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- 2025-12-27 08:45:29
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- FDA approves Phase III Actemra COVID-19 trial
- by An, Kyung-Jin Mar 26, 2020 06:11am
- Actemra product image A late-phase clinical trial in patients with severe case of the 2019 novel coronavirus (COVID-19) would be conducted with Actemra, solely distributed by JW Pharmaceutical in Korea. Roche Group’s Genentech has announced on Mar. 23 the U.S. Food and Drug Administration (FDA) has approved Actemra’s (tocilizumab) Phase III clinical trial in adult patients hospitalized with severe case of COVID-19 to test the medication’s treatment effect and safety profile. The news was out three days after the company informed Actemra is in discussion with FDA about a clinical trial to confirm its effect on COVID-19. Genentech is co-conducting the study with Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Department of Health and Human Service (HHS) Office of the Assistant Secretary for Preparedness and Response. The primary and secondary endpoints are clinical status of a patient and mortality rate, and necessity of mechanical ventilator and ICU. Prior to the U.S. health authority’s approval, Actemra’s clinical trials in COVID-19 patient have been initiated globally to test effect and safety. But the study distinguishes itself from the previous studies with intricately designed protocol. Genentech stressed, “Actemra has not been indicated to treat patients with COVID-19, and its medical evidence on benefit to COVID-19 treatment has been limited.” Following the U.S. HHS’ order, the company plans to provide 10,000 vials of Actemra to the U.S. government. Alexander Hardy, the CEO of Genentech stated, “We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from COVID-19,” and “the company has decided to conduct this clinical trial in partnership with BARDA and to provide Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS” Actemra is a humanized interleukin-6 (IL-6) receptor antagonist. The subcutaneous injection is widely used to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and cytokine release syndrome (CRS). In 2009, JW Pharmaceutical has signed a deal with Chugai Pharmaceutical under the Roche Group over Actemra for the co-development and exclusive sales in Korean market. The medication was released to the Korean market from 2013, after completing a Phase III study. In July 2014, Actemra SC injection with improved patient adherence was released in the Korean market.
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- Celltrion, clinical trial in COVID-19 in July
- by Lee, Seok-Jun Mar 26, 2020 06:10am
- Chairman Jeong-jin Seo of Celltrion said on the 23rd, "This July, human clinical trials will be started for the development of COVID-19 treatments". He added, "It is possible to develop a therapeutic antibody for 1 million people per month after human administration". Chairman Seo shared this business plan through an online press conference held on the same day. According to the company, Celltrion is developing antibody treatments from February to receive COVID-19 confirmed patient's blood. Currently, 300 candidates have been obtained. Antibodies with excellent virus neutralization ability will be selected by April. It is administered to patients as early as mid-July. Celltrion will begin production of cell lines for mass production of antibodies from May, and production of clinical substances to be administered to the human body will be completed by mid-July or end of July. After the human administration has started, it will develop a therapeutic antibody for 1 million people per month. Antibody means an immune protein that binds to an antigen and interferes with the action of the antigen or removes the antigen. Overseas, Genentech and Eli Lilly are developing COVID-19 antibody treatments. The rate of antibody therapeutic development was the fastest. "COVID-19 neutralizing antibody therapeutics are being developed by five companies, including Korea Celltrion, two global large pharmaceutical companies, and two overseas biotechs", said Seo. He added that "Celltrion can be competitive in future developments due to its mass production capacity. In case of emergency, it has also planned to prepare for supply by using CMO partners". Celltrion also undertakes 'super antibody' screening to neutralize various coronaviruses (mutations, etc.). "In March, we will be screening for super antibody screening that neutralizes the COVID-19, as well as the SARS and even the common cold-causing corona virus. We will collect more blood samples and go ahead in speed", he said. It accelerates the development of the COVID-19 diagnostic kit prototype. The product that Celltrion is developing is a method to detect the S protein that is only present in COVID-19. It is different from the existing rapid diagnosis kit that detects the N protein commonly held by various types of corona viruses. "The Celltrion kit is expected to show performance close to RT-PCR, a standard diagnostic method for COVID-19 positive. 15-20 minutes is enough for test results, so it has the advantage of being able to check the test results on the spot". It is planned to apply for CE certification for export to Europe by completing the production of prototypes in late April and completing clinical trials by the end of May through collaboration with specialized companies.
