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- 2026-04-15 11:06:00
- Policy
- Addpharma, entering phase 3 of low-dose Dutasteride
- by Lee, Tak-Sun Apr 01, 2021 06:06am
- Avodart for prostatic hypertrophy and hair loss Addpharma, a subsidiary of Yuhan's improved drug development, has entered phase 3 clinical trials of low-dose tablets of Dutasteride (Avodart, GSK), a hair loss treatment. Currently, Dutasteride is already on the market, but the value of Addpharma's developed products is high as there is no low dose product. The MFDS approved Addpharma's phase 3 clinical trial protocol for AD-208 on the 29th of last month. This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 clinical trial to evaluate the efficacy and safety of AD-208 in male androgen alopecia patients. AD-208 is Yuhan's IMD. However, it is not known in detail what type of drug it is. As a result of the interviews, it was found to be Dutasteride 0.2mg, not conventional Dutasteride 0.5mg. Avodart is released in 0.5mg capsule type. Generics were released due to the expiration of the patent in 2016, and tablet types were also released. JW Pharma was the first to develop Dutasteride in tablet form based on its underlying technology in 2018. It relieves the discomfort of the capsule sticking to the mouth and esophagus. It also became possible to split pills. Due to the long half-life of Dutasteride, some patients with hair loss may take one pill every two days. When taken in half, it is possible to maintain the drug agonism in the blood for a day. Since the drug developed by Addpharma contains only half of the existing content, there is no need for splitting tablets. It is easy to prescribe or dispense, and the patient's adherence to medication is increased. Pharmaceutical companies can expect cost reduction because only half of the ingredients are included. Phase 3 is conducted at 8 hospitals including Seoul National University Hospital. It plans to recruit a total of 130 patients. It is noted whether it will be validated and commercialized.
- Policy
- Baricitinib, Heparin, & NOAC were added as COVID-19 benefits
- by Lee, Jeong-Hwan Apr 01, 2021 06:05am
- Benefits are recognized when Baricitinib is co-administered with Remdesivir for the treatment of COVID-19. Low-molecular-weight heparin and new anticoagulant (NOAC) are also newly added as COVID-19 benefits. Lopinavir / Ritonavir (combination therapy), Hydroxychloroquine, and Ribavirin are eliminated from drugs covered by COVID-19. On the 31st, the MOHW revised and issued some 'details on the standards and methods for applying medical care benefits' with the above contents. The amendment applies to treatments for MERS-CoV and COVID-19. With regard to the target of administration, the standard for COVID-19 treatment will be clarified from the person who is conducting the confirmation test to the confirmed person. And, Corticosteroids are recommended for use in severe COVID-19 patients. Low-molecular-weight heparin and novel anticoagulant (NOAC) are added as reimbursable drugs because COVID-19 increases the risk of blood clots. However, NOAC only recognizes benefits when low-molecular-weight heparin cannot be administered to patients. Baricitinib is also eligible for the benefit, when used in combination with Remdesivir. The opinion that Remdesivir and Baricitinib can be administered in situations in which Remdesivir and corticosteroids cannot be administered in clinical practice guidelines had an impact. Low-molecular-weight heparin and novel anticoagulant (NOAC) are added as reimbursable drugs because COVID-19 increases the risk of blood clots. Meanwhile, the revised regulations for COVID-19 treatment should be reviewed once a year from the effective date.
