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- 2026-05-05 11:35:51
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- Boehringer Ingelheim Korea appoints Ana-Maria Boie as new GM
- by Son, Hyung-Min Jan 25, 2024 05:49am
- Ana-Maria Boie, new General Manager of Boehringer Ingelheim Korea Boehringer Ingelheim Korea announced on the 24th that it had appointed Ana-Maria Boie as the General Manager and Head of Human Pharma. The new GM, Ana-Maria Boie, is a seasoned expert with 24 years of experience in the pharmaceutical industry, in various areas including management, marketing, sales, and ESG. Boie joined Boehringer Ingelheim Romania in 2009 as a marketing manager and has contributed to the company's growth ever since, serving as the national sales manager for the Romania subsidiary, the regional marketing manager for the respiratory BU in the Austria subsidiary, the GM for the Romania subsidiary, and the director of human pharma sales and commercial in the Russia subsidiary. Beyond sales performance, Boie has also made significant contributions in embedding the company's core corporate values into the organization's culture. In 2020, she participated in the development of the ‘Sustainable Development-For Generations (SD4G)’ framework, the company's global core strategy for a sustainable society. In 2021, she was appointed Business Manager for the emerging market region at the company's headquarters in Germany, where she led the development and execution of business strategies across the Mexico-Brazil-South America-India-Middle East-Africa-Turkey (IMETA) markets, and spearheaded the creation of strategies to improve treatment access for underserved populations. GM Ana-Maria Boie, said, "I am very honored to be part of the journey of improving the quality of life for people and animals through innovative therapies in Korea, one of Boehringer Ingelheim’s key markets. I look forward to working with employees and executives of Boehringer Ingelheim Korea, who live by trust, respect, and passion to fulfill the corporate value, and grow the company around Boehringer Ingelheim’s first corporate brand claim, ‘Life Forward.’”
- Company
- Samsung Biologics tops 1 trillion won in profit
- by Chon, Seung-Hyun Jan 25, 2024 05:49am
- Samsung Biologics For the first time, Samsung Biologics has surpassed a yearly operating profit of 1 trillion won among pharmaceutical companies in Korea. Due to the continued growth of CDMO services for biopharmaceuticals, the company has accumulated quarter sales exceeding 1 trillion won in consecutive quarters. According to the Financial Supervisory Service report on the 24th, Samsung Biologics saw an operating profit of 350 billion won in Q4 last year, a 11.9% YoY increase. The annuals sales for the year reached 1.735 trillion won, showing a 11.2% increase from the previous year. Additionally, in Q3 last year, Samsung Biologics became the first in Korea’s history to exceed quarter sales of 1 trillion won, and they continued to show this growth in Q4. Last year, Samsung Biologics gained an operating profit of 1.114 trillion won, a 13.2% increase compared to the previous year. Annual sales reached 3.695 trillion won, demonstrating a 23.1% increase. These figures represent the company's most significant annual sales and an operating profit since its establishment. Samsung Biologics topped annual sales of 1 trillion won for the first time in the history of pharmaceutical companies in Korea. Samsung Biologics became the first in Korea’s history to exceed annual operating profit of 1 trillion won Samsung Biologics, founded in 2011, recorded 66 billion won in an operating profit in 2017, making it the first time the company has generated a surplus. It generated 91.7 billion won in 2019; however, in 4 years it expanded 12 times. Samsung Biologics’ yearly sales figure (left) and operating profit (right) (unit: 100 million won, graph by Financial Supervisory Service). Samsung Biologics focuses primarily on Contract Manufacturing Organization (CMO) and Contract Development Organization (CDO) services for Active Pharmaceutical Ingredients (APIs) and biopharmaceuticals. Currently, the company operates a total of four biopharmaceutical manufacturing facilities. Samsung Biologics has enhanced its CMO capacity through the partial operation of these four factories, attaining the world’s largest production capacity (240,000 liters) in the category of a single manufacturing facility within 23 months of launching the factory in October 2022. “We have reached the highest quarterly sales in our history, primarily due to the revenue generated from the fourth facility’s operation, enhanced operational efficiency in the existing first to third facilities, increased sales volume at Samsung Biologics, and the launch of