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- 2026-05-07 16:19:14
- Company
- LegoChem Bio may receive milestone payments next yr
- by Dec 28, 2022 05:49am
- 2nd generation ADC platform technology owned by LegoChem Bio LegoChem Bioscience’s drug candidates that have been licensed out are making their way into clinical trials. The company succeeded in making licensing deals for 10 antibody-drug conjugate (ADC) pipelines and is expected to start receiving milestone payments in earnest in line with their development progress. ◆Company may earn up to KRW 6.8 trillion if all 10 licensed-out ADC pipelines succeed in commercialization According to industry sources on the 29th, if the drug candidates licensed out by LegoChem Biosciences succeed in commercialization, the receptible milestone payments will amount to KRW 6.84 trillion at most. The company has signed 10 licensing-out deals with other companies. Recently, LegoChem Bio signed a technology transfer agreement with Amgen worth KRW 1.6 trillion. LegoChem Bio had previously signed similar deals with Fosun Pharma, Takeda Pharmaceutical, Iksuda Therapeutics(3 deals), CStone, Pyxis Oncology, Antengene, and SOTIO Biotech. In the deals made with Amgen, Iksuda Therapeutics. Pyxis Oncology, Antengene, and SOTIO Biotech, the company has also secured the right to earn a share of the profit when the drug candidate is commercialized. Its drug candidates that were licensed out are entering the clinical stage one after another. This is raising expectations on the additional milestones that the company may receive in the future The industry expects 5 of the milestone payments deals to pay out next year. 2 of the 3 technology export deals the company made with Iksuda Therapeutics are expected to start global Phase I trials next year. If global clinical trials are initiated, LegoChem Bio will receive a part of the milestone payments payable upon initiation of the trial. For the other 1 deal made with Iksuda Therapeutics, Iksuda plans to submit a clinical trial protocol for 2 drug candidates. If this trial is initiated, it will also allow LegoChem Bio to receive further milestone payments. In the case of Takeda Pharmaceutical, the company plans to derive a drug candidate by next year. SOTIO also plans to do the same within the next year. If the two companies succeed in deriving drug candidates, LegoChem will receive milestone payments for each. Also, expectations are rising on further milestone payments the company can receive after next year. Fosun Pharma is conducting a Phase 1b trial for the anticancer drug candidate LCB14 LegoChem Bio licensed out to Fosun Pharma. A Phase 1 trial is also underway for LCB71 as a treatment for solid cancer and blood cancer, which was licensed out to CStone. ◆Inks a technology transfer deal with the big pharma Amgen...proves technolgy LegoChem Bio signed a series of technology transfer deals with multinational pharmaceutical companies with its ADC platform technology based on its proprietary platform technology ‘ConjuAll’ and ‘LegoChemistry.’ ADCs are a class of cancer therapeutics that combines the advantage of antibody drugs that can distinguish tumor cells using an antigen-antibody response and the highly potent anticancer effect of chemical synthetic drugs. The drugs have the advantage of being able to show high efficacy with low side effects compared to existing technologies. ADCs are also evaluated to have good blood stability. LegoChem Bio is being recognized for owning competitiveness in the field of ADC, as it owns a binding method that can be implemented with a single substance, a linker that can specifically release drugs to cancer cells, and drugs that only activate in cancer cells, etc. In particular, the company’s recent licensing deal with the global big pharma Amgen has been raising expectations for more licensing-out deals to come in the future. LegoChem Bio recently signed a deal to transfer its original ADC platform technology to Amgen and conduct joint research. Under the deal, LegoChem Bio’s platform will be applied to 5 of Amgen’s antibodies to direct 5 targets. The deal totals up to be worth KRW1.61 trillion. If Amgen succeeds in commercializing the drug candidate, LegoChem Bio can separately receive profit. Unlike the upfront payment, the details of the deal, such as the specific amount of milestone payments per development stage were not disclosed. Until now, LegoChem Bio had mostly signed licensing-out deals with small and medium-sized global pharmaceutical companies. The pharmaceutical industry has evaluated LegoChem Bio’s successful technology transfer deal made with the big pharma Amgen as proof of the company’s technological competitiveness.
