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- 2026-04-10 18:48:20
- Company
- Daewoong botulinum toxin Nuceiva launched in Germany and Aus
- by Hwang, Jin-joon Mar 02, 2023 05:52am
- Daewoong Pharmaceutical Botulinum Toxin Daewoong Pharmaceutical announced on the 28th that its botulinum toxin 'Nuceiva' was officially launched in Germany and Austria through Evolus, a cosmetic indication partner in developed countries. Evolus, a partner for cosmetic indications in North America and the European Union, will be in charge of the distribution and marketing of Nuciva in Germany and Austria. Evolus has been preparing for the local release by forming a strategic partnership with Novvia, a local distributor specializing in aesthetic medicine. From the middle of this month, we started product marketing activities targeting local medical personnel. According to a data report published by market research firm Decision Resource Group (DRG), the German botulinum toxin market is estimated at 100 billion won. It occupies the second largest share after the UK in the European Union, which has an annual market size of 690 billion won. As Germany is the most populous country in the European Union, this launch is expected to be a key point for Nuciva to expand its market share in the region. Daewoong Pharmaceutical and Evolus are planning to release Nuciva in other EU countries this year. It plans to launch it in Australia and Singapore, which have recently received product approval, within this year.
- Company
- Jardiance vs Forxiga, competition in chronic kidney dz
- by Eo, Yun-Ho Feb 28, 2023 05:53am
- Competition outside the diabetes area for SGLT-2 inhibitors will further expand this year Following heart failure, this time it is kidney disease. Following AstraZeneca's Forxiga, Lilly and Boehringer Ingelheim's Jardiance also secured indications for chronic kidney disease, and competition is intensifying. In terms of speed, Forxiga is ahead. Forxiga entered the approval process in major countries, including Korea, immediately after approval by the US FDA in April, and added indications for chronic kidney disease in Korea and Europe in August last year. However, insurance benefits have not yet been applied. Boehringer Ingelheim submitted an application for US FDA approval last month. If US approval is completed within this year, it is expected that major countries including Korea will immediately begin approval procedures. Chronic kidney disease (CKD) is a progressive disease that is estimated to affect 700 million patients worldwide. Currently, there are limited treatments available for this patient group, but new treatment options are needed in that chronic kidney disease increases the incidence of cardiovascular events such as heart failure and affects early death. The approval of Forxiga for chronic kidney disease was based on the phase 3 clinical DAPA-CKD study. Forxiga was designated for Priority Review by the FDA earlier this year. According to the DAPA-CKD study, Forxiga reduced the relative risk of decreased renal function, ESKD, and cardiovascular or renal death by 39% compared to placebo in chronic kidney disease stage 2-4 patients with increased UAE levels. The absolute risk reduction rate (ARR) was 5.3% over a median study period of 2.4 years. In the case of Jardiance, the validity was confirmed through the EMPA-KIDNEY study. EMPA-KIDNEY was a broad-spectrum, large-scale SGLT-2 inhibitor-only study involving 6609 patients with a variety of causes. Many of these patients had cardiovascular, renal, or metabolic comorbidities, and both renal and cardiovascular outcomes were evaluated at different CKD severity levels. As a result, Jardiance significantly reduced the risk of renal disease progression or cardiovascular death by 28% compared to placebo. It also significantly reduced all-cause hospitalizations, one of the predefined major composite secondary endpoints, by 14% compared to placebo.
