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- 2026-04-14 13:28:25
- [Reporter's view]COVID-19 Vaccine Development in Asia
- by Jun 02, 2021 06:11am
- The development of COVID-19 vaccine in Asian countries is on track. Currently, about 6 companies in South Korea, 4 in Japan, 3 in Taiwan, 2 in Thailand and 1 in Singapore are developing their own COVID-19 vaccine. All have just entered clinical trials or are preparing for large-scale clinical trials. Chinese vaccines whose clinical data are unknown were excluded. Specifically, Daiichi Sankyo, Shionogi, KMB, AnGes MG in Japan, Medigen, United Biomedical , Adimmune in Taiwan took the lead. Chulalongkorn University and Mahidol University are developing in Thailand. In Singapore, Duke-Nus Medical School is also working with Biotech in the U.S. to conduct research and development. Korea is dominated by Genexine, SK Bioscience, EuBiologics, GeneOne, Cellid, and ST Pharm. They made full use of their specialized areas. Genexine and GeneOne Life Sciences, which are the core of DNA technology, will develop DNA vaccines, while ST Pharm, which is specialized for mRNA, will develop LNP-type mRNA vaccines for the first time in Korea. Japan's Daiichi Sankyo and AnGes MG are RNA and DNA-based, respectively, and Thailand's Chulalongkorn University also tests RNA-based vaccines. Although development is slower than Western countries such as the U.S., the U.K., and Germany, it is meaningful to make vaccines with its own technology. This is because even if there is a shortage of vaccines that are contracted for supply, it can be replaced with domestic vaccines. In Korea alone, the supply of COVID-19 vaccines is still unstable. Unexpected side effects may lead to a shortage of supplies. Domestic vaccines will be reliable in unexpected circumstances. In response, the government signed a contract to supply vaccines to its own country preemptively. The Taiwanese government has signed 5 million dose vaccine contracts with Medigen and United Biomedical respectively. There are already some places that are about to produce commercial vaccines. Of course, there are many steps to overcome before vaccines in Asian countries are commercialized. Some of them may not be able to confirm their efficacy and safety, and development may be suspended. Many of them have no actual drug development experience. Although development can be successful without experience in commercialization like Moderna, probability is not high. Nevertheless, it is meaningful in terms of industry development that there are many companies that develop vaccines. Based on this experience, it is an opportunity to develop various kinds of vaccines. This also leads to securing sovereignty over vaccines. Currently, only 16 (57%) of the 28 essential vaccines in Korea have domestic products. Although it has been pushing for projects to support localization for more than 10 years, its performance is slow. In the meantime, it is good to hear that many Korean companies are focusing their efforts on vaccine development. In Taiwan, vaccines from their own countries could first appear as early as July. United has applied for EUA with health authorities on the 27th of last month. In Korea, we also expect a vaccine developed by a Korean company.
- Policy
- The new rheumatoid oral drug Smyraf was revoked after a year
- by Lee, Tak-Sun Jun 02, 2021 06:10am
- Astellas' Smyraf, which has drawn attention as a treatment for rheumatoid arthritis, withdrew the license in a year. Smyraf is the third domestically licensed inhibitor of Januskinase (JAK) after Xeljanz (Tofacitinib, Pfizer) and Olumiant (Baricitinib, Lilly). However, it failed to complete the registration process and withdrew from the Korean market. The MFDS announced on the 31st that the permits of Smyraf 100mg and Smyraf 50mg from Astellas Korea have been revoked. Smyraf was licensed in January last year as a new drug for rheumatoid arthritis. In particular, although existing rheumatoid arthritis treatments had the disadvantage of injection type, this product was highly anticipated in that it could be taken oral. The oral JAK inhibitor was a third drug following Xeljanz and Olumiant. After the approval, it was reported that this product was negotiated with insurance authorities to register drug prices. JAK inhibitors have mechanisms that inhibit the Jak-STAT pathway involved in the production of cytokines that cause inflammation in the body. In particular, attention has been paid to whether Smyraf will be listed since the fourth JAK inhibitor "Rinvoq (Upadacitinib, AbbVie)" was released in November last year. However, there was no news of listing for Smyraf, and the withdrawal led to Smyraf leaving the Korean market. JAK inhibitors are steadily rising in the domestic market. In the case of Xeljanz, sales of prescription amount outside the market reached ₩12.6 billion last year. In this situation, the news of Smyraf's withdrawal is very disappointing.