- Company
- More companies are overcoming patents for Otezla
- by Kim, Jin-Gu Dec 28, 2022 05:48am
- Pharmaceutical bio companies seeking to release generics for Otezla, a psoriasis treatment that has not been released in Korea, are expanding. In addition to the existing Daewoong Pharmaceutical and Dong-A ST, DongKoo Bio, Huons, and Chong Kun Dang succeeded in overcoming two out of three related patents. If they overcome the remaining usage patents, they will be eligible for early release of the Otezla generic. According to the pharmaceutical industry on the 27th, Chong Kun Dang recently received a decision to establish a claim in a passive judgment to confirm the scope of rights for Otezla's patent filed against Amgen. Otezla is protected by a total of three patents. These are two formulation patents (10-2232154, 10-2035362) expiring in 2032, and one application patent (10-0997001) expiring in 2028. Seven generic companies that are challenging this patent have avoided one out of two pharmaceutical patents in May this year. On top of that, a growing number of pharmaceutical companies have avoided even one remaining pharmaceutical patent. Following the avoidance of the patent, last month by Daewoong Pharmaceutical, Dong-A ST, DongKoo Bio, Huons, and Chong Kun Dang additionally succeeded in avoiding the patent this month. Mother's and Cosmax Pharma, which have not yet been decided, are also expected to win soon. Generics have filed a request for invalidation of the patent. If generic companies succeed in invalidating their use patents, all Otezla patent licenses will disappear in Korea. Generics have finished developing related products. Dong-A ST was approved for phase 1 clinical trial in Korea by Otezla General under the development name of "DA-5215" in March this year. The clinical trial was completed in June. It plans to apply for an item permit as early as this year. Chong Kun Dang also completed the vitality test of Oteszla General under the development name "CKD-235." ◆ Global blockbuster Otezla voluntarily withdraws after failing to register domestic benefits The original Otezla withdrew from the country after failing to register insurance benefits. Otezla was granted domestic permission by Celgene in 2017. At the time of approval, it drew attention as the only oral psoriasis treatment in Korea. Since then, Celgene has been challenged to register its benefits but failed due to differences in positions on drug prices between insurance authorities and companies, and its release was delayed. As Celgene was acquired by BMS in 2019, the domestic launch plan was further twisted. Initially, BMS tried to acquire Otezla's copyright, but FTC ordered the sale because it was concerned about monopoly. Eventually, BMS sold Otezla's global copyright to Amgen. As a result, domestic copyrights were transferred to Amgen. Amgen sat instead of Seeljin at the negotiating table with the insurance authorities but likewise failed to register. Amgen voluntarily withdrew its Otezla item license in June of this year. However, despite the withdrawal of the Korean market, Amgen still holds Otezla's domestic patent rights. Unlike Korea, Otezla is on a roll as one of Amgen's major products globally. According to Amgen, Otezla's sales in the first half of the year were $594 million, up 11% from $534 million in the first half of last year.
- Company
- Why no news is being heard on reimb extension for Bavencio
- by Dec 28, 2022 05:48am
- Merck and Pfizer’s cancer immunotherapy ‘Bavencio (avelumab)’ is having trouble expanding its reimbursement in Korea. Although the agenda has passed deliberations by the Cancer Disease Deliberation Committee (CDDC), the follow-up process was sluggish and no progress has been made for 8 months. According to the pharmaceutical industry on the 27th, the indication expansion agenda passed the Health Insurance Reimbursement and Assessment Service's CDDC deliberations in April, after which no news is being heard on its progress. The agenda was at a standstill because it was not presented for deliberation by the Drug Reimbursement Evaluation Committee (DREC). In April, CDDC established reimbursement standards for Bavencio in bladder cancere The CDDC passed the application submitted by Merck to expand the reimbursement for Bavencio to the bladder cancer (urothelial carcinoma) indication. This was when the reimbursement standards were set for Bavencio as first-line maintenance monotherapy for adult patients with locally advanced or metastatic urothelial carcinoma. However, its reimbursement for the bladder cancer indication is still far off. This is because DREC has not deliberated on expanding the coverage for Bavencio for the past 8 months with no hard plan set for its deliberation in the future. Bavencio is not the only drug that has seen little progress after passing CDDC. Ono Pharmaceutical’s ‘Bratovi’ passed CDDC meetings in January and received reimbursement standards in colorectal cancer, but has not