- LOGIN
- MemberShip
- 2025-12-26 22:50:17
- Company
- 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.
- Company
- 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.
- Company
- 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.”
- Company
- The dismissal of an executive in Lundbeck Korea was unfair
- by An, Kyung-Jin Sep 08, 2020 06:11am
- The National Labor Relations Commission issued an order to reinstate the job, saying that the dismissal of former executives in Lundbeck Korea was unfair. According to related industries on the 7th, the National Labor Relations Commission held an interrogation meeting on July 30 and sided with Mr. A in the case of a ``unfair dismissal request'' filed against the company by former Lundbeck Korea executive A. The National Labor Relations Commission recently issued an award containing the contents. The National Labor Relations Commission acknowledged that the dismissal of Mr. A by Lundbeck Korea was unfairly dismissed, and ordered that Mr. A be reinstated to his original position within 30 days from the date on which he was served, and paid the equivalent of the wages he would have received if he worked normally during the dismissal period. In this regard, Lundbeck Korea held a disciplinary committee on April 13th, and Mr. A notified his dismissal in writing for violating Article 12 of the employment rules. ▲ Article 4 (duty of integrity) ▲ Article 9 (prohibited matters) 5 and 6 ▲ Article 27 (waiting order) Article 82 (Disciplinary) 3, 5, 8, 11, and 12. The company's explanation is that despite the violation of internal guidelines during the selection process of the contractor, and misconduct such as lies and non-cooperation in work, Mr. A did not reflect and his work attitude did not improve. and the dismissal was notified properly. Mr. A received a notification of 'dismissal' from the company on April 16, three days after the disciplinary committee was held, and filed a request for relief from unfair dismissal to the committee on June 2nd. The National Labor Relations Commission said, "The dismissal is an abuse of the disciplinary discretion of the employer due to an excessive amount of dismissal compared to the recognized disciplinary grounds." For example, it is pointed out that the problem of the open tendering process for a contractor is that it is not recognized as a misconduct by Mr. A because the CEO and the head office have the final decision authority and the duty of management and supervision. It was considered that the specific grounds for the claim that Mr. A failed to comply with the work order or disturbed the workplace order were insufficient. Among the multiple disciplinary grounds, it is the position that Mr. A only admits one act of attending the academic conference without approval from the management during the waiting period. According to this decision, Lundbeck Korea must reinstate Mr. A within 30 days of service of the decision and pay the wages for the dismissal period, or request a reconsideration with National Labor Relations Commission within 10 days.
- Company
- The contradiction of generic exclusivity
- by Kim, Jin-Gu Sep 07, 2020 06:13am
- Let's imagine! This is the case when the rule for '1st place' in a marathon is set to be '14 seconds after the first goal scored'. Competition will become meaningless, and only fights will increase. The achievements of legitimate efforts that the first place should receive will be shared by numerous 'joint first prizes'. The controversy over the generic exclusivity system is similar. Due to the regulation that suppresses discrimination, the 'contradiction of common first place' is prevalent. It is often observed that up to 45 items receive the right at the same time, and the product is not released even after receiving the right. As the circumstances look like this, the profits from obtaining generic exclusivity are very small. It is calculated that each item is limited to ₩400 million for 9 months. This is the reason why criticism is constantly raised for promoting free rides over the current system. It is also the reason why the pharmaceutical industry is regretting about the government's revised right. ◆5 years of introduction of the rights, benefits average ₩400 million for 9 months The generic exclusivity system was introduced in earnest in 2015. The purpose of the introduction was to provide benefits for the efforts of active pharmaceutical companies in the development of generics and patent challenges. However, as of five years later, most pharmaceutical companies with the generic exclusivity do not benefit. Dailypharm surveyed the prescriptions of products with generic exclusivity since 2015. The average prescription amount for 9 months during the sales period was only about ₩400 million. According to the MFDS, as of the end of August 2020, 140 generics were launched on the market within the generic exclusivity period. The prescription performance of these items during the period was ₩59.3 billion. It is calculated that the average prescription amount per item (₩59.3 billion ÷ 140 items) is only ₩420 million for 9 months. Although there is a difference in the size of the market and the loyalty of the original for each item, criticism has been raised that it is not effective given the nature of the generic exclusivity. In particular, as the number of pharmaceutical companies that jointly acquire the generic exclusivty, the benefits to each pharmaceutical company decrease. This is why pharmaceutical companies, which have led the patent challenge, are complaining that it is 'free ride'. In the case of generics for Amosartan (Amlodipine+Losartan), 21 companies received the right of the generic exclusivity with 45 items. Of these, only 12 (57%) launched products during the period. 