- Company
- Improved reg. allow price succession of transfer products
- by Chon, Seung-Hyun Jun 02, 2021 06:10am
- Drug price succession in transferred pharmaceutical products has been increasing. As the stepped pricing system is no longer applied to drugs that are relisted due to change of licensees, companies have been actively engaged in the transfer of their products. Some products have seen a twofold increase in their price compared to when the stepped pricing system was applied. According to the Ministry of Health and Welfare (MOHW) on the 30th, Organon Korea’s ‘Ezetrol tab.’ will be listed at a ceiling price of 744 won. Ezetrol (ezetimibe) originally used to be owned by MSD Korea. As the license holder was changed to Organon Korea, a new spin-off of MSD Korea, the drug had to be newly listed on the health insurance benefit list. MSD Korea’s Ezetrol will be removed from the reimbursement list from next month and its license will be transferred to Organon Korea. In January this year, a drug price succession regulation for transferred products was newly added, which allowed Ezetrol to maintain its previous maximum ceiling price of 744 won. In July last year, the drug pricing system was revised to add a stepped-pricing system that reduces the price of drugs that are listed late. The key point of the system was to reduce the price of later entrant generics by 15% when the number of products exceeds 20. In other words, if there are more than 20 drugs listed of the same ingredient, the drug price is set at ‘85% of the drug price of products that does not satisfy the two qualifications’ or ‘85% of the lowest price among the previously listed drugs,’ whichever is lower. Under the system, an unexpected issue arose as the drug products transferred between businesses were being listed at the lowest price among all products in the same category due to the application of the stepped pricing system. In transfers where the license of a pharmaceutical product is handed over to another company, the product needs to undergo a removal and relisting process. Even products that were previously listed are regarded a newly listed product after removal from the benefits list and is inevitably applied the stepped pricing system. The industry had pointed out that it was unreasonable to list transferred products the same as newly listed products, and the MOHW agreed to improve the system. From January, MOHW had made a partial amendment to the ‘Criteria for Decision or Adjustment on Drugs,’ so that in cases ▲where the manufacturer’s position was succeeded; ▲ where the same company switches its license from manufacturing and marketing to import authorization; or ▲ where the company withdraws its license due to business conversion, etc. and receives relicensing for the same product; the product’s price will be calculated at the same ceiling price that was previously set for the removed product. The regulation allows for the succession of the previous drug price in process of removal and relisting the same products in product transfers, etc. 42 ezetimibe products are currently listed in the reimbursement list, and their prices range from 480 won to 746 won. If Organon Korea’s Ezetrol was to be regarded as a newly listed product, its price may not have exceeded 408 won, which is 85% of the lowest listed price of 480 won. However, with the amendment, the company was able to maintain Ezetrol’s price at its previous listing price of 744 won. Recently, the drug price succession is actively being carried out among transferred drug products. In only this month, 4 products succeeded their previous drug price and were newly listed on the reimbursement benefits list. Daewoong Bio’s amlodipine and Valsartan combination ‘V-Forge Tab 10/160mg’ was newly listed at a ceiling price of 1,128 won on the 1st of this month. 1,128 won is the highest price among all products in its category and dose, and is a price 60% higher than the lowest price, which is 699 won. 81 products of the 10/160mg dose Amlodipine and Valsartan combination are currently listed in Korea. Under the stepped pricing system, newly listed products may not exceed a price of 594 won, which is 85% of the lowest price of 699 won among the same products. However, V-Forge Tab 10/160mg was a transferred product from Cosmax Pharma. By entering the market through a transfer, Daewoong Bio was able to be listed at a price that was twice higher than that of newly authorized products. Alvogen Korea’s ‘Maxgrel-A,’ which was newly listed from this month, received a ceiling price of 1,209 won. This is the highest price among the same products. With 35 Maxgrel-A products already listed, the price of a newly listed product in the same class would have had received a price discount through the stepped pricing system. However, Maxgrel-A was able to maintain its highest price by being newly listed through a transfer. If Maxgrel-A was a newly licensed product, its price would not have been able to exceed 732 won, which is 61.4% of the highest listed price. Celltrion Pharm’s ‘Celltrion Neopa,’ and Albogen Korea’s ‘Lutsnal Cap. 0.4mg’ would also have been applied the stepped drug pricing system, receiving a price that is ‘85% of the lowest price’ or ’61.4% of the highest price.’ However, the drugs were able to maintain their previous price as a transfer product.