- Policy
- NECA-KSID publish COVID-19 clinical treatment guideline
- by Lee, Hye-Kyung Apr 01, 2021 06:05am
- The South Korean clinical experts issued advices each on anti-COVID-19 antiviral drug (remdesivir, hydroxychloroquine, lopinavir, ritonavir and favipiravir), steroid, interleukin inhibitor, interferon, convalescent plasma therapy and general intravenous immunoglobulin. For antibody treatments with social issues, such as Rekirona, the experts are currently reviewing literature, and planning to update the guideline every month. National Evidence-based Healthcare Collaborating Agency (NECA) and Korean Society of Infectious Diseases (KSID) co-published a latest RWE-based clinical treatment guideline for treating COVID-19 patients with the said details. An Ebola treatment remdesivir is conditionally allowed (recommended grade B) to be used in patients who require oxygen therapy but do not need a ventilator or extracorporeal membrane oxygen therapy (ECMO) treatment. Also, hydroxychloroquine, a well-known treatment for malaria, was not recommended either alone or in combination (recommended grade C). Meanwhile, the experts highly recommended using steroid for patients with moderate to severe symptoms (recommended grade A). The global clinical scene was in confusion due to uncertainty in COVID-19 treatments, and the World Health Organization (WHO) has informed of some drugs having no efficacy and advised to suspend some drug use. The reviewed literatures used for the clinical guideline in South Korea were from latest worldwide publications (June through December 2020) related to COVID-19. The level of the ultimately selected evidence was categorized by four levels—high, moderate, low and very low—using the evaluation and recommendation GRADE methodology, and the experts deliberated on issuing advice of highly recommended (A), conditionally recommended (B), not recommended (C) or decision deferred (I). The guideline contains advices on using antiviral drug, steroid and 19 key anti-COVID-19 treatments depending on the state of a patient. Taking in account that COVID-19 related research evidences are presented fast around the world, NECA has started researching with KSID to promptly develop the clinical treatment guideline. The two organizations plan to expand the research scope to develop a guideline covering from COVID-19 screening to treatment (both pharmaceutical and non-pharmaceutical treatment) based on the severity of patient symptoms. Principal investigator of the research, Professor Yeom Joon Sup at Severance Hospital said, “The clinical scene has shown high demand for evidence-based clinical treatment guideline on treating pneumonia and other long-term infectious disease. This research would set credible standards in minimizing the confusion on site and providing the best treatment for patients.” Clinical Evidence Research Team Lead Choi Mi-young at NECA commented, “As the world is actively conducting COVID-19 related clinical research and publishing related literature every day, we need to confirm and update the guideline with the latest findings. NECA would continue to research with the healthcare providers from multidisciplinary approach to overcome the COVID-19.”
- Policy
- Tamsulosin-mirabegron drug opens competition in Korea
- by Lee, Tak-Sun Apr 01, 2021 06:05am
- KyungDong Pharmaceutical is to start a Phase III trial on a combination drug consisting of a prostatomegaly treating agent tamsulosin and an overactive bladder treating agent mirabegron. The drug is expected to begin a commercialization race against Dongkoo Bio & Pharma that already received approval on Phase III trial. Without any preceding combination drug with the two agents in the market, the patients would get to appreciate more convenient regimen if the drugs are successfully launched. On Mar. 25, South Korea’s Ministry of Food and Drug Safety (MFDS) granted an approval on KyungDong Pharmaceutical’s 'KDF1905’ Phase III clinical trial protocol. The trial would use tamsulosin and mirabegron as test subject. Tamsulosin is a well-known prostatomegaly treatment, and mirabegron is an overactive bladder treatment. Astellas have developed and been supplying the brands of Harnal-D (tamsulosin hydrochloride) and Betmiga (mirabegron). Particularly, the two drugs have been popular among the South Korean urologic treatment market. UBIST reported Harnal-D has generated 72.6 billion won and Betmiga 65 billion won last year for outpatient prescription. A study result on confirming the improvement in lower urinary tract symptoms expressed in patients with prostatomegaly has been already published. In 2018, a team of researchers led by Professor Hidehiro at Asahikawa Medical University, Japan, observed the voiding symptom in 656 patients using both mirabegron and tamsulosin, and found the patient who used the drugs showed statistically significant improvement compared against the placebo group. Also the combination showed outstanding improvement in treating overactive bladder symptoms compared against the placebo. As the prostatomegaly and overactive bladder treatments are frequently prescribed in combination, the South Korean pharmaceutical companies have been focused on developing a combination drug. But none of them have been commercialized, yet. Besides KyungDong Pharmaceutical, Dongkoo Bio & Pharma has also initiated the Phase III clinical trial from last January on the tamsulosin-mirabegron combination drug. The South Korean company has a strong portfolio with drugs used for dermatologic and urologic treatment. As two companies started the Phase III trials on the same-agent drug, the pharmaceutical industry is closely following the companies to see who nabs the market authorization first. And because the two single-agent drug markets are big, other pharmaceutical companies may change their competition strategy depending on the combination drug’s success in the market.