12 pharmaceutical companies only produced a total of ₩1,160 million during the period (May 9, 2015 to April 1, 2016). This is less than ₩100 million per pharmaceutical company. If the rights were monopolized by one pharmaceutical company rather than 21 pharmaceutical companies, it is expected that the results would not have reached ₩100 million. The rest of the products are similar. In the case of generics for Layla, out of the 14 companies that received the right, only 10 launched the product within the period, and they only recorded an average of ₩430 million during this period. 13 companies for generics for Viread received the right, but only 11 companies released the product within the period. The company that launched the product produced an average of ₩370 million per company. Nine companies challenged generics for Feburic, but only 8 released products, and they only achieved an average of ₩79 million won per company. On the other hand, items with fewer competitors tended to have more profits from generic companies. Hanmi alone challenged the patent for Patanol eye drop (Olopatadine)' and received the right of the generic exclusivity as a generic called Olotadine. During the period, Hanmi recorded ₩1.35 billion in prescriptions. Dong-A ST challenged the patent for Dilatrend (Carvedilol) and received the right as a generic called Vasotrol. During the period, Dong-A ST produced a prescription record of ₩990 million. ◆Generic for Amosartan, In addition, the mess of the generic exclusivity is observed in many products. As of the end of August 2020, there are 387 items that have acquired the right of copyright. Excluding items with different capacity in the same lineup, it is calculated that 244 products have received the right. There are 42 original drug patents that these 244 products have overcome. It means that one original product has an average of 5.8 generics and received the right. This trend is observed to be more frequent in larger items. In the case of Amosartan, 21 pharmaceutical companies received the right for 45 items. It means that only 21 people are tied for first place. Other products are also very similar. Most recently, on the 25th of last month, 13 pharmaceutical companies received rights with 21 items on Forxiga (Dapagliflozin). In 2016, Januvia (Sitagliptin) acquired 22 items from 10 companies, and Janumet (Sitagliptin + Metformin) acquired 33 items of 11 companies. 14 companies and 10 companies, respectively, succeeded in acquiring the right for natural drugs, Stillen 2X and Layla. ◆Even after winning the right, half of them were not released within the period. Why? Although many pharmaceutical companies flocked to acquire the right of the generic exclusivity, it is also confirmed that not many pharmaceutical companies actually launched the product. As of the end of August of this year, there are a total of 255 items that have reached the right sales period or are currently in use, of which only 140 items have actually released products to the market within the right sales period. Only 5 out of 10 products (54.9%) that received the right copyright have put products on the market. There are many reasons for not releasing a product even after obtaining the right through patent disputes. The reason is that it won the right, but failed to prove bioequivalence for the release of generics, felt a burden as the patent dispute with the original company passed to the second or third trial, or judged that it was not marketable. However, it is easy to obtain the right of the generic exclusivity as the number of requests for trial increases. ◆Initial request for trial '14 days' It was introduced in 2015. With the conclusion of the Korea-US FTA, the licensed patent linkage system was introduced in 2012, and the system that grants monopoly rights to patent challenge generics through step-by-step enforcement procedures was also revealed. All three requirements must be met in order to obtain the right of copyright. First, it is necessary to first request a trial (confirmation of invalid or passive scope of rights) for the original patent. Second, it must win the patent trial raised in this way. Third, it is necessary to first apply for approval for generics. Acquiring the right seems tricky because all three conditions must be completed, but it is not. This is because the clues are attached to the first requirement, the request for an initial trial. Under the current law, it stipulates that 'company that makes a claim within 14 days after the initial request for a judgment is also recognized'. This regulation causes the contradiction of the joint first place. After winning the referee, the day after the end of the PMS (reexamination), a bunch of applications for permission continued. It was common for dozens of companies to be bound by consignment and got the right at the same time. The first request for judgment became a ticket for the sale of generics. It is not known exactly why the '14 days' rule in question was included when making the law. Some say that this is because the time it took to be published in the patent gazette after a request for a trial was filed for about 14 days. However, it is said that Korea is the only case in the world that regulates 14 days. A patent expert in the pharmaceutical industry said, "The generic exclusivity in Korea has been reduced to a system that has little practical benefit. Due to the scattered initial request for trial, only pharmaceutical companies that challenged patents have been changed to a structure that is relatively damaged."
- Company
- Court to rule against companies on eye drop pricing?
