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- 2026-05-04 19:44:18
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- K-Bio receives FDA Orphan Drug Designations with novel drugs
- by Son, Hyung-Min Jul 08, 2024 05:45am
- In the first half of the year, Korean biopharmaceutical companies succeeded in obtaining numerous Orphan Drug Designations. Few patients have rare diseases but developing innovative new drugs can create added value and an exclusive position in the market. In the United States, if a drug is designated as an orphan drug, it is provided seven years of the market exclusivity period. Additionally, the company is provided with support for development and reduced taxes. After completing a phase 2 trial, the drug can be conditionally sold. As a result, biopharmaceutical companies in Korea actively seek FDA orphan drug designation. According to industry sources on July 8th, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to novel drug candidates from Boryung, Rzynomics, NeoImmunetech, SPARK Biopharma, SN BioScience, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm and GC Biopharma, and GI Innovation. FDA ODD program grants companies that have developed treatments for fewer than 100,000 patients with rare and incurable diseases incentives such as expedited review, reduced taxes, and market exclusivity. K-Bio pharmaceuticals with FDA-approved Orphan Drug Designations in the first half of the year. (From the top, by month) Novel drug candidates from Boryung (BR-101801), Rzynomics (RZ-001), NeoImmunetech (NT-I7), SPARK Biopharma (SBP-401), SN BioScience (SNB-101), Oscotec (cevidoplenib), Ingenium Therapeutics (Gengleucel), Dr. Noah Biotech (NDC-011), Hanmi Pharm and GC Biopharma (LA-GLA), and GI Innovation (GI-102). Boryung’s BR-101801, a novel drug candidate to treat blood cancer, was the first to receive FDA ODD this year. Boryung is investigating the potential of BR-101801 in various blood cancers, including peripheral T-cell lymphoma and mycosis fungoides. In January, it received the approval for the treatment of angioimmunoblastic T-cell lymphoma. BR101801 is the first-in-class drug candidate to inhibit phosphoinositide 3-kinase (PI3K)γ/ δ and DNA-dependent protein kinase (DNA-PK). It can effectively induce cell death through triple target inhibition and suppress a cancer protein c-Myc. In recently disclosed phase 1b study results, BR101801 was demonstrated as a potential candidate to treat various lymphomas. The clinical studies evaluated the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma (11 patients), T-cell lymphoma (11 patients), diffuse large B-cell lymphoma (2 patients), and marginal zone lymphoma (1 patient). Over a follow-up of 12.9 months (median value), the objective response rate (ORR) in 19 evaluable patients with peripheral T-cell lymphoma and T-cell lymphoma was 31.6%. 4 patients showed complete response (CR), and 2 showed partial response (PR). The progression-free survival (PFS) was confirmed to be 7.5 months, but overall survival (OS) and duration of response (DOR) did not reach median values. For the safety profile, the most common adverse reactions occurred were rashes, an increase in AST/ALT, and coughs. Treatment-associated death did not occur. Boryung plans to apply for a Phase 2 Investigational New Drug (IND) application next year and continue to investigate the efficacy of BR101801. NeoImmuneTech’s NT-I7 received an ODD in the treatment of pancreatic cancer. NT-I7 is a novel drug candidate that targets interleukin (IL)-7, which regulates T-cell development and function. It has been investigated for various indications. Besides the current ODD for pancreatic cancer, NT-I7 received ODDs in the treatment of CD4 lymphocytopenia (2019), multifocal leukoencephalopathy (2020), and glioblastoma (2023). The current ODD in the treatment of pancreatic cancer was based on the Phase 2a results investigating Keytruda combination therapy. The study evaluated the effectiveness and safety of NT-I7 in combination with Keytruda in 50 patients with metastatic colorectal cancer and 48 pancreatic patients who had previously undergone treatments. The clinical results indicated that 3 out of 48 patients with pancreatic cancer have shown