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- 2026-03-14 16:18:04
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- Sales of 26-year-old Gemzar·Zyprexa show rebound
- by Kim, Jin-Gu Feb 27, 2023 05:57am
- The anticancer drug ‘Gemzar‘ and schizophrenia drug ‘Zyprexa' Boryung Pharmaceutical had acquired domestic sales and licensing lights of have enjoyed a rebound in sales. Sales of both drugs had been on a downfall prior to Boryung’s acquisition. Therefore, the analysis is that Boryung’s active portfolio expansion strategy and license acquisition activities have been effective. ◆Gemzar’s sales rise 33% after Boryung’s acquisition...plays a central role in Boryung’s oncology business According to the pharmaceutical market research institution IQVIA on the 25th, Gemzar raised KRW 19.1 billion in sales last year. Gemzar is a first-generation cytotoxic agent that contains gemcitabine. It was released in 1997. Gemzar’s sales have been on a decline until 2020. Its sales, which had reached KRW 14.5 billion in 2018, had fallen to KRW 14.3 billion by 2020. However, sales started rising in earnest starting in 2021. This is an unprecedentedly rare case for a drug that has been on the market for over 25 years. Gemzar’s sales are analyzed to have made a solid rebound after Boryung’s acquisition of its domestic rights in Korea. The company newly established the ONCO (Oncology) division in May 2020. At the time, the company had acquired rights to Gemzar in Korea from Eli Lilly. Quarterly sales of Gemzar (Unit: KRW 100 mil, Source: IQVIA) Building on Gemzar, the company’s oncology business has made rapid growth. Gemzar’s rising sales are analyzed to have driven sales growth of Boryung’s existing oncology drugs, including Campto, Oxalitin, Ditaxel1. In fact, sales of the three drugs had risen 2-9% last year. In the process, Boryung’s oncology business arose as the company's new growth engine. In Q4 last year, Boryung’s oncology business raised sales of KRW 46.4 billion and exceeded the KRW 45 billion made by the company’s existing key hypertension and hyperlipidemia treatment business during the same period. ◆ Zyprexa’s sales show signs of rebound...”Aims to record KRW 50 billion in CNS sales by 2025” Zyprexa’s sales are also showing signs of a rebound since Boryung’s acquisition. Last year, Zyprexa’s sales increased 2% from KRW 14.1 billion in 2021 to KRW 14.4 billion. Zyprexa, the olanzapine-containing schizophrenia treatment market had been released in 1997. Like Gemza, Zyprexa’s sales also was on a continuous decline until Boryung’s acquisition. Its sales, which had been KRW 16.8 billion in 2018, had declined to KRW 14.1 billion in 2021. Quarterly sales of Zyprexa (Unit: KRW 100 mil, Source: IQVIA) However, its sales first made a rebound last year. Boryung acquired all sales and licensing rights for Zyprexa in Korea from Lilly in October last year. Afterward, its quarterly sales had first declined to KRW 3.3 billion in Q2 last year, then made a rebound to and raised to KRW 3.9 billion by Q4. KRW 3.9 billion is the most quarterly sales the product has made since 2019 Q4. With the acquisition, the company announced plans to reinforce its CNS (central nervous system) treatment portfolio around Zyprexa. The company’s goal is to raise its CNS sales to ₩50 billion by 2025. ◆Will the company succeed in raising sales of Alimta as it had for Gemzar and Zyprexa?... Interest rises on whether the company will acquire additional sales rights Currently, the industry's attention is focused on another product Boryung acquired in October last year, Alimta. Boryung acquired the domestic rights for Alimta from Eli Lilly in October last year for KRW 100 billion (USD 70 million). Three products Boryung acquired domestic rights for. (from the left) Alimta, Gemzar, Zyprexa Alimta is a treatment for non-small-cell lung cancer that was approved in 2005. It is used as a chemotherapy for non-squamous NSCLC, and also used in combination with Keytruda. It had raised sales of KRW 21 billion last year. If the company succeeds in raising sales of Alimta as it had for Gemzar and Zyprexa, the company’s Legacy Brands Acquisition (LBA) strategy is expected to gain momentum. LBA is the strategy of acquiring original drugs after patent expiry. Boryung announced it plans to additionally introduce a product in Oncology and one other area this year, and another product in CNS by next year. The industry has been predicting that the company’s plans may be to introduce products through the acquisition of domestic rights through LBA.
