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- 2026-05-06 09:54:42
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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.
- Opinion
- [Reporter’s View] KRPIA's new BOD signifies fresh starts
- by Eo, Yun-Ho Jan 25, 2024 05:49am
- Following its fresh start with new staff members and a restructured board of directors, KRPIA is stabilizing its operations. Previously, Korean Research-based Pharmaceutical Industry Association (KRPIA) faced increasing concerns regarding its operations, primarily involving leadership vacancy. The decrease in the number of board members can be explained by reassignments of CEOs in multinational companies, but the frequent resignations of high-ranking officials, including the Head of Policy Business, Kim Min-Young, have sparked inquiries into the association's responsibilities and functions, resulting in criticisms. KRPIA's operations in the New Year signals a new beginning. Beginning in February, Choi In-Hwa, currently serving as the Access & Policy Cluster lead at Roche Korea, will assume the role of KRPIA’s Head of Policy Business, which has remained vacant for a year. Choi graduated from the College of Pharmacy at Ewha University and began her career as a public pharmacist at the Central Pharmaceutical Affairs Council (CPAC) within the Ministry of Food and Drug Safety (MFDS). Following this role, Choi held positions at Boryung Pharmaceutical, Taejoon Pharmaceutical, and Roche since 2001, accumulating over 20 years of experience in managing policy-related responsibilities, including Market Access (MA) and Regulatory Affairs (RA). Among the MA managers, Choi is called the ‘big sister.’ KRPIA's board of directors currently consists primarily of Korean nationals. Out of the 13 members, which includes KRPIA chairman Dong-Wook Oh, who is the CEO of Pfizer Korea, only two are foreign nationals, resulting in Korean members making up 85% of the board. This trend can be attributed to multinational pharmaceutical companies appointing Koreans as CEOs for their Korean branches instead of foreign nationals, consequently shaping the board of directors as Korean members in the majority. Junil Kim (CEO of Astellas Pharma Korea), JinA Lee (CEO of Bayer Korea), and Albert Kim (CEO of MSD Korea) are Koreans who were newly appointed last year. Among them, Albert Kim holds Canadian nationality. Two new members, Maurizio Borgatta (CEO of GSK Korea) and Christoph Hamann (Merck Korea), are the only foreign nationals. The growing presence of Korean leadership within KRPIA does not necessarily imply that it is the best approach. However, it is worth noting that KRPIA is currently navigating a crucial and significant period in its history. It is reasonable for the KRPIA CEO position to be held by a Korean national, especially considering that multinational pharmaceutical companies are involved in the distribution of new drugs. The CEO's primary responsibility often involves communication with departments responsible for overseeing the drug pricing system in Korea. Especially now, multinational pharmaceutical companies tend to focus on high-priced drug pipelines, and the successful listing of these drugs often hinges on effective communication skills with the government. Additionally, departments within the Ministry of Health and Welfare (MOHW) often favor communication with Korean leaders, further emphasizing the importance of having a Korean national in key positions. Choi's appointment is indeed promising. As she prepares to step down from her role at Roche Korea at the end of this month, her status as a high-ranking official places her in a prominent position for effective communication. She will play a crucial role in engaging not only with association members but also with government departments across various aspects of the pharmaceutical industry. KRPIA is entering a new era of operation, and there is a hope that it will focus on ‘enhancing patient access’ through rational and innovative negotiations with the MOHW, in addition to its role in managing drug pricing.
- 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.