partial response (PR). The median overall survival time (OS) was 11.1 months. Additionally, NeoImmuneTech plans to investigate the potential of NT-I7 in combination with cancer vaccines. A Fabry disease treatment, ‘LA-GLA,’ which is under joint development by Hanmi Pharm and GC Biopharma, successfully received an ODD in the United States. LA-GLA is formulated for once-per-month subcutaneous administration. Fabry disease is a type of lysosomal storage disorder (LSD) resulting from a deficiency in a particular enzyme due to a genetic cause, leading to metabolic alterations. Last month, Hanmi Pharm disclosed results demonstrating that LA-GLA inhibits cell death in podocytes, which is important for kidney function in Fabry disease patients. Also, LA-GLA has significantly improved the peripheral sensory functions and histopathological features of nerve cells. Last month, GI Innovation’s GI-102, a candidate immunotherapy for cancer, received FDA ODD. The company is developing GI-102, which acts on CD80 and interleukin (IL)-2. IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells. According to the clinical results disclosed at the American Society of Clinical Oncology (ASCO 2024) annual meeting, held in Chicago, U.S., response rates of GI-102 have been confirmed in various diseases, such as melanoma and non-small cell lung cancer (NSCLC). An ORR of 17.4% was observed in 23 patients (7 skin melanoma patients, 4 NSCLC patients, and 3 ovarian cancer patients). The reported overall ORR was 42.9%, and the disease control rate (DCR) was 85.7%, including three cases of partial response (cPR) confirmed in patients with metastatic skin melanoma who had previously experienced ICB. GI Innovation aims to obtain conditional approval for its GI-102 and is assessing the potential for technology transport. They are also examining the potential of using GI-102 in combination with NK cell therapy, as well as GI-102 monotherapy.
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- Roche Korea starts reimb process for Columvi in Korea
- by Eo, Yun-Ho Jul 08, 2024 05:45am
- The reimbursement listing process for ‘Columvi,' the first bispecific antibody treatment option for lymphoma, will begin in Korea. According to Dailypharm coverage, Roche Korea's CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) is expected to be presented to the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee meeting on the 10th. Columvi was approved in Korea last December for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. The drug is a third-line treatment option for DLBCL, like Novartis’s chimeric antigen receptor (CAR)-T-cell therapy Kymriah (tisagenlecleucel). The two drugs have different benefits; therefore the choice will likely be based on each patient's condition and circumstance. Columvi demonstrated efficacy in the Phase I/II NP30179 trial in 155 patients with relapsed or refractory DLBCL after two or more prior systemic therapies. Results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate(ORR) of 81%. The efficacy was also consistent across all subgroups. The most common adverse event was cytokine release syndrome (CRS). Adding to the encouraging data, at the 2024 Congress of the European Hematology Association (EHA 2024), the company unveiled the results of the Phase III STARGLO study, which demonstrated an improvement in overall survival (OS) with Columvi. The STARGLO study enrolled patients with relapsed or refractory (R/R) diffuse DLBCL who were not eligible to receive an autologous stem cell transplant after one or more prior systemic therapies, or who had received two or more prior systemic therapies. In the primary analysis (median follow-up 11.3 months), Columvi and gemcitabine+oxaliplatin (GemOx) combination significantly improved the primary endpoint of OS with a 41% lower risk of death compared to rituximab+GemOx. Seok Jin Kim, Professor of Hematology and Oncology at Samsung Medical Center, said, "There had been much unmet need in DLBCL for more effective third-line treatment options for patients who fail first-line or experience repeated relapses. We expect the introduction of Columvi to significantly improve the outcomes for patients with relapsed or refractory lymphoma in Korea."
