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- 2025-12-26 22:50:17
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- Lilly's Olumiant, is clinically approved for COVID-19
- by Kim, Jin-Gu Sep 18, 2020 06:30am
- Olumiant Eli Lilly's autoimmune disease treatment 'Olumiant (Baricitinib)' has begun phase III clinical trial targeting COVID-19 patients in Korea. It is the second clinical trial in Korea related to COVID-19 after Remdesivir by Gilead Science. On the 7th, the MFDS approved a phase III clinical trial plan of Baricitinib (LY3009104) in Lilly Korea for COVID-19 patients. This clinical trial is part of Lilly's global phase III clinical trial. It will be held from this month to next October, and the size of the clinical trial is 600 sujects. Among them, 15 domestic patients are expected to receive medication at Ajou University Hospital. Lilly has already started clinical trial in the US and Europe since last June. According to the company, Olumiant is expected to be able to reduce cytokine storms, one of the symptoms of infection complications caused by COVID-19. In clinical trials previously conducted in Italy, etc., positive results were found in improving the symptoms of COVID-19 patients. The most representative study was conducted in 7 hospitals in Italy from February 20 to March 15 this year. It was published in 'The Journal of Infection' on the 23rd of last month. The researchers administered Olumiant and Kaletra (Lopinavir + Ritonavir) together to 113 patients for 2 weeks in 192 COVID-19 patients, and only Kaletra to the remaining 78 patients. Olumiant Kaletra Lopinavir / Ritonavir As a result, the mortality rate, the intensive care unit admission rate, the discharge rate, and COVID-19 virus detection rate were all positive in the group administered with Olumiant. As for the mortality rate, there were no dead patients in the Olumiant co-administration group, while 5 (6.4%) died in the control group. There was also no intensive care unit admission rate in the co-administration group, whereas 14 patients (17.9%) in the control group occurred. As for the discharge rate, 88 out of 113 patients in the co-administration group were discharged, recording 77.9%, whereas in the control group, 10 out of 78 patients were discharged, which was 12.8%. Two weeks after treatment, the detection rate of COVID-19 was 12.5% in the co-administered group and 40% in the control group. Results of a study on the therapeutic effect of COVID-19 in the combination of Olumiant + Kaletra (Data The Journal of infection) Remdesivir is the only treatment for COVID-19 officially recognized in Korea so far. It is expected to be the second treatment if Olumiant finishes phase III clinical trial and obtains approval as a treatment for COVID-19. Remdesivir In the case of Remdesivir, the effect of shortening the hospital stay has been proven in clinical trials. However, it failed to prove the improvement in mortality. If Olumiant proves an improvement in mortality in this clinical trial, it is expected to receive more attention than remdesivir.
- Company
- Julien Samson will be relocating to the UK headquarters
- by Eo, Yun-Ho Sep 18, 2020 06:29am
- Julien Samson According to related industries, GSK Korea held a town hall meeting on the 16th, and Julien Samson, announced that his current term of office as the head of the Korean subsidiary will be ended in this November. Julien Samson will be relocating to the UK headquarters in December. The successor to lead the Korean subsidiary was Robert Kempton, vice president of the current North Carolina branch. He joined GSK as a field vice president, with responsibility for sales of GSK's ELLIPTA portfolio in 2017 and is currently serving as vice president, global commercial lead, specialty medicine related to infectious diseases from 2018 to the present. Julien Samson, who has been leading GKS Korea since February 2018, was the first foreign president of a domestic corporation. The company has appointed President Hong Yoo-seok in 2014 after former chairman Jin-ho Kim, who has been leading the company since GlaxoWellcome, and CEO Julien Samson was appointed as CEO of GSK Canada's pharmaceutical business (treatment and vaccine) corporation in 2018. After working in public hospitals and government agencies in France, he joined GSK in 2012, and recently, he was in charge of establishing a global sales marketing strategy at the GSK respiratory disease business headquarters in the UK headquarters. Meanwhile, the head of MSD's Korean subsidiary is also replaced. Avi BenShoshan (49), the current CEO, will move to the US headquarters as of November, and MSD Korea will appoint Kevin Peters, the current president of MSD Thailand, as its successor president. With the overseas appointments of Avi BenShoshan and Julien Samson, the composition of the KRPIA’s council is also predicted to change. Abi Benshosan is currently chairman of KRPIA, and Julien Samson is vice chairman.
