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Company
Oral ulcerative colitis drug Zeposia is actively prescribed
by
Eo, Yun-Ho
Feb 06, 2024 06:10am
Prescription of new oral ulcerative colitis drug Zeposia is being actively promoted in general hospitals in Korea. According to industry sources, BMS Korea’s ‘Zeposia Cap (ozanimod)’ has passed drug committee (DC) reviews of major tertiary hospitals in Korea including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, as well as medical institutions including Yeungnam University Hospital, Wonkwang University Hospital, Wonju Severance Hospital, Chonnam National University Hospital, Chosun University Hospital, and Hanyang University Guri Hospital. The drug has been expanding its prescription area after receiving insurance reimbursement in January this year. Zeposia, which is taken once daily orally, was approved in February last year to treat moderate-to-severe active ulcerative colitis in patients who respond adequately to existing treatment or biological agents including corticosteroids, immunosuppressants, etc., or have no response, or have resistance The company applied for reimbursement after approval and passed the Drug Reimbursement Evaluation Committee in August of the same year and was listed for reimbursement this year. Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator used to suppress inflammation by preventing self-reactive lymphocytes from moving to the stomach in ulcerative colitis where immunomodulatory abnormalities are observed. It confirmed the effect of its new mechanism of action in the True North study, which was conducted on adult patients with moderate-to-severe ulcerative colitis. In the study, when evaluating the efficacy of once-daily Zeposia 0.92mg for 10 weeks as induction therapy, 18.4% of ulcerative colitis patients that received Zeposia reached clinical remission at the 10-week mark, which was significantly higher than the 6.8% of patients on placebo. 47.8% of the patients in the Zeposia arm achieved clinical response, which was significantly higher than that of the placebo arm (25.9%). When observing patients who achieved clinical response on Zeposia induction therapy through week 52, at week 52, 37% of patients maintained remission at the 52-week mark of treatment, which was significantly higher compared with 18.5% of those who received placebo. Clinical response was also higher in the Zeposia group than in the placebo group. Tae Il Kim, President of the Korean Association for the Study of Intestinal Diseases (Department of Internal Medicine and Institute of Gastroenterology, Severance Hospital), said, “As ulcerative colitis is a disease that fluctuates between remission and exacerbation and requires long-term treatment, the more treatment options available, the easier it is to tailor a treatment strategy for each patient,” Kim added, "The addition of Zeposia, a novel mechanism of action, is significant because it gives patients another good treatment option to choose from. The advantages of a once-daily oral drug can be very beneficial for patients who are often burdened by the time, cost, and spatial requirements of injectable therapies due to the long-term nature of the disease."
Company
Growth hormone Ngenla can be prescribed in general hospitals
by
Eo, Yun-Ho
Feb 05, 2024 05:54am
The growth hormone ‘Ngenla’ can now be prescribed in general hospitals in Korea. According to industry sources, Pfizer Korea’s once-weekly growth hormone Ngenla (somatrogon) has passed the drug committee (DC) reviews of tertiary hospitals including Seoul Asan Medical Center and Sinchon Severance Hospital, as well as medical institutions including Kangdong Sacred Heart Hospital, Seoul National University Bundang Hospital, Bundang CHA Hospital, and Ajou University Hospital. Ngenla, which was listed for reimbursement since September last year, is reimbursed for pediatric patients who meet all of the following conditions: height falls below the 3rd percentile for their chronological age, is confirmed through two or more growth hormone stimulation tests, and is aged 3 or older with growth hormone secretion disorders where bone age is less than chronological age. A multicenter, randomized, open-label Phase III clinical study for Ngenla was conducted on 228 prepubertal children with growth hormone deficiency from April 2017 to August 2019 in 21 countries, including South Korea. In the study, 224 patients were randomized to receive once-weekly Ngenla (0.66 mg/kg/week) or somatropin (0.034 mg/kg/day). Study results showed that at 12 months, annual height velocity in the Ngenla arm was 10.10 cm/year, and 9.78 cm/year in the somatropin arm. The difference was 0.33cm/year between the two treatment arms. In pre-specified subgroup analyses, height growth rates in the Ngenla arm were similar to those in the somatropin group, regardless of age, gender, or growth hormone secretion levels. Hyun Wook Chae, Professor of Pediatrics at Severance Children's Hospital, said, "With its convenience of once-weekly dosing and prefilled pen formulation, Ngenla had a lower treatment burden compared to daily growth hormone formulations according to a Phase III crossover study on treatment burden, and increased treatment experience satisfaction, making it a preferred treatment option for patients and their caregivers.” He added, “With prescriptions now underway in practice, I believe Ngenla will contribute to improved treatment adherence in pediatric growth hormone deficiency patients and change the paradigm of treatment for growth hormone deficiency patients in Korea."