- Company
- Balloon effect from impurity measures?
- by Chon, Seung-Hyun Mar 25, 2020 06:03am
- Recently, the number of new anti-ulcer drugs that enter the market is rapidly increasing. As the alternative drug market expanded after the Ranitidine’s withdrawal due to excessive detection of impurities in September last year, pharmaceuticals are also actively targeting the generic market. In addition to H2 receptor antagonists such as Famotidine and Laputidine, similar generic products such as Esomeprazole and Artemisia Princeps have also increased significantly. It is pointed out that the generic turmoil in the similar drug market is intensifying due to the balloon effect following the government's strong follow-up of impurities. According to the MOHW's revised notice on a partial revision of Criteria for pharmaceutical reimbursed list & reimbursed upper limit table, from April 1, 9 generic products of “Famotidine 20mg” will be listed on the pharmaceutical reimbursed list. Mirae Pharm, TDS Pharm, Theragen Etex, CMG Pharma, PMG Pharm, SCD Pharm, Daehan New Pharm, and Daewoong Bio sell Famotidine product. Kukje pharm, Arlico, Newgen Pharm, Korea Prime Pharm, Medix Pharm, Eden Pharma, Youngil pharm, Generic products with 'Laputinine', which were approved by eight companies including Kukje pharm, Arlico, Newgen Pharm, Korea Prime Pharm, Medix Pharm, Eden Pharma, Youngil pharm, were also newly added to the list. Famotidine and Laputidine are H2 receptor antagonist drugs and are used for gastric ulcer and duodenal ulcer. It is analyzed that drug companies are actively entering the alternative drug market since last year's banned sales of Ranitidine. The MFDS banned the sale of all products of 'Ranitidine' in late September last year. The market was virtually decided to exit due to the excess detection of the carcinogen N-nitrosodimethylamine (NDMA). September 2019 and April 2020 Famotidine 20mg (left) and Laputidine 10mg (right) Number of health insurance benefits registered (Unit: number, Data: the HIRAAccording to the HIRA, on September 1, last year, a total of 35 other companies were listed for Famotidine 20mg before the ban on the sale of Ranitidine was imposed. However, Famotidine 20mg, listed on April 1, increased 56 companies by 60%. In the case of Laputidine 10mg, the number of products on the reimbursed list increased 11 products from 29 in September last year to 40 in April. The surge in prescriptions of similar drugs after the ban on the sale of Ranitidine drugs is also analyzed as a factor that has pushed the market for pharmaceutical companies. According to UBIST, a pharmaceutical research institute, in December of last year, Outpatient prescriptions for five components, except Ranitidine, of H2 receptor antagonists such as Famotidine, Laputidine, Nizatidine, Cimetidine, and Roxatidine, were ￦10 billion. The prescription size soared 69.5% from August before the occurrence of impurities. The growth of Famotidine and Laputidine was steep. In December of last year, the prescription scale of the single component of Famotidine was ￦3.1 billion, more than three times higher than in August. The size of prescription for Famotidine last year was ￦17.5 billion, an increase of 38.0% compared to the previous year. In December last year, the amount of outpatient prescription for Lafutidine increased by 131.8% from August to ￦3 billion. As the prescription size of Famotidine and Laputidine expanded due to the reflex profit from the withdrawal of Ranitidine, pharmaceutical companies’ market activity was also active. Trends in monthly outpatient prescriptions by component of major H2 receptor antagonists (Unit: ￦1 million, Source: UBIST) Other drugs with similar uses to