new products,” the company explained. In the previous year, they reported the total value of orders of 3.5 trillion won, contributing to a cumulative value of orders of approximately $12 billion. Furthermore, they have successfully secured contracts with 14 out of the top 20 global pharmaceutical companies as their customers. Samsung Biologics is actively responding to the increasing demand for biopharmaceuticals by constructing its fifth facility, which commenced in April last year and is scheduled for completion by April 2025. This fifth facility is strategically designed, incorporating the best practices from facilities 1 to 4, and will have a production capacity of 180,000 liters, successfully expanding the company's total production capacity to 780,000 liters. As part of its portfolio expansion plan, Samsung Biologics is proactively investing in Antibody-Drug Conjugate (ADC) production. The company is currently in the process of constructing manufacturing facilities for ADC production, with a target for completion within this year. Samsung Biologics has also invested in ‘AimedBio,’ a Korean company possessing advanced technology for ADC, and in the Swiss company ‘Araris Biotech’ through the ‘Life Sciences Fund’ it established with Samsung C&T. Samsung Biologics has established a business office in New Jersey, a hub for major pharmaceutical companies, to use it as a communication channel with customers. They plan to further expand into strategically important overseas locations to build a global order network and enhance their competitiveness in terms of sales capabilities. Samsung Biologics' subsidiary, Samsung Bioepis, has recorded a significant milestone by surpassing 1 trillion won in sales, reporting 1.203 trillion won, representing an 8% increase from the previous year. However, its operating profit decreased by 11%, reaching 205.4 billion won. In April 2022, Samsung Biologics incorporated Samsung Bioepis as its 100% subsidiary, and the performance of Samsung Bioepis is now reflected in Samsung Biologics' results. During that period, Samsung Biologics acquired 1,034,185,2 shares of Samsung Bioepis stock, previously owned by Biogen, for 2.7655 trillion won, officially transitioning Samsung Bioepis into a 100% subsidiary of Samsung Biologics. Currently, Samsung Bioepis sells seven biosimilars, including treatments for autoimmune diseases in the United States, such as ‘Hadlima,’ a biosimilar to ‘Humira,’ and treatments for rare blood disorders in Europe, such as ‘Epysqli,’ a biosimilar to ‘Soliris.’ Samsung Bioepis plans to focus on expanding product sales in the global market throughout this year. They plan to finalize the development of their follow-up biosimilar pipeline and prepare for a significant advancement in future businesses, such as ADC research. Samsung Biologics has projected its sales for this year to be 4.1564 trillion won.
- Company
- Sales of Esomezol ·Noltec↑ Nexium↓ in the PPI market
- by Kim, Jin-Gu Jan 25, 2024 05:49am
- Sales of major proton pump inhibitor (PPI) class of antiulcer drugs showed mixed performance last year. ‘Nexium (esomeprazole)’ saw a 4% year-on-year decline in prescriptions, while ‘Lanston LFDT (lansoprazole)’ and ‘Pariet (rabeprazole)’ also saw a decline in prescriptions. Hanmi Pharmaceutical's ‘Esomezol (esomeprazole)’ and Ilyang Pharmaceutical's ‘Noltec (ilaprazole)’ saw an increase in prescriptions last year. However, the increase has slowed down recently. This may be due to the rapid growth of its competitors such as P-CABs (potassium-competitive acid blockers). Presciptions of Esomezol·Esomezol Plus rise 3% in 1 yr…sales growth slows down Hanmi PharmaceuticalAccording to market research institution UBIST, Hanmi Pharmaceutical's ‘Esomezol‘ recorded the highest prescription sales in the domestic PPI anti-ulcer drug market last year. Esomezol prescriptions totaled KRW 61.6 billion last year, up 1% YoY. Hanmi Pharmaceutical launched Esomezol in 2008. Since then, its prescriptions have increased steadily. From 2018 to 2021, prescription sales increased by more than 20% every year. In 2021, it reached the KRW 50 billion mark for the first time and became the market leader. However, since 2022, its sales growth has slowed down. In 2022, sales increased by only 2% YoY, and in 2023, the growth rate decreased further to 1%. Hanmi Pharmaceutical launched Esomezol Plus in 2022 to make up for the slowdown in sales of Esomezol. Esomezol Plus is an immediate-release product that contains esomeprazole and magnesium hydroxide. It is characterized by a faster onset of action than the existing Esomezol. Esomezol Plus generated prescription sales of KRW 1.5 billion in 2022 and KRW 2.6 billion last year. Prescription sales of Esomezol and Esomezol Plus together increased by 3% from KRW 