- Company
- Last year’s sales of Yuhan Leclaza were 16.1 billion won
- by Chon, Seung-Hyun Feb 28, 2023 05:52am
- Cumulative sales of 20 billion won in 1 year and 6 months after release. High growth prospects when promoted to first-line treatment. Yuhan Corporation's anti-cancer drug Leclaza is successfully settling in the domestic market. In the second year of its release, it posted sales of 16.1 billion won, breaking the record for annual sales of a new anti-cancer drug developed in Korea. According to IQVIA, a drug research agency on the 24th, Leclaza recorded sales of 16.1 billion won last year. It increased by 4 times from 4.1 billion last year. Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January 2021. Patients with locally advanced or metastatic non-small cell lung cancer who developed T790M resistance after administration of first- and second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are eligible for the treatment. It acts as a mechanism to inhibit the proliferation and growth of lung cancer cells by interfering with the signal transduction involved in the growth of lung cancer cells. Leclaza entered the prescription market in earnest in July 2021 with its listing on the health insurance benefit list. Sales of 1.5 billion won and KRW 2.6 billion occurred in the third and fourth quarters of 2021, respectively. In the past year, Leclaza's sales have grown even more. It sold 3.2 billion won and 3.7 billion won in the first and second quarters of last year, respectively, and expanded to 4.6 billion won and 4.5 billion won in the third and fourth quarters. Leclaza recorded cumulative sales of 20.2 billion won for a year and a half after its release. Leclaza has already broken the sales record for new anti-cancer drugs developed in Korea. Domestically developed anti-cancer drugs approved prior to Leclaza include Ilyang Pharm's Supect, Dongwha Pharm's Millican, Chong Kun Dang Camtobel, Samsung Pharm's Riavacs, and Hanmi Pharm's Olita. None of these products exceeded 10 billion won in annual sales. Supect recorded sales of 7.6 billion won last year. Supect, which was approved as the 18th domestically developed new drug in January 2012, is a drug used to treat chronic myelogenous leukemia. Supect drew attention as Asia's first treatment for chronic myeloid leukemia, but annual sales have never exceeded 10 billion won since its launch. Camtobel's sales last year were only 3.5 billion won. Camtobel is a drug approved as the 8th domestic new drug in 2003 and is used for ovarian cancer and small cell lung cancer. Leclaza's report card at the beginning of its release is evaluated as a good start. Since anticancer drugs, which are usually used in large medical institutions, can be prescribed after passing the drug committee, it takes a considerable amount of time for sales to occur at the initial stage of release. Due to the nature of direct competition with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anti-cancer drugs developed in Korea to achieve commercial results. Leclaza passed the Pharmaceutical Affairs Committee of major domestic medical institutions one after another. If Leclaza is approved as a first-line treatment, the pace of market expansion is expected to accelerate. Recently, clinical trials have confirmed the possibility of Leclaza as a first-line treatment. Leclaza demonstrated superior safety and efficacy compared to existing treatments in phase 3 clinical trial (LASER301) conducted on 393 patients with active EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer who had not previously received treatment. The clinical results were recently unveiled at the Asian Congress of the European Society for Oncology held in Singapore. Yuhan plans to apply for first-line treatment approval based on the LASER301 clinical trial results. Yuhan Corporation has secured $150 million in license fees for Leclaza. In November 2018, Leclaza was technology exported to Janssen Biotech, and at this time, it received a non-returnable down payment of $50 million. Yuhan received a milestone payment of $35 million from Janssen in April 2020. At the time, Janssen paid Yuhan Corporation an additional milestone when it started clinical trials for the combination therapy of Amivantamab and Leclaza. In November 2020, Janssen paid Yuhan an additional milestone of $65 million as it began recruiting subjects for this clinical trial.
- Company
- Recordati Korean subsidiary was launched
- by Eo, Yun-Ho Feb 28, 2023 05:52am
- Italian pharmaceutical company Recordati Korean corporation was launched. Recordati Korea (Representative Lee Yeon-jae in Asia) announced on the 27th that it will officially launch its Korean branch and Asia-Pacific regional headquarters. The company is an Italian pharmaceutical company with a history of more than 90 years. Accordingly, the corporate name of the existing EUSA Pharma Korea will be changed. Recordati will be in charge of marketing Sylvant, a treatment for multicentric Castleman's disease (MCD), and Carbaglu, a treatment for hyperammonemia, and is preparing a wide portfolio for rare diseases such as Neuroblastoma and Cushing's syndrome. Lee Yeon-jae, CEO of Asia, said, "Recordati has expanded its portfolio for rare pediatric cancers and blood diseases in addition to products for metabolic and endocrine rare diseases, which it originally specialized in through the acquisition of EUSA Pharma."