been deliberated by DREC for a year since. AstraZeneca’s ‘Lynparza’ that was set reimbursement standards for the treatment of BRCA-mutated prostate cancer, To list or expand the indication of anticancer drugs for reimbursement, the agenda needs to pass CDDC deliberations and then undergo reimbursement adequacy review by DREC, drug pricing negotiations with the NHIS, and finally pass the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee deliberations. In general, the statutory processing period for drug reimbursement evaluations conducted by HIRA's CDDC and DREC is set at 120 days (150 days for RSA drugs). However, with reasons such as requests for supplementary data, the statutory review period has not been properly observed until now. In particular, as the review period for reimbursement expansions is unclear and lower priority than new reimbursement listings, predicting when these agendas will be deliberated is virtually impossible. Also, with the rise of the COVID-19 pandemic and the introduction of high-priced new drugs, fiscal soundness has emerged as an important issue. This is why more and more reimbursement expansion deliberations for existing drugs are falling behind in priority. Bavencio’s indication as maintenance therapy that the company is attempting to expand reimbursement to is a sort of 1.5-line therapy used in patients with urothelial carcinoma who have not progressed after using standard chemotherapy. In the Phase III JAVELIN Bladder 100 trial, the median overall survival (OS) was extended by over 7 months for patients who received Bavencio+BSC compared to best supportive care (BSC) care alone and reduced the risk of death by 31%. The 1-year overall survival rate was 71.4% in the Bavencio group, higher than the 58.4% observed in the comparator group. The delay in DREC’s deliberation of Bavencio for reimbursement as maintenance therapy can also be partially attributed to the existence of other cancer immunotherapies. Currently, other immunotherapies including Keytruda, Tecentriq, and Opdivo also own bladder cancer indications. The specific indications approved may differ for each drug. Keytruda and Tecentriq are used in the first line. However, only patients that are PD-L1 positive and who are not eligible for cisplatin-containing chemotherapy are allowed to use the drugs. In the case of Opdivo, the drug is used as a second-line treatment in patients whose disease has progressed after chemotherapy treatment. Keytruda and Tecentiq can also be used in the second line. Pic of Bavencio Some cancer immunotherapies are also allowed reimbursement, but only in the second line. Tecentriq, which had been the only drug approved for reimbursement in the second line, was unable to meet the conditional approval requirements set by the MFDS and was removed from the reimbursement list in September, and Keytruda emerged in its place. Tecentriq withdrew all bladder cancer indications after failing to demonstrate an effect for cancer in a Phase III trial. The company’s actions are also expected to affect its approved indications in Korea. As a result, the only reimbursed cancer immunotherapy option is Keytruda in the second line. The industry sees the availability of a reimbursed immunotherapy option, although in the second-line, and the lack of a second-line option after using Bavencio as maintenance therapy as the barriers that interfere with the reimbursement expansion of Bavencio, as immunotherapies cannot be used in later-line therapies after failing treatment with such in previous lines of treatment. However, this means that patients have to wait until disease progression to use immunotherapies in the second line. And not all patients can use immunotherapies with disease progression. Therefore, the opinion has been raised on the need for earlier use of immunotherapies. Professor Se Hoon Park, Division of Hematology/Oncology at Samsung Medical Center, said, “Due to the limited amount of second-line treatment options for bladder cancer, it could be so far as said that no treatment exists for bladder cancer in the second-line, and we hope that the reimbursement adequacy evaluation for Bavencio will soon progress further based on scientific evidence.” Park said, “If a treatment can safely provide clinically significant effect over existing treatments, its reimbursement adequacy should be evaluated under the same standards regardless of whether the treatment is being used for other cancer types or not.” JinYoung Paik, President of the Korea Kidney Cancer Association, said, “Many bladder cancer patients have been asking about Bavencio’s reimbursement due to the lack of other effective treatment options after receiving first-line treatment with chemotherapy. Bavencio is recommended as standard treatment in overseas guidelines and many significant data have been presented on the drug, but many patients cannot use it for economic reasons. I hope reimbursement discussions on Bavencio be progressed soon.”
