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- 2025-12-26 12:27:06
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- Baculovirus overcomes shortcomings of DNA vaccines
- by Nho, Byung Chul Apr 06, 2021 11:08am
- 김영봉 교수 The development of a COVID-19 ‘DNA and viral vector-based vaccine’ made with 100% domestic technology is well underway. Although in its preclinical stage, the vaccine, once commercialized, is expected to show superior safety and protection over existing COVID-19 vaccines by Pfizer, Moderna, AstraZeneca as well as vaccines from Russia and China. Professor Young Bong Kim of Biomedical Science & Engineering at Konkuk University and his team have recently announced positive results from the preclinical study of their Covid-19 vaccine in development. The study used hamsters to assess the immunogenicity, antibody production, seroconversion rates, and increments in geometric mean concentrations or titers of their Covid-19 vaccine. The key to the COVID-19 vaccine platform being developed by Kim, the world-renown leader in the field of viruses, is the baculovirus. Baculovirus is an insect-derived vector that is considered safe as it is generally non-toxic and non-replicative in human cells. Also, baculoviral-based vaccines have fewer side effects than adenoviral vector-based vaccines. Kim's team constructed a recombinant baculovirus expressing the envelope glycoprotein of human endogenous retrovirus to enhance effective gene delivery into human host cells. In other words, the AstraZeneca vaccine generates an immune response from our body by delivering an adenovirus containing the COVID-19 spike protein to our cells whereas the vaccine developed by Kim’s team inserts the COVID-19 spike protein or its part into a baculovirus that virtually has zero side effects to produce antibodies. This 'baculovirus platform technology' has been patented in Korea in 2010 as well as various other countries including the U.S, the U.K, France, Germany, China, and Japan, and is expected to have high growth potential over the next decade. In particular, the HPV (human papillomavirus) vaccine for cervical cancer requires 2 or more doses for a strong cell-mediated immunity (CMI). The advantage of the platform technology is that neutralizing antibodies to the baculovirus are not generated while baculovirus produces therapeutic antibodies for cervical cancer, enabling patients to receive repeated doses of the vaccine consecutively. In addition to HPV, the efficacy and safety of vaccines using the baculovirus platform has been proven in preclinical trials conducted for MERS and Zika virus. Especially, the ability to actively respond to the rising number of COVID-19 variants is regarded as its greatest strength. “Hamsters vaccinated with two doses of the baculovirus COVID-19 vaccine a week apart showed 99.99% protection against COVID-19 infection, while the control group still showed viral infection," said Kim. He added, “As we are still in our preclinical stages, a large-scale clinical trial will be needed to verify our results. We also need to be prepared for multiple simultaneous outbreaks of infectious diseases, such as MERS and SARS. With various mutations of COVID-19 emerging, we urgently need to secure sovereignty over a more safe and effective vaccine." Meanwhile, the results of the preclinical trial on the MERS-CoV vaccine using the baculovirus platform technology were published on ‘npj Vaccines,’ a sister journal of Nature, and recognized for its academic value.
