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- 2026-05-20 07:30:59
- Company
- Hanmi appealed patent lawsuit of Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusAs soon as the Patent Judge sidede with the original company in the patent dispute of Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment agent, Hanmi immediately announced its appeal. An official from Hanmi said in a call with Dailypharm on the 2nd, "We will appeal immediately and receive a trial for the scope of the patent once again." Earlier, on the 1st, the Intellectual Property Trial And Appeal Board made a decision to raise the hand of the original company in the patent dispute surrounding Galvus. The patent dispute was triggered when Hanmi and Korea United Pharm filed a claim against Novartis to confirm the passive scope of rights. About this trial, Hanmi evaluated that it was a meaningful patent challenge to overcome the high patent barrier of multinational pharmaceutical companies. Hanmi Pharm attempted a new patent evasion strategy to develop Galvus’ generic. Based on four indications (1, 2, 4, and 5 indications) except for one of the five indications applied to Galvus, the marketing authorisation of the MFDS was recently obtained. Galvus 5 indications of Galvus. Hanmi has obtained the marketing authorisation from the MFDS based on the four indications except for the third indication. However, the Intellectual Property Trial And Appeal Board ruled that four indications in addition to one indication excluded by Hanmi have an extended patent. It was the intention that the five indications correspond to a treatment regimen belonging to the same disease group (type II DM). Accordingly, Hanmi decided to appeal immediately and decide the patent court. Separately, Hanmi won the trial of invalidation of the extension of the duration of the patent for a substance at the existing patent tribunal. It was decided that the extended patent period of 187 days was invalid. Novartis appealed to the patent court. The second trial is scheduled for August 13th. An official from Hanmi said, “We expect that Hanmi's action will stimulate the drastic patent challenge of domestic pharmaceutical companies against multinational pharmaceutical companies. we will go to the strong pharmaceutical country based on our own innovation strategy.”
- Company
- Hanmi loses first trial in patent dispute over Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusNovartis won the patent dispute between Hanmi and Novartis over the DPP-4 inhibitor-based diabetes treatment agent Galvus (Vildagliptin). The Intellectual Property Trial And Appeal Board made a decision to dismiss the passive right scope verification trial requested by Hanmi on the 1st. Hanmi has filed a total of eight trials for Galvus patent, but the Board has dismissed it. On the same day, Korea United Pharm also lost. It is expected that the trial will have a significant impact on Novartis' application to the Seoul Central District Court for a prohibition of sales disposition, a lawsuit for patent infringement claim, and a lawsuit to cancel an item license. ◆Hanmi's new strategy, Patent challenge by dividing indications In July 2018, Hanmi filed a judgment against Novartis to confirm the passive scope of rights for Galvus and Galvusmet's material patents. In the following year, Hanmi applied for permission of Vildagle, salt-changing generic for Galvus. Hanmi applied for a product license except one of the five indications of the original drug, Galvus. It was Hanmi's new patent avoidance strategy. Hanmi unveiled the logic that Novartis' patent is limited to only 3 out of 1-5 indications applied to Galvus. The indication is said that it is used dual oral therapy in combination with Metformin, Sulfonylurea, thiazolidinedione in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy. Galvus In other words, Hanmi asserted that since the validity of Galvus’ patent right only affects the indication #3 and not the rest of indication #1, #2, #4, and #5, Vildagle also does not infringe patent of Galvus. Novartis refuted this. In fact, the claims of Hanmi made an unreasonable demand because indications were included in the same scope (type II DMtreatment). The MFDS approved the application for Hanmi in January this year. In April, insurance benefits were decided. However, Hanmi has not yet released the product. As the Intellectual Property Trial And Appeal Board decided to take Novartis side on the 1st, the challenge of Hanmi has been put on hold. Vildagle's release schedule has been postponed indefinitely. ◆Dutasteride was applied, but why is it not Vildagliptin This patent dispute is of great interest in the industry. It is because expectations are raising whether the challenge of Hanmi will be a new path to generic's patent evasion strategy. It is said that Hanmi got a hint from patent dispute of Dutasteride in 2015. Patent dispute of Dutasteride