- by Chon, Seung-Hyun Sep 07, 2020 06:12am
- The end in two years of legal dispute over the eye drop pricing reduction seems to be approaching. The Supreme Court has ultimately ruled against pharmaceutical companies on one of the two pricing reduction litigation cases. And as the government has won both the first and second trials over the other case, it would be unlikely for the pharmaceutical company to win the last appeal. ◆MOHW authorizes pricing reduction on eye drops twice, the Supreme Court’s final decision made on one The pharmaceutical industry sources reported on Sept. 6, South Korea’s Ministry of Health and Welfare (MOHW) has announced the execution suspension on the pricing reduction in 33 eye drops would be lifted. The ministry’s announcement followed the Supreme Court’s decision. On Sept. 3, the Supreme Court dismissed the appeal made by pharmaceutical companies regarding the government’s attempt to bring down the pricing on eye drop products. The Court stated, “The appellant’s claim for the appeal is clearly unjustifiable, therefore, all appeals would be dismissed.” In December 2018, MOHW has decided to lower the pricing on 33 eye drop products. As the affected pharmaceutical companies filed litigation against the decision, they also requested the suspension of execution on the ministry’s action. As the court accepted the request, the pricing reduction was withheld, but the pricing was brought down, nonetheless, with the Supreme Court’s final decision. The legal dispute between the government and pharmaceutical companies over the pricing reduction in eye drops lasting over two years is getting closer to the end. Two separate litigations were conducted, both aiming to revoke the pricing reduction in eye drop products. On Aug. 27, 2018, the Ministry revised its list of reimbursed drugs and upper limit pricing to bring down the pricing of 307 eye drop items by up to 55 percent. The key change was to apply the same pricing standard on single-use eye drops with same concentration of pharmaceutical substance (dose per mL), regardless of the overall amount of the solution. Regarding the ministry’s decision, 20 pharmaceutical companies claimed the pricing reduction on 299 items is unfair, and filed litigation to the Seoul Administrative Court to nullify the government order. Kukje Pharma, Daewoo Pharm, Daewoong Bio, DHP Korea, BINEX, Samchundang Pharm, Sinsin Pharm, CMG Pharma, Youngil Pharm, Inist Bio Pharmaceutical, Ildong Pharmaceutical, Chong Kun Dang, Taejoon Pharmaceutical, Korea Global Pharm, Hanlim Pharm, Hanmi Pharmaceutical, Humedix, Huons and Huons Medicare were part of the litigation. The Seoul Administrative Court ruled in favor of the government in July last year. The group of pharmaceutical companies filed for an appeal, and the Seoul High Court came to the same decision in last July. As the companies have pushed case on, the Supreme Court is currently reviewing the case. Updates on eye drop pricing reduction litigations The latest decision by the Supreme Court was related to another case. Four months after MOHW’s decision to reduce the eye drop pricing, the ministry has again unveiled a partially revised list of reimbursed drugs and upper limit pricing that lowered pricing on 33 eye drop items by eight companies on Dec. 21, 2018. The pricing reduction was ordered on eye drop items listed after the first pricing reduction order, and the ministry meant to apply the same standard. The litigation was filed by Daewoo Pharm, Sinsin Pharm, Youngil Pharm, Reyon Pharmaceutical, Ildong Pharmaceutical, Hanlim Pharm, Huons and Huons Medicare. The eight companies filed the litigation to revoke the ministry’s order to lower the pricing. In November last year, the Seoul Administrative Court has ruled in favor of the government body, and the court reaffirmed its earlier denial of the litigation during the second trial held in last May. Although the order was given later than the first one, the case was processed faster and reached the Supreme Court’s decision earlier. Accordingly, the 20 pharmaceutical companies await the Supreme Court’s ruling on the first pricing reduction order. Nevertheless, as the courts have ruled against the companies in two prior trials, the Supreme Court would be unlikely to rule otherwise. The pharmaceutical companies argued the pricing reduction is an unfair order as the ministry has abused the discretionary power, violated the principle of trust protection, and taken illegitimate proceedings, but the courts denied the claim. And the Supreme Court has discontinued the trial and dismissed the case. The discontinuance of the trial refers to the Supreme Court dismissing the case without a trial, when the court sees no difference in viewing the prior rulings. The Supreme Court basically made a final decision without even holding the trial. ◆Confusion in drug pricing as the court dismissed and reaccepted the request to suspend the pricing reduction Confusion in the pricing in the affected eye drops was caused as the court once dismissed and accepted the request to suspend the execution of pricing reduction order again. While the pharmaceutical companies filed two litigation cases to revoke the pricing reduction orders, they also requested the court to order suspension of execution. And only one request to withhold the pricing reduction order was accepted. Prior to the first trial with 20 pharmaceutical companies, the companies submitted an application to request the Seoul Administrative Court to suspend MOHW’s pricing reduction on eye drop until 30 days after the court’s decision. Eventually, the pricings were lowered, as of Sept. 22, 2018, when the Seoul Administrative Court dismissed the request. But the companies, again, requested the suspension to the Seoul High Court, which accepted the request and recovered the eye drop products’ original pricing, as of Nov. 30, 2018. Every time the litigation cases proceeded to the higher court, the companies requested for the court to suspend the execution, and the rest of the requests were all accepted. Currently, the ministry’s order to lower pricing on 20 companies’ 287 items, related to the first litigation, is withheld. Although the number of items started from 299, the number has gone down due to some companies withdrawing the litigation or reimbursement. The Supreme Court would soon make the decision on the rest of 287 items.