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- The Cancer Committee discusses Tagrisso's first-line therapy
- by Eo, Yun-Ho Apr 06, 2021 06:10am
- #Tagrisso, a third-generation lung cancer targeting anticancer drug, is once again discussed at the Cancer Drugs Benefit Appraisal Committee in about a year. According to related industries, discussions on expanding the benefits of first-line therapy for the third-generation epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (Osimertinib) will be held at the Cancer Drugs Benefit Appraisal Committee, which will be held on the 7th. As Leclaza, a drug of the same class, passed the Cancer Drugs Benefit Appraisal Committee within a month after approval, it is noteworthy whether Tagrisso can pass to expand benefits. Tagrisso was added first-line therapy indications in Korea in December 2018 and aimed to expand benefits in 2019, but in October of the same year, a Phase 3 FLAURA study that confirmed overall survival (OS) in first-line therapy at the Cancer Drugs Benefit Appraisal Committee. It was put on hold that it would have to wait for the full data of the company to be released. Later, along with the additional submission of the full data of the FLAURA study, they expressed their intention to accept most of the fiscal allocation proposals proposed by the government, but the members (specialists) objected that there was a problem with the clinical usefulness. Last May, the expansion of the benefits of first-line therapy was rejected. AstraZeneca's FLAURA China study, which was poster published last year at the online European Society for Medical Oncology (ESMO), added the evidence for confirming OS in Asians. The reason why Tagrisso's first-line therapy benefit extension was rejected was an Asian sub-analysis of FLAURA. Through the study, Tagrisso's OS was 38.6 months, demonstrating 6.8 months improvement compared to the first-generation drugs Iressa (Gefitinib) and Tarceva (Erlotinib). It is the first among EGFR TKIs, and it is encouraging considering that it has admitted the cross-over prescription of patients with confirmed T790M mutations in the first-generation drugs for research ethics. However, it was the Hazard Ratio (HR) of the sub-analysis for Asians. Tagrisso's HR for Asians was only 0.995. The value of 0.995 means that the gap is 0.005 based on 1, meaning that there is no difference from the control group. Based on this, an opinion was raised in academia that Tagrisso's OS is unreliable in Asians to which Koreans belong, and it had a dominant effect on the results of the Cancer Drugs Benefit Appraisal Committee. It is noteworthy what the results of Tagrisso, which added a study on Chinese people, will be produced. Meanwhile, in the FLAURA Chin study using a Chinese cohort, a total of 71 patients were assigned to the Tagrisso group and 65 patients were assigned to the control group. In particular, if the patients in the control group progressed to T790m positive, they could switch to Tagrisso and receive secondary treatment, and 22 out of 65 patients in the control group continued treatment with Tagrisso. As a result, the median OS of the Tagrisso group was 33.1 months, which was 7.4 months longer than 25.7 months of the control group, and the risk of death was reduced by 15.2%.
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- Janssen’s ‘Tremfya’ approved for psoriatic arthritis
- by Apr 06, 2021 06:08am
- Janssen Pharmaceutical Companies of Johnson & Johnson announced on the 5th that the Korean Ministry of Food and Drug Safety (MFDS) approved its psoriatic arthritis treatment ‘Tremfya (guselkumab)’ on March 29th. With the approval, Tremfya may now be used for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug (DMARD) therapy. Tremfya is the first and only interleukin (IL)-23 inhibitor to be approved for the treatment of active psoriatic arthritis in Korea. Tremfya is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at week 0 and 4. Patients who are at high risk for joint damage may consider 100 mg subcutaneous doses every 4 weeks according to clinical judgment and may consider using Tremfya in combination alone or with other disease-modifying antirheumatic drugs (DMARDs). The approval was based on two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which demonstrated that after 100mg SC injection of Tremfya, patients with psoriatic arthritis who had an inadequate response to conventional treatment showed improved signs and symptoms, including joint symptoms and skin symptoms at week 24. In DISCOVER-1, which evaluated patients who were naive to biologics or had an inadequate response to one or two standard therapies, 52% of the patients who received Tremfya every 8 weeks following two starter doses at week 0 and 4 achieved an ACR20 response at 24 weeks. In addition, 50% and 26% of the patient group achieved Psoriasis Area and Severity Index 90 (PASI 90) and PASI 100 response rates respectively, showing a significant improvement compared to the placebo group. In DISCOVER-2 which studied biologic-naïve patients, 64% of the patients who received Tremfya every 8 weeks achieved an ACR20 response at 24 weeks. Also, 69% and 45% of the Tremfya-treated patient group achieved PASI 90 and PASI 100 response rates respectively, showing a significant improvement compared to the placebo group. Integrated analysis of the two studies showed that Tremfya significantly improved enthesitis and dactylitis. From baseline, 50% of the patients who had enthesitis (114/230) and 59% of the patients who had dactylitis showed symptom improvement at 24 weeks since receiving Tremfya every 8 weeks, which is a significant difference from the 29% (75/255) and 42% (65/154) of the placebo group. “We are pleased to be able to provide a new treatment option to patients suffering from psoriatic arthritis in Korea with the approval of Tremfya,” said Jenny Zheng, Area Managing Director of Janssen Korea. “From plaque psoriasis, palmoplantar pustulosis, to psoriatic arthritis, we hope the extended indication will allow Tremfya to be more widely used in the field of psoriasis.” Previously, Tremfya has been approved in Korea for the treatment of adult patients with plaque psoriasis in 2018, and for the treatment of palmoplantar pustulosis in 2019.