was similar to Galvus, but proceeded with another issue. At that time, Generic company claimed that the patent for the substance was extended because original company's Dutasteride (Brand name: Avodart) was limited to the permission for prostate hyperplasia. In other words, it was argued that the patent right has no effect in the case of 'hair loss', another indication of Dutasteride. Based on these claims, the MFDS approved it because Generic company applied only one indication for hair loss. The generic company won the patent dispute. The Intellectual Property Trial And Appeal Board judged that the effective right of Dutasteride patent was limited to prostate hyperplasia and did not affect hair loss. Generic succeeded in launching a hair loss indication and before the patent expired. ◆Pharmaceutical industry expects new patent avoidance strategy The Judge's decision has not been released. However, in the industry, it is persuasive to argue that the case of Dutasteride and Galvus is different. In the case of the Dutasteride dispute, the indications of prostatic hyperplasia and hair loss are markedly different, whereas the Galvus dispute is virtually the same indication and cannot be regarded as the same case. Generic companies was expecting the result. A domestic patent official said, "It is true that we thought about whether to challenge patent evasion in the same way as Hanmi, but the possibility of success did not seem so high, so we were waiting for the result of this dispute." He added that there is no plan to file a referee with this strategy, the Intellectual Property Trial And Appeal Board did not accept the claim that it should judge the identity of medical use based on the individual indication. Another official in the pharmaceutical industry said, "If Hanmi leads the case with an appeal, it is unlikely that the trial will be overturned." The trial is expected to have a significant impact on other lawsuits between Novartis and Hanmi. Three related lawsuits are in progress. Novartis has filed a lawsuit against the Seoul Central District Court for infringement and prohibition of sale and filed a lawsuit against the Seoul Administrative Court to cancel the item permission, which is the main lawsuit of the provisional injunction. Three cases are currently pending. If the court accepts the provisional disposition, it is expected that Vildagle will not be available for the time being.
- Policy
- Korean government designates remdesivir essential drug
- by Lee, Tak-Sun Jul 06, 2020 06:14am
- Product image of remdesivir (Source: BBC) The Korean government has designated specially imported COVID-19 treatment remdesivir, and clinically used COVID-19 treatment Kaletra (lopinavir/ritonavir) as National Essential Drugs. National Essential Drugs are designated to be constantly monitored for stock and supply flow, and to receive support for special importation clearance or contract manufacturing in Korea in case of shortage. After a pan-government deliberation, the Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) has decided expand the list of National Essential Drug from 403 items to 441 on July 2 to better manage the supply of drugs used to respond against disaster or emergency like COVID-19. Minister of Health and Welfare and Minister of Food and Drug Safety come together to agree on the special designation of drugs necessary in the healthcare scene but cannot solely rely on the function of market to stabilize flow of supply. The pan-government meeting for the essential drugs designation consists of nine government bodies including MFDS (chair), Ministry of National Defense, Ministry of the Interior and Safety, Ministry of Health and Welfare and Office for Government Policy Coordination. The latest list newly added total 38 items, such as three COVID-19 relevant drugs (remdesivir injection, lopinavir and ritonavir solutions), 31 drugs to respond against disaster or emergency (epinephrine used for CPR), and four items recommended by related government body like Korea Centers for Disease Control and Prevention (KCDC). Now the National Essential Drug list has 441 items consisting of four COVID-19 related treatments, 46 disaster response or emergency care treatments, 31 emergency antidotes, 31 tuberculosis treatments, 99 hepatitis virus, parasite and other infectious disease treatments, 33 vaccines, and 10 basic parental nutrition solutions. The government constantly monitors supply and stock of the essential drugs, and takes prompt actions to stabilize the supply by MFDS clearing special importation or using contract manufacturing organization to domestically supply the products. MFDS official said, “More of National Essential Drugs would be designated in the future to securely grant patient access to drugs in desperate need of special management,” and “The government would always strive to supply drugs essential to the public health.”
