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- Company
- Boryung develops 4-drug kanarb combo… increases lineup
- by Chon, Seung-Hyun Sep 22, 2023 05:42am
- On the 20th, Boryung Pharmaceutical announced that the Ministry of Food and Drug Safety has approved the Phase III clinical trial plan (investigational new drug, IND) for ‘BR1018,’ its incrementally modified drug candidate for hypertension and dyslipidemia. BR1018 is a four-drug combination that combined amlodipine, atorvastatin, and ezetimibe with fimasartan. Fimasartan is the main active ingredient of Kanarb, a new hypertension drug developed by Boryung. Kanarb was released in 2011 as a new drug for high blood pressure in the angiotensin II receptor blocker (ARB) class and was developed by Boryung with its proprietary technology. Amlodipine is a calcium channel blocker (CCB) type hypertension treatment drug. Atorvastatin and ezetimibe are treatments for hyperlipidemia. The clinical trial for BR1018 will test the drug’s efficacy on 156 patients with essential hypertension and primary hypercholesterolemia for 2 years. The company explained, “As the drug contains 4 ingredients in a single pill, we expect it may improve the patient’s medication compliance.” By releasing a series of combination drugs that use its Kanarb, Boryung has provided various treatment options in the field. In 2013, the company released LaCor, which was a combination of Kanarb and the diuretic hydrochlorothiazide. In 2016, the company introduced Tuvero, a combination of Dukarb (Kanarb+calcium channel blocker (CCB) drug amlodipine) and rosuvastatin, a hyperlipidemia treatment drug. In 2019, the company launched Dukaro, a 3-drug combination drug that combined rosuvastatin with Dukarb, and Akarb, a combination of Kanarb and atorvastatin, for hypertension and hyperlipidemia. In June last year, it released Dukarb Plus, a combination of Kanarb with amlodipine and hydrochlorothiazide. Last year, the Kanarb family recorded prescription sales of KRW 141.8 billion. Its sales have continued to grow at an average rate of more than 23% over the past 5 years. Boryung secured 131 papers and over 72,000 clinical cases related to Kanarb, added an indication for reducing proteinuria, and expanded the age of use. It also demonstrated its effect in controlling blood pressure in stroke patients and reducing stroke recurrence. Boryung plans to continue launching combination drugs and expand clinical research to achieve annual sales of KRW 200 billion by 2026 through the ‘Great Kanarb’ strategy. Currently, Boryung is developing additional Kanarb fixed-dose combinations including BR1015, a combination drug for high blood pressure, and BR1017, a combination drug for hypertension and dyslipidemia. The company had also applied for IND for BR1019, a combination drug that can simultaneously treat high blood pressure and diabetes. Jong-Rae Lim, Head of R&D at Boryung said, “We aim to provide various treatment options to prescribing doctors through continuous development of Kanarb combinations while improving patients’ medication compliance. We will enhance the clinical excellence of our Kanarb family by continuing to add indications through continuous research and investment.”
- Policy
- How Samsung’s biosimilar became covered in the US
- by Lee, Hye-Kyung Sep 22, 2023 05:41am
- Language barriers, insufficient handling of administrative issues related to regulations and visas, difficulties in recruiting and managing local personnel, and lack of a network infrastructure were pointed to as barriers to the Korean pharmaceutical companies’ entry into the U.S. Entry into the U.S. market holds significance in the industry as it is the world's largest pharmaceutical market that leads global technological standards. However, due to the various risk factors that exist, thorough preliminary research and simulation are necessary before making an attempt. The '2023 Global Pharmaceutical-Bio Market Export Support Report' that was issued by the Korea Health Industry Development Institute on the 21st published the difficulties and entry strategies for domestic companies seeking to enter the US market. First, the report said that companies should consider a strategy of being listed in the private insurance market through pricing, like Celltrion Healthcare and Samsung Bioepis. Celltrion Healthcare's Humira biosimilar’ Yuflyma’ was listed on the formulary of OptumRx, which is a subsidiary of one of the top 3 PBMs in the US, United Healthcare. The company pursued a high price strategy of setting the price at USD 6,576, which is only 5% cheaper than the original Humira. It is said that the high drug price allows room for much margin, increasing rebate resources and being advantageous in negotiations with PBMs. Samsung Bioepis’s Humira biosimilar ‘Hadlima’ was listed as a preferred drug in the formulary of Cigna Healthcare, a major private insurance company. The company had set the Wholesale Acquisition Cost (WAC) of its drug at USD 1,038, which was the lowest among all Humira biosimilars in competition in Korea, and 85% lower than that of the original. On the other hand, SK Biopharmaceuticals had prepared a direct sales approach due to a lack of network infrastructure. When using a direct sales system, profitability increases as the number of products sold increases, but initially, it imposes a huge fixed cost burden as the company needs to establish a local corporate body and hire professional sales and marketing personnel. SK Biopharmaceuticals explained that its SG&A expenses have continued to rise for the company since 2019 when it began preparing for a direct sales system. According to KAPAL (Korean-American Professional Association in Life Sciences), difficulties faced by Korean companies entering the US include language barriers, poor administrative management related to regulations/visas, difficulties in recruiting and managing local personnel, and lack of a network infrastructure. It