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- 2026-03-14 21:27:04
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- SK Chemical introduces Lou Gehrig's treatment Teglutik
- by Lee, Seok-Jun Jan 03, 2023 05:41am
- On the 2nd, SK Chemical announced it will be launching ‘Teglutik,’ a Lou Gehrig's disease treatment that was developed by the Italian pharmacuetical company, Italfarmaco, in Korea. The drug is indicated for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neuromuscular disease that is also referred to as Lou Gehrig's disease, and is characterized by progressive degeneration of motor nerve cells and can lead to the paralysis of the limbs and respiratory muscles Teglutik, which contains riluzole, was approved by the Ministry of Food and Drug Safety in May last year as a treatment used to extend life or delay time to tracheostomy in patients with ALS. With no cure currently available for Lou Gehrig's disease in the market, treatment is performed to slow down the symptoms with drugs like Teglutik. Teglutik comes in a suspension formulation, which allows easier intake among patients suffering from difficulty swallowing. The company believes its improved convenience in intake will be of benefit in treating Lou Gehrig's disease. Hyun-Sun Park, Head of SK Chemical’s Pharma Planning Division, said, “We expect the introduction of Teglutik to bring synergy to the company’s well-established portfolio in neurodegenerative disease that includes products such as Wondron Patch and Ongentys Cap.
- Company
- U.S. first possible NASH therapy
- by Jan 02, 2023 06:04am
- ↑Expectations for the first NASH treatmentThe U.S. Madrigal Pharmaceuticals has succeeded in phase 3 clinical trials of Resmetirom, a new drug candidate for non-alcoholic fatty hepatitis (NASH). When new drugs are approved, Resmetirom appears as the first NASH treatment aimed at the 33 trillion won market. Yuhan Corporation, Hanmi Pharmaceutical, and LG Chem are also speeding up the development of NASH new drug candidates through technology transfer or its own clinical progress. On the 20th, Madrigal Pharmaceuticals announced that it has secured a positive top line in phase 3 clinical trials (MAESTRO-NASH), which studies Resmetirom as a NASH treatment. Resmetirom is a thyroid hormone receptor (THR)-beta agonist administered orally. NASH is a disease in which fat accumulated in the liver develops into inflammation, causing liver fibrosis and cirrhosis. It is highly likely to develop in obese and diabetic patients. According to Evaluate Pharma, a pharmaceutical market research company, the NASH treatment market is expected to grow more than 20 times from 277.1 billion won this year to 6.723 trillion won by 2026. It is expected to expand to 33 trillion won by 2030. Phase 3 clinical trials are a study that analyzes efficacy and safety for up to 54 months after administering Resmetirom 80 mg/100 mg and placebo for 52 weeks in 955 patients with confirmed NASH. The first evaluation index is "the standard for resolving more than two points of fibrosis without worsening liver fibrosis" and "the standard for improving the first stage without worsening fibrosis." It was effective in both the 80 mg and 100 mg groups. The clinical trial was successfully completed by obtaining statistical significance compared to the placebo group. The secondary evaluation indicators are 'whether LDL cholesterol decreases at week 24' and 'based on liver enzymes'. The 80 mg group and the 100 mg group reduced LDL cholesterol by 12% and 16%, respectively, to obtain statistical significance. The placebo group increased by 1%. A significant decrease was also confirmed in the liver enzyme standard. Compared to placebo, it was confirmed that fibrosis decreased through biomarkers and imaging tests in the Resmetirom treatment group. Resmetirom was safe and drug resistant in both 80 mg and 100 mg doses. The frequency of severe side effects (SAEs) was similar across the target group, with each group showing around 12%. Paul Freedman, CEO of Madrigal Pharmaceuticals, said, "This clinical trial is reasonably likely to predict Resmetirom benefits and has achieved both major indicators proposed by the U.S. Food and Drug Administration," adding, "We will submit an application for a new drug to approve resmetirom acceleration in the first half of 23." Domestic pharmaceutical companies are also speeding up the development of NASH treatments. Yuhan Corporation signed a technology transfer contract with global pharmaceutical