Company
Enhertu passes the DREC review in KOR
by
Eo, Yun-Ho
Feb 05, 2024 05:54am
Enhertu (trastuzumab deruxtecan). ‘Enhertu,’ which had faced difficulties in securing insurance reimbursement listing due to its exceptional effectiveness, has finally received approval from the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). This approval comes eight months after Enhertu passed the review by the Cancer Disease Review Committee in May last year. Now, Daiichi Sankyo Korea and AstraZeneca Korea will enter the negotiations with the National Health Insurance Service (NHIS) for drug pricing of Enhertu (trastuzumab deruxtecan). Enhertu is at the final stage in the process for reimbursement approval. However, there is still a long journey ahead to complete negotiations for drug pricing with the NHIS and secure reimbursement listing. Previously, after clearing the Cancer Disease Review Committee, Enhertu was rejected eight times by the DREC. For an extended period, the Economic Evaluation Committee did not reach a conclusion regarding Enhertu's cost-effectiveness even though the price suggested by the company was the minimum globally. The delay in decision by the committee may have been due to difficulties in determining the appropriate price for Enhertu because Enhertu’s efficacy, based on Phase 3 clinical trial, differ significantly from that of existing medicine. In a positive turn of the situation, Enhertu received 50,000 votes in a national petition posted on Korea’s public petition website. As a result, the national assembly consistently raised the issue with the government. Under this pressure, Enhertu was likely to be considered for reimbursement listing. Given Enhertu’s limited flexibility in lowering drug pricing, the DREC's approval of this round suggests that the government may have proposed an ICER value in the mid-to-late-range. The remaining question is how much more ‘room’ is left for both sides in drug pricing negotiations. Although HIRA has proposed a flexible pricing range, it seems that negotiations for the company may be restricted. The potential approval of Enhertu for reimbursement is drawing significant attention due to its remarkable improvement in the survival period. The DESTINY-Breast03 clinical study compared Enhertu to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received one or more anti-HER2 therapy. Compared to T-DM1, Enhertu demonstrated an improvement in a progression-free survival (PFS) score. According to the interim analysis reported in 2022, median progression-free survival (mPFS) by blinded independent central review, which was the primary endpoint, was 28.8 months for Enhertu-treatment group. This result was 22 months longer than the 6.8 months mPFS observed in the T-DM1-treatment group. In terms of overall survival (OS), which was the secondary endpoint, the Enhertu-treatment group showed a reduction in the mortality risk by 36% compared to the T-DM1-treatment group. “Enhertu, a treatment for advanced gastric cancer in patients who have received Trastuzumab treatment, is the first and the only HER2 targeting treatment that has a proven record of OS of more than a year. Considering that a small group of patients can benefit from this treatment, I hope Enhertu will be approved for reimbursement soon,” said Rha, Sun Young, a professor from the Division of Medical Oncology in the Department of Internal Medicine at Yonsei Cancer Center.