Ranitidine have also seen a significant increase in the number of generics. In the case of Esomeprazole 20mg (generic for Nexium) increased 16 from 108 to 124 on the benefit list in September. Esomeprazole is a proton pump inhibitor (PPI) -based drug and is most often used as an anti-ulcer agent. Esomeprazole also enjoyed the Ranitidine reflex benefit. Esomeprazole's prescription amount last year was ￦189.3 billion, up 17.1% from the previous year. Esomeprazole's prescription amount increased 20.6% from ￦15.1 billion in September last year to ￦18.2 billion in one month. In December of last year, it exceeded ￦20 billion. September 2019 and April 2020 Artemisia Princeps 90mg Health Insurance Benefits Registered (Unit: pcs, Source: the HIRA)The number of generics participating in the gastritis treatment Stillen market is also on the rise. Stillen is a gastritis treatment with 'Artemisia Princeps' as an active ingredient. Last year, the prescription size of Artemisia Princeps increased by 17.4% from the previous year to ￦87.5 billion. In September of last year, 15 Artemisia Princeps 90mg products were listed, which rose 73% to 26 in 7 months. The industry also complains that the government has been pushing the generics market for alternative medicines as a result of strong measures against impurity medicines. All products of Ranitidine have been discontinued in Korea, while pharmaceutical manufacturers have recovered their products by lot number in the US and Europe. The domestic market containing Ranitidine is about ￦200 billion per year. It is a reality that pharmaceutical companies that have suffered losses due to the sale of Ranitidine have a strategy to make up for other products. An industry insider said, “Excluding all products that have not been found to be harmful to the human body, considerable losses were inevitable and forced to compete in similar markets to make up for the losses”. The US Food and Drug Administration (FDA) issued a statement in November last year that "the hazards of NDMA detected in Ranitidine are comparable to those exposed when eating roasted or smoked meat". An official from a pharmaceutical company criticized, "The ban on the sale of all Ranitidine products in Korea also caused an excessive number of generics".
- Company
- Jina Lee at Bayer stepped up as CEO of Thai Corporation
- by Eo, Yun-Ho Mar 24, 2020 05:20am
- 이진아 총괄Jina Lee, Health BU Head at Bayer, will be represented as the CEO of Thai corporation. Bayer Korea recently announced in its internal announcement that Jina Lee will be appointed as the CDH (Country Division Head) of the Thai Pharmaceutical Division. However, due to the aftermath of COVID-19, the exact departure schedule and the like have not been confirmed. Jina Lee, graduated from the Department of Pharmacy at Duksung Women's University, joined Merck Sereno in 2006 after joining Roche Korea in 1994 and joined Bayer in 2013 as Heart Health BU Head at Bayer. In 2018, she dispatched to Germany's head office marketing department, gained her experience, and returned to a Korean corporation in February last year. From October of last year, she was also a temporary representative for the pharmaceutical business division of a Korean corporation because former Ingrid Drexel was announced as a Turkish corporation. The Korean subsidiary later appointed the new CEO Freda Ta-Ling Lin in December of last year. Meanwhile, Bayer is divided into subsidiaries in the fields of medicine, chemical, and animal medicine such as healthcare, crop science, and material science. After joining Bayer, Jina Lee is said to be leading the cardiovascular business unit, and it is considered to be the leader of the growth of Xarelto (Rivaroxaban).