companies Beringer Ingelheim and Gilead, respectively, in 2019. NASH's new drug candidate "YH25724," which was transferred to Beringer Ingelheim, is undergoing phase 1 clinical trials in Europe. YH25724 is a candidate material developed by Yuhan Corporation. In this process, it is a fusion protein that combines "Hybrid FC" (HyFc), an antibody fusion protein platform technology of bio company Genexine. There are two types of synthetic materials transferred to Gilead, Yuhan Corporation and Gilead will jointly conduct non-clinical research, and Gilead will conduct global clinical trials. Hanmi Pharmaceutical transferred NASH's new drug candidate "Dual Agonist" to MSD in 2020. MSD has been undergoing phase 2 global clinical trials since last year. Another candidate substance, LAPSTriple Agonist, was also designated by the FDA as a fast track development drug for NASH treatment. If it is designated as a fast-track drug, it can have close consultations with the FDA at each stage of development and receive full support. LG Chem is developing its own NASH new drug candidate "LG203003" through the LG Chem Life Science Innovation Center in Boston, USA. In March, the FDA approved a phase 1 clinical plan (IND). In July, phase 1 was launched for 88 healthy adults and NASH patients to observe safety and drug resistance, pharmacokinetics, pharmacology, and changes in fat volume in the liver. LG203003 is a mechanism that suppresses fat accumulation in liver cells by selectively interfering with the activation of DGAT-2, a neutral fat synthase. LG Chem also has another NASH candidate, 'LG303174. It inhibits the expression of VAP-1 protein, which is known to affect inflammation in the liver. In August 2020, LG Chem signed a technology transfer contract from TransThera Biosciences in China to introduce LG303174's right to global development and commercialization.
- Company
- The dismissal of 18 employees of Zuellig Pharma is unfair
- by Jan 01, 2023 10:43pm
- According to the pharmaceutical industry on the 29th, the 11th Civil Affairs Department (chief judge Park Tae-il) of the Seoul Western District Court ruled in favor of some of the plaintiffs in a lawsuit filed by 18 fired Zuellig Pharma SSK against the company on the 22nd. According to the Democratic Pharmaceutical Union, the first trial court judged that "the company's layoffs themselves are invalid due to illegal and unfair dismissal in violation of the current Labor Standards Act." In order for layoffs to meet the prescribed requirements of the Labor Standards Act, they must meet ▲ urgent management needs ▲ company's efforts to avoid dismissal ▲ fair dismissal standards, and target selection ▲ consultation procedures 50 days in advance. The court said, "The layoffs did not meet the urgent management needs and did not make efforts to avoid dismissal." Considering the fact that workers endure unpaid leave at a time when operating losses in 2020 are insignificant, only a small number of customers can operate their business units, and labor costs are mostly operating costs, it is difficult to say that they are in an urgent management crisis. In addition, it was difficult to say that the government took measures to minimize the scope of dismissal, given that it decided to abolish its business unit immediately just a month after the strike ended, which led to the departure of the customer base, which led to the layoffs. Zuellig Pharma SSK, Zuellig Pharma's digital marketing division specializing in healthcare, is divided into a marketing division and a PC (Patient Card) division. The layoffs were made for the PC division. Zuellig PharmaSSK announced a voluntary retirement and dismissal plan in December 2020 along with the abolition of the PC division due to management difficulties. The layoffs took place on March 31, 2021, about three months later. The Democratic Pharmaceutical Union claimed that the company's layoffs were intended to suppress the union. When members of the Zuellig Pharma SSK branch went on strike due to the breakdown of wage negotiations, they fired all members by abolishing the business unit. Four months after the layoffs, SSK CEO Irwan Wolf left Korea after his term in office, making it difficult to hold him accountable. In response to the court's ruling on unfair dismissal, the Democratic Pharmaceutical Union said, "The company seems to be willing to proceed with the appeal, but it will continue its legal struggle until the end for the legitimate reinstatement of laid-off employees."