- InterView
- Patent outlook after Forxiga withdrawal in Korea
- by Kim, Jin-Gu Jan 24, 2024 12:37pm
- Forxiga If ‘Forxiga (dapagliflozin)’, a SGLT-2 inhibitor class treatment for diabetes, is withdrawn from the Korean market, the question is whether companies can begin selling generics containing the same active ingredient for the treatment of heart failure. The answer to the question is that selling Forxiga generics for the purpose of treating heart failure might be challenging. This is because the ‘method-of-use patent' describing the treatment of heart failure has been registered, regardless of the withdrawal of Forxiga from the Korean market. However, generic companies may have options available to treat kidney disease. AstraZeneca has completed the filing of the method-of-use patent for treating heart failure with the patent office. Yet, they must still complete the filing process for the method-of-use patent related to treating kidney disease. Even though the method-of-use patent for heart failure has been registered and listed for reimbursement, Forxiga withdraws from the Korean market In March 2020, AstraZeneca filed the method-of-use patent for Forxiga, which described its use in treating heart failure. The patent, titled ‘the use of dapagliflozin in treating heart failure with reduced ejection fraction,’ is set to expire in March 2040. The company faced challenges before finally obtaining patent registration. Following the initial patent filing, the company received a rejection letter from the patent office and subsequently faced two more rejection decisions. AstraZeneca revised the patent statement three times before successfully registering the method-of-use patent with a description related to heart failure in February 2022. In July of the same year, the patent was listed with the Ministry of Food and Drug Safety (MFDS). Prior to this listing, in December 2020, the indication for 'the use of dapagliflozin in treating heart failure with reduced ejection fraction' was added to the MFDS approval list. The expanded reimbursement will be applied to Forxiga. On the 19th, the Ministry of Health and Welfare (MOHW) announced that the reimbursement for SGLT-2 inhibitors, including Forxiga and Jardiance, will be expanded to the treatment of chronic heart failure, starting next month on the 1st. The issue is that AstraZeneca Korea decided to withdraw Forxiga from the Korean market between the time when the heart failure indication was added, and the reimbursement application was made. In December of last year, AstraZeneca announced its decision to withdraw Forxiga from the Korean market by the first half of this year. AstraZeneca explained it as a "portfolio restructuring decision." AstraZeneca has stated that the supply of Forxiga in Korea is secured enough until its withdrawal. However, there is concern that patients with heart failure may face limited access to Forxiga, as they will need to discontinue its once the remaining stock is depleted. Generic companies would need to challenge the 'method-of-use patent' related to the active ingredient to begin selling drugs for the treatment of heart failure The generic versions of Forxiga only have indications for type 2 diabetes because generic companies have not challenged the method-of-use patent. When generic companies began extensive patent challenges after 2015, the method-of-use patent for heart failure had not been registered. In technical terms, Forxiga generics cannot be marketed for the treatment of heart failure without nullifying the method-of-use patent. After last year’s flood of generics, certain companies used promotional materials claiming their products as being effective in treating heart failure. In response, the MFDS concluded in June last year that "promotion for the treatment of heart failure is a violation of the Pharmacist Act." As a result, companies that used such promotional materials faced a three-month suspension of advertising activities in August. Due to these reasons, generic companies are in a situation where they need to file for nullification of the patent for the use of Forxiga to treat heart failure. However, no generic companies have applied to nullify the patent for Forxiga for treating heart failure. "Many pharmaceutical companies are closely monitoring the potential nullification of the patent through cancellation applications, given AstraZeneca's decision to withdraw Forxiga," a pharmaceutical industry staff has commented and added, "Once AstraZeneca's stance becomes clear, generic companies will likely determine whether to challenge the patent for heart failure." "The headquarters are responsible for managing the patent-related matters, and there are currently no plans for patent cancellation," AstraZeneca has stated. AstraZeneca “undecided on canceling the patent”…Has not registered the kidney disease method-of-use patent The status of the patent for the treatment of kidney disease remains uncertain. Although the indication for kidney disease treatment has been added to the MFDS’s regulatory approval, an official patent has not yet been registered. AstraZeneca submitted a patent application titled 'the use of dapagliflozin in treating heart failure with reduced ejection fraction' in April 2021. However, this patent has yet to be officially registered. The Patent Office has rejected the patent registration twice, and in response, AstraZeneca has filed an appeal against the rejection decision. If the patent for treating kidney disease is officially registered, generic companies may have the opportunity to challenge it through nullification proceedings and gain approval for the indication of kidney disease. However, the current situation is complicated because there is no registered patent for kidney disease treatment, making initiating a challenge through invalidation proceedings impossible. Generic companies may have two options. One option is to wait until the kidney disease method-of-use patent is finally registered and then initiate a nullification proceeding, following a path similar to the heart failure method-of-use patent. Another option is for generic companies to modify their generic approval by adding the kidney disease indication before it is officially registered. If the kidney disease method-of-use patent is registered later, generic companies can address any potential patent infringement lawsuits that AstraZeneca might file in response. Yet, it seems that no generic companies have applied for the addition of the indication for kidney disease at this time. Additionally, AstraZeneca has stated that they are still undecided about whether they will complete the patent registration process for kidney disease, similar to the heart failure patent.
