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- 2025-12-26 15:39:16
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- Tumor-agnostic Rozlytrek applies for NHI coverage
- by Eo, Yun-Ho Jan 20, 2021 06:04am
- A tumor-agnostic anticancer medicine Rozlytrek is shooting for the National Health Insurance (NHI) reimbursement listing. A pharmaceutical industry source reported Roche Korea submitted a reimbursement listing application for a neurotrophic tyrosine receptor kinase (NTRK) targeted therapy Rozlytrek (entrectinib) to a South Korean health authority last year. Approved as an orphan drug in South Korea in last August, Rozlytrek is indicated to treat adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, are locally advanced ROS1-positive or metastatic NSCLC. Technically, the treatment can be prescribed to any cancer patients confirmed to have NTRK gene. The treatment’s approval was based on results from the Phase I/II STARTRK-NG study targeting pediatric patients and the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials. In STARTRK-2, Rozlytrek achieved an objective response rate (ORR) of 56.9 percent in patients with NTRK-positive solid tumors. The patients had ten types of different solid tumor and their median duration of response (DoR) was 10.4 months. And at the European Society for Medical Oncology (ESMO) Asia 2020 convened late last year, Rozlytrek unveiled its Asian subgroup analysis result. The subgroup analysis result found NTRK fusion-positive patients treated with Rozlytrek had ORR of 69.2 percent, the median DoR of 10.4 months, and median progression-free survival (PFS) of 14.9 months. The overall survival (OS) was unable to measure. Among ROS1-positive patient with NSCLC, the researchers confirmed ORR of 69.9 percent and median DOR of 14.9 months, when median OS and median PFS were 28.3 months and 13.6 months, respectively. And a second endpoint, the intracranial ORR (IC ORR) was 100 percent in patients with solid tumors that have a NTRK gene fusion, whereas ROS1-positive patient with NSCLC marked 36.4 percent. The central nervous system (CNS) metastasis progression confirmed with a scan was generally very low. Professor Ahn Myung Ju at the Samsung Medical Center Department of Hematology and Oncology said, “Based on the confirmed clinical evidence of Rozlytrek treatment efficiency in Asian patients and the introduction of the tumor-agnostic treatment to the South Korean market, we can expect to expand the rare cancer patients’ access to treatments customized to personal gene characteristic, and to create a positive cycle of precise medicine, which would feed the patients’ treatment information back to R&D.”
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- Mavenclad can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 19, 2021 06:02am
- New multiple sclerosis drug Mavenclad can be prescribed in general hospitals According to related industries, highly active recurrent multiple sclerosis treatment Mavenclad (Cladribine) by Merck has now passed the drug commitee (DC) of SMC, AMC, Shinchon Severance Hospital, and NCC. Mavenclad is the first short-term oral treatment that has shown a significant overall effect in terms of the degree of physical disability progression, annual recurrence rate, number of active lesions shown on MRI, and major disease activity indicators in patients with recurrent multiple sclerosis. Mavenclad's clinical trial program included long-term follow-up data from the 8-year prospective observational registry PREMIERE study, along with the CLARITY Phase 3 study and CLARITY EXTENSION, ORACLE MS, and ONWARD Phase 2 study corresponding to the CLARITY expanded clinical trial. As a result of post-hoc analysis of patients with high disease activity in the CLARITY 2,3 study conducted for two years, the annual recurrence rate of patients receiving Mavenclad decreased by 67%, and the Extended Disability Status Scale (EDSS), which indicates the degree of disability progression. Also, Mavenclad administration group showed a 82% decrease compared to the control group. However, Mavenclad’s significant adverse reactions are lymphopenia and shingles. The lymphocyte count of patients must be measured before and during Mavenclad administration to patients with multiple sclerosis. It is contraindicated in certain populations, including patients with impaired immune function and pregnant women. Seongmin Kim, Professor of Neurology, SNUH said, "Multiple sclerosis is a chronic inflammatory demyelinating disease that occurs in the central nervous system such as the brain and spinal cord. If not treated, symptoms may worsen and sequelae such as severe disorders may remain, so a new treatment option with high convenience is available. It was a necessary situation. Mavenclad can be taken orally and can help improve the quality of life for patients in that it provides lasting effects for 4 years with only short-term treatment of up to 20 days."
