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- 2026-04-16 06:40:11
- Policy
- Pfizer Korea withdraws a lot of OTC products
- by Lee, Tak-Sun Oct 05, 2020 06:20am
- Pfizer Korea has withdrawn a large number of domestic OTC products. There are only three items left. According to the MFDS on the 28th, Pfizer Korea recently withdrew permission for seven items, including Stresstabs Plus and Caltrate plus. Accordingly, only three items left by Pfizer Korea were Minulet, Alesse, and Cofrel. Even this is not sold directly by Pfizer Korea. Ildong has been selling Minulet and Alesse, and Cofrel has been discontinued due to a manufacturer’s problem. The suspension of Pfizer's OTC department was announced last year when it merged with GSK. The domestic copyright of major items, such as the OTC products, Advil, Caltrate, and the multivitamins, Centrum, has already been transferred to GSK. In December 2018, when the two companies announced the merger of the Consumer Health Care, they reported that GSK owns 68% and Pfizer owns 32%.
- 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
- Policy
- Bavencio, listed on next month at ₩1,226,243/bottle
- by Kim, Jung-Ju Sep 29, 2020 06:21am
- Bavencio (Avelumab) by Merck, used for the treatment of metastatic Merkel cell carcinoma, will be covered by insurance benefits at ₩1,226,243 per bottle starting next month. Since it is an expensive drug, it will follow the RSA track, and will be listed as a refund type in which pharmaceutical companies reimburse a certain percentage of the drug claims to the HIRA, and a expenditure cap. The MOHW announced that the 'revision of Criteria for pharmaceutical reimbursed list & upper limit table' with the above contents was submitted to the agenda of the 17th plenary meeting of the Health Insurance Policy Deliberation Committee on the afternoon of today (25) and was deliberated and resolved. Merkel cell carcinoma is a neuroendocrine cancer that occurs in the skin, and Bavencio is an injection drug that has been approved for 'a monotherapy for the treatment of metastatic Merkel cell carcinoma in adults'. It is treated by intravenous infusion at 10mg/kg every two weeks for 60 minutes. It is a rare cancer that occurs in a very small number of populations (0.35 per 100,000 males and 0.15 per 100,000 females). Life expectancy is less than 2 years. The number of patients for this product in Korea is known to be around 10. On March 22 last year, the company obtained an item permission from the MFDS and submitted an application for insurance registration on May 2 of the same year. After deliberation by the Economic Evaluation Subcommittee under the Pharmaceutical Benefits Advisory Committee held on April 17 of this year, it was officially proposed on June 11, two months later. At that time, the committee recommended the use of this drug in the treatment of metastatic Merkel cell cancer according to the evidence in textbooks and clinical practice guidelines, so it has clinical utility. It was determined that the result of the economic evaluation (cost-effectiveness analysis, ICER) compared to chemotherapy was reviewed at an acceptable level. The Korean Cancer Association and the Korean Cancer Study Group also said that it is a drug that can be considered as a preferred treatment method for patients with metastatic Merkel cell boxes who have failed the first line treatment. It was listed in the excluded countries A7 (US, Japan, France, Germany, Italy, Switzerland, and the UK), and the adjusted average price is ₩1,317,952 per bottle. After passing the committee, when discussing the price of a new drug with the NHIS, the company proceeded with negotiations by following the RSA refund type and Expenditure Cap type. This is a contract in which a pharmaceutical company refunds a certain percentage of the drug billed amount and a certain proportion of the excess of the estimated cap amount to the NHIS. The two sides agreed to ₩1,226,243 taking into account the level of drug prices and fiscal impact of excluded countries. The fiscal impact analysis value is about ₩301 million per year, and the registration date is October 1.
