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- 2025-12-23 03:28:27
- Company
- Lipitor’s sales stay strong for good reason
- by Son, Hyung-Min Apr 25, 2024 05:50am
- Bill Schuster, Country Manager of Viatris Korea The dyslipidemia treatment Lipitor has been able to remain the No. 1 selling drug for 20 years, supported by various clinical evidence. Lipitor has proven its efficacy in patients with dyslipidemia not only globally but also domestically. Based on various clinical evidence, major domestic and international societies still recommend statins as the preferred treatment for dyslipidemia. On April 24, Viatris Korea held a press conference at the Westin Josun Hotel in Seoul to celebrate the 25th anniversary of Lipitor's launch in Korea. Lipitor is the first atorvastatin-based dyslipidemia treatment that had been developed by Warner-Lambert (now Pfizer). Lipitor was approved by the U.S. Food and Drug Administration (FDA) in 1997 and launched in Korea in 1999. Lipitor works by competitively inhibiting the reductive component of HMG-CoA, a precursor for cholesterol synthesis, and hence disrupt the synthesis of cholesterol in the body. Although many dyslipidemia drugs have then entered the market, Lipitor has been the number one selling drug ever since its launch. According to market research firm IQVIA, Lipitor has been on a roll since 2013, surpassing KRW 100 billion in sales. Last year, Lipitor's sales reached KRW 195.7 billion. Among the many dyslipidemia drugs, Lipitor's success has been driven by the company's efforts to secure a wide range of clinical evidence. In addition to the benefits confirmed in global studies, Viatris (then Pfizer) also conducted clinical trials in domestic patients. In the AT-GOAL and AMADEUS trials, Lipitor was found to lower LDL-cholesterol and reduce the risk of cardiovascular disease in Korean patients. In the AT-GOAL trial, 425 Korean patients with dyslipidemia were followed for 8 weeks after being prescribed personalized dosages based on LDL-cholesterol levels and cardiovascular events, and risk group. Results showed that more than 80% of the patients reached their individualized LDL-cholesterol treatment goals within 4 weeks of taking Lipitor. In the AMADEUS trial, 440 patients with type 2 diabetes received tailored doses of Lipitor according to their LDL-C levels, a major cardiovascular risk factor. In the trial, more than 90% of patients reached target LDL-cholesterol levels after eight weeks of Lipitor treatment. In addition, Viatris launched a high-dose version of Lipitor (80 mg) and Lipitor Plus (atorvastatin-ezetimibe) to improve patient convenience. One of the biggest advantages of Lipitor is that it is the only statin that has a secondary cardiovascular prevention indication. Lipitor offers the benefit of reducing patients' risk for secondary prevention of coronary heart disease, including hospitalization for nonfatal myocardial infarction, revascularization, stroke, angina, and congestive heart failure. In addition, Lipitor can be used in adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease. Based on such clinical evidence, Korean and international societies such as the American Diabetes Association, the European Society of Cardiology, and the Korean coronary artery disease societies recommend statins as first-line agents with strong clinical evidence. Dr. Sripal Bangalore, Professor of Medicine at New York University School of Medicine, said, “Lipitor's cardiovascular safety has been established in several pivotal clinical studies over the past 25 years. There is still a great deal of use for Lipitor, not only for LDL-cholesterol reduction but also for the prevention of several cardiovascular diseases.” Hyun-Jung Lim, Head of Marketing at Viatris Korea, said, “We have improved patient convenience by launching not only Lipitor but also high-dose Lipitor and Lipitor Plus. We are planning various programs for dyslipidemia patients in Korea, and look forward to your continued interest."