- Policy
- Generic for Arcoxia were first approved
- by Lee, Tak-Sun Apr 01, 2021 06:05am
- Generic for Arcoxia (Etoricoxib, MSD Korea), an anti-inflammatory analgesic drug, was first approved on the 25th. The first licensed companies also succeeded in avoiding patents and obtained generic exclusivity. The MFDS approved four generic of Etoricoxib on the 25th. Boryung Etoricoxib 30mg, Arlico's Alicoxib 30mg, Reyon's Ecoxia, and Daewoo's Elicoxibe 30mg were licensed. They are produced by consignment by Arlico. These companies also succeeded in patent challenge by avoiding Arcoxia's crystalline patent. Accordingly, it has also obtained generic exclusivity granted to companies that have applied for the first license and succeeded in patent challenge. According to generic exclusivity, the sale of the same drug is prohibited from March 26 to December 25. Four items acquired the Generic Market Exclusivity for 9 months. The Generic Market Exclusivity was acquired, but the sales of the original Arcoxia were also not high. In the nonsteroidal anti-inflammatory analgesic market, Celebrex (Celecoxib, Pfizer) recorded an outpatient prescription of ₩40.6 billion last year. MSD conducted a clinical trial of Arcoxia in Korea. As it was a successor to Vioxx, which was expelled from the market due to cardiovascular risk, it was necessary to dispel the safety controversy. However, it was not easy to settle in the market because Celebrex's sales performance is good and there are more than 100 Celebrex generics out there. Moreover, unlike Celebrex, which has multiple indications, Arcoxia was only recognized for osteoarthritis. PMS on December 22 last year was terminated, and domestic generic companies immediately accepted the application for permission. Since only crystalline patents remained in the patents, generic companies succeeded in avoiding patents early. Generic companies are expected to enter the market immediately after registration. Competition is difficult because there are many items of the same family in the market. However, it is expected to take advantage of the effect of a new product as a first generic and cause a sensation in the osteoarthritis market.
- Opinion
- [Reporter’s Eye] How was working from home for a year?
- by Kim, Jin-Gu Mar 31, 2021 06:09am
- A year has passed since the COVID-19 has bled into people’s daily lives. The pharmaceutical industry also has faced big changes and working from home was one the biggest changes. Although it was forcefully introduced, the work from home system, unlike the beginning of the outbreak, became a norm—the office staffs have been working from home and the sales at site for a long time. After spending some time to get used to it, the companies are now seeing some positive side of the system. A team lead at a multinational pharmaceutical company commented, “The company struggled a bit in the beginning, but the work productivity has improved significantly compared against pre-COVID-19. Now we are rather worried about post-COVID-19.” Of course, there is an opposite side to it. Another company’s team lead said, “Because work tends have its inertia, the high productivity would be maintained for a while. But for a long-term, working from home would not help. There are definitely limitations in creativity and team work.” Both sides are right. The evaluation on working from home would vary depending on the company and team’s ambiance, workload, and position within the organization. Also the evaluation would be based on the work habit, distance from the office, and private issues like child care. Surely, the problem has no definite answer. The U.S., already preparing for the end of COVID-19 before South Korea, is taking interesting stance. Recently, major companies in the U.S. are having heated dispute over whether to continue work from home after the end of COVID-19. Netflix CEO Reed Hastings apparently called work from home a “pure negative.” Meanwhile, Apple CEO Tim Cook sees the outcome of working from home was impressive. And other companies are also contemplating on the pros and cons of working from home. South Korea should also consider the life after COVID-19. As the vaccination has been initiated, the end of COVID-19 is seemingly getting closer. The government anticipates achieving the herd community in coming November. Around early next year, the COVID-19 pandemic that has been draining the South Koreans over a year would finally mark the end. Also the time is coming for the pharmaceutical company to make a decision on either to continue working from home or go back to the office. Working from home was never an option in the beginning. Pharmaceutical companies were forced to work from home as the outbreak spread nationwide. But the companies can decide to stop working from home. And the decision has to be quick and bold. They should avoid the confusion they caused in the beginning at all cost. If some of the companies decide to continue working from home, they would need to be well-prepared. A simple guideline would not cut it. A well-designed remote working system should be established and organizational culture and personnel evaluation system should be entirely reformed. They should be aware the work from home guideline from the bygone days ordering ‘only the essential staffs to report to office’ has a clear limitation.