- Company
- "Allowing switching between atopic dermatitis treatments"
- by Hwang, Byung-woo Jul 05, 2024 05:49am
- More options became available with the approval of biologics and JAK inhibitors to treat atopic dermatitis. However, limitations in switching treatments have been indicated to make effective treatments difficult. Opinions have been suggested that the Korean government must follow the global trend as foreign countries do not limit switching between biologics and JAK inhibitors for treating moderate-to-severe atopic dermatitis. Han Tae-young, Professor of Nowon Eulji Medical Center (Insurance Director at the Korean Atopic Dermatitis Association)During a press conference hosted by Abbvie, titled 'Press conference for the latest Rinvoq value for atopic dermatitis,' on July 3rd, Professor Han Tae-young of Nowon Eulji Medical Center (Insurance Director at the Korean Atopic Dermatitis Association), emphasized the need for switching between treatments. Switching treatments has become a persistent issue in clinical practice for atopic dermatitis due to increasing treatment options and a growing number of patients. Concerns have been raised about fairness in comparison to psoriasis, another area in dermatology where switching treatments is more possible. "Few countries among major nations limit reimbursement for switching therapies. In South Korea, reimbursement is not available for switching between biologics and JAK inhibitors, posing challenges for effective treatment.," Han stated. Typically, the efficacy of atopic dermatitis treatments is assessed based on the Eczema Area and Severity Index (EASI)-75 achievement rate. Currently approved treatments show varying efficacy levels: some achieve up to 80% efficacy by the 52-week mark, while others demonstrate 60% or lower efficacy, indicating variability depending on the patient. "Various treatments are available for atopic dermatitis, but in cases where there is no response, some patients may not experience any benefit," Han said. "Atopic dermatitis is a condition with heterogeneous characteristics that requires finding the proper treatment for each patient. However, this process can be hindered if switching treatments is not allowed." Presented by Professor Han Tae-young at the press conference on July 3rd.Until now, the Health Insurance Review and Assessment Service (HIRA) and the Korean Atopic Dermatitis Association have discussed switching between treatments. However, no progress has been made due to a lack of evidence. Recently, revising guidelines in domestic and major countries indicates a positive change. They have mentioned the latest guidelines from major countries such as the United States and Europe for switching treatments, thereby increasing the possibility of switching treatments. The 2024 guidelines updated by the American Academy of Dermatology, notably the first update in a decade since 2014, strongly recommend biologics and JAK inhibitors for the treatment of moderate-to-severe atopic dermatitis. They also include recommendations for switching therapies if initial treatments fail. "It is recommended that switching to other biologics or JAK inhibitors be considered in cases of inadequate treatment response or when the treatment cannot be used due to side effects," Han mentioned. When switching between treatments for atopic dermatitis was initially discussed, there was insufficient evidence based on guidelines. However, there are increasing expectations as switching between treatments is mentioned. Han explains that the HIRA increasingly anticipates supplementary data from the Korean Atopic Dermatitis Association regarding switching between treatments as the situation evolves. "To establish evidence, the association plans to gather patient data showing favorable treatment outcomes through switching therapies, even in cases where they are not covered by insurance," Han said. "They intend to present this data to support their initiative. However, predicting an exact timeframe is challenging, considering the detailed information requested by the HIRA."
- Company
- HLB ‘FDA meeting complete...no supplement data required'
- by Son, Hyung-Min Jul 05, 2024 05:48am
- HLB announced on the 2nd that it had completed the meeting with the U.S. Food and Drug Administration (FDA) to resume the license review of its new liver cancer drug. At the meeting, which was attended by HLB's US subsidiary Eleva and Chinese partner Jiangsu Hengrui Pharmaceuticals, the FDA said it "strongly recommends submitting a re-examination application" to expedite the main review, which was delayed due to the issuance of the complete response letter (CRL), and delivered an official Post Action Letter (PAL) along its position. HLB is interpreting the letter as meaning that "no additional supplementary information will be requested as Jiangsu Hengrui Pharmaceuticals has already faithfully submitted supplementary data regarding the points raised after the CMC on-site inspection visit in December for camrelizumab, which is used in combination with rivoceranib, a new drug for liver cancer." In May, HLB announced that it had received a CRL from the FDA regarding the application submitted requesting the approval of the combination therapy rivoceranib and Jiangsu Hengrui Pharmaceuticals’ immune-oncology drug camrelizumab as a first-line treatment for liver cancer. The primary reason for the CRL was reportedly due to a BIMO (Bioresearch Monitoring) finding, which identified the manufacturing facility and key clinical sites for camrelizumab. At the time, the company explained that the CRL was due to a facility issue. Regarding BIMO on-site inspection, the FDA said that "the BIMO was not the primary reason for issuing the CRL. The BIMO will be conducted during the re-examination period upon submission of the documentation." Now that the uncertainty surrounding the liver cancer drug has been removed, HLB plans to focus on completing the remaining steps for its global approval. Yong-Hae Han, CTO of HLB, said, “We were assured by Jiangsu Hengrui Pharmaceuticals that they have already submitted sufficient supplementary documents to address the FDA's points, so we plan to fully prepare and submit our request for re-examination as soon as possible. Although our plan was somewhat delayed than scheduled, it was an opportunity for us to conduct a complete inspection of the production plant to enhance the external credibility of our product quality, and were able to officially reflect the superior data of our new liver cancer drug to the application. We expected these changes to have a positive effect in the future."
