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- 2026-03-18 20:22:39
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- Choline alfoscerate coverage reduction order suspended again
- by Chon, Seung-Hyun Oct 05, 2020 06:20am
- The court has once again approved to halt the administrative order on the cognitive enhancer ‘choline alfoscerate.’ Previously, the court has decided to suspend the order until the final ruling of the litigation, but another litigation case added 30 days to the already-approved order suspension. According to the industry sources on Oct. 28, the Seoul Administrative Court has decided to withhold the effect of partially revised health insurance reimbursement standard the pharmaceutical companies filed litigation against on Oct. 25, regarding the choline alfoscerate coverage reduction, for 30 days from the day the litigation is concluded. Represented by the law firm Lee & Ko, 39 pharmaceutical companies and one individual, including Daewoong Bio, has requested the order suspension. On Sept. 26, the Ministry of Health and Welfare (MOHW) issued a revised notice on the reimbursement standard, which stipulated adjustment of choline alfoscerate coverage. From this month and on, the government’s new reimbursement standard was supposed to raise the patient copayment rate from 30 percent to 80 percent, if a patient who has not been diagnosed with dementia were to use a choline alfoscerate drug. The court ruled, “Halting the administrative order on choline alfoscerate does not seem to significantly affect the public welfare.” The court also pointed out the patients could continue to use choline alfoscerate, regardless of the burdening copayment rate, or give up on the drug use due to reduced healthcare benefit on the drug. Moreover, the court judged the coverage adjustment on choline alfoscerate with insufficient clinical evidence could bring a grave impact on the related market as it would defame the credibility and reputation of the drug and the companies. Currently, two litigation cases against the administrative order on choline alfoscerate are in process. The law firm Shin & Kim is representing 39 companies and eight individuals including Chong Kun Dang, and the law firm Lee & Ko is representing 39 companies and one individual. Shin & Kim and Lee & Ko have filed the litigations on Sept. 27, immediately after the ministry issued the notice. The order suspension request made by Shin & Kim has been approved until the day of the final ruling. And now, the request by Lee & Ko has been accepted as well. The two cases do not conflict issues on respective order suspension. Meanwhile, MOHW has reportedly filed an appeal on the Shin & Kim case.
- Company
- Merged BMS-Celgene to offer ERP after all
- by Eo, Yun-Ho Oct 05, 2020 06:20am
- Initially merged with almost no downsizing, Bristol-Myers Squibb (BMS) and Celgene have ultimately decided to slim down the organization in South Korea. According to the pharmaceutical industry sources, BMS Korea has recently decided to issue the Early Retirement Program (ERP) as a result of acquiring Celgene. The staff reduction would focus on marketing and sales, which would also include executive-level layoffs. The compensation would be severance pay worth additional eight months on doubled service years, which would add up to maximum 48 months (standard pay) plus more premium. The offer is considered one of a top-level ERP condition ever offered by a multinational pharmaceutical company in South Korea. In last March, BMS has announced newly formed divisions and new head personnel for the Business Unit (BU). At the time, the multinational company integrated the Oncology and Hematology Departments. Although some employees with overlapping positions left the company, but official downsizing did not take a place. Nevertheless, the delay in immunotherapy Opdivo (nivolumab) coverage expansion, sales stagnation and pricing reduction and generic launch of off-patent Eliquis (apixaban) seemed to have affected the decision to provide ERP. In January last year, BMS has decided to acquire Celgene for USD 74 billion (86.40 trillion won). The Celgene acquisition was processed with cash and stock transaction, and the legal process is still in progress at the moment. Through the acquisition, BMS has also obtained anticancer therapy Revlimid, and the next-generation immune CAR-T cell therapy option, taken over from a deal with Juno Therapeutics
- Company
- Ildong is accelerating the development of Lasmiditan
- by Kim, Jin-Gu Sep 29, 2020 06:20am
