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- 2026-04-15 11:06:05
- Company
- Local companies in panic over ‘Eliquis’ patent suit result
- by Kim, Jin-Gu Apr 09, 2021 05:56am
- The winner and loser of the long patent suit were reversed in the end. After losing the first and second trial, BMS finally got the upper hand in the fight with the generic manufacturers with a favorable ruling by the supreme court. On the other side, the generic companies are in hot water due to the unexpected result. In addition to immediately discontinuing the sale of its generics, the companies are expecting a massive damages claim will be filed by the original drug’s company. The ruling will also affect the price cut that was previously ordered for Eliquis. If the ruling is finalized, the price cut disposition will be pushed back to the patent expiry date. ◆Case remanded to Patent Court… Attention on whether the final ruling sides with the Supreme Court's decision On the 8th, the Supreme Court’s Special 3rd Division reversed and remanded the original ruling of the patent invalidation suit in the appeal filed by BMS against Navipharm, Huons, Intron Biotechnology, and Alvogen Korea. The lawsuit is linked to multiple other suits filed by BMS including the patent infringement suit as well as the administrative suit filed in objection to the disposition to reduce the ceiling price of Eliquis. Considering the gravity of the issue, the Supreme Court rendered an en banc decision. The Supreme Court’s ruling is not final. As the Supreme Court reversed the original judgment, the case will once again be tried by the Patent Court. However, as most trials for remanded cases follow the higher court’s decision, which would be the Supreme Court’s decision in this case, expectations are leaning towards BMS’s victory. ◆Patent infringement suit to pace up… generic sales highly likely to be discontinued With the victory, BMS expects to be able to achieve three goals. First is the discontinued sale of generics. The prescription of Eliquis has been dwindling with the release of its generics. According to U-BIST, outpatient prescription sales of Eliquis had increased annually from 19.5 billion won in 2016 to 49 billion won in 2019. However, its sales dropped 3% to 47.7 billion won last year. On the other hand, prescription sales of generics of Eliquis have been rapidly increasing, from 1.2 billion won accrued from July to December in 2019 to the 8.3 billion won last year. The numbers suggest that the release of generics had some effect in reducing Eliquis prescriptions. BMS also plans to speed up the patent infringement suits filed against each generic company. Around 10 relevant suits are currently in progress. The cases were waiting for the Supreme Court's judgment on this case to determine whether the generic drugs infringed upon BMS Korea's patent right. If BMs wins the patent infringement suit, BMS will also be able to enjoy reflective benefits from the discontinuation of its generics. ◆ Full-fledged claim for damages deemed inevitable.…calculation of the compensation amount is key BMS's second purpose is to file claims for damages against the generic companies. The Supreme Court's ruling recognized the validity of the drug substance patent. If the court recognizes the patent infringement of the generic companies in subsequent infringement lawsuits, BMS will meet all the requirements to claim compensation for damages. Eliquis generics that were released since June 2019 include ▲Chong Kun Dang’s ‘Liquisia’ ▲Samjin Pharm’s ‘Elxaban’ ▲Yuhan Corp’s ‘Yuhan Apixaban’ ▲Hanmi Pharm’s ‘Apixban’ ▲Aju Pharm’s ‘Eliban’, and ▲Yooyoung Pharm’s ‘Yupix.’ Last year, prescription sales of Liquisia were 2.6 billion won, and 1.1 billion won for Yuhan Apixaban. The key lies in the reinforced standards used for the calculation of compensation for damages since last December. Last year, the National Assembly passed an amendment to the Patent Act that would strengthen the standards used to calculate damages caused by patent infringement. Previously, the compensation was calculated by multiplying the 'range of production capacity' by the 'profit per unit.' However, the newly amended act that took effect in December last year adds an amount calculated by multiplying the 'amount exceeding range of the production capacity' by the 'reasonable royalty.' For instance, under the previous law, if the patent holder's production capacity was 100 but the infringer sold 1000, the patent holder was unable to receive compensation for the 900 that exceeds the patent holder's production capacity. However, the amended act allows for the company to receive compensation for the exceeding 900 products as well. At first sight, the prescription amount of the original Eliquis overwhelms the amount of generics prescribed. However, experts believe the result may differ depending on how 'production capacity' is interpreted. Nevertheless, faced with potential claims for damages by BMS, generic companies are now moving to voluntarily discontinue sales of their generic products. An unnamed official of one company that sells a generic of Eliquis stated, "After the ruling, we are considering whether we should voluntarily stop selling our product." ◆Price cut disposition for Eliquis may be suspended until September 2024 The third is to nullify the drug price cut disposition. In July 2019, the government had notified BMS that it would lower the price ceiling of Eliquis by 30% with the reason being the release of its generics. However, BMS had filed a suit with the Administrative Court to suspend the price cut as the final ruling has not been made on its substance patent suit. BMS's request was to suspend the execution of the price cut disposition until the Supreme Court's ruling. The court accepted the company's request, therefore Eliquis is currently being sold at the same price, at 1,185 won per tablet. With the Supreme Court's ruling adding support, the government's justification to execute price cuts based on the introduction of generics will not be able to stand. The substance patent of Eliquis will expire on September 9th, 2024. If the Patent Court ruling is in line with the Supreme Court ruling, the launch of Elquis's generics will be postponed to September 2024. Also, in that case, it is highly likely that the price of Eliquis will be lowered in October 2024.
