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- 2026-03-18 20:22:38
- Company
- MSD Korea appoints Seongpil Kim as executive director
- by Nov 05, 2020 06:40am
- Kim Seong-pil (left), new executive director of MSD Korea anticancer drug division, Jae-yeon Choi, new CEO of Taiwan MSD (right) MSD Korea (CEO Kevin Peters) announced on the 1st that it had appointed Kim Seong-pil (43 years old), executive director of the anticancer drug division. In December 2018, the new executive director of Seongpil Kim joined MSD Korea as the 'Commercial Operations Lead', which led to double-digit growth. He has also contributed significantly to the implementation of the biomarker strategy so that the company's anticancer drug portfolio can be used for patients in need. Prior to joining MSD Korea, he served as CEO at Elanco. Prior to that, he managed the sales of the anticancer drug division, the cardiovascular division, and the diabetes division at Lilly Korea. He graduated from Korea University Department of Business Administration and obtained an MBA from Northwestern University's Kellogg School of Business. Managing Director Seong-pil Kim said, "MSD's anticancer drug business unit gathered employees with extraordinary passion and vision to lay the foundation for MSD to grow into a leading company in the anticancer drug field in a short time." He said, "Based on our excellent organizational capabilities, we will continue to position ourselves as a business unit that can contribute to Korean medical staff and cancer patients." On the other hand, Choi Jae-yeon (47 years old), managing director of MSD Korea's anticancer drug division until recently, led the business growth and organizational innovation of the division, and was recognized for the achievement of making the company a leading company in the field of anticancer drugs. This is the first time a Korean has been elected as the CEO of MSD. Jae-yeon Choi, the new representative of Taiwan MSD, joined MSD Korea in 2017 and led external cooperation departments such as market access, rental, communication, etc. Prior to joining MSD Korea, she oversaw the marketing team and anticancer drug division of Lilly Korea, leading product and portfolio strategy and digital marketing. She majored in French from Hankuk University of Foreign Studies and obtained an MBA from Northwestern University's Kellogg School of Business.
- Company
- Multinational companies rush to appoint new CEOs
- by Eo, Yun-Ho Nov 05, 2020 06:40am
- (From left) CEO Kim Younhee, Choi Ho-jin and Kim So-eun Multiple Korean subsidiaries of multinational pharmaceutical companies are reporting their news of newly appointed top executives. Just in the latter half of the year, six companies have welcomed their new leaders. According to pharmaceutical industry sources, Sanofi Pasteur Korea, Galderma Korea, Ono Pharma Korea, MSD Korea, Organon Korea and GlaxoSmithKline (GSK) Korea eighter elected or nominated new CEOs. Apparently, South Korean CEOs were appointed at Galderma Korea, Ono Pharma Korea and Organon Korea. Since October, Galderma Korea elected CEO Kim Younhee, a new Korean CEO after two years. Former CEO Rene Wipperich, elected after former CEO Park Heung Bum, was transferred to Swiss office after serving two years in South Korea since September 2018. Ono Pharma Korea welcomed a new leader only after a year as former CEO Yang Min-yeol retired. A South Korean would continue to oversee the multinational company as former Vice-president Choi Ho-jin is taking over the position. Prior to CEO Yang’s appointment, former CEO Takashi Kishi used to manage the company. Along with CEO Choi’s personnel news, Ono Pharma is resuming its process to seek reimbursement and expand indication on immunotherapy Opdivo that the industry once evaluated the company’s attempt to be sluggish. Split from MSD, Organon has nominated the current South Korean External Affairs Lead, Kim So-eun, as a new CEO. Kim would lead the company from February next year. While former CEO Avi BenShoshan has been promoted to take a position at the headquarters, MSD Korea nominated Kevin Peters, from the Thai office, as a new CEO. (From left) CEO Kevin Peters and Pascal Robin Regarding the Organon spin-off, MSD’s Korea labor union and the management are in dispute. The new CEOs would have to face the imminent issue and urgently take actions to successfully complete the corporate reorganization procedure. Besides MSD Korea, Sanofi Pasteur Korea and GSK Korea are also maintaining the non-Korean leadership. In last August, Pascal Robin stepped in as a new CEO of Sanofi Pasteur Korea. The position was vacant for a couple of months, as former CEO Baptiste de Claren resigned last June. GSK Korea is bidding farewell to current CEO Julien Samson by the end of the month for him to take his position at the headquarters. Robert Kempton, a vice-president from the U.S. North Carolina office, is now nominated as a new CEO at the Korean office. Leading the South Korean branch since February 2018, Samson was the first foreigner CEO of the office. Previously, CEO Hong Yoo-seok was elected in 2014 as a successor of former CEO Kim Jin-Ho, who led the company from the time of GlaxoWellcome. Hong later nominated Samson as a next CEO, when he was promoted to lead the pharmaceutical business unit (therapeutics and vaccines) at GSK Canada in 2018.
