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- 2025-12-26 19:25:59
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- Talzenna didn’t pass the Cancer Assessment Committee
- by Eo, Yun-Ho Dec 01, 2020 06:15am
- The government is conservative about breast cancer-related insurance benefits for PARP inhibitors. According to related industries, Pfizer's Talzenna (Talazoparib) was submitted to the HIRA's Cancer Assessment Committee held on the 25th, but failed. As the range of indications for breast cancer of PARP (poly ADP ribose polymerase) inhibitors such as Talzenna is wide, insurance authorities are concerned. Prior to the Cancer Assessment Committee was skeptical about the indications for breast cancer even at the time of AstraZeneca's Lynparza (Olaparib). As a result, discussions about the benefit of PARP inhibitors for breast cancer have to look forward to next year. There are some differences in the indications for breast cancer between the two drugs. Lynparza includes ▲adult patients with breast cancer susceptibility gene (gBRCA) mutation and human epithelial growth factor receptor 2 (HER2) negative metastatic breast cancer who have previously experienced chemotherapy treatment, and in the case of Talzenna, locally advanced patients are added. Indications for these drugs include the area of triple-negative breast cancer (TNBC), which lacks treatment options, and is attracting attention from academia. Another PARP inhibitor, Takeda's Zejula, has not yet secured an indication for breast cancer. However, in the case of Zejula, ▲ there is a single maintenance therapy for platinum-sensitive recurrent highly serous ovarian cancer that fully or partially responds to platinum-based chemotherapy that is negative for gBRCA, that is, All-comer. The discussion is also skeptical. Talzenna's efficacy was evaluated by comparing the Talzenna alone group and the group selected by the research team in the 431 HER2-negative local advanced or metastatic breast cancer patients with gBRCA mutations who had previously experienced up to 3 chemotherapy treatments. It was verified through an open label, randomized, multinational, large-scale phase III clinical study, EMBRACA. The median progression-free survival (mPFS), the primary endpoint of EMBRACA, was 8.6 months in the Talzenna group alone, and significantly improved compared to 5.6 months in the chemotherapy group. The risk was found to be 46% lower.
- Company
- Lynparza, a big change in the tx of BRCA-mutated cancer
- by Dec 01, 2020 06:15am
- "Most ovarian cancers are found in the 3rd to 4th stage because there is no subjective symptoms. After the first treatment, 70% recur within 3 years, and the 5-year survival rate is only 38%. Maintained by the release of Lynparza. The prognosis of patients is greatly improved through therapy. In particular, the first published 5-year follow-up result among PARP inhibitors suggests the possibility of long-term survival of ovarian cancer." Professor Byungki KimByung-ki Kim, Professor of obstetrics and gynecology, University College of Medicine, told a press conference on the 27th that the appearance of the first PARP inhibitor Lynparza (Olaparib) had on the treatment of ovarian cancer. On this day, AstraZeneca Korea held an online press conference on the topic of Lynparza's clinical value and significance in the field of ovarian cancer treatment, in celebration of the 5th anniversary of Lynparza's launch in Korea. Lynparza, launched in Korea in August 2015, is a targeted anticancer drug targeting BRCA. Not only can it be used for secondary or higher therapy, but recently it is expanding its scope to maintenance therapy. The SOLO-1 study is a phase III demonstrating the efficacy of Lynparza as a primary maintenance therapy for advanced ovarian cancer with BRCA mutations. At the third year of study, Lynparza reduced the risk of disease progression and death by 70% compared to placebo. Subsequent SOLO-2 studies demonstrated the effectiveness of Lynparza as a second-line maintenance therapy. A real-world study in Korea was conducted on Lynparza maintenance therapy. This study shows actual clinical results in the field of BRCA mutant highly serous recurrent ovarian cancer. As a result of the analysis, the median progression-free survival (mPFS) of patients taking Lynparza was 14.6 months, and the progression-free survival rate (PFS) was 42.4% at 24 months of treatment. This data is similar to the results of the Lynparza STUDY-19 study, which did not include Koreans, and Professor Kim interpreted it to mean that the effect of Lynparza appeared at least the same or better than the clinical trial of Korean patients. In particular, Professor Kim viewed Lynparza as the best option for patients with BRCA mutations. Currently, Zejula, the competitive drug, can be used as a first-line maintenance therapy for ovarian cancer patients regardless of the BRCA mutations. Zejula is widely used, while Lynparza provides specialized treatment options for patients with BRCA mutation and HRd positive. Of course, Zejula also obtained data on BRCA mutations and HRd positive patients through subgroup analysis. However, the Lynparza data dominate when it comes to drug selection. Professor Kim said, "All-comer (Zejula) drugs also have subgroup analysis data, but there is definitely a difference in mortality risk (HR)." "When it comes to patients with BRCA mutant ovarian cancer, Lynparza is a breakthrough without a choice. The benefits they receive are completely different," he said. What are Lynparza's future prospects? Professor Kim expected that in the future, Lynparza could be used as a drug used at all stages, such as platinum-based chemotherapy at all stages. He said, "According to the current data, Lynparza is a one-time use only for the 1st or 2nd phase. Whether it can be used in both 1st and 3rd phases, it is necessary to secure evidence through additional research." He said, "If the recurrence occurs after a certain period of time after taking Lynparza in the future, it is expected that Lynparza can be used again."