- Company
- Possible reimb expansion for 2nd-gen BTK inhibitor Brukinsa
- by Eo, Yun-Ho Apr 25, 2024 05:50am
- BeiGene Korea The pharmaceutical industry is focusing on whether the second-generation BTK inhibitor 'Brukinsa' will overcome the last stage and acquire insurance reimbursement expansion. According to industry experts, BeiGene Korea is in negotiations with the National Health Insurance Service (NHIS) seeking approval for Brukinsa (zanubrutinib) in mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL) indications. If there are no expected delays in the negotiations, Brukinsa is set to be expanded for reimbursement in the first half of the year. The following indications for Brukinsa are included for expanding reimbursement: monotherapy treatment of adult patients with MCL who have received one or more prior therapy, monotherapy treatment of adult patients with CLL or SLL who have received one or more prior therapy, and treatment of patients with CLL or SLL who are either 65 years of age, or older or 65 years of age or younger with accompanying diseases and no prior therapy. Last May, Brukinsa was listed as a monotherapy drug for the treatment of adult patients with Waldenstrom macroglobulinemia (WM) who have had one or more prior therapy. Previously, BeiGene attempted to have Brukinsa listed for MCL, CLL, and CLL indications. However, the application was not approved by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA). On their third attempt, the company progressed to the negotiation stage for drug pricing. Accordingly, the Korea Alliance of Patient Organization demanded an expansion of reimbursement for MCL and CLL indications for Brukinsa in a statement issued last year. Meanwhile, Brukinsa is a targeted anticancer agent that inhibits the survival and proliferation of malignant B cells by blocking Bruton's tyrosine kinase (BTK) protein, a signaling molecule that affects the survival and development of B cells. BTK inhibitors approved in South Korea are Janssen Korea’s 'Imbruvica (ibrutinib),' AstraZeneca Korea’s ' Calquence,' and Ono-Pharma Korea’s 'Velexbru (Tirabrutinib Hydrochloride).'
- Company
- 19 K-biosimilar products sold in 11 markets after 12 yrs
- by Chon, Seung-Hyun Apr 25, 2024 05:49am
- Domestic pharmaceutical and biotech companies have succeeded in commercializing biosimilars in 11 areas. In the 12 years since Celltrion's Remsima was introduced, 19 biosimilars have received domestic approval. Among the companies, Samsung Bioepis has entered 9 markets, the most among Korean companies. According to the Ministry of Food and Drug Safety, Samsung Bioepis received approval for Stelara’s biosimilar Epyztek on November 11. This is the first time Samsung Bioepis has received approval for a Stelara biosimilar in Korea. Stelara, which was developed by Janssen, inhibits the activity of interleukin (IL)-12/23, a type of inflammatory cytokine related to autoimmune diseases, and is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Annual global sales of the drug amount to approximately KRW 14 trillion. Samsung Bioepis has successfully commercialized the first biosimilars in Korea in 3 areas this year. In January, Samsung Bioepis obtained marketing authorization from the MFDS for Episcli, a Soliris biosimilar. Soliris is a treatment for rare diseases such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome developed by Alexion, with global sales of approximately KRW 5 trillion. Also, the company obtained marketing authorization for Eylea biosimilar Afilivu in February. Eylea, which was developed by U.S.-based Regeneron, has indications for wet (neovascular) age-related macular degeneration. Macular degeneration is an ocular disease caused by aging and inflammation of the retinal macula, the nerve tissue in the center of the retina of the eye. In severe cases, it can cause blindness. With Samsung Bioepis succeeding in commercializing the first biosimilars in three markets in Korea this year, domestic pharmaceutical and biotech companies have now received approval for biosimilars in a total of 11 areas. Domestic companies first tapped into the biosimilar market in 2012 when Celltrion was granted approval for Remsima. Remsima is a biosimilar product of Remicade, an autoimmune disease treatment. Samsung Bioepis received MFDS approval for Remicade biosimilar Remaloce in 2015. Korean pharma and biotech companies have been receiving approval for their biosimilar products in the Enbrel, Humira, Herceptin, Mabthera, Avastin, Lucentis, and Nesp markets. In 2015, Samsung Bioepis received approval for its first biosimilar of Enbrel, Etoloce. In the Enbrel market, LG Chem received approval for the second Enbrel biosimilar, Eucept in 2018. Celltrion commercialized its second biosimilar, Herzuma, in 2014. Herzuma is a Herceptin. Herzuma was the first biosimilar of an anticancer drug that was released by a Korean company. Samsung Bioepis entered the Herzuma market second in 2017 with the approval of its Samfenet. In 2015, Celltrion received domestic approval for Truxima, a biosimilar of the anticancer drug Mabthera. A total of 3 domestically developed biosimilars have been approved in the autoimmune treatment Humira market. In July 2020, Samsung Bioepis received approval for Adalloce, the first Humira biosimilar, and Celltrion received approval for Yuflyma in June 2021. LG Chem received approval for Xelenka in December of last year, which became the third new entrant into the Humira market. Samsung Bioepis successfully commercialized its first biosimilar, Onbevzi, of the cancer drug Avastin in March 2021. Avastin is an anticancer drug indicated for the treatment of metastatic colorectal and metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. In September 2022, Celltrion received domestic approval for the second Avastin biosimilar, Vegzelma. In 2022, 2 Lucentis biosimilars entered the domestic approval stage. Lucentis is used to treat eye diseases such as macular degeneration and diabetic macular edema. In May 2022, Samsung Bioepis received domestic approval for Amelivu, a biosimilar of Lucentis. In October of the same year, Chong Kun Dang obtained a domestic license for Lucentis biosimilar LucenBS. In 2018, Chong Kun Dang’s biosimilar Nesbell, a biosimilar of the anemia drug Nesp, reached the commercialization stage. In total, 19 biosimilars from Korean companies have been approved as of now. By company, Samsung Bioepis had the most biosimilars with 9, and Celltrion entered 6 markets. LG Chem and Chong Kun Dang each released 2 biosimilars.