- Company
- Pharmaceutical shares capitalization of ₩56 trillion
- by Chon, Seung-Hyun Jan 01, 2023 10:42pm
- This year, pharmaceutical bio companies' stock prices were sluggish. It has never recovered from its peak on the first day of the stock market opening. The market capitalization of major companies fell by more than 56 trillion won. More than two out of ten have seen their market capitalization shrink by less than half in a year. According to the Korea Exchange on the 29th, the KRX Healthcare Index closed this year at 2,634.49. It fell 29.2% in a year from 3721.17 at the end of last year. The KRX sector index is an index that divides listed stocks in the securities market and KOSDAQ market into 17 industrial groups and selects and calculates representative stocks for each industry group. KRX Healthcare consists of 83 major pharmaceutical bio shares selected by the exchange. This means that stock prices of major pharmaceutical bio companies listed in Korea fell 29.2% on average. This year, pharmaceutical bio companies' stock prices have remained sluggish throughout the year. The KRX Healthcare Index recorded 3751.82 on January 3, the first day of its opening this year, the highest this year. The KRX Healthcare Index fell 27.4% in six months to 2,723.45 on June 23 but recovered 20.6% to 3,284.61 on August 9. However, it fell again, falling to 2,463.10 on October 13. It fell 34.3% in nine months compared to January 3. The KRX Healthcare Index has been on a slight rise since November but failed to make up for the previous decline. As a result, the KRX Healthcare Index fell sharply for the second consecutive year. The KRX Healthcare Index soared 89.3% from 2915.31 to 5517.31 in 2020 but fell 32.2% to 3742.91 last year. At the end of this year, the KRX Healthcare Index shrank 52.3% compared to two years ago. This year, most of the market capitalization of major pharmaceutical bio companies fell sharply from the end of last year. As of the end of last year, the market capitalization of 92 pharmaceutical bio companies that made up the KRX Healthcare index totaled 222.3191 trillion won, down 55.834 trillion won to 166.4851 trillion won in a year. The market capitalization of major pharmaceutical bio companies has decreased by 25.1% in a year. 86 out of 92 major pharmaceutical bio companies saw their market capitalization decrease compared to the end of last year. SK Bioscience evaporated 11.5689 trillion won from 17.2125 trillion won in market capitalization at the end of last year to 5.6436 trillion won in a year. In June, SK Bioscience was the first Korean company to receive a license for SKY Covione multi, a vaccine for preventing COVID-19, as the 35th new drug developed in Korea. However, as SKY Covione was not used much and the size of the COVID-19 vaccine consignment business of multinational pharmaceutical companies decreased, the stock price fell significantly. The stock price of SK Bioscience was 73,500 won, down 67.3 percent from 225,000 won at the end of last year. Celltrion's market capitalization was 22.5992 trillion won, down 4.7143 trillion won from 27.3135 trillion won at the end of last year. Celltrion Healthcare decreased by 3.2552 trillion won from 12.43 trillion won to 9.1781 trillion won during the same period. Celltrion Pharmaceutical's market capitalization has decreased by KRW 2.246 trillion over the past year. SD Biosensor, SK Biopharm, Seehene, Mezzion, Hanmi Science, Samsung Biologics, Alteogen, BNC Korea, and GC Pharma saw their market capitalization fall by more than 1 trillion won this year. The market capitalization of 20 out of 92 major pharmaceutical bio companies has decreased by more than 50% in a year. Mezzion's market capitalization fell 82.0% from KRW 1.932 trillion to 347.6 billion won. BNC Korea, Anterogen, Cellid, Ubiotics, Eyegene, and Aptabio saw their market capitalization fall by more than 70% in a year. Enzychem, Genexine, SK Bioscience, Medpacto, Prestigebiologics, Korea Pharma, Geneone Life Science, Seegene, GC Cell, PCL, United Pharmaceutical, and Olivia Pharma have seen their market capitalization fall by less than half compared to 1 year ago.
