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- 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.
- Company
- MSD has appointed So-eun Kim as the first CEO of Organon
- by Oct 29, 2020 05:51am
- So-eun Kim, the first CEO of Organon & Co. MSD announced on the 27th that it has appointed So-eun Kim (49 years old), currently managing director of MSD Korea, as the new CEO of Organon & Co, which will be newly established through the spin-off in the first half of 2021. Organon & Co's term of office begins on February 1, 2021, when the division of the company in Korea is completed. Since joining MSD Korea in 1998, the new CEO So-eun Kim has played various roles in MSD domestic and overseas for about 23 years. She has served as Head of the External Affairs, Primary Care, and Commercial Operations divisions, and has led Marketing and Sales Excellence (MSE) in Asia Pacific. She has been in charge of the division of the company as a transition lead at MSD Korea since last February. New CEO So-eun Kim said, "Organon & Co. will grow into a global healthcare company that provides specialized solutions for women's health based on the continuous growth of various products such as cardiovascular, respiratory, dermatological, and musculoskeletal systems." She added, "In the case of the Korean branch, we will build a corporate culture so that employees can enjoy various opportunities for growth in a horizontal and flexible environment while pursuing the company's continuous growth and leadership."
- Company
- Evrysdi is expected to enter Korea
- by Eo, Yun-Ho Oct 28, 2020 06:03am
- The third SMA treatment is expected to enter Korea following Biogen's Spinraza approved in 2017 and Novartis' Zolgensma, which is currently undergoing approval review. According to related industries, Roche also submitted an application for Evrysdi (Risdiplam) to the MFDS after approval from the US FDA in August. All of these drugs are treatments for Spinal Muscular Atrophy (SMA), and detailed indications, formulations, dosages, and dosages are different. Zolgensma (Onasemnogene abeparvovec), a gene therapy drug and an expensive drug with a concept of 'one-time treatment', is still under review, and Evrysdi, which is an oral drug and continuously administered, is considered to have relatively shortened the screening period. Evrysdi's indications are for 'adult and infant SMA patients over 2 months'. Evrysdi's FDA approval was based on the results of a FIREFISH study in infants aged 2 to 7 months and SUNFISH in children and adults aged 2 to 25 years. In SUNFISH conducted in 180 SMA type II or III patients, Evrysdi demonstrated motor function improvement at 12 months as measured by MFM-32, a motor function evaluation scale. In addition, in the FIREFISH of infant SMA patients 2-7 months of age after type I, 88% of patients receiving Evrysdi for 2 years continued to survive without a ventilator for 2 years. Over two years, 59% of infants were able to sit without assistance for at least 5 seconds on the basis of the Bailey Infant and Toddler Development Test (BSID-III), which measures total infant and toddler developmental exercise. In addition, 65% of infants were able to hold their neck for 1 year, 29% were able to turn themselves over for 1 year, and 30% were able to stand using supports. Meanwhile, Spinraza (Nusinersen) was listed on the insurance benefit list in April last year, accepting the Refund type and the Expenditure Cap type of the total amount limit of the Risk Sharing Agreement (RSA). At the time, due to the efforts of both the government and pharmaceutical companies, the maximum amount of domestic insurance coverage in Spinraza was set at ₩92,359,131 per bottle. It is unclear how long Zolgensma and Evrysdi will take from domestic approval to reimbursement list.
- Company
- Sanofi launches Dupixent '200mg' in Korea
- by Oct 28, 2020 06:02am
- Sanofi-Aventis Korea (CEO Kyung-eun Bae) announced that it will release Dupixent PFS 200mg (Dupilumab), a biologic drug for atopic dermatitis and asthma on the 26th. Accordingly, Dupixent is available in two doses, 200mg in addition to the 300mg previously released. According to the MFDS, Dupixent 200mg can be used for moderate-severe atopic dermatitis patients aged 12 years or older, weighing less than 60kg. After the initial administration of 400mg, it has been approved as a maintenance dose of 200mg every two weeks. Atopic dermatitis is characterized by the intensity of symptoms such as severe itching, rash, dry skin, cracked skin, crusts, and sores during adolescence. Atopic dermatitis patients with adolescents experience difficulties in school life, such as exclusion and harassment of their peers due to outward symptoms, and negatively affected academic performance. In fact, 46% of adolescent patients answered that symptoms of atopic dermatitis affect their school life, and about 26% of patients said they felt a high level of anxiety disorder. Dupixent 200mg has been tested for efficacy and safety profile in LIBERTY AD ADOL clinical trials. In this study involving 251 patients with moderate-severe atopic dermatitis, the Dupixent 200mg and 300mg groups showed a 66% improvement in lesion size and severity at 16 weeks. There was a clinically significant improvement in the quality of life index. Hee-kyung Park, president of Sanofi Genzyme, a specialty care division of Sanofi-Aventis Korea, said, "We are pleased to be able to introduce all of the new doses of Dupixent in Korea." "We look forward to improving their accessibility, and we will do our best to make Dupixent an innovative treatment option for suffering patients in the future."