- Ildong’s Headquarters Ildong is accelerating the development of a new class of migraine treatment 'Lasmiditan'. A large-scale phase III clinical trial is in progress, close to 300 as a bridged clinical trial, and it is confirmed that the registration of subjects has recently been completed. According to the pharmaceutical industry on the 25th, Ildong recently completed registration as a subject for Lasmiditan-related bridging clinical trial. Ildong was approved for phase III clinical trial from the MFDS in December of last year, and recruited subjects from 13 institutions including Seoul National University Hospital and Nowon Eulji Medical Center. The number of people participating in the bridging clinical trial reached 288. This is unusual considering the fact that normal bridging clinical trials are conducted in units of dozens of people. This explains that Ildong is working hard on the development of Lasmiditan. Lasmiditan is a new class of migraine medication that was approved by the US Food and Drug Administration (FDA) in October last year. As a treatment for acute migraine headaches, it is receiving great attention because it is a new drug that has been released in 20 years. In the United States, Reyvow by Eli Lilly was approved. The domestic copyright is owned by Ildong. Ildong signed a contract with the original developer, CoLucid, in 2013, and acquired the copyrights in eight ASEAN countries, including Korea. It is the first and only therapeutic agent that acts on the serotonin (5-HT)1F receptor. Previously, there were Triptan-based treatments, but there are cardiovascular side effects. But Lasmiditan selectively acts on serotonin receptors, so there is no cardiovascular side effects due to vasoconstriction. Ildong plans to complete phase III clinical trials by the first half of next year and apply for NDA. The launch is likely to be done in 2022. An official of Ildong said, “Generally, only about phase I is performed for bridging clinical trials, but in the case of Lasmiditan, due to the nature of a migraine headache, it is necessary to closely examine the efficacy and safety, so not only phase I but also phase III is carried out on a large scale.” He said that the drug's value and reliability will be greater if it undergoes large-scale phase III clinical trials.
- Company
- Korean rare disease drug Hunterase market share surges
- by An, Kyung-Jin Sep 29, 2020 06:20am
- Product image of Hunterase Developed with South Korean-made rare disease treating technology, Hunterase (idursulfase-β) continues to top the market. The treatment’s market share gap with Elaprase (idursulfase) that used to dominate the Hunter syndrome market has tripled as Hunterase maintains market share of over 70 percent. While the treatment is generating significant sales in Central America and North Africa, its commercial value is to grow even further as it prepares for the Chinese and Japanese markets. A pharmaceutical market research firm IQVIA reported on Sept. 24, GC Pharma’s Hunterase has generated 8.8 billion won in the second quarter of the year. The sales in first half of the year accumulated to 17.6 billion won, taking up 72.3 percent of the market. Although the figure went down by 0.5 percent compared to 17.7 billion won last year same time, the treatment has been dominating the market with the sales still tripling the competitor’s. In the same time, Sanofi Genzyme’s Elaprase has only made 6.7 billion won. In 2008, GC Pharma has licensed in the technology from Samsung Medical Center Professor Jin Dong Kyu and co-developed Hunterase to treat patients with Hunter syndrome. After Ministry of Food and Drug Safety (MFDS) green lighting the drug in 2012, the Korean company successfully commercialized the world’s second Hunter syndrome treatment, following after Sanofi Genzyme’s Elaprase. Hunter syndrome is a rare, inherited disorder, diagnosed roughly in one out of 100,000 to 150,000. Caused by deficiency of an enzyme called idursulfase, the disease has poor prognosis as patients express skeletal abnormality, cognitive impairment other unpredictable symptoms when not treated in adequate timing and have life-expectancy of around 15 years. There are about 70 to 80 cases reported in South Korea. Quarterly market share of two Hunter syndrome treatments in Korea (Unit: %) Source: IQVIA Launched in 2008, Elaprase was the only prescription treatment for treating Hunter syndrome accessible in South Korea, up until Hunterase was released. Although it used to generate 7 billion won per quarter, Elaprase’s quarterly sales have plunged to around 3 billion won ever since Hunterase entered the market in the third quarter of 2012. The global drug has raised 3.4 billion won in the second quarter taking up the market share of 28 percent. Basically, the two-thirds of the market were handed to Hunterase. Hunterase’s market presence has been consistently growing since it was released. According to IQVIA’s data, the sum of two Hunter syndrome treatments in last year’s second quarter marked 12.2 billion won, which has gone up by 17.1 percent from the second quarter of 2016. When Elaprase’s sales were stagnating for last four years, Hunterase has been pushing the market expansion. The Korean drug’s