Company
New drugs and biosimilars to compete in the PNH market
by
Chon, Seung-Hyun
Feb 02, 2024 12:28pm
New drugs and biosimilars have shifted the competitive landscape of the treatment market for paroxysmal nocturnal hemoglobinuria (PNH), which Soliris and Ultomiris have previously dominated. PNH is a rare, life-threatening disorder characterized by the destruction of red blood cells in the blood, leading to symptoms such as dark-colored urine and acute renal failure. According to industry sources on the 30th, Samsung Bioepis’s Epysqli, a biosimilar version of Soliris, has recently received approval in Korea. This marks the first domestic approval of a Soliris biosimilar. Following the European approval of Epysqli in May of last year, Samsung Bioepis has now secured approval in Korea. Samsung Bioepis’s Epysqli. AstraZeneca owns Soliris, an inhibitor of complement component 5 (C5), with global sales amounting to 5 trillion won (about $3.7 billion won). Soliris works by binding to the C5 protein, inhibiting complement activity and thereby preventing the destruction of blood cells. Samsung Bioepis conducted a global Phase 3 clinical trial from August 2019 to October 2021. The trial demonstrated the clinical bioequivalence of Epysqli to the original medicines. AstraZeneca and Samsung Bioepis form the competitive landscape of the Soliris market. However, Soliris distributor AstraZeneca is switching to the C5 complement inhibitor Ultomiris. AstraZeneca introduced Ultomiris as a replacement for Soliris, as it expects the European patent to expire in 2023 and the U.S. patent to expire in 2027. Ultomiris offers an extended dosing interval of once every 8 weeks, in contrast to the intravenous administration of Soliris, which requires dosing every 2 weeks. According to the drug market research company IQVIA, Soliris, which once had sales of 44 billion won in 2018, has experienced a steep decline in sales, with figures dropping to 31 billion won in 2020 and further down to 10.1 billion won in 2022. In Q3 last year, Soliris net sales saw a year-on-year drop of 23.7%. In the same period, Ultomiris sales showed rapid growth. Released in Q3 2021, Ultomiris topped sales of 43.2 billion won in 2022. In Q3 last year, Ultomiris sales saw a year-on-year increase of 14.2%. New drugs, beyond biosimilars, are waiting to be released in Korea A competitive landscape is expected in the PNH market as drugs other than Soliris and Ultomiris await release. One of the major pharmaceutical industry competitors is Novartis. Novartis' oral PNH treatment, Fabhalta, was recently approved in the United States. Fabhalta is a B-factor inhibitor that controls the destruction of red blood cells in the complement alternative pathway. Fabhalta's advantage is its formulation. Unlike existing intravenous formulations like Soliris and Ultomiris, Fabhalta is an oral medication that provides greater convenience. Novartis is currently conducting five Phase 3 clinical trials in Korea to evaluate the efficacy and safety profile of Fabhalta. The efficacy of Fabhalta was confirmed in patients who did not respond to C5 complement inhibitors or had not receive previous treatment. In clinical trials, Fabhalta treatment resulted in a hemoglobin level increase of more than 2 g/dL from baseline in the absence of red blood cell transfusions in 82% of the patients at 24 weeks. AstraZeneca has also achieved success in developing an oral treatment. On the 19th, AstraZeneca stated that their orally available inhibitor of D factor Voydeya received approval in Japan. Voydeya can be administered in combination with C5 inhibitors to adult patients with PNH who did not respond well to C5 complement inhibitors. Voydeya is assessed to help mitigate the side effects of C5 complement inhibitors, which can lead to extravascular hemolysis (EVH) and subsequent anemia in certain patients. The approval of Voydeya was based on a multi-national Phase 3 ALPHA clinical trial. In clinical trials, Voydeya met key assessment criteria, including hemoglobin levels, in patients who exhibited EVH when administered with C5 complement inhibitors. The safety profile evaluation has shown common side effects, including headaches and diarrhea. Voydeya has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) status by the European Medicines Agency. In addition to Voydeya, Roche is developing a new C5 complement inhibitor called crovalimab. Crovalimab is currently undergoing review for approval in the United States, Japan, and Europe. Under development as a subcutaneous (SC) delivery, crovalimab’s efficacy has been demonstrated in a once-every-four-week treatment.