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- Big Pharmas busy reaching out for KRAS targeted therapy
- by Kim, Jin-Gu Jan 18, 2021 06:14am
- Global pharmaceutical giants are eager to develop targeted therapy for ‘Kirsten rat sarcoma viral oncogene homolog (KRAS)’ mutation, initially considered as an impenetrable technology for last four decades. Apparently, KRAS mutation is found in about one out of four cancer types. Specifically, the mutation is frequently found in cancer types with bad prognosis like lung cancer, colon cancer and pancreatic cancer. Pioneered by Amgen, small and big companies like Novartis, Sanofi, Bayer, Boehringer Ingelheim, Merck and Mirati Therapeutics are fiercely competing against each other to dominate the blue ocean. ◆Why did MSD bet USD 2.5 billion on candidate medicine in preclinical trial phase? On Jan. 13 (local time), MSD exclusively licensed-in an anticancer candidate medicine targeting KRAS from Japanese-based Otsuka Pharmaceutical’s subsidiaries, Taiho and Astex. MSD has agreed to pay maximum 2.5 billion dollars (approximately 2.75 trillion won) including an upfront payment of 50 million dollars (approximately 55 billion won). To win the competition against Revolution Medicines, Boehringer Ingelheim decided to put forth a colossal bet. The reason behind MSD’s massive payment for a candidate medicine at a preclinical trial level coincides with the recent global pharmaceutical industry trend. Lately, the global pharmaceutical industry is hectic with KRAS targeted therapy R&D. Although the technology was thought to be impossible to crack for last 40 years, KRAS targeted therapy nabbed the Big Pharmas’ attention after Amgen showed the possibility in the commercialization in 2019. ◆40 years of going nowhere, KRAS targeted therapy results in a first clinical findings in 2019 KRAS is one of factors that cause cancer. KRAS activates transmission of signals from the cell surface receptor to the nucleus. It is at the same level as anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), which already have developed targeted therapy for. It is actually the first cancer-causing gene the human race has discovered. But since the first discovery in 1982, the relevant treatment development was sluggish for four decades. Compared to other cancer-forming genes, KRAS has more frequent mutations and transforms the protein structure into a wide array of variations. And it has been hindering the targeted therapy development until lately. The frequency is apparently high for the KRAS mutation causing a number of lethal cancers like lung cancer, colon cancer and pancreatic cancer. And vast amount of researches were done to study the gene, but all of them failed at the end. In 2013, however, a group of researchers at University of California found a groundbreaking discovery of ‘binding pockets.’ Since then it was picked up as a candidate medicine and its first clinical findings were announced in 2019 after completing the preclinical phase. ◆Amgen takes the lead in R&D, sotorasib initiates Phase III clinical trial First, it was Amgen who presented the clinical results. AMG-510, also known as sotorasib, is evaluated as a frontier among the KRAS targeted therapy candidates. The Phase I clinical trial kicked off from August 2018. The result of the trial was unveiled at the 2019 International Association for the Study of Lung Cancer (IASLC). Cancer patients with non-small cancer lung cancer (NSCLC), colon cancer or pancreatic cancer showing KRAS mutation participated in the clinical trial. Five out of ten NSCLCL patients in the study had the KRAS mutation. A Phase II clinical trial, unveiled at the European Society for Medical Oncology conference last year, also demonstrated positive results. After using sotorasib in 53 patients with NSCLC, their progression-free survival (PFS) marked 6.3 months while the response rate reached 32.2 percent. Amgen is still currently conducting the Phase III trial that compares the drug against cell-killing chemotherapy docetaxel. In late last year, the U.S. Food and Drug Administration (FDA) designated the investigational drug as a Breakthrough Therapy. Besides the AMG-510 single therapy, the company is also running a clinical trial on a combination therapy with other various anticancer treatments. The drug is likely to get approval within this year at earliest. ◆Mirati, Sanofi, Novartis, Boehringer, Moderna and Bayer all on board Mirati Therapeutics is following Amgen closely. The company kicked off the clinical trial in January 2019, and now MRTX849 is in process of running a Phase 1/2 study. The Phase II interim analysis was disclosed late last year. The objective response rate (ORR) in 51 patients with NSCLC marked 45 percent. The company aims for the FDA approval in the latter half of the year. Moreover, Sanofi and Revolution Medicine are collaborating together on developing RMC-4630 since June 2019. In a partnership with Araxes Pharma, Johnson and Johnson started a clinical study on ARS-3248 from July 2019. Eli Lilly initiated the clinical trial on LY3499446 in November 2019. Last year, Mirati and Novartis started working on another candidate medicine TNO155, and its Phase 1/2 clinical trial began from last April. Navire Pharma and Erasca respectively started Phase I trial on BBP-398 in last August and Phase I trial on ERAS-601 in last December. Even more companies like Boehringer Ingelheim, Bayer, Moderna, Merck and Jacobio Pharmaceuticals are now into seeking KRAS targeted therapy with preclinical trial ongoing. In South Korea, Orum Therapeutics is reportedly exploring KRAS related R&D