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- Reimbursement expanded for Takeda’s Adcetris and Alunbrig
- by Eo, Yun-Ho Apr 06, 2021 06:08am
- Takeda Korea has achieved continuous success in expanding reimbursement for its anticancer drugs, increasing the company’s hold over the market. According to industry sources, starting from April 1st, the government has decided to grant reimbursement for Takeda Korea’s antibody-drug conjugate ‘Adcetris (brentuximab vedotin)’ as a first-line treatment for Hodgkin and non-Hodgkin lymphoma and its anaplastic lymphoma kinase(ALK) tyrosine kinase inhibitor (TKI) ‘Alunbrig (brigatinib)’ as a first-line treatment for ALK-positive advanced non-small cell lung cancer (NSCLC). Takeda Korea had also previously received approval to expand the scope of reimbursement for its poly ADP-ribose polymerase (PARP) Inhibitor, ‘Zejula (niraparib)’ as maintenance treatment. Specifically, Adcetris can now be prescribed with reimbursement as first-line treatment for patients with previously untreated Hodgkin lymphoma and for patients with previously untreated CD30-positive systemic anaplastic large cell lymphoma (ALCL) who have an IPS (International Prognostic Score) of 4 or higher (If the patient is ALK-positive, those who have an IPS of 2 or higher may be covered) ‘Hodgkin lymphoma (HL)’ and 'systemic anaplastic large cell lymphoma (sALCL),’ a non-Hodgkin lymphoma subtype, are malignant tumors that develop in the lymphoid tissues that make up the immune system. In general, 30% to 40% of stage 3 to 4 HL patients experience treatment failure despite first-line treatment with the existing combination chemotherapy, ABVD (adriamycin+bleomycin+vinblastine+dacarbazine). Also, 26% of the ABVD treated group experienced disease progression, relapse, or death within 5 years. For Alunbrig, a new reimbursement criterion has been added for the first-line treatment of locally advanced or metastatic NSCLC, and the phrase ‘those who have been previously treated with crizotinib’ was removed from the second-line reimbursement criteria. The decision to approve the first-line administration of Alunbrig was based on the government’s review of the NCCN guidelines, where Alunbrig is recommended as category 1 preferred regimen for ALK-positive NSCLC, and that its Phase 3 trial results demonstrated that its clinical utility is comparable to other reimbursed replacements like ‘Alexenza (alectinib)’ and ‘Zykadia (ceritinib).’ However, reimbursement is not approved for patients wishing to change therapies for no specific reason or those receiving Alexenza or Zykadia that wishes to switch to a different ALK inhibitor due to disease progression. Myung-Ju Ahn, a professor of Hematology & Oncology at Samsung Seoul Medical Center said, “In addition to meeting the unmet demand that still remains in the current treatment environment, its ease of medication also provides a therapeutic advantage as it only requires a once-daily intake for disease management."
