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- 2026-05-09 07:23:58
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- JAK inhibitors may fall to 2nd-line due to safety concerns
- by Nho, Byung Chul Sep 16, 2021 05:59am
- With the health authorities seriously considering changing the reimbursement standards for Janus kinases (JAK) inhibitors which have recently been caught up in controversy over its safety issues, what the results will be is gaining industry-wide attention. According to industry sources, the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA) have been collecting opinions from relevant academic societies on the clinical efficacy and sequential therapy (first-line·second-line treatment) of JAK inhibitors for consideration. Although there had been cases where the authorities had removed drugs from the insurance benefit list according to the revocation of licenses, the authorities’ preemptive and voluntary action to change and amend the prescription guidelines is very rare, to the extent that actual cases of such examples are difficult to find. This is interpreted as the health authorities’ determination to take a step closer to advancing regulatory science for public health and prioritizing the patient’s safety in drug intake in line with the vision set by the FDA, the authority that is considered the international standard for drug approval and regulations. Recently, the MFDS had issued a Dear Healthcare Professional Letter regarding the safety of JAK inhibitors such as Pfizer’s ‘Xeljanz (tofacitinib),’ Lilly's ‘Olumiant (baricitinib),’ ‘Abbvie’s ‘Rinvoq PR Tab (Upadacitinib),’ etc. The MFDS’ measure was made after reviewing the results of the FDA’s randomized, large-scale clinical trial on the safety of ‘tofacitinib’ that was released on the 1st. The FDA had announced that tofacitinib increased the risk of serious heart-related events such as heart attack, stroke, cancer, blood clots, and death. The drug that is receiving particular interest among the JAK inhibitors is Pfizer’s Xeljanz, which had already had a safety issue in 2019 in addition to the heart attack risk that was discussed this time. Xeljanz is an oral JAK inhibitor indicated for rheumatoid arthritis and ulcerative colitis. After discussions with Pfizer, the FDA had ▲changed the ulcerative colitis indication from first-line to second-line and ▲added warnings to refrain from prescribing the drug to patients at risk of embolisms, at the time of issue development. On why the health authorities have made such prompt measures to address the issue of JAK inhibitors is considered to be because this is the second time the safety issue of the JAK inhibitor Xeljanz rose in 3 years with concerns for two side effects - increased risk of heart attacks and the 'risk of embolism.'. The prospect is that the academic society will show neutral or tacit consent to the authorities' move to amend the other reimbursement standards after changing the scope of approval. As in the FDA’s case of restricting Xeljanz's indication from first-line to second-line, where academic societies abroad made changes to the prescription guidelines after taking a neutral stance in respect to the opinions set by the regulatory authorities, rather than showing strong consent. If the Korean health authorities and academia reach a consensus on changing the indication for JAK inhibitors from 1st line to 2nd line treatment, the market for injectable traditional biopharmaceuticals is highly likely to expand. The current market established for JAK inhibitors is around ₩30 billion, and the prescription market for biologics such as Humira, Remicade, Simponi, Mabthera, Actemra, Cosentyx, Kynteles, and Stelara is around ₩350 billion annually.