- Company
- AML treatment Rydapt can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 03, 2020 06:18am
- Novartis' new acute myelogenous leukemia drug 'Rydapt' can be prescribed in general hospitals. According to the related industry, acute myeloid leukemia (AML) treatment, Rydapt (Midostaurin) has passed the pharmaceutical committee (DC, drug commitee) of Big 5 Hospitals, such as Seoul National University Hospital and AMC. It was approved as an orphan drug in Korea last year as a FLT3 inhibitor and can be prescribed for ▲combination of high-dose Cytarabine with standard Cytarabine or Daunorubicin induction therapy for new AML patients with positive FLT3 mutation ▲Aggressive systemic mastocytosis, systemic mastocytosis with hematologic neoplasm, mast cell leukemia. FLT3 inhibitors are also well known as 'HM43239', Hanmi’s candidate. The effectiveness of Rydapt has been demonstrated through ATIFY studies. The study was the largest of all clinical trials involving 3,277 AML patients with specific gene mutations. Patients treated with Rydapt in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy experienced significant improvement in overall survival (OS) with a 22% reduction in the risk of death compared with chemotherapy plus placebo. In patients in the Rydapt arm, OS was 74.7 months vs. 25.6 months in the placebo arm. AML is the most common form of leukemia, accounting for about 65% of adult acute leukemias. The incidence increases with age. AML is primarily treated by administering 2 to 3 drugs such as Anthracycline in combination. The problem is that after the first chemotherapy, up to 50% of cases of recurrence of leukemia cells fall below 5%, even if the degree of 'complete remission' reaches 50 to 70%. Official from Society of Hematology said, “It is important to reduce the number of cancer cells in the early stages of AML. We are looking forward to the emergence of an option that can be prescribed to patients who are not able to apply induction techniques, which is an important issue.”
- Opinion
- [Reporter’sView] Finding the key in platform technology
- by An, Kyung-Jin Jul 03, 2020 06:18am
- The world is eyeing on companies developing platform technology for novel drug. In last few years, Korean bio technology companies like ABL Bio, LegoChem Biosciences and Alteogen have signed deals worth over a trillion won with global pharmaceutical companies on rights over platform technology that facilitates drug delivery. Each in last November and June this year, Alteogen signed two licensing agreements with global pharmaceutical companies on human hyaluronidase (ALT-B4) technology that enables intravenously injected biologics to also work as subcutaneous injection. The company earned 35 billion won from the two companies licensed in the platform technology. The number already exceeds the Korean company’s sales in last year totaling at 29.2 billion won. From last year and on, LegoChem Biosciences have inked three deals on antibody-drug conjugate (ADC) technology. The technology mediates efficient delivery of drug to cancer cells by improving the unstable linkers between protein and antibody. In March last year, LegoChem licensed out three ADC-applied novel anticancer therapies to Millennium Pharmaceuticals, a subsidiary of Takeda Pharmaceutical. And in April and May this year, the Korean company signed deals for the U.K.-based Iksuda Therapeutics to hold exclusive rights to use the ADC technology and ADC-based cancer therapy. A platform technology is defined as source technology to apply on development of new drugs. Such technology can enhance medication convenience or benefit by changing injection to oral administration or switching intravenous route to self-injectable subcutaneous injection. The biggest appeal of the platform technology in novel drug development is the potential of expansion. Generally, the probability of candidate medicine to receive sales approval at Phase I clinical trial stage is 10.4 percent, at Phase II is 16.2 percent and at Phase III is 50.0 percent. Even a company with multiple new drug pipelines cannot be completely free from the probability of failure. On the contrary, platform technology holds less risk in failure as it could be used on different candidate drug when it fails in other. For instance, Hanmi Pharmaceutical took a blow when Sanofi returned the rights over efpeglenatide, but if the neutropenia treatment Rolontis (eflapegrastim) gets approval from the U.S. Food and Drug Administration (FDA) within this year, the Lapscovery technology’s potential could be reevaluated. Like the licensing agreements LegoChem or Alteogen signed, an exclusive rights or a novel therapy based on the technology could be transferred. But also the licensing profit could be maximized by signing a non-exclusive deal on the technology. Good news to the Korean industry is that the world’s perception on Korean pharmaceutical and bio companies have significantly improved in last few years. The Korean industry’s successful outcomes are yet to be tangible, but there are many companies with platform technologies on par with other global companies. Hopefully, the heightened interest on the platform technology would induce investment on these promising companies.