62.4 billion in 2022 to KRW 64.2 billion last year. The situation is not so different for Ilyang Pharmaceutical's Noltec. Noltec’s prescriptions rose 3% YoY to KRW 42.3 billion last year. From 2018 to 2020, Noltec’s prescription sales increased by more than 10% every year. In 2021, the year-on-year prescription growth rate decreased to 8% and further decreased to 3% in 2022 and 2023. Nexium KRW 33.5 billion→KRW 32.3 billion…prescriptions decreased for 3 consecutive years Other major PPIs performed poorly in the outpatient prescription market in general. AstraZeneca's Nexium posted prescription sales of KRW 32.3 billion last year. This is down 4% from the KRW 33.5 billion it had made in 2022. It was the 3 consecutive year the company saw a decline in prescriptions since 2021. Nexium’s sales grew steadily until 2020 and had long been a leader among PPI class anti-ulcer drugs, but prescriptions declined for the first time in 2021. With the decline, the company had to hand over its market lead to Hanmi Pharmaceuticals' Esomezol. In 2022, the decline was even greater. Prescription sales dropped from KRW 42 billion in 2021 to KRW 33.5 billion, dropping 20% in one year. Daewoong Pharmaceutical has concluded its copromotion agreement for Nexium (left) and is selling Nexium’s generic version, Nexierd (right) from 2022 The industry pointed to the change in domestic sales rights as one of the reasons for the decline in Nexium's prescription performance. Previously, Nexium was co-promoted and co-sold by Daewoong Pharmaceutical, but AstraZeneca and Daewoong chose to part ways at the end of 2021. Daewoong decided to focus its sales efforts on the launch of Nexium's potential competitor, Fexuclu (fexuprazan). So, Ildong Pharmaceutical took over the place of Daewoong Pharmaceutical and copromoted sales of Nexium ever since. Ildong aimed to synergize Nexium’s sales with another PPI antiulcer drug, Rabiet (rabeprazole), but both Nexium and Rabiet experienced a sales decline as a result. Daewoong decided to part ways with Nexium and launch a generic version of Nexium. Since 2022, the company started selling its Nexium generic Nexierd in 2022. At the same time, it sold Nexiquin, another generic version of Nexium, through its subsidiary Daewoong Bio. Nexierd and Nexiquin landed in the market in 2022, recording prescription sales of KRW 7.5 billion in the first year. However, sales dropped 8% to KRW 6.9 billion last year. Lanston·Pariet·Rabiet show slowdown in sales…influenced by rise in competition, including P-CAB etc. Takeda's Lanston LFDT (lansoprazole) has also seen a decline in its prescriptions for 3 consecutive years since 2021. Last year, prescription sales of Lanston LFDT were KRW 21.7 billion, down 7% YoY. The drug had made a personal new record in 2020 with KRW 32.8 billion in prescriptions, but it fell to KRW 30.8 billion the following year, and further declined to KRW 23.4 billion in 2022. Sales of Takeda's other PPI anti-ulcer drug, Dexilant DR (dexlansoprazole), have stagnated recently. Presciptions of Dexilant had increased from KRW 17.1 billion in 2020, to KRW 18.8 billion in 2021, then to KRW 20.9 billion in 2022. However, last year, it sold KRW 20.9 billion, the same as in the previous year. Eisai’s Pariet (rabeprazole) generated KRW 19.6 billion last year, down 4% YoY. Pariet’s prescription sales steadily expanded from 2018 to 2022 but saw a decline for the first time last year. Ildong Pharmaceutical's ‘Laviet’ decreased by 2% from KRW 19.4 billion in 2022 to KRW 19.1 billion last year. Sales of Daewon Pharmaceutical's Eswoamp (esomeprazole) fell 6% to KRW 18.8 billion from KRW 20 billion during the same period, and Takeda's Pantoloc (pantoprazole) fell 5% to KRW 12.1 billion from KRW 12.7 billion. The industry pointed to the rise of its competitors as one of the reasons for the sluggish sales of the major PPI class anti-ulcer drugs. P-CAB class drugs are one representative. The rapid rise in prescription sales of HK Inno.N’s ‘K-CAB (tegoprazan)’ and Daewoong Pharmaceutical's ‘Fexuclue (fexuprazan),’ had relatively slowed down sales of PPI drugs that have the same indication. K-CAB recorded prescription sales of KRW 158.2 billion last year. Since its launch in 2019, it has made strong growth, recording a 20% YoY increase in sales. Fexuclue recorded prescription sales of KRW 53.5 billion last year. After launching in July 2022 and generating sales of KRW 12.9 billion by the end of the year, its sales rose even more steeply last year. The rise of PPI+antacid combination drugs is also analyzed to have contributed to the decline of PPI single-agent drugs. The PPI+antacid market grew rapidly, recording KRW 19.8 billion in 2020, to KRW 27.6 billion in 2021, to KRW 44.2 billion in 2022, and then to KRW 53.8 billion last year.
