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- 2026-03-18 21:32:49
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- The issue is that the NHIS is entitled to indemnity or not
- by Kim, Jin-Gu Sep 14, 2020 06:14am
- A legal dispute has begun between the NHIS and 36 domestic pharmaceutical companies regarding Valsartan's claim for right to indemnity. At the first trial, the issue emerged as an issue whether the NHIS exercises the right to indemnit. The judiciary questioned whether they were eligible to claim from the NHIS, not from patients under the Product Liability Act. On the morning of the 10th, the 21st Division of Civil Affairs of the Seoul Central District Court proceeded to a lawsuit for the existence of a debt filed by 36 pharmaceutical companies, including Daewon Pharmaceutical, against the NHIS. It was the first trial on the right to indemnify Valsartan. Previously, the NHIS requested ₩2.1 billion worth of compensation from 69 pharmaceutical companies related to the Valsartan case in July last year. The reason was that the pharmaceutical company should take responsibility for the health care finances being invested due to Valsartan. Accordingly, 36 companies, including Daewon Pharmaceutical, filed a lawsuit against the NHIS for the existence of debt. The intention was that there was no need to fulfill the right to indemnify the NHIS. It was argued that impurities were detected irresistibly even though pharmaceuticals were manufactured in a legal process not only domestically but also globally, and it was excessive to ask pharmaceutical companies to be liable for compensation as the impurities were recognized with the development of science. In the first trial, the qualifications of the NHIS were the main issue. The judge asked, "If a pharmaceutical company sells medicines, the NHIS buys them directly?" It was a question asking whether the NHIS, not the direct buyer, was entitled to claim the right to indemnify. In response, the NHIS replied, "If a patient receives a diagnosis, prescription and takes medicines, it can be a buyer because it pays money in the form of reimbursement in the end." The plaintiff, Daewon Pharmaceutical, gave the NHIS tit for tat. Daewon Pharmaceutical said, "The defendant is said to be the final and ultimate buyer, but it is impossible under civil law. The NHIS is not entitled to claim." The judge asked again that it was only partially supported by the health insurance system for the patient's purchase of medicines according to the claims of the NHIS, and wasn't that the party?" Then, the NHIS said, “As the patient stopped taking medicines, they began to use generic substitution, and damage occurred to the NHIS accordingly. Under the Product Liability Act, the qualification to claim (reimbursement rights) is not a 'consumer' but a 'victim'. However, how to interpret the victims specified in the Product Liability Act was no longer covered in this trial. In the next trial, a fierce legal dispute between the plaintiff and the defendant is expected over the interpretation of the victim under the Product Liability Act. The next trial is scheduled for 11 AM on November 19th.
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- Korean drug industry prepares for Peramiflu generic
- by Kim, Jin-Gu Sep 11, 2020 06:29am
- Peramiflu supplied by GC Pharma South Korean pharmaceutical companies are speeding up the launch preparation for a flu drug Peramiflu (peramivir) generic. After filing trials for invalidation of original patent late last year, ten pharmaceutical companies recently applied for the generic approval. If Ministry of Food and Drug Safety (MFDS) approves the generic and the companies win the ongoing patent dispute, the Peramiflu generics would be accessible in the market from coming winter at earliest. The pharmaceutical industry sources reported on Sept. 11 that three Korean pharmaceutical companies have applied for approval on their Peramiflu generics in the last two months. Peramiflu is an influenza drug sold by GC Pharma in South Korea. GC Pharma licensed the drug from the U.S.-based BioCryst and received the Korean health authority approval in 2010. The drug has a valid substance patent that expires on Feb. 12, 2027. Apparently, 10 Korean companies have challenged Peramiflu’s patent by filing a patent nullification case in December last year. Ilyang Pharmaceutical, Penmix, JW Pharmaceutical, Kolon Pharma, Kolmar Korea, Kolmar Pharma, HK Inno N, Chong Kun Dang, and Hanmi Pharmaceutical are part of the case. Sources confirm three companies among the patent challengers have applied for the item approval so far. Apparently, all three companies have their own manufacturing facilities. The applications were submitted to MFDS on July 22, 30, and Aug. 14, respectively. As a result, the three companies have met two out of three prerequisite conditions (first to file patent trial and first to apply for approval) to win the preferential sales rights. Only one condition is left for them to achieve—they would need to win the patent trial. The patent trial proceeding has reportedly picked up its speed again after being delayed by COVID-19 for a while in the first half of the year. The industry expects the trial decision to be made by the end of the year at earliest. The industry insiders also predict the generic could be released in winter, if the companies win the patent trial. An official from a pharmaceutical company challenging the Peramiflu patent noted, "Currently, the patent dispute is actively progressing on paper. We are expecting the Intellectual Property Trial and Appeal Board to conclude the trial within this year," and “meanwhile, the company is proceeding with patent dispute and item approval to launch the generic in coming winter.” Peramiflu is an improved formulation of oseltamivir, a substance of the top selling influenza treatment Tamiflu. When Tamiflu has to be administered orally for five days, Peramiflu can be effective with only a single intravenous injection for 15 to 30 minutes. Boosted by its convenience, Peramiflu is rapidly growing in the flu treatment market. According to pharmaceutical market research firm IQVIA, Peramiflu has made 7.1 billion won last year. Compared to 2 billion won generated in 2017, the sales almost tripled in three years. In last two years, sometimes the supply was unable to keep up with demand and some regions experienced shortage.