- Company
- Nocdurna can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 16, 2021 05:59am
- #iNight urination treatment "Nocdurna" has been settled on the prescription ticket of a general hospital. According to related industries, Nocdurna (Desmopressin), co-sold by Ferring and Chong Kun Dang, passed DC, drug committee of Big 5 General Hospital such as SNUH, SMC, Seoul St. Mary's Hospital, and except for Sinchon Severance Hospital. In addition, Korea University Anam Hospital, NMC, Inje university Busan Paik hospital, Inje university Ilsan Paik hospital, Ewha Womans University Medical Center, Pusan National University Hospital, Haeundae Paik Hospital, Ajou University Hospital, Chonnam National University Hospital, and Chungnam National University Hospital also completed the process Ferring and Chong Kun Dang have been jointly selling "Minirin," a treatment for night urination, since 2019. Nocdurna, which signed an additional contract, is said to have reduced the burden of hyponatremia, which was feared in elderly patients, with Minirin's low-dose product. Nocdurna improves night urination symptoms caused by night urination, which overproduces urine at night, accounting for up to 88% of the causes of night urination. As a new treatment that can reduce the number of night urination in adults and improve the quality of sleep, Nocdurna 50 μg is administered once a day for men and Nocdurna 25 μg is administered once a day for women. As a result of the phase 3 study, Nocdurna 25μg and Nocdurna 50μg were found to be effective in controlling night urine-related symptoms in women and men, respectively. Nocdurna reduced the average number of night urination compared to placebo, and extended the initial sleep period due to increased time until the first night urination. Compared to placebo, the quality of life and sleep related to night urine have increased significantly. Meanwhile, Nocdurna, like the existing anti-diuretic hormone drug (Desmopressin), is covered by insurance benefits to treat night urination symptoms caused by nighttime urination.
- Company
- Idiance reveals the results of Venadaparib
- by Kim, Jin-Gu Sep 16, 2021 05:59am
- Idience, a new drug development company of Ildong Holdings, announced on the 14th that it will announce the results of phase 1b clinical trials of the targeted anticancer drug Venadaparib (IDX-1197) at the ESMO conference to be held from the 16th to the 21st. Venadaparib is a new drug candidate for targeted anticancer drugs based on precision medicine with a PARP (Poly ADP-ribose polymerase) inhibitory mechanism. Currently, Idience is conducting phase 1b/2a clinical "VASTUS" to evaluate the safety, tolerability, and effectiveness of Venadaparib in solid cancer patients with homologous recombination recovery mutations. What will be announced this time is the first interim result of the VASTUS test released through the American Cancer Society (AACR) in April. According to the abstract released on the 13th, Venadaparib was administered to metastatic BRCA mutated breast cancer patients, and there were no nausea, fatigue, or loss of appetite corresponding to Grade 3, which is the main side effects of existing PARP inhibitors.In particular, excellent efficacy was observed, with an objective response rate (ORR) of 80% of 10 patients administered Venadaparib, Idiance said. The company explained that it plans to secure additional related data through follow-up research. Based on the results of the clinical phase 1b study, Idience is known to have initiated phase 2a clinical trials. The ORR levels of Venadaparib observed in breast cancer patients with BRCA mutations are very meaningful compared to conventional PARP inhibitors, an Idiance official said. "We will continue further clinical studies to prove the excellent anticancer effect of Venadaparib."
- Company
- Novartis Korea appoints Byungjae Yoo as new head
- by Eo, Yun-Ho Sep 15, 2021 06:11am
- Byungjae Yoo, new General Manger of Novartis Korea Byungjae Yoo, the former Managing Director of Johnson & Johnson Medical North Asia, has been appointed as the new head to lead Novartis Korea. The company had recently announced through an internal notice that Yoo will be officially appointed as its General Manager from October 1st. This will be the second time since the company's establishment that the Korean subsidiary will be managed by a Korean leader. After completing his MBA at Harvard Business School, the newly appointed General Manager Yoo had joined J&J in 2006 through the company’s International Recruitment & Development Program. Since then, Yoo had held various roles in the company, including ones in North America’s Endovascular team, DePuy UK, and DePuy Australia. In Korea, he had served in the Cardiovascular Care Business Unit across North Asia and then appointed the Managing Director of Johnson & Johnson North Asia to oversee Korea, Taiwan, and Hong Kong. Although Novartis has been operating its oncology and pharmaceutical division independently as separate divisions, with reimbursement discussions for the CAR-T therapy ‘Kymriah (tisagenlecleucel)’ and SMA treatment ‘Zolgensma’ in progress, on what synergy will the appointed new head bring remains to be seen. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Galdsden in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015.