- Policy
- Approval of Moderna's COVID-19 vaccine is imminent
- by Lee, Tak-Sun Apr 09, 2021 05:55am
- Moderna is applying for approval of COVID-19 vaccine from the MFDS sooner or later. It is reported that GC Pharma, in charge of the license and distribution of the vaccine, will have the necessary data for the license and will submit an application for approval next week as soon as possible. On the 8th, a government official said, "GC Pharma has the permit data and is almost ready to apply." "As soon as possible, applications for permits will be filed next week." Moderna's COVID-19 vaccine signed a contract with the government and Moderna in January and decided to introduce 20 million people in the first half. At the end of February, GC Pharma was selected as a license and distribution company through bidding. It is known that GC Pharma has been preparing for a permit application in consultation with Moderna. The introduction of a new vaccine is urgently needed as the supply and demand of COVID-19 vaccine is becoming difficult worldwide. The government aims to inoculate 10 million Koreans in the first half. However, the supply and demand situation of officially licensed vaccines is not good. AstraZeneca vaccine is produced by SK Bioscience in Korea, but the supply of 3.5 million individual contracts will begin at the end of May. Accordingly, the government is in a position that it may review measures to restrict exports depending on the situation. Moreover, AstraZeneca vaccine has recently been controversial over the restriction of use due to the side effects of blood clots. The second approved Pfizer vaccine will come in 3 million people in the second quarter. However, this is only a fraction of the total contract volume of 13 million people. Janssen vaccine, which was licensed on the 7th, signed a purchase contract with the government for 6 million people, but the specific supply timing is unknown. In order for the vaccine to be supplied smoothly, the approval must be carried out quickly. In the case of Moderna vaccines, it will not be too late to proceed with a permit review in order to be able to import in the second quarter. However, in the case of Moderna vaccine, it is expected to proceed immediately without prior review because it has received urgent approval and verification in the US and EU, and clinical data has been accumulated. Then, it is analyzed that approval is possible even in May after a review period of about 40 days. If it is imported immediately upon approval, it will be helpful for vaccination. Moderna vaccine, like Pfizer's vaccine, is an mRNA-based vaccine, and it was found to be 95% effective when vaccinated twice in a phase 3 clinical trial. If supply is available without disruption, it will be of great help to the government's goal of forming group immunity by November.