- Company
- Equfina can be prescribed at general hospitals
- by Eo, Yun-Ho Mar 31, 2021 06:08am
- Equfina, a treatment for Parkinson's disease from Esai, can be prescribed in general hospitals. According to related industries, Equfina (Safinamide) has passed the drug committee (DC) of Seoul National University Hospital and Asan Medical Center among Big 5 medical institutions, and is undergoing landing procedures at major medical institutions. According to the MOHW notice, it was applied health benefits as 'adjuvant therapy of Levodopa-containing drugs in patients with idiopathic Parkinson's disease with movement agitation symptoms'. Equfina was approved by the MFDS on June 24, 2020 as a once-a-day Levodopa supplemental therapy for Parkinson's disease patients. Equfina is a third-generation monoamine oxidase-B (MAO-B) inhibitor that doubles as dopaminergic and non-dopaminergic signaling. It showed significant improvement in motor and non-motor symptoms in Parkinson's disease patients with motor agitation in a phase 3 clinical trial. Levodopa is mainly used as a standard treatment for Parkinson's disease, but it is reported that about 75% of levodopa can cause complications when taking Levodopa for a long time for more than 5 years. Equfina is an adjunct therapy for Levodopa, can be reduced by long-term use of levodopa. Results of a Phase 3 clinical trial (SETTLE study) to evaluate the efficacy and safety of Equfina in Parkinson's disease patients with motor agitation symptoms, the ON time of drug efficacy without dyskinesia compared to placebo in patients who took Equfina for 24 weeks. A significant improvement effect of was observed. Equfina significantly reduced the OFF time of Levodopa as an adjunct therapy for Levodopa compared to placebo, and showed a significant decrease in the time to disappear regardless of the type of concomitant drug or the degree of exercise agitation. In the SETTLE study, as a result of the PDQ-39 score, which assesses the quality of life of Parkinson's disease patients, the change from the baseline PDQ-39 score of the 50-100mg/day group of Equfina was -3.17, which was improved compared to -0.68 in the placebo group. In another phase 3 clinical study, Study 016, the Equfina 100mg group showed a statistically significant improvement in the PDQ-39 score compared to the placebo group. In particular, in terms of emotional well-being, the change at 24 weeks from baseline in the Equfina 100mg group was -5.14, which was improved compared to the placebo group. Sung Young-hee, professor of neurology at Gachon University's Gil Hospital, said, "If Levodopa is administered for 5 years or longer to Parkinson's disease patients, motor fluctuations and complications may occur. Therefore, not only symptom control but also the possibility of complications that may occur in the future is considered.” She added, "By administering Equfina as an adjunct therapy to Levodopa, the dose of Levodopa can be reduced, so it will increase the duration of dyskinesia-free medication and help manage complications."
- Company
- “EMA authorizes Rekirona, sales projected at KRW 1.2 tln”
- by Kim, Jin-Gu Mar 31, 2021 06:06am
- The financial experts project Celltrion's COVID-19 monoclonal antibody treatment Rekirona injection’s (regdanvimab) sales in Europe would hit 1.2 trillion won as the European Medicines Agency (EMA) has granted conditional approval on the treatment. Leveraged by the Rekirona sales in Europe, the experts also projected Celltrion’s annual sales revenue this year would surpass 3 trillion won. Researcher Sun Min-jeong at Hana Financial Investment published a report with the said details. Previously, Celltrion announced EMA has issued advice on the use of Rekirona, prior to the formal marketing authorization. Based on the advice issued, European countries are authorized to use the South Korean drug to treatment patients with COVID-19. Researcher Sun Min-jeong explained, “Following the monoclonal antibody treatments by Regeneron Pharmaceuticals and Eli Lilly, Rekirona is now the third antibody treatment that received the conditional approval in Europe. However, unlike the U.S., European countries have not yet procured sufficient volume of the antibody treatments.” The researcher elaborated, “Due to the slow nature of monoclonal antibody treatment production, the drug makers would not be able to supply sufficient volume of the drugs promptly.” The COVID-19 treatments by Regeneron Pharmaceuticals and Eli Lilly would be unlikely to get supplied to the European market in time, which leaves a good window for Celltrion’s Rekirona to tackle the market. Celltrion expects to manufacture 3.2 million doses of Rekirona injection at maximum. The researcher stressed, “Besides the 100,000 doses secured from last year, the first and second plants and the overseas contract manufacturer would be able to produce 1.3 million doses, 1.3 million doses and 600,000 doses, respectively.” Regarding the pricing, the report estimated it would “differ depending on the contract signed with each country, but considering the U.S. government has settled with Eli Lilly to supply bamlanivimab for USD 1,250, Rekirona would be priced around the same level.” The reported explained, “Generally, the drug pricing in Europe is about 70 percent of the U.S. price. Rekirona is expected to be priced at 875 dollars (approximately 1 million won) per dose.” The researcher predicted, “Celltrion’s Rekirona sales revenue would reach 1.2 trillion won, based on the said pricing estimation. Accordingly, Celltrion’s overall sales revenue for the year would skyrocket by 77 percent compared against last year, and generate 3.3 trillion won.” In last year, the South Korean company has made 1.85 trillion won from sales only.