- Company
- Phase 1/2 of CJ Bio's Microbiome has been applied
- by Dec 28, 2022 05:48am
- CJ Bioscience announced on the 26th that it has submitted an IND of phase 1/2 of the Microbiome immuno-cancer drug "CJRB-101" to the U.S. Food and Drug Administration (FDA). CJRB-101 is a new immuno-cancer drug candidate secured by CJ Bioscience. It was developed through various immunological reviews based on the strain library that CJ has built. It is listed in the EFSA and has high safety for human administration, and unlike existing intestinal microorganisms, process development for mass production of medicines is underway, enabling long-term clinical trials for cancer patients. Phase 1/2 clinical trials evaluate the safety and preliminary efficacy of CJRB-101 in patients with metastatic cancer such as advanced or non-small cell lung cancer, head and neck squamous cell carcinoma, and melanoma. It will be conducted by a number of clinical trial institutions in the United States and Korea and will recruit 46 people in phase 1 and a total of 120 people in phase 2. The drug resistance, safety, and effectiveness of the immuno-cancer drugs Keytruda and CJRB-101 are evaluated in combination. In order to expand the utilization of new drug candidates, CJ Bioscience decided to conduct a clinical efficacy evaluation at the same time for lung cancer as well as other cancers (head and neck cancer and skin cancer) with high marketability and incidence It will submit a clinical trial plan to the Ministry of Food and Drug Safety in the first half of next year. CJ Bioscience was launched earlier this year as a subsidiary of CJ's Red Bio (pharmaceutical and healthcare). An official from CJ Bioscience said, "It is expected that CJRB-101 and immune checkpoint will be used together to increase the low response rate of existing immuno-cancer drugs and provide new treatment opportunities for intractable patients who do not see the effect of immuno-cancer drugs."
- Company
- Kisqali Extends PFS by 1 yr in poor prognosis breast cancer
- by Dec 28, 2022 05:48am
- Novartis Korea announced on the 26th that the progressive and metastatic breast cancer treatment Kisqali has extended the progressive survival period by about one year compared to the first treatment of hormone receptor-positive (HR+)/human epithelial cell growth factor 2 negative (HER2-) breast cancer patients. The results of this study were presented at the San Antonio Breast Cancer Conference (SABCS 2022) held from December 6 to 10. The company's Kisqali RIGHT Choice study is the first phase 2 clinical trial to compare CDK4/6 inhibitor Kisqali and endocrine therapy combinations in aggressive pre-menopausal and transmenopausal HR+/HER2-progressive breast cancer patients. It was conducted on 222 patients with HR+/HER2-progressive breast cancer in premenopausal and menopause transitions that show aggressive characteristics, such as patients with visceral metastasis with symptoms and patients with rapid progression of diseases or symptoms. In particular, more than 50% of patients with intestinal metastasis crises were included in this study. CDK4/6 inhibitors and endocrine therapy are used as standard treatments in the primary treatment of HR+/HER2-progressive breast cancer patients, but combination chemotherapy is still used in patients with rapid disease progression or intestinal metastasis crisis. Kisqali demonstrated an extension of the progression-free survival period (PFS) even in the group of patients who are difficult to treat through a RIGHT Choice study. As a result of phase 2, the median PFS value of the Kisqali combined group was 24.0 months, which was 11.7 months longer than the 12.3 months of the control group (HR=0.54). The median time until treatment failure in the Kisqali combined group was 18.6 months, which was longer than 10 months compared to 8.5 months in the control group (HR=0.45). In terms of safety, the combined Kisqali group had a lower incidence of serious adverse reactions related to treatment and the resulting discontinuation rate of treatment compared to the combined chemotherapy group. Kisqali showed a similar safety profile to existing data. Yoo Byung-jae, CEO of Novartis Korea, said, "Kisqali has confirmed the benefits of extending the progressive survival period in patients with fast cancer progression or poor prognosis, such as visceral metastatic patients with symptoms."