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- Celltrion's COVID-19 antibody tx reduces progression by 54%
- by An, Kyung-Jin Jan 18, 2021 06:13am
- Rekirona The result of Phase II clinical trial of Rekirona (Regdanvimab), COVID-19 antibody treatment developed by Celltrion, has been revealed for the first time. It is evaluated that it is useful to efficiently manage medical resources while reducing the incidence of severe patients requiring inpatient treatment by more than half and reducing the recovery period. Celltrion presented the results of global II clinical trials related to Rekirona at the 2021 High1 New Drug Development Symposium online event hosted by the pharmaceutical society of Korea on the 13th. This is a multicenter study that compared the efficacy and safety of 327 patients with mild or moderate COVID-19 infection with standard treatment and administration of Rekirona or placebo. 327 COVID-19 patients from Korea, Romania, Spain and the United States participated and completed the final medication on November 25 last year (Korean time). The data introduced on this day are the results of an analysis of 307 mild and moderate patients who were confirmed to be infected with COVID-19 immediately before administration. The presentation was made by Professor Joong Sik Eom (Infectious Internal Medicine, Gachon University Gil Medical Center), chief researcher (PI) and advisor. The researchers set the percentage of patients who died or required hospitalization or oxygen therapy due to COVID-19 infection by the 28th as the efficacy evaluation index. As a result of the analysis, when Rekirona 40mg/kg was administered to patients diagnosed as mild or moderate, the probability of progression to severe was decreased by 54% compared to placebo group. The severe progression rate of moderately ill patients over 50 is 68%. The benefits are expected to increase when Rekirona is administered to patients with higher disease severity in the elderly. The time it takes for the symptoms of COVID-19 to disappear was 5.4 days in Rekirona group, which was shortened by more than 3 days from 8.8 days in the placebo group. In the case of moderate or moderately ill patients over 50 years old, the time it took for symptom recovery after administration of Rekirona was more than 5-6 days with placebo. After administration of Rekirona, the time required for the concentration of virus in the body to decrease by 1500 times was 7 days, which was 3 days shorter than 10 days in the placebo group. No serious adverse events, including death, were reported among the patients participating in the clinical trial. There were no cases of discontinuing the study due to adverse events. Professor Eom said, "When Rekirona is administered to mild or moderate COVID-19 patients, it has been proven to significantly reduce the rate of progression to severe and shorten the recovery time. 56% of the participating patients over 50 years old and those with pneumonia were proven to be an encouraging result in that the participation rate of the high-risk group was high at 60%." Although it is phase II clinical trial, it is expected that it will greatly contribute to the management of medical resources by securing treatment beds to reduce confusion in the treatment field and to provide conditions to focus on moderately high-risk patients. Celltrion officials have completed production for 100,000 people in preparation for conditional marketing authorization of Rekirona. It is planning to conduct phase III clinical trial on a wider range of patients in 10 countries and further verify the safety and efficacy of Rekirona. It plans to conduct phase III clinical trials in more than 10 countries around the world to further verify the safety and efficacy of Rekirona confirmed in phase II clinical trials in a wider range of patients. A Celltrion official said, "We have already completed production for 100,000 people and are thoroughly preparing a supply plan so that we can supply them to the medical field as soon as we acquire CMA." He said, "We are systematically preparing a plan to produce treatments for up to 2 million people so that global supply will not be disrupted in accordance with the timing of approval in major overseas countries."
