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- 2026-04-08 16:59:23
- Opinion
- [Reporter’s View] Conglomerates expanding into the pharma
- by Kim, Jin-Gu Jan 26, 2024 05:51am
- M&A activities have made headlines in the pharmaceutical and biotechnology (pharma and biotech) industries in early 2024. Hanmi Pharmaceutical, a leader in the Korean pharmaceutical industry, has officially confirmed its merger with OCI group, a chemical company. Additionally, Orion has acquired LegoChem Biosciences, a globally recognized bioventure company. Major conglomerate companies are expanding their scopes into the pharma and biotech industries. In the previous year, Hanwha Group entered the biotechnology materials, components, and equipment sector, while in 2022, Lotte Group launched Lotte Biologics. CJ CheilJedang also made a comeback to the industry by acquiring the microbiome company Cheonlab, three years after selling HK Inno.N. The pharma and biotech companies such as Samsung, SK, and LG have announced their plan for increased investments. This trend reflects the pharma and biotech industries as a favored choice for business expansion among many conglomerate companies. It is expected that these conglomerate companies will play a central role in shaping the future of the Korean pharma and biotech industries. Currently, there are varying opinions on the industry outlook. However, a prevailing positive analysis is emerging concerning the increased investment in the Korean pharma and biotech industries. Until now, one of the significant differences between the Korean pharma and biotech industries and global big pharma has been investment size. Korean companies’ business model of licensing out potential candidate products to global big pharma is prevalent because Korean companies often struggle to manage the substantial costs associated with completing the clinical process. The entry of conglomerate companies with substantial available funds into the pharma and biotech industries has the potential to bolster R&D capacity. At the same time, concerns are emerging regarding the current trend, given the distinctive nature of the pharma and biotech industries. In the industry, drug development entails costs and time. Enormous investments and enduring patience until the final product is achieved are prerequisites. Typically, it takes around 10 years to identify a candidate product and bring it to market following clinical trials. Even if efforts to expedite development through open innovations, a waiting period of at least 4-5 years may be necessary. According to the report from the Biotechnology Innovation Organization (BIO), the average success rate of new drug development projects to obtain FDA approval for marketing between 2011 to 2020 stands at 7.9%. Even if a company secure FDA approval, it does not guarantee a business success. Successful commercialization and achieving business success in the global market are distinct processes. Korean industry giants have frequently achieved success through a method referred to as, ‘compressed growth’ in their respective fields. The question now arises whether the pharma and biotech industries will experience a similar period of compressed growth. These industry giants must endure extended periods of efforts until they reach success, while recognizing the possibility of commercialization failure. "Some employees from other subsidiaries seem to view the pharma and biotech industries as resembling a 'money pit,’ characterizing it as a sector that demands substantial financial resources but lags in delivering outcomes,” staff member from the pharma and biotech industries said. "From their perspective, our sector appears to require substantial investments, yet immediate returns are not apparent. However, this viewpoint may not be entirely fair." Conglomerate corporations entering the pharma and biotech industries with substantial investments is a positive development. However, more than financial investment is needed. Equally crucial, alongside these significant investments, is patience. It remains to be seen whether these large corporations can withstand a long and challenging journey through clinical trials, coupled with the weight of potential setbacks and failures.
- Policy
- MOHW “Drug pricing for listed drugs is set to be reduced"
- by Lee, Jeong-Hwan Jan 26, 2024 05:50am
- The Ministry of Health and Welfare (MOHW) In February, the government will post the outcomes of notifications of the second-round review & assessment, analyzing the upper limit of standards and requirements associated with the drug pricing reduction of currently listed generics. The adjusted prices will take effect on March 1st. The drug pricing reduction related to market-based actual transactions will be determined in the next round of implementation due to an incomplete review of national essential drugs and drugs in short supply. On the 24th, the Ministry of Health and Welfare (MOHW) representative explained the notifications mentioned earlier during a meeting with KSPANEWS. The MOHW initially planned to implement the drug pricing reduction in January, following re-assessment of reimbursement listed drugs and a survey of prices in actual transactions. However, this implementation was postponed. The MOHW has decided to implement the drug pricing reduction, reflecting the outcomes of the second-round reassessment of listed drugs, beginning on March 1st, following the notification process in February. Yet, the reduction related to the actual transaction will be postponed until further notification. There are approximately 1,000 items related to drug pricing reductions for listed drugs. However, the MOHW has clarified that considering the significant changes in drug pricing for a substantial number of drugs, they have included a preparatory period to minimize misunderstandings between pharmacies, marketing companies, and pharmaceutical companies. The MOHW has sought the opinions of companies to prevent the recurrence of the confusion that occurred during the first-round reevaluation of drug pricing reduction for listed drugs. In the initial round, the simultaneous processing of drug pricing reduction related to the volume-price linkage negotiations led to confusion among pharmacies and pharmaceutical companies. "We have not yet finalized the implementation date of price reduction associated with actual transactions due to ongoing reviews related to essential drugs and concerns surrounding the drugs in short supply," a representative of MOHW explained.