- Policy
- Kwang Dong competes with Elyson for Nebivolol
- by Lee, Tak-Sun Sep 29, 2020 06:21am
- Kwang Dong headquarters located in Seocho-dong Kwang Dong is challenging the market by obtaining approval for all three high and low doses of the hypertension treatment 'Nebivolol HCl'. This is the second case that 3 doses have been approved since Elyson was approved. On the 28th, the MFDS approved Kwang Dong's Nebilet M 1.25mg, 2.5mg and 5mg. Nebilet M is a generic for Menarini's Nebilet that was approved in Korea in 2006. However, Menarini has Nebivolol 5mg. Only Kwang Dong and Elyson have Nebivolol 1.25mg and 2.5mg. Elyson's Nebistol 5mg was approved in 2012, Nebistol 2.5mg in 2013, Nebistol 1.25mg in 2017. The indication requires a low-dose product. For indications for hypertension, adults with essential hypertension should take 5mg once a day, and patients with renal failure should take 2.5mg once a day as an initial dose. In addition, the elderly over 65 years old are also required to take 2.5mg orally at the initial dose. For chronic heart failure indications, elderly patients over 70 years of age start treatment with 1.25 mg once a day, and if necessary, the dose is increased to 2.5 mg once a day, 5 mg once a day, and 10 mg once a day. Although Elyson has already licensed three doses and is selling them, Kwang Dong's generic is drawing attention because the product name is similar to the original. It seems that it inherits the originality because only M was added to the original drug name, Nebilet. Kwang Dong is expanding its alliance by signing an exclusive sales contract with Menarini, an original company of Nebilet, for nail athlete's foot treatment 'Flucare' earlier this year. Interest is also focused on whether there was a partnership between the two companies this time. However, Nebilet is an imported drug, and Nebilet M, which was approved this time, is an item produced in Korea by Kwang Dong. Currently, there are only 12 single formulations of Nebivolol HCl in Korea, including the original. It is analyzed that the number of participating companies is limited due to the small market size. In the first half of this year, Menarini's Nebilet sales amounted to ₩3.5 billion, and Elyson's Nebistol was ₩1.5 billion. It is noteworthy whether Kwang Dong, which has been approved for three doses at once, will emerge as a new dark horse.
- 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.
- Opinion
- [Reporter’s view] Nikola and Korean Pharmaceutical Market
- by Kim, Jin-Gu Sep 28, 2020 06:21am
- Money flows into unsubstantiated expectations. Money begets money. The stock value jumped over the moon. Before long, It came to light. Stock prices plummeted, and investors fell into despair. It is a story about the American hydrogen truck company 'Nikola'. It was once called the second Tesla and received the attention of investors, but only controversy remains. The driving video they released turned out to be that the vehicle did not run on its own, but was ridiculously rolled on the hill. Eventually, founder Trevor Milton took responsibility for the controversy and resigned. The US Department of Justice and financial authorities have launched an investigation into the alleged fraud. The reason that raised Nikola's stock price was anticipation. Investors were hoping that it would become the second Tesla. Instead of looking at the entity of the company, they focused only on the commonalities with Tesla. Even GM, the leading automobile company in the United States, has invested $2 billion, and it said only plausible words. The Nikola crisis abroad has great implications for the Korean pharmaceutical bio stock market. Expectations that have no substance are about to collapse someday. Many pharmaceutical companies have announced that they will develop a treatment and vaccine for COVID-19. Of course, most of them are in the midst of R&D according to their plans. However, there are certainly companies where the substance is not clear. After the news that it will start developing, there is no more news. Even patient recruitment for clinical trials has not been completed. Several media began to question the company's ability and willingness to develop. Financial authorities are repeating investment warnings. Nevertheless, stock prices rise endlessly. The time is approaching when reality will be revealed. It is not yet known whether Tesla or Nikola will be the reality of the pharmaceutical companies to be confirmed soon. However, there is too much uncertainty to buy a dream only with unsubstantiated expectations. What is needed in an era of uncertainty called COVID-19 is coldness.
- 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.
