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- Remsima SC is the idea of CEO Jung-jin Seo
- by An, Kyung-Jin Feb 19, 2020 06:35am
- View of the ECCO 2020 venue [Vienna, Austria=Reporter An, Kyung-Jin] On the 15th (local time), the annual meeting of the European Crohn's Disease Colitis Association (ECCO 2020) completed a four-day campaign. The ECCO 2020 Conference, which marks the 15th anniversary of this year, was a place to realize that K-Bio's technology has taken a step up. The launch of the first subcutaneous injection (SC) formulated biosimilar with the Infliximab has attracted the attention of attendees as local release and event timing fit exquisitely. There has also been an active debate about whether biopharmaceuticals modified with only the same ingredient should be interpreted as a biobetter. ◆The development of Remsima SC was the CEO’s idea. it was lucky Sung-Hyun Kim, Clinical Planning Team, Celltrion→Seong-hyun Kim, Celltrion's clinical planning manager, met at the ECCO 2020 conference site and said that chairman Seo Jung-jin is the key to success in developing the world's first subcutaneous injection (SC) with Infliximab. Kim, who met at the Celltrion Healthcare booth on the 14th (local time), is not aware of the question whether there is a company developing a Remsima SC competitive drug. The president’s ideas helped to begin clinical development, with good timing and luck. Jung-jin Seo, who is attached to the next pipeline, frequently meets with local medical staff in Europe. He ordered a development review after hearing the need for subcutaneous injection from nurses who used Remicade. Kim said, "There is a lot of opinion that Remicade is good in the medical field, but there is only intravenous injection type, so convenience is low. It is hoped that the emergence of subcutaneous drugs will completely change the perception of the disease". Also added, “The process was painful, but the results were good. We are waiting for feedback on the 15th of last month with the European Medicines Agency (EMA) completing the application for the Remsima SC indication”. ◆Remsima SC is a biobetter? it is Innovative Inflixmab A variety of questions have been asked when the expectation is that Infliximab subcutaneous injections can be introduced in the field of inflammatory growth disease (IBD), which is popular among young people in their 30s and 40s. As a key topic, the issue of how to approach Remsima SC, which only changed the route of administration of Remsima, between a new drug and a biosimilar, emerged as a key topic. Prof. Shomron Ben-Horin named top 10 research Prof. Shomron Ben-Horin (Tel Aviv University Sheba Medical Center, Israel) announced ECCO's 'Top 10 Highlights' program. They all agreed that Remsima SC is an advanced drug over biosimilars. It is a response to the question that whether there is no problem in accepting it as a biobetter when changing the intravenous injection into a subcutaneous injection in the auditorium immediately after the announcement of the clinical results of Remsima SC. The argument was based on the results of a one-year clinical trial of Remsima SC in patients with inflammatory bowel disease. Infliximab was administered to 131 patients with Crohn's disease (CD) and ulcerative colitis (UC). Serum drug concentrations and therapeutic effects were maintained in both groups who received subcutaneous injections from week 6 to 54 and who received subcutaneous injections from intravenous injection at week 30. Foreign reporters from all over the venue were also noticeable The introduction of Remsima SC has enabled the 'Dual Formulation' strategy of maximizing the effect of the initial intravenous treatment and maintaining the drug effect by administering Remsima SC by patient self-administration without visiting the hospital. After the presentation, Ho-woong Kim, Head of Medical and Marketing Division, Celltrion Healthcare, said, “Since the application for the Remsima SC permit, the term biobetter was first introduced after the regulatory agency raised the need for a new track, not a new drug or a biosimilar. Recently, various terms such as 'value-added medicine' or 'innovative Infliximab' have been used. Although the terminology is different, there is no disagreement about the ultimate improvement over biosimilars". ◆Samsung's three biosimilars save EUR 1.8 billion in Europe →At this year's ECCO conference, much data about biosimilars was released. In the years since biosimilars were introduced in Europe, real world data on various clinical cases accumulated at the medical field have been released. Biogen, which is a partner of Samsung Bioepis, is supplying long-term follow-up of patients who have been prescribed biosimilars in Germany, the UK and France. There have been voices that the original drugs and biosimilars were not significantly different in terms of therapeutic effects or safety, and biosimilars were positively evaluated for their financial savings. Pharmaceuticals, insurance companies, and PBMs are competing autonomously, which is different from the US, where entry barriers were high. Early adopters of biosimilars, Europe