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- Qurient, expects a big deal for Q203, Q301, Q702, & Q901
- by An, Kyung-Jin Sep 11, 2020 06:28am
- There are high expectations for Qurient to sign a large technology transfer contract in the second half of the year. All four key tasks, including immune anticancer drugs, atopic dermatitis and multi-drug-resistant tuberculosis treatment, are all in the process of discussing technology export, and there is a possibility that at least one contract will be signed within this year. Qurient held IR(Investor Relations) on the 9th to 10th to introduce the status of the project. Qurient is a new drug development company established in July 2008. In February 2016, it was listed on the KOSDAQ market through a special listing of technology growth companies. Make full use of the project management-based network research and development (R&D) business model. It is a type of NRDO (No Research Development Only) that introduces promising initial tasks from outside and then entrusts them to external research institutes to conduct research and development. Qurient shared the development status of four key new drug tasks at IR on this day. ▲Immune anticancer drugs 'Q702' and 'Q901' ▲Multi-drug resistant tuberculosis treatment 'Q203' ▲Atopic dermatitis treatment 'Q301'. All four projects are in the process of negotiating technology exports with global pharmaceutical companies, and some have opened up the possibility of signing contracts within this year. Introduction of new drug projects held by Qurient (Source: Qurient IR) In terms of the speed of development, Qurient believes that two types of multi-drug-resistant tuberculosis treatment 'Q203' and atopic dermatitis treatment 'Q301' are the right time to transfer technology. Both types have secured successful initial clinical data. Multi-drug-resistant tuberculosis treatment 'Q203' (Telacebec) ended phase IIa clinical trial last December. As a result of drug treatment for 14 days, 'Q203' showed clear anti-tuberculosis efficacy compared to two commercially available resistant tuberculosis treatments. It is explained that the interest of Big Pharma increased as it was published in the New England Journal of Medicine, an internationally recognized academic journal earlier this year. Since it was previously designated as an orphan drug and a drug subject to rapid review, it predicted that it is possible to quickly enter the market through the conditional approval procedure after completing phase IIb clinical trial. Cream-typed atopic dermatitis treatment, 'Q301', also secured successful data in phase IIb, and ended last May. Although in the early stages, the immune anticancer drugs 'Q702' and 'Q901' are at the stage of successful technology export with a differentiated mechanism. Qurient said, "We are reviewing various business alliance plans such as technology export for all pipelines the company has. We can not comment on specific timing, but we expect rapid results." "In the long term, it was established in Dortmund, Germany earlier this year. "We plan to focus on the development of proteasome inhibitors through a joint venture, QLi5 Therapeutics."
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- Hunterase by GC Pharma is entering the Chinese market
- by Chon, Seung-Hyun Sep 11, 2020 06:28am
- Hunterase by Green Cross is entering the Chinese market GC Pharma announced on the 9th that Hunterase, a treatment for Hunter syndrome, has obtained a license from the NMPA of China. This is the first time that a drug for Hunter syndrome has been approved in China. Hunterase by Green Cross GC Pharma applied for Hunterase's item license, July of last year in China, and was designated as a priority subject of review by the NMPA in September. The commercialization of Hunterase in China and other China region is undertaken by “CANBridge Pharmaceuticals,” which has signed an export contract. Hunter syndrome, referred to as 'type II mucopolysaccharide', is a rare congenital disease that shows various unpredictable symptoms such as skeletal abnormalities and decreased intelligence, and dies early around 15 years of age. In general, it occurs at the rate of 1 in 150,000 males, and one of the Greater China countries, about 1 in 50,000 to 90,000 cases occurs in Taiwan, and it is known that the incidence rate in East Asian countries is higher. Currently, more than 3,000 patients with Hunter syndrome in China are estimated. GC Pharma developed Hunterase as the world's second hunter syndrome treatment in 2012 and is now supplying it to 11 countries around the world. It is also planning for Hunterase to enter Japanese market. GC Pharma' partner, Clinigen K.K., applied for an item license of 'Hunterase ICV (intracerebroventricular)', a ventricular administration method, to the Japan Pharmaceutical and Medical Device Administration (PMDA) in March. Hunterase ICV is a novel formulation in which drugs are administered directly to the ventricle by inserting a device into the head. ICV has the advantage of overcoming the limitations of existing intravenous formulations that do not improve the symptoms of decreased intelligence because drugs can not penetrate the blood brain barrier (BBB). Eun Chul Huh, President at GC Pharma said, “It is of great significance in that we are able to provide new treatment environments and opportunities for patients with Hunter syndrome in China. I will do my best.” James Xue, CEO of CANbridge, said, "The approval of this product will be an important step forward in our efforts to commercialize the desperately needed treatment for rare diseases in China and around the world."