- Policy
- 33 seriously ill patients are eligible for free Remdesivir
- by Kim, Jung-Ju Jul 03, 2020 06:18am
- Gilead Science Korea's COVID-19 treatment 'Remdesivir' was supplied to Korea on the 1st of today. A total of 33 seriously ill candidates will be eligible for the first free application. However, they request to be administered at the discretion of the attending physician, and whether or not to administer is determined according to the selection criteria. Jung Eun-Kyeong, Head of Central Disease Control Headquarters at the KCDC, today (1st) at the regular briefing, explained the number and severity of serious patients currently considered as the primary target. According to the Head Jung, there are reports that Remdesivir shortens the treatment period through several clinical trials. Statistically, it is still unclear, but the supply was decided by special import because the drug is expected to reduce the mortality rate. The government has decided on the selection criteria for the target of the treatment so that it can be administered to patients who have not passed 10 days, which can be called early onset. In addition, it was limited to patients receiving oxygen therapy which chest x-ray or CT pneumonia, oxygen saturation was 94% or less. Jung Eun-Kyeong, Head of Central Disease Control Headquarters said, "The criteria for this medication were selected in consideration of experts' advice and recommendations from the central clinical committee operated by the National Medical Center, and by the MFDS, but the request is made at the discretion of the attending physician.” She added that there are basic treatment policies in the early stages of the onset such as administering antiviral drugs to suppress the growth of viruses, and using treatments such as Dexamethasone, which has anti-inflammatory effects, depending on the progress. It will be necessary to check the dosing criteria while checking the onset period. On the other hand, as of 2:50 pm on the first day that the application for medication was started, there are no medical institutions that have requested to apply for Remdesivir.
- Policy
- It started supplying Remdesivir to Korea for free for July
- by Lee, Tak-Sun Jul 03, 2020 06:17am
- Remdesivir (BBC)Gilead's 'Remdesivir', a COVID-19 treatment, is supplied to Korea. In the month of July, the supply will be used free of charge. It is planned to be purchased and used through price negotiations after August. The director of The KCDC (Jung Eun-Kyeong) announced that it will supply Remdesivir, which was specially imported as a treatment for COVID-19, from July 1. On June 29, after the MFDS' decision on special imports, the KCDC signed a free drug supply contract with importer Gilead Science Korea (USA) on the 29th of last month through consultation on domestic introduction. However, it was decided that the amount of introduction would be closed according to the terms of the contract with Gilead. Patients who can receive Remdesivir are limited to severe patients with pneumonia and who need oxygen therapy. Therefore, hospitals that treat severely ill patients should request the National Medical Center to supply medicines, and the National Medical Center, if necessary, consults with the central clinical committee for emerging disease control to determine who should be administered. Jung Eun-Kyeong, Director of the KCDC, said, "We plan to do our best to secure treatments by continuing to cooperate with Gilead Sciences Korea to secure additional volumes of Remdesivir." The KCDC plans to secure free supplies until July, and purchase from price negotiations after August.