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- LG Chem in full throttle seeking anti-obesity and NASH drug
- by An, Kyung-Jin Jan 15, 2021 06:10am
- LG Chem showcased its key new drug pipelines targeting obesity and non-alcoholic steatohepatitis (NASH) at a global event. The South Korean company plans to make the chimeric antigen receptor T (CAR-T) cell therapy and stem cell therapy development into their future growth engine. On Jan. 13, LG Chem announced it would participate in the virtually convened JP Morgan Healthcare Conference 2021 to present the key findings in 40 new drug pipelines. The South Korean company’s session presentation was led by the president of LG Chem Life Sciences Company, Son Jeewoong. At the event, the company addressed the key pipeline such as gout treatment currently undergoing clinical trial, hereditary obesity treatment and NASH treatment. The gout treatment LG Chem is developing as a ‘best in class’ is a new drug that inhibits excessive secretion of uric acid, a major cause of gout. In the Phase I trial in the U.S., the investigational drug was confirmed to effectively lower the uric acid level by only administering once-daily regardless of meal consumption. The drug was evaluated to have verified superior effect and safety compared to existing options as no adverse reaction of hepatotoxicity and cardiovascular system was reported. The company plans to complete the Phase II study in the U.S. in the second quarter and analyze the result. The company’s investigational anti-obesity drug activates an appetite regulating melanocortin-4 receptor gene (MC4R). In last November, an injection with the same mechanism was approved by the U.S. Food and Drug Administration (FDA), but LG Chem’s drug is expected to improve the administration convenience as a first orally taken drug in the class. In September last year, the FDA designated the drug as an orphan drug and granted a market exclusivity benefit to delay a follow-on drug approval for seven years. The investigational NASH drug that prevents expression of vascular adhesion protein 1 (VAP-1) related to liver inflammation and fibrosis currently has an ongoing Phase I clinical trial in the U.S. Its preclinical trial found the drug lessens the risk of drug-drug interaction by being highly selective on the target protein. Considering there is no NASH treatment commercialized worldwide at the moment, LG Chem is speeding up the Phase I clinical trial to complete it in the first quarter of 2022. And at the event, the Korean company also specified the plan to develop a breakthrough anticancer treatment utilizing CAR-T cell and induced pluripotent stem cell (iPSC) therapies. The presenter excitedly expressed the company’s commitment to seek a next-generation stem cell therapy using a treatment-purpose gene. President Son Jeewoong of LG Chem Life Sciences Company noted, “After the merge, the company invested approximately 600 billion won in R&D and drove the open innovation on at all corners to expand our pipeline with 40 candidate medicine. The company would leap as a global bio company with a foundation to continuously release innovative new drug to the market, and also enhance the global new drug competitiveness through constantly conducted clinical trials in the U.S.”