Company
Ildong patents its new GLP-1 drug candidate in CN and JP
by
Lee, Seok-Jun
Feb 02, 2024 12:28pm
Ildong Pharmaceutical(CEO: Woongsup Yun) announced today that it has acquired substance patents for its metabolic disease drug candidate 'ID110521156' in China and Japan. ID110521156 is a new drug candidate being developed through Ildong’s subsidiary Yunovia ID110521156 is a glucagon-like peptide-1 receptor agonist class of medication that acts as an analog of the GLP-1 hormone, which regulates blood sugar levels by inducing insulin secretion in the body. GLP-1 hormone is produced in pancreatic beta cells and is known to be involved in insulin synthesis and secretion in the body, reduction of blood sugar level, regulation of gastrointestinal motility, and appetite suppression. According to Ildong Pharmaceutical, ID110521156 is a new small molecule compound that serves the same function as the GLP-1 hormone. It has the advantage of being relatively more stable structurally compared to biological agents such as peptides and is easy to design and synthesize in terms of commercialization. Ildong’s subsidiary, Yunovia, is conducting a Phase I trial to evaluate its tolerability, safety, and pharmacokinetic properties of 110521156. Depending on its commercialization progress including clinical development, the company plans to develop the candidate into a new drug targeting type 2 diabetes and obesity in the future. An Ildong official said, “We have acquired patents for our drug candidate in major markets such as Korea, the United States, China, Japan, India, and Australia, to facilitate a favorable environment for 110521156’s global commercialization. While securing rights to our new drug substance, we also plan to pursue business partnership strategies, such as licensing out and open innovation.
Company
Roche’s Crovalimab receives Orphan Drug Designation in KOR
by
Eo, Yun-Ho
Feb 02, 2024 12:28pm
The new PNH drug candidate 'crovalimab' has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) announced so through an orphan drug designation notice on the 1st. Crovalimab, which was discovered by Japanese drugmaker Chugai Pharmaceutical and developed by Roche, is a treatment for paroxysmal nocturnal hemoglobinuria (PNH) that is currently undergoing approval processes in the United States, Europe, and Japan. Crovalimab is a novel C5 inhibitor that is recycled within the bloodstream, enabling sustained complement inhibition through low-dose, subcutaneous (SC) administration every 4 weeks. The drug’s potential was confirmed in the pivotal Phase 3 COMMODORE2 trial, which directly compared crovalimab to AstraZeneca's Soliris (eculizumab) in PNH patients. Results from the study demonstrated that crovalimab, administered as SC injections every four weeks, achieved disease control and was non-inferior with comparable safety to eculizumab, a current standard of care, given intravenously every two weeks In the trial, 78% of patients who received crovalimab experienced adverse events (AEs) compared with 80% of those given Soliris, and the most common adverse AE was infusion-related reaction. Efficacy and safety data from a separate Phase III COMMODORE 1 trial also supported the favorable benefit-risk profile of crovalimab in PNH patients who switched to crovalimab from currently approved C5 inhibitors. Meanwhile, the competition in the PNH market is expected to intensify further. AstraZeneca had launched ‘Ultomiris (ravulizumab)’ as a successor to its Soliris, ahead of Soliris’s patent expiry in Europe in 2023 and in the U.S. in 2027. Ultomiris is administered intravenously every 8 weeks, compared with the once every 2 weeks administration required for Soliris. In the case of Novartis, it received approval for its oral PNH treatment, Fabhalta (iptacopan) in the U.S. Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (Intra and extravascular hemolysis). Joining the competition, Samsung Bioepis’s Soliris biosimilar, ‘Epysqli’ was also approved in Korea recently. It was the first domestic approval granted to a Soliris biosimilar in Korea, and Samsung Bioepis also received approval for its Epysqli in Europe last year.
Company
Onureg is now available in general hospitals
by
Eo, Yun-Ho
Feb 01, 2024 12:39pm
BMS Pharmaceutical Korea’s Onureg (azacitidine), a new drug for treating acute myeloid leukemia (AML). General hospitals can now prescribe ‘Onureg,’ an oral acute myeloid leukemia drug. According to industry sources, BMS Pharmaceutical Korea’s Onureg (azacitidine), a new drug for treating acute myeloid leukemia (AML), has recently passed the Drug Committee (DC) of Big 5 tertiary general hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital, as well as 40 hospitals across the country. Onureg received approval in Korea in March 2022 and passed the Health Insurance Review and Assessment Service's (HIRA) Cancer Drug Review Committee in December of the same year. Subsequently, Onureg has been included in the insurance reimbursement listing since August after passing the HIRA’s Drug Reimbursement Committee. Reimbursement for Onureg is provided if all the following criteria are met: ▲Cytogenetically defined as being at severe to high risk, ▲Has no history of using a hypomethylating agent (HMA), ▲Having no history of stem cell transplantation, ▲55 or older, and patient’s general state is not suitable for stem cell transplantation, ▲Administered within 7 days before and after 4 months of achieving complete remission (first CR or Cri) after receiving induction chemotherapy. The effectiveness of Onureg was demonstriated in Phase 3 QUAZAR AML-001 clinical study, which enrolled 472 patients with AML. Based on clinical results, patients who received Onureg had a median overall survival (mOS) of 24.7 months, an extension of 10-month compared to the 14.8 months observed in those treated with control. This improvement represented a 31% reduction in mortality risk. The rate of surviving patients in the Onureg-treated group at year one post-treatment was 73% (place group: 56%), and at year two post-treatment was 51% (place group: 37%). Onureg demonstrated higher survival rates than the placebo group in both periods. Onureg treatment prolonged relapse-free survival (RFS) by 5.3 months in patients to 10.2 months, thus demonstrating its effect in reducing the risk of relapse. "For patients with AML who have achieved remission following standard-dose induction chemotherapy but are not eligible for stem cell transplantation, receiving secondary treatments, aiming to prolong the state of complete remission (CL) and minimize the risk of relapse as possible, is critical. The reimbursement of Onureg is good news for patients with AML who were previously unable to receive maintenance therapy due to limited treatment options," Cheong, June-Won, a Professor in the Division of Hematology at the Department of Internal Medicine at Severance Hospital, stated.