- Company
- Pharma companies fail to suspend renegotiations for CAs
- by Chon, Seung-Hyun Sep 15, 2021 06:11am
- Once again, the suspension of execution for the second negotiation order to retrieve reimbursement that was paid for choline alfoscerate (cholinergic agent) that was filed by pharmaceutical companies was dismissed. In other words, the companies have failed to suspend the execution of both the first and second negotiation order to retrieve reimbursement. According to industry sources on the 14th, the 9th Administrative Branch of the Seoul High Court dismissed the appeal to suspend execution of the order for renegotiations on choline alfoscerate products that was filed by 26 companies including Chong Kun Dang on the 8th. The suit was filed for the second negotiation order that was issued by the government to negotiate the terms for retrieving the reimbursement paid for choline alfoscerate drugs. At the end of last year, the Ministry of Health and Welfare ordered the National Health Insurance Service to make insurance retrieval agreements on choline alfoscerate drugs. The order was to reach agreements with the companies that ‘If the clinical trial fails, the full amount of health insurance prescriptions, from the date the clinical trial design submission was submitted to the MFDS to the date of indication removal, should be returned to the NHIS,.’ After the companies refused to negotiate, the MOHW again ordered renegotiations in June last year. Upon order, two groups consisting of 26 companies including Daewoong Bio and 26 companies including Chong Kun Dang filed for the cancellation and suspension of execution of renegotiations. In July, the suspension of execution filed by Daewoong Bio and others was dismissed, and the suspension of execution of negotiations filed by Chong Kun Dang and others was also dismissed. Chong Kun Dang and others again re-appealed but the case was again dismissed. As a result, all pharmaceutical companies that requested suspension of executions failed to suspend renegotiations for reimbursement retrieval. Prior to the second try, the companies had filed administrative suits and suspension of execution for the first renegotiation order as well. At that time, two groups consisting of 28 companies including Daewoong Bio and 28 companies including Chong Kun Dang separately filed their cases, but both cases were dismissed by the Supreme Court. The suspension of execution filed by Chong Kun Dang, etc. was first dismissed in January, then again dismissed at the appeal hearing in May. Chong Kun Dang and others filed for a reappeal, and but this was again dismissed last month. The suspension of execution filed by Daewoong Bio and others was dismissed at the first and second trial and then dismissed again by the Supreme Court in July without hearing as discontinuance of a trial. Meanwhile, the companies have also reached an agreement with the NHIS to negotiate for the retrieval of reimbursement. Recently, the NHIS had reached an oral agreement for negotiations with companies to retrieve the reimbursement paid for choline alfoscerate drugs. The NHIS and the companies agreed that the companies will back 20% of the health insurance prescriptions amount paid from the date of submission of the clinical trial design to the MFDS to the date of indication removal if the clinical trial on choline alfoscerate drugs fail and its indication is deleted. However, despite reaching such agreements, the companies are continuing with litigations to defer negotiations. The companies have filed all-round lawsuits, including suits for cancellation and suspension of execution to block negotiations, but none were dropped since.
- Company
- Who is the winner of the domestic toxin in the US market?