- Company
- Potential of AVEO Oncology acquired by LG Chem
- by Jan 24, 2024 05:46am
- LG Chem's subsidiary AVEO Oncology is showing results in intractable cancers. AVEO, which was acquired by LG Chem in 2022 for about KRW 750 billion, specializes in developing new anticancer drugs and has recorded annual sales of about KRW 200 billion. AVEO owns Fotivda (tivozanib), which has been approved in the U.S. for the treatment of Stage III or higher renal cell carcinoma. In addition to Fotivda, AVEO is developing first-in-class drugs for refractory cancers such as head and neck cancer and triple-negative breast cancer through novel mechanisms of action. According to industry sources on the 23rd, AVEO’s head and neck cancer drug candidate, ficlatuzumab, recently entered Phase III clinical trials. Ficlatuzumab is a new head and neck cancer drug candidate that targets hepatocyte growth factor, or HGF, and c-MET. In the trial, AVEO is evaluating the efficacy and safety of ficlatuzumab in combination with Merck’s Erbitux(cetuximab) in patients with recurrent or metastatic (R/M) human papillomavirus(HPV)-negative head and neck squamous cell carcinoma. In the Phase II study, ficlatuzumab+Erbitux demonstrated superior efficacy compared with Erbitux monotherapy. After 2 years of follow-up in 58 patients with head and neck cancer, the ficlatuzumab plus Erbitux combination achieved a median progression-free survival (PFS) of 3.7 months and an objective response rate (ORR) of 19%. Two patients achieved a complete response (CR) and four patients achieved a partial response (PR). Overexpression of c-Met was associated with a reduced risk of disease progression in the HPV-negative arm. The efficacy of Erbitux monotherapy was not demonstrated during the same period. AVEO is also exploring the potential of ficlatuzumab in combination with chemotherapy in patients with pancreatic cancer and acute myeloid leukemia in early clinical trials. In both studies, ficlatuzumab demonstrated efficacy activity and an acceptable tolerability profile. AVEO plans to further evaluate the efficacy of ficlatuzumab in various solid tumors. AVEO develops candidate substances for intractable cancers, including triple-negative breast cancer and pancreatic cancer In addition, AVEO is also accelerating the development of its oncology pipeline. Among them, the new drug candidate in the fastest clinical stage is AV-203. AV-203 is designed to inhibit both ligand-dependent and -independent HER3 signaling. Ligand specifically binds to the receptor. HER3 is a receptor whose expression has been identified in a number of solid tumors, and to date, no new cancer drugs have been developed that target this biomarker. In addition to AV-203, Daiichi Sankyo's patritumab is currently being evaluated for HER3-mutated breast cancer. AVEO has completed a Phase Ia study of AV-203 in patients with advanced solid tumors. AV-203 was well tolerated in multiple tumor models, including breast, head and neck, lung, ovarian, and pancreatic cancers. In the trial, AV-203 demonstrated early signs of activity in HER3-responsive ligands, heregulin or neuregulin, that was consistent with those confirmed through preclinical data. Therefore, AVEO plans to continue to a Phase 1b study. AVEO is also conducting clinical trials for its AV-380. AV-380 is an innovative new drug candidate that targets growth differentiation factor 15 (GDF15). GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Cancer cachexia is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue. 80% of cancer patients are known to suffer from cachexia. Preclinical data confirmed that inhibiting GDF15 with AV-380 can reverse the effects of cachexia. In addition, AVEO is also conducting a preclinical study for AV-353 in patients with triple-negative breast cancer in collaboration with the Mayo Clinic in Minnesota, USA. AV-353 is an inhibitory antibody specific to Notch 3, a signaling pathway that is important in cell-to-cell communication involving gene regulation mechanisms that control multiple cell differentiation processes during the entire life cycle. The Notch 3 receptor pathway has been implicated in multiple diseases, including cancer, cardiovascular diseases, and neurodegenerative conditions. AVEO is leveraging its Human Response Platform to secure its drug pipeline. All of its drug candidates in development including ficlatuzumab, AV-203, AV-380, and AV-353, were developed using AVEO's proprietary Human Response Platform.