- Company
- Monthly sales of OTC Allegra rise 30% on average
- by Jung, Sae-Im Feb 28, 2023 05:52am
- Sales of Sanofi’s third-generation antihistamine drug ‘Allegra’ has risen 30% on average per month ever since it entered the over-the-counter (OTC) drug market. According to the market research institution IQUVA, sales of the OTC Allegra have risen 29% on average per month, ever since its release in March to the allergy season in October of the same year. Since its launch, 44% of pharmacies nationwide have been supplying Allegra. Allegra’s sales had risen significantly during the spring and fall season when allergic rhinitis worsens. Its sales, which had been in the KRW 20 million range in the first month of March of last year, had risen over fivefold to KRW 120 million in April. Even in the non-allergy season, its sales had been in the KRW 60 million range. And after entering fall, in September and October, its sales recorded KRW 200 million and 140 million each. Allegra is an antihistamine OTC that contains fexofenadine as the active ingredient. Most third-generation antihistamine drugs are ethical drugs (ETCs) that can only be prescribed at hospitals, but the 120mg dose of Allegra was approved as an OTC. The release of the OTC and ETC versions has created a synergy effect and positively impacted prescription sales of Allegra as well. According to the company, prescription sales of Allegra last year reached KRW 7.5 billion, which is a 16% increase from the previous year. Allergic rhinitis is an inflammatory autoimmune disease that is commonly confused with the cold. Typical symptoms include sneezing, stuffy nose, runny nose, and itchy eyes. Although a series of first and second-generation antihistamine drugs have been released to treat symptoms of allergic rhinitis, side effects such as drowsiness have been cited as an issue. Allegra is a third-generation fexofenadine drug that is an improved version of the first and second-generation antihistamine drugs. It has fewer side effects of drowsiness as it does not pass through the blood-brain barrier or bind to histamine cortical H1 receptors with a quicker effect. The OTC Allegra contains 10 tablets per pack, and one tablet (120mg) should be taken once daily before meals with plenty of water. It relieves symptoms of allergic rhinitis within 60 minutes the effect lasts for 24 hours after intake. With this improved convenience in intake and undergoes minimal hepatic metabolism, the drug can be taken with less concern. Sanofi has been paying close attention to the tangible results brought by Allegra in the ETC and OTC markets over the past year. As the drug enters the second year of release this year, the company aims to actively conduct diverse campaigns to increase and expand demand. For this, Sanofi plans to promote the various strengths of Allegra by carrying out a Spring digital campaign in March of this year. For the campaign, the company will prepare an advertisement that points out the various causes of allergic rhinitis that people may easily encounter in daily life. By portraying how Allegra relieves the symptoms quickly without concern over drowsiness, the company will emphasize the key message of how Allegra is 'a third-generation antihistamine allergy medication that is effective and lasts for 24 hours that can be taken with less concern over drowsiness.’ The advertisement will not only be broadcasted on TV but be available online via YouTube and Naver. A Sanofi official said, “As we enter the second year of Allegra’s release, we plan to spur up brand awareness-raising activities. We will conduct broad marketing activities to make known the efficacy and effect of third-generation antihistamines.”
- Policy
- Negotiations on the Brukinsa price have begun
- by Lee, Tak-Sun Feb 28, 2023 05:52am
- Crysvita and Dupixent are also negotiating drug prices. It has been found that Chinese pharmaceutical company BeiGene Korea has entered into drug price negotiations with the NHIS for Brukinsa capsules 80mg sold domestically. When the NHIS drug price negotiation is completed, the drug will be covered through a report to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare. According to the industry on the 27th, The NHIS recently disclosed this fact on its website. Since April 2019, The NHIS has been disclosing the drugs ordered by the Ministry of Health and Welfare to NHIS for drug price negotiations on its website for the public's right to know. According to the Ministry of Health and Welfare's negotiation order, the drug price negotiations will be carried out within 60 days between the NHIS and pharmaceutical companies. At the HIRA held on the 9th, this drug was judged to be eligible for reimbursement for WM. WM is a rare blood cancer in which the bone marrow produces many abnormal white blood cells that crowd out healthy blood cells. Previously, the US FDA approved Brukinsa as a WM treatment in September 2021. Meanwhile, the NHIS said Crysvita 10, 20, and 30mg were also included in the drug price negotiations. This drug also passed the committee on the 9th, and the negotiation period was shortened from 60 days to 30 days after prior consultation with The NHIS as a drug to improve the quality of life for children. Crysvita is used for 'FGF23-associated hypophosphatemic rickets and osteomalacia'. The NHIS also said that drug price negotiations are underway for Dupixent, which passed the committee in January. Dupixent, which is currently receiving reimbursement for adult atopic dermatitis, is undergoing reimbursement procedures for pediatric atopic dermatitis.