- Company
- Samsung Bioepis’ Stelara biosimilar is approved in Europe
- by Chon, Seung-Hyun Apr 24, 2024 05:44am
- Samsung Bioepis Samsung Bioepis announced on the 23rd that the European Commission (EC) granted marketing authorization for its Stelara biosimilar Pyzchiva. The final marketing authorization comes 2 months after Pyzchiva received a positive opinion for marketing authorization from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) in February. Pyzchiva’s original drug Stelara, which was developed by Janssen, is an autoimmune disease treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It inhibits the activity of interleukin (IL)-12,23, a class of proinflammatory cytokines involved in the adaptive immune response. It posts annual global sales of approximately KRW 14 trillion. The company explained, “EC’s approval of Pyzchiva further extends our portfolio for autoimmune diseases by including an interleukin inhibitor to our existing 3 tumor necrosis factor-alpha (TNF-α) inhibitors - Benepali, Flixabi, and Imraldi.” Samsung Bioepis has currently 7 biosimilar products commercialized in the European market. The company has 7 biosimilar products in the European market. Samsung Bioepis currently sells biosimilars of Enbrel, Remicade, Humira, Herceptin, Avastin, Lucentis, and Soliris in the European market.” Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, said, "We are pleased to be able to receive European approval for our interleukin inhibitor Pyzchiva. We will continue to secure various autoimmune disease treatments and develop new drugs to provide patients with more treatment options."
- Company
- Prostate cancer drug Pluvicto’s approval imminent in Korea
- by Eo, Yun-Ho Apr 24, 2024 05:44am
- The new metastatic castration-resistant prostate cancer drug ‘Pluvicto’ is set to soon be commercialized in Korea. According to industry sources, the Ministry of Food and Drug Safety is in the final stages of reviewing Novartis Korea's targeted radioligand therapy ‘Pluvicto (lutetium (177Lu) vipivotide tetraxetan)’ for its marketing authorization. Its formal approval is expected in the first half of the year. In June 2023, Pluvicto was recognized by the MFDS for its innovation and designated the drug as the 6th drug in the Global Innovative products on Fast Track (GIFT) program. In addition, Novartis has also applied to participate in the pilot approval-evaluation-negotiation linkage system with Pluvicto, which is expected to accelerate insurance reimbursement discussions after approval. Pluvicto is a radioligand therapy indicated for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. It is regarded as a next-generation breakthrough therapy that delivers therapeutic radioisotopes to prostate cancer cells through the binding of radioisotopes (177Lu) and PSMA, triggering cancer death. The drug has been recognized for its innovation overseas as well, being designated as a Breakthrough Therapy and granted priority review, and quickly received FDA approval (March 2022). Meanwhile, Pluvicto’s efficacy has been demonstrated in the Phase III VISION study. In the Phase III VISION study, Pluvicto met both primary endpoints of OS and rPFS, reducing the risk of death by 38% and the risk of radiographic progression or death (rPFS) by 60% compared to standard of care monotherapy. In addition, approximately one-third (30%) of patients with evaluable disease at baseline demonstrated an objective response with Pluvicto+best standard of care (BSoC), compared to the 2% in the BSoC monotherapy arm