- Company
- Whanin ends sales of Sandoz antidepressants
- by Dec 01, 2020 06:15am
- Sandoz's supply of four antidepressants, which Whanin supplied, will end this year. According to the drug distribution industry on the 27th, Whanin announced that the supply of four Sandoz antidepressants will be suspended as the contract with Sandoz ends on the 30th. The items are ▲Sandoz Escitalopram 5·10·15mg ▲Paroxetine 20mg ▲Sultran 50·100mg ▲Mirtax 15·30mg/Mirtax ODT 15·30mg. The actual contract termination is on December 24th. Whanin has been selling Sandoz antidepressants since 2011. In February 2011, it signed an exclusive domestic sales contract for Sultran and Paroxetine, and in 2012, Sandoz Escitalopram was added. In 2015, it continued co-promotion for 4 antidepressants, including Mirtax. As of last year, Whanin's psychiatric treatment sales amounted to ₩130 billion, accounting for 81.7% of total sales (₩159.1 billion). Whanin is focusing on strengthening its own lineup of products for CNS, such as treatments for epilepsy and Parkinson's disease. In addition, in preparation for the recent increase in production, it has decided to acquire a pharmaceutical plant in Hyangnam of Janssen Korea for ₩46 billion. Whanin is also planning to end supply of Novartis Korea's Atorvin Tablet 10·20mg on the 24th of next month.
- Company
- TNBC treatment adds newly approved immunotherapy option
- by Eo, Yun-Ho Nov 30, 2020 06:21am
- Anticipation is heightening for the use of an immunotherapy Tecentriq (atezolizumab) in the triple-negative breast cancer (TNBC) treatment scene. Pharmaceutical industry sources reported Roche Korea’s PD-L1 inhibiting immunotherapy Tecentriq has recently successfully expanded the indication as a first-line treatment for TNBC, combined with nanoparticle albumin-bound (nab) paclitaxel, in the U.S. and now in South Korea. Moreover, the U.S. health authority also additionally indicated the drug to treat the disease in combination with Merk’s PD-1 inhibiting chemotherapy Keytruda (pembrolizumab) as a first-line treatment. The medical scene is closely following the news with an anticipation of opening more practical options of immunotherapy in TNBC treatment area currently lacking a variety of options. Since Roche Korea submitted the National Health Insurance (NHI) reimbursement application last month, the South Korean health authority is currently in process of reviewing the coverage on Tecentriq. However, it is still unknown how long the listing procedure would take. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government after the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. In the Phase III IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression-free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. Keytruda has even longer way to go. Although there is no apparent barrier yet, the drug’s reimbursement expansion for the first-line lung cancer treatment has been sluggish so far. In the KEYNOTE-355 study, evaluating PFS in patients with locally recurrent unresectable or metastatic TNBC, the Keytruda combination therapy resulted in statically meaningful improvement in reducing the risk of disease progression or death by 35 percent through a first-line treatment in patients, who had not been previously treated with chemotherapy and the expression of tumor PD-L1 was over CPS 10. The mPFS in the Keytruda combination therapy group marked 9.7 months, when the chemotherapy-only group reached 5.6 months. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. For a long time, chemotherapy was the only option for patients with TNBC. Roche’s targeted therapy Avastin (bevacizumab) still remains as a non-reimbursed option, although it was the first one to win the indication in South Korea. But the selection of TNBC treatment options has been widened recently with a poly ADP ribose polymerase (PARP) inhibiting targeted therapy Lynparza (olaparib) and other immunotherapy added to the market.