- Company
- New strength Uptravi may be prescribed at general hospitals
- by Eo, Yun-Ho Jul 05, 2024 05:48am
- A new dosage strength of the pulmonary arterial hypertension treatment Uptravi may now be prescribed at general hospitals in Korea. According to industry sources, the 600㎛ dose of Janssen Korea’s Uptravi (selexipag) passed d the drug committees (DCs) of tertiary hospitals such as the Seoul National University Hospital, Sinchon Severance Hospital, and other medical institutions including the Pusan National University Hospital, and Hanyang University Hospital. Originally, Uptravi was approved in 3 doses - 200, 400, and 800 μm - but doctors prescribing 600 μm, had prescribed the 200μ and 400 μm doses together. Therefore, the addition of the 600 μm dose has been positively received for improving compliance. Uptravi is the first non-prostanoid prostacyclin selective IP receptor agonist for pulmonary arterial hypertension in Korea. It has high selectivity to the IP receptors involved in vasodilatory function. In particular, it is the only pulmonary arterial hypertension treatment in Korea that was approved for reimbursement even as a sequential three-drug combination therapy. Patients with pulmonary arterial hypertension who were previously using endothelin receptor antagonists and phosphodiesterase-5 inhibitors but did not see adequate treatment effect are allowed reimbursed use of Uptravi. It also owns competitivity in that it is an oral, twice-daily treatment that can be taken orally and allows for individualized maintenance dosing in patients with pulmonary arterial hypertension. Uptravi is also the first oral prostacyclin class pulmonary arterial hypertension treatment to demonstrate a reduction in mortality and morbidity in a clinical trial (GRIPHON). In a total of 1,156 patients with pulmonary arterial hypertension, the relative risk of death or morbidity was reduced by 40% in the Uptravi combination arm compared to placebo In addition, the Uptravi combination therapy was associated with a reduced risk of death and morbidity in patients previously taking endothelin receptor antagonists and phosphodiesterase-5 inhibitors for pulmonary arterial hypertension. Pulmonary arterial hypertension is a rare condition characterized by increased resistance in the blood vessels in the lungs, which can be fatal in severe cases. A 2003 study reported a median survival period of 2-3 years after diagnosis. Symptoms of pulmonary arterial hypertension include shortness of breath, fainting, chest pain, and edema, and the condition may significantly reduce exercise capacity.