- Company
- Pharmbio wins over Novartis’ Revolade in patent dispute
- by Kim, Jin-Gu Apr 23, 2024 05:37am
- Pharmbio Korea has won the first trial in a patent dispute over Novartis' 'Revolade.' Pharmbio Korea has won the first trial in a patent dispute against 'Revolade (eltrombopag olamine),' a treatment for primary immune thrombocytopenia (ITP), following SK Plasma. Pharmbio Korea received a generic biological license application (BLA) prior to winning the first trial, but the company may face a high risk in launching the product. It is highly possible that the patent holder, Novartis, will appeal to the verdict. According to industry sources on the 22nd, the Intellectual Property Trial and Appeal Board (IPTAB) decided on the validity of three Revolade formulation patents brought by Pharmbio Korea against Novartis, issuing a favorable ruling on the claim validity on the 19th. There are five patents for Revolade, including two substance patents and three formulation patents. The substance patents expired in August 2021 and May of last year, while the remaining three formulation patents are set to expire in August 2027. In July last year, Pharmbio Korea filed for passive confirmation of scope of rights for three patents. SK Plasma filed a similar suit in the same month, following Pharmbio Korea. While Pharmbio Korea was the first to file the petition, SK Plasma secured a victory decision two months before. On January 31, SK Plasma received the decision to establish their claim. Pharmbio Korea has already obtained a generic BLA for Revolade. In March last year, it received a BLA for two doses of 'Korea Pharmbio Eltrombopag Olamine Tab.' SK Plasma has not yet completed the development of the generic. Pharmbio Korea has secured a BLA for a generic product, but launching it may pose challenges despite winning the first trial. This is because Novartis is anticipated to appeal. Novartis has already filed a lawsuit to cancel the decision after the first trial against SK Plasma in a similar patent dispute. Given Novartis' loss to Pharmbio Korea in the same patent dispute, there are similar expectations that Novartis will appeal to the IPTAB in the pharmaceutical industry. Revolade is a primary immune thrombocytopenic purpura (ITP) treatment developed by Novartis. ITP is an autoimmune disease in which the immune system attacks platelets as if they were foreign substances. Revolade treats this disease by stimulating platelet production. Initially developed by GSK, Revolade's patent and product rights were transferred to Novartis when GSK sold its oncology division to Novartis. In 2010, Revolade was approved in Korea as a treatment for patients with ITP, and in 2018, it was additionally approved for severe aplastic anemia indications. The following year, Revolade's sales saw significant growth after its reimbursement scope expanded to include severe aplastic anemia. According to pharmaceutical market research firm IQVIA, Revolade's sales, which were less than KRW 4 billion until 2018, increased to KRW 4.9 billion in 2019, KRW 7.6 billion in 2020, KRW 8 billion in 2021, and KRW 8.6 billion in 2022. Last year, it recorded sales of KRW 9 billion, a 5% increase from the previous year.