- Company
- Multinational Pharmaceuticals, COVID-19 Relief Goods
- by Eo, Yun-Ho Mar 24, 2020 05:19am
- Multinational pharmaceutical companies make donations to overcome COVID-19 crisis. According to the related industry, Korean corporations from multinational pharmaceutical companies such as Novartis, Mundipharma, Bayer, and Ferring, including the Korean Research-based Pharma Industry Association (KRPIA), have supported donations and relief supplies this month (March). Novartis recently donated 30,000 masks to the vulnerable. For the vulnerable people who are having difficulties in supply and demand, the company has delivered masks supported by the global headquarters to the KOREA PHS. The KOREA PHS is sponsoring educational and social welfare organizations approved by the MOEL, and are carrying out various sponsorship projects for the health and safety of the vulnerable to overcome this situation. On the 18th, Mundipharma donated a sanitary product kit to overcome COVID-19 crisis to the Seoul branch of the KACCC. Hygiene kits have been prepared to help personal hygiene management, such as washing hands of children and adolescents, in a situation where it is difficult to secure a quantity due to the recent increase in demand for hygiene products. the KACCC is a non-profit organization that provides integrated education and social welfare services to help children and adolescents in need of social care throughout the country enjoy a safe and happy life. Hygiene products will be delivered to each child center in the Seoul area and will be provided to children in need. Pharmaceutical companiesIn the case of Bayer, opinions were collected for each division. The company's contrast agent’s business division supported 280 contrast agents worth ￦13 million for chest coronary augmentation in severe COVID-19 infected patients through the Korean Open Doctors Society composed of medical workers. In addition, Bayer Healthcare recently provided 500 Redoxon vitamins to the Wolseong Social Welfare Center to support overcoming COVID-19 crisis in the Daegu region, which is struggling with the massive spread of COVID-19. Ferring Pharmaceuticals purchased 2,000 hand sanitizers and 200 protective clothing as donations from employees who voluntarily raised them, and donated them to the Daegu Metropolitan City Office's Disaster Safety Response Headquarters on the 5th. This donation started with the suggestion of one employee, and the purpose was to help the Daegu and Gyeongbuk areas, which suffered the most from the COVID-19 crisis. The KRPIA, a representative organization of multinational pharmaceutical companies, decided to donate ￦100 million to the Korean Red Cross so that they could be used at the COVID-19 quarantine site. Individual donations of pharmaceutical's employees are also conducted. If employees participate in a small fundraising, the KRPIA will add donations to the matching fund. The donations are sent to the Senior Citizens Support Center for Living Alone, which is affiliated with the Ministry of Health and Welfare, and are used to purchase emergency kits for food and beverages and supplies for health aids to the elderly living alone in vulnerable groups, including Daegu and Gyeongbuk. Avi BenShoshan, President of the KRPIA said, "Global pharmaceutical companies, as part of the Korean society, will strive to contribute to the efforts of various local communities to overcome COVID-19. We will accelerate our R&D activities to develop vaccines and therapeutics that are our duties".
- Company
- Listed ovarian anticancer Zejula applies for new indications
- by Eo, Yun-Ho Mar 23, 2020 06:28am
- PARP inhibitor Zejula Anticancer treatment Zejula, listed for pharmaceutical reimbursement last year, is now preparing for expanded label. According to related industry on Mar. 23, Takeda Pharmaceuticals Korea has recently submitted an application to expand reimbursement on DNA repairing Poly ADP-ribose Polymerase (PARP) inhibitor Zejula (niraparib). The anticancer treatment is targeting two additional indications; monotherapy for the maintenance treatment of BRCA-negative patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy; and monotherapy to treat relapsed ovarian cancer after receiving third or later-line chemotherapy. Zejula is the first PARP inhibitor, used regardless of BRCA, indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian (fallopian tube or primary peritoneal cancer), who are in response (complete or partial) to platinum-based chemotherapy in Korea last March. Although it was listed for reimbursement last December, the first reimbursement standard is limited to patients with BRCA mutation. However, in major clinical studies, Zejula has demonstrated outstanding improvement on median Progression-Free Survival (mPFS) against placebo. For the fourth-line treatment indication was based on mutlicenter, open-label QUADRA study in adult patients with ovarian cancer, who have received third or later-line treatment. During the clinical study, Zejula demonstrated clinical efficacy with an object response rate (ORR), a primary efficacy endpoint. The patient group with platinum-sensitive homologous repair deficiency (HRD) demonstrated ORR of 24 percent, where as BRCA-positive platinum-sensitive group, BRCA-positive platinum-resistant group and BRCA-positive platinum-refractory group recorded ORR of 39 percent, 29 percent and 19 percent, respectively. And median duration of response (mDOR), a secondary efficacy endpoint, of Zejula was 8.3 months for platinum-sensitive HRD patient group. The study concluded the treatment’s safety profile can be adequately managed with adjusted dosage. Zejula was listed for reimbursement at a price of 76,400 won. The Korean health authority evaluated the treatment is more cost-efficient than AstraZeneca’s Lynparza (olaparib). But because Lynparza was listed with risk sharing agreement (RSA) and pharmacoeconomic evaluation-exemption track, the identical expenditure cap RSA was applied on Zejula as well.