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- SK Biopharm's new epilepsy drug licensed in Europe
- by An, Kyung-Jin Apr 06, 2021 06:08am
- #SK Biopharmaceuticals announced on the 31st that Cenobamate, a new epilepsy drug, has obtained sales permission from the EC on the 30th (local time). It has been about two months since it received a recommendation for marketing approval from CHMP under the European Medicines Agency (EMA) last month. Through this sales permit, SK Biopharm has secured a total of 1232.2 million dollars (about 140 billion won) worth of technology fees from partners. In addition to the $110 million milestone for European permits received from Angelini Pharma, which is responsible for local sales in Europe, the company will receive an additional $13.22 million milestone for each phase from the sale of its first contract partner, Arvelle Therapeutics. SK Biopharmaceuticals signed a Cenobamate technology transfer contract with Arvelle Therapeutics in February 2019.As Arvelle Therapeutics was acquired by Angelini Pharma earlier this year, it transferred 12% of its existing Arvelle stake to Angelini Pharma. At that time, it secured $31.76 million, a portion of the sale proceeds. SK Biopharmaceuticals expects earnings to improve as sales of'Cenobamate' begin in Europe within this year. Angelini Pharma, a European partner, announced that Cenobamate will be released in 41 countries in Europe from the third quarter of this year under the product name'ONTOZRY'. Starting with major countries such as Germany, France, Italy, Spain, and the UK, it is planned to be released sequentially to Iceland, Norway, and Liechtenstein, which are the signatories of the European Free Trade Agreement. Since May last year, SK Biopharm has started selling three Cenobamate under the product name Xcopri through SK Life Science, a US subsidiary. Unlike the US, the European market has a structure to receive royalties from sales by implementing a commercialization strategy through partners. When the commercialization of'ONTOZRY' begins in earnest, SK Biopharm can secure up to $585 million as a milestone linked to sales performance. Since royalties from sales are separately received, the scale of revenue can be expanded according to the sales volume. The company is confident in its marketability as there has been high interest in'ONTOZRY' in Europe before the approval. At the time of the contract in 2019, SK Biopharm recorded the highest record in exports of central nervous system (CNS) drug technology to Europe. In August of last year, it was selected as a promising innovative treatment by MHRA in the UK, and in December of the same year, as the clinical results were announced at the annual conference of the European Academy of Neurology, it was evaluated as the best-in-class drug in the same category. As the partner company changed from Arvelle to Angelini Pharma, its sales and marketing capabilities have also strengthened. Angelini Pharma is one of the top three pharmaceutical companies in Italy and has a product line specialized in the CNS field, such as pain, depression, and schizophrenia. “Our efforts to provide breakthrough treatments to patients with epilepsy in Europe are paying off,” said SK Biopharm's President Jo Jung-woo. "We will continue to develop new treatment options for patients with the central nervous system and fulfill our role as a global comprehensive pharmaceutical company," he said. Pierluigi Antonelli, president of Angelini Pharma, said, "We expect ONTOZRY to be a new hope for epilepsy patients suffering from unexpected seizure symptoms. We will build an innovative product portfolio to meet the needs of CNS patients."
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- Dispute over Eliquis patent will be closed in six years
- by Kim, Jin-Gu Apr 05, 2021 05:51am
- Eliquis The six-year-old Eliquis (Apixaban) substance patent lawsuit will be closed next week in the Supreme Court. If the Supreme Court overturns the judgment of the first and second trials and takes the side of the original company, BMS, an all-round lawsuit for damages against related generic companies is expected and attracts attention. The ruling is expected to affect Eliquis prices. It has not yet been lowered even after the generic launch, because BMS has filed a court request to suspend the drug price reduction until the final conclusion of substance patent lawsuit for Eliquis is concluded. According to the pharmaceutical industry on the 2nd, the Supreme Court announced on the 8th the date of the appeal decision on the patent registration invalidation lawsuit filed by BMS against Navipharm, Huons, Intro Bio Pharma, and Alvogen Korea. On March 20, 2015, the dispute over substance patents will be closed after more than six years after Navipharm et al. requested an invalidation trial against a substance patent of BMS. In the preceding 1st and 2nd trials, a generic company has won. In February 2018, the