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- 2026-05-07 19:09:58
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- Influenza alert in three years
- by Chon, Seung-Hyun Sep 20, 2022 05:57am
- The influenza (flu) alert, which disappeared after the spread of COVID-19, was issued. September 12 years after 2010, influenza alert has come. The pharmaceutical industry is Corona 19 that virtually died out after the spread of flu drug market to expect a revival of the atmosphere. According to the industry on the 19th, the Korea Centers for Disease Control and Prevention issued a flu epidemic warning nationwide on the 16th. The Korea Centers for Disease Control and Prevention issued a flu pandemic warning nationwide between September 4 and September 10 this year, with 5.1 suspected flu patients per 1,000 outpatients exceeding the epidemic standard (4.9). The number of suspected cases per 1,000 for the past 23 weeks, outpatient clinics, flu, the highest this year. 4.8 members leapt over the last 12 weeks. In previous years, the flu epidemic standard was set at 5.8 per 1,000 outpatients, but this year, COVID-19 and the flu are likely to spread at the same time. It is the first time in two years and six months that the number of suspected flu patients per 1,000 outpatients has exceeded five since the ninth week of 2020. It has never exceeded five since it recorded 6.3 in the ninth week of the first week of March 2020. This means that the flu has never been prevalent for more than two years. This is the aftermath of a significant decrease in the incidence of infectious diseases due to strengthening personal hygiene management such as hand washing and wearing masks after the spread of COVID-19. As social distancing was lifted this year, the number of flu patients gradually increased. In the last 24 weeks, the number of suspected flu patients per 1,000 outpatients was only 1.8 but tripled in three months. The pharmaceutical industry is expecting a rebound in flu treatments that have virtually disappeared since the spread of COVID-19. According to UBIST, a drug research institute, the amount of outpatient prescriptions for flu treatments in 2019 recorded 22.5 billion won. However, it fell to 8.8 billion won in 2020, and only reached 40 million won last year. In the past two years, the size of the flu treatment market has decreased by 99.8%. It was reduced by 99.9% in three years from 44.7 billion won in 2018. The flu treatment market recorded 8.4 billion won in the first quarter of 2020, but plunged 99.8% to around 10 million won in the second quarter when COVID-19 began to spread in earnest. The flu treatment market recorded less than 100 million won for nine consecutive quarters from the second quarter of 2020. In the first half of this year, the prescription for flu treatment was less than 100 million won. After the spread of COVID-19, the flu treatment market virtually disappeared as the number of flu patients decreased sharply due to strengthening personal hygiene management such as washing hands and wearing masks. The Oseltamivir market, which is most commonly used as a flu treatment, has virtually disappeared. Oseltamivir is the active ingredient of Tamiflu. In the first half of this year, Oseltamivir's out patient prescription market was only 92 million won. It was only 60 million won in the first quarter and 32 million won in the second quarter. The size of Oseltamivir prescription in 2019 recorded 22.4 billion won, falling to 8.7 billion won in 2020 and shrinking to 40 million won last year. Pharmaceutical companies expect the flu treatment market to rebound as the number of flu patients increases. An industry official said, "We will consider whether to expand the production and supply of treatments while looking at the trend of expanding flu patients in the future."