- Company
- Samsung BioLogics did not receive 45.5 billion won
- by Dec 27, 2022 06:10am
- Cytodyn Main Pipeline (Data = Cytodyn)Samsung BioLogics has been in conflict with U.S. bio company Cytodyn over the past year to pay for commissioned production (CMO). Conflicts have continued for a year as Cytodyn is overdue the promised cost of the biopharmaceutical CMO. Late payments more than doubled from $13.5 million (17.2 billion won) in January this year. According to the U.S. Securities and Exchange Commission on the 26th, Cytodyn told Samsung BioLogics in a third-quarter report that the balance of overdue payments related to Leronlimab CMO was $35.7 million. Cytodyn is an American bio company that is developing AIDS, cancer, non-alcoholic fatty hepatitis (NASH), and COVID-19 candidates. In May 2019, Samsung BioLogics signed a contract with Leronlimab CMO for AIDS treatment. At that time, the minimum guarantee amount for the contract was $31 million (39.5 billion won). The minimum guarantee amount increased to $50.22 million (64 billion won) through a change in contract terms in July 2020. It is a contract that guarantees sales of $246 million (313.7 billion won) by 2027 through the production of commercial products if the license is successful. Cytodyn said Samsung BioLogics should pay $35.7 million in arrears. (Data = US Securities and Exchange Commission) Leronlimab is a fully humanized IgG4 monoclonal antibody treatment that targets CCR5 used in the process of the virus penetrating T cells as a mechanism to suppress cell infection of the HIV virus. Clinical trials for severe COVID-19 patients were also conducted through drug re-invention, but there was no significant difference from the placebo group in terms of efficacy. The payment conflict erupted when Cytodyn did not pay $13.5 million (17.2 billion won) to Samsung BioLogics at the end of last year. Samsung BioLogics sent a written notice to Cytodyn earlier this year demanding payment. According to the disclosure, the balance of arrears increased to $38.1 million as of May 31. As of August 31, it was slightly reduced to $35.7 million. The overdue balance seems to have decreased as some of the payments were made. Cytodyn said, "We will make reasonable efforts to fix serious violations. If we do not make reasonable efforts during the correction period, Samsung BioLogics can terminate the contract," and explained, "Cytodyn management is continuously discussing with Samsung BioLogics to solve the problem."
- Company
- LG Chem's Humira biosimilar applies for domestic permission
- by Dec 27, 2022 06:10am
- A researcher at LG Chem is looking at the data.(Source: LG Chem)LG Chem announced on the 23rd that it has applied for permission for Humira biosimilar LBAL items to the Ministry of Food and Drug Safety. Indications include rheumatoid arthritis, psoriatic arthritis, axillary spinal arthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Betchett enteritis, and meningitis in adults. In addition, children (6 to 17 years old) have Crohn's disease, idiopathic childhood arthritis, and childhood plate psoriasis. LG Chem was approved on May 27, 2016, for a phase 3 clinical trial to evaluate the equivalence of LBAL and Humira in patients with active rheumatoid arthritis who responded inappropriately to Methotrexate. After registering the first target on June 23, 2016, the last target visit was completed on February 1, 2018. LG Chem confirmed equivalence in the LBAL and Humira groups as clinical results. In the safety sector, the incidence of adverse reactions (AE) was similar in the LBAL and Humira groups. The incidence of significant adverse reactions (SAE) was 8.3% in the LBAL group and 4.7% in the Humira group, showing no significant difference. There was no adverse reaction that resulted in death. LBAL is a biosimilar developed in a high-concentration formulation like Humira. It is a product that improves patient convenience by removing citrate that can cause pain to patients. An official from LG Chem said, "We expect to provide patients with more options for treating autoimmune diseases through the previously released Eucept and LBAL."