maximum price with coverage is 2,254,200 won, which is about 17.6 percent lower than Elaprase (2,651,616 won). As the follow-on drug was offered with lower pricing, the Hunter syndrome treatment market has been expanded and the rare disease patients’ access to treatment was improved. Currently, Hunterase is indicated to be administered 0.5 mg per kilogram of patient’s body weight once-weekly. For instance, a child weighing 36 kg would need to pay 6,762,600 won to receive 18 mg per dose. In a year, the number would add up to 351.66 million won. Because the number of competitors is low with limited number of patients, the companies are expecting high profit for providing life-long doses of the needed enzyme. Hunterase’s quarterly sales in domestic and overseas markets (Unit: KRW 100 million) Source: GC Pharma Also, Hunterase has been performing well in the overseas markets as well. GC Pharma says Hunterase’s export in the first half of the year reached 5.2 billion won, which was 35.4 percent of the overall sales. The drug’s export of 20.3 billion in last year surpassed the domestic sales of 18.7 billion won for the first time. At the moment, GC Pharma supplies Hunterase to markets in Central America and North Africa, and it has been improving the drug’s commercial value by lately entering other global markets. Early this month, GC Pharma won an approval by China’s National Medical Products Administration (NMPA) for Hunterase. Care Pharma Hong Kong, a rare disease treatment specializing offshoot of Canbridge Pharmaceuticals, licensed out the development and commercialization exclusivity in China, Taiwan, Hong Kong and Macao regions and successfully passed the Chinese pharmaceutical authority after 20 months since the partnership deal in January last year. The Korean company estimates there are 3,000 Hunter syndrome patients in China. The drug is expected to significantly leverage the international sales as it was approved as the first Hunter syndrome treatment in China with a sizable market. Soon, the drug would be knocking on the Japanese market as well. GC Pharma’s partner, Clinigen K.K. has submitted a New Drug Application in last March to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for their approval review on Hunterase Intracerebroventricular (ICV). Hunterase ICV is administered to the brain directly to deliver the medicine to cerebral ventricles. The specific administration route can overcome the limitation of other intravenous injection that cannot improve the cognitive improvement as the medicine fails to permeate through the blood-brain barrier (BBB). The global Hunter syndrome treatment market only has a handful of competitors. The limited size of the rare disease patients would ultimately hinder the domestic market expansion, but Hunterase is strategizing to rather consistently grow its global market presence in new overseas markets.
- Company
- Pfizer Korea launches Cresemba in Korea
- by Eo, Yun-Ho Sep 28, 2020 06:20am
- Pfizer Korea launched Cresemba (Isavuconazole), an invasive fungal infection treatment in Korea. Cresemba is an antifungal drug approved for the treatment of invasive aspergillosis in adults over 18 years of age and invasive mucormycosis, which is not suitable for administration of Amphotericin B in adults over 18 years of age, and obtained marketing permission. Cresemba has a broad antifungal spectrum, so it can treat both invasive aspergillosis and invasive mucormycosis, and is the only Azole-based antifungal agent in Korea with indications for invasive mucormycosis. In addition to the launch of Cresemba in Korea, Pfizer launched a campaign to raise awareness of diseases related to fungal infections with executives and employees in celebration of World Fungal Infection Awareness Week. It has been designated by the Centers for Disease Control and Prevention (CDC) to save more patients' lives by reducing delays in diagnosis and treatment by raising awareness of these fungal infections. Company officials hope that the launch of Cresemba in Korea will improve access to treatment in patients with invasive fungal infections, whose treatment options have been limited, and will continue to do their best to provide innovative treatment options to patients suffering from fatal fungal infections. Cresemba obtained approval from the US FDA in March 2015. Cresemba is a drug jointly developed by Basilea in Switzerland and Astellas in Japan, and Pfizer holds the right to sell in the EU and the Asian-Pacific region, including Korea. Astellas has been approved in the United States and Japan. This drug was found to have a lower mortality rate than Voriconazole (Vfend) in a clinical trial in 516 patients with invasive aspergillosis. The mortality rate of all causes at 42 days in the entire group was 18.6% (48/258 patients) in the Isavuconazole group and 20.2% (52/258 patients) in the Voriconazole group.