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- Patent term extensions for advanced biologicals under review
- by Kim, Jin-Gu Sep 20, 2022 05:56am
- The Korean Intellectual Property Office (KIPO) is pursuing a plan to apply the patent term extension system to advanced biological products that were left unattended within the system through law amendments. According to the pharmaceutical and biopharmaceutical industry on the 19th, KIPO prepared a systemic reform plan that contained the amendments above and is collecting industry opinion. Under the current Patent Act, the subjects eligible for the patent term extensions are stipulated in Article 7 of the Enforcement Decree of the Patent Act. However, the application of the regulation is limited to ‘drugs’ that are allowed marketing authorization under the Pharmaceutical Act or to ‘psychotropic substances’ under the Narcotics Control Act. When the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals was separately enforced from the Pharmaceutical Affairs Act, it resulted in advanced biopharmaceuticals such as the latest gene and cell therapies being omitted from the extension list. In fact, Novartis had applied for two patent term extensions for Kymriah, which was approved as an advanced biopharmaceutical product, but its patent term extension is not being recognized due to the continued incomplete legislation. Industry concerns are rising over the confusion that would increase in the scene with more than 20 advanced biopharmaceuticals from pharmaceutical companies in Korea and abroad being approved one after another since Kymriah, including Novartis’s Zolgensma and Luxturna. To address this, KIPO is reviewing a plan to add ‘Advanced biopharmaceuticals approved under the Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ to subjects eligible for patent term extensions in Article 7 of the Enforcement Decree of the Patent Act This reform plan is expected to be discussed with the other reforms being prepared by KIPO, including ▲adjusting the number of patent rights that can be extended per item ▲introducing an upper limit on the duration of valid patent rights and ▲ introducing remedies after extension rejection decisions. However, unlike other reform plans, including advanced biopharmaceuticals in the patent term extension regulation, is expected to proceed more smoothly, as the position between the original and generic companies is not that different.
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- 41 were vaccinated in 11 days with K-COVID-19 vaccines
- by Sep 19, 2022 05:57am
- SK Bioscience’s COVID-19 vaccine is being released To address the low vaccination rate for Korea’s first homegrown COVID-19 vaccine, SKYCovione, the government has greatly expanded the eligibility for the vaccine. With the expansion, whether allowing the use of domestic vaccines to those who received their 1st to 3rd vaccinations will increase utilization of homegrown vaccines is gaining attention. However, the release of the Omicron-specific vaccine in Kores that is scheduled for next month is expected to act as a variable. During the opening remarks made by the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters, Ki-Il Lee (2nd Vice Minister of Health and Welfare), during the CDSCH meeting held on the morning of the 16th, Lee said, “The CDSCH will expand the scope of vaccine eligibility for SKYCovione from the primary (1st and 2nd) vaccination to 3rd and 4th booster shots.” With the decision, people may reserve their 3rd and 4th vaccinations with SKYCovione through http://ncvr.kdca.go.kr or the call center, or receive same-day vaccinations at public health centers or some assigned medical institutions. The government explained that SKYCovione can be used as booster shots as its safety and efficacy of the SKYCovione have been demonstrated. Clinical trials for SKYCovione booster vaccinations, an investigator clinical trial led by KDCA, are currently in progress, and its results have not yet been released. According to the interim results of the trial, SKYCovione induced neutralizing antibody responses an average of 11 times higher in the original COVID-19 virus (Wuhan strain), 51.9 times higher for Omicron BA.1, and 28.2 times higher for Omicron BA.5 after vaccination with SKYCovione in 5 treatment groups. After the CDSCH meeting, Young-rae Sohn, Head of the Social Strategy Unit of the Central Disaster Management Headquarters, explained, “We first recommend mRNA vaccines for those who are receiving booster shots, however, those who do not wish to further receive vaccinations with mRNA vaccines for various reasons, such as discomfort after receiving primary and secondary vaccinations with mRNA vaccines, may receive additional vaccinations with SKYCovione.” In other words, Pfizer and Moderna’s mRNA vaccines are first recommended as boosters until formal approvals are granted to SKYCovione in that indication, but those aged 18 years or older who cannot or do not want to receive mRNA vaccines can receive SKYCovione as boosters. Such a decision has been deemed to be made despite the non-availability of clinical trial results for the indication as a preemptive