- Company
- Hanmi to turn efpeglenatide crisis around with new partner
- by An, Kyung-Jin Sep 10, 2020 06:24am
- Hanmi Pharmaceutical’s glucagon-like peptide-1 (GLP-1) agonist ‘efpeglenatide,’ initially licensed out to a global pharmaceutical company Sanofi in 2015, was ultimately returned to the South Korean company. Four months after when the global company indicated its intention to return the rights on the drug May, Sanofi has decided to suspend clinical studies on the antidiabetic treatment and officially informed each clinical institutes. Hanmi Pharmaceutical plans to take over all five Phase III clinical trials Sanofi was conducting, and look for new opportunities to commercialize efpeglenatide. Over the past three years, three global Phase III clinical trials on efpeglenatide have recruited 5,391 participants, and collected a vast amount of data. Various options are in discussion, such as finding a new commercialization partner in the antidiabetic treatment field, exploring new indications treating other metabolic diseases, and developing a combination therapy with the Korean company’s new drug pipeline. ◆Sanofi says “R&D strategy has changed,” and returns the rights over efpeglenatide after five years Apparently, the sign of the contract termination was looming from last year. CEO Paul Hudson at Sanofi, held an investors event to talk about R&D strategies in late last year. He declared the company "would halt researches in the diabetes and cardiovascular programs." His plan is to focus R&D investment in four areas, including oncology, blood disorders, rare disease, and neurology diseases. Even at the time, Sanofi had unchanged commitment to continue developing the long-lasting GLP-1 agonist efpeglenatide. The company was determined to complete the five Phase III clinical trials on efpeglenatide, but wanted find another commercialization partner to take charge of global sales and marketing activities after receiving the approval. CEO Paul Hudson affirmed, “It was the best decision for the successfully launch of efpeglenatide while maximizing the productivity of our research engine. It was irrelevant to efficacy and safety of the substance, and it would make no changes on license-in agreement with Hanmi Pharmaceutical." However, Sanofi overturned its initial position in just five months, and informed Hanmi Pharmaceutical of its intention to return the rights over efpeglenatide. The two companies concluded the efpeglenatide returning procedure on Sept. 8 (local time) after a 120-day negotiation period as stated on the contract terms. Hanmi Pharmaceutical would not take any legal actions like litigation for damage compensation the company has previously claimed. Sanofi is expected to hand over all data collected from the on-going Phase III clinical trials to Hanmi Pharmaceutical, and step away from the entire development process. Hanmi Pharmaceutical has also agreed to take over the one Phase III clinical trial to be completed in October. Including the compensation and research cost coverage, the conditions for breaching the contract were undisclosed. ◆Market competition intensified with oral GLP-1 agonist Rybelsus The pharmaceutical industry pin points the cause of Sanofi giving up on developing efpeglenatide lies on the pipeline growing unattractive for the market. The global GLP-1 agonist market is expanding rapidly. Nevertheless, the industry sees that the latecomers would struggle to enter the market as multinational pharmaceutical companies like Novo Nordisk and Eli Lilly are firmly dominating the market. (From left) Product image of Victoza, Ozempic, Rybelsus and Trulicity Eli Lilly's once-weekly subcutaneous injection Trulicity (dulaglutide) owns majority of the share in the single therapy market. In addition, Novo Nordisk is expanding its market presence as it added newly launched the world's first oral GLP-1 agonist Rybelsus (semaglutide) to its existing line up of once-daily subcutaneous injection 'Victoza (liraglutide)' and once-weekly injection 'Ozempic (semaglutide).'. Lily's Trulicity generated global sales of USD 4.23 billion (approximately 4.91 trillion won), surging by 29 percent compared to the previous year. The drug is expected to reach its new record in yearly sales as it made 2.50 billion dollars in the first half of this year. Novo Nordisk's three GLP-1 agonists have earned overall DKK 33.22 billion (approximately 6.26 trillion won). The Danish company’s first GLP-1 Victoza had a sales dip of 21.93 billion kroner, but the company had even more significant growth with the recently launched Ozempic sales increasing up to 11.24 billion kroner, and newly released Rybelsus making 50 million kroner. In the first six months of the year, the Ozempic sales grew up to 9.60 billion kroner, and surpassed Victoza sales reaching 9.23 billion kroner. Rybelsus marked six-month sales of 584 million kroner immediately after its release. The three drugs’ sales in total reached 19.4 billion kroner (approximately 3.65 trillion won) in the first half of the year. A GLP-1 agonist efpeglenatide has extended the administration term to once-weekly by incorporating Hanmi Pharmaceutical’s key platform technology, ‘Lapscovery’. However, the industry experts analyze the investigational drug’s competitiveness as a follow-on drug is faltering when Trulicity and Ozempic dominate the once-weekly injection market and even an oral option Rybelsus emerges. ◆Hanmi with 6,000 participants’ data, committed to rekindle efpeglenatide’s potential The industry experts address Sanofi’s three-year worth of abundant clinical data as an engine to bring efpeglenatide back to life. Sanofi has been operating five Phase III clinical trials since it signed the deal over efpeglenatide from Hanmi Pharmaceutical in 2015. Two years into the deal, a Phase III AMPLITUDE-M study that