- Company
- Skyrizi approved for palmoplantar pustulosis
- by Son, Hyung-Min Apr 23, 2024 05:36am
- Yoo Sang Baek, Professor of Dermatology at Korea University Guro Hospital Whether Skyrizi will be able to address the patients’ unmet needs for patients with palmoplantar pustulosis with its ease in administration is receiving attention. As a maintenance therapy, Skyrizi can be administered every 12 weeks, making it easier to dose than other treatments. Doctors have analyzed that the use of such new biological agents would be highly useful for patients with palmoplantar pustulosis, as existing treatments had little effect until now. On April 22, AbbVie Korea held a press conference at Andaz Hotel in Apgujeong, Seoul, to celebrate the approval of Skyrizi, a psoriatic disease treatment, for palmoplantar pustulosis. Skyrizi is a biologic agent developed by AbbVie that inhibits interleukin (IL)-23, and the drug was approved for the treatment of palmoplantar pustulosis on the 9th, extending its indication. Skyrizi inhibits IL-23, which is involved in inflammation and has been shown to be effective in several chronic immune-mediated diseases, including psoriasis. Palmoplantar pustulosis is a condition characterized by rashes, blisters, red spots, and sterile pustules on the palms and soles, and is often accompanied by intense itching and pain. People with palmoplantar pustulosis may experience crusting, thickening, erythema, and other changes at the same time. 90% of people with palmoplantar pustulosis also have plaque psoriasis and psoriasis on other parts of the body at some stage of the disease. In particular, these patients are particularly challenged by frequent disease exacerbations, partial remissions, and recurrence. Depending on the severity of the disease, topical pharmacotherapies, phototherapy, and systemic oral medications have been used to treat palmoplantar pustulosis, but have seen little effect. This is why whether the indication extension granted for Skyrizi will address the unmet need for patients with palmoplantar pustulosis is receiving attention. The indication extension to palmoplantar pustulosis was based on the results of the JumPPP study, a Phase 3 clinical trial conducted in Japan to evaluate the efficacy and safety of Skyrizi in 119 adult patients with moderate-to-severe palmoplantar pustulosis. Results showed that Skyrizi achieved a mean reduction in PPPASI (Palmoplantar Pustulosis Area and Severity Index) of -11.96, compared to -8.48 in the placebo arm. The PPPASI achievement rate at Week 16 was 41.4% for Skyrizi and 24.1% for placebo. Symptom improvement with Skyrizi was maintained through Week 68. As maintenance therapy, Skyrizi can be administered every 12, providing convenient dosing. Yoo Sang Baek, Professor of Dermatology at Korea University Guro Hospital, said, “The advantages of Skyrizi are in its significant effect in treating psoriatic disease and convenient dosing of 4 times a year. There are other treatment options, such as guselkumab, but they are not covered through a special health insurance co-payment calculation rate, thereby incurring a much out-of-pocket cost. Some patients revert to their previous treatment due to financial difficulties. This is why it is important to have a number of new treatment options available."
- Company
- Novartis fosters innovative talent through focus on purpose
- by Eo, Yun-Ho Apr 23, 2024 05:36am
- Novartis Korea has gone through a period of transformation over the past few years. As part of the global headquarters' large-scale reorganization, the company's long-established oncology and pharmaceutical businesses were merged. Although the businesses were operating under one name, Novartis, the two departments were operated independently. In fact, Marketing and Sales, as well as supporting departments such as Market Access, Government Affairs, and Licensing, were all organized separately. However, through the integration process, all of the departments were merged into one and led by a single head. As a result, a general manager of the integrated corporation was appointed for the first time since its establishment, and Novartis Korea was reborn. Dailpharm interviewed Hyunhee Lee, head of People & Organization (P&O) at Novartis Korea, a company that has been leading the innovative new drug business, including gene therapy drugs represented by CAR-T drugs, about the company's vision, ideal talent, and welfare benefits. Hyunhee Lee, head of People & Organization (P&O) at Novartis Korea-Could you first briefly introduce us to Novartis Korea? Globally, Novartis has approximately 78,000 employees in 143 countries. We have about 500 people at Novartis Korea. About half of our employees are internal staff, and the overall gender ratio is 52% female and 48% male. The ratio of female managers is 64% and the ratio of female executives is 68%, which is high among global companies. The average age of our workforce is 40, with around 60% of the workforce belonging to the MZ generation. The number of employees reaching retirement age at Novartis is also increasing. While we can't generalize, there have been cases where we extended the retiring employees’ terms of service through contract positions based on company and individual needs. I think it’s now time to think about career programs that fit the aging workforce. - Novartis has a significant number of female executives, which may partially be because the company is a multinational company. I think our culture encourages diversity and inclusion, and Novartis has a strong culture of employee ownership and initiative - a culture where you can be yourself and reach your full potential. There are a number of career development trainings, platforms, and sessions for women, including the Accelerating Women Leadership Program (AWLP). We also plan succession and talent reviews in a way that emphasizes diversity, including gender balance in the process of appointing executives and managers. The company culture is also very horizontal. All executives including the CEO listen to employees and emphasize an employee-driven and ownership culture. -What kind of employee does Novartis look for? Novartis' mission is to "Reimagine Medicine, Together.” The most important