C level for extreme risk group at under 40 mg/dL. With an expectation of more assertive use, ezetimibe was also listed as second-line treatment option following statin treatment. Despite the release of new medicine like PCSK-9 inhibitors, the Korean guideline generally took the conservative approach. And what are the thoughts of Korean clinical doctors on dyslipidemia treatment strategy after the newest edition of the guideline was published more than a year ago? Daily Pharm interviewed Kim Hyo-soo, the then Professor at Department of Internal Medicine of Seoul National University Hospital, on the issue. At the time of publishing, he was the chairman of the society and has actively supported prescription of ezemitib at any time. - About setting 'treatment target of LDL-C level 55 mg/dL' and 'ezetimibe as first-line treatment,’ did you think it was too soon? In my opinion, ezetimibe is not in any way insufficient to be a first-line treatment. But many did not see a good reason to add ezetimibe to the first-line treatment option, when a patient can reach the target level with statin monotherapy. So the guideline recommended medical professionals to prescribe the medicine to patients struggling to manage the cholesterol level only with statin. Treatment target level of LDL-C actually differs among many clinical trials. When setting 70 mg/dL as an idealistic level, the needs for ezetimibe as a first-line treatment are low to be honest. But it’s another story when setting the level at 55 mg/dL. Usually the level is unreachable with statin monotherapy. It needs a combination therapy with ezetimibe. Personally, I prescribe statin-ezetimibe combination therapy as first-line treatment. In other words, each doctor’s level of lowest value varies, so the guideline had to take a rather careful approach. On a side note, I did suggest setting 55 mg/dL as target LDL-C level when we were updating the guideline. Now I’m looking into 35 mg/dL, even. - What had enabled ezetimibe to lower LDL-C level and to ultimately prevent cardiovascular events? LDL-C can be divided into apolipoprotein B (ApoB)-48 and ApoB-100. Previously, only ApoB-100 was considered to be accumulated as plaque, but apparently studies have found ApoB-48 also works the same. Now it’s more convincing that statin’s ApoB-100 synthesis inhibition combined with ezetimibe’s ApoB-48 absorption inhibition is lowering LDL-C level more effectively. For a long time, hyperlipidemia treatment was solely dependent on statin and the practice has prescribed a high dose of it. Combination therapy with non-statin class, previously quite unpopular, is now gaining the attention and PCSK-9 inhibitor, expensive but powerful in dropping LDL-C level, is also used more often. The time has changed, eventually. - Is there a particular patient group you would especially recommend ezetimibe combination therapy? Cholesterol absorption is accelerated in diabetic patients. With more favorable condition for cholesterol absorption than non-diabetic patient, ezetimibe could deliver more dramatic effect. Ezetimibe would also be effective for patient group with high blood sugar level, because it does not increase chance of diabetes onset when used, whereas statin does. Postprandial hyperglycemia is a vital issue for a diabetic patient, but newer studies say postprandial lipidemia is also as bad. Ezetimibe inhibits postprandial lipidemia, which would be beneficial to diabetic patients. For my clinical practice, I have often used ezetimibe to lower diabetic patients’ cholesterol level. As a matter of fact, I conducted a research on less explored area of effect of the drug on blood glucose. The researchers are currently analyzing data collected from about 200 people. - Many have mentioned of PCSK-9 inhibitor, but apparently it tends to be administered once-monthly (originally indicated for once-biweekly) as the drug use is mostly non-reimbursed, despite its outstanding efficacy. Is it alright to change the interval? For a patient, relapsed disease like acute coronary syndrome (ACS), myocardial infarction (MI) and peripheral artery disease (PAD) are critical to their condition. And those patients’ LDL-C level has to be lowered more aggressively. And if adding ezetimibe does not work, then PCSK-9 inhibitor has to be used. But, it is expensive. And that is why many of them are administered once a month, but their LDL-C level ranging from 70 mg/dL to 80 mg/dL is usually halved or more. A patient that ticks off more than two of high-risk conditions—diabetic, hypertension, age 65 and up, cigarette smoking, hypercholesterolemia—is advised to take PCSK-9 inhibitor. I personally consider using PCSK-9 inhibitor when a patient’s cholesterol level is not controlled with rosuvastatin-ezetimibe combination therapy.