- Company
- Korea develops 2 new drugs and 2 biosimilars in 2022
- by Chon, Seung-Hyun Dec 29, 2022 06:04am
- In Korea, domestic pharmaceutical companies succeeded in developing 2 new drugs this year. The new drugs developed by SK Bioscience and Daewoong Pharmaceuticals reached the commercialization stage. This is the most amount of biosimilars developed in Korea in 7 years since 2015. ◆SK Bioscience receives approval for the first new homegrown COVID-19 vaccine...Daewoong receives marketing authorization for a new diabetes drug According to the Ministry of Food and Drug Safety on the 28th, domestic pharmaceutical and biohealth companies received approval for 2 new drugs this year. In June, SK Bioscience’s COVID-19 prevention vaccine SKYCovione Multi inj received marketing authorization in Korea as the 35th homegrown new drug. SKYCovione Multi Inj is a COVID-19 vaccine that induces an immunological response by administering the company’s proprietary gene recombination technology. SK Bioscience first discovered the COVID-19 vaccine candidate jointly with the Institute for Protein Design at the University of Washington. It was funded by Bill & Melinda Gates Foundation (BMGF) and Coalition for Epidemic Preparedness Innovation (CEPI), and the company succeeded in commercializing the drug after 2 years. On the 30th of last month, Daewoong Pharmaceutical received approval for its diabetes treatment Envlo as the 36th new homegrown drug. Envlo was approved as an adjunct to diet and exercise therapy in Type-2 diabetes patients. Envlo may be used as monotherapy, metformin combination therapy, and metformin and gemigliptin combination therapy. Envlo is the first SGLT-2 inhibitor class antidiabetic developed in Korea. The drug reduces blood sugar levels by inhibiting the reabsorption of glucose in the kidneys and allowing it to be excreted as urine. In October, Daewoong Pharmaceutical confirmed the blood sugar reduction effect and safety of the drug through a Phase III trial that was conducted on Type 2 diabetes patients. Envlo was first developed by GC Corp, and Da Daewoong acquired its exclusive license in 2016. With this, a total of 6 new drugs developed by Korean pharmaceutical companies were approved in the past 2 years, starting last year. In January last year, Yuhan Corp’s anticancer drug ‘Leclaza’ was approved, and in February and March, Celltrion’s COVID-19 treatment ‘Regkirona’ and Hanmi Pharmamceutcial’s neutropenia treatment ‘Rolontis’ received MFDS approval, respectively. In December last year, Daewoong Pharmaceutical’s ‘Fexclu’ was listed as the 34th new domestically developed drug. ◆3 homegrown biosimilars enter the market for the first time in 7 years since 2015 Korean pharmaceutical and bio companies have received approval for 3 biosimilars this year. Celltrion, Samsung Bioepis, Chong Kun Dang etc. succeeded in commercializing one biosimilar each this year. In May, Samsung Bioepis received approval for its Lucentis biosimilar Amelivu in Korea. Lucentis, which is being marketed by Roche and Novartis, is a drug used to treat macular degeneration and diabetic macular edema. It is a blockbuster drug that made KRW 4.4 trillion in global sales last year. Amelivu is the first biosimilar of Lucentis to be introduced to Korea. In October, Chong Kun Dang received marketing authorization in Korea for its Lucentis biosimilar, LucenBS. In September, Celltrion’s Avastin biosimilar, the anticancer drug Vegzelma was approved. And in March last year, Samsung Bioepis received approval for the first Avastin biosimilar Onbevzi, followed by Celltrion. No. of approved biosimilars developed by Korean companies by year (Unit: product amount, Data: MFDS) This is the first time in 7 years since 2015 that Korean pharma and bio companies received approval for 3 biosimilars. In 2012, Celltrion first released its Remicade biosimilar Remsima and then a Herceptin biosimilar Herzuma in 2014. In 2015, Celltrion developed 1 and Samsung Bioepis developed 2 biosimilars. Celltrion received approval for Mabthera biosimilar Truxima, and Samsung Bioepis commercialized its Enbrel and Remicade biosimilar Etoloce and Remaloce. In 2017, Samsung Bioepis received approval for Adaloce and Samfenet. Their respective original drugs are Humira and Herceptin. In 2018, LG Chem and Chong Kun Dang developed one biosimilar each, and last year, Samsung Bioepis and Celltrion received approval for one biosimilar each. By company, Samsung Bioepis received approval for most biosimilars, with 6 approvals. Celltrion follows with 5 approvals.