- Company
- Targeted therapy Tagrisso back on track expanding coverage
- by Eo, Yun-Ho Sep 25, 2020 06:06am
- A third generation targeted therapy Tagrisso is getting back on its track to seek reimbursement as a first-line treatment for patients with lung cancer. The pharmaceutical industry sources confirmed, AstraZeneca Korea has submitted an application to expand reimbursement on its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) as a first-line treatment. After failing to pass the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last May, the company is resuming the process in five months. Adding the first-line treatment indication in December 2018, Tagrisso sought after the reimbursement expansion in 2019, but the South Korean health regulators deferred the decision by claiming the decision should be made when the Phase III FLAURA study reveals full data on overall survival (OS) as a first-line therapy. Although the company handed in additional data from the FLAURA study and accepted the government-proposed financial burden sharing plan, the Cancer Deliberation Committee members argued the treatment demonstrated issues in clinical efficacy and denied the reimbursement expansion. AstraZeneca’s new weapon of choice is the FLAURA China extension cohort study unveiled as a poster presentation at European Society for Medical Oncology (ESMO) conference convened online recently. The study provides specific OS data in Asian race. The toughest barrier that hindered Tagrisso from expanding the reimbursement was the Asian subset analysis. The study found Tagrisso’s OS was at 38.6 months, which improved OS in Iressa (gefitinib) and Tarceva (erlotinib) by 6.8 months. The findings were encouraging as Tagrisso was the first EGFR TKI, and the researchers counted even the cross over prescription on patients with confirmed T790M mutation. However, the subset analysis on Asian race showed skeptical hazard ratio (HR). Among the Asian participants, the HR was only around 0.995. The figure was basically within the margin of error from the value 1, which meant the targeted therapy failed to show meaningful improvement compared to the controls. Based on the unsatisfying result, the scholars claimed “The Tagrisso OS in Asian race, also covering the South Koreans, is not credible,” and the claim eventually influenced the Cancer Deliberation Committee’s decision. Now that Tagrisso has prepared the study results from China, the previous decision on reimbursement expansion could be overturned. The FLAURA China study incorporated a total of 71 participants using Tagrisso and 65 participants using control in China cohorts. The control group participants were allowed to cross over to Tagrisso as a second-line treatment, once they advanced as T790m-positive, in which 22 out of 65 patients were the case. As a result, Tagrisso group’s OS median reached 33.1 months, or 7.4 months longer compared to the control group with 25.7 months, while the risk of death was reduced by 15.2 percent.
- Company
- Janssen MA Director Lim Kyunghwa promoted to Janssen APAC
- by Eo, Yun-Ho Sep 24, 2020 11:59am
- Director Lim Kyunghwa Market Access (MA) Director Lim Kyunghwa at Janssen Korea is to be promoted to Janssen Asia Pacific. The pharmaceutical industry sources reported, Director Lim would be appointed as a new MA Director at Janssen Asia Pacific from coming October. Temporarily, Lim would be remotely working from South Korea amid COVID-19, but she would be working at the Asia Pacific Region Office later. Director Lim, currently leading the MA at Janssen Korea, has earned her master’s and doctorate degrees from Sookmyung Women’s University, as well as MBA from Korea University. Her career in MA started when she joined Chong Kun Dang, and she gained rich MA experiences from Boehringer Ingelheim and Novartis. Moreover, Director Lim is currently serving as a Co-chair of MA Committee at Korean Research-based Pharmaceutical Industry Association (KRPIA). Due to her promotion, KRPIA is to appoint a new co-chair on Sept. 28. KRPIA is also readying for a series of new personnel changes in Board of Directors, as the current Chairman Avi BenShoshan and Vice-Chair Julien Samson are returning back to the headquarters.
