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- 2026-04-08 22:18:31
- Company
- Domestic market withdrawal of Forxiga remains a mystery
- by Kim, Jin-Gu Dec 14, 2023 05:47am
- Pic of ForxigaAstraZeneca’s decision to withdraw its SGLT-2 inhibitor diabetes drug Forxiga (dapagliflozin) from the Korean market is being considered an unusual move by the industry. This is because the decision to pull out of the Korean market would essentially mean giving up KRW 50 billion in annual sales for AstraZeneca. While AstraZeneca's official position is that the decision is part of the company’s "portfolio overhaul," the mysteries surrounding the decision are not expected to be resolved anytime soon. Therefore, the industry's eyes are on AstraZeneca's next move, especially as it has been in stark contrast with MSD’s treatment of Januvia (sitagliptin). MSD Korea, which had faced a similar situation with Januvia, had sold its domestic sales rights for a large sum to a Korean company. #SB Company suddenly decides to withdraw ‘Forxiga,’ whose prescription sales exceed KRW 50 billion from the Korean market#EB According to industry sources on the 12th, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. The withdrawal is limited to the single-agent drug Forxiga. Its metformin combination Xigduo, sitagliptin combination Sidapvia, and saxagliptin combination Qtern will continue to be supplied through local pharmaceutical companies. Forxiga is an SGLT-2 inhibitor class diabetes drug. It was approved in Korea in 2013. Since then, it has rapidly increased its prescription sales. The annual prescription amount for the drug exceeded 30 billion won in 2019 and reached the 50 billion won mark last year. Yearly prescriptions of Forxiga (Unit: KRW 100 million, Data: UBIST). In Korea, it had dominated the SGLT-2 inhibitor market with Boehringer Ingelheim Korea’s 'Jardiance empagliflozin).’ Among single-agent drugs, prescriptions had been KRW 51 billion for Forxiga and KRW 48.3 billion for Jardiance last year. Sales of Astellas' Suglet (ipragliflozin) and MSD's Steglatro (ertugliflozin) accounted for less than KRW 5 billion during the same period. The joint sales agreement AstraZeneca had made with Daewoong Pharmaceutical is said to have contributed to the increase in prescription performance in Korea. Daewoong has been jointly selling Forxiga since 2018. The agreement between the two companies will end at the end of this year. Forxiga's rise to prominence hit a major inflection point earlier this year. Forxiga’s substance patent expired in April. More than 60 pharmaceutical companies launched generic versions of Forxiga upon patent expiry. This coincided with reimbursement for the use of SGLT-2 and DPP-4 inhibitor combinations, heralding a very fierce competition between the original and generic companies. AstraZeneca Korea deployed an aggressive defense strategy to maintain Forxiga’s position in the market. It filed an administrative appeal against the price reduction made upon entry of the generic version. At the same time, it applied for an injunction for the stay of execution of the government's price reduction. The court granted the request. As a result, the price of Forxiga is set to remain at the same level until February next year. AZ "Drug price reduction disposition unreasonable”…U-turns its stance after half a year The enforcement order was cited on June 1. However, just over 6 months later, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. This is a 180-degree turnaround for the company, as this means the company decided to abandon Forxiga just half a year after it challenged the Ministry of Health and Welfare's decision to lower the drug's price with an administrative lawsuit. AstraZeneca's official position is that it is "discontinuing the domestic supply of Forxiga to realign the company's portfolio." On the surface, this seems to indicate that the