- Company
- Celltrion seeks to expand influence in EUR with Remsima SC
- by Hwang, Byung-woo Jul 05, 2024 05:48am
- Celltrion is expanding to expand the drug’s market share with the addition of Remsima SC’s dosing regimens that followed the EMA’s recommendation for the drug’s marketing authorization. The autoimmune disease treatment Remsima SC recently received final approval from the European Commission (EC) for the 'allowance of additional dosing regimens and dose escalation.’ Remsima SC is the world's first subcutaneous (SC) formulation of infliximab (Remicade), an autoimmune disease treatment that was previously available only as an intravenous (IV) formulation. The approval comes about a month after the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on Remsima’s labeling change application. Remsima SC is a subcutaneous injection formulation that offers improved convenience in administration. It has been gaining presence in the market, with sales exceeding KRW 300 billion last year. In the U.S., the drug has been recognized for its differentiated benefit, signing agreements with PMS including large companies, since its launch in March. According to the market research institution IQVIA, Remsima SC had a 21% market share in the 5 major European Union markets (EU5) as of Q4 last year. The Remsima family, which includes Remsima and Remsima SC, had a 74% share in the EU5. Celltrion believes that the additional dosing regimen and dose escalation approvals in Europe, where it previously launched Remsima SC, will allow the company to expand its market share. Also, the company expects the added approvals will help provide patients with more optimized and personalized treatment. The recent approval is based on global clinical trials on Crohn's disease (CD) and ulcerative colitis (UC) and adds two new treatment options. First, in terms of the dosing regimen, 3 IV doses can be added to the initial IV regimen in CD and UC patients, with Remsima SC administered from week 10. In terms of dosing escalation, the new approval allows for as-needed escalation of Remsima SC as maintenance therapy in patients with CD, allowing patients who experience a decrease in efficacy after receiving 120 mg of REmsima SC to be dosed up to 240 mg. This is expected to improve access for patients who have been unable to obtain payment coverage because the use of the increased dose had not been reflected in the label. A Celltrion official said, "The expanded approval for the dosing regimen and dose escalation will increase patient-specific prescriptions and further strengthen the competitivity of Remsima SC, which will lead to increased market share. We can now offer patients in Europe the opportunity to choose from more flexible options and allow more convenient self-administration."
- Company
- Will the shingles market shift affect NIP?
- by Hwang, Byung-woo Jul 04, 2024 05:52am
- The withdrawal of Zostavax from the shingles market is complicating the calculation of the National Immunization Program. In the government's 'National Immunization Program Priorities' study, there had been a large gap between the priorities of live and recombinant shingles vaccines, but with the number of live shingles vaccine options being reduced to one, the need for more options has increased considerations. Pic of Zostavax, SKYZoster, ShingrixIn late May, MSD Korea reported to the MFDS the discontinuation of its shingles vaccine, Zostavax. The final stock-out date is difficult to predict, but the discontinuation will bring to an end a nearly 15-year run of the drug since its approval in April 2009. Upon the withdrawal of Zostavax, the remaining options in Korea will be GSK's Shingrix and SK Bioscience's SKYZoster. The two vaccines have distinct characteristics. SKYZoster is a live attenuated vaccine, which means it is easier to access due to the lower costs required for its vaccination than its competitors. On the other hand, Shingrix is an inactivated vaccine that can be administered to immunocompromised and immunosuppressed patients who have previously been unable to receive live attenuated shingles vaccines. However, the high price and the two-dose regimen are considered hurdles. The shingles vaccine is one of the most common non-reimbursed vaccines, and with the withdrawal of Zostavax, its use is usually left to market choice. However, the issue arose with its planned introduction to the NIP. In the government's mid-to-long-term plan for NIP, the shingles vaccine was divided into live vaccines (SKYZoster, Zostavax) and recombinant vaccines (Shingrix). Live vaccines ranked 5th vs. recombinant vaccines ranked 15th among all vaccine priorities To summarize, the live vaccine was ranked 5th out of 15 vaccines, while the recombinant vaccine was ranked 15th and last. Although both were for shingles, they were prioritized differently. In a literature review of the effectiveness of live and recombinant shingles vaccines, live vaccines were found to be effective in 9 studies compared with a control group, but their effect decreased over time. In the case of recombinant vaccines, a total of 9 studies reported their significant vaccine effect, with 2 studies reporting a significant effect when assessed 7 years after vaccination. Despite the longer duration of effect seen with the recombinant vaccines, live vaccines are higher up on the priority list because of their cost-effectiveness. A cost-effectiveness study on implementing a live shingles vaccine for adults aged 60 years and older in the NIP found that its implementation was not a cost-effective strategy in the short term, but was cost-effective in the long