was a contrary mood. Exhibition booth of Biogen, a partner of Samsung Bioepis A Biogen official (at the end of 2019), who met at the ECCO 2020 conference booth, was prescribed biosimilars to more than 200,000 patients. The three biosimilars that Biogen sells have saved over €1.8 billion in healthcare costs in Europe. ” Biogen has three biosimilars developed by Samsung Bioepis in Europe, including Renflexis (Remicade Biosimilar), Flixabi (Biosimilar) and Imraldi (Humira Biosimilar). Imraldi, which had released an event in October 2018, actually made annual sales of $184 million last year, the first year of its release. It is a self-diagnosis that Amgen, Sandoz and Mylan have released biosimilars at the same time, gaining market leadership with a sharp increase in sales despite the fierce competition. ◆Gastroenterologists, waiting in line at 'Remsima SC' clinical booth, it is amazed at how much things have changed Ho-Woong Kim, Head of Medical Marketing Division, Celltrion Healthcare→Ho-woong Kim, Celltrion Healthcare Director, Medical & Marketing Division, met at the meeting of ECCO 2020 on May 14 (local time), said that it is amazed at how much things have changed, just a few years ago, it was difficult to get clinical advice, but now it's completely different. Since the positive clinical results of Remsima SC were revealed at the ECCO 2018 conference last year, it is said that interest has increased enough to inquire about participation in the study abroad. Kim said, “Many researchers are curious about the background that the efficacy, immunogenicity and safety have been maintained despite the change in formulation from intravenous injection to subcutaneous injection. and the successful commercialization of high-impact Infliximab subcutaneous injections has received positive reviews”. Celltrion's experience in biosimilar products, such as Remsima and Truxima, has been accumulated for many years. In addition, quality and trust in the company also contributed to the introduction. Kim said that during the event, he had meetings with foreign researchers of the best in the field of inflammatory diseases, from full-time executives to active executives. Researchers willing to participate in the clinical trials lined up and feel their company's status has changed.
- Company
- New migraine preventive Emgality cleared in general hospital
- by Eo, Yun-Ho Feb 19, 2020 06:34am
- Korean general hospitals are swiftly implementing a new migraine preventive medication, Emgality, on their prescription drug code. According to a pharmaceutical industry insider, migraine-preventing calcitonin gene-related peptide (CGRP) antagonist Emgality (galcanezumab) has been launched last December. And it has been passed by Drug Committees in Seoul National University Hospital, Severance Hospital, Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. The drug is a humanized monoclonal antibody that binds to CGRP, causing migraine symptoms in brain, and blocks its binding to the receptor. The Korean government has approved the new drug has been as the first in its class. Designated as an orphan drug in last April, the drug has been approved to market in last September. Recently, the U.S. Food and Drug Administration (FDA) has additionally indicated the drug as a treatment for episodic cluster headache. Emgality’s approval was based on six-month long EVOLVE-1 and EVOLVE-2 trials with 1,773 patients with episodic migraine headache (monthly average four to 14 migraine headache days (MHD)), and three-month long REGAIN trial with 1,113 patients with chronic migraine headache (monthly average 15 headache days, more than eight MHD). The two trials treating patients with episodic migraine headache for six months compared mean changes of monthly average migraine headache days from baseline (9.2 MHD in Emgality group, 9.1 MHD in placebo group) and demonstrated improved treatment effect of the drug than the placebo. For six months time in the EVOLVE-2 trial, particularly with Korean participants, 226 patients in Emgality group has reduced monthly average MHD by 4.3 days, or two days more than placebo group (450 patients) that reduced MHD by 2.3 days. Among the Emgality-treated group, 59 percent of the patients had 50 percent less MHD, 34 percent of them had over 75 percent less MHD, and 12 percent of them had 100 percent less MHD. Whereas, 36 percent, 18 percent and 6 percent of placebo-treated group had 50 percent, more than 75 percent and 100 percent less MHD, respectively. Professor Chu Min Kyung of Neurology Department at Severance Hospital explained, “Migraine headache could unimaginably damage patient’s quality of life. Patients with average four to five MHD in a month could expect to improve their quality of life with preventive treatment. While anti-hypertension and anti-epileptic medications were recommended for migraine preventive treatment, Emgality’s launch is a hopeful news to the patients.” Meanwhile, a series of CGRP-class medications have been released throughout last year. Besides Emgality, Aimovig (erenumab) co-developed by Novartis and Amgen and Ajovy (fremanezumab) by Teva have entered the market.