- Company
- OTC pain reliever market grows surges, Tylenol up by 30%
- by Kim, Jin-Gu Sep 07, 2020 06:12am
- The OTC pain reliever market was yet again dominated by Tylenol and Geworin in the first half of this year. Compared to the first half of last year, specifically, Tylenol’s sales have surged 30 percent. Geworin, EZN6 and Tak-sen followed the market leader on the leader board and generated the highest six-month sales on the record. ◆Tylenol makes KRW 18.6 billion, Geworin KRW 9.7 billion—the highest half-a-year sales yet Product image of Tylenol According to the pharmaceutical market research firm IQVIA on Sept. 2, Janssen’s Tylenol line-ups have generated overall 18.6 billion won from last January through June. It was the highest sales marked by an OTC pain reliever brand launched in South Korea. Compared to last year’s first half at 14.3 billion won, the sales soared by 30 percent. It was the biggest sales made in half a year. Among the three Tylenol line-ups (Tylenol tablet, Tyleno 8-hour ER tablet, Women’s Tylenol tablet), Tylenol tablet and Tylenol 8-hour ER tablet led the exceptional sales growth. Compared to same time last year, the two products grew by 29 percent and 38 percent, repsectively. The market experts evaluate the surge in Tylenol sales were indirectly driven by the COVID-19 epidemic. In last March, the World Health Organization (WHO) advised to use acetaminophen (Tylenol), instead of nonsteroidal inflammatory drug (NSAID) ibupropen, in a suspected case of COVID-19. Although WHO’s recommendation was revoked within two days as the initial statement lacked sufficient evidence, the number of consumers buying acetaminophen kept growing. In fact, pharmacies in Korea often experienced Tylenol shortage during the first half of the year. Samjin Pharm’s Geworin came in second with sales of 9.7 billion won accumulated in the six months. Compared to 8.9 billion won made in last year same time, the figure grew by 7 percent. Geworin also marked its highest half-a-year sales. Geworin also shares the same substance acetaminophen with Tylenol. Nevertheless, Samjin Pharm’s newly launched ‘Geworin soft capsule’ did not perform as much as the company hoped for. The new form of Geworin made a little more than 200 million won in the six months. In last February, the Korean company released Geworin soft capsule, which was the first line-up expansion in the Geworin brand after 41 years. As well as changing the form into a soft capsule, the new Geworin product switched the major substance from the original acetaminophen into ibuprofen. 2020 H1 sales in top OTC pain relievers (Unit: KRW 100 million) Source: IQVIA ◆Sharp increase in EZN6 and Tak-sen, closely tailgating the market leaders The third place was taken by Daewoong Pharmaceuticals EZN6. The five line-ups under the same brand has generated overall 3.5 billion won, making 20 percent jump from 2.9 billion won made in last year same time. EZN6 has been making a steep growth recently. Five years ago in 2015, the brand has made 1.5 billion won and barely took a place in the top 10 OTC pain reliever market. But in 2017, the brand’s sales soared to 2.5 billion won and proudly took a place on the fifth. And in the first half of this year, EZN6 brand has generated sales up to 3.5 billion won. The brand’s outstanding growth has put itself on the third place, surpassing Hanmi Pharmaceutical’s Maxibupen and Chong Kun Dang’s Penzal on the leader board. GC Pharma’s Tak-sen came in fourth with sales reaching 2.8 billion won in the first half of the year. Compared to last year same time, the sales have grown by 6 percent from 2.6 billion won. Tak-sen has also experienced a rapid surge in the sales growth. Compared to five years ago (1.7 billion won) and three years ago (2.2 billion won), this year’s sales marked 59 percent and 25 percent growth, respectively. On the top 10 OTC pain reliever market, the brand’s ranking has leapt from eighth to fourth. Recent sales growth in top OTC pain relievers (Unit: KRW 100 million) Source: IQVIA ◆The rest of the market followed by Penzal, Maxibupen, Carol, Anyfen, Brufen, Champ and Advil The rest of the OTC pain reliever market’s ranking was followed by Chong Kun Dang’s Penzal (2.3 billion won), Hanmi Pharmaceutical’s Maxibupen (2.1 billion won), Ildong Pharmaceutical’s Carol (1.9 billion won), Ahn-gook Pharmaceutical’s Anyfen (1.8 billion won), Samil Pharm’s Brufen (1.4 billion won), Dong-A Pharmaceutical’s Champ (1.4 billion won), Pfizer’s Advil (900 million won), Kyung Dong Pharm’s GNAL-N (500 million won) and Dong Wha Pharm’s Trisfen (200 million won). In particular, Maxibupen (38 percent), Anyfen (23 percent), Penzal (28 percent) and Brufen (25 percent) experienced a steep fall in the sales from last year same time. The pharmaceutical industry views the COVID-19 has significantly affected the OTC pain reliever market in the first six months of the year. As less number of patients visited hospitals and pharmacies amid COVID-19, more consumers tried to stock up first-aid kits including OTC pain relievers. The general OTC pain reliever market sales have grown about 5 percent compared to last year same time.