term. Compared to the current self-vaccination practice, its introduction to NIP was analyzed as a cost-saving strategy from a societal perspective. Also, the ICER tended to decrease with age, when assessed in 60 to 75-year-old subjects. Another study found that the cost-effectiveness of the vaccine would be maintained at KRW 85,000 and that the cost-effectiveness would decrease if the cost of the vaccination increased above KRW 95,000. However, recombinant vaccines are expected to have greater uncertainty in terms of cost-effectiveness compared to introducing a live vaccine, although information on the exact pricing of recombinant vaccines was limited before the launch of Shingrix late last year. In the actual study, the annual estimated cost of the shingles vaccination support program for people aged 70 and older was about KRW 28.2 billion for a single dose of the live shingles vaccine and KRW 98.3 billion for two doses of the recombinant vaccine, which is a threefold difference. Fewer options remain for shingles vaccine...attention focused on the expanded influence of Shingrix Given the effectiveness and cost of the vaccine, the researchers concluded that introducing a live shingles vaccine in the NIP was practical. The problem is that at the time of the study, there were two live vaccine options, but with the withdrawal of Zostavax, there only remains 1 live vaccine option in the market. It would be difficult for SKYZoster to enter the NIP alone given the multiple aspects that require consideration, including price competition. In particular, it is more inefficient to supply both live and recombinant shingles vaccines at the same time than to introduce live and recombinant shingles vaccines separately for people over 70 years of age. In addition, the growing presence of Shingrix since its launch may rise as an issue for the government in the future. Last year, Shingrix’s sales reached KRW 38.4 billion (IQVIA) and rose to No.1 in the country. In the same period, rival vaccines SKYZoster sold KRW 26.2 billion and Zostavax sold KRW 22.3 billion. At the time of its launch, the vaccine was criticized for its high cost, as it costs up to KRW 600,000 for two doses, but it has been gaining share in general hospitals based on its strength as a quadrivalent vaccine that can be administered to immunocompromised individuals and its high prevention rate of over 90%. As a result, it is hard to ignore Shingrix in the shingles NIP discussion amid the vaccine’s rising market share based on cost-effectiveness alone. However, it remains to be seen whether the pharmaceutical company will be able to accept the cost of vaccination set by the government. Currently, it is not possible to confirm the cost of Shingrix vaccination from HIRA’s non-reimbursed medical expenses information, but it is observed that its cost per single dose is in the low KRW 200,000 range on site. An industry official said, "With the withdrawal of Zostavax, there are many considerations that need to be made in the discussion of introducing shingles vaccines in the NIP, including vaccine type and price. As price is important for NIP in addition to effectiveness, how these points are coordinated in the future will be an important factor in the entry of NIP."
- Company
- MBK Partners to acquire Japan pharma for KRW 3 trillion
- by Kim, Jin-Gu Jul 04, 2024 05:52am
- MBK Partners, the largest private equity firm in South Korea, will acquire Japanese company Alinamin Pharmaceutical for JPY 350 billion (around KRW 3.75 trillion). MBK Partners has been actively pursuing M&A in the biopharmaceutical and healthcare sectors in South Korea and overseas. Within the past year and a half, the company acquired Medit, Osstem Implant, and Geo-Young. The value of these M&As amounted to KRW 11 trillion. According to foreign press on July 3rd, MBK Partners agreed to acquire Japanese company Alinamin Pharmaceutical from Blackstone for JPY 350 billion on the same day. Alinamin Pharmaceutical was previously a business unit of Takeda Pharmaceutical. In 2021, Takdea Pharmaceutical established Takeda Consumer Healthcare Company Limited and sold the company to Blackstone. The acquisition amount was said to be JPY 240 billion (around KRW 2.06 trillion). The pharmaceutical industry is drawing attention to MBK Partners’ recent activities. Since the end of 2022, the company has succeeded in blockbuster M&As in the biopharmaceutical and healthcare sectors. In December 2022, MBK Partners announced the acquisition of Medit, a provider of intra-oral scanner, for KRW 2.425 trillion. The acquisition was completed in March last year. In January last year, MBK Partners and UCK consortium acquired the dental implant company Osstem Implant for KRW 2.6 trillion. The two companies established a special purpose company (SPC) named Dentistry Investment Co and acquired 96% of Osstem Implant’s shares. MBK Partners also acquired Japan’s elderly care business Unimat and Hitowa Holdings. Unimat was acquired for US$300 million (about KRW 370 billion), and Hitowa Holding was acquired for JPY 90 billion. In April, the company sought to acquire South Korea’s largest pharmaceutical distributor, Geo-Yeong. MBK Partners signed a Stock Purchase Agreement (SPA) with Blackstone to acquire Geo-Young. The agreement stated that MBK Partners would acquire a 71.25% stake in Geo-Young’s holding company, Cho Sunhae GY Holdings Co., for KRW 2 trillion. With the acquisition of Alinamin Pharmaceutical, MBK Partners has completed six biopharmaceutical and healthcare sector M&As in South Korea and Japan in the past year and a half. The company invested over KRW 11 trillion.