- Company
- “APAC countries need NPM in the age of expensive drugs”
- by Eo, Yun-Ho Sep 17, 2020 06:30am
- A pharmaceutical industry expert suggested Asian-Pacific countries should also take novel payment models into account in this age of high-cost drugs. On Sept. 16, the ‘International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific 2020’ hosted a web session on ‘ICER Threshold for Innovative Medicines – Harmonization with Novel Payment Model (NPM).’ A presenter for the session, Dr. Kevin Haninger of the Pharmaceutical Research and Manufacturers of America (PhRMA) explained about the concept of NPM and introduced various cases in HTA countries including Canada, Australia and the U.K. Following are the NPM types Dr. Haninger talked about; Combination-based pricing: This NPM type grants pricing specifically based on a drug the applicant drug is combined with. For instance, the pricing of ‘Drug A’ would differ when it is used alone, or used in combination with ‘Drug B.’ Switzerland and Italy are using the NPM type at the moment. Indication-based pricing: Considering the number of drugs expanding its indication is increasing lately, the NPM differentiates a drug’s pricing depending on the level of innovativeness each indication has. Such NPM was addressed during recent talks on expanding indications for an immunotherapy, and Korean Research-based Pharmaceutical Industry Association (KRPIA) has also proposed it to the South Korean health authority as an amendment to the current regulation. At the moment, Australia, Switzerland, the U.S and other countries have adopted the system. Outcome-based payments: An outcome-based payment model is also used in South Korea, as a type of risk sharing agreement (RSA). The model allows the health authority to share the risk in pricing depending on the level of demonstrated drug efficacy. Roche’s immunotherapy Tecentriq has received healthcare reimbursement after accepting the differentiated reimbursement coverage based on patient reaction rate. Over-time payments: The model applies stepped pricing and offers payment installments depending on the patient’s administration period. This type has been suggested when discussing reimbursement on one-time treatment Zolgensma treating spinal muscular atrophy (SMA) or CAR T-Cell therapy. The U.S. and Italy are currently using the system. Reviewing each model, Dr. Haninger recommended using the combination-based pricing and indication-based pricing. According to him, only Australia among all Asian-Pacific countries has implemented the NPM types. He elaborated, “As more and more innovative but expensive treatments are developed, we to think of more broadened approach. Currently, most of Asian-Pacific countries are highly dependent on incremental cost-effectiveness ratio (ICER) threshold based on quality-adjusted life-year (QALY), which hinders improvement in patient’s treatment access.” “By applying various NPM, the health authorities should strengthen medical accessibility in general. NPM can be a solution for the delayed reimbursement listing procedure caused by foreign governments referring to pricing in other countries,” he added.
- Company
- Hanmi promotes clinical use of Keytruda & FLX475
- by Sep 17, 2020 06:29am
- Hanmi is entering a phase II clinical trial that uses a combination of CCR4 target oral immuno-cancer drug (FLX475), which is being developed in Korea, and MSD's immuno-cancer drug Keytruda (Pembrolizumab). To this end, Hanmi announced on the 15th that it has signed a contract with MSD to supply Keytruda for clinical cooperation and clinical cooperation with FLX475-Keytruda. In the first half of next year, Hanmi plans to start phase II in Korea and China, which measures the efficacy and safety of combination therapy for gastric cancer patients in Korea and China. Keytruda, which is necessary for clinical use, is provided by MSD for free. FLX475 is the first oral regulatory T-cell inhibitor developed by US biotechnology company RAPT Therapeutics, and Hanmi secured exclusive rights for development and commercialization in China, including Korea, Taiwan, and Hong Kong by transferring this candidate substance from RAPT Therapeutics last December. Although the prevalence of gastric cancer in Korea is the second largest among all carcinomas, there are limited known appropriate treatments. Hanmi expects this clinical trial to be a test that can confirm the value of the combination therapy of FLX475 and Keytruda in the field of gastric cancer. Se-Chang Kwon, President of Hanmi, said, "As Korea is the country with the highest incidence of gastric cancer in the world, the clinical development of these two drugs is expected to be an innovative treatment option for patients in need of treatment. We will do our best to obtain rapid development and approval." Hanmi is currently building and developing around 30 innovative new drug pipelines in the fields of metabolic diseases, anticancer and rare diseases such as NASH, and is continuing its efforts to expand its innovative portfolio of anticancer drugs through open innovation. Based on multilateral cooperation with various partners, the anticancer pipeline will be further strengthened.