- Company
- Soliris competitor Roche’s Enspryng readies for South Korea
- by Eo, Yun-Ho Nov 04, 2020 06:09am
- Apparently, Enspryng, a Soliris (eculizumab) competitor, is making a move to enter the South Korean market. The pharmaceutical industry sources reported Roche Korea has recently submitted an approval application on a neuromyelitis optica spectrum disorder (NMOSD) treatment Enspryng (satralizumab) to the Ministry of Food and Drug Safety (MFDS). The final decision on the approval would be made in the first half of next year. Previously, the drug was designated as a rare disease drug. When Enspryng is released to the market, Soliris developed by Alexion and supplied to the Korean market by Handok would be the sole competitor of the drug. However, Enspryng is expected to dominate the NMOSD therapeutic area, as Soliris is only indicated to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) in South Korea. Currently in the U.S. market, Enspryng and Soliris are in competition, where Enspryng is highlighted with comparatively inexpensive price. In June last year in the U.S., Alexion was able to expand Soliris’ indication to treat NMOSD, but the company has not taken a related action in the South Korean market. Enspryng’s efficacy was confirmed in SAkuraStar and SAkuraSky studies with Aquaporin-4 (AQP4) antibody-positive adult patients. In the SAkuraStar monotherapy study’s AQP4 antibody-positive group, 76.5 percent of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1 percent with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with baseline immunosuppressant therapy, 91.1 percent of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8 percent with placebo. NMOSD is a rare, lifelong and debilitating autoimmune disease of the central nervous system that primarily damages the optic nerves and spinal cord, causing blindness, muscle weakness and paralysis. The autoantibody destroying the function of AQP4 on nerve cell is the main cause of the disease. Without a specialized treatment available to date, patients are typically prescribed with high dose of steroid, and the patients with severe level of condition either use immunoglobulin as a blood product or undergo plasmapheresis.
- Company
- AstraZeneca objected to the second judgment of Forxiga
- by Kim, Jin-Gu Nov 04, 2020 06:08am
- Forxiga AstraZeneca lost the second trial of Forxiga's material patent. And AstraZeneca announced that it would appeal to the Supreme Court. AstraZeneca said in a separate statement on the 30th that it disobeyed the judgment of the Patent Court of Korea on the 29th. The Patent Court of Korea sided with 19 companies including Kukje Pharma in a lawsuit related to Forxiga substance patents on the 29th. AstraZeneca said that the criteria for judging the progressiveness of optional inventions are too strict in Korea. AstraZeneca argues that the criteria for judging the progressiveness of optional inventions currently applied by the courts were established by the Supreme Court rulings in the late 1990s and early 2000s, and that the criteria do not meet international standards. AstraZeneca said, "There is a possibility that Eliquis' substance patent, which is pending in the Supreme Court, has recently been referred to the entire consensus, and a new standard for judging the progressiveness of the optional invention is proposed." It criticized, "Even so, we are sorry for the patent court ruling that was made without confirming this case." AstraZeneca said, "No one will be willing to invest in the Korean pharmaceutical industry unless the protection of substance patents is faithfully implemented in Korea." And it also stressed, "We hope that excellent patents in the pharmaceutical field will receive reasonable protection." There are a total of two Forxiga material patents. One expires on April 7, 2023, and the other expires on January 8, 2024. The ruling, which was won by 19 generic companies, concerns a patent that expires in 2024. In the case of the patent expiring in 2023, Dong-A ST is the only one who won the first trial with the “Pro-drug” strategy.