measure to increase the utility of domestic vaccines. Although vaccinations started for SKYCovione on the 5th, the rate has been very low. According to the KDCA, the cumulative number of people that received vaccination with SKYCovione as of midnight on the 16th was 41 (1st vaccination), a mere 5.8 persons per day. This is less than 0.1% of the initial lot of 609,000 SKYCovione vaccines of the 10,000,000 vaccines purchased in advance by the government. This is because 97% of those eligible for primary vaccinations with SKYCovione have already received vaccinations. On the other hand, as the vaccination rate dropped greatly to reach 75.1%, for the 3rd vaccination and 16.5% for the 4th vaccination, allowing the use of SKYCovione as such booster shots are expected to greatly increase the use of SKYCovione. However, one variable that lies in its use is that foreign vaccines targeting the Omicron variant have already arrived in Korea and will begin vaccinations next month. On the 15th, 805,000 doses of the bivalent vaccine by Moderna that targets both the original strain (Wuhan strain) and the BA.1 subvariant arrived in Korea. 806,000 courses of the bivalent vaccine additionally arrived on the 17th. Pfizer’s bivalent vaccine is also being reviewed. The KDCA has recommended the new bivalent vaccine as a priority for high-risk groups, such as those aged 60 years or older, those hospitalized or serving in long-term care facilities, and those who are immunocompromised, and as a second priority for people in their 50s, those with underlying diseases, and healthcare workers. In addition, group facility officials and adults aged 18 to 49 are also allowed to receive vaccinations but were excluded from subject recommendations. Therefore, it is expected that demand for the Omicron-targeting vaccines will become higher than that for SKYCovione in October. The demand for SKYCovione may increase in groups who are not subject to the recommendations made for the bivalent vaccines, but whether this alone will increase the vaccination rate for SKYCovione remains in question, as the overall will to receive vaccinations in itself had dampened greatly. According to the ‘COVID-19 vaccine awareness survey’ published by Byung Chul Chun’s team of the Department of Preventive Medicine and Vaccine Innovation Center at Korea University College of Medicine, less than half –45.7%-- of the 1,500 adult survey respondents over the age of 19 responded that they are willing to receive COVID-19 vaccinations this winter. 30.5% responded that they have no will to receive COVID-19 vaccinations at all. In other words, 3 of 10 respondents said they would not receive vaccinations. Furthermore, with Moderna and Pfizer hastening the introduction of their bivalent vaccines that target Omicron subvariants (BA.4/5), their gap with domestic vaccines is expected to widen further. The authorities are discussing the possibility of receiving marketing authorization for its Omicron subvariant-targeting bivalent vaccines that were approved by the US on the 31st of last month.
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- Breast cancer drug Nerlynx can be prescribed
- by Eo, Yun-Ho Sep 19, 2022 05:56am
- Breast cancer drug Nerlynx can be prescribed in general hospitals. According to related industries, the oral tyrosine kinase inhibitor Nerlynx, which inhibits Bixink Therapy's HER2 protein, passed the Drug Committee (DC) of the Big 5 Advanced General Hospital, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. However, as it is still a non-reimbursed drug, it is expected to take some time until the prescription is reimbursed. This drug was submitted to the Health Insurance Review and Assessment Service in February, but it was judged that the benefit standard was not set. Bixink Therapetics plans to submit it again in the second half of this year. HER2-positive early breast cancer has a 1.89 times higher tendency of brain metastasis than HER2-negative breast cancer. The high incidence of brain metastasis is interpreted to mean that it directly affects the survival rate. When comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with cerebral metastasis is only 10.7%, which is a significant difference compared to the 34% of patients with metastatic breast cancer. Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed. However, in the case of current standard therapy treatments, drugs that prevent brain metastasis or prove treatment effects are still insufficient. In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in HER2-positive early breast cancer women by 42% and reduced the risk of developing or dying of brain metastasis by more than 59%. Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S. FDA as an extended adjuvant therapy for early HER2 positive breast cancer patients in July 2017. In February 2020, the indication for the treatment of metastatic HER2 positive breast cancer was expanded. Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension adjuvant therapy for early breast cancer patients who are HER2 positive and hormone receptor positive within one year of the completion of Herceptin-based treatment after surgery."