Patent Tribunal ruled that Eliquis' substance patent was invalid. Based on this trial decision, patent challengers tried to release generics for Eliquis early. Prior to this, the patent was also successfully overcome, so it was possible to release it early. However, when BMS applied for a temporary injunction to prohibit patent infringement at the Seoul Central District Court, the release of the generic was put on hold. The Seoul Central District Court accepted the application, and the generics companies had to postpone the release date of September of that year. In March 2019, the Patent Court ruled that substance patents were invalid, similar to the Intellectual Property Trial and Appeal Board. Generics for Eliquis were released one after another. After June 2019 ▲Chong Kun Dang's Liquisia ▲Yuhan's Yuhan Apixaban ▲Samjin's Elxaban ▲Hanmi's Apixban ▲Ajou's Apixaban ▲Yooyoung 's Yupix have been released. It is analyzed that the release of generics has had some effect on the decline in prescription performance of Eliquis. The outpatient prescriptions for the past five years have steadily increased from ₩19.5 billion in 2016 to ₩49 billion in 2019, but fell 3% to ₩47.7 billion last year. The total prescription amount of generics for Eliquis surged from ₩1.2 billion in 2019 to ₩8.3 billion last year. As of last year, Liquisia was ₩2.6 billion, Elxaban was ₩1.7 billion, and Yuhan Apixaban was ₩1.1 billion. Considering the rise in monthly prescription performance, it is expected to exceed ₩10 billion this year. If the Supreme Court approves Eliquis' substance patent, BMS' lawsuit against patent infringement and claims for damages are expected based on this ruling. The generic company is in a situation where it has to return the sales revenue it has earned so far in the event of a discontinuation of generic sales. The ruling is also expected to affect the lawsuit over Eliquis price cut. Earlier, the government announced that it would cut the upper limit by 30% in July 2019 based on the launch of generics. However, BMS applied for suspension of execution to the administrative court because the final result of the substance patent lawsuit did not come out. As a result, Eliquis price remains the same as before. If the Supreme Court takes side with BMS, Eliquis price is likely to remain as they are. If BMS loses, it will be cut from next month. An official in the pharmaceutical industry said, "Like the first and second trials, there is a high possibility of denying the progressiveness of the optional invention." “However, since the Seoul Central District Court has accepted the BMS' provisional injunction application, there is a possibility that a judgment different from the first and second trials may come out.”
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- OB-GYNs fume over the price hike of HPV vaccines
- by Moon, sung-ho Apr 05, 2021 05:51am
- The medical community is in turmoil over the news that MSD Korea will raise the price of ‘Gardasil 9,’ its 9-valent HPV vaccine. Relevant doctors’ associations are determined to discuss countermeasures for the unilateral price increase carried out by the pharmaceutical company. The Korean company in charge of domestic sales of the vaccine also brace for the burden that it would need to bear due to the price hike. On the 30th, industry sources said that MSD Korea has recently sent a notice that it will increase the supply price of its human papillomavirus vaccine by 15% to front-line clinics and hospitals. MSD Korea's position was that the price hike was inevitable due to the inherent complexity of production, long production periods, and quality control processes required for the vaccine. Some clinics and hospitals have been using the news of the price increase in April as a marketing tool to encourage customers to vaccinate sooner than later. Gardasil 9 is indicated for the prevention of cervical cancer, vulvar cancer, vaginal cancer, anal cancer, and genital warts caused by 9 types of the HPV virus (HPV Types 6, 11, 16, 18, 31, 33, 45, 52, 58). However, as Gardasil 9 is not provided as part of the Korean National Immunization Program (NIP), it is currently administered without reimbursement in front-line clinics and hospitals. The average non-reimbursed price of Gardasil 9 in clinics and hospitals range from 107,928 won to 202,524 won. As Gardasil 9 is administered through a 3-dose schedule, at most, roughly 600,000 won will be required to complete the vaccination. Based on the non-reimbursed price disclosed by the Health insurance Review and Assessment Service (HIRA), a price hike of 15% from April will increase the price of a single dose of Gardasil 9 to range around 120,000 won to 240,000 won. “Clinics and hospitals cannot individually protest against the pharmaceutical company’s unilateral decision to increase the price,” said one gynecologist who owns a clinic in Seoul. “My pharmaceutical sales representative had told me about the rumors of