company intends to reorganize its portfolio around anti-cancer drugs such as Tagrisso, Imfinzi, and Lynparza and focus on related businesses. In the industry, there are also assumptions that the market withdrawal decision was driven by the rush of generics that entered upon patent expiry and the pressure of excessive competition. Others argue that AstraZeneca Korea has exhausted resources and accumulated fatigue negotiating with the government to expand reimbursement for its Forxiga and other key products such as Tagrisso. However, those who believe otherwise point to how Forxiga's influence in the market remains strong even though more than 60 companies have launched generic versions of the drug. In fact, Forxiga's outpatient prescription performance has increased slightly YoY after the release of its generics. In Q2, Forxiga's prescriptions totaled to KRW 14.1 billion, up 15% YoY. In Q3, prescriptions increased 4% YoY to reach KRW 13.7 billion. While generic products generated KRW 3.9 billion in prescriptions in Q2 and KRW 6.8 billion in Q3, they did so by opening up new markets rather than by taking over Forxiga's share. Moreover, Forxiga’s indication was being expanded to not only diabetes but also heart failure and kidney disease. Forxiga has recently added a series of indications. They were for ▲ the treatment of heart failure with reduced ejection fraction (HFrEF), ▲ left ventricular ejection fraction/ heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), and ▲ chronic kidney disease (CKD). Of these, the company had applied for the drug’s reimbursement in HFrEF and CKD. The company was also reportedly conducting negotiations with the government for reimbursement extensions until recently. From AstraZeneca's point of view, extending Forxiga's reimbursement to heart failure could have further increased the prescription amount. In contrast with MSD's sale of Januvia rights … Competition will intensify to close the KRW 50 billion void The pharma industry focused on how MSD decided to sell Januvia’s domestic sales rights before patent expiry. Pic of JanuviaJanuvia is a DPP-4 inhibitor class diabetes drug. Januvia has various similarities to Forxiga, such as the fact that it is a flagship item with a prescription value of KRW 42.6 billion last year and a large number of generics were launched after its patent expiry in July this year. In May, Chong Kun Dang signed a licensing agreement with MSD to acquire domestic rights for 3 products - Januvia, Janumet, and Janumet XR. Chong Kun Dang will acquire all domestic sales, distribution, licensing, trademark, and manufacturing rights for the 3 Januvia series drugs. The contract amount was 45.5 billion won. Chong Kun Dang paid MSD an upfront payment of KRW 23 billion and additional milestone payments of KRW 22.5 billion based on sales performance. MSD made a considerable profit by handing over all domestic rights for the antidiabetic drugs to Chong Kun Dang ahead of Januvia's patent expiration, at a time when generics were expected to be launched. The deal was seen as a win-win, as MSD could focus on sales and marketing of its other products instead of competing with domestic drugmakers, and Chong Kun Dang could secure a stable cash cow that brings in over KRW 100 billion a year. On the other hand, AstraZeneca made a contrasting move, deciding to withdraw from the Korean market instead of selling the rights for Forxiga to a Korean company. The company had made no moves to sell Forxiga's domestic rights to any company. AstraZeneca also drew the line regarding its plans to resupply Forxiga in Korea. An AstraZeneca Korea official said, "We have secured enough domestic supply to last until the first half of next year. We are discussing patient protection measures with the Ministry of Food and Drug Safety. However, at this time, we are not considering resupplying the drug after the first half of next year."