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- Companies are ending a series of phase 3 of core R&D
- by Lee, Seok-Jun Sep 15, 2022 05:55am
- Samchundang ends phase 3 of Eylea biosimilar. Top line of Ildong's Zochova will be unveiled around November. Pharmaceutical companies' core R&D phase 3 is ending one after another. Corporate value is expected to change depending on the results. Some companies are seeking foreign permission using phase 3 data. DAE HWA recently completed an application for permission for Liporaxel, a gastric cancer drug containing Paclitaxel. The application for permission is based on Liporaxel efficacy and safety data. The clinical trial compared the efficacy and safety of Liporaxel and Paclitaxel injections Taxol as a secondary treatment for patients with advanced gastric cancer. Liporaxel, which was licensed in Korea in 2016, is the world's first PO Paclitaxel. Currently, Paclitaxel is being used as a single drug recommended by CSCO in China for secondary treatment of advanced gastric cancer. Samchundang also recently ended phase 3 of the Eylea biosimilar (SCD411). Phase 3 of SCD411 was conducted on 576 patients with macular degeneration in 15 countries, including the United States and Japan, starting with the first patient administration in September 2020. Comparative studies such as effectiveness and safety between SCD411 and Eylea were conducted. Samchundang expects to receive the final phase 3 clinical report of SCD411 in January 2024. The company is also pushing for partner contracts along with producing phase 3 results. Negotiating partners conducted a final due diligence in July this year to evaluate the production and quality management eligibility of SCD411. At the end of August, Ildong completed a phase 2/3 in Korea of Zochova (S-217622), a candidate for oral COVID-19 treatment. Topline results are expected to be produced around November. Ildong is co-developing Zochova with Shionogi, Japan. Ildong has been conducting phase 2b and phase 3 of Zochova for patients infected with mild, moderate, and asymptomatic COVID-19 in Korea. The size is 204. CTC Bio ended the administration of CDFR0812 phase 3 clinical trial patients at the end of April. Phase 3 of CDFR0812, which has been held since 2019, was conducted with 795 people. It is currently under statistical analysis and the results are expected to be released within this year. The substance is non-reimbursed and can be released immediately upon approval by the Ministry of Food and Drug Safety. CTC Bio has signed a business partnership with Dongkoo Pharmaceutical Co. for CDFR0812. Dongkoo owns about 5% of CTC Bio. A market official said, "As phase 3 of core R&D materials of pharmaceutical companies are terminated one after another, results are expected to be drawn soon. "Company value will fluctuate depending on when and when the data results are released," he analyzed.
- Company
- NSCLC drug Rybrevant can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 15, 2022 05:55am
- Janssen’s new lung cancer drug Rybrevant can now be prescribed at general hospitals in Korea. According to industry sources, the anticancer drug Rybrevant (amivantamab), which is used to treat EGFR exon 20 insertion non-small-cell lung cancer (NSCLC) that is insensitive to currently available EGFR tyrosine kinase inhibitors (TKIs), has passed the review of drug committees tertiary hospitals in Korea including the Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other institutions nationwide, such as Konyang University Hospital, Kyungpook National University Hospital, Seoul National University Bundang Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. However, Rybrevant’s still non-reimbursed in Korea. Janssen Korea applied for reimbursement but was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. The company is known to be preparing to reapply for reimbursement. EGFR exon 20 insertion mutation in NSCLC is so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to expenditure cuts. Although lung cancer in itself is not rare, NSCLC with EGFR exon 20 insertion mutation can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. Rybrevant, which is well known for its use in combination with ‘lasertinib (Leclaza),’ was the first targeted therapy approved in Korea for the treatment of NSCLC with EGFR exon 20 insertion mutations in February this year. The approval for the drug was based on the results from the CHRYSALIS study, where the drug demonstrated an overall response rate (ORR) of 40% and a 4% complete response (CR), 36% partial response (PR) rate in with Rybrevant use as monotherapy. The US Food and Drug Administration (FDA) granted accelerated approval based on Phase I trial results in recognition of its value as a treatment for a rare type of cancer. Following approval in the US, the drug also was designated for expedited review and approved in Korea as well. However, the issue lies in whether its value will be accepted during reimbursement review. As the drug was approved based on data from a single-arm clinical trial without a control group, Rybrevant needs to take the pharmacoeconomic evaluation exemption track for reimbursement. Therefore, the key is whether Rybrevant’s value as a treatment for rare cancer, not just lung cancer, will be acknowledged during the reimbursement review. Byoung-Chul Cho, Chief of the Lung Cancer Center at Yonsei Cancer Center, said “EGFR exon 20 insertion presents in various subtypes, and the sub-analysis of the CHRYSALIS study showed that Rybrevant showed an even response rate across rate in several subtypes. In addition to its target inhibition effect, Rybrevant shows more promise due to its immune cell-directing activity.”