- Policy
- The NIID-Moderna discusses the cooperation plan for R&D
- by Kim, Jung-Ju Mar 31, 2021 06:06am
- The quarantine authorities are holding a video conference with Moderna, a COVID-19 vaccine company, to discuss cooperation measures such as R&D. It plans to continue development cooperation not only with related companies but also with US research institutes. KWON Jun-wook, Vice Head of Central Disease Control Headquarters explained this at a regular briefing on the 'COVID-19 Outbreak in Korea' held today (26th). Previously, the NIID held a short video conference with the president of Moderna at 10 pm on the 25th. They exchanged and discussed each other's proposals on cooperation, research and development, and production of vaccines. He said, "We plan to proceed with more detailed cooperation plans, such as signing an MOU with Moderna, centering on the NIID through working-level discussions in the future. We will conduct video conferences with the NIAID and develop cooperation with other vaccine manufacturers." The quarantine authorities will then distribute and disclose public briefings or materials as soon as results or results are released after working-level consultations.
- Policy
- Is Forxiga generic same as solvate-modified drug?
- by Lee, Tak-Sun Mar 30, 2021 06:06am
- A product image of Forxiga Pharmaceutical companies developing generics of an antidiabetic Forxiga are concerned that the products would get struck by receive sales ban due to preferential sales rights. The related criteria are not clarified enough for companies to predict the result. According to the pharmaceutical industry sources on Mar. 29, the companies are hectic developing generic drugs sharing the same active pharmaceutical ingredient (API) with AstraZeneca’s antidiabetic treatment, sodium-glucose co-transporter-2 (SGLT2) inhibitor Forxiga (dapagliflozin propanediol hydrate). So far none of the companies have requested for approval review, but seven bioequivalence tests were approved to this date. There are already 50 Forxiga follow-on drugs consisting of the API, dapagliflozin. But these drugs do not share the same solvate as Forxiga’s (propanediol hydrate). And 23 out of the follow-on drugs have received the preferential sales right. Solvate is a compound of higher order created between solvent molecule and ion. Generally, when a solvate consists of water molecule, it is then called hydrates. They won the preferential sales rights as their request to nullify Forxiga’s second patent (to expired on Jan. 8, 2024) was accepted. The preferential sales rights were validated as the companies won against the AstraZeneca’s appeal to overturn the decision. The case is currently pending at the Supreme Court as the multinational pharmaceutical company requested for further consideration. However, some generic companies are also participating in this case. Generic companies plan to release their products immediately after the first substance patent (to be expired on Apr. 7, 2023), if the patent nullification decision is sustained. But the issue is in the preferential sales rights won by the solvate-modified products. When the preferential sales rights come effective, same products cannot be sold. The preferential sales rights are effective from Apr. 8, 2023 through Jan. 7, 2024. The generic makers are now conflicted if the generics are considered as identical to the solvate-modified product. Typically, salt-modified drugs are not categorized as same as an original or generic drugs. However, it is unclear whether the solvate or hydrate-modifying drug is the same drug. If the generic drug is not the same drug, the patent-evading generic can be sold from Apr. 8, 2023, regardless of the preferential sales right. Otherwise, the generics would be unable to enter the market until Jan. 7, 2024, and the release date would be pushed by nine months. Even the industry is disputing over whether the solvate-modified drugs and generic drugs should be considered the same. An industry associate explained, "If the Ministry of Food and Drug Safety (MFDS) has reviewed the solvate-modified drug based on the submitted evidence like a salt-modified drug in the first place, then it should be considered different like a salt-modified drug." On the other hand, some argue that in the U.S., a solvate-modified drug falls under the same category as a generic, therefore, it should be considered the same. MFDS has yet to publish a clear guideline on the issue. The ministry is to start the discussion, when the generics request for the approval. With the ambiguous standard, generic makers are thinking of delaying the market release by nine months. A pharmaceutical industry patent expert commented, “The conflict is deepening as the number of drugs with solvate like Forxiga is extremely limited and there has not been a case where a solvate-modified drug receiving the preferential sales rights. MFDS should clarify the guideline before the generics applies for the market approval the set the order right”