compared efpeglenatide against placebo on the blood glucose level reduction effect was initiated from late 2017, and four Phase III clinical studies have started as of last year. Following are the four Phase III trials; AMPLITUDE-D study compares efpeglenatide against Trulicity plus metformin combination therapy; AMPLITUDE-O study evaluates efpeglenatide’s effects on the cardiovascular system in type 2 diabetes patients; AMPLITUDE-L study administers efpeglenatide and other existing insuling treatment to type 2 diabetes patients; and AMPLITUDE-S additionally administers efpeglenatide to type 2 diabetes patients, who cannot control blood sugar level even after using metformin alone or metformin and sulfonylurea combination. AMPLITUDE-M, AMPLITUDE-D and AMPLITUDE-O studies have completed subject registration. Total 5,391 participants registered for the three studies. Considering the number of participants registered for the remaining two studies, the number would sum up to around 6,000. Hanmi Pharmaceutical plans to conduct and complete the AMPLITUDE-M study scheduled to end in October. AMPLITUDE-M study is the first Phase III clinical study initiated by Sanofi after it licensed in efpeglenatide. Companied called for participants from 56 research institutes in four countries including the U.S., Germany, Poland, and the U.K. from December 2017, and compiled the roster with 406 participants by early September last year. The endpoint of the study is to evaluate the change of goal is to evaluate the rate of change in hemoglobin A1c at week 30 of the treatment. The entire study is scheduled to conclude by next month after the participants’ visits and data collection. Based on the efpeglenatide data collected so far, Hanmi Pharmaceutical is determined to turn the crisis around with a plan to seek a new commercialization partner and also by opening options to explore new indications and research about combined treatment effect with other Lapscovery-based pipelines.
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- Pfizer pays ￦12 million to Upjohn‘s employees
- by Sep 10, 2020 06:23am
- Pfizer Pharmaceuticals Korea decided to pay ￦12 million in consolation to the employees of Upjohn who were transferred to Viatris, which was created as a merger with Mylan. According to the pharmaceutical industry on the 8th, Pfizer Pharmaceutical Korea has concluded negotiations with the union on consolation payments following the division and merger of Pfizer Upjohn. Previously, Pfizer Pharmaceuticals Korea separated its patent-expired drug business division to establish Pfizer Upjohn and merged with Mylan. Since then, the management and the union have conducted intense negotiations under the condition of a 'A special contract not to file a lawsuit' that the employees of Upjohn will not file a lawsuit based on their move. After several negotiations, the labor and management agreed on August 31 to pay ￦12 million in condolences to all employees. According to the Supreme Court precedent in 2013, ‘the right to refuse to move,' which allows workers to refuse to move in the event of a division of a company, is not recognized, but the current situation after 7 years may be changed in a new way. It is known that the labor and management agreed to pay the consolation money on the premise of a sub-complaint agreement, as the possibility that the case law could be overturned if the Pfizer Industry employees, whose tranfer was determined, file a lawsuit. Meanwhile, MSD Korea, which is in the process of dividing the corporation following Pfizer Pharmaceuticals, is expected to have related negotiations after the list of executives and employees is announced.
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- KDDF invests KRW 263 bln for 9 years but goal unachieved
- by Chon, Seung-Hyun Sep 09, 2020 05:52am
- The three government ministries’ first project to provide all-around support on new drug development, the Korea Drug Development Fund (KDDF) has ended its nine-year program. Although the goal of ‘developing 10 global new drugs’ was unachieved and the initially planned budget fell short, the project resulted in 50 license-out deals and it was evaluated to have implemented a new paradigm for government R&D support. The second project launching next year is expected to allocate more than five times of the first project’s budget, as well as an improved systematic support. ◆KDDF ending nine years of program, 50 license-out deals signed According to industry sources on Sept. 9, KDDF has finished their entire program as of Sept. 8. Started from September 2011, nine years of the R&D support program was wrapped and the foundation was dismissed. KDDF was the first and only pan-government pharmaceutical R&D support project in South Korea. The Ministry of Science and ICT (MSIT, formerly known as Ministry of Science, ICT and Future Planning at the time of establishment), the Ministry of Trade, Industry and Energy (MOTIE), and the Ministry of Health and Welfare (MOHW) have jointly invested 1.6 trillion won (530 billion won by government, 530 billion won by private) for over 10 years through R&D investments to seek 10 global new drugs. It was the first project to support that backed the entire life cycle of new drug development from candidate medicine exploration to commercialization. Experts evaluate KDDF has laid out a new paradigm for supporting R&D at a pan-government level, as their own R&D capability was well-incorporated to establish an effective R&D support system. For nine years, KDDF has supported 162 projects after reviewing 590 projects claiming for their R&D support. At the end, 50 projects were licensed out. The overall deals are valued at approximately 13.7 trillion won. KDDF official said, "The outcome is seen as a milestone in the history of new drug development in South Korea." In