- Company
- Will Luxturna will be deliberated by DREC for reimb?
- by Eo, Yun-Ho Feb 27, 2023 05:56am
- Industry attention is focused on whether progress will be made in discussions for the reimbursement of the one-shot retinal dystrophy treatment Luxturna. It was found that it is highly likely that Novartis Korea’s Inherited Retinal Dystrophy (IRD) treatment Luxturna (voretigene neparvovec) will be presented as an agenda for deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee next month (March). Although the company applied for reimbursement of the drug in September 2021, no progress had been made on its listing since then. Being a high-priced one-shot treatment for a non-life-threatening condition, these factors have acted as a barrier to the reimbursement listing until now. By replacing the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene, Luxturna restores the visual function of an IRD patient with a single administration. In other words, the drug provides a fundamental cure for IRD. Therefore, the passage depends on how well the company conveys the value of Luxturna in preventing blindness to the authorities. In the U.S., the drug was granted a Breakthrough Therapy Designation by the FDA in 2014, the drug was approved as an orphan drug in 2016, then granted priority review and a fast-track designation in 2017. IRD is a rare intractable disease in which vision loss occurs due to mutations in genes responsible for the structure and function of retinal photoreceptors. In addition to over 20 ophthalmologic diseases, there are currently over 300 genes that have been identified as being associated with IRD. IRD, which is caused by the mutation in the RPE65 gene, causes abnormalities in the visual cycle of the retina that converts visual information into a neural signal and delivers it to the brain. The mutation in the RPE65 gene reduces the RPE65 protein essential to the visual cycle and destroys the retinal cell, gradually narrowing the field of vision to eventually result in blindness. Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, which was 1.6 points higher than the 0.2 points in the control group.
- Company
- US approval of Celltrion Yuflyma was delayed
- by Feb 24, 2023 05:53am
- Celltrion has confirmed that the U.S. Food and Drug Administration (FDA) will complete the Yuflyma final approval review by May of this year. Celltrion announced on the 23rd that it had confirmed that the final approval review of Yuflyma would be completed by May of this year while continuing discussions with the FDA. Earlier, the U.S. approval process for Yuflyma was somewhat delayed as foreign finished drug manufacturers in charge of finished product production received criticism from the FDA. Celltrion emphasized that the delay in FDA approval of Yuflyma was due to the situation of overseas finished manufacturing plants that had nothing to do with Celltrion's own technology. Overseas finished drug manufacturing plants received an appropriate grade by resolving the issues pointed out after FDA inspections. The conformity level is a level given when a manufacturer voluntarily requests corrective action when unreasonable matters are found but the violation is not serious. Celltrion Group will be able to sell Uplyma in the US from July 1 after reaching a patent agreement with a company that owns Yuflyma's original drug. Apart from FDA approval, we are working on a pre-work to introduce the product to the US market in time for the launch. Celltrion Healthcare acquired Celltrion USA in August last year for direct sales in the United States, securing a license and distribution network for pharmaceuticals in the United States. It has completed securing local experts to lead the US business by recruiting Thomas Nusbickel, who has extensive experience in biosimilar commercialization at global pharmaceutical companies, as CCO of the US corporation.
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- Shingrix may be prescribed in 93 general hospitals in Korea
- by Eo, Yun-Ho Feb 24, 2023 05:52am
- The shingles vaccine ‘Shingrix’ has quickly landed in medical institutions in Korea after starting vaccinations. According to industry sources, GSK Korea’s recombinant vaccine Shingrix passed review by drug committees of 93 medical institutions in Korea, including tertiary hospitals - Samsung Medical Center, Seoul National University Hospital, Asan Medical Center - as well as general hospitals - Kangbuk Samsung Medical Center, Kyung Hee University Medical Center, Korea University Hospital (Buro, Anam, Ansan), Soonchunhyang University Hospital Seoul, Ajou University Hospital, and Hanyang University Hospital. Considering how vaccination had started in December in earnest, the vaccine has settled quickly in the market. Shingrix is the first shingles vaccine approved in Korea that combined a non-live antigen with GSK's vaccine adjuvant. It offers protection from shingles in adults over 50 who are at increased risk of shingles from age-related decline in immunity. In two Phase III clinical trials (ZOE-50, ZOE-70) that were conducted on 15,411 adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group and over 90% efficacy in those aged 70 years and above. The rate of serious adverse events was similar in the Shingrix arm and the placebo arm. The interim analysis of the ZOSTER-049 (ZOE-LTFU) extension study that was conducted to follow up ZOE-50 and ZOE-70 showed that Shingrix’s shingles prevention effect continued for at least 10 years after vaccination. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or have solid cancer, blood cancer, or received solid organ transplants that have an increased risk of shingles are also eligible to receive vaccination with Shingrix. Kyung Young Yoon, Professor of Infectious Disease at Korea University Anam Hospital, said, “Complications from shingles greatly reduce patients' quality of life. Therefore, it is important to prevent this in advance. As the first and only non-live recombinant vaccine approved in Korea that demonstrated a prevention effect and safety profile through global clinical trials, I believe Shingrix will open a new paradigm in shingles prevention in Korea.” Meanwhile, GC Biopharma and Kwangdong Pharmaceutical signed a co-promotion and distribution agreement with GSK for Shingrix in Korea and are carrying out promotional activities for the vaccine.