- Company
- Sanofi, to supply flu vaccine, Vaxigriptetra nationwide
- by Sep 17, 2020 06:29am
- Sanofi Pasteur (CEO Pascal Robin) announced on the 15th that it has supplied the flu vaccine 'Vaxigriptetra' nationwide. Sanofi Pasteur said that this year's flu vaccine is included in the NIP, and as the number of recipients expanded due to the spread of COVID-19, patients in need of flu prevention can receive the vaccine on time. Vaxigriptetra can be inoculated at public health centers, consigned medical institutions, and major hospitals and clinics from this day. Sanofi Pasteur selected Singer Song Ga-in, friendly to all ages, as a model of Vaxigriptetra to actively promote the importance of preventing flu, which is emphasized by COVID-19. It conveys the message, 'This year's flu prevention is not an option, it is essential.' It is said that Song Ga-in's positive image across all generations and particularly favorable to the elderly and chronically ill patients who need flu prevention, effectively conveyed the message 'Flu prevention is essential'. Vaxigriptetra was conducted in 6 large-scale global clinical trials (4 continents including Europe, Asia, South America, Oceania, etc.) with more than 13,000 participants. Good immunogenicity and safety data were confirmed. Vaxigriptetra is an imported finished product that Sanofi Pasteur, a global vaccine specialist with 120 years of tradition, completes from raw material to packaging at a production facility in France and supplies it to Korea. Sanofi Pasteur supplies the flu vaccine to 150 of 227 countries (about 66%) worldwide. "Flu prevention is more essential than ever to support the healthcare system in the threat of COVID-19," said Pascal Robin, general manager of Sanofi Pasteur. “It is important to recognize that people can play a major role in building immunity to protect themselves, their families, and those vulnerable to infection,” he added.
- Company
- Growth hormone market fluctuates with Pfizer’s supply issue
- by Kim, Jin-Gu Sep 17, 2020 06:29am
- The growth hormone injection market generating annual sales of 150 billion won had a fluctuating sales rank in the first half of the year. While LG Chem is still leading the market, Pfizer in the second place was dropped to the fifth place due to its global supply suspension. On the contrary, LG Chem, Dong-A ST and Novo Nordisk boosted their sales amid Pfizer’s absence. According to a pharmaceutical market research firm IQVIA on Sept. 15, the growth hormone market was valued at 77.3 billion won in the first six months of this year. The figure grew by 10 percent from 70.1 billion won in same time last year. The growth hormone market is growing every year. The annual sales in 2015 marked 76.3 billion won and reached 91.7 billion won, 101.8 billion won, 126.6 billion won, and 145.7 billion won in 2016 through 2019. The market predicts the sales would break through the 150 billion won mark this year. Growth hormone injection market sales growth in last five years (Unit: KRW 100 million) Source: IQVIA LG Chem has been topping the market with its lineup of Eutropin, Eutropin Plus and Declage. In the first half of the year, the three products generated total 29.8 billion won, which surged by 28 percent from same time last year at 23.2 billion won. Except for the market leader, the leader board had a major shuffle. Pfizer’s Zinotropin that used to be in the second place climbed down to the fifth, but Dong-A ST’s Growtropin, Merck’s Saizen, and Novo Nordisk’s Norditropin jumped up the ladder. Pfizer’s Zinotropin barely made 6.7 billion won in the first half of the year. Compared to 14.7 billion won made last year, it took a steep 54-percent (8 billion won) fall. The market experts analyze the sudden drop in Pfizer’s sales was impacted by the drug supply issue prevalent around the world. Late last year, the global company headquarters halted the supply, when a regular check up confirmed the risk of affecting the product quality found in the production line located in Belgium. With already distributed stocks in South Korea, Pfizer’s sales were not significantly affected until the fourth quarter last