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- Reimbursed ALL new drug Besponsa lands code at Big 5 fast
- by Eo, Yun-Ho Jan 14, 2020 06:29am
- After the green light from Korean health authority, the reimbursed Besponsa (inotuzumab) injection has quickly found its position on general hospitals’ prescription code list. According to pharmaceutical industry sources, an antibody-drug conjugate (ADC) prescribed for acute lymphoblastic leukemia (ALL), Besponsa injection has been listed for reimbursement in October last year and currently, landed its code on every Korea’s Big Five tertiary hospitals’ prescription code list. Drug Committee (DC) at Samsung Medical Center and Seoul Asan Medical Center passed the injection’s code, while Emergency DC at Seoul National University Hospital, Severance Hospital and Seoul St. Mary’s listed the code. Their prompt action proves how doctors had significant needs for Besponsa. Besposa’s reimbursed indications are for secondary or tertiary remission induction therapy in adult patient aged over 18 years with relapsed or refractory B-cell precursor ALL. To this day, the only therapy option a relapsed or refractory ALL patient could take for curing the condition is hematopoietic stem cell transplantation (HSCT). And for the patients to receive HSCT, they first have to reach complete remission (CR) before the procedure. So far, Glivec changed the whole landscape of chronic myelocytic leukemia (CML) in the leukemia treatment sector. Since then, a number of competitive target therapy options, such as Tasigna (nilotinib), Sprycel (dasatinib), and Supect (radotinib), were released in the market. But for acute leukemia, especially for ALL, there was no more novel treatment other than Blincyto. Compared to other existing anticancer therapy, Besponsa easily doubles CR rate and help the patient to go through HSCT and to get cured. Last year, National Comprehensive Cancer (NCCN) Guideline recommended Besponsa as a category 1 treatment option. A hematologic academic society official commented, “For patients with ALL, having an access t ADC or immunotherapy before their condition worsens would take them to completely different treatment landscape.” In the Phase 3 INO-VATE ALL trial, a randomized open-label study to compare Besponsa and other existing anticancer therapy, the CR rate or CR with incomplete platelet recovery (Cri) for patients treated with the ADC was 80.7 percent compared to 29.4 percent with chemotherapy. Also, 48 percent of patient administered with Besponsa had HSCT, demonstrating improved figure than the 22 percent patients treated with chemotherapy. Minimal residual disease (MRD) negative result indicates small number of cancer cells in the body after anticancer treatment and also provides important prognosis works as a prognostic factor. As for the clinical trial, patients treated with Besponsa showed MRD negative of 78.4 percent, and other group treated with chemotherapy showed 28.1 percent. Whereas two-year overall survival rate and three-year overall survival rate in patients treated with Besponsa reached 22.8 percent and 20.3 percent, respectively, comparatively higher than chemotherapy-treated patients with 10 percent and 6.5 percent, respectively.
- Company
- Tae-han Kim, CEO of Samsung BioLogics, attends JP Morgan
- by Lee, Seok-Jun Jan 13, 2020 06:27am
- Samsung BioLogics will present the main event space (Grand Ballroom) for two consecutive years at the JP Morgan Healthcare Conference. It is the first Korean company to make a main event space presentation. President Tae-han Kim makes a presentation by himself. Kim's attendance at the JP Morgan conference was unclear due to the prosecution's investigation into Samsung Biologics intentional accounting fraud. Tae-han Kim, CEO of Samsung Biologics, is presenting at the 2019 J.P. Morgan Healthcare Conference.Samsung BioLogics announced on the 12th that it will participate in the JP Morgan Healthcare Conference, the world's largest global investment event, held in San Francisco, USA. Samsung BioLogics was assigned the Main Track in 2017 and 'Grand Ballroom' last year and this year. Both are the first Korean companies. The Grand Ballroom is a large 800-seat presentation venue. Only a few major global pharmaceutical companies, such as Pfizer, Roche and Johnson & Johnson, are known to be assigned. The announcement will be made by CEO Tae-han Kim and Vice President John Lim. Samsung Biologics will present its achievements, 2020 goals, and mid- to long-term visions under the theme of 'Innovation and Growth of Samsung in Biologics Industry' in a presentation on Wednesday afternoon 15th. Meanwhile, the JP Morgan Conference, which marks its 38th anniversary this year, is the largest investment event in the healthcare sector, in which 500 pharmaceutical bio companies from around the world, invited by the global investment bank JP Morgan, announce major business results and visions.