- Company
- Tabreca can now be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Feb 23, 2023 05:46am
- The first MET-targeted anticancer drug, ‘Tabrecta’ can now be prescribed at hospitals in Korea. According to industry sources, Novartis Kore’s Tabrecta (capmatinib) passed the drug committees of the Big-5s general hospitals including Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Sinchon Severance Hospital, and medical institutions including the National Cancer Center, Pusan National University Hospital, etc. MET mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). No treatment option had been available in this type until now, which is why attention has been rising for new drugs in the area. Tabrecta targets c-MET and was first approved as a treatment for MET exon 14 skipping mutation in NSCLC in the US in May 2020. However, the issue of reimbursement still remains an obstacle. The company applied for reimbursement in November 2021 after receiving marketing authorization in Korea. However, the agenda was unable to pass review in both Health Insurance Review and Assessment Service’s Cancer Disease Review Committee meetings in August and last month this year. Whether Novartis will apply for and succeed in listing the drug for reimbursement remains to be seen. The drug’s efficacy was confirmed through the GEOMETRY mono-1 trial in 97 patients with METex14. In the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Meanwhile, Novartis is also actively studying the combined use of Tabrecta with other therapies. In particular, its combined use is expected to be able to address the issue of resistance that patients acquire after treatment with EGFR inhibitors. As such, combined use of Tabrecta with AstraZeneca’s 3rd generation EGFR TKI Tagrisso (osimerbinib) is also underway. More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum-based chemotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) mutation, T790M negative, MET-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso. Professor Ji-Youn Han, Department of Hemato-oncology, National Cancer Center, said, “Patients who have MET amplification or overexpression have a very poor prognosis. In this sense, with the prompt introduction of MET inhibitors becoming ever important, the approval of Tabrecta, a treatment that demonstrated clear efficacy in MET exon 14 skipping mutation, holds great significance.”
- Company
- Neulasta's sales surpassed those of Neulapeg
- by Kim, Jin-Gu Feb 23, 2023 05:46am
- Neulasta and NeulapegNeulasta and Neulapeg are competing for the lead in the neutropenia treatment market. In the fourth quarter of 2021, Neulapeg took the lead by surpassing the original product, Neulasta, for the first time after its release, but from the first quarter of last year, Neulasta took the lead again, widening the gap with Neulapeg. In the pharmaceutical industry, there is an analysis that the change is due to the replacement of sales partners. Boryung led rapid growth by co-selling Neulapeg with GC Pharma until 2021 but started co-selling Neulasta in partnership with Kyowa Kirin last year. According to IQVIA, a pharmaceutical market research institute, on the 23rd, sales of Neulasta last year were 31.4 billion won. It increased by 29% compared to 24.5 billion won in 2021. During the same period, Neulapeg showed a decrease of 6% in one year from 22.8 billion won to 21.5 billion won. Neulasta is classified as a second-generation neutropenia treatment. Neutropenia treatment is a drug that prevents the side effects of lowering immunity due to a decrease in the number of neutrophils in the body when cancer patients are administered anticancer drugs. Neulapeg is a kind of Biobetter product upgraded from Neulasta. GC Pharma applied PEGylation technology, which attaches polyethyleneglycol only to a specific location, to increase purity and stability and increase the half-life of the drug compared to existing treatments. By 2021, the neutropenia treatment market has developed in such a way that Neulapeg is chasing Neulasta. Released in 2014, Neulapeg had minimal initial commercial success. Until 2018, most quarterly sales were less than 1 billion won. However, as Boryung's sales power increased, it began to show a steep upward trend. GC Pharma signed a joint sales contract with Boryung in October 2018 for Neulapeg. Since then, it has exceeded 3 billion won in the 4th quarter of 2019, 4 billion won in the 4th quarter of 2020, and 