- Company
- Rinvoq is granted reimb for ankylosing spondylitis
- by Son, Hyung-Min Dec 14, 2023 05:47am
- AbbVie Korea holds press conference in celebration of Rinvoq’s reimbursement approval in ankylosing spondylitis on the 13th The use of JAK inhibitors, which had been used for rheumatoid arthritis and atopic dermatitis, has been expanded to ankylosing spondylitis. On the 13th, AbbVie Korea held a press conference at Andaz Seoul Gangnam in Gangnam-gu, Seoul to celebrate the reimbursement of its Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib) for severe active ankylosing spondylitis. Rinvoq was granted reimbursement for the treatment of adults with severe active ankylosing spondylitis on the 1st. Rinvoq is reimbursed for use in patients with severe active ankylosing spondylitis who have had an inadequate response to or had to discontinue treatment with tumor necrosis factor-alpha (TNF-α) blockers or interleukin (IL)-17 inhibitors. With the reimbursement extension, Rinvoq can now be used to treat patients with ankylosing spondylitis in addition to other inflammatory diseases such as atopic dermatitis, rheumatoid arthritis, and ulcerative colitis. Its efficacy and safety were confirmed in adult patients with active ankylosing spondylitis through the SELECT-AXIS 1 Phase II/III study and the SELECT-AXIS 2 Phase III study. In the SELECT-AXIS 1 study, which included patients naïve to biologic disease-modifying drugs, the Rinvoq arm achieved a 52% response rate at Week 14 in terms of ASAS40 (defined as a ≥40% improvement in response per Assessment of SpondyloArthritis International Society standards), which was higher than the placebo arm. In the SELECT-AXIS2 study, which observed patients who had failed biologic therapy, the ASAS40 response in the Rinvoq arm was 45% at week 14, demonstrating an efficacy compared to the 18% in the placebo arm. The mean reduction in pain was -3.00 in the Rinvoq arm and -1.47 in the placebo arm. Unmet needs remain in ankylosing spondylitis…Rinvoq and other JAK inhibitors emerge as alternatives #I2Ankylosing spondylitis is an autoimmune disease in which the spine joint becomes inflamed and gradually stiffens. Inflammation of the spinal joints causes pain, stiffness, and other symptoms. If left untreated, the joints can become stiff and become immobile. The number of affected patients has been increasing steadily every year. According to the Health Insurance Review and Assessment Service’s Healthcare Big Data, the number of patients with ankylosing spondylitis in Korea was 52,616 in 2022, showing a steady increase over the past 5 years. Results of a treatment satisfaction survey conducted on patients with ankylosing spondylitis showed that about half of patients are dissatisfied with their current treatment. Despite significant improvements in clinical outcomes, unmet needs remain in achieving remission, pain control, fatigue, and psychological issues (anxiety, depression). Therefore, it is analyzed that the reimbursement of JAK inhibitors, such as Xeljanz (tofacitinib) and Rinvoq, will be able to improve patient outcomes. Seung-Jae Hong, Professor of Rheumatology at Kyung Hee University Hospital, said, "I believe that the introduction of oral agents such as Rinvoq for the treatment of ankylosing spondylitis will greatly benefit patients. As Xeljanz is considered to be associated with a high risk of cardiovascular disease (CVD) based on the clinical results, we believe Rinvoq would become a more popular reimbursed choice in the field."
- Company
- Reimb of latecomer leukemia drug Bosulif imminent
- by Eo, Yun-Ho Dec 14, 2023 05:47am
- Bosulif, a new leukemia treatment, is expected to receive reimbursement next year. According to the pharmaceutical industry, Pfizer Korea successfully completed drug pricing negotiations with the National Health Insurance Service for Bosulif (bosutinib), a Chronic Myelogenous Leukemia (CML) treatment. Bosulif will be presented to the Health Insurance Policy Review Committee of the Ministry of Health and Welfare, and if approved, it will be reimbursed starting in January 2024. Following its FDA approval in 2012, Bosulif was authorized for use much later in Korea, in last January. Bosulif is a second-generation targeted therapy similar to Novartis Korea’s Tasigna (Nilotinib), BMS Korea’s Sprycel (Dasatinib), and Il-Yang Pharmaceutical’s Supect (Radotinib). Given that there are already established drugs in the same category, no difficulties are expected in the course of its reimbursement approval. The efficacy and safety of Bosulif has been confirmed in Phase 3 NCT02130557 study, which enrolled newly-diagnosed CML patients. The primary endpoint of Bosulif was major molecular response (MMR) by 12 months. Bosulif-treated patients had MMR of 47%. Patients treated with the comparator drug, first generation drug Gleevec (imatinib), had MMR of 36%. MMR by Month 60 was 74% for Bosulif versus 66% for Gleevec. After 60 months of follow-up, the median time to MMR in responders was 9.0 months for bosutinib and 11.9 months for Gleevec. Many next-generation targeted therapies are already available in the field. These include the third-generation Korea Otsuka Pharmaceutical's Iclusig (Ponatinib), and a fourth-generation Norvatis’ Scemblix (Asciminib).