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- Stepped pricing to put pressure for patent challenge
- by Kim, Jin-Gu Jan 14, 2021 06:16am
- The stepped drug pricing system, revived since last July, seems to have affected the pharmaceutical industry’s patent strategy. The pricing system would create a structure to naturally diminish the drug pricing competitiveness in other companies, when 20 or more companies simultaneously and successfully challenge the patent. Pharmaceutical companies’ patent strategy originally focused on winning the preferential sales right, but the revised pricing system would unfold even more competitive patent challenge scene as the success would not only bring the preferential sales right but also more favorable generic pricing. Some complain now the companies are inevitably pressured to challenge the patent to defend the generic competitiveness. ◆Patent challenge inevitable to claim better generic pricing According to the pharmaceutical industry source on Jan. 14, the pharmaceutical companies are to face heated competition to nab the generic approval first as the stepped pricing system has been enforced from last July. The core objective of the system is to differentiate the pricing after listing a 20th product with a same substance. 53.55 percent of the original’s pricing would be applied on up to first 20 drugs to be listed. And other drugs listed afterwards would be applied with pricing lower by 15 percent each. In other words, up to 19th generics, except for the one original drug, would be able to receive the pricing level of the upper limit. Considering the reimbursement listing is decided once every month, the stepped pricing system has been technically extended to a first-come-first-served approval competition. Stepped pricing system effective from July 2020 With the shift in regulation, generic makers would be pushed to challenge patent to obtain the maximum pricing. The approval competition would be passed straight on to patent challenge competition. As for pharmaceutical companies, the regulatory change has increased the benefit in patent challenge. Previously, the benefit was limited to earning a preferential sales right, but now it can also grant the top pricing. But in the same sense, a company that did not challenge the patent would have to market their generic later and cheaper than others. ◆49 generic makers challenged Jardiance patent when new pricing system emerged Some say the patent challenge scene has gotten saturated already due to the revised pricing system. Product image of Forxiga For instance, over 60 companies, started from Chong Kun Dang, have challenged the crystalline form patent on Boehringer Ingelheim’s sodium-glucose cotransporter-2 (SGLT2) inhibiting antidiabetic treatment Jardiance (empagliflozin). Eventually, the ruling was in favor of 50 generic companies. The interesting part of the proceeding was the timing of these patent challenge cases. Most of the companies filed the patent litigations after April 2019, when the framework of the stepped pricing system surfaced. Starting from Chong Kun Dang in March 2015, 12 companies requested for the patent nullification, in which all of them lost. Three years later, Chong Kun Dang retried and requested for the negative confirmation of the scope in January 2018. The Korean company was alone during the legal case, but it won in May 2019. From June 2019, other generic makers tried their luck. 49 companies challenged the exact same patent as of August last year. The industry notes the swarm of patent challenge rushed in after the stepped pricing regulation came in sight. The majority of them were shooting for the ‘good pricing.’ A pharmaceutical industry insider explained, “Usually the patent challenge is filed within 14 days from the day of first case registration to win the preferential sales rights. But for Jardiance patent, the tens of companies jumped into the patent challenge a year and a half after Chong Kun Dang began the patent challenge.” He added, “It could be that some tried after Chong Kun Dang’s success, and some joined the legal suit to not fall behind in the pricing competition.” ◆Patent challenge could mean nothing if generic not developed before patent expiration Regardless of increased benefit in challenging a patent, some raise the voice of concern. Small and medium enterprises without the capacity to challenge the original patent argue the regulation is cutting them out of pricing competition. 25 companies have challenged AstraZeneca’s antiplatelets Brilinta (ticagrelor) and received the preferential sales rights before the patent expires late this year. The preferential sales would be protected from November this year to August next year. Assuming the 25 companies would all launch their products, other generics to be released to the market after August next year would receive already reduced pricing. And there is no guarantee of the maximum pricing to all who successfully challenged the original patent overcoming all difficulties. Product image of JardianceCurrently, 19 companies have evaded product patent on AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin) to be expired January 2024. These companies can launch their generics after April 2023. But if one of them fails to finish developing their generic by April 2023, any of other 25 companies that evaded the product patent can launch their generic from January 2024. Regardless of all resources put into the legal case, the company would lose the upper limit pricing when their generic is not ready to be launched when the patent is expires. A pharmaceutical industry insider said, “The patent challenging competition was initially intense to begin with for the sake of preferential sales right. But exclusivity in the market for nine months and receiving lower pricing are quite different story. The generic makers would now have to engage in even more fierce competition centering patent challenge.”