- Opinion
- [Reporter's view] Tylenol is out of stock
- by Jun 02, 2021 06:10am
- As vaccinations began in earnest, the Tylenol crisis broke out in pharmacies. The Tylenol crisis has become inevitable as vaccinations for people aged 75 or older and those aged 65-74 have been implemented following preferential vaccinations for essential social workers. The government and the media are instructing people to take Tylenol if they have a fever after the inoculation. If pharmacists order Tylenol through wholesale, only the quota amount is supplied, so there are always times when the stock is tight or out. "Do you have Tylenol in stock?" "No, but we have the same active ingredient as Tylenol." "Oh, never mind." "Do you have any masks in stock?" "There are no more masks any more" This situation is similar to the mask crisis of the past. Pharmacies with relatively stable supply and demand through Jansen direct transactions do not mean that the situation is better. It is exhausting to guide dozens of consumers to take "after vaccination." Pharmacies are innocent, but it's as if they've become sinners. The pharmacy said this. "The moment I took out Tacenol, the patients looked different. That's exactly where I am going to do business. I don't know why I have to be a merchant, not a pharmacist, with a same pill." The Korean Pharmaceutical Association also urged the government to take Tylenol. The reason why patients only look for Tylenol at a time when many APAP are in sufficient stock is that health authorities have mentioned Tylenol directly since the beginning of the vaccine, causing confusion in their choice of fever reducer. Through the KCDA, the Korean Pharmaceutical Association asked each district health center to guide them to take APAP such as Suspen, Bukwang's Tacenol, and Penzal when fever symptoms occur after inoculation. The government, which authorizes the people to "Tylenol," should correct this issue. The situation has already deteriorated to persuade patients that pharmacies have the same ingredients and that other pharmacies do not have Tylenol. The MFDS has unveiled 70 items that have the same efficacy and effect as acetaminophen preparations, but pharmacists question their effectiveness. Since Tylenol has already been so deeply established in the public's perception, it is necessary to come up with effective measures, saying that the release of 70 products will not be much help unless campaigns and advertisements are combined. The target will also be expanded sequentially. Pharmacies say there will be a bigger problem in the future than it is now. It seems necessary to come up with measures quickly before vaccinations for the entire country are implemented in earnest.
- Company
- The FDA's final decision on Rolontis remains
- by An, Kyung-Jin Jun 01, 2021 06:11am
- View of Hanmi The FDA's due diligence on the domestic manufacturing facilities of Rolontis, a drug that Hanmi exported technology, has entered the final stage. The final process for obtaining final FDA approval has been completed as scheduled. Hanmi's partner Spectrum is rushing to prepare to enter the U.S. market worth about ₩3 trillion in preparation for FDA approval within this year. According to an industry on the 1st, FDA pre-approval inspection of Hanmi's Pyeongtaek Bio Plant, which produces undiluted liquid of Rolontis (Eflapegrastim), is underway. The schedule, which was scheduled from the end of last month to the beginning of this month, is progressing smoothly. "We cannot reveal the specific schedule," a source at Hanmi said. The FDA's due diligence has been carried out as scheduled. The due diligence of the Pyeongtaek Bio Plant is the final step for Rolontis' FDA sales license. "Rolontis' remaining procedures related to BLA have been completed," said Spectrum Pharmaceuticals, a U.S. partner of Hanmi. In the aftermath of COVID-19 infection, we were forced to proceed with due diligence at the Pyeongtaek plant," he said, stressing several times that final approval is possible once due diligence is completed." Rolontis is up to the FDA's decision. It is predicted that it will be able to obtain FDA's permission as early as this year. "If there was a problem with the clinical data, the FDA would have sent a CRL in October last year after completing the review of Rolontis," said Joe Turgeon, CEO of Spectrum Pharmaceuticals. "I'm confident that the rest of the process was fine. We are looking forward to FDA approval." Rolontis is a bio-new drug that Hanmi Pharmaceutical Co. transferred to Spectrum in Spectrum in 2012. Cancer