5 billion won in the 2nd quarter of 2021, respectively. In particular, in the fourth quarter of 2021, it recorded quarterly sales of 6.3 billion won, surpassing Neulasta (5.6 billion won) and rising to the top of the market. Neulasta, new sales in one year ↑ 29% In the pharmaceutical industry, it is analyzed that the change of sales partner had a significant impact on the change in the market landscape. Boryeong, which led Neulapeg's growth until 2021, started selling Neulasta instead of Neulapeg last year. Boryeong, which contributed to Neulapeg's rise to the top at the end of 2021, led to the recapture of Neulasta, a competing product. Jeil has been co-selling GC Pharma Neulapeg since last year. Jeil had experience co-marketing Neulasta from 2014 to 2017. The gap between Neulasta and Neulapeg is widening after the change of sales partners. The gap between the two products, which was only 700 million won in the first quarter, Neulasta 6.5 billion won and Neulapeg 5.8 billion won, widened to 3.4 billion won in the fourth quarter, 8.4 billion won and 5 billion won. ◆Rolontis, a third-generation new drug, sales of KRW 1.8 billion in 2 months after the launch Rolontis is a third-generation treatment that appeared in the neutropenia treatment market after 16 years. Hanmi Pharmaceutical's Labscovery technology was applied. Compared to existing drugs, the half-life in blood was longer, so the frequency of administration was reduced to once every 3 weeks. Hanmi Pharm received domestic approval for Rolontis in March 2021. In November of last year, Rolontis was listed on the health insurance benefit list. In just two months of benefit, Rolontis posted sales of 1.8 billion won, proving its growth potential. Sales of Handokteva Lonquex and Dong-A ST Dulastin, which were second-generation products, exceeded the 4Q sales. Lonquex and Dulastin posted sales of 1 billion won and 600 million won, respectively, in the fourth quarter of last year.
- Company
- Celltrion Eyelea expands U.S. patent
- by Feb 22, 2023 05:55am
- Celltrion researcher is conducting formulation research.(Photo by Celltrion)Celltrion is conducting an additional trial for invalidation of the U.S. patent for the eye disease treatment "Eylea." According to industries on the 17th, Celltrion recently filed an IPR (Inter Parts Review) with the U.S. Patent and Trademark Office, claiming that Eylea's composition patent developed by Regeneron is invalid. Eylea is a biopharmaceutical for treating ophthalmic diseases that treat macular degeneration and diabetic macular edema. It is a blockbuster drug that recorded $9.4 billion (about 12 trillion won) in global sales in 2021. Celltrion is developing the Eylea biosimilar 'CT-P42'. In April last year, it completed the recruitment of global phase 3 clinical patients. A total of 13 countries, including Germany and Spain, recruited patients with diabetic macular edema, which are clinical targets. Celltrion claimed that paragraph 1-18 of US patent number US 10464992 was invalid in this IPR. The patent is about polysorbate 20, sodium phosphate buffer, sucrose, etc., which are commonly used to stabilize vascular endothelial cell growth factor (VEGF) inhibitors such as Eylea. The IPR petition number is PTAB IPR2023-00462. In the petition, Celltrion stressed that the method of utilizing polysorbate 20, sodium phosphate buffer, and sucrose applied to Ailia is not novel content that can be protected by patents. Earlier in November last year, Celltrion won the first trial of an invalidation lawsuit against Regeneron for two Eylea patents (patent number US 9254338, US 9669069). This lawsuit is a lawsuit in which Celltrion jointly participated in the IPR filed by Mylan against the original company Regeneron in May 2021 through an application for participation in the lawsuit in December 2021. Celltrion also filed a lawsuit against one patent (patent number US10857231) related to Eylea formulation in September 2021. In March last year, Regeneron, the patent holder, declared the final abandonment of the patent, leading to a victory in the invalidation lawsuit. Celltrion plans to commercialize CT-P42 in time for the expiration of material patents and monopoly rights after the development of CT-P42 is completed. The patent for Eylea material is scheduled to expire in June this year in the U.S. and in May 2025 in Europe, respectively. The expiration date of the U.S. market monopoly has been extended to May 2024.