- Company
- Opdivo resumes indication expansion in NSCLC as first-line
- by Eo, Yun-Ho Nov 03, 2020 05:58am
- The pharmaceutical industry sources reported Ono Pharmaceutical and Bristol Myers Squibb (BMS) have recently submitted an application to expand indication on a programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab) in combination with a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immune checkpoint inhibitor Yervoy (ipilimumab) to treat patients with non-small cell lung cancer (NSCLC) as a first-line treatment. In last May, the U.S. Food and Drug Administration (FDA) has approved Opdivo plus Yervoy combination as a first-line therapy on NSCLC patients with programmed death-ligand 1 (PD-L1) expression over 1 percent. Also the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an approval recommendation on the combination therapy as well. The Phase 3 CheckMate-9LA study confirmed the efficacy of the Opdivo plus Yervoy combination treating patients with NSCLC as a first-line treatment. CheckMate-9LA is an open-label, multi-center, randomized Phase 3 trial that evaluated Opdivo plus Yervoy combined with two cycles of chemotherapy, compared to chemotherapy alone, as a first-line treatment in patients with metastatic NSCLC regardless of PD-L1 expression and histology. In the study, study, the combination of Opdivo plus Yervoy plus two cycles of chemotherapy resulted in superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR), and met primary and secondary endpoints. An interim analysis following up the patients at least for 8.1 months found that the Opdivo plus Yervoy combined with two cycles of chemotherapy reduced the risk of death by 31 percent, compared to chemotherapy alone. Moreover, a longer follow-up of at least 12.7 months was able to verify the median OS of the Opdivo plus Yervoy combined with two cycles of chemotherapy marking 15.6 months, which continued to improve OS than the chemotherapy alone at 10.9 months. In the same extended follow-up, the combination therapy demonstrated improved OS regardless of PD-L1 expression. And in patient group with PD-L1 expression less than 1 percent, the risk of death was reduced by 38 percent, when the risk was reduced by 36 percent in patient group with over 1 percent expression. Comparing the combination therapy against the chemotherapy alone, the one-year PFS rate was at 33 percent and 17 percent, respectively, whereas their ORR were at 38 percent and 25 percent, respectively. In South Korea, Opdivo in combination with Yervoy, indicated to treat patients with renal cell carcinoma, is in process of seeking the healthcare reimbursement listing. In last June, the Cancer Deliberation Committee has passed the combination therapy.