- Opinion
- [Reporter’s View] Supply disruptions disclosed in real-time
- by Lee, Hye-Kyung Jan 24, 2024 05:46am
- As of January 10, it became possible to view the list of medicines that are at risk of short shortages or interruptions in real time. The Ministry of Food and Drug Safety (MFDS) has improved the quarterly drug manufacture, import, and supply interruption information system on the Nedrug webpage to allow real-time updates. As a result, not only the status of supply interruption and shortage of drugs, but also the expected date of supply normalization, the reason for the interruption, and alternative drug items are transparently disclosed. Previously, the Ministry of Food and Drug Safety disclosed manufacture, import, and supply interruptions reported by pharmaceutical companies up to 60 days in advance every quarter, leaving the information checked through the website ‘outdated.’ As a result, medical institutions and pharmacies have been checking the list of shortage and discontinued drugs through their wholesalers. However, it has been difficult to determine when and for what reason the shortage occurs for drugs that they do not deal with. Also, consumers who did not know the status of drug supply had no way of knowing which drugs were in short supply in the field. However, after the MFDS released the list of drug supply interruptions, we learned that the brain function enhancer Semion (nicergoline) had experienced a supply interruption due to facility issues and that the shortage of asthma treatment drug ‘Montelukan ODT 10mg (montelukast sodium)’ was due to a surge in sales and will be normalized around January 26. The MFDS’s decision to expand the disclosure of drug-related information is not only helpful for the consumers but also for those in the clinical and pharmaceutical field. The MFDS, which had been reluctant to disclose various information, has changed its stance and started to actively disclose information in 2022. The contact information for each department in the organizational chart, which was previously kept private, is now available on the website, and new drug approval information is released in real time through a press release. The status of approvals for each medical product every week and the status of drugs subject to information disclosure are also disclosed every month. The real-time reporting of drug supply interruptions is considered a positive change that MFDS MInister Yu-Kyung Oh has been making toward an 'open MFDS' since her appointment in 2022. The general election is coming up on April 10. There is a lot of talk about her resignation from the MFDS due to the ‘general election shake-up' that always occurs during the general election season. It is this reporter’s hope that the positive changes that have been made so far will not be reversed regardless of who is appointed.
- 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.
- Policy
- Handok-Sanofi launches hypertension combo drug Aprovasc
- by Lee, Tak-Sun Jan 24, 2024 05:45am
- Aprovasc, a hypertension combination drug co-developed by Handok and Sanofi Aventis Korea, will enter the market in earnest with reimbursement on the 1st of next month. The product is a combination drug of ARB-class irbesartan, which was developed by Sanofi, and CCB-class amlodipine besylate. This is the first irbesartan-amlodipine combination released to the market. It was approved in Korea in November last year and completed the reimbursement listing process time. According to industry sources on the 23rd, three dosage forms of Aprovasc Tab will be listed starting on Feb. 1. The drug is indicated for essential hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy. Aprovasc received premium pricing as an incrementally modified new combination drug and for being a product of Handok’s, a company designated as a Korea Innovative Pharmaceutical Company. As a result, Aprovasc Tab 300/5mg will be listed at KRW 119.2/tablet. Aprovasc Tab 150/5mg and Aprovasc Tab 150/10mg also received a 68% premium in their pricing, but Handok listed them at lower prices, at KRW 854 and KRW 988, respectively. Aprovasc has gained industry attention as the two companies - Sanofi and Handok had partnered on the drug from development to sales. irbesartan (brand name: Aprovel) is an ARB-class hypertension drug developed by Sanofi. The two companies signed a license agreement in October 2019 for the development, manufacture, and licensing of Aprovasc in Korea. Since then, Handok has conducted domestic clinical trials and confirmed superior blood pressure-lowering effects compared with irbesartan monotherapy in two Phase III trials. The two companies will also collaborate on sales activities. Handok will be in charge of the manufacturing, and the two companies will copromote the drug in the highly competitive domestic hypertension combination drug market. Currently, the ARB+CCB hypertension combination drug market is crowded with products such as Hanmi Pharmaceutical’s Amosartan, Boehringer Ingelheim’s Twynsta, Novartis’s Exforge, Daiichi Sankyo’s Sevikar, and Chong Kun Dang’s Telminuvo that post annual prescriptions (based on UBIST) of more than KRW 50 billion. With such viable competitors already occupying the market, the industry expectation is that Handok and Sanofi will have difficulty generating high sales in the short term as a late entrant. However, the industry also predicts that the product will be able to secure basic demand from patients who had difficulty controlling their blood pressure while being on Aprovel, as the irbesartan monotherapy drug Aprovel is the best-selling antihypertensive drug with an annual prescription volume of KRW 10 billion.