- Company
- Tagrisso’s 1st-line reimbursement rejected once again
- by Eo, Yun-Ho Apr 09, 2021 05:55am
- With ‘Tagrisso’ once again failing to expand its reimbursement, it seems that it may take a while for 3rd generation EGFR TKIs to be prescribed as 1st-line in Korea. According to industry sources, the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) decided it was inappropriate to expand the reimbursement of Tagrisso to first-line in non-small cell lung cancer (NSCLC). After receiving approval to extend its indication to first-line treatment in December 2018, AstraZeneca first applied for the expanded reimbursement in 2019. However, the Cancer Disease Review Committee in October that year decided to defer the decision until full data from the Phase 3 FLAURA trial, which studied the overall survival (OS) of NSCLC patients treated first-line, is disclosed. AstraZeneca then submitted the full FLAURA data and expressed the will to accept most of the budget sharing plan proposed by the government. However, faced with strong opposition from committee members (specialists), the company failed to expand Tagrisso's reimbursement to first-line last May. AstraZeneca had attempted to reverse the decision once more by submitting OS data from FLAURA China that confirmed Tagrisso’s OS benefit in Asian patients, but the committee’s response was, once again, a ‘No.’ In the FLAURA China trial that studied a cohort of Chinese patients, 71 patients were randomly assigned to the Tagrisso-treated group, and 65 patients in the control group. Patients in the control group were allowed to cross over to 2nd-line Tagrisso when their disease progressed with T790M mutation. Among the 65 patients, 22 continued their treatment with Tagrisso. In the trial, the median OS of the Tagrisso-treated group was 33.1 months, which was 7.4 months longer than the 25.7 months of the control group. Also, Tagrisso reduced the risk of death by 15.2%.
- Company
- Qsimia's sales exceeded ₩200 billion
- by An, Kyung-Jin Apr 09, 2021 05:55am
- Alvogen Korea surpassed ₩200 billion in annual sales for the first time since its launch in Korea. Qsymia, an obesity treatment drug released at the beginning of last year, and the obesity treatment Qsymia, which was released earlier last year, produced the largest sales. According to the Financial Supervisory Service on the 7th, Alvogen Korea's sales last year reached ₩211.1 billion, up 11.3% from the previous year. For the first time since the establishment of the branch, annual sales exceeded the ₩200 billion. Operating profit was ₩17.3 billion, up 19.3% from the previous year. Sales and operating profit of Aalvogen Korea by year (Unit: ₩100 million, Source: the FSS) The predecessor of Alvogen Korea is KEUNWHA, founded in 1958. Alvogen Group, a foreign company, entered the domestic market with the acquisition of KEUNWHA in 2012. Alvogen acquired Dream Pharma, which was owned by Hanwha Group with funds raised through KEUNWHA in 2014, and changed its name to Alvogen Korea by merging the two companies the following year. The product with the highest performance ever is Qsymia. Alvogen Korea was launched from Vivus in the US in 2017. After securing the domestic copyright of Qsymia, a combination of Phentermine and Topiramate, it launched in partnership with Chong Kun Dang at the beginning of last year. After its release, Immediately after its release, Qsymia shook the domestic obesity treatment market with Saxenda by NovoNordisk. In the first quarter of last year, it ranked second in domestic obesity treatment sales with sales of ₩4.3 billion, and sales increased to ₩5.8 billion in the second quarter and ₩6.5 billion in the third quarter. Last year's cumulative sales of Qsymia reached ₩22.5 billion, and the market share reached 15.7%. Alvogen Korea’s sales declined slightly for the first time in 2019. However, both sales and operating profit have rebounded after a year due to the success of the new product. Alvogen Korea posted a net profit of ₩6.9 billion last year. This is a 49.3% increase from the previous year. The company is paying a cash dividend of ₩8.5 billion in 7 years since 2014. The largest shareholder of Alvogen Korea is Alvogen Korea Holdings Co., Ltd. (100% stake).
- Company
- Betadine, disposes of 3 months of advertising suspension
- by Nho, Byung Chul Apr 08, 2021 05:55am
- Mundipharma's Betadine Throat Spray (Povidone Iodine) was suspended from advertising by the MFDS. Mundipharma recently sent a notice regarding administrative disposition to pharmacies that handle the product, and requested cooperation in the removal of Betadine advertising installations in pharmacies. The advertisement business suspension period is from the 29th of this month to the 28th of June. Betadine's suspension of advertising business is a result of the recognition of inappropriate advertisements due to the lack of ad review in the press release posted on the Betadine Throat Spray product website in December of last year. Mundipharma's Betadine was controversial about false hype around October last year. Sales representatives of Kwang Dong, who are in charge of sales, provided small billboards (POPs) with contents such as 'Povidone = 99.9% death of COVID-19' to pharmacies at the end of 2019, and the MFDS launched an investigation of false hype. According to pharmaies, the POP at the time contained contents such that Povidone kills 99.9% of COVID-19, inactivating within 30 seconds, Povidone was recommended as an interim guideline for the World Health Organization, and the content that gargle solution mixed with Povidone is effective in suppressing COVID-19 was included. Povidone's recently announced anti-COVID-19 inhibitory effect is a cell experiment conducted in a laboratory. According to Article 68(5) of The Pharmaceutical Affairs Law, advertisements on the name, manufacturing method, efficacy or performance of pharmaceuticals, etc. are not allowed unless permission has been obtained or a report has been filed. Povidone Throat Spray obtained only indications for sore throat. However, no punitive administrative measures were taken by the health authorities, and it was replaced by retraining sales staff, collecting and disposing of POP promotional materials, promising to prevent recurrence, and posting an apology. Mundipharma said, "Sales of Betadine are the same as before. However, it is impossible to display advertisements and promotional materials in the pharmacy for the product for the next three months. We will sincerely answer inquiries through the sales representative in charge."