- Company
- EUA for Zochova was not requested
- by Kim, Jin-Gu Dec 29, 2022 06:04am
- The government also keeps the door open to "monitoring overseas situations"...U.S. and Europe are under review. Ildong Pharmaceutical is expected to shift its strategy of introducing oral COVID-19 treatment Zochova (s-217622) in Korea from the EUA to conditional permission. On the 28th, the Central Disease Control Headquarters announced that it would not request Zochova's EUA from the Ministry of Food and Drug Safety. The Central Disease Control Headquarters explained that the decision was made after discussing the safety of Zochova and the necessity of emergency introduction in Korea three times with related ministries and infectious disease management committees. The pharmaceutical industry predicts that although the EUA has failed, Ildong Pharmaceutical will continue to push for the introduction of Zochova in Korea due to conditional approval. The EUA is not applied by a developer, but if the Korea Centers for Disease Control and Prevention deems it necessary, it asks the Ministry of Food and Drug Safety to approve it, and the Ministry of Food and Drug Safety quickly reviews and approves it. Conditional approval is applied by a developer and judged by the Ministry of Food and Drug Safety. It is expected that there will be an application for conditional approval from Ildong Pharmaceutical in the near future. A pharmaceutical industry official familiar with the company's internal situation said, "It means that there is no urgent need to introduce the drug in Korea, not the drug itself," adding, "It is expected to turn its domestic introduction strategy with conditional permission instead of EUA." "It has become a EUA in Japan and has begun reviewing emergency use approval in the U.S. and Europe," he said. "If the U.S. and Europe decide to introduce drugs, it will also help with domestic conditional approval." The government, too, has not completely blocked the possibility of introducing Zochova in the country. An official from the Korea Centers for Disease Control and Prevention said, "We will continue to monitor whether Zochova is approved for overseas emergency use, follow-up clinical results, and purchase and utilization situations." Zochova is an oral antiviral drug containing Ensitrelvir. It is a mechanism to selectively suppress 3CL-protease to prevent the proliferation of the SARS-CoV-2 virus that causes COVID-19. As a result of phase 2 and 3 clinical trials conducted in Japan and Korea, it took about 167.9 hours based on the median value to improve the symptoms of COVID-19 when Zochova was administered, which was significantly reduced compared to 192.2 hours in the placebo group, proving its effectiveness. The reduction of viral RNA in the body, a secondary evaluation variable, also met the criteria for validation. On the 4th day of the clinical trial after 3 doses of Zochova, viral RNA was found to have decreased in the Ensitrelvir administration group by 1.4 log10 copies/ml compared to the placebo group. Regarding the safety of the drug, no serious side effects or deaths occurred, and the drug resistance was also excellent. Unlike conventional treatments that require two or three tablets a day for five days, Zochova can be administered one tablet a day for five days.
- Company
- Daewoong and Neurorive will codevelop new antidepressant
- by Lee, Seok-Jun Dec 29, 2022 06:03am
- On the 28th, Daewoong Pharmaceutical announced it had signed an agreement with Neurorive to conduct joint research and development for a new drug candidate for depression. Under the agreement, the two companies will be jointly developing ‘NR-0601,’ a multi-target, non-narcotic oral depression treatment. Neurorive is a bio venture company that researches central nervous diseases including depression and Alzheimer’s. It is studying NR-0601 as the first new drug in its antidepressant pipeline. NR-0601 is an oral antidepressant that was derived using Neurorive’s drug screening platform that sends electric signals to living brain tissues to check the response of nerve cells. It has a multi-targeted mechanism of action and is expected to provide faster recovery from strong depression compared to conventional monoamine oxidase inhibitor oral antidepressants. It has a higher potential to work on patients with treatment-resistant depression (TRD) that do not respond to existing treatments. One in three patients with major depressive disorders is known to have TRD. Both companies will be collaborating in all stages of clinical development of NR-0601 which will enter clinical trials next year. Daewoong Pharmaceutical will be responsible for research to improve drug formulation, process development, chemistry, manufacturing and controls (CMC), good manufacturing standards (GMP), and advisory activities for clinical trials. Neurorive will be in charge of non-clinical development and testing, discussions with various regulatory authorities including MFDS, filing an investigational new drug (IND) application, and clinical development. Daewoong Pharmaceutical’s new drug product center that will take care of the research for improving drug formulation and the manufacture of investigational drug candidates owns various patents and differentiated technologies including its combination drug technology (Modified Release and Absorption by Tablet in Tablet MORATAT™, Double-Layered-Tablet DOLTAB®) technology), its sustained release technology ( the Multi-Target controlled release System, MuTAS™), and solubilizing technology (Nanotechnology of Optimal wet-Milling, NATOM®).
- 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.”