- Policy
- Immunotherapy Bavencio coverage green lit for skin cancer
- by Lee, Hye-Kyung Sep 28, 2020 06:20am
- The South Korean health authority has granted reimbursement on Merck’s immunotherapy Bavencio injection (avelumab). The Health Insurance Review and Assessment Service (HIRA) plans to accept public opinion on the unveiled revised Notice on Pharmaceuticals for Cancer Patient’s Prescription and Administration until Sept. 17. Without much of objection, the reimbursement would be granted from Oct. 1. Bavencio was initially approved as a single agent therapy to treat adult patients with metastatic Merkel cell carcinoma (MCC). The treatment is now listed as a second-line treatment in adult patients with metastatic MCC, who have not been treated with immune checkpoint inhibitor like a PD-1 inhibitor. To expand the treatment’s reimbursement standard, HIRA has confirmed the National Comprehensive Cancer Network (NCCN) guideline recommending Bavencio as Category 2A for treating patients with metastatic MCC, based on a single-arm, open-label Phase II trial findings on the treatment’s efficacy in patients aged over 18 with Stage IV MCC progressed after receiving one or more anticancer therapy, which demonstrated median overall survival (mOS) of 12.9 months, median progression-free survival (mPFS) of 2.7 months, and overall response rate (ORR) of 33.0 percent. The reimbursement decision was passed as a retrospective observational study on MCC patients who have used second-line or later chemotherapy that found the treatment’s improved clinical efficacy compared to mOS 5.7 months, mPFS 2.0 months and ORR 23 percent. However, the general immune checkpoint inhibitor reimbursement condition, ‘to be used only in healthcare institutes capable of responding on emergency cases of unpredicted adverse reaction, and administered by a well-experienced doctor with sufficient knowledge in anticancer therapies,’ would be applied the same. And also the healthcare benefit would be limited to patients who have not been treated with other PD-1 inhibitor-like immune checkpoint inhibitor. Now the reimbursed use of Bavencio would be available to patients with MCC, as well as basal cell skin cancer and squamous cell skin cancer. Also, HIRA clarified the off-label chemotherapy use evaluation standard and exempted case of post-approval (use prior to HIRA president’s approval) with the new notice the agency disclosed. Previously, the standard only stipulated a healthcare institute meaning to use off-label chemotherapy to undergo review by a multidisciplinary review board and request an approval by the president of HIRA via template application for off-label use of chemotherapy supplemented with evidential data. Nonetheless, the amended standard added new standard for the president of HIRA to either dismiss or return the off-label use application, if the required evidential data is not submitted. And the applicable healthcare institute would be not allowed to request or use off-label chemotherapy in following cases; an alternative standard of care exists within the scope of notified, approved or already-recognized off-label therapy; inevitability or medical necessity cannot be proven; the off-label use is for supplementary or maintenance therapy before or after a surgery; and use of an off-label cancer therapy seeking for the approval has been rejected previously after a review. Meanwhile, the stipulated re-assessment period clause—‘the president of HIRA should constantly monitor the system execution status, and re-assess relevant laws and environment at a one-year point since the regulation is notified, to reflect needed changes until the two-year point of the regulation’—was removed. HIRA official said, “As the progress and status are reported to Cancer Disease Deliberation Committee, the agency decided to delete the regulation on the re-assessment period after reviewing the public opinion.”
- Policy
- Teribone's price will be cut from the 26th
- by Kim, Jung-Ju Sep 28, 2020 06:20am
- The price cut was finally decided in an administrative lawsuit to cut the drug price of Teribone inj 56.5 μg (Teriparatide). Since the company voluntarily withdrew the lawsuit due to lack of profit, no other drug price changes are expected in the future. The Seoul Administrative Court recently ruled against a lawsuit for cancellation of drug price cuts (revision of the 'Pharmaceutical Benefit List and Upper Limit Table No. 2020-38) filed by Dong-A ST. Accordingly, the suspension of execution, which the company requested and accepted by the court along with the lawsuit, also ended and price cut was imminent. According to the court, the suspension of enforcement of the notice will end in 25th. Accordingly, from the next day, the 26th, the price will drop to the price planned by the government through ex officio adjustment. The lawsuit came when the MOHW included the drug in the drug price cut list last month. The MOHW applies the so-called `half-price drug price' when a generic is registered for the first time, and is listed at a price of 53.55% of the original. However, if the number of companies with the same product is less than 3 even after a year has passed, the addition is maintained until the number of companies with the same product reaches 4 or more, and when the conditions disappear, the drug price is lowered through ex officio adjustment. Initially, Teribone inj was listed on the reimbursement list at 90% level in conjunction with the drug price of Forsteo in accordance with the 'Pharmaceutical Determination and Adjustment Criteria.' The cut was decided, and in conjunction with this, the drug price of Teribone inj 56.5μg was also reduced. Accordingly, the company has filed a lawsuit against the MOHW. The expected reduction is 22.2% from the current ₩73,287 to ₩57,001. In August, Lilly lost to Daewon in a lawsuit to cut the drug price of Forsteo, and the drug price cut of Dong-A ST Forsteo was finally decided without appeal. In other words, Teribone inj is automatically reduced in price separately from litigation. Due to such circumstances, Dong-A ST decided that the lawsuit was not profitable and decided to withdraw. Medical institutions should take care when making a claim, reflecting the drug price cut.