the price increase earlier on this year, so I actually ordered more in advance.” Furthermore, the medical community is voicing complaints as they will not be able to directly charge the 15% price increase applied from April to their patients. “Some hospitals and clinics are encouraging people to vaccinate in advance; however, it is unlikely that the people will be able to receive all three doses of the vaccine in the limited time period," another ob-gyn explained, “We can’t charge or explain the price hike to the patients awaiting their last vaccination if they have already received the first and second dose before March.” Faced with such strong opposition, HK inno.N, the company that signed a joint sales agreement for 7 vaccines including Gardasil 9 with MSD Korea, is also positioned in a fix. HK inno.N had prepared a marketing team dedicated to the sale and marketing of the 7 vaccines this year and was moving to expand its sales capacity. However, HK inno.N’s position is that they have no say regarding vaccine prices. Despite the burden they will have to bear selling the more expensive vaccines to hospitals and clinics, the company has to follow MSD Korea’s decision regarding the price increase. As a result, the Korean Association of Obstetricians and Gynecologists (KAOG) decided to hold a meeting to gather opinions on the matter. The association plans to hold an internal meeting first and discuss countermeasures. ”It may already be late, but we plan to discuss the issue and garner opinions at the association’s level.” said Lee Gi-Chul, vice president of insurance at KAOG. “The problem was in the unilateral notice. We will have to discuss the price hike with the pharmaceutical company and then notify our members.” “Up until now, pharmaceutical companies used to consult relevant expert associations before carrying out measures like price increases for vaccines, etc. However, the system seems to have changed now." Lee continued, "We will discuss ways and create a system so that relevant medical groups and pharmaceutical companies can discuss their options in advance when similar issues arise.”
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- Novartis' Xolair self-administration prescribed at GHs
- by Eo, Yun-Ho Apr 02, 2021 06:06am
- The self-administration formulation of the asthma treatment ‘Xolair’ can now be prescribed at general hospitals. According to industry sources, Novartis Korea’s Xolair (omalizumab) prefilled syringe 75mg solution has passed the review of drug committees (DCs) in 8 general hospitals nationwide, including the Seoul National University Hospital, Seoul Asan Medical Center, and Cheonnam National University Hospital. On December 20th, 2018, Novartis had abruptly withdrawn Xolair's application amid negotiations with the National Health Insurance Service (NHIS) after receiving the nod on its reimbursement feasibility. The reason for the sudden withdrawal was the company's concern over its impact on the Chinese market, as the drug price set in Korea may negatively affect the drug price in China as well. The incident made an exemplary case of the ‘Korea Passing’ phenomenon. After launching Xolair in China in 2019, Novartis reconducted the pharmacoeconomic evaluation procedure to apply for reimbursement listing in Korea. As a result, the Xolair injection was first listed in July last year. The maximum reimbursed price for the Xolair injection and the Xolair prefilled syringe injection in 150mg is 271,700 won, and 143,000 won for the Xolair prefilled syringe injection in 75mg. However, due to Novartis’s internal supply issues, the Xolair prefilled syringe 75mg solution started reimbursement in January of this year. The prefilled syringe 150mg solution will be reimbursed from October. Novartis's plan is to quickly proceed with the landing process in general hospitals as soon as the supply of pre-field syringe solutions begins. Various trials on Xolair including the ASTERIA, GLACIAL, OPTIMA, XTEND-CIU, and X-ACT have demonstrated that Xolair ▲rapidly improves symptoms and quality of life of chronic idiopathic urticaria patients; ▲alleviates symptoms of patients who do not respond to antihistamine treatment or leukotriene receptor antagonists; ▲is safe and continuously effective for long-term use; ▲can manage symptoms when used for retreatment after discontinuation. The clinical effect of Xolair in treating allergic asthma has been confirmed through the INNOVATE study conducted on 419 patients from 108 centers in 14 countries. The rate of clinically significant asthma exacerbations, the primary efficacy endpoint in the INNOVATE trial, was 0.68 for the Xolair group and 0.91 for the placebo group, demonstrating a significant difference between the two groups. Response of patients evaluated using the Global Evaluation of Treatment Effectiveness (GETE) showed that 64.3% of the patients responded favorably to Xolair, as reflected by a GETE rating of “excellent” or “good."