- Company
- Camzyos’s reimbursement in KOR will be redeliberated today
- by Eo, Yun-Ho Jul 04, 2024 05:52am
- Reimbursement deliberations for Camzyos, a new drug for obstructive hypertrophic cardiomyopathy (oHCM) that had received a redeliberation decision in the past, will again commence today. According to industry sources, BMS Korea's obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten) will be presented to the latest Drug Reimbursement Evaluation Committee of the National Health Insurance Review and Assessment Service on the 4th. Therefore, whether Camzyos will be deemed adequate for reimbursement and move on to the drug price negotiation stage with the National Health Insurance Service remains to be seen. After passing the Economic Evaluation Subcommittee, Camzyos was sent to DREC faster than expected but received a pending decision at the DREC meeting. Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM. It improves left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin, relaxing the overcontracted heart muscle. Due to the lack of a cure, oHC has long been managed with off-label drug use. In fact, the European Society of Cardiology (ESC) revised its HCM guidelines for the first time in 9 years with the introduction of Camzyos. Before then, HCM guidelines have been based on small observational data reported from individual institutions, retrospective analyses, or expert consensus opinions. Therefore, Camzyos was a game-changer in the field. After demonstrating its significant effect in two large-scale Phase III randomized controlled trials (RCTs), Camzyos was recommended at the highest evidence level, A, for the first time among treatment options in the ESC guidelines. The American College of Cardiology (ACC) and American Heart Association (AHA) are also currently preparing to update their guidelines. Based on the Phase III trial data, Camzyos received a breakthrough therapy designation (BTD) and was approved by the US FDA. Based on these factors, Camzyos appears to meet the criteria for an innovative new drug announced by the government last year, where: ▲ there is no substitute or therapeutically equivalent product or treatment; ▲ has shown clinically meaningful improvement, such as a significant prolongation of survival period; ▲has received the Ministry of Food and Drug Safety’s GIFT (Global Innovative products on Fast Track) designation, US FDA’s Breakthrough Therapy Designation (BTD), and was approved through the European EMA’s Priority Medicines scheme (PRIME). The drug’s efficacy was confirmed through the EXPLORER-HCM trial. In the trial, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than 2 times compared with placebo. In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement. Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos. 7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks.