- Company
- ‘I believe in MSD Korea and the Korean government'
- by Eo, Yun-Ho Jan 24, 2024 05:46am
- Patrick Tung Executive Director, Regional Market Access Head, Asia Pacific at MSD Applying for reimbursement extensions to 13 indications at the same time is an unprecedented move. This move was made by MSD Korea for its immuno-oncology drug Keytruda (pembrolizumab), and the case has been marked as a ‘historical first’ ever since the introduction of the positive-listing system in Korea. Applying for the reimbursement of 13 indications is not an easy task. Since Keytruda is a risk-sharing agreement (RSA) drug, each indication must undergo an evaluation process similar to that of a new drug to be eligible for reimbursement. Indications approved through Phase III trials must go through a pharmacoeconomic evaluation review to prove cost-effectiveness, while those approved based on Phase II trials must negotiate with the government and waive the pharmacoeconomic evaluation process. As expected, the process was not easy. Since applying for reimbursement extensions last year, Keytruda has had 7 indications submitted to the National Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee, but none have crossed the threshold. The remaining 6 indications are scheduled to be presented in the first CDDC meeting of the new year in 2024. Dailypharm met up with Patrick Tung, Head of Market Access at MSD Asia Pacific, to find out more about the company’s plans to expand Keytruda's reimbursement coverage in Korea. -It's 13 indications. You've gained quite a lot of attention with the simultaneous application. Why did you use this strategy to extend reimbursement for Keytruda in Korea? The 13 indications we applied for this time are all aggressive cancers that threaten patients' survival, but for which no or only a few alternative options exist. Therefore, there remained a dire need for improved access to treatments that have verified efficacy. Keytruda has demonstrated its value in all 13 of the indications. We believe it is our responsibility to improve access so that as many patients as possible can enjoy the therapeutic benefits of Keytruda. To help address the unmet need in the treatment field, we decided to apply for a reimbursement extension for all 13 indications at once. - There must have been some heated discussions within the company before applying, What were your biggest concerns? What advice did you give to the Korean team? When you put the patients first, applying for the reimbursement extension by itself was not a difficult decision. Our only concern was that since we were applying for so many indications at once, it would take quite some time for the government officials to review and process the application. Rather than advice, I have expressed my support for the Korean team. The market access team at MSD Korea is made up of skilled and experienced professionals, so I'm sure they'll eventually get it done. -Do you expect the reimbursement standard to be extended to cover all 13 indications? Honestly, it is difficult to predict the outcome at this point. However, I believe we will be able to find a solution as long as we share the common goal of improving access to treatment for cancer patients in Korea. Our Korean team and MSD are ready to work together to find that solution. However, this is the first time MSD has ever applied for the reimbursement of 13 indications at once as well. As this is unprecedented in Korea, HIRA will also need to conduct a thorough review taking many factors into consideration. – How is Keytruda being reimbursed in countries in the Asia-Pacific region? It is reimbursed in some countries and the cost is fully by the patient in others. However, in general, reimbursement for Keytruda is increasing worldwide across multiple indications. The number of reimbursed indications has been increasing in particular in the Asia Pacific region. For example, many countries, including Australia, Taiwan, and Singapore, have been continuously making efforts to extend reimbursement for Keytruda. For example, in Australia, the Pharmaceutical Benefits Advisory Committee gave a positive recommendation and confirmed Keytruda’s reimbursed use for early triple-negative breast cancer and metastatic or recurrent triple-negative breast cancer this year, following last year's approvals for cervical cancer and urothelial cancer. - Is there a reimbursement system that you would like Korea to refer to? Over the past year, we have seen reimbursement progress made for several indications in Australia. Taiwan is also making significant progress in expanding Keytruda’s reimbursement, and encouraging discussions are being made in some emerging countries as well. While it's difficult to replicate what is being done in these other countries, many countries, such as Australia and the United Kingdom, are taking a flexible approach to reimbursement for products with multiple indications. Also, Canada and other European countries have introduced concepts such as Multi-Year Multi-Indication, which allows drugs to be priced and contracted based on prescription volume, which allows the countries to reduce the time to reimbursement compared to the current system. A proposal to adopt a similar concept has recently been submitted in Australia and is currently being reviewed by the PBAC. Of course, the situation in these countries is very different from Korea, including their ICER threshold, but can still be good cases to consider when devising ways to move more flexibly within the current system. - What factors in the Korean reimbursement environment do you believe are contributing to the relative delay in Korea’s reimbursement of innovative cancer drugs compared to other countries? Korea seems to have a great and very rigorous insurance system. In any country, you need a system that is flexible enough to accommodate new products that provide real value to patients when they come to market. We do not need to ‘reinvent the wheel.’ It's about learning from the past and finding ways to make new products work within the existing regulatory environment. Also, it's not just the system that needs to be flexible. Flexibility is also needed in the funding of innovative medicines. The UK has a Cancer Drug Fund to ensure rapid access to cancer drugs, so creating a fund like this can be a good idea. We understand that the Cancer Drug Fund has been so successful that the UK has created an additional Innovative Medicines Fund to expand the range of eligible drugs.