fact, momentous R&D outcomes in the Korean pharmaceutical and bio companies have been supported by KDDF. Some of major deals worth over 1 trillion won, such as Janssen licensing the technology of Yuhan’s anticancer treatment 'Lazertinib,' Alteogen's ‘hyaluronidase’ platform technology transferred to a global company and Hanall Biopharma licensing out autoimmune disease treatment technology to Roivant. However, most of the deals have not been paid out completely. For the Lazertinib deal, Yuhan has received a total of USD 85 million (about 100 billion won) including a down payment of 50 million dollars. Supported by KDDF from the initial R&D phase, SK Biopharmaceutical's anti-epileptic drug XCOPRI successfully won the U.S. Food and Drug Administration (FDA)’s approval last year. Major performance review on Korea Drug Development Fund (Source: KFFD) KDDF official noted, "Beyond the R&D support, the foundation also offered various programs and consulting to leverage the potential of Korean new drug development." KDDF’s BRIDGE Track sought after early stage license-out opportunity to bridge the translational gap between university, research labs and the industry. And Advancing Clinical Trial (ACT) program gave consulting on clinical trial for nonclinical research and pre-clinical trial phase. When selected as a supported R&D pipeline, the main research institute and KDDF constructed an organic joint development system for consulting specific to development stage and monthly joint meeting to discuss the direction of R&D pipeline. CEO of KDDF Muk Hyunsang noted, “The nine years of the foundation’s program has come to an end after researching and developing 162 projects with 91 research institutes, while expanding experience and skills and training outstanding researchers in the process.” ◆Failed to achieve the initial goal of ’10 global new drugs,’ only about halfway done Nevertheless, some experts say KDDF's outcome did not meet the initial expectations. When KDDF was launched, it declared the goal of ‘developing 10 global new drugs’, but there has not been a drug worthy of the title, ‘global new drug,’ yet. As the whole process of new drug development from candidate medicine discovery to R&D completion takes approximately two decades, the experts criticize the government has set the bar too high to begin with. In 2013, KDDF revised its goal from 'developing more than 10 global new drugs by 2020' to 'licensing out more than 10 global new drugs by 2020.’ Moreover, KDDF's R&D support budget was far short of the original plan. The plan was to put down a budget of 530 billion won, for the beneficiary companies to match the investment to reach over 1 trillion won in R&D investment. However, KDDF's R&D support was totaled at 263.2 billion won, investing almost 70 billion won per year. The foundation’s annual R&D support budget was not fixed, but appropriated according to the expenditure. Unused budget in a year also meant budget deduction in the following year. An industry insider pointed out, “It is difficult to predict the amount of financial support for the next year due to the system of setting the amount based on the nature of the pipeline.” Vision by Korea Drug Development Fund (Source: KFFD) ◆New state-led new drug development program to kick off next year, budget expands significantly Although KDDF will be dissolved as the program ends, the new state-led new drug development program would kick off from next year. The new national new drug development program that passed the preliminary feasibility evaluation in June, in accordance with the National Finance Act, would provide support on all phases of new drug development. The inter-ministerial program would bring precedent programs by MOHW, MSIT and MOTIE together to support R&D pipelines, resembling much of the KDDF business structure. The national new drug development program would consist of four projects: research on expanding the technological base of new drugs, research on establishing a new drug R&D ecosystem, new drug clinical trial development, and support for new drug R&D commercialization. The feasibility of national new drug development program was approved with allocation of budget totaling at 2.18 trillion won for 10 years from 2021. The state funding of 1.47 trillion would be provided. If the program fully delivers the budget for a decade, fivefold of what KDDF presented for R&D support (263.2 billion won) would be accessible. Initially, the supervising ministries suggested injecting 2.80 trillion for the new drug development program (1.95 trillion won by state funding, 83.1 billion won by private capital), but the overall budget was decreased by 600 billion won as preliminary feasibility evaluation recommended. The preliminary feasibility evaluation recently disclosed by the Korea Institute of S&T Evaluation and Planning (KISTEP) reported the participating ministries suggested the goal of the program to license out 75 cases of global technologies, valued at over 20 billion won each, and 45 cases valued at over 100 billion won. It has set more detailed objectives of receiving five new drug approvals in the U.S. and Europe by 2030, and eight approvals by 2015. Also the ministries aims to develop two new global drugs valued at 1 trillion won per year. The government bodies’ goal also included obtaining 1,859 overseas patents, winning 269 IND approvals, signing 100 license-out deals, receiving seven orphan drug designations, and generating 100 billion won worth of an annual import substitution effect. A MSIT official stated, "The national new drug development program has only passed the preliminary feasibility evaluation, and the ministries are still in process of drawing up detailed action plan and organization structuring plan, which would be finalized before the program kicks off next year."