aspect of the company's mission is to find people who are motivated by the company's goal of reimagining medicine to improve and extend the lives of patients. Our 4 corporate behavioral values are summed up as ICUI, which stands for Inspired, Curious, Unbossed, and Integrity. In other words, we are looking for people who align with and practice these 4 behavioral values. – What are the qualifications for new hires, and what is the hiring process like? Also, what is the criteria for applying for an experienced position? e We do not have a regularized process for large-scale new recruitments. We hire applicants with the necessary experience and qualifications for each job and function ad hoc. We do not have any specific educational requirements or mandatory qualifications (such as English language certifications or recognized certification scores). However, in general, we conduct three rounds of interviews after the initial screening, including one English interview. -Many university students these days hope to join a multinational pharmaceutical company. Do you have any advice for university students who are interested in joining Novartis (excluding nurses, pharmacists, etc.) We are not actively recruiting new college graduates, but we have had intern programs in the past and it is one of our priorities this year. We are also planning to organize career fairs to help university students get to know Novartis better. My advice to university students who are interested in joining Novartis would be to prepare a story about a project or task that they have worked on on their initiative and derived results. It is important that they have taken ownership and initiative, and that they can tell their own story about a result that they have made from start to finish. We often call this an 'Elevator Speech', or ‘Elevator pitch,’ for example, it would be good to be prepared to explain your story in a short time, like when you take the elevator from the 1st floor to the 49th floor where Novartis Korea is located, in case you have that opportunity to talk to an influential person in the elevator. With so many different stakeholders involved in our industry, communication skills are also very important. It's important to develop a persuasive communication style that brings collaborative synergy. -What programs do you offer for the employees’ self-development once they are hired? As part of Novartis' purpose-driven corporate culture, we are committed to creating a workplace where employees are encouraged to think about why they do what they do and how they can take ownership of their work. First, ‘Make Your Move’ is an initiative that allows employees to explore and experience work across departments. We have an open internal recruitment system, with opportunities to move to other departments at any time, resulting in an internal hiring rate of over 60%. Talent Brokering is held monthly globally and monthly in APMA (Asia Pacific, Middle East, and Africa). Each country is transparent about open roles or availability of short-term – 3-month, 6-month, and 1-year - projects. We've created a practical platform for our employees to use as bridgeheads for their careers beyond the local region, and discussions are always ongoing within the platform. Last year, employees in Korea had the opportunity to participate in more than 6 regional and global projects, and as Novartis Korea rose to become one of the top 10 countries in the world, employees from various regions such as those from the Swiss headquarters have also applied to come to Korea to test their skills. - What reward programs or incentives do you have? Incentives are given based on sales targets. For departments other than sales, there are separate bonuses allocated based on base salary for each job and position, which are weighted by company performance and individual performance. In addition to the sales awards, Novartis has a reward system called ‘GEM (Go the Extra Mile),’ which looks for gems that align with key pillars of our strategy. In addition, we have a variety of other recognition programs, including the Star Awards given at the APMA regional level and the CEO Field Awards, for which employees are invited to the Novartis Basel headquarters to meet with Chairman Vas Narasimhan. We also have a Spark program in place to encourage and reward employees throughout the year. The reward system utilizes points that can be cashed in to encourage organic collaboration between departments. - Is there a limit for annual salary increases? Novartis conducts an annual market wage survey to determine the market value of compensation for each role and job code based on a market-based approach to compensation and recommends a compensation range of 70-130% of the market median, but there is no set limit. -How is the evaluation process done, since half of the positions are internal positions? We have eliminated the traditional rating-based personnel evaluation system and have established a feedback-based evaluation culture. At least once every quarter, managers and employees exchange feedback on the employees’ performance and seek ways for improvement. - We also want to know about the company's welfare benefit system. The company's welfare policies emphasize individual autonomy. We offer flexible and hybrid work arrangements so you can choose where you work. Also, new hires receive a special 5-day paid vacation. This is to give them time off to rest during the closing period around Christmas to the beginning of the year. We offer at least 21 vacation days, which is 15 statutory vacation days plus 6 days, which increases by 1 day every 2 years up to 34 days. Maternity leave is 98 days, 8 days more than the stipulated 90 days, and male employees can also take about 14 weeks of paid paternity leave when their spouse gives birth. In addition to the leave system, there are welfare programs such as kindergarten support for preschoolers and full tuition support for middle, high school, and university, as well as various family-oriented programs and events. In addition, the company has several employee-led programs in place, including establishing ‘N-chive,’ a one-stop archive for company policies, internal processes, and in-house programs.