- Company
- Ilyang's leukemia treatment Supect, approved by Russian GMP
- by Oct 28, 2020 06:02am
- The factory that manufactures Ilyang's Supect has passed the GMP (Manufacturing, Processing, Packing or Holding of Drugs) due diligence conducted by the Russian government. According to the pharmaceutical industry on the 26th, the Ministry of Industry and Trade of Russia determined that Ilyang’s plant located in Jecheon-si, Chungcheongbuk-do on the 20th (local time) was suitable for manufacturing and quality control standards, and approved GMP compliance. This plant is where Ilyang manufactures Supect, which was completed in 2015. The validity period for GMP conformity approval is until September 25, 2023. The Russian government conducted due diligence on the Ilyang Biopharm’s plant from September 21 to 25. The due diligence was conducted by video conference due to COVID-19. This GMP due diligence was carried out by Ilyang for Supect's entry into Russia as a leukemia treatment, but as it is combined with the COVID-19 clinical trial, expectations of shareholders are growing together. Supect is a Korean new drug No. 18 developed by Ilyang. Ilyang initially attempted to advance Supect into Russia as a treatment for leukemia. Targeting leukemia, it was approved for Phase III clinical trials and conducted GMP due diligence. It has not yet entered the leukemia clinical trial. At the same time, Ilyang also explored the possibility of Supect as a treatment for COVID-19. Ilyang , which confirmed the inhibitory effect of the COVID-19 in an in vitro experiment in March, was approved by Russia on May 28 and is undergoing clinical trials. In the pandemic, the clinical progression of COVID-19 was faster than that of leukemia. The industry is speculating that it will be able to speed up commercialization with rapid production if only the effectiveness of COVID-19 treatment is proved in phase III as it has been approved for GMP compliance. It is predicted that the GMP due diligence will be exempted because the Corona 19 clinical trial is a drug repositioning method. However, Ilyang has expressed concern about the direct link between the GMP compliance approval and COVID-19 clinical trial. Another variable is that it is difficult for Ilyang to grasp the progress as the local pharmaceutical company 'R-Pharm' is entirely leading COVID-19 clinical trial. Ilyang has delegated all authority to R-Pharm for the Russian clinical trial of COVID-19. R-Pharm signed an export contract with Ilyang in December 2014 for Supect. R-Pharm is conducting clinical trials for 185 mild and severe COVID-19 confirmed patients at 29 institutions in Russia and Republic of Belarus. An official at Ilyang said, "This GMP due diligence was done on the manufacture of Supect as a leukemia treatment, and was planned from the beginning of this year." He added, "If Supect is commercialized as a treatment for COVID-19, there is a possibility that due diligence may be exempted, but this is something the Russian government will judge."
- Company
- Tecentriq as 1st reimbursed immunotherapy for TNBC and HC
- by Eo, Yun-Ho Oct 27, 2020 06:12am
- An immunotherapy Tecentriq (atezolizumab) is seeking for the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported Roche Korea has recently submitted an application to expand reimbursement for indication to treat patients with TNBC and also hepatocellular carcinoma. In early this year, Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, won the health authority’s approval to treat patients with TNBC as a first-line treatment, and it also earned an approval to treat liver cancer as a first-line treatment through Avastin (bevacizumab) combination therapy. Once it successfully expands its coverage, Tecentriq would be the first immunotherapy option for the two cancer types. However, it is still unknown how long the listing procedure would take. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government as the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. Meanwhile, the two indications barely had any treatment option and an emerging option of an immunotherapy heightened the interest of medical academics. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy marked the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.” The efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 41 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. Professor Kim Doyoung of Gastroenterology Department at Severance Hospital noted, “Beside the OS, the improvements in the response rate and PFS were positive findings. We are glad to have found an immunotherapy option in the liver cancer area that has no other alternative than Nexavar. Hopefully, the drug can meet the highly unmet medical needs in the future.”