year, but it eventually got crippled in this year. Regarding the issue, Pfizer Pharmaceutical Korea official said, “The supply to Korea has been resumed from May,” and “The company is expecting the sales to recover in the latter half of the year.” Top growth hormone product sales from 2015 H1 through 2020 H1 (Unit: KRW 100 million) Source: IQVIA Due to Pfizer’s supply issue, Dong-A ST and Novo Nordisk had the window of opportunity to leverage their sales. Dong-A ST’s Growtropin sales marked 15.9 billion won and instantly came in second. In same time last year, the injection made 12 billion won and placed itself in the fourth place. On the other hand, Novo Nordisk’s Norditropin sales reached 10.2 billion won and took the fourth spot. Compared to last year making 5.9 billion won, its sales skyrocketed by 72 percent. The market experts see the injection to have benefited the most from Pfizer’s supply gap. But apparently, Merck’s Saizen did not get to benefit from Pfizer’s suspended supply. In last year, the company was in the third place, but the sales dipped by 1 percent from 12.7 billion won to 12.5 billion won. Moreover, SciGen Korea’s Scitropin made 1.3 billion won, and Ferring Korea’s Zomacton made 900 million won. A pharmaceutical industry insider explained, “Regardless of declining birth rate, the growth hormone market has been surging as the expanded healthcare reimbursement was granted since last year,” and as “Pfizer took a hard hit with the supply issue in the first half of the year, its competitors aggressively tackled the market.”
- Company
- Where can clinics get flu vaccines?
- by Sep 16, 2020 06:26am
- "All pharmaceutical companies say they don't have flu vaccine stock. I am already worried because the quantity I received from the public health center is small." A Doctor of Clinic A in Seoul said in this way that he called all of the sales staff at pharmaceutical companies that supply flu vaccines, but said it was hard to get supplies. Due to COVID-19, flu vaccine shortages are occurring as expected. Pharmaceutical companies have increased production compared to last year in anticipation of an increase in demand this year, but supply is rapidly exhausting. This is because the private market volume has drastically decreased as the number of people eligible for NIP increased. It is estimated that about 19 million people are eligible for free vaccination this year. It is an increase of 5.19 million people from the previous year. There are many clinics and hospitals looking for supplies, but the supply of them is insufficient. Online orders were sold out as soon as the quantity was released, even though the number of purchases per person was limited to 100. Salespeople in charge receive dozens of inquiries a day asking for flu vaccines. Mr. B, an employee in charge of the flu vaccine sales, said, “Calls are pouring out at the local hospital asking if there is a vaccine. I am sorry that the supply has been exhausted” "It is being used up faster than ever since it was operated with only 70% of the volume than last year," he complained. He added, "Even clinics and hospitals with an existing transaction history can only place orders for About half of last year's amount." There are also frequent inquiries through employees of other pharmaceutical companies because some clinics and hospitals do not have or limited deals with flu vaccine vendors and can not obtain quantities. Mr. C, an employee who sells flu vaccines, said, “I get a lot of calls from third-party employees of other companies contacted by a hospital they are acquainted with.” Some hospitals even raged when the stock was not available. If the salesperson in charge tells them that there is no stock available, the clinic or hospital calls the senior executive of the pharmaceutical company to fire the person in charge or gets angry. An official from a flu vaccine manufacturer said, "There are many hospitals that want to secure supplies in advance in a pandemic situation. Since the vaccine is still in the early stages of supply and shipments are being released every week, the shortage phenomenon will get better sooner or later."