patients subject to myelosuppressive chemotherapy are administered for treatment or prevention of neutrophilia. It is a family of "G-CSF" (grain globular stimulators) that stimulates granulocytes to increase the number of neutrophils, similar to Amgen's blockbuster drug "Neulasta" (Pegfilgrastim). If "Rolontis" receives FDA's final approval, Hanmi will release its first bio drug to the U.S. market that combines Labscovery platform technology that increases the duration of bio-medicine in the body. Given that Pyeongtaek Bio Plant has passed the FDA's strict due diligence standards, it can also enjoy the achievement of recognizing biopharmaceutical manufacturing technology. It is estimated that long-term G-CSF markets in the U.S. are worth ₩3 trillion. Amgen's "Neulasta" accounts for about 70%, Mylan's "Fulphila" and Coherus' "Udenyca" account for the remaining 30%. Spectrum has been conducting new global clinical trials since March last year, apart from "Rolontis" licensed clinical trials. It is a study that administers Rolontis on the day of myelosuppressive chemotherapy (Docetaxel+Cyclophosphamide). Existing treatments in the G-CSF family are difficult to administer on the same day as anti-cancer drugs, so patients have to be hospitalized or visit the hospital again the next day. Spectrum is conducting a reaction evaluation by administering Rolontis for 30 minutes, 3 hours, and 5 hours after chemotherapy to ease this hassle. Its strategy is to secure differentiation from competitive drugs by maximizing convenience of patients. Spectrum's management team said at a recent conference call, "Patients' enrollment on the same day of Rolontis is going smoothly. We expect to be able to announce research results by the end of this year. It will serve as data that can differentiate itself from competitive drugs after market release." Hanmi did not disclose specific terms of the contract regarding the transfer of Rolontis technology at the time of the initial contract with Spectrum. However, it is possible to estimate the size of the contract through a report submitted by Spectrum to the U.S. securities and exchange commission (SEC). Spectrum agreed that "If Rolontis obtains FDA's final sales license, Spectrum will pay Hanmi $10 million (about ₩1.9 billion) in technical fees." After its release, it pays an additional percentage of royalties each year depending on net sales.
- Policy
- Comparing Cellid with Janssen·AZ… SK Bio with Novavax
- by Lee, Tak-Sun Jun 01, 2021 06:11am
- With the Ministry of Food and Drug Safety announcing lowered standards for conducting Phase III clinical trials to promote the development of domestically developed COVID-19 vaccines, commercialization of Korean COVID-19 vaccines is likely to happen sooner than expected. In particular, domestic vaccines that were not able to enter the Phase III stage may be able to enter the market early by conducting comparative effectiveness clinical trials with previously approved products. On the 31st, the MFDS released the “Standard Draft for Covid-19 Vaccine Clinical Investigation Plans" on the 31st. In particular, the draft allows comparative clinical trials (phase 3) with previously approved vaccines. On the 31st, the MFDS released the “Standard Guideline for Covid-19 Vaccine Clinical Trial Plans.” In particular, the guideline allows comparative clinical trials (phase 3) with previously approved vaccines. Until now, clinical trials of COVID-19 vaccines had to demonstrate its efficacy compared to placebo. In the WHO guidelines, the efficacy of the investigational drug is compared with placebo in 150 subjects diagnosed with COVID-19. For example, if 15 out of the 150 patients received the investigational drug and the others received the placebo, the drug’s effect becomes 90%. AstraZeneca, Pfizer, Moderna, and Janssen’s vaccine were all approved through this method. However, issues that administering placebos to patients is ethically wrong as COVID-19 vaccines that are already commercialized do exist, and that an excessive amount of time and money is spent on the developer’s part when conducting placebo studies have been raised. According to MFDS, to conduct a Phase III trial in a country with a COVID-19 incidence rate of 0.4%~1.2%, a minimum of 20,372 to a maximum of 60,112 subjects is needed. However, the guideline presented by MFDS for comparative effectiveness clinical trials only requires an administration record for a minimum of 4,000 subjects. The comparative clinical trial would need to demonstrate that the vaccine is non-inferior or superior