- Company
- AstraZeneca focuses on improving competitiveness of NMOSD
- by Eo, Yun-Ho Apr 22, 2024 05:45am
- (From upper left) Soliris, Ultomiris. AstraZeneca focuses on improving the competitiveness of neuromyelitis optica spectrum disorder (NMOSD) treatments. The company aims to target the market as its new blockbuster drugs, 'Soliris (eculizumab),' which is used to treat paroxysmal nocturnal hemoglobinuria (PNH), and 'Ultomiris (ravulizumab),' which is a treatment for neuromyelitis optica spectrum disorder (NMOSD), expand indications. In 2021, Soliris received approval for an expanded indication for NMOSD in South Korea. After a prolonged discussion about its listing for insurance reimbursement, Soliris can now be reimbursed for insurance under expanded criteria starting this month (April). The specifics of reimbursement criteria include adult NMOSD patients aged 18 and above who test positive for anti-aquaporin-4 (AQP-4) antibodies, with at least two symptom relapses within the past year or at least three relapses within the past two years (including at least one relapse in the past year). Soliris can be prescribed when 'Mabther (Rituximab)' or ' Enspryng (satralizumab)' treatment cannot be continued due to relapses or side effects following administration. In terms of Ultomiris, after a failed attempt last September, it secured U.S. FDA approval for an additional indication last month. Ultomiris has a higher adherence rate than Soliris. While Soliris requires injections every two weeks, Ultomiris is administered every eight weeks, resulting in longer intervals between doses. The expansion of Ultomiris indications is based on the global Phase 3 CHAMPION-NMOSD study results. During the 73-week treatment period (median value), none of the patients who received Ultomiris relapsed, resulting in a reported 98.6% reduction in relapse risk compared to the control group. On average, NMOSD is a chronic autoimmune disorder that affects the central nervous system. It is estimated to impact approximately 200,000 people worldwide and is more commonly found in women aged 30 to 40. Initially recognized as a variant of multiple sclerosis, a chronic inflammatory demyelinating disease of the central nervous system, NMOSD was distinguished from multiple sclerosis upon the discovery of disease-specific antibodies (aquaporin-4 [AQP4]-IgG) in opticospinal myelitis patients' serum. According to the Korean Society of Neuroimmunology, as of 2017, about 3.56 individuals per 100,000 are estimated to be affected by NMOSD. It is estimated that there are over 1,000 NMOSD patients in South Korea. The average onset age of NMOSD in South Korea is reported to be 43 years old, with a prevalence that is 4.7 times higher in females than in males.
- Company
- Will Padcev be deemed cost-effective and receive DREC review
- by Eo, Yun-Ho Apr 22, 2024 05:45am
- Whether the reimbursement discussions for Padcev, a new antibody-drug conjugate for bladder cancer, will make progress is gaining attention. According to industry sources, Astellas Pharma Korea’s Padcev (enfortumab vedotin), which passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in February, has completed pharmacoeconomic evaluations and is being reviewed by the subcommittee. Whether the agenda will pass the subcommittee review and be presented to the Drug Reimbursement Evaluation Committee remains to be seen. The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet. The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. The key to Padcev’s successful reimbursement is in receiving a beneficial ICER threshold from the government in recognition of its innovativeness, like Enhertu (trastuzumab deruxtecan), which was listed in April. Padcev is also known to meet the government's preferential treatment standards for innovative new drugs. The standards are ▲ there is no substitute or therapeutically equivalent product or treatment ▲ demonstrated clinically meaningful improvement, such as a significant extension in survival ▲ the new drug has been approved by the Ministry of Food and Drug Safety under Article 35(4)(2) of the Pharmaceutical Affairs Act (designation of priority review) and were approved through the fast-track (GIFT) or received a breakthrough therapy designation (BTD) by the US FDA or a priority review (PRIME) by the European Union’s EMA. Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 39% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group. Mi-so Kim, Professor of Oncology at Seoul National University Hospital, explained, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later line therapies after using immunotherapy in the second-line due to the lack of a standard later line treatment option. Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and will open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.”