also advised that preliminary research, thorough simulation, and advice from local experts and the experienced should be used to address the difficulties. In other words, companies need to understand and overcome local environmental and cultural differences, including by thorough localization of personnel and business operations, understanding and accepting the high wages and flexible working conditions, and taking a long-term approach based on an understanding of the relatively slow business progress and invest the time for information collection and networking to continuously develop its technology and intelligence property to successfully enter the US market. Although the CDMO infrastructure in the US is saturated, the government announced a policy to strengthen manufacturing. This is expected to expand medical and pharmaceutical production facilities and bases in the US, and the situation could be used in favor of the Korean companies as it would allow the companies to receive incentives and secure leadership in local production. New investment in the field of new drug development and clinical trials has been increasing in the US, and the government has been investing particularly in cancer treatment. Anticancer drug development and clinical trials account for 40% of all clinical trials conducted in the US, therefore, companies can seek entry into relevant fields through licensing out, technology transfers, and M&A with companies related to anticancer drug development.
- Product
- Will Insulin being sold out persist for a long time?
- by Kim JiEun Sep 22, 2023 05:41am
- There are signs that the sell-out of insulin preparations will continue for a long time. Some pharmaceutical companies have announced the timing of the resumption of supply, but the wholesale industry predicts that the current crisis will not be resolved in the near future. Novo Nordisk Pharmaceuticals recently announced the schedule for the resumption of the supply of Xultophy FlexTouch and Novorephid to pharmaceutical wholesalers. According to the information provided this time, the expected supply resumption date for Xultophy FlexTouch Injection 100U/ml, 3.6mg/ml is the first week of November, and for Novorephid 100U/ml is the fourth week of September. The company said, “We are continuously working to normalize the supply of Xultophy Flextouch Injection products.” The company explained, “We will secure supply so that patients who have been prescribed Xultophy FlexTouch Injection can continue treatment and provide information on the expected supply resumption date.” A company official added, “We deeply apologize for any inconvenience caused to patient care or work due to the instability of product supply due to the global imbalance in supply and demand.” According to the industry, Novo Nordisk had previously announced the resumption of Xultophy supply in September, but this announcement announced that it would resume supply in November, effectively delaying the restart by about two months. As of September 21, products such as Tresiba and Trulicity were still unable to be ordered from online malls, and it was confirmed that product supply and shipment were not smooth in the wholesale industry. Local pharmacies and the industry predict that if patients with long-term prescriptions flock to hospitals and clinics ahead of the long Chuseok holiday next week, the difficulties faced by front-line pharmacies due to shortages of insulin preparations may double. An official from the wholesale industry said, “Items such as Tresiba and Trulicity have been stocked and shipped in small quantities since August, but it is difficult to meet all the demand. In the case of Xultophy, it has not been seen in the market for several months even though there is considerable demand.” “As the resumption of supply has been postponed again to November, difficulties will inevitably arise at pharmacies where prescriptions for the product are delivered,” he said. This official said, “As this Chuseok holiday is so long, the number of visits to hospitals and pharmacies by patients with long-term prescriptions may increase next week.” He said, “If this happens, there could be another shortage of insulin products.”
- Company
- Next-gen asthma drug Tezspire to soon be introduced to KOR
- by Eo, Yun-Ho Sep 22, 2023 05:41am
- The next-generation drug for severe asthma, ‘Tezpire' is soon expected to enter the Korean market. According to industry sources, AstraZeneca Korea has submitted an application for the approval of ‘Tezspire (tezepelumab)’ in H2 to the Ministry of Food and Drug Safety and is receiving its final review. Whether AstraZeneca will be able to continue on its lineage in the field of asthma with Tezspire after failing to list its ‘Fasenra (benralizumab)’ for reimbursement remains to be seen. As a viable competitor to Sanofi’s ‘Dupixent (dupilumab),’ Tezspire inhibits the action of the thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades, to block the inflammatory chain reaction. The drug was approved by the US FDA in 2021 as a treatment for adult and pediatric patients aged 12 years and older with severe asthma., and added a self-injection formulation to its approval in February this year. Tezspire demonstrated a consistent and significant reduction in asthma exacerbation in the Phase II PATHWAY trial and Phase III NAVIGATOR trial, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status, and fractional exhaled nitric oxide (FeNO). In the study, the most common adverse reactions shown in patients who received Tezspire were pharyngitis, rash, arthralgia, and injection site reactions. The findings from the NAVIGATOR study were published in The New England Journal of Medicine in May 2021. The Korea National Enterprise for Clinical Trials had designated Tezspire as the No.1 drug in need of urgent introduction to Korea in its report on the ‘List of foreign new unintroduced drugs that should be promptly Introduced to Korea.’