- by Nho, Byung Chul Sep 14, 2021 05:55am
- As Medy Tox received the rights of the improved botulinum toxin candidate MT10109L from AbbVie on the 8th, competition in the U.S. market for domestic Toxin companies is expected to intensify. The size of the US botulinum toxin market is about 2 trillion won, the largest sales in the world. For Korean companies, the United States is an essential country to expand global sales. Currently, Daewoong's Nabota (Jubo) is the only domestic product that is officially distributed. Hugel also submitted an application for an item license for Letybo 50 and 100 units to the U.S. Food and Drug Administration (FDA) in April this year, making it visible to enter the U.S. market directly through Hugel America. Hugel and Daewoong are entering the U.S. market. On the 8th, Medy Tox rights return and license contract for the neurotoxin candidate MT10109L signed with Allergan was terminated. With the contract signed in 2013, Allergan (AbbVie) will transfer all rights, including clinical data conducted by Allergan, to Medy Tox. Shinhan Financial Investment announced on the 9th that Medy Tox is likely to proceed with its own licensing process, and that it is also possible to sell botulinum toxin products by Medy Tox through Evolution. In fact, Medy Tox is currently the largest shareholder with a 13.7% stake in Evolus. Daewoong said in a statement on the 10th, "The possibility of selling Evolus in a report issued by Shinhan Financial Investment on the 9th is clearly false," adding, "Evolus can never handle competitors other than Nabota under a botulinum toxin exclusive license contract with Daewoong." All of these are disclosed in the disclosure data." In July, USPTO PTAB sided with Galderma, a Swiss pharmaceutical company, in 2019 regarding the long lasting effect of new botulinum toxin formulations patent registered in the U.S. by Medy Tox in 2018. Medy Tox said in a statement at the time, "The results of the first trial on Galderma's patent objection have been released, and we are considering applying for a review to maintain the patent." It has nothing to do with the production or sale of our products developed with the technology, he said. However, in the same month, Revance Therapheutics, a U.S. botulinum toxin company, also raised the issue of Patent No. 9480731, which includes the long lasting effect of new botulinum toxin formulations, to USPTO PTAB. An official from the pharmaceutical industry said, "Repeated lawsuits related to text between domestic companies in the global market, including Korea, can only provide opportunities to competing multinational companies. In particular, this method should be avoided to prevent negative perceptions of Korean healthcare companies in the global market."
- Company
- Pharmaceutical companies lost the impurity valsartan lawsuit
- by Kim, Jin-Gu Sep 14, 2021 05:55am
- The government won a lawsuit filed by the government and the pharmaceutical industry over the cost-responsibility issue of follow-up measures for impurity drugs. On the 9th, the Civil Affairs Division 21 of the Seoul Central District Court sided with the NHIS in a lawsuit filed by Daewon Pharmaceutical and 35 other companies against the NHIS. Pharmaceutical companies participating in the lawsuit must pay each reimbursement claimed by the NHIS unless they appeal separately. In addition, pharmaceutical companies must pay for the litigation. The case originated when the NHIS claimed reimbursement from 69 pharmaceutical companies in October 2019. The total amount of compensation was 2.03 billion won. The plan is to return health insurance finances paid as follow-up measures during the 2018 Valsartan crisis from pharmaceutical companies. The NHIS was working on exchanging impurity drugs prescribed to existing patients with new drugs. Pharmaceutical companies that protested the NHIS measure filed a lawsuit. Pharmaceutical companies claimed that unexpected impurities have become newly recognized with the development of science, and that it is excessive to pay indemnity as they were manufactured in a legitimate process. The lawsuit drew keen attention from the pharmaceutical industry in that impurities were detected in Ranitidine, Metformin, Losartan, and Irbesartan after the Valsartan crisis. This is because the outcome of the lawsuit is likely to determine the responsibility for the impurity crisis in the future.