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- JW Pharm sells ₩10 bil with Actemra in 1H 2022
- by Chon, Seung-Hyun Sep 15, 2022 05:55am
- Actemra, JW Pharmaceutical’s rheumatoid arthritis treatment, rose and settled as the company’s flagship product, exceeding KRW 10 billion in sales in 1H this year. The product's increase in sales was fueled by the increase in its prescription as a rheumatoid arthritis treatment and its increased use as a COVID-19 treatment. According to the market research institution IQVIA on the 14th, Actemra recorded KRW 11.4 billion in sales 1H this year, a 39.7% YoY increase from the same period last year. The drug had raised KRW 6.2 billion in Q1 this year, which was a 59.9% YoY increase from the previous quarter, and then raised KRW 5.2 billion in Q2, marking a 21.2% increase. Although its growth slowed down in Q2 compared to Q1, the product still continued on its high growth. Quarterly sales of Actemra (Unit: KRW 1 million, Source: IQVIA) Actemra was approved in Korea in 2012 as a treatment for rheumatoid arthritis and other autoimmune diseases. The drug inhibits the binding of ‘Interleukin-6,’ the protein that causes inflammation in the body, and its receptor, in the body. JW Pharmaceutical introduced this new biologic drug after entering into a license agreement with Chugai Pharmaceutical, a subsidiary of Roche, for the co-development and exclusive marketing right of Actemra in Korea. The new drug candidate was developed by Chugai Pharmaceutical, based on which JW Pharmaceutical conducted clinical trials at major large hospitals in Korea including the Seoul National University Hospital, and received domestic approval. It is indicated for the treatment of adult patients with rheumatoid arthritis and children with juvenile idiopathic arthritis. Actemra did not exert much presence in the early stages of its release. The drug exceeded KRW 10 billion in annual sales for the first time in 2018. Actemra’s sales rose steeply since last year. After recording KRW 3.8 billion in sales in Q4 2020, it broke its own sales record for 5 consecutive quarters until Q1 this year. It is evaluated that the reliability of Actemra in the field has risen with its accumulated prescription experience in rheumatoid arthritis. Actemra has also attracted further attention as it had shown excellent therapeutic effects in patients who do not respond to TNF-alpha inhibitors like Humira, Seretide, and Enbrel. Recently, its sales growth has increased further with its rising demand for COVID-19 treatment purposes. Since last year, Actemra has been used off-label in more than 60 hospitals nationwide for the treatment of severely ill patients with COVID-19. Off-label use refers to the use of existing drugs on the market for purposes other than what it was approved to treat after receiving approval from each institution’s institutional review board (IRB). Demand for Actemra increased significantly in the domestic field after the U.S. Food and Drug Administration (FDA) and the European Commission (EC) authorized emergency use of Actemra as a treatment for severely ill patients in need of artificial respiration due to COVID-19 infection in June and December last year, respectively. The demand for Actemra, therefore, had surged last year to cause a shortage in its supply one time. Actemra’s scope of reimbursement was extended to COVID-19 treatment in March this year. The Ministry of Food and Drug Safety granted emergency approval for Actemra in March for use in severely ill COVID-19 patients over the age of 2. Actemra's high growth has led to improved company performance. JW Pharmaceutical’s operating profit rose 173.7% YoY to record KRW 10.3 billion in Q2, and sales rose 12.4% to record KRW 163 billion.