- Company
- Avastin biosimilars occupy over 40% of Avastin mkt
- by Chon, Seung-Hyun Jul 03, 2024 05:51am
- Homegrown biosimilars are rapidly expanding their influence in the KRW 100 billion-a-year Avastin market. Biosimilars’ sales have increased to exceed 40% in less than 2 years. Samsung Bioepis' Onbevzi led the growth with sales close to the original drug. According to the market research firm IQVIA, the market size of bevacizumab anticancer drugs in Q1 this year reached KRW 32.7 billion, up 10.8% year-on-year. Compared to the KRW 21.1 billion in Q1 2022, the market has expanded 54.8% in 2 years. The original bevacizumab drug is Roche’s Avastin. It is an anti-cancer drug used for metastatic colorectal and metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. Samsung Bioepis' biosimilar has been the main driver of the recent market expansion for bevacizumab. Samsung Bioepis launched its biosimilar Onbevzi in September 2021, and Celltrion and Alvogen Korea have also entered the Avastin market thereafter. In the first quarter, Onbevzi’s sales increased 33.1% year-on-year to KRW 13.1 billion. This is more than 7 times the sales in two years from KRW 1.8 billion in Q1 2022. Onbevzi showed strong growth immediately after its launch and surpassed KRW 10 billion in sales in Q2 last year. It has recorded sales in the KRW 10 billion range for 4 consecutive quarters through Q1 this year. This is the first time that a domestically developed biosimilar product has exceeded KRW 10 billion in quarterly sales. Celltrion's Remsima posted sales of KRW 9.1 billion in Q1. Celltrion's Vegzelma, however, posted sales of less than KRW 100 million in Q1, unable to show prominence in the market. The analysis is that the fact that Onbevzi was the first biosimilar product to enter the market, along with its customized sales force, maximized the synergies. Samsung Bioepis signed an exclusive distribution agreement with Boryung shortly after Onbevzi’s approval in Korea. Boryung is a Korean company that has strengths in anti-cancer drug sales. In May 2020, Boryung established a new ONCO (oncology) division. The organization that was under the specialty pharmaceuticals division was made independent as a separate division. It secured the rights to various anti-cancer drugs and biosimilars from domestic and foreign companies and acquired Gemzar and Alimta through its Legacy Brands Acquisition (LBA) strategy, which involves buying the rights to original anti-cancer drugs. Boryung also secured the domestic rights to Samsung Bioepis' Avastin and Herceptin biosimilars in 2021. Samsung Bioepis' Samfenet reported first-quarter sales of KRW 1.9 billion, up 79.3% from 2 years ago. Onbevzi’s sales accounted for 40.0% of the Avastin market. This is the first time that a single domestically developed biosimilar product has exceeded 40% share in the anti-cancer drug market. The gap between Onbevzi and Avastin (KRW 18.8 billion) sales was only KRW 5.8 billion. As of Q1, the market share of the 2 domestically developed biosimilars, Onbevzi and Vegzelma, was 40.3% in the Avastin market. Sales of the original Avastin remained unchanged. Avastin’s sales in Q1 were KRW 18.8 billion, down 3.0% YoY. Avastin has maintained quarterly sales in the range of KRW 18 billion to KRW 19 billion range since Q1 2022 when it reported sales of KRW 19.3 billion. Avastin's growth was stable from Q1 to Q3 2021, with sales of KRW 28.7 billion, KRW 30.2 billion, and KRW 30.8 billion, but in Q4 2021, Avastin's sales fell 28.6% from the previous quarter to KRW 22 billion. The sales gap was caused by lower drug prices due to the emergence of biosimilars. The price of Avastin 0.1g/4mL was lowered by 30% from KRW 338,387 to KRW 231,271 in October 2021 due to Onbevzi’s listing. The price of Avastin 0.4 g/16 mL was lowered by 30% from KRW 1,073,531 to KRW 752,746. In principle, when a biosimilar is listed in the domestic drug pricing system, the upper price limit (insurance price ceiling) for the original drug is lowered by 30% compared to before patent expiry. Price of 'Items developed in partnership with innovative pharmaceutical companies, companies of the same status, and a subsidiary of multination companies, or items first approved in Korea, or items produced in Korea' are granted up to 80% of the original product’s price before patent expiry for both original drug and its biosimilars. However, as Samsung Bioepis is not a certified innovative pharmaceutical company, Avastin's drug price has been reduced to 70% of the original price. Although Avastin experienced a reduction in sales due to the price reduction, it has since generated similar sales in terms of volume, minimizing the additional sales gap due to the entry of its biosimilars. Given how Avastin did not experience a significant sales decline after the price reduction, Onbevzi effectively created a new market that generated over KRW 10 billion in quarterly sales. As a result, Onbevzi’s market entry reduced the price of the original drug by 30% and resulted in significant savings for insurance finances and patients.