- Policy
- Will Enhertu be reimbursed using flexible ICER threshold?
- by Lee, Tak-Sun Dec 14, 2023 05:47am
- With the government reportedly planning to flexibly apply the Incremental Cost-Effective Ratio (ICER) threshold, whether the breast cancer treatment Enhertu (fam-trastuzumab deruxtecan, Daiichi Sankyo) will finally find its way to reimbursement is gaining attention in Korea. The drug’s reimbursement review is currently stuck in HIRA’s pharmacoeconomic evaluation stage. The drug was unable to pass the stage due to the longer period of administration, which rather increased drug cost, despite its significantly better effect than existing drugs. Therefore, a more flexible application of the ICER threshold during pharmacoeconomic evaluation is expected to allow Enhertu’s passage. According to the industry on the 13th, a plan to flexibly apply the ICER threshold for innovative new drugs in consideration of their innovative value was shared at the public-private consultative body meeting for 'Measures to recognize the appropriate value of innovative new drugs’ that was held on the 12th. The current ICER threshold is flexibly used to evaluate the cost-effectiveness of drugs in consideration of the severity of the disease, impact on quality of life, and innovativeness of a new drug. As the criteria used to evaluate the economic feasibility of a new drug with an improved effect, it determines the additional cost spent by a new drug compared to its comparator for the improved efficacy or each unit of use. If a drug’s ICER threshold is less than or equal to a certain level, the drug is interpreted as being cost-effective to its comparator. In general, the level is set at around KRW 50 million for anti-cancer and rare disease drugs and around KRW 30 million for other general drugs. Enhertu’s price had reportedly exceeded the ICER threshold of KRW 50 million. The industry believes that if the threshold is flexibly applied according to the characteristics of each drug, it could serve as a breakthrough for Enhertu’s reimbursement which is stuck in the pharmacoeconomic evaluation process. However, concerns have been raised about the strict standards set on which innovative new drugs may receive flexible application of the ICER threshold. To be eligible for flexible application of the ICER threshold, a new drug must meet all of the following criteria: ▲ has a new mechanism of action or substance, ▲ has no alternative treatments (including drugs) available, ▲ has shown clinically significant improvement, such as a significant extension in survival, ▲ received a Breakthrough Therapy Designation (BTD) from the U.S. FDA or approved as a Priority Medicines (PRIME) by the European Medicines Agency (EMA), and ▲ is a treatment for a rare disease or an anti-cancer drug. Enhertu must also meet all of the criteria above to receive preferential treatment in its pharmacoeconomic evaluation process. The industry believes Enhertu can meet the criteria for innovative new drugs and receive preferential treatment. Although Enhertu’s reimbursement passed the Health Insurance Review and Assessment Service (HIRA) Cancer Disease Deliberation Committee’s review after redeliberation in May and set reimbursement standards, it has been unable to pass the Drug Reimbursement Evaluation Committee evaluation ever since. The agenda is said to be stuck in the pharmacoeconomic evaluation stage.