- Company
- Roche: Fast listing was all about improving patient access
- by Eo, Yun-Ho Nov 02, 2020 06:13am
- President Nic Horridge An anticancer treatment specializing pharmaceutical company, Roche has been viewed to stand relatively “aloof” from seeking the health insurance reimbursement. But now Roche seems to be picking up its speed. Their last two years have been different; the company successfully expanded the reimbursement on targeted therapy Alecensa in anaplastic lymphoma kinase (ALK) lung cancer as a first-line therapy, immunotherapy Tecentriq in lung cancer as a second-line therapy after listing in urothelial carcinoma, and targeted therapy Perjeta in early stage of breast cancer. Also the multinational company is under review for expanding the reimbursement on Tecentriq as a first immunotherapy in triple-negative breast cancer (TNBC), and antibody-drug conjugate (ADC) Kadcyla in breast cancer as a maintenance therapy, as well as for receiving reimbursement on a new flu drug Xofluza. President Nic Horridge at Roche Korea is in the center of such dynamic change. Appointed as a president of Roche Korea in October 2018, Horridge once said “We prioritize in the patients’ access to treatment more than anything else.” Daily Pharm interviewed President Nic Horridge about his perspective on the changed Roche and the prospects. -Soon, it would be two years since you took the position. And Roche’s products are receiving the reimbursements fast, which is a positive change in the company. It is gratifying for the public to notice the accelerated speed in the reimbursement listing process. Many may think of drug approval, when talking of pharmaceutical accessibility. But the healthcare reimbursement is crucial to secure the practical access to the treatments. We are proud of Roche’s close engagement with the South Korean government. The fact that the company’s products are meeting the government’s level of pharmaceutical value to win the reimbursements fast means significant to the company. Regarding the topic, I would like to express my gratitude to our staffs at Roche. Personally, this is one of the proudest parts of my career in South Korea—improving the Korean patients’ access to new drug. Specifically, Kadcyla and Perjeta are attempting various tactics to achieve complete recovery. In the lung cancer treatment area, Tecentriq and Alecensa contributing to the patients’ treatment benefit is also an outstanding performance. -What was your impression on the National Health Insurance (NHI) benefit system, and what do you think is the changes it needs? To be honest, my first impression of the South Korean reimbursement scene was that ‘it is not that easy.’ But a government trying to take the most value out of pharmaceutical purchasing cost is common in every country, so it does not necessarily make the Korean government too special or difficult. The upside of Korea is that the general review and decision making process are thorough, which makes it clear for the pharmaceutical companies to see what should be done and proven to list the drugs in the market. The system seems to clarify which evidence should be provided to reflect the needs of the healthcare providers and patients and to prove the value of the drug. And it even suggests which role should a company play as the government’s partner. Regardless, the time taken for the reimbursement listing in South Korea is relatively longer than other countries with similar regulatory environment. -Roche has been fruitful in the breast cancer therapeutic area, and its presence in the market seems to be outstanding. But with new immunotherapy line-ups, the company seems to have expanded to other cancer areas. Is there any challenge in the sales and marketing? This is the part we have been deeply contemplating about. And this applies not only to anticancer treatment fields, but also in other fields as well. To tackle the issue, we need to first study the issue the consumers have and then try to provide fitting solution. To do so properly, we need to push up our work efficiency, and take an agile stance on resource utilization. -Avastin, with its patent term coming to expire soon, is actually having its second golden age. While it is considered as the best combination drug for both targeted therapy and immunotherapy, we assume the health authority’s pressure to bring down the pricing would get greater. For any drug, patent term expiration is inevitable. This is the reason why Roche cannot cease to pursue innovation and annually invest USD 12 billion, or 20 percent of the entire sales from the group, to develop new drugs. The healthcare providers and patients would continue to look for Avastin, and the company would also continue to provide support for the market in an environment we can adequately provide such support. As Avastin has been recently studied to create remarkable synergy effect in combination with an immunotherapy, we plan to provide support regardless of the types of the cancer. But the weight of the innovation would be on Tecentriq than on Avastin. -Many news reporters were surprised to find out Tecentriq winning the NHI reimbursement. The South Korean government proposed pharmaceutical companies to cover the initial administration cost, and Roche was the only company with an immunotherapy option to accept the deal. Was there any regret in the decision? We are exhilarated to expand the patients’ access to Tecentriq with the company’s decision. Even if we turn back the time, we would make the exact same decision. It was a positive experience considering how we shared constructive talks with the government. -Roche’s reputation as a market leader in the anticancer treatment scene has been lately challenged as other companies are leading the immunotherapy competition and other anticancer businesses. What is your plan to maintain that title? Roche has the richest pipeline among the healthcare industry. There are 20 candidate medicines in late development phase, scheduled to be released in about five years. In South Korea, the company would continuously expand Tecentriq’s reimbursement in treating lung cancer and liver cancer, and pursue reimbursement on Kadcyla in treating early stage of breast cancer. Meanwhile, a neurotrophic tropomyosin receptor kinase (NTRK) gene targeted therapy Rozlytrek was recently approved. With the drug targeting a specific biomarker regardless of the types of cancer, the company is determined to continuously improve patients’ access to treatment.