- Company
- Botulinum share in domestic market is 93%
- by Chon, Seung-Hyun Sep 09, 2020 05:47am
- Among domestically produced and imported botulinum toxin preparations, products developed by Korean companies accounted for more than 90%. Following Medytox, Hugel, and Daewoong Pharmaceutical, Huons Global and Pharma Research joined. The three types of Meditoxin, whose license was decided to be canceled, recorded ￦82.2 billion in production last year. According to the MFDS on the 7th, the domestically produced and imported botulinum toxin formulation last year was ￦213.5 billion. It decreased by 0.3% from ￦214.2 billion in 2018, but increased 2.5 times in 4 years from ￦85.5 billion in 2015. This is the result of a survey of products that reported production and import performance to the MFDS. For imported products, an exchange rate of ￦1,200 per dollar was applied. The botulinum toxin formulations registered last year's production and import records are a total of 10 products including Meditoxin, Botulax, Nabota, Innotox, Botox, Xeomin, Liztox, Rientox, Coretox, and Dysport. A domestic company, Medytox, has three products, including Meditoxin, Innotex, and Coretox, and the remaining companies are selling one product each. Yearly Botulinum Toxin Production Performance (Unit: ￦million, Source: the MFDS) Among the total production and import of botulinum toxin products, the proportion of products from domestic companies overwhelmed the imported products. The production of botulinum toxin preparations of domestic companies such as Meditoxin, Botulax, Nabota, Innotox, Liztox, Rientox, and Coretox last year was ￦198.5 billion, accounting for 92.2% of the total. The proportion of domestically developed botulinum toxin production decreased slightly from 95.2% in 2018, but considering that Allergan and Ipsen entered generic maraket, the share of over 90% is an unusually high proportion. Some of the products produced by domestic companies are sold in overseas markets, but even if exports are excluded, they dominate the original imported products. Market share of domestically produced botulinum toxins by year (Unit: %, Source: the MFDS) Not only existing companies such as Medytox, Hugel, and Daewoong Pharmaceutical, but also Huons Global and Pharma Research Bio recently jumped into the botulinum toxin market as generics and made results. Production performance of Meditoxin was ￦104.1 billion last year, accounting for nearly half of the total production and imports, but decreased by 13.9% from ￦120.8 billion in 2018. However, Innotox and Coretox, generics for Meditoxin, are recording high growth with production values of ￦10.5 billion and ￦2.5 billion respectively last year. In the case of Meditoxin, the license was canceled in June due to the suspicion of manipulating documents, except for 200 units out of the four doses of 50, 100, 150, and 200 units. Last year's production of the three products that were canceled last year amounted to ￦82.2 billion, or 78.9% of the production of Meditoxin. While the court cited an application for suspension of execution of the three types of Meditoxin's license cancellation, collection, and disposal orders last month, it became possible to sell even the main lawsuit. If sales are finally banned, it is expected that a significant loss in sales will be inevitable for Medytox. Botulinum toxin production and import performance by item (Unit: ￦million, %, Source: the MFDS) Production performance of Hugel's Botulex increased 5.4% from ￦55.7 billion in 2018 to ￦58.7 billion last year, while production performance of Nabota by Daewoong last year decreased 26.9% from the previous year. Huons Global recorded ￦5.8 billion in production of Liztox, a botulinum toxin drug developed last year. After recording production of ￦2.3 billion for the first time in 2016, it has increased every year, including ￦3.2 billion in 2017 and ￦3.5 billion in 2018. Huons Global received a license for export under the brand name Hutox in October 2016, and then received an official license under the product name Liztox in April 2018. Phamar Reserch BIO’s “Rientox” recorded the first production performance of ￦4.1 billion last year. Phamar Reserch BIO is a company that changed its name after BioC&D, a bio company, was acquired by Phamar Reserch Product in January 2018. It obtained a permit for export in February of last year, and although it has not yet been released in Korea, it seems that sales have occurred in overseas markets. Allergan's Botox imports last year stood at ￦7.3 billion, up 69.2% from the previous year, but it was far short of domestically developed products. The report of Xeomin by Mertz and Dysport by Ipsen also posted only ￦6.2 billion and ￦1.6 billion last year.