- Policy
- Bioequivalence reevals speed up in line with drug price reev
- by Lee, Hye-Kyung Sep 21, 2023 05:24am
- With the number of items requiring equivalence tests expanded as such, the Ministry of Food and Drug Safety is also accelerating the reevaluation of those that were previously approved. In particular, it is said that the review is being further accelerated this year as its timing overlaps with the reevaluation of the insurance price ceiling amount, which requires self-bioequivalence tests. So-Hee Kim, Director of the Bioequivalence Evaluation Division at the Ministry of Food and Drug Safety's National Institute of Food and Drug Safety Evaluation, said so at a press briefing it had held together with the Drug Evaluation Department. Director Kim explained, "The initial results of the Ministry of Health and Welfare's 'insurance price ceiling reevaluations (standard requirements)' have come out, and pharmaceutical companies are showing mixed responses based on their results. At the time of the drug pricing reevaluations that were conducted, the MFDS reviewed the equivalence reevaluation of many items in a short period of time, and have completed the first review and are reviewing the data again,” The MFDS has expanded the scope of equivalence reevaluations to include all prescription drug generics, starting with oral tablets (uncoated tablets) this year, tablets (film-coated tablets) in 2024, and capsules, granules, and syrups in 2025. For the equivalence reevaluation, subject companies would have to submit a bioequivalence testing result or plan by March of every year. If the companies find it difficult to submit the test result report by then, they may first submit a plan, and submit the results by December after completing the test according to plan. The reevaluation results will be released around February of the following year. The problem was the drug price reevaluations that took place this year. Generic drugs subject to drug price reevaluations had to satisfy both requirements - conducting bioequivalence tests and using registered raw drug substances - to receive the highest insurance price. For items that are subject to both equivalence reevaluations and drug price reevaluations, it was difficult for the companies to submit a notice of completion of their bioequivalence tests in accordance with the drug pricing reevaluation schedule under the Ministry of Food and Drug Safety’s plan. Kim explained, “ The MFDS also had to conduct many equivalence reevaluations in a short period to meet the pricing reevaluation schedule. The review of the items subject to drug price re-evaluation has been completed, and we are now reviewing the remaining equivalence re-evaluation data.” For companies to receive the highest price, the MFDS had to submit a notice of completion of the equivalence reevaluation review to HIRA within the drug pricing reevaluation period, which forced the MFDS to also accelerate its review. Kim said, “Pharmaceutical companies have been expressing difficulties. We have been guiding ways to resolve their issues to help them follow the government’s policies.” Regarding the need to engage in continuous communication with the pharmaceutical industry to respond to various issues including the recent reevaluations, Young-Rim Kim, Director-General of the Drug Evaluation Department, explained the plan. Director-General Kim said, "Last March, we launched CHORUS (CHannel On RegUlatory Submission & Review) to discover two-way agendas between the industry and the MFDS industry, and we are forming and have been operating five branches to allow various companies to cooperate with working-level members that directly carry out the actual work.” He added that CHORUS plans to announce the performance of each branch this year and establish a plan for next year at the H2 CHORUS workshop. In addition to related associations and industry meetings, it plans to strengthen communication with companies that directly meet reviewers. Director-General Kim said, “We have procedures in place so that companies can officially request a supplementary meeting or in-person consultation when applying for marketing authorizations. The temporary restrictions made on phone consultations for relevant departments due to COVID-19 have been lifted. Now, companies can call for consultation without any time limit.” However, as only 124 review personnel are available in the Institute which needs 135, the institute lacks the manpower to address the absolute number of civil complaints. For example, the U.S. FDA has 8,000 review personnel. Director-General Kim said, “We will take the domestic pharmaceutical industry environment into consideration, adjust the timing, and approach it step by step to ensure that the policy is well established and implemented, and we will fully listen to the industry’s opinions during the process.”
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