- Policy
- Lipiodol takes government’s pricing reduction to the court
- by Kim, Jung-Ju Jul 03, 2020 06:17am
- The government’s price reduction on Lipiodol Ultra Solution (iodized oil), supposed to be effective from July 1 with the release of generic, is now heading to the courts as the company objected to the decision. Until the judgment is made, the court has allowed Guerbet Korea to sell the drug for the original reimbursed price temporarily. The Seoul Administrative Court has ordered a suspension on the execution of the new list of reimbursed drugs and maximum reimbursed price, as the company filed a litigation case to drop the government’s action. On June 23, Korea’s Ministry of Health and Welfare (MOHW) has initially decided to lower the pricing of Lipiodol as the generic drug Fattiodol by Dongkook Pharmaceutical was listed. According to the government’s calculation of reimbursed drug price, MOHW authorizes adjustment of maximum prices of first-in-class drug and other products with the same administration method, substance and formulation when a generic drug is listed. The initial adjustment of the pricing would have lowered the price of Lipiodol in 12.8 g/ 10 mL dose at 190,000 won to 133,000 won by 30 percent from July 1. And the premium pricing benefit on the original was supposed to be removed from May 1 next year, which would once again lower the pricing from 133,000 won to 101,745 won. However, the company has filed litigation against the government decision and now the court is taking over the decision. The original price of 190,000 won would be temporarily maintained until Aug. 24. But if the case extends in longer period of time, the suspension of the pricing reduction would also be prolonged. For now, MOHW plans to follow the court’s order until Aug. 24, and inform further changes accordingly.
- Policy
- Amgen's Eylea biosimilar has been approved for Phase III
- by Lee, Tak-Sun Jul 02, 2020 06:10am
- Amgen is conducting a phase III clinical trial on Eylea biosimilar in Korea. Recently, Samsung Bioepis' Eylea biosimilar has also been approved for phase III clinical trials in Korea, so the Korean market is expected to face strong competition between Big Pharma and native biosimilar companies. On the 29th of last month, the MFDS approved a multi-national clinical trial phase III for 'ABP-938' by Korea Parexel. An Eylea biosimilar, ABP-938 is being developed by Amgen. This is a randomized, double-blind, phase III clinical trial comparing the effectiveness and safety of ABP938 and Eylea (Aflibercept) in subjects with wet age-related macular degeneration. A total of 566 people from various countries will participate, and 50 people will be recruited in Korea. Clinical trials will be conducted at SMC, SNUH, AMC, Seoul St. Mary’s hospital, and Korea University Anam Hospital. Eylea, along with Lucentis, is the world's most used treatment for macular degeneration, licensed in March 2013. Based on IQVIA, last year's sales amount was ₩46.8 billion. Competition for the development of biosimilars is intensifying as patents expire in the US this year. Samsung Bioepis, SCD Pharm, and Alteogen are developing as domestic pharmaceutical companies, and Amgen and Mylan have entered the development competition as US companies. As a domestic clinical trial, Samsung Bioepis' biosimilar was approved for phase III on the 11th of last month along with Amgen. Alteogen is undergoing clinical trial phase I in May last year. SCD Pharm announced in May that it had been approved for phase III clinical trial by the US FDA. It is expected that sales competition will intensify as Big pharma such as Amgen have recently entered the development of biosimilars.
- Company
- Lee Heeseung to oversee MA-GA-PR at MSD Korea
- by Eo, Yun-Ho Jul 02, 2020 06:09am
- A former senior director at Novartis Korea, Lee Heeseung is to be appointed as a leader of the External Affairs department at MSD Korea. According to the pharmaceutical industry sources told the latest personnel decision by MSD Korea. Lee Heeseung would take over the position of External Affairs Lead from July 15. Three teams including Market Access (MA), Government Affairs (GA), and Public Relations (PR) are operating under the umbrella of the External Affairs department at MSD Korea. The soon-to-be Lead would oversee all three teams. Lead Kim So Eun, who has been in charge of the External Affairs so far, is newly appointed as a Translation Leader for MSD spin-off Organon. A new CEO would be appointed for the full-fledged spin-off company. MSD Korea insiders are speculating the latest personnel decision was made to appoint Kim as the CEO of Organon Korea. Lee Heeseung started her career from a PR agency Edelman Korea and joined Novartis Korea in 2016 managing the PR operation. In 2019, she worked at Visa Korea to manage marketing in Korea and Mongolia.