- Company
- Can HPV vaccine for men be included in the NIP?
- by Eo, Yun-Ho Nov 30, 2020 06:21am
- It is worth paying attention to whether vaccinating men with HPV vaccine can be included in the National Immunization Program (NIP). Earlier this month, Hye-young Choi, a member of Democratic Party of Korea said that the human papillomavirus (HPV) vaccine NIP, which is currently being conducted only for 12-year-old girls, includes both men and women under 18 years of age. Representatively initiated the 'Amendment of the Act on the Act'. HPV is a virus that is transmitted through sexual contact and can be infected by both sexes, regardless of gender. Most of them disappear naturally when infected with HPV, but if they are continuously infected, women can develop cervical cancer, vulvar cancer, and vaginal cancer, and anal cancer and genital warts can appear in both men and women. The HPV vaccine, which is well known as a cervical cancer vaccine, is a necessity that if inoculated to men, it can prevent the occurrence of penile cancer, oral cancer, oropharyngeal cancer, anal cancer, and genital warts related to HPV 16 and 18 as well as preventing female cervical cancer. .In fact, Korean academia also recommends HPV vaccination for both men and women .In 2019, the Korean Society of Infectious Diseases revised the guidelines for adult vaccination after 7 years, adding males to the HPV vaccination recommendations .Cancer centers designated by the World Health Organization (WHO), American Cancer Society (ACS), and National Cancer Institute (NCI) prevent HPV in male and female adolescents aged 13 to 15 by 2020 with the goal of eradicating cancer caused by HPV, regardless of gender .It announced a plan to increase the inoculation rate to 80% .In addition, 20 out of 37 OECD countries include boys for HPV vaccination .However, the current domestic NIP includes only 12-year-old female adolescents who are eligible for free HPV vaccination .Woong Ju, professor of obstetrics and gynecology at Ewha University Seoul Hospital, said, "As a result of an active policy that includes boys in the HPV vaccine NIP in 2013 in Australia, the annual cervical cancer mortality rate is expected to drop to 1 per 100,000 population in 2034 ."It is necessary to expand the target of domestic NIP policy to both men and women, and to carry out active HPV prevention projects." Last August, at the Korean Gynecological Oncology Spring Association, Sohn Gyeong-bok at Ewha Womans University College of Pharmacy, presented the theme of 'A Study on Economic Evaluation of HPV Vaccine 12-year-old Male and Female Vaccination.' He confirmed that HPV vaccine vaccination for men and women at the age of 12 is more cost-effective than the current NIP and non-vaccinated groups .When both men and women were vaccinated with the HPV vaccine, the number of HPV-related cancer patients decreased by 30% in both men and women .Currently, Korea's NIP is asking one of the two-valent vaccines 'Cervarix' and the tetravalent vaccine 'Gardasil' to be inoculated as a cervical cancer vaccine.