- Company
- Ildong Idience presents 1st interim results for Venadaparib
- by Kim, Jin-Gu Jan 25, 2024 05:50am
- On the 22nd, Idience, the new drug development subsidiary of Ildong Pharmaceutical, announced that they have presented the research findings related to 'Venadaparib' at the 2024 ASCO Gastrointestinal Cancers Symposium held from the 18th to the 20th. Venadaparib is a novel targeted anticancer candidate product with a mechanism focused on selective inhibition of ‘Poly ADP-ribose polymerase (PARP).’ Idience is currently engaged in clinical development efforts for various cancer types, including gastric cancer, breast cancer, ovarian cancer, and cancers with resistance to PARP inhibitors. Idience participated in a poster session at the symposium where they shared interim results from the Phase 1 clinical study. This study involved a combination therapy of Venadaparib and chemotherapy irinotecan in patients with gastric cancer undergoing third- or fourth-line treatments. According to the presentation, in the evaluable patient group (11 patients) who received an appropriate dosage combination of Venadaparib and irinotecan, the objective response rate (ORR) was 36.4%, with a median progression-free survival (mPFS) of 5.6 months. In the clinical trial, it was observed that among all the patients enrolled, the ORR was significantly higher at 60% in the subset of gastric cancer patients (5 patients) with homologous recombination deficiency (HRD), a marker for cancer treatment. “Considering that Lonsurf (trifluridine/tipiracil), which is used as third-line standard treatment for metastatic gastric cancer, has shown ORR at 4% and mPFS of 2.0 months, the clinical result of Venadaparib is promising,” Idience staff stated. Additionally, “Current Venadaparib study is particularly valuable because considering that human epidermal growth factor receptor 2 (HER2) expression is a marker for classifying HER2-positive gastric cancer and HER2-negative gastric cancer, Venadaparib efficacy was evaluated in patients with HER2-positive gastric cancer or HER2-negative gastric cancer, “ Idience staff emphasized. Since the current study confirmed Venadaparib's competitiveness and novelty compared to existing treatments, the company plans to speed up its development process, aiming to receive approval for the clinical entry (Phase 2/3) next year. Furthermore, the company intends to utilize the expedited assessment and approval system to accelerate its commercialization agenda. Idience is one of the subsidiaries of Ildong Holdings, formerly Ildong Pharmaceuticals. The company owns several pipelines related to anticancer drugs. Currently, Idience operates businesses, including clinical development of new candidate drugs, which includes Venadaparib, license-out, and open innovations.
- Policy
- Chong Kun Dang cuts price of its Lucen BS by half
- by Lee, Tak-Sun Jan 25, 2024 05:50am
- Chong Kun Dang is offering a bargain price for its biosimilar. The company has decided to cut the price of its 'Lucen BS', a biosimilar of the macular degeneration treatment Lucentis (ranibizumab, Novartis), by half from next month. As a result, the price difference between it and the original product, as well as it and Samsung Bioepis’s biosimilar, has widened significantly. According to the industry on the 23rd, Chong Kun Dang will voluntarily reduce the insurance price ceiling of its biosimilar 'Lucentis' by half from next month. Accordingly, the price of Lucen BS Inj 10mg/ml and Lucen BS Prefilled Syringe will be reduced from KRW 300,000 to KRW 150,000. Lucen BS was launched in January last year and is the first biosimilar of the macular degeneration treatment Lucentis in Korea. At the time, Lucen BS and Samsung Bioepis ‘Amelivu’ were listed simultaneously. The two companies set the price of their generic drugs at a much lower price than the original, at a price lower than the calculated amount. At the time of its reimbursement listing in January, the price of Lucen BS was KRW 300,000, which was 37% of the original drug’s price at the time. The price difference between it and the original drug as well as Samsung Bioepis’s product has become even greater now that Lucen BS’s price has been cut by half. Currently, the original Lucentis costs about KRW 580,000 per vial, while the biosimilar Amelivu costs KRW 350,000 per vial. With Lucen BS’s price set at KRW 150,000, patients will be able to access the biosimilar at 25% of the original price. Lucen BS’s price difference with another biosimilar, Amelivu, is KRW 200,000, making Lucen BS even more competitive in the market. Chong Kun Dang conducted a Phase III trial for Lucen BS from September 2018 to March 2021 at 25 hospitals, including Seoul National University Hospital on a total of 312 patients with neovascular (wet) age-related macular degeneration. Analysis of the primary efficacy endpoint, which compared the best-corrected visual acuity (BCVA) in 3 months after drug administration, showed that the proportion of patients with vision loss of less than 15 letters was 97.95% (143/146 patients) in the Lucen BS arm and 98.62% (143/145 patients) in the original drug arm, meeting the range of equivalence between the two drugs.
- Company
- 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.