- Policy
- Review underway for nation's first DPP-4+SGLT-2 inhibitor
- by Lee, Tak-Sun Apr 08, 2021 05:55am
- Domestic companies are one step closer to commercializing DPP-4 inhibitor and SGLT-2 inhibitor combination therapies in Korea. Until now, there were only imported DPP-4+SGLT-2 inhibitor combination therapies available, but Korean pharmaceutical companies have now started to target the market with new developments. According to industry sources on the 7th, Dongkoo Bio&Pharma recently submitted an application to the Ministry of Food and Drug Safety for the approval of its PP-4 inhibitor with SLGT-2 inhibitor combination "Citaflojin Tab.." The submission is also stated in the company’s business report that was recently uploaded on the electronic disclosure system. The business report indicates that the company will apply for the marketing approval of its diabetes combination candidate ‘'DKB19002” in March. The industry predicted DKB19002 to be a new combination drug for diabetes that combines a DPP-4 inhibitor and an SGLT-2 inhibitor. The two inhibitors are current leaders in the diabetes treatment market. DPP-4 inhibitors block the breakdown of GLP-1 to increase levels of active GLP-1. Key products include Januvia, Trajenta, and Zemiglo. SLGT-2 inhibitors block glucose reabsorption, which leads to urinary glucose excretion and lowers blood glucose levels. Key products include Suglat and Jardiance. With the two types of drugs being most often prescribed for the treatment of diabetes, technology to combine the two inhibitors have also been actively studied in Korea. For example, LG Chem has been conducting a clinical trial for the commercialization of its combination therapy that combines the DPP-4 inhibitor gemigliptin with the SGLT-2 inhibitor dapagliflozin, and Aju Pharm has also been conducting a trial on its linagliptin and dapagliflozin combination. The product Dongkoo Bio&Pharma submitted its application for is also predicted to be a DPP-4 inhibitor and SGLT-2 inhibitor combination therapy. Currently, all combination therapies approved in Korea are imported items such as AstraZeneca's Qtern (dapagliflozin-saxagliptin) and MDS’s Steglujan (ertugliflozin-sitagliptin). However, with the price yet to be listed for the drugs, the combination therapies are not being actively prescribed in Korea. Therefore, chances of success are deemed to be high if domestic companies succeed in preoccupying the market through rapid development. All eyes are on whether the DPP-4 inhibitor and SGLT-2 inhibitor combination will sweep the diabetes treatment market.