- Company
- Keytruda leads the market for 3 consecutive years
- by Chon, Seung-Hyun Feb 22, 2023 05:54am
- The immuno-oncology drug Keytruda has topped the rank in pharmaceutical sales for 3 consecutive years. Also, new drugs from multinational pharmaceutical companies, such as Gardasil 9, Prolia, Opdivo, and Dupixent showed strong growth and joined the KRW 100 billion club after exceeding KRW 100 billion in sales last year. On the 22nd, according to the pharmaceutical research institution IQVIA, MDSD's Keytruda's sales topped the market by recordeingKRW 239.6 billion last year. This is a 19.7% YoY increase from the previous year. This is the third consecutive year the drug has held the lead after taking the top spot for the first time in 2020 with sales of KRW 155.7 billion. Also, Keytruda’s sales exceeded 200 billion won for 2 consecutive years since 2021. Keytruda is an immune checkpoint inhibitor that inhibits PD-1 proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The drug is currently approved for 16 cancers: ▲Lung cancer, ▲head, and neck cancer, ▲ Hodgkin lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer. It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea. In the early years of its release, in 2016 and 2017, its sales had only been KRW 100 billion and KRW 12.2 billion. However, its sales started to surge with reimbursement approval. After reimbursement was applied for non-small-cell lung cancer (NSCLC) in August 2017, its sales soared over fivefold to KRW 70.3 billion in 2018, and then exceeded KRW 100 billion by 2019. In 2020, the drug outsold the then-lead Lipitor and rose to the lead. Last year, Keytruda continued strong growth amid favorable and unfavorable events. Keytruda’s insurance ceiling price had fallen 25.6% with its reimbursement extension to first-line treatment of NSCLC in March this year. Its sales in Q1 last year had fallen 8.4% compared to the same quarter the previous year due to the price cut – to KRW 40.4 billion – but it recovered its momentum after the benefits from its first line reimbursement were applied in earnest. When considering the price cut that was applied to Keytruda, its sales volume has increased by over 60%. New drugs from multinational pharmaceutical companies showed strong sales and made the ranks last year. MSD’s HPV vaccine Gardasil 9 ranked third last year with sales of KRW 117 billion, rising 61.2% from the previous year. Gardasil 9 is an improved version of the company’s Gardasil, which offers protection for four serotypes (6, 11, 16, and 18). Gardasil 9 offers protection for five more serotypes (31, 33, 45, 52, 58) than Gardasil. Also, It contains the most HPV types among cervical cancer vaccines. Vaccinations among males for Gardasil 9, which was released at the end of 2016, have also been rising every year with the news spreading that Gardasil 9 offers protection for HPV-related diseases other than cervical cancer, such as anal cancer, genital warts, and precancerous lesions. Also, the revaccination rate has also risen greatly among adults who already received vaccination after the recommended age was expanded from 9-26 to 27-45 in July 2020. Sales of Gardasil 9 had increased over twofold in 2 years from KRW 42.5 billion in 2020 to exceed KRW 100 billion for the first time last year. Amgen’s Prolia ranked fourth raising KRW 115.7 billion YoY last year. Prolia, a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone, was released in November 2016 in Korea. Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017. After additionally being approved for reimbursement in the first line from April 2019, Prolia’s sales rose explosively and its annual sales exceeded KRW 100 billion for the first time. Prolia is copromoted by Chong Kun Dang in Korea. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo increased 29.3% YoY to record ₩109.9 billion this year. Opdivo, which was approved in 2015, recorded a high growth rate of 64.7% in two years from the 66.7 billion it had earned in 2020, and its annual sales exceeded 100 billion for the first time last year. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 36.3% YoY to record ₩105.2 billion last year. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or who cannot use topical therapies. Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020, and exceeded KRW 100 billion last year. Roche’s Perjeta’s annual sales rose 9.4% YoY to record KRW 102.7 billion last year. Perjeta is approved for use in combination with docetaxel and trastuzumab in patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. The drug was approved for reimbursement to treat patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy in 2017. After the drug was granted selective reimbursement in May 2019, trastuzumab and combination therapy settled as the standard adjuvant therapy and its sales exceeded KRW 100 billion. Among new drugs developed by domestic pharmaceutical companies, HK.Inno.N’s K-CAB’s sales rose 16.0% YoY to record KRW 104.8 billion and ranked eighth last year. K-CAB, which was released in March 2019. It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion.