- Company
- Talks on new payment system in the age of high-cost drugs
- by Eo, Yun-Ho Sep 16, 2020 06:25am
- Pharmaceutical experts are initiating talks on setting adequate Incremental Cost-Effectiveness Ratio (ICER) threshold to design a new payment model fitting the age of high-cost drug. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific 2020, convened online from Sept. 14 through 16, would be hosting a session titled ‘ICER Threshold for Innovative Medicines – Harmonization with Novel Payment Model (NPM)’ on Wednesday. Most of health authorities in countries currently using Health Technology Assessment (HTA) provide refund to pharmaceuticals that have proved clinical benefit and cost-effectiveness during an assessment process. However, the pharmaceutical industry has been insisting that a practical solution is needed for the latest biopharmaceutical-focused pipelines relatively more expensive than the conventional chemical drugs. At the session facilitated by Professor Suh Dong-churl of Chung-ang University College of Pharmacy, Dr. Kevin Haninger of the Pharmaceutical Research and Manufacturers of America (PhRMA) would explain about the concept of NPM and introduce various cases in HTA countries including Canada, Australia and the U.K in terms of harmonizing ICER threshold with other indicators used to decide healthcare reimbursement. After the presentation, a panel discussion would be held with representatives from the industry, government and academia. As a panelist for the pharmaceutical industry, Senior Director Kim Eunsuk of MSD Korea would point out the limitation of the current HTA system in South Korea and address the rationale of flexible ICER threshold. Director So Soomi of Health Insurance Review and Assessment Service (HIRA) as a government panelist would share the prospective approach the agency is planning to take for the payment system as well as the NPM implementation plan. Initially organized to be hosted in Seoul, the ISPOR Asia Pacific 2020 was inevitably held online due to COVID-19.
- Company
- Boryung,launches Tuvero (Arahkor Pre) in Mexico
- by An, Kyung-Jin Sep 16, 2020 06:25am
- Two-way live broadcast in Korea and Mexico Boryung announced on the 14th that it held a web symposium of Tuvero, a combination drug for hypertension and dyslipidemia, based on Kanarb in Mexico on the 11th (time in Korea) and began to launch in earnest. Tuvero is a combination drug that includes Kanarb(Fimasartan), an ARB (angiotensin II receptor blocker)-based hypertension drug developed by Boryung, and Rosuvastatin, a dyslipidemia drug. It was named Arahkor Pre in Spain. The sales and marketing activities in Mexico are handled by local partner Stendhal. The company expects the market demand to be very high as 'Arahkor Pre is the first ARB+Statin combination drug to be released in Mexico. According to Boryung, a number of local specialists in Mexico attended the web symposium, which was broadcast in two-way live in Korea and Mexico in the aftermath of COVID-19, showing hot interest in the new product. At the web symposium under the theme of 'Innovation in the Cardiovascular Risk Reduction, Introducing Arahkor Pre', a total of four speakers including Prof. Jin Joo Park (Seoul National University Bundang Hospital), Prof. María Guadalupe Castro, Universidad La Salle (ULSA), Prof. Joshua Elias (XXI Century National Medical Center), and Prof. Abel Alberto Pavía López, Centro Médico ABC, presented the latest information on cardiovascular disease treatment and the current status of cardiovascular disease in Mexico. Ignacio Conde Carmona (director of Stendhal), who was in charge of the web symposium on that day, said, "The combination of hypertension and dyslipidemia has a number of clinical results that significantly lower the incidence of cardiovascular disease." He added, "Arahkor Pre, a combination of Fimasartan, which has excellent blood pressure lowering effects, and Rosuvastatin, the most widely used dyslipidemia drug, is expected to provide new treatment options for cardiovascular disease patients and medical staff in Mexico." "Arahkor Pre, which clinical effect has been confirmed in the treatment of cardiovascular diseases in the domestic market, is the first ARB+Statin combination drug to be released in Mexico," said Sung-won Choi, executive director of the global business division of Boryung. "We will focus on Arahkor Pre's rapid market settlement by sharing our global marketing know-how, including Korea, with Stendhal, which has formed partnerships and improved synergy since 2013," he said.