- Company
- K-mRNA Consortium support group to gain momentum
- by Nho, Byung Chul Sep 13, 2021 05:57am
- The research and development move of the K-mRNA Consortium formed to develop the next-generation COVID-19 vaccine is expected to gain further momentum. The consortium consisting of Hanmi, ST Pharm, GC Pharma and KIMCo announced on the 9th that Dong-A ST, a major pharmaceutical company in the development and production of specialized drugs in Korea, and E-Cell, a company specializing in bio-original materials, participated in the consortium. Since the launch of the consortium in June, the progress of the project has accelerated, and material companies and others seem to be joining as partners. Dong-A ST is one of the representative pharmaceutical R&D companies in the domestic pharmaceutical bio industry, and will actively support the consortium's future application for approval of mRNA vaccines, clinical development, and licensing based on its rich experience and capabilities. E-Cell is Korea's first leading bio-materials, parts, and equipment company that developed disposable bio-processing equipment and consumables such as disposable cell culture devices and disposable mixer bags. At the time of launch, the consortium, which announced that it would expand additional participation from raw and subsidiary materials companies, universities, and research institutes, plans to open the door to companies that can play a role in the rapid implementation of the successful model of the entire cycle. Currently, the consortium is developing the COVID-19 mRNA vaccine candidate STP2104 with the aim of entering phase 1 clinical trial within the year and commercializing it following conditional permission in the first half of next year. The consortium is managing its schedule without a hitch, such as regularly sharing information and consulting with the MFDS every month for rapid clinical implementation. In addition, it is preparing to establish a production system of 100 million doses of mRNA vaccine, which is the national vaccination volume, by the end of 2022. In addition, a separate COVID-19 vaccine is being developed to respond to the delta mutation virus. In this regard, ST Pharm, which is in charge of the consortium's clinical part, is conducting a preclinical efficacy evaluation after selecting an additional mRNA vaccine candidate, STP2130.
- Company
- Pharma companies speed up delivery of urology combo drugs
- by Kim, Jin-Gu Sep 13, 2021 05:56am
- Korean pharmaceutical companies have been rushing to develop combination treatments for various urologic diseases, such as those for prostatic hypertrophy+erectile dysfunction or benign prostatic hyperplasia+overactive bladder. Many patients with urogenital disorders suffer various conditions at once, including enlarged prostate, erectile dysfunction, overactive bladder, etc. The market size for the single-therapy agents that treat each separate condition is considerable. With no other combination therapy than Hanmi’s ‘Gugutams’ authorized in Korea, the industry’s interest in the combo drug market has been rising. Pic of Hanmi Pharm As of the 13th, the only drug approved as a combination therapy for hypertrophy+erectile dysfunction in Korea by the Ministry of Food and Drug Safety is Hanmi Pharmaceutical's ‘Gugutams.’ Gugutams is a combination of the prostate treatment ‘tamsulosin’ and erectile dysfunction treatment ‘tadalafil.’ At the time of its release in 2016, Gugutam’s performance did not meet expectations, due to low awareness of the urogenital disease in general. However, with increased awareness, the product became a steady seller, reaching ₩2.1 billion in sales last year. On this, Dongkook Pharmaceutical and Yuyu Pharma have jumped in to compete in the combination treatment market for benign prostatic hyperplasia+erectile dysfunction that combines tadalafil with ‘dutasteride,’ which is another ingredient used for benign prostatic hyperplasia. No combination treatment has yet been approved for this combination in Korea. Dongkook Pharmaceutical has started Phase III clinical trials on its dutasteride+tadalfil combo, ‘DKF-313,’ earlier this month at the Seoul Asan Medical Center. The company expects the Phase III trials to be complete by the end of next year. Yuyu Pharma is also developing a combination therapy using the same two ingredients. The company received approval for the Phase III trial in 2018, however, before starting the Phase III trial, a need to change the formulation was raised, and the company decided to start over from Phase I. Also, the development of combination treatments for benign prostatic hyperplasia+overactive bladder is actively underway. KyungDong Pharm and Dongkoo Bio&Pharma are competing to develop the combo treatment. In March this year, KyungDong Pharm received approval to start Phase III trials for its ‘KDF1905,’ which combines the benign prostatic treatment tamsulosin with overactive bladder treatment ‘mirabegron.’ Dongkoo Bio&Pharma had also previously received approval for the Phase III trial of its tamsulosin+mirabegron combination in January last year. Ildong Pharmaceutical and Jeil Pharmaceutical had also developed combinations using tamsulosin and another overactive bladder treatment ‘solifenacin.’ The two companies have completed Phase III trials for their combinations. However, Ildong Pharmaceutical decided to discontinue the development of its drug last year. Jeil Pharmaceutical had not applied for the marketing authorization of its drug for over 2 years since the completion of its Phase III trial. Also, CTC Bio’s development of its combination treatment for premature ejaculation+ erectile dysfunction is in its final stages. It is a combination of the premature ejaculation treatment ‘clomipramine’ and the erectile dysfunction treatment sildenafil. The company plans to apply for marketing authorization of its combination drug after completing its Phase III trial within this year.