- Company
- Suganon by Dong-A ST, approved for Phase II/III in the US
- by An, Kyung-Jin Sep 24, 2020 06:19am
- Suganon Dong-A ST announced on the 22nd that the diabetes treatment 'Suganon' (Evogliptin) has been approved by the US Food and Drug Administration (FDA) for Phase IIb/IIIa clinical trial plan (IND) for aortic heart valve calcification. Suganon is a diabetes treatment based on DPP-4 inhibitor developed by Dong-A ST. In order to use Suganon other than diabetes, Dong-A ST transferred the technology of a substance patent for Suganon and a patent for the treatment of aortic heart valve calcification of Asan Medical Center in Seoul, and established a joint venture Rednvia. In January of last year, Rednvia signed a technology transfer contract with Dong-A ST for the development and sale of aortic heart valve calcification treatment for Suganon and has been developing it. In June 2019, the MFDS approved Phase II Clinical Trial Plan (IND) for aortic heart valve calcification, and initiated Phase II clinical trial in Korea for 225 patients. In July of this year, the FDA received Phase IIb/IIIa clinical trial IND. Researchers from renowned medical institutions in the United States, such as Mayo Clinic and Massachusetts General Hospital, have confirmed participation in this clinical trial. Rednvia has unveiled its plan to accelerate product commercialization as much as possible by working closely with researchers from these institutions and receiving clinical research funding from the National Institutes of Health (NIH). Dong-A ST Chairman Eom Dae-sik said that this clinical trial is an attempt to re-create a drug for a new drug that has been successfully developed and we will work closely with us to complete the development of the treatment. Rednvia CEO Hoonmo Lee said, "I am very pleased to be able to obtain the approval of Sugarnon's US clinical IND after collaborating with excellent researchers and institutions, and we will do our best to successfully perform clinical trials." According to the data provided by the company, the treatment of aortic heart valve calcification is entirely dependent on surgery as there is currently no cure. In particular, elderly patients have a high risk of death during surgery, and there is a problem that reoperation should be considered every 10 years. If the oral drug Suganon completes clinical trials in Korea and the United States and succeeds in commercialization. High marketability is expected if commercialization is successful. Rednvia is known to be examining the discovery of a combination drug candidate targeting fibrosis in order to develop Suganon as a treatment for not only aortic heart valve calcification, but also non-alcoholic steatohepatitis (NASH).
- Company
- Suganon, a new domestic drug that is evolving
- by An, Kyung-Jin Sep 23, 2020 08:06pm
- Suganon Suganon (Evogliptin), a diabetes treatment developed by Dong-A ST's proprietary technology, has stepped up its competitiveness. Despite the return of rights, efforts are being made to improve the value of new drugs while seeking new indications. The growth of domestic sales has gained momentum, and it is advancing into overseas markets by completing sales in India and Russia. According to Dong-A ST on the 23rd, the cumulative sales of two types of Suganon and Sugamet this year were ₩16 billion, which doubled from the same period last year. This is the figure calculated based on the company's own shipments from January to August this year. In eight months, the company announced a new record in annual sales, surpassing ₩14.2 billion in sales last year. Suganon is a diabetes treatment based on DPP-4 inhibitor developed by Dong-A ST. It has a mechanism of action that inhibits insulin-secreting hormone-degrading enzyme (DPP-4). Dong-A ST entered the domestic DPP-4 inhibitor market with the release of Suganon in March 2016. In May of the same year, it launched Sugamet, a combination drug that combines Metformin with Suganon, and is in fierce competition with competitors. Suganon and Sugamet had difficulty in securing market share at the beginning of their release as they entered the market as the latest among the nine DPP-4 inhibitors sold in Korea, but their market influence is steadily increasing. From mid-2018, the third year of its release, its quarterly sales exceeded ₩3 billion, and since the second quarter of last year, it has become the company's flagship item by breaking the record for quarterly sales. It is analyzed that the fact that the high selectivity to DPP-4 enzyme is high and that it has little effect on the metabolism of other drugs was actively appealed, and that the reliability of medical staff increased as the prescription experience in the treatment field was accumulated. Quarterly sales of Suganon and Sugamet (Unit: ₩100 million, Source: Dong-A ST) Suganon will also enter the overseas market. Dong-A ST has signed technology transfer contracts with many global pharmaceutical companies, including India and Nepal in December 2012, Brazil in 2014, 17 countries in South America and 3 countries in the CIS (Commonwealth of Independent States) including Russia in 2015. After signing a contract with Alkem, an Indian