to the comparator drug (commercialized drug) at week 4 after vaccination through comparison of their neutralizing antibodies. However, for the safety review, at least 4,000 subjects (≥3,000 in the test group, 1,000≥ in the control group) will need to be enrolled in the trial. MFDS announced that by cohort, approximately 20% of the subjects should be 65 years or older and that over 5,000 participants should initially register for the trial in consideration of the 20% dropout rate. The comparator vaccine should be an item approved in Korea and be produced using the same platform. Currently, 5 domestic pharmaceutical companies have been conducting clinical trials on domestic COVID-19 vaccines. Cellid’s vaccine is being developed using a viral vector platform, SK Biosceincec and EuBiologics are basing their vaccine on a recombinant vaccine platform, and Genexine and GeneOne Life Science are using a DNA vaccine platform to develop the vaccines. The companies have not completed their Phase II trials yet. To be approved to progress to Phase III trials, the companies would need to first submit the results of their Phase II trial and be verified on the dosage and regimen. Under the new guidelines, by platform, Cellid will be able to conduct a comparative effectiveness clinical trial with Janssens or AZ’s vaccine. SK Bioscience and EuBiologics will be able to conduct the trial with Novavx’s vaccine. However, as only items that are approved in Korea may be used as comparators, the Novavax vaccine, which has not been approved in Korea yet, would not be immediately available for use as a comparator. Genexine’s DNA vaccine will not be eligible for the comparative effectiveness clinical trial as there is no DNA platform vaccine currently approved in the world. Therefore, Genexine would need to conduct its Phase III trial in the traditional way. Genexine plans to conduct its Phase III trial in Indonesia and other countries. The comparative effectiveness clinical trials may be conducted in a multinational manner. However, the proportion of domestic subjects must exceed 10%. An MFDS official said, “the long-term safety and immunogenicity data of vaccines are analyzed even after approval. Products approved by MFDS may be used for inoculation purposes in Korea.”
- Company
- 3-way race between ultra-expensive new orphan drugs to start
- by Jun 01, 2021 06:11am
- With Novartis’s gene therapy ‘Zolgensma’ approved, 3 new drugs have been introduced into the Korean spinal muscular atrophy (SMA) market, a market that previously had virtually no treatment available. The introduction of 3 new drugs in just 3 years marked the start of a full 3-way race between the new SMA treatments in Korea. In the U.S. where the race had already started, Spinraza’s share in the market has been decreasing. As to whether the situation would be the same in Korea is gathering attention. The Ministry of Food and Drug Safety (MFDS) has approved Novartis’ ‘Zolgensma (onasemnogene abeparvovec-xioi)’ as the second advanced biological product in Korea. Zolgensma can be used in SMA patients with a double allelic mutation in the SMN1 gene who have been ▲ clinically diagnosed as SMA Type 1 or ▲ has three or fewer copies of the SMN2 gene. Zolgensma’s different mechanism of action works as a strength over to Spinraza or Evrysdi SMA is a serious rare disease in which muscles gradually degenerate as motor nerves are damaged due to a gene defect in the survival motor neuron 1 (SMN1) gene. One out of every 10,000 infants around the world are diagnosed with SMA, and in Korea, around 30 patients (per 300,000 infants) are diagnosed with SMA every year. The severity of SMA is deeply associated with the number of copies of the “backup” SMN2 gene. The SMN2 gene may produce and compensate at most 10% of the SMN protein unable to be produced by SMN1. Patients with Type 1 SMA that have only 1-2 SMN2 copy genes may experience 95% loss of their motor neurons, and 90% of the patients die before reaching age 2. In Korea, there had been no SMA treatment available until 2017. Biogen’s ‘Spinraza’ was the first to be approved in December 2017, opening up a new treatment paradigm. 자료: 각사 Spinraza is an RNA-based treatment. It is an antisense oligonucleotide splicing modulator that promotes protein production by binding to the pre-mRNA sequence of the SMN protein produced by SMN2. After Spinraza, Roche also received approval for its RNA-based treatment, ‘Evrysdi.’ Unlike Spinraza, which is an injection formulation, Evrysdi is an oral formulation and is cheaper. However, this oral drug needs to be taken every day. Evrysdi has not yet been released in the Korean market. Zolgensma’s mechanism of action is completely different from the two drugs that were previously approved. Unlike Spinraza and Evrysdi, which use the “backup” SMN2 gene to increase the production of proteins, Zogensma completely replaces the function of the missing SMN1 gene to produce SMN proteins. When the replacement, made with a recombinant AAV adeno-associated virus (AAV9), is given to an infant by intravenous infusion, it works as an SMN1 gene and produces proteins. It is also called a 'dream cure' as patients can expect to be completely cured with just a single treatment. As a “one-shot treatment,’ the cost of the drug is also ultra-expensive. The cost of a single Zolgensma infusion costs 2.5 billion won. This is 25 times higher than the cost of Spinraza. However, Novartis explains that the cost-effectiveness of Zolgensma is quite high considering that Spinraza or Evrysdi would cost 0.3-0.5 billion won every year. Spinraza’s sales falter and Evrysdi strong in the U.S…. how about Korea? The SMA market in Korea is currently dominated by Spinraza. Based on IQVIA, Spinraza sold 72 billion won in sales last year. However, with the entry of Zolgensma and the yet-to-be-introduced Evrysdi, the market dominion in Korea is expected to change. Changes in the U.S. SMA market that is already in the 3-way race, can be used as a reference to predict the future of the Korean market. In the U.S. Spinraza’s sales have been showing a decline with the introduction of Zolgensma and Evrysdi. After selling 233 million dollars (approx. 257.3 billion Korean won) in Q1 2019, its sales had started falling from Q2 2020. The sales fell to under 200 million dollars in Q3 2020 to record 183 million dollars (approx. 202.1 billion won), then to 149 million dollars (approx. 164.5 billion won) in Q1 last year. This was a 36% decline in sales over the past 2 years. On the other hand, Zolgensma’s sales have shown a similar record every quarter since its introduction, since Zolgensma is a one-shot treatment that does not accumulate patients. After recording 150 million dollars (165.6 billion won) in Q3 2019 when it started to be prescribed in earnest, its sales have stayed steady in the 100 million to 130 million dollar range (143.5 billion won) every quarter. Evrysdi, which was introduced last in the U.S. market, has been relatively rapidly gaining its share compared to the other two competitors. After receiving approval in August 2020, Evrysdi sold 9 million dollars (9.9 billion won) in Q3 of the same year, which increased to 51 million dollars (56.3 billion won) in Q4, then to 87 million dollars (96.1 billion won) in Q1 this year. It may have had the lowest sales record, but its sales growth is the fastest among the three products. Based on the trend, U.S. experts expect Evrysdi to record the highest sales in 2026 based on its low-cost and oral formulation. Of course, the U.S.’s case may not apply 100% to Korea, as the Korean market is most strongly influenced by whether the drug is reimbursed as well as the reimbursement criteria. However, Spinraza’s sole lead in the Korean market is expected to continue for the time being, until reimbursement is approved for Evrysdi and Zolgensma. Also, there is criticism that the current insurance policy structure makes it difficult to accommodate ultra-expensive drugs like Zolgensma. The various clinical trials ongoing with Spinraza are also a variable. Spinraza has been conducting various clinical trials to maintain its lead in the SMA market; one of which is on asymptomatic infants. This study investigates whether administering Spinraza in advance to infants that have been genetically diagnosed with SMA helps to maintain a normal level of motor function in the patients. If Spinraza is approved for the indication to treat infants with confirmed SMN1 gene defect or mutation prior to diagnosis, Spinraza will be available at the very front-end, before any other treatment. In addition, Biogen has started more aggressive trials as well. The Phase IV RESPOND trial studies the benefit of switching to Spinraza in patients who showed a suboptimal clinical response to Zolgensma. Biogen identified cases of some patients who received Zolgensma but were insufficiently treated and found that switching to Spinraza may bring additional benefits to these patients. A long-term follow-up study showed that 4 out of 10 patients that had previously received Zolgensma have switched to Spinraza to continue their treatment.