- Company
- Daewoong attempts at first Lupron Depot generic in the US
- by Chon, Seung-Hyun Dec 13, 2023 05:38am
- Daewoong Pharmaceutical is seeking to enter the U.S. anticancer market with the global pharmaceutical company, Zydus Worldwide DMCC. Daewoong Pharmaceutical announced on the 11th that it had signed a licensing agreement with Zydus Worldwide DMCC. to co-develop and commercialize the anticancer drug DWJ108U Depot suspension injection. The value of the agreement is estimated to be near KRW 12.22 billion at most. This includes an upfront payment of $9.24 million (KRW 12.2 billion), development and commercialization milestones of $2.55 million (KRW 3.4 billion), and an additional supply agreement worth $66.89 million (KRW 88.5 billion). Under the agreement, Zydus will be assuming full responsibility for the joint clinical development and commercialization of Daewoong’s Depo injection product in the US market. The contract term is seven years after launch in the US and may be subject to change depending on the drug’s release date in the US. DWJ108U, which is being jointly developed by Daewoong Pharmaceutical and Zydus, is the first generic of ‘Lupron Depot’ to be introduced to the US. Lupron Depot was released in the US in 1898, but due to the difficulty of developing a generic version of the drug, no generic product has ever passed the Abbreviated New Drug Application (ANDA) process in the U.S. market. The US leuprolide acetate market is valued at approximately $1.6 trillion, with Lupron Depot holding a dominant position in the market. Daewoong Pharmaceutical's DWJ108U utilizes the emulsion principle to encapsulate the drug in microscopic polymer particles, which is the same manufacturing method as the original Lupron Depot. If DWJ108U is approved as a generic for Lupron Depot in the United States, it will be approved for 4 indications at once - prostate cancer, premenopausal breast cancer, endometriosis, and uterine fibroids. Daewoong Pharmaceutical will be responsible for the pre-clinical studies, production, and supply of the product, with Zydus pursuing its clinical development and commercialization in the US market. Seng-Ho Jeon, CEO of Daewoong Pharmaceutical, said, “Although Lupron Depot has been in the US market for 35 years, no single generic product to date has been introduced to date due to difficulties in its development. With Zydus, who owns a strong presence in the US market, we plan to complete the clinical trials of DWJ108U, the first generic version of Lupron Depo, and successfully introduce it to the US anticancer drug market." Sharvil Patel, Managing Director of Zydus Lifesciences, said, "The agreement is another step towards strengthening our injectable portfolio, and is an important step towards enabling access to affordable generic versions for patients in the US. This is an important milestone and we are happy to work with Daewoong for a generic version of Lupron Depot, and wish for its successful launch in the US.” Zydus Worldwide DMC is a wholly-owned subsidiary of Zydus Lifesciences, a global pharmaceutical group headquartered in Ahmedabad, India. The company owns 36 manufacturing sites worldwide. Fourteen of these facilities are US cGMP certified. The company is an expert in regulatory approvals, with more than 350 ANDAs approved in the U.S. alone. Last year, Zydus sales in the US market were approximately $1.2 trillion and total global sales were approximately $2.7 trillion.
- Policy
- Only CKD and Jeil have high-dose Xeljanz generics approved
- by Lee, Hye-Kyung Dec 13, 2023 05:38am
- Pfizer Jeil Pharm received approval for its ‘Topazan Tab 10mg,’ a high-dose generic version of the rheumatoid arthritis treatment ‘Xeljanz (tofacitinib citrate).’ With the Ministry of Food and Drug Safety’s approval of Topazan Tab 10mg on November 11 in addition to the Topazan Tab 5mg that was approved on November 27, Jeil Pharm now owns both low- and high-dose generic versions of Xeljanz. Following Boryung, which received approval for ‘Boryung Tofacitinib TAb 5mg (tofacitinib aspartate) as the first Xeljanz generic in August 2020, 58 generics have been approved to date, but Chong Kun Dang is the only company that received approval for both the 5mg and 10mg doses. Reasons include safety concerns and reduced indications associated with the higher dosage formulation, and even the outpatient prescription amount of the original shows this clear difference in demand between the low and high doses. The low dose is approved for five indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, polyarticular juvenile idiopathic arthritis (pJIA), and juvenile psoriatic arthritis, whereas the indication for the high dose formulation is limited to ulcerative colitis. In addition, post-marketing surveillance studies of Xeljanz have shown that the drug is associated with an increased risk of blood clots in ulcerative colitis. The MFDS also added a warning to the drug’s label in 2020, cautioning healthcare providers to evaluate the risk of thrombosis in patients with ulcerative colitis and to cautiously use Xeljanz 10mg in patients with risk factors for thrombosis. With persisting safety concerns over the higher dose, according to the market research institution IQIVA, out of the KRW 15.9 billion sales of Xeljanz in 2021, the 5mg dose accounted for about KRW 13 billion, while the 10mg dose accounted for only a mere KRW 2.1 billion. Meanwhile, Xeljanz owns a substance patent that expires in November 2025 and a crystalline patent that expires in November 2027. 20 companies, led by Chong Kun Dang, have tried to overcome it by filing an invalidation trial, and 16 companies including Boryung Pharmaceutical, have tried to avoid the patents by filing a passive scope of patent rights trial. As a result, generic companies succeeded in avoiding Xeljanz’s patent in January 2018, and then won the invalidation trial in November 2019, thereby removing the crystalline patent from the green list in March 2020. As a result, Xeljanz generics that are being granted marketing authorization will be launched after November 2025, when the substance patent expires.