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- SGLT2i+DPP4i combos' performance falls short of expectations
- by Kim, Jin-Gu Jan 23, 2024 06:02am
- A large number of 'SGLT-2 inhibitor (SGLT2i)+DPP-4 inhibitor (DPP4i)' combinations entered the market after Korea’s insurance reimbursement was extended to cover ‘SGLT-2 inhibitor + DPP-4 inhibitor’ combinations, however, their sales performance in the first year is falling short of expectations. Of the major products that have been on the market since May, only 3 generated more than KRW 2 billion in prescriptions by the end of the year. Of the more than 30 dapagliflozin+sitagliptin combination products released since September, most prescriptions sold less than KRW 100 million by the end of the year. In the field, prescribers are noting how the extended reimbursement is applied to the 3 drug combinations of SGLT2i+DPP4i+metformin. Therefore, rather than adding metformin to the newly launched SGTL2i+DPP4i two-drug combination drugs, prescribers have been mainly prescribing the combination by adding a single SGLT2i agent to existing DPP4i+metformin combination drugs. SGLT2i+DPP4i combo mkt size KRW 8.8 bil… Esglito>Zemidapa>Qtern According to the pharmaceutical industry on the 23rd, the outpatient prescription market for SGLT2i+DPP4i combination was KRW 8.8 billion last year. Behringer Ingelheim's Esglito (empagliflozin+linagliptin)’ has shown the highest prescription performance, generating KRW 2.7 billion in prescription sales in the 8 months following its reimbursement listing in May last year. This was followed by LG Chem's Zemidapa (dapagliflozin+Zemiglo) and AstraZeneca's Qtern (dapagliflozin+saxagliptin), each of which recorded KRW 2.1 billion. Qtern is being sold by Ildong Pharmaceutical in Korea. The rest of the combination drugs have all posted less than KRW 1 billion in sales. Chng Kun Dang’s ‘Exiglu-S Tab (dapagliflozin+sitagliptin) posted KRW 600 million, Dong-A ST’s Sugadapa (dapagliflozin+evogliptin) posted KRW 500 million, and AstraZeneca's Sidapvia (dapagliflozin+sitagliptin) for KRW 200 million. Of these, all products other than Sidapvia, have been sold in earnest since their reimbursement listing in May last year. Sidapvia was launched in September last year after the patent expiry of Januvia (sitagliptin). The drug is manufactured and supplied by SK Chemicals in Korea. Other dapagliflozin+sitagliptin combinations launched alongside Sidapvia have accumulated less than KRW 100 million in prescriptions from September until the end of the year. Industry expresses performance is 'below expectations'...Different response from when the 96 companies were approved The market was formed after reimbursement was extended to combination therapy in Korea for diabetes in April last year. At the time, the government extended reimbursement to the SGLT2i+DPP4i+metformin combination. In May, the SGLT2i+DPP4i combination drugs were approved The pharmaceutical industry had initially predicted that demand would rise for combination products, especially those that combined SGLT2i and DPP4i since it was the first time the combined use of SGLT2i and DPP4i was reimbursed in Korea. In fact, the pharmaceutical industry had shown great attention, with 96 companies receiving approval for the 2-drug combo around the period of the reimbursement expansion. In April, the patent for the flagship SGLT2i class drug Forxiga (dapagliflozin) expired. The companies that owned original DPP4i drugs rushed to launch combination products that contained dapagliflozin. In September, the patent for Januvia (sitagliptin), the flagship DPP4i class drug, also expired. The expiration of the patents for the top drugs in each class led to a flurry of launches of dapagliflozin+sitagliptin combinations. But now last year's outpatient prescription performance results are out, and the industry consensus is that the performance of the 2-drug combinations is a disappointment. Even when considering that it was the first year of sales, it was not up to expectations. When taking the dapagliflozin+sitagliptin two-drug combination as an example, 34 companies have launched their product since September, but their combined prescription sales amounted to only KRW 1.4 billion. The average prescription per company is less than KRW 50 million. Combination drugs that used original drugs fared similarly. Taking Esgliteo, the highest-selling drug last year that posted KRW 2.7 billion as an example, its components, the single-agent drugs ‘Jadiance (empagliflozin)’ and ‘Trajenta (linagliptin),’ generated prescription sales of KRW 58.1 billion and KRW 61.3 billion, respectively, last year. "Prescribing the more familiar DPP4i+metformin combination"...New combinations at a crossroads The