- Company
- 19 Korean companies partially win Forxiga patent dispute
- by Kim, Jin-Gu Nov 02, 2020 06:13am
- Product image of Forxiga A South Korean court ruled in favor of the generic companies in an appeal case for a patent dispute on an antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Forxiga (dapagliflozin). The original company AstraZeneca lost another patent litigation in a higher court after losing from the Intellectual Property Trial and Appeal Board’s case. On Oct. 29, the Patent Court has rejected AstraZeneca’s appeal filed in last May to undo the preceding Intellectual Property Trial and Appeal Board’s decision ruled for 19 pharmaceutical companies with the generics. Regardless, the generic companies again won the five-month-long appeal case. The following companies participated in the case; Kukje Pharma, Intro Biopharma, Han Wha Pharma, Daewon Pharmaceutical, KyungDong Pharmaceutical, Dong-A ST, Samjin Pharm, JW Pharmaceutical, Boryung Pharmaceutical, Jeil Pharmaceutical, Yungjin Pharm, Chong Kun Dang, Ildong Pharmaceutical, Alvogen Korea, Dongwha Pharm, Korea United Pharm, Korea Biochem Pharm, Hanmi Pharmaceutical and Sinil Pharmaceutical. Most of them received the preferential sales rights in last August, as their preceding case allowed them to meet the qualifications of filing and winning the first patent challenge. Accordingly, the companies would be able to release their generics early beginning from Jan 8, 2024. The patent dispute around Forxiga started from 2015. The companies developing the generics first challenged the pharmaceutical formulation patent. They both won the negative patent scope confirmation and the patent nullification cases. The generic companies also challenged the substance patent. Forxiga has two substance patents. One is to expire on Apr. 7, 2023, and another one on Jan. 8, 2024. The latest decision was made on the patent expiring on Jan. 8, 2024. A legal expert commented, “The second patent was on a compound sharing a different number of carbons compared to another original substance. Based on the similarities, the Patent Court has reportedly stated the Forxiga substance lacked novelty and non-obviousness.” However, the generic companies failed to overcome the patent expiring in 2023. Only Dong-A ST with the ‘prodrug’ strategy won the first trial. Refusing to accept the Board’s decision, AstraZeneca has filed an appeal to the Patent Court to revoke the decision. If Dong-A ST also wins the second trial, it would be able to precede the launch of other follow-on drugs with the preferential sales rights by about seven months.
- Company
- Boryung recorded the largest quarterly sales performance
- by An, Kyung-Jin Oct 30, 2020 05:54am
- Boryung Boryung's quarterly performance improved even amid the economic downturn caused by COVID-19. The growth of new drugs introduced by multinational pharmaceutical companies, centering on Kanarb Family developed with their own technology, has contributed to the improvement of the performance of the Prescription drugs division. Boryung announced on the 27th that its operating profit for the third quarter was ₩12.9 billion, an increase of 8.4% year-on-year. During the same period, sales amounted to ₩145.4 billion, a 4.4% increase from the previous year, and net profit fell 2.1% to ₩8.1 billion. The company's third quarter sales are the largest quarterly sales since the company was founded. The new record for the previous quarter was ₩138.9 billion in the fourth quarter of last year. The cumulative operating profit in the third quarter was ₩36 billion, up 10.0% from last year, and sales increased 7.5% to ₩414.1 billion. The reason that Boryung was able to continue its sales increase for three consecutive quarters despite the spread of COVID-19 is due to the sales of Kanarb Family. According to UBIST, a drug market research institute, the outpatient prescription for Kanarb (Fimasartan) in the third quarter was ₩12.6 billion, up 6.2% from ₩11.9 billion a year earlier. The cumulative prescription amount of Kanarb this year was ₩37 billion, up 5.2% from the same period last year. Kanarb is an ARB (Angiotensin II receptor blocker) series hypertension treatment developed by Boryung's own technology. Since its launch in the domestic market in March 2011, it has increased its sales every year, but the rise was even steeper due to Valsartan’s impurity situation two years ago. Boryung steadily launched combination drugs based on Kanarb. The