- MK-6482, the next rising anticancer drug is being developing
- by Won, jong-hyuck Feb 19, 2020 06:34am
- The development of the next generation of targeted anticancer drugs, which combines the Nobel Prize-winning theory with the field of chemotherapy, is entering the second half. The first is about the advanced renal cell carcinoma. Von Hippel-Lindau (VHL) works by the Dana-Farber Cancer Institute, winner of the 2019 Nobel Prize in Medicine, revealing a new mechanism by which the 'defective protein' is involved in cancer development. The main character is a substance that intensively targets 'HIF-2α' generated in patients with VHL deficiency in collaboration with MSD, a multinational pharmaceutical company. It is noteworthy that the drug is a first-in-class product that has elicited an overall response rate of 24% in patients who were previously unresponsive to treatment with VEGF inhibitors or immune checkpoint inhibitors. The first clinical data for the next generation of targeted anticancer drugs in advanced renal cell carcinoma was released on the 18th at the Genitourinary Cancers Symposium (GUCS). First, the substance is an oral target anticancer drug developed by MSD and is called MK-6482. And this is a once-daily formulation that has a mechanism of action that targets HIF-2α, which is involved in the production of new angiogenesis that supplies nutrients to renal tumors. This is the first therapeutic agent (first in class) among the oral HIF-2α inhibitors. Clinical data from this 13-month follow-up (median) reported a 24% overall response to treatment in the patient group receiving the test substance. The key is that 55 patients who responded to MK-6482 had previously been diagnosed with advanced clear cell renal cell carcinoma and had advanced experience in chemotherapy. In particular, they were patients who used PD-1/L1 family of immune checkpoint inhibitors, including VEGF inhibitor family of target anticancer agents, before MK-6482. Toni Choueiri, Ph.D., author of the Dana-Farber Cancer Institute, said in a recent report that the response rates reported in these late-stage trials are remarkable, the anticancer drugs in the renal cancer field fail repeatedly in major clinical trials, and that the situation is expected to show good results in improving PFS. Professor Toni Choueiri said, "In transparent cell renal cell carcinoma, about 90% of patients show a defect in a specific protein called von Hippel-Lindau (VHL), and VHL deficiency eventually promotes HIF protein activation and accelerates cancer progression by promoting angiogenesis in tumor cells". "This is a collaborative study with William Kaelin Jr., Ph.D. of the Dana-Farber Cancer Institute, which won the Nobel Prize in medicine last year for VHL-related research, and it shows the development of MK-6482, the first HIF-2α inhibitor". Phase III clinical trials begin, with 22 patients in 6 domestic hospitals In Phase I/II clinical trials, 55 patients with advanced renal cell carcinoma at the age of 63 years (medium) with previous experience with chemotherapy were enrolled. Thirty-nine (71%) of these patients eventually discontinued treatment, with cancer progressing (55%) in most cases. In the interim analysis, 81% of patients treated had expected response rates for more than six months, and 29% had been treated for more than 12 months. The median progression free survival (PFS), an important criterion, was 11 months. In terms of safety, four patients died of disease-related adverse events during the study, but none of the treatment-related adverse events occurred. Grade 3~5 to adverse events were observed in 65% of the patients, five of whom had to reduce the dose due to toxicity issues. Phase III clinical trial is a comparative study with anti-cancer drug 'Everolimus', and PFS is a major evaluation index, and it has entered full-scale clinical trials. In Korea, the same phase III clinical trials have begun in full-scale clinical trials in February, after approval by the Ministry of Food and Drug Safety. In relation to MK-6482, label disclosure, randomization, and phase III clinical trial studies submitted by MSD Korea will be followed by a late phase clinical trial comparing MK-6482 to Everolimus in patients with advanced renal cell carcinoma who have experienced disease progression after PD-1 / L1 and VEGF-targeted therapies. Starting from February of this year, it is scheduled to proceed until September 2025, and 22 patients will be participating in the registration of 736 global clinical patients. Meanwhile, MK-6482's post-clinical domestic participatory hospitals will be held in six locations including Chungnam National University Hospital, National Cancer Center, The KUMC, Yonsei Severance Hospital, Samsung medical center, and Asan medical center.