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- Jung-Jin Seo, COVID-19 tx will be applied within this year
- by An, Kyung-Jin Sep 09, 2020 05:46am
- Jung-Jin Seo, Chairman at Celltrion is giving a keynote lecture on the first day of GBC Jung-Jin Seo, Chairman at Celltrion announced that he will apply for approval for emergency use of COVID-19 antibody treatment within this year. The strategy is to finish early phase I clinical trial of the COVID-19 antibody treatment, which started at the end of July, and start an integrated phase II and III clinical trial at the end of this month to complete the effectiveness and safety verification. It will also start commercial batch production this month to enable mass production as soon as it obtains emergency use approval. He gave a keynote lecture on the theme of 'Post COVID-19 Era, Crisis is an Opportunity' at the 2020 Global Bio Conference (GBC) online event hosted by the MFDS, and introduced the current status of COVID-19 antibody development. According to the announcement on the day, the Phase I clinical trial of the antibody 'CT-P59' for the treatment of COVID-19 developed by Celltrion has recently been administered to healthy subjects. It is a policy to end phase I clinical trial in Korea early, and to discuss with regulatory agencies to simultaneously proceed with phase II and III clinical trials from the end of this month. Celltrion believes that it will be able to apply for an emergency use approval at the end of the year if its efficacy and safety are verified in the Phase II clinical phase. If phase III clinical trial is completed in May next year as planned, the world's first COVID-19 antibody treatment will be developed. He said, "We hope to start an integrated phase II and III clinical study this month through cooperation with regulatory agencies. We plan to start large-scale production from this month in order to respond to global demand, centering on domestic COVID-19 patients. It is also progressing without a hitch.” He predicted that it would be difficult for the neutralizing antibody formation rate to exceed 50% with only the gene-recombined and protein-recombined vaccines that are currently being developed. Since it is difficult for the vaccine under development to have a complete preventive effect, the company is in a position to put all efforts into accelerating the time of development of the treatment. He said, "At this stage, the best way to lower the mortality rate of COVID-19 patients is early diagnosis and early treatment," he said. "Korea is developing antibody treatments and blood system drugs as a world leader. The production capacity is unrivaled enough to account for 15%,” he emphasized. It is evaluated that it has high competitiveness as a production base even if the leading position in the development of COVID-19 treatment or vaccine is lost to advanced countries such as the United States. He also said, "Korea is developing the world's leading antibody treatments and blood system treatments. If the protein-recombined COVID-19 vaccine being developed overseas succeeds in commercialization, we will suggest securing the quantity of vaccines for domestic use as the top priority in the consignment production contract process. He said, "Celltrion will play at the forefront to turn the national crisis caused by COVID-19 into an opportunity."
- Company
- The government is worried about the generic exclusivity
- by Kim, Jin-Gu Sep 08, 2020 06:12am
- The generic exclusivity system is about to change in the fifth year of its introduction. Until now, the industry has been criticized for 'free ride' over this system. The core of the system is the grant of monopoly rights, and the contradictory situation in which monopoly was impossible was repeated. The discrimination power was lowered by the process of acquiring the generic exclusivity by anyone, which led to a reduction in substantial benefits. As a result of the Dailypharm analysis, the average benefit per item that has acquired the right so far has reached an average of ₩400 million. For the pharmaceutical company that led the patent challenge and generic development, it was a collapse. It is said that the MFDS, the main ministry in charge, agrees to such criticism from the pharmaceutical industry. It is from the same reason that they have come up with improvements one after another in the fifth year of the generic exclusivity system. However, in the pharmaceutical industry, there is no change in ‘the requirements for first trial', which is the core cause of the problem. In this regard, it is reported that the government intends to separate this part and promote it in the form of legislative legislation. ◆The first improvement plan by the MFDS excluding the right of consignment items Let's take a look at the proposals made by the MFDS. First of all, this is the result of the 'Public-Private Council for Reinforcing International Competitiveness of Generic Drugs' announced on July 16th. As one of the measures to strengthen the competitiveness of generics, the MFDS has decided to ``exclude consignment generics from the generic exclusivity''. The permission of the right for consigned items was another reason for the scattering of right along with the initial request for trial. In fact, there were frequent cases of receiving only the right without developing generics. As many as dozens of companies boarded the train for the generic exclusivity at the same time. For example, in the case of “Sarpogrelate SR,” 23 companies received the generic exclusivity, but manufacturers are only Sinil and Kukje. 22 companies entrusted the production of generics to Sinil. Generic for ‘Alitoc (Alitretinoin)’ is more biased. Thirteen companies received the right for the generic exclusivity, all of which are produced by Donkko. The same is true of Stillen 2X and Layla. For generics for Stillen 2X, all 14 companies that received the generic exclusivity were assigned to Richwood (Poonglim), and for generics for Layla, all 10 companies left to Mothers Pharmaceuticals. Most of the major large items had similar circumstances. 