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- Chong Kun Dang co-market Xofluza with Roche
- by Chon, Seung-Hyun Mar 23, 2020 06:27am
- Chong Kun Dang announced on the 19th that it recently signed a joint sales contract with Roche Korea for domestic distribution of the influenza treatment drug 'Xofluza'. Xofluza by RocheRoche Korea and Chong Kun Dang jointly handle marketing and sales of Xofluza, and Chong Kun Dang is responsible for distribution. Xofluza is a drug used to treat influenza virus A/B infection in adolescents and adults over 12 years of age. This product has attracted attention as a new antiviral drug with a new mechanism of action developed after about 20 years since Tamiflu. Unlike conventional oral influenza treatments, which had to be administered for 5 days, Xofluza improved medication convenience so that it could be treated with only one dose. After taking it, it is evaluated that the symptom relief rate is fast and the time to stop the influenza virus detection is shortened. Nic Horridge, President of Roche Korea, said, "Xofluza is an influenza treatment with a new mechanism of action that suppresses the replication of influenza viruses. It has the convenience of a single dose. In cooperation with Chong Kun Dang, who has expertise in sales and marketing, we will present solutions to treatment areas that the existing antiviral drugs have not met and contribute to the promotion of public health”. President Young-ju Kim of Chong Kun Dang said, “We have continued to cooperate with Roche Korea in 2012 by jointly selling Tamiflu for the treatment of influenza. It is expected that this agreement will further strengthen cooperation between the two companies and show synergy”.
- Company
- Daewoong vs Allergan, patent dispute for two years
- by Kim, Jin-Gu Mar 20, 2020 06:25am
- Belkyra (double-chin reduction treatment)The patent dispute between Daewoong Pharmaceutical and Allergan surrounding double-chin reduction treatment 'Belkyra' has not been concluded for the second year. According to the pharmaceutical industry on the 19th, the dispute began in March 2018, two years ago. Daewoong Pharmaceutical filed an invalidation trial of patents for Belkyra against Allergan. In April, the next month, a defensive confirmation trial for the scope of rights was filed. However, even after two years, the referee hasn't even reached a first-final conclusion. It is the consistent evaluation of industry officials that it is unusual, considering the fact that if a normal patent dispute is short, the conclusion can be reached in four months. That doesn't mean that the fights between the two sides are very intense. Of the two referees, only one oral hearing was conducted recently at the invalidation trial. There has not been a full-fledged dispute in a defensive confirmation trial for the scope of rights. In the industry, it is interpreted that the respondent, Allergan, is using a 'time-wasting' strategy. So far, the evaluation that the strategy has worked is dominant. In a defensive confirmation trial for the scope of rights, Allergan submitted 'application for designated period extension' four times over two years. The judges accepted it. In the invalidation trial, Allergan made the same attempt three times. Allergan's time-wasting strategy is also confirmed in the divisional patent application. Allergan registered a new patent of Belkyra on January 9 this year. Some of the existing patents were divided and registered as new patents. It was part of the 'Evergreening strategy' that continues its existence through the split registration. In the patent trial and patent registration, the time-wasting strategy is developed in two tracks. Eventually, Daewoong Pharmaceutical presented a new challenge to the split patent. Daewoong Pharmaceutical raised a judgment to confirm the passive scope of rights. in the new Belkyra formulation patent on the 17th. In conclusion, there are three patent disputes between Daewoong Pharmaceutical and Allergan in Belkyra. The key is the invalidation trial. It is expected that the rest of the judgment will be decided in a similar way depending on the conclusion of the Judge by the Patent Judge. In the industry, the invalidation trial is expected to proceed in earnest. Actually, the Patent Judge showed the will to continue the hearing by changing and designating the judge on the 4th of this month. It is said that oral hearing has also been recently conducted. An official from the pharmaceutical industry said, "It is judged that an active time-wasting strategy was effective in defending the patent strategy (Allergan).However, considering that the oral hearing has recently been held, it is expected that the referee, who has drawn for over 2 years, will accelerate".