- Company
- The market share of GLP-1 diabetes drug Trulicity is 99%
- by An, Kyung-Jin Nov 30, 2020 06:21am
- TrulicityTrulicity, a diabetic treatment administered once a week, continues to dominate in the GLP-1 analog market. Despite the confusion of COVID-19 outbreak, it has set a new quarterly sales record, reaching ₩40 billion in annual sales. It is leading the market expansion by recording a market share of over 99% with only a single item. According to the drug market research agency IQVIA on the 26th, four GLP-1 analogues such as Trulicity (Dulaglutide), Lyxumia (Lixisenatide), Victoza (Liraglutide), and Byetta (Exenatide) in the third quarter made ₩11 billion in sales. This is an increase of 7.8% from ₩10.2 billion in the same period last year. The GLP-1 analog is a drug developed using the hormone GLP-1 (Glucagon-Like Peptide-1), which is involved in the regulation of blood sugar in the body. GLP-1 hormone promotes insulin secretion immediately after a meal, thereby lowering blood sugar, and when blood sugar falls below a certain level, it reduces insulin secretion and helps prevent hypoglycemia. Trulicity, the latest release, virtually ranked the entire market with 99.4% market share. The sales of Trulicity in the third quarter were ₩10.9 billion, a 9.8% increase from ₩10 billion a year earlier. Excluding Trulicity, the quarterly sales of the three items did not reach ₩70 million. The accumulated sales of Trulicity in the third quarter of this year amounted to ₩30.8 billion. Trulicity is the only long-lasting drug administered once a week among GLP-1 analogs on the market. Despite the fact that it was released to the market as the latest among the drugs of the same class in May 2016, sales continued to rise sharply every quarter, increasing its influence in the GLP-1 analog market. It started with ₩1.4 billion in the first year of its launch and exceeded the high of ₩12.2 billion the following year, and the sales in 2018 were ₩27 billion and ₩37.5 billion in 2019, causing a blast. If the current trend continues, annual sales could exceed ₩40 billion. Quarterly sales and Trulicity share of major GLP-1 analogues (Unit: ₩million, %, Source: IQVIA) Lilly Korea has been conducting joint sales activities with Boryung since the launch of Trulicity. It is with the intent to expand the partnership that has been built up through the anticancer drug GemZar into the area of diabetes. With the synergy between the two companies' partnership, Trulicity accounts for about one-third of Boryung's sales after 4 years of release. The quarterly sales of three GLP-1 analogues such as VIctoza, Byetta, and Lyxumia were around ₩3 billion, but the total market size expanded rapidly after the release of Trulicity. It was 2.5 times larger than ₩4.4 billion in the first quarter of 2016, just before the release of Trulicity. Unlike the existing GLP-1 analogue, which had to be injected once or twice a day due to a fast-acting mechanism, the number of injections was reduced once a week, and the convenience was improved with a pen-type formulation. The fact that the recommended level of GLP-1 analogues was raised in domestic and foreign diabetes treatment guidelines, and that the combination therapy with basal insulin was recognized as a benefit at the end of 2017 also acted as a catalyst for the increase in sales. On the other hand, the GLP-1 analog administered once a day continues to be sluggish. Sanofi's Lyxumia is in the process of withdrawing from the market. Sanofi formalized a plan to withdraw two formulations of Lyxumia earlier this year. The total amount of ₩152 million until the third quarter of this year is the inventory that was previously held by wholesalers. At the time, no specific reason was disclosed, but the fact that the company decided to reduce investment in the diabetes business unit was pointed out as the background for the withdrawal of the permit, as sales decreased rapidly after the emergence of competitive products. AstraZeneca's Byetta has a cumulative sales of ₩2 million this year. Novo Nordisk's Victoza barely exceeded ₩150 million in sales for 9 months. Unlike the obesity treatment Saxenda, which differs only in dosage with the same ingredient, it does not show its presence in the market. As a variable for the GLP-1 analog market in the future, Novo Nordisk's generics can be discussed. Novo Nordisk is in fierce competition with Trulicity in the global market as it obtained the approval of the U.S. Food and Drug Administration (FDA) for the GLP-1 analog Ozempic(Semaglutide) administered once a week at the end of 2017. In September of last year, Rybelsus, which converted Ozempic to oral use, received FDA approval. It is an analysis that the market can be reorganized depending on the timing of the two products being released in Korea.