10 companies each entrusted the production of Januvia (Sitagliptin) and Janumet (Sitagliptin + Metformin) to three consignors. Excluding Chong Kun Dang, Hanmi Pharm, and Dasan Pharm, Kyungdong Pharm, SCD Pharm, Samjin Pharm, Jeil Pharm, Youngjin Pharm, Yuyu Pharm, and Korea Prime Pharm received the right without direct production of generics. Generic production from 21 pharmaceutical companies for Amosartan (Amlodipine + Losartan) was concentrated in three consignment companies, and production of 'Viread (Tenofovir)' from 13 companies was concentrated in five consignment companies. These are the cases in which a pharmaceutical company recruits dozens of Consignment companies to file a patent lawsuit when they devise a formulation development and patent strategy. From the consignee's point of view, it is a strategy that can maximize consignment production income while reducing the risk of patent litigation. This is the reason why some point out that pharmaceutical companies have invited free rides for generic exclusivity by sharing patent strategies. ▲ The number of companies that acquired the right for major items and the number of consignment manufacturers The number of companies that acquired the right copyright for major items and the number of consignment manufacturers This resulted in a feeling of relative deprivation. This was because the efforts for product development and patent overcoming were in vain. Criticism came out that it did not fit the purpose of the generic exclusivity system. Additionally, it was pointed out that the excessive number of unnecessary lawsuits increased social costs, and that the burden of complaints on the original company, the patent holder, was increased. The improvement plan requires revision of the Pharmaceutical Affairs Act. Currently, the published proposal is the opinion of the public-private council. Even if an amendment to the Pharmaceutical Affairs Act containing these contents is legislated, the gateway to the passage of the National Assembly remains. Taking this into account, it is an observation that at least one year remains before this alternative is actually applied to the field. ◆The MFDS Improvement Proposal Second'Unable to delete trick patents The second is the content contained in the 'Partial Amendment to the Pharmaceutical Affairs Act', which was announced on August 20th. The key is to prevent the 'trick' of the patent holder (original company) in advance. The main point is to restrict the deletion of patents in the case of medicines that have received the generic exclusivity. Under the current regulations, the patent right registered in the patent list can be deleted upon request by the patent holder. In this case, the company that received the generic exclusivity cannot exercise the right. It is possible to enter the market without restrictions, not only for items that have received the right, but also for other generics. This is because the right qualification automatically disappears as the patent right is deleted. It is reported that after the actual generic exclusivity system was implemented, several original companies made such an attempt to check the items of right . However, it is explained by the MFDS that there has been no instance of a patent right being deleted after acquiring the right. The industry explanation is a little different. It is explained that there have been no cases of deleting a patent since the right was acquired, but there were often cases where a patent was deleted during the patent evasion process before the right was obtained. Accordingly, there is an opinion in the industry that the timing of the patentee's discretionary restriction of deletion of patents should be set to “the point of filing a patent trial” rather than “after obtaining the right”. ◆What is the improvement of the'initial request for trial requirements? Although there are some disagreements, the domestic pharmaceutical industry is generally welcoming the two institutional changes. With regard to the exclusion of generic exclusivity for consignment items, most of them agree to the purpose of the fact that free rides are greatly reduced. Many of the positions that the patentee's discretionary measures not to delete a patent are also welcomed in that it protects the rights of generics. However, there are many opinions that it is unfortunate when it comes to the entire system. This is because the 'initial request for trial', which can be said to be the cause of the abuse of right. Taking generic for Amosartan as an example, if only the measures to exclude the rights of consignment items are applied, the number of pharmaceutical companies that can acquire rights will be reduced from 21 to 3. On the other hand, if the requirements for the initial request for trial are improved, only one place can receive the right copyright. The case of 'Trajenta' is similar. When only consignment items are limited as specified by the MFDS, 12 companies receive the right, but if the initial request for a trial is improved, one will receive the right. ▲ Trajenta's copyright holders An official from a domestic pharmaceutical company said, "As long as the requirements for the initial request for trial stipulated on 14days, we cannot fundamentally prevent the abuse of right." A patent attorney in the pharmaceutical and bio field also said, "There is a requirement for an initial request for a trial in the background that the generic exclusivity system has fallen to the level of a generic ticket. The exclusion of the generic exclusivity for consignment items will have some effect, but it is more active in order to properly recognize the price of the effort. Institutional change is necessary." ◆"First request for trial, promoting legislative legislation rather than government legislation, In this regard, according to the results of Dailypharm, it is reported that the MFDS is trying to improve the requirements for initial request for trial through the legislation rather than the government legislation. Several officials from the pharmaceutical industry and the National Assembly gathered saying, "We know that the MFDS is pursuing the government legislation to exclude the right of generic exclusivity of consignment items, and the improvement of the initial request for trial in the form of a legislative legislation." Government legislation and legislative legislation are customarily clear in their strengths and weaknesses. In the case of government legislation, it takes a long time for the legislation to pass, but the passing rate is high. The bill is thoroughly reviewed in the process of pre-evaluation, legislative notice, public hearing, consultation with related ministries, and deliberation by the city council. On the contrary, the time for legislative legislation to be initiated is short. A joint motion of 10 or more members of the National Assembly is a prerequisite. However, the passing rate tends to be slightly lower than that of government legislation. In view of this, the MFDS is pursuing a more conservative and reliable method, the exclusion of the generic exclusivity of consignment items, while the improvement of the initial request for adjudication is undertaken by a two-track strategy that speedily promotes through the legislative legislation. It is not yet known exactly what the bill will contain in relation to the improvement of the initial request for trial. However, instead of deleting the 14-day rule in question, it is effective to eliminate the requirement for the initial request for trial. In this case, the requirements for obtaining the right are reduced from three to two. An official in the pharmaceutical industry said, "If only the 14 days rule is deleted, there is a possibility that the number of requests for trials will increase. By allowing applications to be made, transparency is secured and free rides are also expected to decrease.”