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- JW Pharma is speeding up the development of Dumirox·Actemra
- by Jan 13, 2021 06:12am
- Dumirox and Actemra, which are monopolized by JW Pharma's domestic development and copyright, are emerging as a possible treatment for COVID-19 On the 8th, the MFDS approved sponsor-investigator trials for patients with COVID-19 of Dumirox 100mg (Fluvoxamine maleate), an antidepressant drug. With the approval of this clinical plan, AMC will conduct a randomized, placebo-controlled method to investigate the treatment effect of Fluvoxamine maleate for 406 mild COVID-19 patients admitted to the Community Treatment Centers. Dumirox is a selective serotonin reuptake inhibitor as an antidepressant primarily prescribed for patients with depression and obsessive-compulsive disorder. It was developed by Abbott in the United States, and JW Pharma secures the exclusive copyright in Korea. It is widely known as Luvox abroad. Dumirox has already proven the effectiveness of COVID-19 treatment in overseas clinical trials. According to the online edition of the Journal of American Medical Association on November 12 last year, research has shown that Dumirox can help prevent the condition from becoming severe by significantly reducing the likelihood of hospitalization for patients with COVID-19. Eric Lenze, Wallace and Lucille K. Renard Professor of Psychiatry at the University of Washington School of Medicine, USA, conducted a clinical trial in Illinois and Missouri in 152 patients with COVID-19, mild to moderate, aged 18 years or older, in self-isolation at home. "Six out of 72 people who took placebo were classified as severely ill, whereas all 80 people taking Dumirox did not get worse," the research team said. "We found that Dumirox may reduce the risk of hospitalization and death in patients with COVID-19." Rheumatoid arthritis treatment Actemra (Tocilizumab) has been shown to lower the mortality rate of critically ill patients with COVID-19 abroad, and the UK government recommended that the treatment be prescribed for the treatment of COVID-19 starting on the 8th (local time). According to the Guardian on the 7th, a study by the Remap-Cap research team showed that the mortality rate of the group receiving general treatment was 35.8%, while the mortality rate of those receiving Actemra treatment was 28%. In addition, patients injected with Actemra left the intensive care unit 7 to 10 days earlier than the control group. In September of last year, global pharmaceutical company Roche unveiled the results of EMPACTA, the second global phase III clinical trial of Actemra, a rheumatoid arthritis treatment to be developed as a treatment for COVID-19. A total of 389 patients were studied, and the risk of dying or wearing a ventilator was 44% lower than that of placebo. The third global phase III clinical trial REMDACTA, which Roche is in cooperation with Gilead Sciences, is also raising expectations. REMDACTA is a trial that evaluates efficacy and safety as a combination therapy of Remdesivir and Actemra, and has been in progress on a total of 450 COVID-19 patients since June of last year. JW Pharma is developing a treatment for COVID-19 through its own new drug strategy. JW Pharma recently secured the right to own and use the results of a study on COVID-19 infection animal model of CWP291 from the Korea Research Institute of Bioscience and Biotechnology (KRIBB), and entered the subsequent development stage. As a result of the efficacy evaluation for the golden hamster of CWP291, a high rate of improvement in lung lesions was shown, and an excellent reduction effect was also confirmed in the amount of virus remaining in the lung tissue (PCR). This can be judged as the result obtained by the GRP78 binding mechanism that CWP291 was identified in the clinical phase I study of the existing target anticancer drug. GRP78 is reported as a host factor for several single-stranded RNA viruses, including COVID-19, MERS, Dengue, Zika, and Japanese encephalitis in many academic data.
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- Sanofi financially supports adolescent Dupixent users
- by Jan 13, 2021 06:11am
- On Jan. 11, Sanofi Aventis Korea (President Kay Bae) presented a patient drug expense support program to partially cover the cost of Dupixent Prefilled injection 200 mg (dupilumab) prescribed to adolescent patient with atopic dermatitis. The program aims to contribute in improving the patients’ quality of life by financially supporting the patients with the drug expense, and to allow them to receive the treatment at the right timing. A topical treatment Dupixent is a first ever biologic drug to be indicated to treat adolescent and adult patients aged 12 years or older with moderate to severe atopic dermatitis. After the 300 mg dose, 200 mg dose was also released to the South Korean market in last October. 200 mg of Dupixent is injected to an adolescent patient aged 12 years or older with atopic dermatitis but weighing less than 60 kg. Other adolescent patients weighing over 60 kg and adult patients are administered with 300 mg. At the moment, the drug’s National Health Insurance reimbursement covers only the adult patient. As a result, Sanofi has decided to operate a program to cover a part of the adolescent patients’ pharmaceutical expense. Patients prescribed with 200 mg of Dupixent, whose median household income level is under 180 percent. Adolescent patient with severe case of atopic dermatitis has high probability of experiencing negative social interactions, such as bullying and isolation struggling with mental issues like anxiety, inferiority and depression. The company anticipates the financial support program to not only grant access to the treatment, but also give benefit of improving the quality of life. Sanofi Aventis Korea’s Specialty Care business unit CEO Park Hee-kyung commented, “To provide treatment access to adolescent patients with moderate to severe atopic dermatitis, who are neglected from the National Health Insurance benefit, the company has decided to contribute a part of Dupixent 200 mg expense.” The company’s call center and website can be reached for any inquiry on the partial refund and expense support on Dupixent.