- Company
- First generic release isn't related to original price cuts
- by Kim, Jin-Gu Nov 30, 2020 06:20am
- The Supreme Court of South Korea finally ruled that the company that launched First Generic due to the success of its patent strategy had no reason to be responsible for lowering the drug price of the original drug. The results of the Zyprexa (Olanzapine) lawsuit came out after 10 years. The result of this lawsuit received great attention from domestic companies in that the strategy for early release of generics was decided. On the 26th, the Supreme Court's Civil Affairs Division dismissed Lilly's appeal in a lawsuit against Hanmi for drug price cuts. The Supreme Court's Civil Part 3, which was held at the same time, also took the side of Myungin in a lawsuit for damages that Myungin filed against Lilly Korea. This complicated lawsuit, which has lasted more than 10 years, began in 2008 when a trial was filed for invalidation of the patent for Lilly's schizophrenia treatment Zyprexa. At that time, Hanmi claimed Zyprexa's patent invalidation trial and won the second trial, and then released Olanza, generic for Zyprexa in 2011. Myungin, which confirmed this judgment result, later released Neurozapine, generic for Zyprexa, too. However, the Supreme Court overturned the second trial, and Lilly filed damages to both companies (Hanmi and Myungin) on the basis of this. It was intended to compensate for the profits obtained from selling generics. However, Lilly also filed a lawsuit against Hanmi and Myungin to compensate for damages as the drug price of Zyprex was lowered due to the release of the generic. It was the first in Korea to claim damages for the price cut of the original drug. The cost of the lawsuit was ₩1.5 billion to Hanmi and ₩47 million to Myungin. In this case, Hanmi won both the first and second trials, but Myungin lost both. Regarding Hanmi, the court ruled in favor of both the first and second trials, saying, "Hanmi released the generics through a legitimate patent challenge, and the drug price cut is due to exercise of the discretion of the MOHW and no causal relationship is formed. On the other hand, for Myungin, the court ruled against defeat with the effect of "since it released generics after recognizing the drug price cut of Zyprexa, it must compensate for the damages caused by the drug price cut." In 2016, Lilly appealed to Hanmi and Myungin appealed to Lilly. The Supreme Court's ruling on this day is the final result of a lawsuit that has been going on for the past 10 years. It is the first lawsuit in Korea to dispute whether or not to compensate for the price cut of the original drug, and as a result of this, the first-generic strategy of generic pharmaceutical companies itself could collapse, which attracted great attention from the industry. In fact, if domestic companies lose, they could suffer from cost cuts of the original product, which could amount to tens of billions of billions of won. However, the final decision of the Supreme Court provided an opportunity for domestic pharmaceutical companies to actively pursue patent challenges for the early release of generics. Kim Yoon-ho, chairman of The KPPI (Korea Pharmaceutical Patent Institution), said, "We have completely escaped from a situation where domestic companies' patent challenges for the launch of first generics may be reduced." In particular, he said, "It is a meaningful decision that not only establishes an active patent strategy, but also reduces the burden of health insurance finances and drug costs for patients."
- Company
- Prevenar and Sky Cellflu soar, Keytruda tops again
- by Chon, Seung-Hyun Nov 30, 2020 06:20am
- The novel coronavirus infection (COVID-19) has shuffled the top pharmaceutical market leader board. While immunotherapy Keytruda topped the market again, the sales in a pneumococcal 13-valent conjugate vaccine Prevenar 13 and a flu vaccine Sky Cellflu 4 surged dramatically. The sales in innovative new drugs like Tagrisso and Prolia also grew noticeably. According to a pharmaceutical market research firm IQVIA on Nov. 25, MSD’s Keytruda generated 41.6 billion won in last third quarter. Compared to the same quarter last year, the figure soared by 25.9 percent and topped the market for three consecutive quarters, pushing Lipitor down. Top ten pharmaceutical sales in the third quarter of 2020 (Source: IQVIA) Keytruda took the lead for the first time in last first quarter by making 34.7 billion won and approximately 40 million won difference with cholesterol-lowering Lipitor. In the second and third quarters, Keytruda widened the gap with Lipitor. At the third quarter point, Keytruda accumulated sales of 113.8 billion won, which was 8.6 billion won more than Lipitor with 105.2 billion won. If the drug continues the trend, it is highly likely to take the top spot this year, when it marks the sixth year of launch. Released to the South Korean market in 2015, Keytruda is an immune checkpoint inhibitor that blocks PD-L1 receptor from biding with PD-1 pathway on the surface of T-cell and activates immune cells to treat the tumor cells. Immediately after the market release, Keytruda’s sales have remained around 3 billion won, but the figure grew rapidly since the second half of 2017. The demand on the drug has surged as the healthcare insurance coverage was granted from August 2017 as a second-line therapy treating patients with non-small cell lung cancer (NSCLC). Keytruda’s sales in the first quarter of 2018 surpassed 10 billion won, and climbed up to the 20 billion won-line in the following fourth quarter. From the second quarter last year, it has reached the 30 billion won-line, and exceeded 40 billion won in