- Company
- Hanmi·Chong Kun Dang, leading the erectile dysfunction tx
- by Chon, Seung-Hyun Sep 04, 2020 06:53am
- The growth of the domestic erectile dysfunction treatment market has slowed. In the aftermath of COVID-19, the market size has decreased from last year for the first or second consecutive quarter. Generics by Hanmi and Chong Kun Dang are leading the market. According to IQVIA, a drug research institute on the 3rd, the market for erectile dysfunction treatment in the first half of last year was ₩54.5 billion, a 2.6% decrease from the same period last year. In the first quarter, it fell 4.8% from the previous year, and in the second quarter, it decreased by 0.4%. Compared to the first quarter, it showed a slight recovery in the second quarter, but the market's growth has declined. Quarterly erectile dysfunction tx market size (Unit: ₩million, Source: IQVIA) The market for erectile dysfunction treatments continued to expand in size. In the first half of 2017, it increased by 7.2% from the same period last year, and in the first half of 2018 and 2019, the growth rate was 2.3% and 7.4%, respectively. This year, there is a possibility that the spread of COVID-19 led to the sluggishness of erectile dysfunction drugs. It is evaluated that the growth trend has declined due to the prolonged COVID-19, as patients' visits to hospitals were reduced and sales marketing activities were also restricted. The industry diagnoses that the erectile dysfunction treatment market is vulnerable to external factors such as the epidemic of infectious diseases because the severity is lower than that of chronic diseases such as high blood pressure and diabetes, and the nature of essential materials is weak. There is still low recognition that erectile dysfunction is a disease that needs to be treated urgently, which means that changes in the external environment can affect the market growth. PalPal, Viagra, Gugu, Sendom from top left In general, sales growth of major erectile dysfunction drugs also slowed down. However, generics by domestic companies such as Hanmi and Chong Kun Dang are still taking the lead in the market. Hanmi's PalPal, a leading product for erectile dysfunction treatment, recorded sales of ₩5.2 billion in the first half of the year, down 4.9% from the same period last year, but the sales are still huge. PalPal is a generic product containing Sildenafil, which Hanmi released shortly after the expiration of Viagra's patent in 2012. Since beating Viagra in 2013 and Cialis in 2015,It is keeping its unrivaled lead. PalPal has more than doubled sales of the original product Viagra. Considering that PalPal is less than half the price of Viagra, it is possible to calculate that the actual sales volume is more than four times. Among the generic products, Hanmi's Gugu increased by 12.5% from the previous year with sales of ₩2 billion in the first half. In the first quarter, it recorded a growth rate of 6.8%, and in the second quarter, sales increased by 18.0% from the previous year. Considering that major erectile dysfunction treatment products recorded a combined sluggishness, the growth is remarkable. Gugu beat Cialis in the second quarter of last year, and in the second quarter of this year, and pursued Viagra by ₩100 million. Quarterly sales trend of major erectile dysfunction drugs (Unit: ₩million, Source: IQVIA) Hanmi took up 26.3% of the total erectile dysfunction treatment market as of 2Q with only two products due to the promotion of PalPal and Gugu. On the other hand, sales of Viagra and Cialis are sluggish. Viagra's sales in the first half of the year were ₩2.1 billion, down 12.1% from last year. Cialis recorded only ₩1.6 billion, down 5.6% from the first half of last year.