- Company
- The NHIS signed a MOU with Viatris to manage chronic dz
- by Eo, Yun-Ho Sep 15, 2022 05:55am
- Viatris is working with the NHIS to improve the chronic disease management environment. The NIHS and Viatris signed a MOU at the headquarters of the Wonju Industrial Complex in Gangwon-do on the 1st to utilize educational materials for patients with chronic medical care. Through this business agreement, the two institutions said they will contribute to efficient disease management by diversifying the contents to be used for patient education and counseling in the pilot project for chronic disease management in primary care. Viatris will establish mutual cooperation to improve the quality of patient education materials by providing chronic disease education contents for public interest purposes and proposing the use and improvement of educational contents provided by Viatris. The primary medical chronic disease management pilot project is a project to provide continuous health care services by conducting a comprehensive evaluation of hypertension and diabetes patients at local clinics and establishing individual management plans from January 2019. Viatris, which signed an agreement with the corporation, is a Korean subsidiary of Viatris, a global healthcare company launched in November 2020 by Upjohn, which was Pfizer's business division, combined with Mylan. Park Ji-young, head of NHIS' chronic disease management office, explained, "We expect that doctors and patients' educational satisfaction will increase by utilizing high-quality educational materials provided by Viatris in clinics participating in the project." Kwon Yong-cheol, executive director of the Viatris Department of Medicine, said, "We are happy to contribute to the primary medical chronic disease management project. Viatris will continue to strive to fulfill its social responsibilities as a global healthcare company to improve treatment access and provide information for patients and medical staff based on experience accumulated in chronic diseases such as high blood pressure, diabetes, and dyslipidemia, he said.
- Company
- Complicated patent extension period than foreign countries
- by Kim, Jin-Gu Sep 14, 2022 05:50am
- The current system is advantageous for multinational companies, and many domestic companies welcome reorganization. The system for extending the duration of drug patents is expected to be reorganized. The Korean Intellectual Property Office established a related TF and prepared an improvement plan, and recently inquired about opinions in the pharmaceutical bio industry. The direction of improvement of the system, which has sharp interests between the original and generic companies, is largely in international harmony with the United States and Europe. ◆Xeljanz patent period, 27 years in Korea, 25 years in the U.S. and Europe...From institutional differences The Korean Intellectual Property Office has come up with a total of four improvement plans, and as one of them, it is known that it is considering allowing it to extend only one of the several patents registered in one drug, such as the U.S. and Europe. According to the pharmaceutical bio industry on the 14th, Pfizer's rheumatoid arthritis treatment Xeljanz has a patent duration of 25 years in the United States. This is the result of an extension of five years, which was delayed by clinical trials or permission and examination by regulatory agencies, for 20 years of the typical patent period. In the case of Europe, a 25-year patent period is guaranteed. Xeljanz has a patent duration of 27 years in Korea. This is because the basic patent period is 20 years, but the extended patent duration is different. The reason why the extended patent duration of the U.S., Europe, and Korea is different despite the same drug and the same patent is due to differences in institutions between countries. The original company registers as many patents as possible when it develops a single drug. About 10 patents are also attached to one drug, including material patents, usage patents, usage and capacity patents, formulation patents, and crystalline patents. This is because the more patents there are, the more advantageous it is to defend the challenges of generic companies. In the United States and Europe, only one of the several patents registered in one drug item is selected and extended. In fact, Pfizer applied for an extension of the duration (up to five years) for two material patents and one legal patent in Korea, respectively. In the process of recognizing the extension of the duration of the three patents, overlapping occurred between each period. As a result, the patent period for Xeljanz in Korea was set to be about two years (732 days) longer than that of the United States and Europe. ◆Each of several patents can be extended…Original company patent period is 1~2 years longer Each company is very active in extending the duration of patent rights in Korea because the longer the patent period