- Opinion
- [Reporter’s View] Amid hopes for K-drugs, beware
- by Eo, Yun-Ho Dec 13, 2023 05:38am
- It is not only the patients that are now interested in the research and development of new drugs. The interest in high-value-added industry and aspirations for the development of the domestic industry has never been hotter. Industry development is good. New drugs? Even better. However, the rise of the stock market bubble that stirs investment interest in the sector is potentially detrimental to the advancement and success of the industry and new drug discovery. New drug development would not have risen as a trend if it was easy. Due to rising interest in Korea's biopharmaceutical industry grows, information about the pharmaceutical industries’ clinical trial failures, discontinuation, or efficacy issues are being constantly covered online. When successful, reports on these clinical trials make it into the headline news. The current trend is understandable. Biosimilars from companies like Samsung and Celltrion are increasingly gaining recognition in the US and Europe, and the Korean government is coming up with a favorable drug pricing policy for domestically produced new drugs, based on the government's premise of devising a measure to foster the biopharmaceutical industry. Let’s get one thing clear. Suceeding in new drug development is far from easy. According to an analysis conducted by the Biotechnology Innovation Organization (BIO) in the US, which examined data from 9,985 clinical trials either completed or underway by the U.S. Food and Drug Administration (FDA) from 2006 to 2015, the success rates were 63.2% for Phase 1, 30.7% for Phase 2, and 58.1% for Phase 3 clinical trials. When these rates are calculated to determine the probability of a new drug reaching the commercialization stage, the number renders to a mere 9.6%. Development discontinuation and clinical trial failures in the pharmaceutical industry are common; it would rather be odder if they didn't occur. However, the issue lies in transparency. It's a fact that numerous pharmaceutical companies have jumped on the new drug development bandwagon, trying to take advantage of the rising tide. Clinical data on candidate substances and presentations made at international conferences are being often distributed indiscriminately without adequate drug information. Its phrases, "shows superior effectiveness compared to drug X," "the first treatment for X cancer," or "significantly improves survival duration," seem to be primarily aimed at influencing investor psychology, Such headlines do seem attractive, but the articles frequently lack basis. Detailed information, such as the number of patients involved in clinical trials, the duration of the research, and quantitative data from comparing different cohorts on the drug's effectiveness and safety, are not provided. Moreover, drug descriptions are frequently oversimplified to terms like ‘good drug’ stated by a company personnel. Keep in mind that drug discovery is science and has patients as the end-customers. Any success in new drug development by Korean companies are encouraging news. Therefore, other companies should embrace the transparency and open up information for a fair evaluation. They must stop worrying about IR (Investor Relations). Just as they addressed the rebate issue, it is now the time for the companies to dispel any doubts about stock price manipulations.