- Policy
- If the MFDS followed the EMA instead of the FDA for Belviq
- by Lee, Tak-Sun Feb 19, 2020 06:33am
- Appetite suppressant At the time of approving Belviq, banned by the MFDS on the 14th, it would be regrettable that it had not been approved in accordance with the European EMA's decision. The European EMA disagreed with the approval due to side effects from animal testing, and the developer voluntarily withdrew the application. The US FDA, on the other hand, approved it in June 2012, subject to post-marketing studies on cardiovascular risk. Belviq was licensed in Korea through Ildong, an importer, in February 2015. In April of last year, Belviq XR was approved. Belviq was designated for re-examination at the time of domestic approval and was ordered for post-marketing investigation for six years from February 2015 to February 2021. Developed by the US Arena Pharmaceuticals, Eisai owns all rights in the United States, and Arena owns all rights in Europe and Asia. In 2012, Ildong gained copyright through a contract with Arena. The MFDS issued an order to suspend sales and recall in Korea on the 15th, referring to the US FDA's withdrawal order for Lorcaserin. U.S. distributor Eisai is reportedly withdrawing from the United States. As a result, Ildong Pharmaceutical, a domestic seller, is expected to exit the market by returning the permit. All items on the market will be recovered. Belviq's problem is the risk of developing cancer. The U.S. FDA reviewed CAMELLIA-TIMI 61, a clinical trial conducted by Eisai, and concluded that the longer the treatment period, the greater the incidence of cancer compared to the placebo group. In the past five years, over 12,000 patients with high cardiovascular risk were overweight or obese, and 520 cases of primary cancer were diagnosed in 462 patients (7.7%) in the Lorcaserin group and 470 cases, 423 patients (7.1%) in the placebo group. In particular, the incidence of some types of cancer, such as pancreatic cancer, colorectal cancer, and lung cancer, was higher in the Lorcaserin-administered group than in the placebo-administered group. In fact, Belviq's issue was whether it was safe in cardiovascular disease. This is because the obese drug Sibutramine has been withdrawn from the market due to side effects of 'cardiovascular disease'. Eisai also conducted a post-marketing investigation with an emphasis on cardiovascular safety. As a result of the 'CAMELLIA-TIMI 61' clinical trial, the annual incidence of cardiovascular events (MACE) was 2.0% in the Belviq group (Lorcaserin 10mg, twice daily), and 2.1% in the placebo group. The risk of adverse effects on the cardiovascular system was negligible. But because of the unexpected side effects of developing cancer, Belviq eventually got stuck. Earlier, the European EMA rejected Belvik's approval in an animal trial in late January 2013 for side effects such as tumor induction, heart valve disorders and mental illness. Although it was not related to the human test, it was the conclusion that the results of animal experiments were actively reviewed. On January 16, the FDA announced that it would review the issue of cancer, and the MFDS announced that it would distribute safety letters to review domestic and international permits and usage. In the meantime, information on cancer incidence increased in animal experiments is reflected in the permit, and the association with humans is unknown. However, the fact that the incidence of cancer has increased in animal experiments is not included in the Belviq permit, which was granted in February 2015, but in the Belviq XR, which was granted last year. This is why the MFDS has been actively aware of the issue at the time of its approval. If the agency had listened to the European EMA decision and not the US FDA, the risky drug would not have been used in the patient. Belviq was launched in Korea in the first quarter of 2015 and recorded sales of ₩13.6 billion in IQVIA, ₩15 billion in 2016, ₩12.2 billion in 2017, and ₩9.8 billion in 2018. While selling more than ₩50 billion, no measures were taken in Korea.