- Policy
- Novo applies for approval of the first oral GLP-1 treatment
- by Lee, Tak-Sun Apr 08, 2021 05:55am
- An oral tablet formulation of the GLP-1 receptor agonist diabetes treatment that was previously only available as an injection is preparing to launch in Korea. The drug is Novo Nordisk’s ‘Rybelsus (semaglutide).' Novo Nordisk has recently applied for the approval of its Rybelsus tablet to the Korean Ministry of Food and Drug Safety (MFDS). With Lilly’s GLP-1 RA Trulicity (dulaglutide) gaining popularity in the diabetes treatment market, the emergence of a tablet formulation with improved convenience may likely trigger market restructuring. On the 7th, industry sources have said that Novo Nordisk had recently submitted an application for the market approval of its Rybelsus tablet to MFDS. As the first GLP-1 receptor agonist to be ever approved, Rybelsus was approved by the FDA on September 20th, 2019. Semaglutide is the sucessor ingredient of Novo Nordisk’s Victozas·Saxenda (liraglutide). In Korea, Victoza is sold as a diabetes treatment and Saxenda as an obesity treatment. Since its launch, Saxenda immediately swept the domestic obesity treatment market, earning 36.8 billion won in sales according to IQVIA in Korea last year. The injection formulation of semaglutide is sold under the brand name Ozempic, and the oral formulation is sold under the name Rybelsus. Rybelsus is receiving attention as GLP-1 receptor agonists are gaining popularity in the diabetes treatment market. GLP-1 RAs are drugs made using the GLP-1 hormone which is involved with the body’s blood glucose control. GLP-1 increases insulin secretion after meals to lower the glucose levels, and when it falls below a certain level, reduces insulin secretion. According to IQVIA, the once-weekly injection Trulicity had sold 41.8 billion won last year, which was an 11.4% increase from the previous year. A stream of studies showing that GLP-1 RAs are more effective than the more commonly used DPP-4 or SGLT-2 inhibitors in reducing HbA1c, body weight, or blood glucose level have added to the increasing popularity of GLP-1 RAs. However, due to its injection-only formulation, patients had preferred to use drugs of other classes that were available in an oral form. Therefore, the introduction of Rybelsus, the first GLP-1 RA to be provided as an oral tablet, may have the potential to be a game-changer that reshapes the diabetes treatment market that is being led by DPP-4 and SGLT-2 inhibitors.
- Company
- Zytiga listed as a prostate cancer selective benefit
- by Apr 08, 2021 05:55am
- Janssen announced on the 7th that it will be applied as a first-line treatment for patients with high-risk metastatic prostate cancer with hormone-responsiveness from the 1st. Zytiga, as a CYP17 inhibitor, was approved by the MFDS in July 2012 as a treatment for metastatic castration-resistant prostate cancer, and added hormone-responsive high-risk metastatic prostate cancer treatment indications in June 2018. With this amendment, Zytiga can be used in patients newly diagnosed with hormone-responsive high-risk metastatic prostate cancer (mHSPC). If two or more of the three conditions are satisfied, such as visceral metastasis (excluding lymph node metastasis), which can be confirmed by imaging tests such as MRI, Prednisolone and Androgen blockade therapy (ADT) are applied in combination. Metastatic hormone-sensitive prostate cancer (mHSPC) is a stage that still shows a therapeutic response to hormone therapy or androgen blockade (ADT) among stage 4 prostate cancers that cannot be operated because metastases to other organs have already been confirmed. After this stage, if it progresses to the stage of metastatic castration-resistant prostate cancer that no longer responds to hormone therapy, it is difficult to cure it and the survival period is only 1-2 years. Zytiga significantly improved overall survival (OS) in a newly diagnosed hormone-responsive high-risk metastatic prostate cancer (mHSPC). Accordingly, the National Cancer Network (NCCN) recommended Zytiga as a treatment option first. Seong-il Seo, a professor of urology at Samsung Medical Center, said, "Through the application of Zytiga's insurance benefits, hormone-responsive high-risk metastatic prostate cancer (mHSPC) patients can receive treatment while reducing the economic burden. We look forward to improving our quality of life.”