- Company
- Jeil will exclusively supply Norvatis’ 9 ophthalmic drugs
- by Nho, Byung Chul Dec 12, 2023 10:33pm
- Jeil is venturing into the field of ophthalmic diseases for the first time. Jeil Pharmaceutical (CEO Sung Suk-Je) announced on the 11th that it has signed an exclusive distribution agreement with Novartis Korea (CEO Yoo Byung-Jae) for the sale and supply of nine drugs in ophthalmic diseases including glaucoma and conjunctivitis. to target the ophthalmic disease market. With this partnership, Jeil will be venturing into the field of ophthalmic diseases for the first time. Jeil plans to enter the market in Jan 2024 and establish its position in the field of ophthalmic diseases, including in glaucoma and conjunctivitis. Under the agreement, Jeil will receive exclusive sales and distribution rights in Korea for six glaucoma treatments and three conjunctivitis treatments from Novartis Korea. The nine drugs will include Elazop, Simbrinza, Azopt, Travatan, Izba, and Duotrav for ocular hypertension and open-angle glaucoma, zs well as Pazeo, Pataday, and Patanol for allergic conjunctivitis. These nine drugs recorded sales of 25 billion won in Korea last year, according to IQVIA. In particular, Elazop holds a 14% market share in the glaucoma eye drop combination market in Korea, rendering annual sales of over 11 billion won, and is also consistently prescribed in the global market. “We are pleased to be partnering with Novartis, a global healthcare company,” said Sung Suk-Je, CEO of Jeil Pharmaceutical. Sung added, “We will concentrate our efforts on broadly supplying these globally recognized, excellent ophthalmic disease treatments to improve the quality of life for patients in Korea.” “Novartis will focus on the sales of retinal disease treatments Beovu and Lucentis," said Yoo Byung-Jae, CEO of Novartis Korea. "Through our partnership with Jeil, which has strong competitiveness in terms of sales power at hospitals and clinics, we will make our best efforts to stably supply ophthalmic treatments, particularly glaucoma and allergy treatments, to patients and medical professionals in Korea.”
- Company
- Evenity and Prolia sales surge...combined sales rise 47%
- by Kim, Jin-Gu Dec 12, 2023 05:38am
- Amgen’s two osteoporosis treatments, Prolia (denosumab) and Evenity (romosozumab) are repeatedly posting high growth in sales. Together, these two treatments generated over 130 billion won in Q3 sales, dominating the osteoporosis treatment market in Korea. In the first-line, osteoporosis treatment is trending towards sequential Evenity followed by Prolia for high-risk fracture osteoporosis patients. With this approach increasingly becoming the norm, the analysis is that these two treatments are deemed to be making a synergistic effect, leading to improved outcomes. Prolia's Q3 cumulative sales up 33% YoY…over 150 bil won expected by the end of the year According to the market research institution IQVIA, Prolia’s cumulative sales in Q3 were 111.5 billion won, representing an increase of 33% year-over-year (YoY) from the 83.8 billion won last year. Prolia was approved in September 2014 in Korea. It is a biologic for osteoporosis that targets RANKL, an essential protein for the formation, function, and survival of osteoclasts that destroys the bone. Prolia began seeing an upward sales trend after its reimbursement as a second-line treatment in 2017. The sales growth became steeper after Prolia received expanded reimbursement as a first-line treatment in April 2019. Quarterly sales of Prolia In 2019, Prolia's sales were 47.3 billion won, and this nearly doubled to 92.1 billion won in 2021 over two years. Last year, its annual sales expanded to exceed 100 billion won. If the current sales growth continues, its annual sales are projected to reach close to 150 billion won by the end of the year. The analysis is that both the expansion of reimbursement and enhanced sales efforts contributed to Prolia's growth. Amgen has been co-marketing Prolia with Chong Kun Dang since September 2017. This method of collaboration involves Amgen focusing on general hospitals, while Chong Kun Dang handles the drug's sales and marketing in secondary hospitals and clinics. Evenity's salses rise 61% YoY… accelerated by Prolia’s sales growth Evenity, which was released following Prolia, is showing an even steeper growth. This year, its cumulative sales for Q3 reached 19.7 billion won, an increase of 61% YoY. Evenity is an osteogenic agent with a dual effect of promoting bone formation and inhibiting bone resorption. Amgen's strategy for marketing for Evenity is 'sequential Evenity followed by