- Company
- JW Holdings patent pancreatic cancer diagnostic kit in US
- by Nho, Byung Chul Feb 19, 2020 06:33am
- JW Holdings has also successfully patented an early-stage pancreatic cancer diagnostic technology in the U.S. JW Holdings (CEO Han Seong Gwon) announced on Feb. 17, the United States Patent and Trademark Office (USPTO) has granted a patent on source technology of the world’s first ‘multi-biomarker diagnostic kit’ that identifies pancreatic cancer in early stage through a simple blood test. From Professor Paik Young-k’s team at Yonsei University, JW Holdings licensed the innovative source technology in 2017, of a diagnostic platform testing each level of cancer with human body substance found in early and late-stage pancreatic cancer patients.. To this date, a diagnostic method of testing CA19-9, a common antibody expressed in late-stage pancreatic patient, has been used, frequently. But JW Holding is the only company in the world to own a source technology to diagnose pancreatic cancer by testing complement factor b (CFB) found in early-stage patient. After patenting the source technology in Korea in 2016, JW Holdings has patented the technology in Japan (2018) and in China and Europe (2019). With its subsidiary company JW Bioscience, JW Holdings has been developing multi-biomarker measuring kit and diagnostic algorithm, including CFB and CA19-9. And with Professor Kang Chang Moo’s research team at Severance Hospital, the Korean pharmaceutical company is to initiate an exploratory clinical trial from this year on 500 patients including pancreatic cancer patients. JW Holdings official stated, “Following the patent approval in Japan and Europe, the U.S. with highly complicated patent review standards have finally recognized the technology and rights of CFB-based early-stage pancreatic cancer diagnostic kit and completed the patent procedure. By continuing to work on the technology and commercializing it in the future, the company would lead the higher value-added global market of in-vitro diagnostics.” Taking the lives of a thousand patients a day in worldwide, pancreatic cancer is diagnosed in about 6,600 patients in Korea a year. Among all cancer types, early-stage diagnostics in pancreatic cancer is crucial as it has the lowest five-year relative survival rate of 11 percent. But, because pancreas is surrounded by other organs and early symptoms are barely noticeable, early diagnosis for the cancer has been significantly difficult. Academic societies, such as the American Association for Cancer Research, predict the pancreatic cancer would be ranked at second place for the cause of cancer patient’s death in 2020, because there is no early diagnostic marker is available until now. Market research company, Mordor Intelligence found the global pancreatic cancer treatment and diagnostics market was recorded at USD 1.73 billion (about 2 trillion won) in 2015. And they argue the market would grow up to 3.19 billion dollars (about 3.7 trillion won).
- Policy
- MOHW to require reimbursement negotiation for generic
- by Kim, Jung-Ju Feb 19, 2020 06:32am
- Even generic drugs, reimbursed pricing decided according to set formula, would have to negotiate with the insurer about the insurance benefit. The government is aiming to establish legal basis to prevent companies evading pricing reduction by listing the same drug as another, and also to require post-management. Basically, the revision is constructing legal foundation for further drug pricing system revision. Korea’s Ministry of Health and Welfare (MOHW) posted a draft of revised ‘Regulation on National Health Insurance Reimbursement Standard’ on Ministry of Government Legislation’s board. The draft has been more specified than the version unveiled at Health Insurance Policy Deliberation Committee’s (HIPDC) subcommittee meeting in last December, as a part of this year’s drug pricing system revision plan. MOHW would improve generic drug pricing system by mandating negotiation track for generics, currently exempted from pricing negotiation before reimbursement listing, to fine-tune contract terms, and by preventing companies to wiggling out of pricing reduction penalty. Also the revision would stipulate the government to authorize maximum reimbursed price as well. The draft focuses on four following issues; improving reimbursement decision-making principle with detailed pharmaceutical reimbursement deciding principles and prioritization system; stipulating rejection on reimbursement applicant evading drug pricing reduction penalty; unifying pharmaceutical reimbursement application procedure; and establishing government-authorized track and revising related procedure. First, the government plans to set detailed reimbursement deciding principles and implement pharmaceutical reimbursement prioritization system. With the changes, the government would be able to decide on listing items considering sustainability of limited National Health Insurance resources. At the same time, the changes in detailed principle and prioritization system would be stipulated on the regulation. Another new regulation would stipulate the government regulator rejecting pharmaceutical companies avoiding drug pricing reduction. When the change is finalized, the government regulator could legally shut off a company penalized to reduce drug pricing for providing illegal rebate but trying to evade it by applying for reimbursement as another item under company’s subsidiary. The pharmaceutical reimbursement listing procedure would be unified as well. All drugs that passed reimbursement feasibility review would have to complete negotiation within 60 days and decide on an outcome. This would legally require a generic item, or non-negotiated drug automatically priced by set formula, to negotiate with