- Company
- Will Tagrisso finally be reimbursed with public support?
- by Eo, Yun-Ho Feb 28, 2023 05:52am
- The D-day has finally been revealed. Will the lung cancer treatment ‘Tagrisso’ finally succeed in extending reimbursement to the first line? According to industry sources, AstraZeneca’s EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment Tagrisso will be deliberated at the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee meeting on March 22. A dire need had long existed. The public petition urging for the extension of reimbursement benefits to the first line for Tagrisso that had been filed earlier this year had received consent from 50,000 people. Patients desperately want it, but doctors are saying no to it. Under such strange circumstances, Rep. Jung-Sook Suh of the People Power Party had pointed to the need to extend reimbursement, upon which the Ministry of Health and Welfare expressed intent on its review. The pharmaceutical company had also expressed its strong will to extend Tagrisso’s reimbursement to the first line, by accepting the financial-sharing plan proposed by the authorities. Four years have already passed. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, upon review by the Cancer Disease Deliberation Committee in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of Tagrisso in NSCLC patients in the first-line was disclosed. Although AstraZeneca submitted the full FLAURA data and expressed their will to accept most of the financial-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) that raised an issue over the drug’s clinical efficacy. At the time, the largest obstacle that impeded Tagrisso’s reimbursement in the first line was the Asian subgroup analysis results of the FLAURA trial. Tagrisso’s overall survival (OS) in the trial was 38.6 months, a significant extension of 6.8 months over its first-generation comparators ‘Iressa (gefitiniib)’ and ‘Tarceva (erlotinib)’. The results were encouraging, considering how Tagrisso was the first EGFR TKI to demonstrate efficacy in the first line and that crossover prescriptions were allowed for research ethics in patients with confirmed T790 mutations while receiving treatment with its first-generation comparators. However, the issue was the hazard ratio (HR) of the Asian subgroup analysis. HR was 0.995 when separately analyzing Asian patients that received Tagrisso. An HR of 0.995 means that the difference between Tagrisso and the control group is 0.005, which could be interpreted as that there is virtually no difference between Tagrisso and its comparator. This was why the academic society raised the opinion that ‘Tagrisso’s OS in Asians, including Koreans, was not reliable in the first line,’ and the opinion had a dominant influence on the results of the CDDC review. Many others have expressed different views on the subgroup analysis results. A primary efficacy endpoint exists for all trials, and subgroup analysis results are only presented as a reference only when the trials satisfy the primary efficacy endpoint. This is the universally accepted concept in virtually all academia beyond medicine. However, the expert committee pointed to the subgroup analysis as the key reason for the non-reimbursement even though the trial succeeded in demonstrating the OS, which was the purpose of the trial. Regardless of what happened in the past, the agenda is again awaiting CDDC review. Tagrisso has reinforced support with drug price cuts and real-world data that was announced last year. In other words, the company has strengthened grounds for support from the financial and effect aspect. Therefore, the industry’s attention is on whether Tagrisso will be able to produce a different result this time. Meanwhile, the real-world study evaluated the effect of Tagrisso in the first-line in clinical practice in 660 NSCLC patients with EGFR mutations from 2018 to 2020. 583 of the patients received Tagrisso in the first line, and the other 76 received another EGFR-targeted cancer therapy. Actual measurement was taken every 6 months in the 583 patients that received Tagrisso. The median follow-up period was 24.6 months. Results of the study showed that the median progression-free survival (mPFS) in patients that were administered Tagrisso was 20.0 months. This is even longer than the mPFS of 18.9 months that had been identified in the global Phase III trial of Tagrisso. By mutation, Tagrisso’s mPFS in patients with exon19 deletions was 23.5 months. In those with L858R mutations, the PFS was 17.0 months. In terms of OS, the median OS was 33.1 months in the Tagrisso arm, 7.4 months longer than the 25.7 months in the control group, reaffirming Tagrisso’s overall survival of over 3 years.