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- Ferring & Chong Kun Dang signed a contract for Nocdurna
- by Jan 13, 2021 06:11am
- Ferring Korea and Chong Kun Dang announced on the 11th that they have signed a joint sales contract for 'Nocdurna Sublingual Tab (Desmopressin acetate)', a treatment for nocturia. Following the signing of this contract, Ferring Korea will be in charge of marketing for general hospitals from the 18th, and Chong Kun-dang will be in charge of sales and marketing on clinics. Ferring Korea and Chong Kun Dang have been jointly selling Minirin, a treatment for nocturia since 2019. Nocdurna with an additional contract is Minirin's low-dose product. Nocdurna improves the symptoms of nocturia caused by polyuria at night, which accounts for up to 88% of the causes of nocturia. It is a new treatment that improves the safety of patients to reduce the number of nocturia in adults and improve the quality of sleep. Nocdurna 50 μg is administered once a day for men, and Nocdurna 25 μg is administered once a day for women. According to the results of the Nocdurna Phase III study, Nocdurna 25 μg and 50 μg were effective in controlling nocturia-related symptoms in women and men, respectively. Compared to placebo, Nocdurna reduced the average number of nocturia and increased the time to first nighttime urination, prolonging the initial sleep period. Compared to placebo, the quality of life and sleep quality associated with nocturia increased significantly. Yong-beom Choi, CEO of Ferring Korea, said, "We are pleased to sign a joint sales contract for Minirin and Nocdurna with Chong Kun Dang. We hope that Nocdurna will make it easier for elderly patients over 65 who are suffering from sleep disturbances due to nocturia." Chong Kun Dang CEO Kim Young-joo said, "Based on Chong Kun Dang's excellent sales force, we will do our best so that more domestic nocturia patients can Nocdurna’s benefit at clinics visited by many patients."
- Company
- Celltrion's CT-T43 was approved for Phase III clinical trial
- by Kim, Jin-Gu Jan 13, 2021 06:10am
- Celltrion announced on the 8th that it has received approval for the Phase III clinical trial plan of Stelara (Ustekinumab)'s biosimilar. Janssen's autoimmune disease treatment Stelara is a mechanism that inhibits interleukin (IL)-12·23, and has indications for psoriasis, Crohn's disease, and ulcerative colitis. It is known that global sales amount to ₩7 trillion. Celltrion plans to compare the efficacy, pharmacokinetics, and safety of CT-T43 and Stelara at 7 domestic institutions. Clinical trials are conducted simultaneously with global trials. Global clinical trials are conducted in Europe and Korea with 446 patients. Global clinical trials have already begun with European approval on December 21st last year. This phase III clinical trial aims to end in the second half of 2022. Celltrion plans to commercialize the CT-P43 in September 2023 and July 2024, when Stelara's material patents expire in the United States and Europe. Celltrion will secure a diverse portfolio in the autoimmune disease treatment market when CT-P43 is commercialized. Celltrion has two types of Remicade biosimilar Remsima (IV and SC), Herceptin biosimilar Herzuma, and Rituxan biosimilar Truxima. In addition, it is developing Humira biosimilar CT-P17 and Xolair biosimilar CT-P39. CT-P17 is expected to be approved in Europe in the first half of this year, and CT-P39 is aiming to end clinical trials in the first half of 2023.