National Health Insurance Service (NHIS). NHIS not only negotiates reimbursed price of a new drug, but also handles contract regarding supplier’s responsibility, patient protection (accessibility) and financial stability. And the insurer would be able to include generic in their scope as well. A pre-negotiation with the president of NHIS could be conducted, for the manufacturer to flawlessly process the actual negotiation procedure. Also a new track would be available for pricing negotiation-exempted drug to expedite the negotiation procedure. Reporting to the Minister of Health and Welfare would follow after Drug Reimbursement Evaluation Committee (DREC) deliberation, and the result would be notified to the president of NHIS. The streamlined procedure seems to be the government’s solution to the new DREC changing the reimbursement listing procedure and requiring face-to-face briefing for DREC that slowed down the expedited non-negotiated track. The revision would touch up the government-authorized pricing calculation and listing procedure as well. The changes would apply for when reimbursement standard needs adjustment based on a change in label, overseas label and reimbursement status, and clinical evidence. This would also legally stipulate the listed drug reevaluation, the government is lately pushing on. In detail, the government could order a negotiation between NHIS and applicant company when it is needed for stable supply. But when the government authorizes the negotiation, the reimbursement decision would have to be made after it to properly reflect the amended listing procedure. Considering the drug pricing system revising plan the government has, the above changes would be specified and finalized before the second half of the year.
- Product
- What drug will be replaced by Belviq’s withdrawal?
- by Lee, in-bok Feb 18, 2020 10:49am
- As Ildong’s Belviq, which dominated the obese drug market for a long time, is finally exiting the market, there is a growing interest in which drug will fill this gap. Obesity experts are predicting that safety-oriented prescriptions may be available for the time being, while Saxenda and Qsymia are expected to benefit directly. The Ministry of Food and Drug Safety recently decided to stop selling and recall Belviq(lorcacerin) because of the risk of cancer. The U.S. Food and Drug Administration (FDA) has recommended its recovery, saying the risk is greater than the benefit. As a result, Eisai in charge of the U.S. sales, immediately took over its own collection, and Ildong, a domestic sales company, is also in the process of collecting it. According to IQVIA, a global market research firm, Belviq has been overwhelmingly occupying the No.1 ranking in the obese market until 2018 since it landed in Korea in 2015. Indeed, in 2018, Belviq's outpatient prescriptions amounted to ₩9.07 billion, the highest in the obese drug market, beating Dietamin(₩8.48 billion) and Hutermin (₩7.86 billion). Literally the market dominated by the number one leader suddenly withdrawn from the market is bound to be a big ripple Obesity experts point out that safety will be an issue for obesity prescriptions for the time being. It is believed that Belviq could also create the same situation, reflecting on the safety controversy that has been taking place for the time being after the 2010 Reductil(Sibutramine) eviction Professor A, a member of the Korean society for the study of obesity, said, "The safety issue for obesity drugs persisted for a while even when Reductil was evicted as a cardiovascular safety issue, and Belvik is also likely to create such a situation". What kind of drugs are obese experts considering as a substitute for Belviq? First of all, Saxenda(Liraglutide) is expected to be nearing peak item. Prescriptions have already increased since last year, conquering the obese drug market, and safety issues cannot be ignored. Professor A said, "I think that the Saxenda, which was developed with GLP-1 diabetes, will benefit as much as it has been tested for safety, also, it's already been imprinted on obese patients and for now it's almost the only drug that is free from safety issues". In fact, Saxenda has already led the reorganization of the overweight drug market, surpassing Dietamin(₩9.3 billion) and Belviq(₩8.8 billion), recording outpatient prescription amounts of ₩15.1 billion in the third quarter of 2019. With the disappearance of the biggest competitor among them, there is a prospect that Saxenda’s prescription may be accelerated. However, some are expecting the limited competitiveness of the Saxenda. Rather, Oral medications will be more popular because the characteristics of the drugs are completely different An executive of the DAOR said, “Saxenda has long-term safety data, but it just quotes past clinical trials. Furthermore, there may be a difference in compliance when switching to injection in that Belviq is oral”. He said, "While Qsymia is likely to benefit from the new drug effect, some people are considering Phentamines, which have been prescribed for a long time". Some experts predict that Belviq's withdrawal will not have a big impact on the market right away. Obesity drugs are not a long-term use treatment itself, and it is not urgent enough to change the prescription to another drug right now. Professor B, a member of the Korean society for the study of obesity, said, "Stopping a medication used to treat obesity right away does not cause a problem immediately. Belviq's withdrawal will not have a big impact on the market". In addition, the professor said, "Because it is a drug that has been prescribed a lot, Pharmaceuticals will go for the potion and aggressively market it, but I think that the potion won't be moved to other drugs right now, although the potion may come down".