is, the more advantageous it is to the original company. A total of 24 new drugs were newly licensed in Korea last year. As in the case of Xeljanz, two to three patents were registered per item, and the entire patent period was extended by applying for an extension of the duration of each patent. The problem is that while registration is easy in the case of the duration of the drug patent, it is very difficult to overcome the generic. According to the Korean Intellectual Property Office, from 1999 to last year, when the patent extension system was implemented, the number of applications for the extension of the patent period by original companies totaled 750. Among them, a total of 612 cases were registered, 65 were rejected, and 22 were returned or withdrawn. The remaining 48 cases are under review as of the end of last year. It means that if the original company applies for the extension of the patent period, 9 out of 10 cases will succeed. The results of generic to the extended patent duration are pessimistic. There have been challenges over the duration of patents extended from 2015 to last year, but they have not been completely overcome once. ◆ Domestic pharmaceutical company 'yes' vs multinational pharmaceutical company 'no'…Delivering Opinions to the Korean Intellectual Property Office Multinational pharmaceutical companies are opposed to the reorganization plan, given that the current system is favorable to the original company. In fact, it is known that the KRPIA conveyed its opposition to the Korean Intellectual Property Office. A local pharmaceutical company official said, is "patent an extended duration that it is impossible to overcome the Patent and Trademark Office in the direction is welcome and reform the system." and "A release of significant impact on NHS finances in the process of the delay." Another pharmaceutical industry official said, "The current patent extension system is quite similar to Japan's system." "As the global pharmaceutical bio-industry environment has changed, it seems meaningful to reorganize Korea's system in the U.S. and European ways," he said.
- Company
- Novartis Korea to close down Respiratory BU next month
- by Sep 14, 2022 05:50am
- Novartis Korea is expected to close down its Respiratory Business Unit and dispose of related products from October this year. According to industry sources on the 14th, Novartis Korea’s Respiratory Business Unit will be officially closed down next month as part of the company’s large-scale reorganization in progress at the global level. Currently, Novartis Korea is operated in two business units - Pharmaceuticals BU and Oncology BU. The Pharmaceuticals BU consists of Cardiovascular & Metabolic Diseases; Autoimmunity, Transplantation & Inflammatory Diseases; Skin Diseases. The global reorganization is being made to first integrate the Pharmaceuticals and Oncology Business Units and then divide them into an Innovative Medicines (IM) Division and an off-patent drug division. Specifically, as of October this year, Novartis Korea will be reorganized into 5 Business Units, ▲Hematology, ▲Solid Tumor, ▲CV & GTX, ▲Immunology, and ▲ In-Market & Business Innovation. The unit that had been in charge of respiratory diseases has been removed in the process. Novartis’s respiratory pipeline consists of ‘Enerzair (indacaterol/glycopyrronium/mometasone),’ a three-drug combination drug for asthma, and ‘Atectura (indacaterol acetate/mometasone),’ a once-daily fixed-dose combination drug. Both drugs are fairly new in the market, being approved in December 2020 and granted reimbursement in September last year. However, sales of the two drugs have been low, making around KRW 800 million in 1H this year. The company is speculated to have made this decision after judging that the growth potential of its respiratory treatments is low. Xolair, Novartis Korea’s highest-grossing asthma treatment, was allocated to the Immunology BU due to its mechanism of action and excluded from the restructuring process. When a dedicated unit is shut down, products in its care may be transferred outside. However, due to the small sales volume of the relevant products, their effect on the company's aggregate sales is expected to be negligible even with such a transfer. Employees in the Respiratory BU will also be reassigned. According to a Novartis Korea employee, the Respiratory Unit has around 10 people, including those in charge of marketing and sales. With the shutdown of the Respiratory BU, about 30% of them are known to have applied for voluntary retirement (ERP) that is being offered by the company. Novartis Korea said, “We are in the process of reorganizing our business units to focus on our core therapeutic areas in line with the strategic direction taken by our headquarters. Employees in our Respiratory BU that apply for voluntary retirement will go through relevant procedures, and those who do not will be reassigned to other departments according to their wishes and business needs.”