- Policy
- New drug Zavicefta Inj, and more completed drug pricing nego
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- Pfizer Korea’s new drug The two drugs Pfizer Korea’s ‘Zavicefta Inj’ and ‘Dulackhan Easy Syrup,’ which were in negotiations for a drug pricing increase due to short supply, have reached agreements in negotiations with the National Health Insurance Service (NHIS), and they are expected to receive reimbursements starting next year. The chronic kidney disease treatment ‘Kerendia Tab’ and genetic retinal disease treatment ‘Luxturna’ have completed drug pricing negotiations and are awaiting reimbursement next month. According to industry sources on the 19th, NHIS recently updated the listing of pharmaceuticals that have completed the drug pricing negotiations. The updated listing of new drugs that have completed negotiations included Kerendia Tab 10 mg/20 mg (finerenone, Bayer Korea), Luxturna (voretigene neparvovec, Novartis ), Zavicefta Inj 2g/0.5g (ceftazidime/avibactam). Among the drugs, Zavicefta Inj has omitted the upper limit amount negotiations and proceeded to the negotiations of the estimated amount of claim. Kerendia was approved by the Ministry of Food and Drug Safety (MFDS) in May 2022 as a treatment for chronic kidney disease in adult patients with type 2 diabetes. According to the American Diabetes Association’s (ADA) Standards of Care in Diabetes, Kerendia is suggested for use in combination with SGLT-2 inhibitor in patients who have an increased risk of cardiovascular events or sustained chronic kidney disease progression or those who are unable to use the SGLT-2 inhibitor. Accordingly, it is expected that Kerendia will be used more frequently in combination with SGLT-2 inhibitors, including Forxiga and Jardiance, which are used in treating chronic kidney disease. Starting next month, Chong Kun Dang Pharmaceutical will be responsible for sales and marketing of Kerendia. Luxturna is indicated for use in pediatric and adult patients who have sufficient surviving retinal cells but lost vision due to inherited retinal dystrophy caused by biallelic RPE65 mutations. Luxturna, a gene therapy, is a ‘one-shot treatment’ that can be administered as a single dose. The drug has garnered attention to whether it would pass the hurdle of insurance benefit due to its high price, with a non-reimbursement price of up to 1 billion won. Finally, the company secured the reimbursement listing through a risk-sharing agreement (RSA) with the NHIS, reducing the burden of insurance benefit expenses. Pfizer's Zavicefta Inj is a combination drug that combines "ceftazidime," a third-generation cephalosporin antibiotic, with "avibactam," an enzyme inhibitor that inhibits the function of beta-lactamase enzymes responsible for breaking down beta-lactam antibiotics, to maintain its antimicrobial potency. Zavicefta Inj has emerged as an alternative treatment option for treating multi-drug-resistant gram-negative bacteria or carbapenem-resistant intestinal bacteria, which previously had limited available treatment options. Two products that contain Lactulose Solution as their active ingredient have successfully reached an agreement in drug price negotiations, namely "Lactuse Syr" by Access Pharma and "Dulackhan Easy Syrup" by Chong Kun Dang Pharmaceutical. These Lactulose-based formulations, used for pediatric constipation, have been known as chronic shortage drugs due to limited supply compared to demand. Lactuse Syr, an imported item facing shortages, is anticipated to see increased availability in the market due to a rise in its drug price. Dulackhan Easy Syrup production is expected to increase following another drug pricing increase after 2022. Gilead Science Korea's Biktarvy Tab has completed the price-volume agreement type 'Na', which is expected to result in a reduction in drug pricing.