- Company
- Astellas notified distributors, Betmiga cannot be returned
- by Kim, Jin-Gu Jun 01, 2021 06:11am
- BetmigaConfusion in pharmacies is expected to continue for a while over the lowering of the drug Betmiga (Mirabegron), an irritable bladder treatment. The pharmaceutical industry and the outpatient pharmacies predict that it will take at least a year for the drug price to be finalized. According to the pharmaceutical industry and pharmacies on the 28th, Astellas Pharma Korea Betmiga PR will be lowered from the 1st of next month. This is because Chong Kun Dang and Hanmi Pharmaceutical succeeded in overcoming patents and released generic. The MOHW has announced that it will lower the upper limit of the original Betmiga from June 1 following the release of generic drugs. However, it is highly likely that Betmiga's drug prices will not be reduced. Astellas disobeyed the second trial's ruling, and the case went to the Supreme Court. Astellas lost the second trial of Betmiga's use-and-crystal patent dispute with 11 companies, including Hanmi, on January 22 this year. Astellas filed an appeal with the Supreme Court on March 3. At the same time, it is said that it filed an injunction with the administrative court to suspend the execution of the drug price notice. Since the related case has not yet been finalized, it is a request to postpone administrative disposition until the Supreme Court ruling is made. This is why Astellas notified distributors of "nonreturnable" and "non-settle balance" by saying, "There is no reduction in drug prices in June." In fact, the same thing happened earlier in the patent dispute surrounding Eliquis. BMS, the original company, maintained an insurance upper limit of ₩1,185 per party by dragging the case to the second trial and applying for an execution suspension of drug prices at the same time, even though generic was released after the first trial was lost. When the second trial was lost, the MOHW warned of a drug price cut, but the BMS applied for an execution suspension of the drug price cut as it dragged the case back to the third trial and eventually the insurance upper limit price was maintained. The case was overturned in the third trial and eventually BMS succeeded in delaying the drug reduction until September 2024. It took about two years for the final sentence (April 8, 2021) to be made after the third trial was held in the Eliquis case (May 3, 2019). Considering this, the pharmaceutical industry and pharmacies predict that it will take at least a year to reach a final conclusion on the reduction of Betmiga prices. Unlike the first and second trials, the Supreme Court does not disclose the date of the sentence to the public. This explains that the company's non-returnable measures and the pharmacy's confusion over them will continue for more than a year. However, there is a possibility that the conclusion may be unusually early. The Supreme Court will decide within four months whether to deal with the case in earnest from the second trial. This is called the discontinuity of trials period, and if the Supreme Court judges that the hearing is unnecessary, the second trial will be finalized before October. "Astellas submitted a statement of grounds of the final civil application," a pharmaceutical industry source said. "We expect a new claim to be made in the Supreme Court, which is different from the second trial," he said. "We believe that the possibility of disccontinuity of trials is low at the moment." For Bayer's new oral anticoagulant Xarelto (Rivaroxaban), the situation is different from that of Betmiga. Bayer is also said to have applied for suspension of execution in the government's disposition to lower drug prices because the lawsuit has not been completed. However, Bayer was defeated in the Supreme Court in December last year. The Supreme Court dismissed Bayer's appeal and sent it back to the Patent Court. Xarelto's prices are likely to remain until the Patent Court has reached the conclusion of the remand trial. In general, the period of judgment is shorter than that of the Supreme Court for destruction and repatriation. This means that the chaos in the pharmacy disappears more than in the case of Betmiga.