- Company
- Nubeqa, approval for a combination therapy indication
- by Eo, Yun-Ho Dec 23, 2022 06:06am
- It is expected that the prescription of the combination therapy of the prostate cancer treatment Nubeqa will be possible in Korea. According to related industries, Bayer Korea recently submitted an application to the Ministry of Food and Drug Safety to expand the Taxotere combination therapy indication of an oral androgen receptor inhibitor (ARi) Nubeqa for treating vision nmCRPC. Nubeqa is an androgen receptor inhibitor with a unique chemical structure that binds to androgen receptors to inhibit the growth of prostate cancer cells through strong antagonism. The corresponding indication of this drug has been validated through an ARASENS phase 3 study. The metastatic hormone-sensitive prostate cancer patient group with Nubeqa and ADT and Taxotere on ARASENS 3 demonstrated a statistically significant improvement in total survival compared to the control group with ADT and Taxotere. The patient group using Nubeqa, ADT, and Taxotere showed a statistically significant delay in the period required for the pain to progress. The clinical results were announced at the 2022 Urology Cancer Symposium (ASCO GU) of the American Society for Clinical Oncology held in February, and were published in the medical journal "New England Journal of Medicine." Nubeqa has not yet applied for insurance benefits in Korea, so it is expected to take time to lead to actual prescription activation. The drug has not been registered since the HIRA Cancer Disease Review Committee ruled it unsuitable in February 2021.
- Company
- 1 of 2 patent suits filed this year proceed to the 2nd round
- by Kim, Jin-Gu Dec 23, 2022 06:06am
- It seems that the patent disputes in the pharma and bio industry will continue on in the long term. Among the 20 major rulings made during the first trial, 11, over 50% are being retried in a second trial by the Patent Court of Korea. Both the winning and losing parties of the patent suit that had been filed against Boryung Pharmaceutical’s fixed-dose combination for hypertension, ‘Dukarb (fimasartan and amlodipine),’ opted to continue their dispute in a second trial. In the case of the patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+sacubitril),’ the original company appealed after the generic drug companies won the first trial. In the case of the dispute over the DPP-4 inhibitor class antidiabetic ‘Galvus (vildagliptin),’ the agenda is being fiercely tried again from square one after the Supreme Court's ruling of remand after reversal, and Novartis is also further countering by filing a trial for the active confirmation of the scope of rights. ◆Generics companies win first trial on Entresto... Novartis appeals According to industry sources on the 23rd, 21 major trial rulings and judgments have been made this year for patents in the industry. The number excludes cases where the company voluntarily withdrew its suit after requesting judgment. 20 of the cases received a ruling from the Intellectual Property Trial and Appeal Board (first trial), and 1 received a ruling from the Patent Court of Korea (second trial). Of the 20 cases that received a ruling in the first trial, 11 cases chose to continue on to the second trial. This means that more than half of the parties of major disputes did not accept the decision of the first trial. Pic of EntrestoEntresto’s patent dispute is one representative example. The dispute was sparked after its generic companies simultaneously filed suits to invalidate and confirm the passive scope of rights on Entresto’s 6 patents. Starting with Elyson Pharm, 13 companies challenged ▲1 use·composition patent ▲ 1 salt·hydrate patent (un-listed in the patent register) ▲1 use patent ▲1 crystalline form patent ▲2 substance patents for Entresto. The first trial was concluded in favor of the generic companies. Generic companies succeeded in challenging 1 use·substance patent, 1 crystalline form patent, and 2 substance patents. The remaining trials for the use patent and salt·hydrate patent have not been concluded yet. The company of the original drug, Novartis, decided to continue on the fight to the second trial for the crystalline form patent and the use·composition patent in March and July of this year. The company has given up the trials for its other 2 substance patents. Entresto has no drug substance patent, and the role is replaced by the use·composition patent and crystalline form patent. Therefore, Novartis plans to focus its defense strategy around these two patents. ◆Both the winning and loser parties appeal to ruling for Dukarb... long-term dispute inevitable Pic of Dukarb Two conflicting rulings were made in the first trial for Boryung’s Dukarb patent. Among 40 generic companies that challenged Dukarb’s patent, 2 won against Boryung, while the others lost. 29 of the companies filed a new trial on the same patent at the same time. If the first trial they attempted was made to avoid the patent by confirming the passive scope of rights, the companies added a patent invalidation strategy after losing the first trial. From the generic company’s perspective, whether it receives a winning decision from the Patent Court of Korea or a new ruling from the Intellectual Property Trial and Appeal Board, the company will