this year’s third quarter. The demand for Keytruda in the prescription market continued to grow amid COVID-19. A pneumonia vaccine Prevenar 13 had an exponential growth. In the third quarter, the vaccine made 24.2 billion won, doubling last year third quarter’s sales. Prevnar 13 is a pneumococcal conjugate vaccine (PCV13) that prevents infection from 13 types of pneumococcal pneumonia (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Provided to all age groups older than 6-week-old, the vaccines for adults are distributed by Chong Kun Dang, whereas Korea Vaccine is in charge of distributing vaccine for children and infants. Prevenar 13’s sales usually peak in the fourth quarter, when typically the demand for vaccination surges, and drop in the first quarter. This year’s first quarter sales grew more than the previous quarter, making 17.6 billion won, and its growth continued on for the second and third quarters, surpassing the quarterly sales 20 billion won-line for the first time. Quarterly sales growth of Prevenar 13 (Unit: KRW 1 million) Source: IQVIA The sources analyze Prevenar 13’s sales soared due to COVID-19. They evaluate the use of the vaccine in adults has leapt sharply as many were convinced by a number of experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself. Besides Prevenar 13, Sky Cellflu 4 also entered the top ten as it generated 21.1 billion won amid COVID-19. Sky Cellflu Quadrivalent by SK Bioscience Sky Cellflu is an influenza vaccine solely developed by SK Bioscience that earned the health authority’s approval in 2015. Unlike typical egg-based vaccine, the Korean-made quadrivalent vaccine is produced with top-of-the-line aseptic culture system, which does not require preservative. As all flu vaccines for this year were quadrivalent and the supply for the vaccines increased with COVID-19, Sky Cellflu 4’s sales skyrocketed. The amount of influenza vaccines distributed to the South Korean in this influenza season was about 29.5 million doses with an increase of 20 percent from last year. The Korean company raised the Korean market distribution volume as it predicted the surge in flu vaccine demand due to COVID-19. SK Bioscience shipped about 9 million doses with 70 percent jump compared to last year. AstraZeneca’s anticancer treatment Tagrisso continued to generate significant sales. The third quarter sales were 32.4 percent higher than last year, as it generated 27.9 billion won. Tagrisso is a second-line treatment prescribed to NSCLC patients who developed tolerance in EGFR tyrosine kinase inhibitors (TKIs) like Iressa, Tarceva and Giotrif. The medicine is considered a third-generation treatment that overcame EGFR-TKI tolerance. After receiving the healthcare reimbursement from December 2017, Tagrisso has been growing consistently in South Korea. The sales in the third quarter of 2017 marked 2.7 billion won, but it grew by tenfold in just two years time. Amgen’s osteoporosis treatment joined the top ten by making 20 billion won in the third quarter. Released to the South Korean market in November 2016, Prolia is a biologic osteoporosis treatment directed against receptor activator of nuclear factor-κB ligand (RANKL), which interferes with the formation, activation, and survival of osteoclasts. The drug’s sales started taking off since it was listed for reimbursement in 2017 as a second-line treatment. And Prolia’s sales exploded when it successfully expanded the reimbursement as a first-line treatment from April last year. Also its sales partnership with Chong Kun Dang gave a boost as well.
- Company
- Beovu treating AMD passes the first gate to reimbursement
- by Eo, Yun-Ho Nov 26, 2020 06:05am
- A novel neovascular age-related Macular Degeneration (AMD) treatment Beovu (brolucizumab) has passed the first threshold to win the healthcare reimbursement in South Korea. The pharmaceutical industry sources reported the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) recently green lit Novartis Korea’s Beovu. On Nov. 13, DREC approved of the drug reimbursement feasibility, but it was ultimately decided as a conditional non-reimbursement due to the conflict in drug pricing. However, as Novartis Korea accepted the offered conditions, the drug’s reimbursement feasibility was then cleared. A next generation treatment for wet AMD, Beovu is an anti-vascular endothelial growth factor (anti-VEGF) drug that suppresses endothelial cell proliferation and vascular permeability. The drug is administered once-monthly for the first three months, and once every three months then after. A Phase II HAWK study and a Phase III HARRIER confirmed Beovu’s efficacy by comparing against Eylea (aflibercept). The two studies, incorporating 1,817 patients aged 50 and over with wet AMD, found the drug to have non-inferiority versus the reference group through the primary endpoint—the change in best-corrected visual acuity (BCVA) at year one (week 48). In both clinical trials, approximately 30 percent of patients gained at least 15 letters at year one. In HAWK and HARRIER, Beovu showed superior effect of improving retinal fluid compared to the reference drug, as fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF) after receiving Beovu as a treatment. A professor of ophthalmology at Seoul National University College of Medicine, Yu Hyeong Gon said “Beovu’s outstanding anatomical effect is proven based on the clinical data showing improved vision and fewer numbers of patients with remaining retinal fluid compared to the reference drug. As the treatment can be administered in three month interval, the patients with wet AMD would enjoy the new treatment option that comes with convenience and less burden.”