- Policy
- NSCLC targeted therapy Vizimpro approved in Korea
- by Lee, Tak-Sun Feb 18, 2020 06:35am
- Pfizer Pharmaceutical Korea’s non-small cell lung cancer (NSCLC) targeted therapy Vizimpro has been approved to market in Korea. The treatment is a second-generation targeted therapy like Boehringer Ingelheim’s Giotrif. On Feb. 14, Ministry of Food and Drug Safety (MFDS) has approved Pfizer Pharmaceutical Korea’s three Vizimpro tablets (dacomitinib) in 15 mg, 30 mg, and 45 mg doses. The treatment has been indicated as a first-line therapy for locally advanced or metastatic NSCLC patients with epidermal growth factor receptor (EGFR) gene deletion in exon 19 or exon 21 L858R substitution mutations. AstraZeneca’s Tagrisso also shares the same indication. Apparently, EGFR is overexpressed in more than 70 percent of NSCLC patients, which affects proliferation of cancer cells and metastasis. EGFR tyrosine kinase inhibitor (TKI) targeted therapy generally defines all treatments with mechanism of using a molecule to block EGFR in cells. The EGFR TKI even has third-generation targeted therapy that overcame the initial tolerance in earlier drugs. AstraZeneca’s Iressa (gefitinib), Roche’s Tarceva (erlotinib) are first-generations, Boehringer Ingelheim’s Giotrif (afatinib) is a second-generation. And AstraZeneca’s Tagrisso (osimertinib) is a third-generation. Lazertinib, currently in development by Yuhan, is also a third-generation EGFR TKI treatment. Newly approved Pfizer’s Vizimpro is in the same class of second-generation EGFR TKI as Giotrif. However, it would also compete straight against Tagrisso as well, because they share the same indication. But Tagrisso’s reimbursement has not been cleared for first-line treatment. In a transnational clinical study with 452 patients, Vizimpro demonstrated statistically meaningful improvement in progression-free survival, compared to that of gefitinib. Sub-analyzing Asian-region patient group treated with the second-generation targeted therapy, the median progression-free survival was recorded at 16.5 months, whereas the first-generation gefitinib group was at 9.3 months. The pharmaceutical industry predicts the follow-on EGFR TKI treatment Vizimpro would set lower pricing than predecessors to ease into the market. The targeted therapy has won the U.S. Food and Drug Administration’s approval in September 2018.
- Policy
- Avastin additional coverage approved for colorectal cancer
- by Lee, Hye-Kyung Feb 18, 2020 06:35am
- Combination therapy of Avastin (bevacizumab) plus irinotecan plus low-dose capecitabine (mCAPIRI)’ treating metastatic colorectal cancer would receive insurance benefit from Mar. 1. Moreover, indications to treat patients with stage IIB or later mycosis fungoides, primary cutaneous anaplastic large cell lymphoma (pcALCL), or Sézary disease have been added to Adcetri’ (brentuximab). The drug’s current reimbursement is limited to second-line or later treatment for relapse or refractory CP30 positive anaplastic large cell lymphoma. Health Insurance Review and Assessment Service (HIRA) is collecting public opinion on the said changes made. Without any issue, they would come in effect from Mar. 1. HIRA has reviewed expanding coverage of Avastin to also cover for an ‘irinotecan plus mCAPIRI plus bevacizumab combination therapy.’ Initially, the drug was approved to treat metastatic colorectal cancer as a combination therapy with fluoro pyrimidine class chemotherapy. According to a literature review on textbook, guideline and clinical trial studies, the combination therapy has not been mentioned on either text or National Comprehensive Cancer Network (NCCN) guideline. But a 2018 guideline by European Society of Medical Oncology (ESMO) has mentioned it to have ‘study in progress,’ and a Phase 3 clinical trial comparing noninferiority of 'FOLFIRI plus bevacizumab’ and FOLFIRI has confirmed noninferiority with median overall survival of 16.8 months and 15.4 months. The combination therapy has been granted for reimbursement as a second-line treatment. HIRA explained, “The reimbursement on the drug has been granted for treating metastatic colorectal cancer as it could enhance convenience of outpatient treatment better than the already reimbursed therapy, and it could also provide more option of treatment to patients.” Additionally indicated to treat patients with CD30 positive cutaneous T cell lymphoma, who has been treated with one or more systemic treatment, Adcetris is recommended as category 2A by NCCN guideline for treating mycosis fungoides, primary cutaneous anaplastic large cell lymphoma (pcALCL), or Sézary disease. In Phase 3 ALCANZA study, the patient group with stage IIB or later mycosis fungoides and primary cutaneous anaplastic large cell lymphoma (pcALCL) demonstrated overall reaction rate (ORR) of 70.8 percent, and specifically 62.5 percent of the group had reaction over four months. And 18.8 percent of the group experienced complete response. HIRA official said, “The reimbursement on the treatment was approved considering the specific indication lacks other alternative treatment option.”