- Company
- One-on-one briefing sessions with doctors are not allowed
- by Apr 08, 2021 05:55am
- It is expected that MSD Korea will in principle ban one-on-one product presentations for individual doctors from May. Business restrictions are much stronger than the industry's 'fair competition rules'. According to the pharmaceutical industry on the 7th, MSD Korea announced plans to improve CP to its employees on the 5th. From May, it will prohibit one-on-one product presentations between doctors and sales staff. This is a measure according to the global headquarters' criticism that the cost used for one-on-one product presentations is excessive and the cost-effectiveness is low. MSD Korea emphasized that one-on-one product presentations are not allowed in principle, but they gathered the opinions of each sales team, saying that special exceptions can be considered. The company will review the opinions gathered by mid-April and finalize the new regulations, and it is expected to take effect from May. However, employees point out that the company's claim that one-on-one product presentations are not allowed in principle does not comply with not only the Pharmaceutical Affairs Act but also the industry's voluntary fair competition regulations. Under the current the pharmaceutical affairs law, food and beverages can be provided within ₩100,000 at product presentations. In addition, in Article 10 of the 'Fair Competition Regulations and Detailed Operation Standards for Pharmaceutical Transactions' published by the KRPIA, which MSD Korea belongs to, in the case of a product briefing session that explains its own medicines by visiting individual nursing institutions, member companies provide food and beverage and A small amount of promotional materials can be provided with the company name or product name entered, and in this case, it must be ₩100,000 per day for food and beverages (limited to 4 times a month) and less than ₩10,000 for promotional materials.' The '2021 CP Guidebook' published by the KRPIA on the 1st also contained the same content. Multinational and domestic pharmaceutical companies are conducting one-on-one product presentations within the limit of ₩100,000 per person for food and beverage in accordance with these CP regulations. The CP regulation of MSD Korea follows Article 10 of the KRPIA regulation, and the explanation for one-to-one product-related explanation (PRE) is also clearly stated. 'One-on-one PRE is not included in small meetings (product presentations for 2 to 25 people), but must comply with the KRPIA rules.' Considering that the average cost per person for a one-on-one product presentation at MSD Korea is about ₩60,000, the evidence that the cost is excessive is insufficient. Some employees criticized the company's decision as a one-sided measure that did not take into account the business environment. The competition situation with other pharmaceutical companies and the sales target suggested by the company remain unchanged. However, it is argued that limiting meetings, which are allowed by other pharmaceutical companies, is overpressing the business environment. One MSD Korea employee said, "It is also said that the regulations will be strengthened in the so-called Simple PRE, in which an employee eats light meals of less than ₩10,000, such as coffee or sandwiches, with a doctor." He said, "There is a lot of anxiety that the company is in the process of changing its business to online rather than offline and further reducing the organization drastically." In response, MSD Korea said, "MSD always prioritizes transparent and legitimate business execution based on high ethical standards. Current issues are closely monitored internally and externally, this is a part of reflecting them in internal regulations, and there is no clear decision yet."
- Policy
- The NHIS sequentially began managing the entire drug cycle
- by Lee, Hye-Kyung Apr 08, 2021 05:54am
- The NHIS prepares management measures such as treatment effect and cost effectiveness after registration. The NHIS sequentially began managing the entire drug cycle. The NHIS began recruiting external researchers to prepare post-evaluation plans based on actual clinical data after listing drugs exempted from PE Study. This research service is part of the preparation of a full-cycle management plan for drugs that the NHIS decided to pursue in earnest from this year after establishing a drug price management office. The NHIS aims to reinforce the bargaining power for the benefit of excellent therapeutic and economical drugs through full-cycle management such as item permission, the registration, distribution and supply, and follow-up management, and to elaborate contract management so that supply and quality problems can be prevented. The follow-up management of drugs exempted from this PE study corresponds to the registration stage during the entire cycle. The exemption from the PE study is applied to drugs such as a small number of target patients, although it is necessary to apply benefits as a treatment to patients when a new drug such as a rare disease treatment or an anticancer drug is listed. However, as most of these drugs are priced at high prices, it has been said that treatment effects and cost-effectiveness post evaluation after registration are necessary due to the financial burden of health insurance due to continued use. Accordingly, the NHIS plans to prepare a rational system improvement plan in connection with the post-evaluation of exemption from PE study, and a plan for evaluating treatment effectiveness and cost effectiveness using actual clinical data (RWD) through this study. Specifically, in the case of using RWD ▲ Collection of post-evaluation data sources such as request data and medical record data for medical institutions, re-examination by the MFDS, and domestic and overseas clinical trial data after registration ▲ Scientific and systematic clinical effect verification using pharmacodynamic research design and analysis suitable for drug characteristics Through long-term cost-effectiveness estimates such as indicators and model construction, financial impact, social issues, and available data sources are considered to lead to the selection of pilot analysis drugs. The NHIS revealed the necessity of this study, saying, "Through this study, it is necessary to evaluate the treatment effect and cost-effectiveness of drugs exempted from the PE study, and to prepare a follow-up management plan based on this."