- Company
- Daiichi Sankyo Korea appoints Jeongtae Kim as new CEO
- by Eo, Yun-Ho Feb 27, 2023 05:57am
- Kim Jeong-tae, new presidentDaiichi Sankyo Korea appointed Vice President Kim Jung-tae (49) as the new CEO. Daiichi Sankyo announced on the 20th that it will appoint Vice President Kim Jeong-tae as the new CEO and President Kim Dae-jung will retire on March 31. Accordingly, from April 1st, President Kim Dae-jung will support the company as an advisor, and new President Kim Jung-tae will be inaugurated as the representative. President Kim Jeong-tae graduated from the College of Pharmacy at Sungkyunkwan University, obtained an MBA from Korea University, and has accumulated extensive experience and expertise by holding various positions at Daiichi Sankyo Korea and Daiichi Sankyo Headquarters. He started his career in 2008 at Daiichi Sankyo Korea's Pharmacy Team (Regulatory Affairs, Pricing, and Reimbursement), and has led the process of business restructuring and vision establishment for Daiichi Sankyo Korea through management planning and business development. Since 2017, he has been in charge of strategic planning in the Daiichi Sankyo Headquarters Business Promotion Department after marketing for the ASCA (Asia, South & Central America) region of Daiichi Sankyo. After returning to Daiichi Sankyo Korea in 2020, he led the Marketing MR General Department, which oversees marketing and sales operations.
- Product
- Daewoong/Novartis promise to cooperate
- by Kim JiEun Feb 27, 2023 05:57am
- On the 22nd, the Korea Pharmaceutical Association (Chairman Choi Kwang-Hoon) disused stock medicine return TF (Team Leader Jung Hyeon-cheol) held a meeting with Daewoong Pharmaceutical and Novartis Korea regarding the return of unused stock medicine and announced that they had agreed to actively cooperate in a settlement. In the case of Daewoong Pharmaceutical, through a meeting with the pharmaceutical society, wholesale shipments are 100%, returns are collected from base logistics within 1 month after being received, the balance is deducted for the settlement method, and a separate settlement rate is deducted for other return processing conditions. It was confirmed that there is no criterion. In addition, at the meeting with the Pharmacy Association, Novartis Korea explained that the return of unused medicines in stock is carried out only when the Pharmacy Association returns business is implemented, and regarding the practice guidelines for return work, 100% of the wholesale shipment price is collected in the reverse order of wholesale transactions, and the settlement method is warehousing. Explained how to deduct the balance within 3 months after The Pharmaceutical Association said at this meeting that these pharmaceutical companies explained that there were some setbacks due to the fact that the contents of the Pharmacy Returns Project were not clearly communicated to practitioners. The pharmacist association agreed to increase contact with pharmaceutical companies in the future and seek ways to coexist at the same time and explained that through this meeting, they had a meaningful time listening to pharmaceutical companies' difficulties related to the promotion of the pharmacists' return business and discussing solutions. Jeong Hyeon-cheol, head of the return TF team, said, “We will continue to hold meetings with pharmaceutical companies that have not participated in the return business in March to do our best to achieve the best results among all unused inventory drug return businesses.” Team leader Jeong also said, “The unwanted inventory drug return TF will continue to cooperate with pharmaceutical companies and distributors so that all returns from pharmacies can be collected without a hitch by the end of March, and settlement can be made sequentially from April.” said. Meanwhile, through this meeting, 143 pharmaceutical companies agreed to cooperate with the pharmacist association's return business, and 102 pharmaceutical companies confirmed detailed guidelines such as settlement rates. The association plans to provide related data to local branches or distribution associations at the end of this month, along with interim aggregated data for entering pharmacy returns.
- Company
- 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.