- Company
- GSK and Pfizer intensify treatment conflicts after merger
- by An, Kyung-Jin Feb 18, 2020 06:34am
- There is a friction over the integration process of Pfizer Korea and GlaxoSmithKline's Consumer Health Division. Pfizer Pharmaceutical's union raises suspicions that GSK will endorse unfair changes in working conditions in the process of employee succession. There are ten days left to launch an integrated corporation, and a possibility that variables may arise during the merger process if employees refuse to transfer largely. According to the related industry on the 14th, Pfizer Korea’s labor union had an emergency meeting with about 50 employees of Consumer Health Division in the afternoon. The intent is to seek a response to GSK's notification that Pfizer's Consumer Health Division employees must submit a written consent by this coming 17th to agree to transfer to GSK on the condition that they agree to change the disadvantage of working conditions. Pfizer and GSK Korea have been pursuing related procedures since the merger with Consumer Healthcare in 2018. As GSK establishes a joint venture with 68% of the joint venture and Pfizer's remaining 32%, GSK is committed to 100% succession of Pfizer employees. The organization of the headquarters has already completed the establishment of a joint venture and transfer of its employees in August last year, and GSK & Pfizer Consumer Health Korea is expected to launch a corporation on the 24th as the related procedure has reached its final stage. The problem arises from the fact that labor negotiations over working conditions have not progressed even though the date of incorporation is approached ten days in advance. Pfizer's union argues that GSK, the owner of the negotiating bargaining agreement, has asked Pfizer employees to change their working conditions to be 100% identical to GSK, and the gap has not narrowed. It is pointed out that the employee's options were limited because the company insisted employees should approve changes of disadvantages in working conditions if employees want to transfer with GSK for more than two months since last December On the 10th, Pfizer's labor union, Pfizer's human resources officers and GSK's human resources officers agreed that even if employees want to transfer, whether they agree to changes of disadvantages in working conditions are left to the opinion of individuals. But, they took back their words in four hours. It also uncovered that employees of Pfizer Pharmaceutical Consumer Business Division of Korea had to submit an agreement by e-mail by the 17th that they would agree to change the disadvantage of working conditions and change the retirement pension system if they want to transfer work. Yun-gyu Park, the chairman of Korea Pfizer labor union, said, “It is a serious offense to allow GSK transfers under the conditions of work conditions and retirement pension, and employees who were unilaterally notified by e-mail are not able to get out of shock”. Pfizer Korea's HR team tipped off that GSK had an attitude problem and raised objections to the headquarters. According to Park, most employees complain about the wide difference in working conditions such as benefits and ranks. For example, Pfizer has six ranks and GSK has three levels. According to the GSK standard, even if there are paid health leave, sick leave and other leave, medical expenses support, and retirement pension system, the company must bear a considerable disadvantage. Apart from the difference in the basic labor system, he also pointed out that the entire agreement contained many poisonous clauses. It was also predicted that confusion would be inevitable if the majority of the 53 members of the Consumer Health team refused to do so. It is pointed out that the launch of an integrated corporation may have a problem. The two companies have not disclosed their official position. Pfizer and GSK officials said, "There is currently no formal issue that can be revealed, except that the two companies are in the process of merging the consumer healthcare business".