industry has raised various interpretations on the lower-than-expected performance of the drugs. First of all, one analysis was that the new combination drugs were not well received in the field. The government's diabetes benefit extension was for the three-drug combination of SGLT2i+DPP4i+metformin. The SGLT2i-DPP4i two-drug combination by itself is not covered. As a result, prescribers were left to choose one of three options: SGLT2i+DPP4i combo and metformin, SGLT2i+metformin combo and DPP4i, or SGLT2i and DPP4i and metformin. The problem is that prescribers were relatively more familiar with the SGLT2i+metformin or DPP4i+metformin combinations that were already on the market, compared with the more newly introduced SGLT2i+DPP4i combinations. "To use the newly approved SGLT2i+DPP4i combinations, patients would need to change all of their existing medications, whereas DPP4i+metformin combinations require patients to add a single SGLT2i to their existing medications, so there is less patient resistance," explained one endocrinologist. "Also, the combination drugs are not very competitive price-wise when compared with prescribing each drug separately," he added. In the case of the dapagliflozin plus sitagliptin combination, supply issues with sitagliptin also played a role. In the case of sitagliptin, one contract manufacturer manufactures products for 10 or more companies. The production capacity of the contract manufacturers has reportedly become overwhelmed, manufacturing the ingredients for so many companies. Some companies are also reportedly having difficulty producing products for companies due to difficulty procuring raw materials that need to be imported from India. However, there is also industry opinion that it is too early to tell whether SGLT2i+DPP4i combination products will be successful in the market. As there is still a possibility that the sitagliptin contract manufacturers will be able to stabilize their supply, and as related products are in the early stages of their launch, there remains enough potential for future market expansion.
- Company
- Will Verzenio secure expansion for early breast cancer?
- by Eo, Yun-Ho Jan 23, 2024 06:02am
- Lily Korea ‘Verzenio’, which faced difficulties in expanding its reimbursement standards last year, is now drawing attention to see if it will pass the review this time. According to industry sources, Lily Korea’s CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st. Their second attempt to expand the reimbursement is for Verzenio’s indication in early-stage breast cancer. Verzenio faced challenges in initial attempt to expand its indication for early-stage breast cancer when it was presented to the Cancer Disease Review Committee. Despite submitting the application and waiting for six months, Verzenio was presented to the committee in May of the previous year, but the result was ‘reimbursement standards non-established.’ After five months, Verzenio re-submitted its reimbursement application to the HIRA in October. After Verzenio was resubmitted, a national petition was posted on the Cheong Wa Dae public petition website in the same month, advocating for ‘the reimbursement of Verzenio as a targeted treatment for early-stage breast cancer’. In the most recent application, clinical evidence was added, including the five-year outcomes from the monarchE study, presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The data used for the follow-up research were based on the four-year data presented at the 2022 San Antonio Breast Cancer Symposium held in December and an article published in The Lancet Oncology. The primary endpoints, which were invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), showed clinically significant differences between the Verzenio treatment group and the control group (endocrine therapy alone) that was even more pronounced in five-year data compared to the four-year data. In year 5, the primary endpoint invasive disease-free survival (IDFS) demonstrated an approximately 8% difference. Verzenio appears to have a potential carry-over effect through the fifth year even after the completion of the two-year treatment period. Besides the endocrine therapy letrozole generic, Verzenio is the only treatment option available in HR+/HER2- type early-stage breast cancer. On November 18, 2022, Verzenio received expanded approval for its use in combination with endocrine therapy in the adjuvant treatment of patients with HR+/HER2- high-risk early-stage breast cancer and who have lymph node-positive recurrence. The following are specific indications: ▲Four or more lymph node metastases, ▲1-3 lymph node metastases with a tumor size of 5 cm or larger, ▲Histological grade 3 limited recurrent high-risk patients.