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- Salespersons got worked up about pharmacy’s poor sales
- by Jung, Hye-Jin Mar 19, 2020 06:26am
- Pharmaceutical industry sales managers are also suffering from the economic downturn in the medical institution caused by the aftermath of COVID-19. This is due to the fact that some retail pharmacies refuse to pay monthly payments to pharmaceutical salesmen due to a decrease in prescriptions. Even at the end of February, quite a few managers had trouble collecting the bills. However, with the prolonged COVID-19 situation, there are not a few pharmacies that already have difficulty making payments in March, so pharmaceutical companies are suffering in silence. According to the pharmaceutical industry on the 18th, there are quite a few pharmacies that will delay drug payments to pharmaceutical companies due to sluggish sales. In particular, pharmacy managers not only provide product descriptions, but also discuss the details about pharmacy matters and help pharmacists and pharmacy staff, and even after COVID-19 , the main job changed from general medicine promotion to procurement and sales of masks. The biggest concern for pharmaceutical pharmacy managers right now is collection in March. It is known that a number of pharmacies are notifying that it will be difficult to make payments in March. In fact, it is known that the average prescription received in March has been reduced to less than 100 prescriptions/day in one ophthalmology center around Seoul. It is a prescription that came out in close to 300 cases/day in the same month last year. Another pharmacy located in Seoul, also said that prescriptions per day plummeted from 250 to 100 cases per day. Although it varies by region and condition, most pharmacies are suffering from a decrease in patient sales and a drop in prescription sales due to COVID-19. “We had a hard time collecting pharmacies in the last week, even last month when the COVID-19 issue began to take off”, said one pharmaceutical company representative. "Some employees delayed the payment of pharmaceutical companies because of difficulties in pharmacies, so it was said that they gave up about half of their pharmacies". As a result of summing up the prescription trends of the pharmacies he was charge of, the representative said that the decrease in sales was a general phenomenon in the pharmacy. In particular, pharmacies with more than half the number of prescriptions reduced are noticeable. "It's hard to whinge about this situation even worse at a pharmacy," said a representative in charge. Many pharmaceutical companies are working from home, but even this is far from Salespersons. Prior to the sale of public masks, pharmacies requested more masks, so some sales representatives lined up in front of markets and household goods stores to obtain masks. Since the pharmacy started selling public masks, there are a number of pharmaceutical companies in charge of mask packaging, social security number identification, and mask sales.
- Company
- Samsung Biologics, CDO for alzheimer's treatment
- by Lee, Seok-Jun Mar 19, 2020 06:26am
- Samsung Biologics announced on the 17th that it has signed a CDO(Contract Development Organization) partnership with Aprinoia, a Taiwanese company that is developing Alzheimer's treatment. Aprinoia is a Taiwanese bio-venture with specialized technology in developing medical equipment and therapeutics for the diagnosis of degenerative neurological diseases. It is considered a leader in the development of 'tau protein' target antibodies that have been identified as a key cause of Alzheimer's. Samsung Biologics signed a contract to develop a candidate cell line for Aprinoia’s Alzheimer treatment, and provide development services ranging from process development, clinical sample production, and clinical trial planning (IND) submission. In addition to Aprinoia, Samsung Biologics is also undertaking contracts with more than 20 Chinese customers. To date, Samsung Biologics has conducted a total of 48 CDO projects, supporting bioventure drug development and globalization, including clinical trial approval applications and license out support.