- Company
- GC Biopharma receives WHO Pre-Qualification for Barycela
- by Kim, Jin-Gu Feb 21, 2023 05:52am
- Pic. of Barycela GC Biopharma announced that the World Health Organization (WHO) has granted prequalification (PQ) for its varicella vaccine, Barycela. Vaccines that receive the WHO prequalification decision after a review of their safety and efficacy become eligible for procurement by the United Nations agencies to be used in national immunization programs. With the approval of its varicella vaccine, the company now owns 3 PQ vaccines along with its H1N1 pandemic and seasonal influenza vaccines. Barycela is a live attenuated varicella virus vaccine that contains the MAV/06 strain, a virus exclusively attenuated by GC Biopharma. The product has improved stability while containing a higher amount of virus compared to its previous product. In a global trial, the company demonstrated Barycela’s noninferiority in terms of immunogenicity and an equivalent level of safety compared with Varivax, an existing prequalified vaccine in the market. The vaccine is produced in a state-of-the-art aseptic system through cell culture, virus infection, and purification. It has the characteristic of being the only varicella vaccine produced without antibiotics. With the WHO's PQ decision, the company believes that there is a rising possibility that its ‘MAV/06 strain’ will be registered in the WHO Technical Report Series (TRS) in addition to the previously listed OKA strain. Also, GC Biopharma plans to actively target the global market with Barycela by utilizing the global supply network it had previously established supplying its existing varicella vaccine. Eun Chul Huh, President of GC Biopharma, said, “We hope to continue contributing to reducing the world's social and economic cost incurred by varicella outbreaks with Barycela.” In 1993, GC Biopharma received approval for ‘Suduvax,’ the first varicella vaccine in Korea and the world's second varicella vaccine. Over 28 million doses of Suduvax have been sold worldwide over the past 3 decades through PAHO and others.
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- 3rd PARPi Talzenna may be prescribed at hospitals in Korea
- by Eo, Yun-Ho Feb 21, 2023 05:52am
- Korea’s third PARP inhibitor, ‘Talzenna’ can now be prescribed at general hospitals in Korea. According to industry sources, Pfizer Korea’s breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) treatment ‘Talzenna (talazoparib)' passed the drug committee reviews of various medical institutions in Korea, including the National Cancer Center St. Mary’s Hospital and Yeouido St. Mary's Hospital. Talzenna was approved in Korea in July 2020 as monotherapy for the treatment of adult patients with germline BRCA mutations who have HER2-negative locally advanced or metastatic breast cancer with previous treatment experience. Afterward, the company applied for reimbursement, and the agenda was selected for review by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in November of the same year but was unable to pass CDDC deliberations, and no progress had been made since. The health authorities are known to have been expressing concerns about reimbursing PARP inhibitors like Talzenna in breast cancer due to their broad indication in the disease. AstraZeneca’s Lynparza was the first PARP inhibitor to receive reimbursement in Korea. Lynparza was listed for reimbursement in October 2017 and was applied the Expenditure Cap type of the Risk Sharing Agreement (RSA) through the pharmacoeconomic evaluation exemption system. Listing of Takeda’s ‘Zejula’ followed in December 2019. The drug may be prescribed as maintenance monotherapy for adult patients with platinum-sensitive recurrent ovarian cancer who are in complete or partial response to platinum-based chemotherapy. However, its first reimbursement was only approved for approved the BRCA-positive indication. However, both drugs are experiencing difficulty extending reimbursement to breast cancer. Meanwhile, Talzenna’s efficacy was demonstrated through the large-scale, open-label, randomized, international Phase III trial, EMBRACA. The trial compared the efficacy of Talzenna monotherapy versus chemotherapy of the investigator’s choice in patients with gBRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease. Results showed that the median progression-free survival (mPFS), the primary efficacy endpoint, was 8.6 months for the Talzenna monotherapy arm, which was a significant improvement compared with the 5.6 months in the chemotherapy arm. Also, the risk of disease progression or death was 46% lower in the Talzenna monotherapy arm compared to the chemotherapy arm. Such significant improvement in PFS in patients treated with Talzenna was consistently observed across major patient subgroups, which were defined by the number of prior cytotoxic regimens, hormone receptor status (HR+ or TNBC), and history of CNS metastases. Also, the secondary endpoint, objective response rate (ORR), was 62.6% for the Talzenna monotherapy arm, which was more than double the 27.2% achieved in the chemotherapy arm.