be eligible to release its generic early. This is why companies that challenge the patent are mobilizing all available strategies. Boryung Pharmaceutical also filed a lawsuit against the two pharmaceutical companies that won against the company in the first trial to annul the trial decision. As a result, the Dukarb patent dispute, which began in March last year, is expected to be prolonged to even after the substance patent for Kanarb expires in February next year. ◆Galvus dispute to continue to the end...Novartis files active confirmation of the scope of rights # i3 The patent dispute around Galvus was also inconclusive this year. The analysis is that the conflict has been prolonged for more than 5 years due to the sharp differences in the position of the two parties. The situation had also intensified with Novartis' counteract, filing a trial for the active confirmation of the scope of rights. The conflict began in 2017 when Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals claimed part of the term extended for the substance patent of Galvus invalid. The generic companies won the first trial. In the second trial, the court overruled the first court’s decision and ruled in favor of the original company. In the third trial, the Supreme court questioned the qualifications of the original company that filed the appeal and remanded it back to the first trial. With the remandment, the dispute resumed in the first instance court. Unlike in the previous first trial, the Intellectual Property Trial and Appeal Board ruled in favor of the original company, and generic companies appealed once again. Currently, Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals are waiting for the second trial ruling. Apart from the dispute, Novartis had filed a trial for the active confirmation of the scope of rights against Kyongbo Pharmaceutical, Ahn-Gook Pharmaceuticals, and Korea United Pharm. The active confirmation of the scope of rights is filed by the original companies to protect their patent rights from generic companies. The suit is rarely filed in the domestic pharmaceutical and bio-industry. Kyongbo and the others have already released their generic versions after they won the first trial. The substance patent for Galvus expired in March of this year. However still, Novartis plans to see the dispute to the end and be recognized for the generic companies’ patent infringement. If Novartis wins, it will be possible to claim damages due to patent infringement. All companies that released Galvus generics will be subject to claims for damages. Also, Roche and Alvogen Korea received mixed results over the 3 use patents for Avastin. Alvogen Korea won 2 trials and Roche succeeded in defending 1 claim. Both companies decided to appeal and take the dispute to the second trial. However, Roche withdrew the lawsuit it had filed for cancellation of the trial decision in September and plans to focus on the case appealed by Alvogen Korea. In the patent dispute over Monterizine Cap, Hanmi Pharmaceuticals filed an appeal for the cacellation of the trial decision against 20 pharmaceutical companies after losing the first trial.
- Company
- New HCV drug Epclusa lands in hospitals with reimb
- by Eo, Yun-Ho Dec 22, 2022 05:52am
- The Hepatitis C treatment ‘Epclusa’ is rapidly landing in hospitals for prescriptions after being granted reimbursement in Korea. According to industry sources, Gilead Science Korea’s oral chronic hepatitis C treatment Epclusa (sofosbuvir/velpatasvir) has passed the Drug Committees (DCs) of the Big-5s including the Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, and Shinchon Severance Hospital, as well as other major medical institutions including Ajou University Hospital, Hallym University Sacred Heart Hospital, Pusan National University Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Chungnam National University Hospital, and Chungbuk National University Hospital. When considering how the drug has only been listed for reimbursement on the 1st of last month, the drug is quickly landing at hospitals for prescriptions in Korea. Epclusa can be administered with reimbursement in adult and pediatric patients 23 years or older, weighing at least 30 kg, with any genotype of the chronic hepatitis C virus, regardless of the stage of cirrhosis or previous treatment experience. With the approval, Epclusa became the only treatment in Korea that can be prescribed with reimbursement regardless of HCV genotype or stage of fibrosis from November. Epclusa is a fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an NS5A replication complex inhibitor. The drug demonstrated a 99% treatment success rate (SVR12) in the ASTRAL-1 study conducted on patients with chronic HCV infection genotypes 1, 2, 4, 5, and 6 , without cirrhosis or with compensated cirrhosis. Also, in the ASTRAL-4 study, the treatment success rate was 94% in patients with decompensated cirrhosis using Epclusa. Meanwhile, according to the HCV treatment guidelines issued by the Korea Association for the Study of the Liver, Epclusa is recommended for patients with all HCV genotypes, with or without compensated cirrhosis, with or without treatment experience. Also, Vosevi is recommended as a retreatment for patients with chronic hepatitis C that have previously failed DAA treatment.