- Company
- Janssen's young man who saved her life after a hit & run
- by Eo, Yun-Ho Nov 26, 2020 06:04am
- Ji Hyun-joo, Director "When I got my mind, I knew I was under the car. I was just shouting for help, but someone talked to me." At eleven o'clock on the night of February 17, Ji Hyun-Joo (48 yrs old) Korea Johnson & Johnson (J&J), general director of Consumer Health Care AP, returned to the company (LS Yongsan Tower) after a dinner in late winter, when it was still cold. She lost her mind when she recognized the car rushing towards her after getting off the taxi at the back door of the building. The car struck her as it was, and crushed her left arm. She fell stunned and injured her right shoulder, which could endanger her life. Was she lucky? Im Ji-hoon (37 yrs old) Korea Janssen (located in the same building as a J&J subsidiary), who left the office late after work, heard the sound of a bang and ran to the site. A bigger crisis awaits at the site of the accident. What happened to the car that caused the accident, it was a situation where the director would step on the body without stopping. He ran straight away and pushed the vehicle first. It is a later story, but he said that he thought that he was "already dead" when he saw Ji director at the time. He intuited,'Oh, this driver is drinking.' He told the driver to get out of the car. The driver was drunk as expected. It is said that he smoked a cigarette while jovializing at him taking pictures for evidence. He left the driver first, called 911 and approached her. Fortunately, she came back to consciousness, and he got her husband's phone number and contacted her. Thirty minutes after the accident, a 911 ambulance was able to carry her to the hospital emergency room, and she underwent emergency surgery. The driver left the car as it was at that time, and later surrendered, and a trial is currently underway. Director Ji Hyun-Joo, who returned after an unexpected accident, and Deputy General Manager Im Ji-hoon, a lifesaver◆6 months of rehabilitation and return to work With a fracture of both humerus and the resulting rotator cuff tear, she almost lost both arms. She couldn't move her arms right after the surgery to pin her muscles, and her daily life was impossible at all. She expected to be able to use her arm after removing the cast, but she couldn't listen because her muscles were already stiff. A caregiver, who resides 24 hours a day, had to stand by her for about five months. Eventually, after six months of long rehabilitation, she was able to return to work. The company's help was great for her return. J&J suggested returning to work in a part-time form first, checking her physical condition from time to time. Her arm condition (left) and the monitor and chair supported by the company The company, which had implemented a flexible work system due to the aftermath of COVID-19, provided a dedicated monitor and ergonomics chair at her home for her with discomfort. She is currently working at J&J through telecommuting. “The company has helped me a lot for my return. Even after I return to work, the company checks my condition regularly and discusses the timing of the full-time transition. There is no anxiety about returning to normal, nor the pressure for a quick return. We are sending encouragement and support in line with 'me'." Deputy Director Im Ji-hoon◆Joint donation made with life saver and settlement money "He is literally a lifesaver. I can't really thank you in words. I wanted to somehow compensate, so I offered some of the settlement money as a token of gratitude, but I refused. But I said again that my heart was too heavy. , They offered to donate to the Children's Foundation under a joint name." It saved a person's life, but he did not come forward and commended his work, awarded a citation, and shared examples of talks through town hall meetings, but he is still embarrassed. "I'm glad she was just alive. If anyone other than me saw the situation, she would have run to help. I could go to the hospital 5 months after the surgery, but she recovered to some extent. I was really grateful to see it. Oh, the Children's Foundation was originally a place where there was exchange such as voluntary activities at the company level, and it was a personal support. Her accident is, of course, an accident that should never happen again. However, due to this accident, J&J and Janssen, which felt like subsidiaries but actually different companies, united as one. The company also offered psychological counseling using in-house programs to prepare for the trauma that may have been received by him. J&J and its subsidiary Janssen are emphasizing 'Credo', which has been passed down since its inception. The first is the patient and the doctor, the second is the staff, the third is the community, and the company's Credo, which respects the care and values of people, hangs everywhere. Credo, which has been spreading consistently, is perhaps deeply engraved in the company's employees.