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- Sotatercept receives orphan drug designation in Korea
- by Eo, Yun-Ho Jan 22, 2024 05:49am
- Sotatercept, a new drug candidate for pulmonary arterial hypertension (PAH), has been designated an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced the drug’s designation in the first orphan drug designation announcement it made in the new year. Sotatercept, which is being developed by Merck, is being regarded to have changed the treatment paradigm for PAH. The substance, which is a combination of a protein complex, activin, and the transforming growth factor-β (TGF-β), reverses disease progression by blocking abnormal signaling between cells in the pulmonary blood vessels. Pulmonary arterial hypertension is a condition characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. which leads to heart failure. In Korea, about half of the patients with PAH die within 5 years. More than 10 drugs are available for the condition in Korea, including phosphodiesterase type 5 inhibitors and endothelin receptor antagonists, but many patients suffer from severe symptoms despite being on a combination of two or three drugs. The efficacy of the drug has been confirmed in the pivotal Phase III STELLAR trial. Patients were randomized 1:1 to sotatercept or placebo to assess the efficacy and safety of the drug. Results showed that the sotatercept group improved in 6-minute walk distance (6MWD, primary endpoint) by 40.1 m, compared with a decline of –1.4 m in the placebo group Also, 38.9% of patients in the sotatercept group achieved all of the multi-component improvement endpoints, the secondary endpoint of the study, which included an improvement of 30m or more in the six-minute walk test. This was 4 times longer than the 10.1% in the placebo group. The US FDA will decide whether to approve sotatercept by March 26, the target action date it had set under the Prescription Drug User Fee Act (PDUFA).
- Company
- First oHCM drug Camzyos applies for reimb in Korea
- by Eo, Yun-Ho Jan 22, 2024 05:49am
- The first-ever obstructive hypertrophic cardiomyopathy (oHCM) treatment, ‘Camzyos,’ is being reviewed for reimbursement in Korea. According to industry sources, BMS Korea has recently applied for the reimbursement listing of its new obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten). Therefore, whether the drug will be deliberated by the Health Insurance Review and Assessment Service within the first quarter of this year remains to be seen. 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. Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle. In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, 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 two 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. oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body. Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure. Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone. Meanwhile, the European Society of Cardiology revised its HCM guidelines for the first time in nine years with the introduction of Camzyos and recommended it as a second-line treatment. Among all treatment options for oHCM, Camzyos received the highest level of evidence, level of evidence A. Previously, no other recommended drug option had a higher level of evidence than B.
- Company
- Hemlibra reduces risk of exercise-associated bleeding
- by Lee, Seok-Jun Jan 19, 2024 05:44am
- JW Pharmaceutical’s hemophilia A treatment ‘Hemlibra (emicizumab)’ The research findings, which include data on the physical activities of patients treated with JW Pharmaceutical’s hemophilia A treatment ‘Hemlibra (emicizumab)’ and their safety profile, have been published in the International Journal of Hematology (Int J Hematol). Hemlibra is an innovative new drug that mimics the function of blood coagulation factor VIII, which is usually deficient in patients with hemophilia. It is unique in that it can be used to treat hemophilia A in both patients with antibodies and those who are resistant to existing treatments (factor VIII drugs). A single subcutaneous injection of Hemlibra can yield a lasting preventive effect for up to four weeks. Last May, reimbursement subjects were expanded to patients with non-antibody severe hemophilia A patients aged one or older. According to the company, the research team led by Professor Keiji Nogami from the Department of Pediatrics at Nara Medical University conducted the study, which enrolled 107 patients with non-antibody severe hemophilia A with an average age of 35, from Jan. 2019 to May 2021. The research team evaluated the relationship between patients' physical activity and measurements such as bleeding events and safety using the electronic patient reporting application 'ePRO' and wearable activity trackers following Hemlibra treatments. The research findings showed that, following Hemlibra treatments, 47 out of 74 patients aged six or older engaged in various physical activities over eight days at 5 weeks, 25 weeks, 49 weeks, 73 weeks, and 97 weeks. ePRO recorded 396 physical activities, while wearable activity trackers recorded 329 activities. Based on the data from wearable activity trackers, walking exercise was the most common physical activity among patients, with 24 individuals (32.4%) participating. This was followed by cycling with 11 patients (14.9%) and soccer with 4 patients (5.4%). The range of activities patients engaged in included high-intensity exercises such as basketball, skiing, and tennis, in addition to soccer. In the ePRO data, it was observed that bleeding occurred only twice during the recorded exercise sessions. 106 patients with Hemophilia A reported a mean annualized bleeding rates (ABR) of 0.91. During the study, zero bleeds were reported in 57 patients, making 53.8% of the total. “This research holds significant value as it demonstrates that patients, when treated with Hemlibra, can participate in various physical activities without requiring additional injections of factor VIII drugs before exercise. We hope that Hemlibra will allow more individuals with Hemophilia A to engage in a wide range of physical activities without limitations, “ a representative from JW Pharmaceutical stated.