- Company
- Jardiance marks new milestone in heart failure treatment
- by Whang, byung-woo Sep 13, 2021 05:55am
- With the SGLT-2 inhibitor, Jardiance (empagliflozin), proving its efficacy in heart failure with preserved ejection fraction (HFpEF), on how it will affect the domestic prescription market for heart failure is gaining attention. As another SGLT-2 inhibitor, Forxiga (dapagliflozin), was the first to receive approval for heart failure with reduced ejection fraction (HFrEF) indication, whether Jardiance’s study results could become the solid blow that could overturn the drugs' positions is gaining industry interest. The competition among SGLT-2is that are expanding their indications from their existing diabetes indications to heart failure as well as chronic diseases is also a special point of interest. The full results of the EMPEROR-Preserved clinical trial that demonstrated Jardiance’s effect on heart failure were presented recently at the ESC Congress 2021. The study showed a 21% reduction in the relative risk of cardiovascular death or hospitalization using Jardiance in HFpEF patients with or without diabetes compared to placebo, meeting its composite primary outcome. Also, in the analysis of its major secondary endpoint, Jardiance reduced the relative risk of first and recurrent heart failure hospitalization by 27%, and significantly delayed kidney function decline. On this, Jung-Woo Son, Professor of Cardiology at Wonju Severance Hospital, said, “It is encouraging that a treatment had been able to meet its primary outcome in HFpEF, in the midst of all other trials failing development for the condition. The outcomes with regards to cardiovascular deaths were a little disappointing, but the results showed enough benefit in other areas.” Dong-Ju Choi, President of the Korean Society of Heart Failure who participated as the head coordinator in the trial, stressed that the study reflected Korea’s heart failure treatment environment as 13 Korean medical institutions participated in EMPEROR-Preserved trial. With such strengths, the sentiment in the field is that there is no reason not to prescribe Jardiance after its approval as the clinical benefits are clear. However, how the prescription patterns will change will need to be observed in comparison to Forxiga, which was approved for HFrEF. A cardiology professor from a tertiary hospital in Korea who requested animosity said, “The good performance shown by Forxiga and Jardiance, has even raised discussions on their class effect. Since we have already been using Forxiga for HFrEF, doctors will be preferring Forxiga for the time being, however, there is a possibility that Jardiance will attract attention due to its versatility.” In particular, the professor predicted prescription of Jardiance would increase for patients whose diagnosis between HFrEF and HFpEF is unclear. He said, “There are heart failure patients who belong in the range between HFrEF and HFpEF, and Jardiance will have an advantage in preoccupying this market as it has presented results for both HFrEF and HFpEF. However, I know Forxiga is also conducting studies to cover the relevant areas, so on how the results will be remain to be seen.” As such, the majority of the HCPs in Korea are positive about the performance and expandability of SGLT-2is in heart failure. Therefore, the only barrier is in the drugs' progress in receiving approval and reimbursement. Forxiga is currently approved for HFrEF but is not reimbursed yet. And Jardiance is aiming to gain approval for its HFpEF indication based on its EMPEROR-Reduced trial within this year. Some industry experts have cautiously anticipated that the two drugs may be concurrently approved for reimbursement after Jardiance is approved for its HFpEF indication. Also, Boehringer Ingelheim and Lilly plan to submit the HFpEF results from their clinical trial to regulatory authorities within the year, but considering the domestic situation in which approval for drugs is processed only after FDA approval, it is unclear whether the drug will immediately be approved for prescriptions. Another variable that exists is Entresto. Novartis has applied for approval to expand the drug’s indication to the HFpEF indication.