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- ST Pharm, registered a global phase I of STP1002
- by An, Kyung-Jin Sep 16, 2020 06:25am
- A US clinical trial of a new oral colon cancer treatment drug being developed by ST Pharm is on track. One out of three local clinical trial institutions that announced their entry this year began recruiting subjects, taking the first step toward commercialization. According to clinicaltrials.gov operated by the National Institutes of Health (NIH) on the 14th, ST Pharm recently registered a new global phase I clinical trial plan related to the new chemical synthesis drug 'STP1002'. This test is the first FIH (first-in-human) clinical trial to administer the world's first oral colon cancer treatment 'STP1002' by ST Pharm to humans. The purpose is to confirm the maximum tolerated dose (MTD) of STP1002 in 30 adult patients with advanced solid cancer, and to confirm safety, tolerability, and pharmacokinetics (PK) characteristics. The primary efficacy evaluation criterion is dose-limiting toxicity(DLT) and severe adverse events that may be associated with test drug administration. As secondary efficacy endpoints, treatment emergent adverse event (TEAE) occurred during the treatment period and plasma concentration after oral administration of STP1002 are evaluated. ST Pharm's 'STP1002' was approved by the US Food and Drug Administration (FDA) in December last year for Phase I Clinical Trial Plan (IND). In June of this year, three institutions, including the University of Southern California, the University of Colorado, Denver, and Northwestern University, began clinical trials. Last month, CU Denver was the first to start administering test drugs to subjects. Registered subjects are classified into 5 cohorts, taking the prescribed dose of STP1002 for 21 days once a day and following a schedule with a 7-day withdrawal period. The plan is to complete all schedules related to phase I clinical trial such as recruiting subjects, taking test drugs, and analyzing results by next July. Animal test results of STP1002 (Source: ST Pharm IR) ST Pharm derived STP1002 through a two-year joint research with the Korea Research Institute of Chemical Technology from 2014. It is a candidate substance for a synthetic new drug that inhibits the growth of cancer cells by inhibiting the enzyme Tankyrase. ST Pharm expects that STP1002 will have a therapeutic effect on colon cancer patients who are resistant to Erbitux, an existing colorectal cancer treatment, or have a mutant genotype such as K-RAS and N-RAS. According to ST Pharm, as a result of a 4-week repetitive preclinical toxicity test on an animal model transplanted with cancer cells derived from colon cancer, STP1002 was not associated with significant toxicity and side effects. It showed differentiation compared to anticancer drugs. In the efficacy evaluation, the response rate of Tumor Growth Inhibition (TGI) was 49-70% and excellent tumor suppression effect was proved. ST Pharm is developing 'STP1002' as an oral drug that is taken once a day. Given that existing colon cancer treatments such as Erbitux and Avastin are IV formulations, it is evaluated that they have the potential to replace the $1.9 billion colon cancer treatment market based on convenience of use if they are successfully commercialized. After securing colon cancer as the first indication, it plans to expand the indications to non-small cell lung cancer, breast cancer, and liver cancer through combination with drugs of other mechanisms, such as immuno-anticancer drugs. ST Pharm is implementing an Innovative Virtual R&D strategy with low cost and high efficiency while actively utilizing internal and external networks such as Dong-A ST, the Korea Research Institute of Chemical Technology, and Asan Medical Center in Seoul. Currently, it is carrying out new drug tasks such as non-alcoholic steatohepatitis (NASH) treatment, influenza treatment, viral infection treatment such as polio, and oral anticoagulant. In addition to the colon cancer treatment 'STP1002', AIDS treatment 'STP0404' is about to enter clinical trials as Phase I Investigational Medicinal Product Dossier(IMPD) in France was approved at the end of April. When the French local clinical trial of STP0404 begins in earnest, a total of two global clinical trials will be conducted simultaneously.