Prolia' regimen. Evenity is administered monthly for one year for patients with osteoporosis at high risk of fracture to rapidly increase bone density and reduce fracture risk. The patients are then administered Prolia, once every six months, to continue treatment over a longer period. The pharmaceutical industry’s analysis is that this treatment approach is increasingly becoming common in clinical prescription settings. Also, the analysis is that this sequential administration of Evenity followed by Prolia is contributing to the sales growth. Evenity was approved in Korea in June 2019. It was listed for reimbursement in Dec. 2020, which led to significant sales starting the following year. The sales from Evenity increased by 42%, from 12.3 billion won in 2021 to 17.4 billion won last year. It is forecasted that the sales will exceed 25 billion won by the end of this year. In fact, two treatments from Amgen have effectively dominated the osteoporosis treatment market in Korea. Combined, these two products recorded sales of 131.2 billion won up to Q3, representing a YoY increase of 37% from the 96 billion won recorded in the last year. Quarterly sales of major OP treatments With the rapid rise in sales of Amgen's two treatments, the existing bisphosphonate class of osteoporosis treatments generally showed poor performance. Hanmi Pharmaceutical's RaboneD Cap. recorded a 9% decrease in sales, down from 7.3 billion won in Q3 last year to 6.7 billion won in Q3 this year. Meanwhile, sales of Daewoong Pharmaceutical's Daewoong Zoledronic Acid Inj. also fell 20%, from 5.2 billion won to 4.1 billion won. During the same period, Jeil Pharmaceutical's Bonviva and Bonviva Plus recorded a 26% decrease in sales, dropping from 6.4 billion won to 4.7 billion won. Jeil Pharmaceutical has been in charge of the domestic sales of Bonviva and Bonviva Plus since October last year, taking over the rights from Handok. Bonviva Plus is Vitamin D reinforced version of Bonviva. Among the major bisphosphonate class treatments, Eli Lilly's Forsteo Inj. showed an increase in sales. Forsteo Inj.'s cumulative sales in Q3 amounted to 11.6 billion won, showing a growth of 19% YoY.
- Policy
- KIDS ‘Oral VEGFR-TKI use may increase risk of AAD’
- by Lee, Hye-Kyung Dec 12, 2023 05:38am
- The Korea Institute of Drug Safety & Risk Management (President: Jeong Wyan Oh, KIDS) announced that the use of Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor (VEGFR-TKI) was associated with an increased risk of aneurysm and artery dissection occurrence. The findings were published in the internationally recognized American Medical Association (AMA) journal, JAMA Network Open (IF=13.8) on November 29. Recently, the U.S. FDA identified an association between VEGF-TKI inhibitors such as sorafenib and pazopanib and the development of aneurysms and arterial dissection through an analysis of the FDA Adverse Event Reporting System (FAERS) data and reflected the results in the indication of identified drugs. Korea’s Ministry of Food and Safety also reflected the association in the indications of affected drugs after conducting a safety information review. The MFDS conducted a study to investigate the risk of aneurysm and arterial dissection associated with the use of VEGFR-TKIs in the Korean population, after deeming that prior epidemiologic studies were lacking in Korea. The study collected information on 127,710 cancer patients aged 40 years or older who were prescribed VEGFR-TKIs or capecitabine based on the National Health Insurance Service’s insurance claims data (2007-2020) and followed them for 1 year after use. Among patients receiving VEGFR-TKIs, the incidence of AAD within 1 year of treatment initiation was 6.0 per 1000 person-years (1,000 subjects observed for 1 year). The incidence of AAD in those receiving capecitabine was 4.1 per 1000 person-years, showing that the risk of AAD occurrence was significantly higher by 1.48 times (95% CI, 1.08-2.02) among patients prescribed VEGFR-TKIs than those receiving capecitabin. The incidence and risk of AAD were significantly higher among patients treated with VEGFR-TKIs than those treated with capecitabine in females (2.08 times), older adults aged 65 years or older (1.42 times), and patients with dyslipidemia (1.58). KIDS President Oh said, “The study holds significance as that it demonstrated the possibility of an association between aneurysm and arterial dissection and the use of VEGFR-TKIs in cancer patients in Korea. This is expected to not only increase the treatment effect but also reduce socioeconomic losses and contribute to building a safer drug use environment."