cumulative prescription amount of Dukarb, a combination drug of Kanarb and a calcium channel blocker (CCB) drug Amlodipine, in the third quarter was ₩25.9 billion, up 24.0% from last year. Outpatient prescriptions for Tuvero, which combines Kanarb with Rosuvastatin, a hyperlipidemia drug, and Lacor, which combines Kanarb with a diuretic, cost 3.7 billion won and 5.4 billion won respectively. At the beginning of this year, the prescription of Dukaro, a three-drug drug for hypertension and hyperlipidemia, was worth ₩3.5 billion, and Akarb, a combination drug for hypertension and hyperlipidemia, which was recently released, was prescribed for about ₩100 million. In the third quarter of this year, the cumulative prescription amount of 'Kanarb Family', which includes five types of 'Kanarb' and combined drugs, amounted to ₩75.7 billion. The prescription size increased by 19.0% from last year due to the effect of new product launches. If the current trend continues, the annual prescription amount is expected to exceed ₩100 billion. Prescription drugs, which obtained copyrights from multinational pharmaceutical companies, are also expanding externally. The anti-ulcer drug Stogar has been prescribed for ₩15 billion for 9 months this year, making it a leading prescription item among single H2 receptor antagonists. Stogar is a Rafutidine-based H2 receptor antagonist. At the end of last year, the scale of prescriptions increased by 58.1% in one year due to the suspension of Ranitidine due to the detection of impurities. Trulicity, a GLP-1 analog-based diabetes drug introduced and sold by Eli Lilly, posted a prescription performance of ₩26.1 billion, up 11.8% from the same period last year. Boryung is producing most of the new drugs introduced at its own factory, except for some jointly sold products. This is evaluated as securing higher profitability than other mid-sized pharmaceutical companies in Korea.
- Company
- Novartis "No more order suspension for Myfortic 3rd trial"
- by Kim, Jin-Gu Oct 30, 2020 05:54am
- Although Novatis took an appeal case on the pricing reduction order for Myfortic Enteric Coated Tablet to the Supreme Court, the company has reportedly decided to not request to halt the administration order. Even if the South Korea’s Ministry of Health and Welfare (MOHW) issues an order to bring down the drug pricing according to the second trial, the company means to give up on the request to delay the order execution until the end of the Supreme Court decision. Sources analyze the multinational company has felt the pressure from the National Assembly. According to pharmaceutical industry sources on Oct. 23, Novartis has recently made the decision during an internal meeting. ◆Requested postponement of pricing reduction order criticized as ‘buying time’ Typically, when a pharmaceutical company files litigation against MOHW’s order to reduce the drug pricing, the company simultaneously request the administrative order to be suspended. Basically, the company is asking the court to postpone the pricing reduction until the final decision is made. Most of the court cases accept such request, which is why the public makes reproachful comment about the pricing reduction litigation naming them ‘time-wasting’ or ‘abuse of the judicial system.’ Regardless of the court rules in favor of MOHW’s administrative order, the pharmaceutical company has opportunity to appeal. And for those appeals in the second and third trials, the companies again request the court to suspend the order. Taking the case until the third trial, the company buys time as much as possible before the pricing reduction. As for the company, it is more profitable to file litigation, while maintaining the original pricing and making sales. So far, MOHW won all eight cases of pricing reduction order litigations. Considering the precedents, the public point a figure at companies routinely filing litigation with a hidden agenda to suspend the administrative order. The office of Democratic Party Lawmaker In Jaekeun claimed the NHI financial loss is projected at 150 billion won from 2018 through last July due to repeatedly delayed drug pricing order. ◆The public label litigation ‘time-wasting,’ Novartis says “No more order suspension in third trial” To this date, total 17 cases resembled such case. And Novartis’ Myfortic is a great example. With generics launching in April 2018, MOHW issued a notice stating the pricing of Myfortic would be reduced by 30 