pharmaceutical company in 2012, it completed the sale of Suganon in India in March of last year, after obtaining approval for sale from the Drug Controller General of India (DCGI) in December 2018 and March 2019. It also started sales in Russia through Geropharm, a Russian pharmaceutical company that it had a relationship with in 2015. Entering this year, it applied for a new drug license (NDA) for Suganon to a Brazilian regulatory agency, and 17 countries in South America are also undergoing national development and approval procedures. Dong-A ST is also focusing on developing a new market for Suganon. It was exported to the US pharmaceutical company Tobira Therapeutics in 2016 for a technology export of 61.5 million dollars, and returned it after 1 year and 6 months, and the goal of developing a treatment for non-alcoholic steatohepatitis (NASH) was failed. This is because Tobira's R&D strategy changed as it was acquired by a large global pharmaceutical company Allergan. Suganon In January of last year, Dong-A ST signed a technology transfer contract with Rednvia for the development and sale of aortic heart valve calcification treatment for Suganon and began development. Rednvia is a joint venture established by transferring technology to a substance patent for Suganon, a diabetes treatment drug developed by Dong-A ST, and a patent for aortic heart valve calcification treatment at Asan Medical Center. Rednvia began its global clinical development step in earnest by receiving approval from the US Food and Drug Administration (FDA) for a local Phase IIb/IIIa clinical trial plan (IND) that evaluates the efficacy and safety of Suganone in treating aortic heart valve calcification. Researchers from renowned medical institutions in the United States such as the Mayo Clinic and Massachusetts General Hospital have confirmed their participation, reflecting the high interest of the treatment field. Rednvia has been conducting phase II clinical trial in 225 patients with aortic valve calcification in Korea since last year. The goal is to accelerate the commercialization of products as much as possible by receiving clinical research funding from the National Institutes of Health (NIH) while simultaneously operating both Korean and US clinical trials. Since there is no officially licensed treatment for aortic heart valve calcification, and it has to rely entirely on surgery, it is expected that if Suganon succeeds in commercialization, it will have high marketability. Rednvia is also re-challenging for NASH indications, which were once frustrated. In order to develop a combination drug that targets fibrosis in NASH patients, it is examining the discovery of candidate substances that can create synergy with Suganon.
- Company
- Samsung signed manufacturing collaboration with AZ
- by Eo, Yun-Ho Sep 22, 2020 05:47pm
- AstraZeneca and Samsung Biologics announced the signing of a long-term supply agreement. Under this agreement, valued at approximately $330.8 million, Samsung Biologics will provide large-scale commercial manufacturing for drug substance and drug product of AstraZeneca biologics therapeutics. The contract value could grow to $545.6 million upon each other’s agreement. Today’s announcement follows a Letter of Intent that was signed in June at Samsung Biologics headquarters in Songdo, South Korea, jointly with AstraZeneca’s Korean office represented by Country President, Mr. Juno Sangpyo Kim and Samsung Biologics CEO Dr. Tae Han Kim. Also present at the event were South Korean government officials, and Kim JaeJoon, Director of Bio-Convergence Industry, Ministry of Trade, Industry and Energy and Jung Taegil, Director of Division of Health Industry Promotion , Ministry of Health and Welfare. Mr. Leif Johansson, Chairman of the Board and Ms. Margareta Ozolins Nordvall, Senior Vice President Supply APAC of AstraZeneca joined via a virtual meeting platform. The new collaboration enables AstraZeneca to build on Korea’s world-class bio-health industry and to expand its biologics manufacturing capabilities into Asia Pacific. Pam Cheng, EVP Global Operations and IT, AstraZeneca said, “This long-term partnership with Samsung Biologics strengthens our manufacturing capabilities, and ensures we are well-positioned to continue to deliver our exciting portfolio of new and established biologics medicines to patients with quality, speed and efficiency.” Dr. Tae Han Kim, CEO of Samsung Biologics mentioned, “We are very proud to partner with AstraZeneca, a company with a rich history of science-led innovation to serve patients,” and added, “At Samsung Biologics, our people share this common purpose to help our clients bring innovative solutions to different arrays of diseases, and we look forward to delivering on our promise to aid in AstraZeneca’s ongoing expansion program.” In December last year AstraZeneca signed a collaboration agreement to accelerate Korean bio-health innovation with leading governmental and industry partners. As part of the agreement, AstraZeneca is accelerating efforts to drive collaboration with Korean biopharmaceutical manufacturers. AstraZeneca also has manufacturing collaborations with SK biotek and SK bioscience.