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- Aldactone, which was frequently sold out, is resupplied
- by Apr 02, 2021 06:05am
- Pfizer Korea's diuretic drug Aldactone, which was often sold out, is scheduled to resume supply. According to the distribution industry on the 27th, the supply of Aldactone (Spironolactone) 25mg is expected to resume from the 29th. It was earlier than the April 8th, the resupply date originally expected by the company. Aldactone is often sold out due to continued supply disruption. Last year, there were five reports of production, import, and supply interruptions and shortages to the MFDS. In December of last year, Pfizer expected to resume supply around February, but it was postponed for another two months. This is because it has not been able to resolve the supply and demand of drug substance. Aldactone was available from April. Pfizer Korea said, "We apologize for the inconvenience caused by the sold-out of Aldactone, and we will do our best to stabilize supply." Sanofi Aventis' amyotrophic lateral sclerosis drug Rilutek, which has been out of stock for nearly two years, is also scheduled to be supplied at the end of April. Sanofi Aventis explained, "We expect Rilutek to resume supply from the fourth week of April. Based on the shipping date to the wholesaler, there may be 1-2 days difference by region. There are no product codes, insurance, and benefit related changes," Sanofi explained. Rilutek has not resumed supply since it temporarily sold out in October 2019. This is due to a shortage of main ingredient raw materials in overseas manufacturers. It was expected to resume in February 2020, but the company delayed the schedule until January this year. Finally, supply started at the end of April. Sanofi Aventis said, "We apologize once again for any inconvenience caused by supply instability. We will do our best to supply the product smoothly with patient health as our top priority."
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- Only hope for pancreatic cancer Onivyde seeking for coverage
- by Eo, Yun-Ho Apr 01, 2021 06:08am
- The pancreatic cancer with highly unmet medical needs may welcome a newly listed drug. The pharmaceutical industry sources reported Servier Korea’s Onivyde (Irinotecan Hydrochloride) would be deliberated by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). Requested for the National Health Insurance (NHI) reimbursement last July, the drug is finally starting the practical discussion on the listing after about six months. Onivyde has requested for reimbursement on an indication to treat patients, who have failed a first-line gemcitabine-based treatment, as second-line 5-FU/LV combination therapy. But Onivyde faces an unexpected challenge. The South Korean government has recently decided to significantly reform the anticancer treatment reimbursement standard used for pancreatic cancer. As a result, HIRA is to enforce the revised notification of drugs prescribed and administered to cancer patients reflecting the details from Apr. 1. According to the change, the division between the first and second tier anticancer treatments has been removed, and the first tier anticancer therapies (10 items including cisplatin monotherapy) were delisted, while gemcitabine plus paclitaxel combination, previously categorized as a second tier anticancer treatment for first-line palliative therapy with reimbursement, can be now also prescribed for second-line therapy. As patients with pancreatic cancer had extremely limited option for a first-line therapy so far, the patients would greatly appreciate the government’s new reimbursement expansion decision. But the latest change can be burdening for Onivyde. As many of anticancer treatments initially not listed for reimbursement as second-line or later therapy are now listed, the government’s standard on reviewing the reimbursement feasibility, such as ICER, could get tougher. Medical experts complain the government should have included Onivyde, when discussing about the reimbursement listing reform. Professor Yoo Chang-hoon of Oncology Department at Asan Medical Center noted, “To this date, we talk about the second and third-line treatment with a lot of pancreatic patients. Because they do not get coverage, we also check on their private medical expense insurance. It is regrettable that Onivyde has not gotten reimbursement, yet, even it has global Phase III trial and Asian subset analysis data and Korean RWE.” The global multicenter Phase III trial NAPOLI-1 study has confirmed Onivyde, in combination with a standard second-line treatment option '5-FU/LV,' significantly improved the treatment outcome on patients, who did not respond to first-line gemcitabine-based treatment. The drug raised awareness of the importance of sequential combination strategy in treating metastatic pancreatic cancer. It is the only treatment recommended as a Category 1 by NCCN guideline when second-line gemcitabine-based anticancer therapy is used to treat patients with metastatic pancreatic cancer.