percent. The order has been delayed even until now. The tablet is still priced at 1,382 won (180 mg). In last month, the court for the second trial has ruled the same as the first trial and said the order was just. The company relentlessly filed an appeal to the Supreme Court. The pharmaceutical industry suspects Novartis would request for the third suspension on the administrative order when filing the appeal. But the company confirmed the third request would not be made. Novartis official on the phone with Daily Pharm stated, “The company has decided not to seek for administrative order suspension to lessen wasted resources and unnecessary l confusion.” The industry experts analyze the company felt the heavy pressure from the lawmakers at the National Assembly. During the National Assembly annual audit by the Health and Welfare Committee convened on Oct. 13, Lawmaker In Jaekeun criticized “Administrative litigation and request for pricing reduction suspension have ultimately become a formality to solely benefit pharmaceutical companies.” “An indemnity should be demanded or a penalty should be imposed on companies filing money-making litigation that buys time without a clear purpose,” the lawmaker added. ◆Is it fair to order pricing reduction before the final decision on patent litigation is made? Besides the request to halt the administrative order, Novartis has submitted a petition for an appeal and plans to clearly confirm if the pricing reduction order was just. The point of the litigation is to see if it was fair for the government to bring down the original’s pricing, due to a generic launched before the patent litigation was fully concluded. The current regulation allows a generic company to release a follow-on drug, when the company wins during the patent dispute. It does not matter either the Intellectual Property Trial or the Appeal Board (first trial) or the Patent Court (second trial). Once a generic challenges and overcomes the original’s patent, it can be released in the market. And when a generic enters the market, MOHW drops the original’s price. But Novartis claims the pricing reduction before the second or third trial is unfair as sometimes the decision from the first trial could be overturned. The company explains the price reduction during the in between time would make a loss for the company. The Novartis official said, “The company calls for the Supreme Court’s decision to judge if the current government statute regarding the pricing reduction is adequate. During the third trial, the company would assertively appeal the unfairness.”
- Company
- Interview: More options in CDK4/6 inhibitor-Faslodex
- by Eo, Yun-Ho Oct 29, 2020 05:52am
- Professor Kim Ji Yeon The emergence of cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in treatment of patients with human epidermal growth factor receptor 2-negative (HER2-) breast cancer has brought a change in treatment pattern. Technically, chemotherapy was the only option in the hormone receptor-positive (HR+) and HER2- breast cancer. Ibrance (palbociclib), the first CDK4/6 inhibitor to be approved in South Korea in 2016, was already under the limelight from the R&D phase, and it firmly took root in the therapeutic scene as the healthcare reimbursement was granted on the aromatase combination therapy in post-menopausal female patients as the first-line treatment in November 2017. But still, there was an unmet medical needs—the Faslodex (fulvestrant) combination therapy as a second-line therapy. Regardless of relentless attempts to receive the healthcare reimbursement, the indication is yet to be listed for over two years. However, the restraint was lifted in last June. Now, the patients can fully take advantage of the benefits from CDK4/6 inhibitor. And as Verzenio (abemaciclib) and Kisqali (ribociclib) are either listed or to be listed soon, the patients have two more options besides Ibrance. Daily Pharm interviewed Professor Kim Ji Yeon at Samsung Medical Center Hematology-Oncology division and heard her story of the prospects in utilizing CDK4/6 inhibitor. -What is the significance in having the reimbursed option of Faslodex combination therapy? As for a healthcare provider, more than anything, CDK4/6 inhibitor is an option that lessens the concern of ‘relapse.’ Up until recently, the healthcare coverage was limited to the aromatase combination therapy for the first-line treatment. The reimbursement expanding to Faslodex combination therapy is providing benefits to more people, and healthcare providers are now treating the patients in peace. Being able to prescribe a CDK4/6 inhibitor in combination with Faslodex in patients whose cancer advanced after a tamoxifen adjuvant treatment is a blissful option for patients. -With the expanding coverage, follow-on drugs (Verzenio and Kisqali) have also won reimbursements. Especially, soon-to-be-listed Kisqali even covers pre-menopausal female patients. Which factors should patients consider when choosing a CDK4/6 inhibitor? Surely, Kisqali would be prevalently used among pre-menopausal patients. In the past, CDK4/6 inhibitor in combination with an aromatase inhibitor was the only option after prescribing tamoxifen adjuvant hormonal therapy following a bilateral salpingo-oophorectomy (BSO). But now patients skip BSO and simultaneously use Kisqali plus aromatase inhibitor and gonadotropin releasing hormone (GnRH) agonist. The healthcare providers also try to avoid BSO. However, patients using Ibrance or Verzenio after having a BSO do not have to get injected every month. Specifically, Ibrance is prescribed for two to three months’ worth at once as it rarely causes adverse reaction. On the contrary, patients using Kisqali would have to visit hospital to get injected once a month. -You have mentioned Ibrance is advantageous regarding adverse reaction. Does that mean between various CDK4/6 inhibitors, there are differences in adverse reactions? Apparently, the adverse reaction depends on whether the CDK4/6 inhibitor blocks ‘4’ or ‘6’ more, or other types of CDK including CDK2 or hinders cyclin activity. Verzenio and Kisqali tend to frequently cause stomach related adverse reaction. Patients usually complain about having diarrhea with Verzenio and having nausea or indigestion with Kisqali. On the other hand, Ibrance has reported barely any adverse reaction related to stomach. Nevertheless, reduction in neutrocyte and bone density, compared against Verzenio, were more frequently reported from Ibrance. Moreover, Kisqali and Ibrance share similar level of hematological adverse reaction like the reduction in neutrocyte. For instance, most of adverse reaction experienced from using Ibrance is reduction in neutrocyte, whereas Verzenio causes relatively insignificant changes in the neutrocyte level, but more prevalent adverse reactions in stomach are found. But, the patients directly feel the stomach related adverse reactions, when the reduction in neutrocyte level is almost unnoticeable for patients unless they have fever or a drop in immunity level. -It sounds like the preference on Ibrance would be up to patients’ situation It is so. An elderly patient over 70 would highly prefer Ibrance. Even patients in their 60s could prefer Ibrance, if they have underlying diseases like diabetes and hypertension, or not feel the best condition. -But the experts say the downside of Ibrance is no available data on overall survival (OS). Generally, an anticancer treatment clinical trial produces statistics based on a primary endpoint, and prioritizes in improving the Progression Free Survival (PFS) within the smallest group of patients. As a first CDK4/6 inhibitor, Ibrance’ statistics had to focus on PFS than any other endpoint. The first-in-class drugs tend to go through generically conventional design of clinical study. Kisqali’s study was designed to analyze OS and PFS by setting the OS as the key secondary endpoint. A latecomer can learn from the first-in-class drug and take a bolder step in a clinical study. Personally, the most integral factor would be the hazard ratio in PFS. All three of the drugs showed similar level of hazard ratio ranging from 0.5 to 0.6. When CDK4/6 inhibitors’ real world data accumulate in the future, more clear answer would be given. -The recent trend in the indication expansion among anticancer treatments seems to highlight adjuvant therapy after the release to diversify the indication. Do you think the adjuvant therapy is crucial in CDK4/6 inhibitors? To be honest, I am skeptical about the need of patients in stage 2 or earlier taking CDK4/6 inhibitor, while enduring the adverse reaction. As 40 percent to 50 percent of stage 3 patients would relapse, administering CDK4/6 inhibitor for two to three years would make sense when the OS benefit is significant. But, there is also concern about which medication to use when the cancer cells metastasize after using CDK4/6 inhibitor in adjuvant therapy.