- Company
- Beovu can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 01, 2021 06:11am
- AMD treatment Beovu became available in general hospitals with insurance coverage. According to related industries, Novartis Korea's Beovu (Brolucizumab), which has been registered since April, passed drug committees of more than 30 medical institutions including Seoul National University Hospital and Sinchon Severance Hospital. Wet AMD treatment Beovu, in combination with VEGF-A, is a mechanism that inhibits neovascular expression and retinal effusion, administered once a month for the first three months and once every three months. Beovu's efficacy has been demonstrated through two three-phase clinical trials HAWK and HARRIER studies compared to Eylea (Afribercept). Clinical studies of 1,817 patients with macular degeneration related to the age of 50 and older demonstrated noninferiority compared to controls at 1 year (48 weeks) in BCVA (Best-Corrected Visual Acidity) changes, the primary evaluation index. Beovu also demonstrated that the proportion of patients with improved maximum corrective vision (BCVA), which is a secondary evaluation index, by more than 15 letters, was also non-equivalent compared to the control group at week 48. (HAWK study: 34% Beovu group, 25% Eylea group; HARRIER study: 29% Beovu group, 30% Aflibercept group) Furthermore, patients with intra-retinal fluid (IRF)/sub-retinal fluid (SRF) were also significantly lower in the Beovu group, showing superior improvement over controls. Kang Se-woong, an ophthalmologist at Samsung Medical Center, said, "AMD is a disease that can be blind within two years without proper treatment and requires active and effective treatment from the beginning. "Beovu, which is effective not only in improving vision but also in improving the retina, which causes direct degeneration of the macula, will be covered by insurance benefits and will be able to provide patients with effective treatment options." "In particular, as Beovu allows us to maintain a longer, three-month treatment interval than conventional treatment, it is expected that the burden of treatment and the possibility of discontinuation of treatment will be reduced in AMD, where continuous treatment is important," he added. AMD, one of the top three causes of blindness in the elderly population aged 65 and older, is a disease in which vision is degraded due to the metamorphosis of the macular region in charge of vision. Macular degeneration is caused by structural changes and damage to the retina and macula by leaking effluent or blood from abnormally produced blood vessels (new blood vessels). As it is a disease that causes vision loss and blindness, the main treatment goal of Neovascular (Wet) Age-Related Macular Degeneration is focused on improving vision, and anatomical changes should also be considered for effective treatment.
- Company
- Pacenra(Fasenra) can be prescribed at the general hospitals
- by Eo, Yun-Ho May 31, 2021 06:02am
- The severe asthma treatment "Pacenra" is available at general hospitals. According to related industries, Pacenra (or Fasenra, Benralizumab) of Astra Zeneca Korea has passed drug committee (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital , Ajou University Hospital, and Wonju Severance Christain Hospital. Pacenra is approved for use as an additional treatment in adult patients with severe anaerobic asthma if it is not properly controlled by conventional treatment, and is then administered once every four weeks for the first three months. One of the reason for asthma management is to reduce the risk of asthma deterioration. Pacenra is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa). It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity. The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effectors cells such as natural killer (NK) cells. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation. According to the SIROCCO study of 1,205 patients with severe asthma worldwide, including 122 Korean patients, the annual asthma exacerbation rate compared to placebo was reduced to 45% in once-four weeks and 51% in once-eight weeks. In addition, another clinical CALIMA study confirmed that the annual asthma exacerbation rate compared to placebo decreased by 36% in the once-in-a-week group and 28% in the once-in-eight-week group, significantly reducing the annual asthma exacerbation rate in the placebo group. In both studies, the change in FEV1 (1-second forcing capability) compared to baseline was measured, and consistent improvement over placebo was shown. In order to evaluate the long-term safety and efficacy of Pasenra in patients with severe anacid, there was no significant difference compared to placebo in the SIROCCO study and BORA study, a 56-week safety assessment extension study of 1926 patients participating in CALIMA study. Asthma, meanwhile, is associated with an unexpectedly high mortality rate. The death rate of hospitalized patients due to asthma is about one-third, and the cost of asthma-related patients requiring emergency treatment or hospitalization accounts for more than 80% of the total asthma-related costs. In particular, eosinophilic inflamination is present in 50% of asthma patients, which can cause poor lung function, worsening asthma, and increased exacerbation rates. Despite proper ICS therapy, patients with eosinophilic inflamination asthma with high levels of eosinophil are often not managed by conventional therapy such as ICS-LABA therapy, which is life-threatening due to pain caused by symptoms and frequent deterioration of diseases.