Company
SK Biopharm’s new drug tops 500 bln won in US sales
by
Kim, Jin-Gu
Feb 01, 2024 12:39pm
SK Biopharmaceuticals. SK Biopharmaceuticals’ Cenobamate, a new epilepsy drug, has generated cumulative sales of 500 billion won in the United States since its launch four years ago. Previously, SK Biopharmaceuticals struggled with operating losses almost every quarter, except for occasional profits from technology exports. However, the company has now turned to achieve profits, primarily attributed to the success of Cenobamate. With its U.S. direct sales system in place, SK Biopharmaceuticals anticipates a high gross profit margin increase of mid-90%. SK Biopharm’s operating profit reached 15.2 billion won in Q4 last year, swinging to profitability after eight quarters of loss According to the pharmaceutical industry on the 30th, SK Biopharmaceuticals recorded 354.9 billion won in revenue last year, a 44% increase from the previous year at 246.2 billion won. In the same period, the company’s operating loss reduced from 131.1 billion won to 37.1 billion won. The company reduced its operating loss by 94 billion won year-on-year. Notably, the company succeeded in turning black in almost eight quarters since Q4 2021. The operating profit in Q4 was 15.2 billion won. SK Biopharmaceuticals’ quaterly earnings (Unit: 100 million won, Source: Financial Supervisory Service). Since its launch in the stock market in Q2 2020, SK Biopharmaceuticals had faced challenges with consecutive operating losses. Except for occasional profits from technology exports in Q1 2021 (75.9 billion won surplus) and Q4 2021 (134 billion won surplus), the company continued to record operating losses. In Q4 of last year, SK Biopharmaceuticals shifted to achieving operating profit, even without factoring in profits from technology exports. The company attributes this success to the increased sales of Cenobamate in the United States. Cenobamate’s sales in the U.S. have seen a steep increase, accumulating a total of 530 billion won in sales Cenobamate’s sales in the United States were 270.7 billion won, a 60% increase year-on-year. Cenobamate, which received approval from the United States Food and Drug Administration (FDA) in November 2019, was launched in May of the following year. Since its launch, Cenobamate’s sales in the United States have experienced significant yearly growth, achieving 12.7 billion won in 2020, 78.2 billion won in 2021, and 169.2 billion won in 2022. Since its launch, Cenobamate has generated a cumulative total of 530.8 billion won in sales. The industry analysis predicts that if the current growth trend continues, sales in the U.S. market will expand to approximately 400 billion won, with cumulative sales reaching 900 billion won by the end of this year. The trend of Cenobamate sales in the U.S. market (Unit: 100 mllion won, Source: Financial Supervisory Serivce). SK Biopharmaceuticals explained that Cenobamate’s new-to-brand prescriptions (NBRx) have steadily increased over the past year. As of December last year, 44 months after its launch, Cenobamate recorded NBRx of 26,000, which is 2.2 times higher than that of the competing drug. SK Biopharmaceuticals plans to increase the number of monthly Cenobamate prescriptions to 30,000. Simultaneously, the company aims to become number one in recording prescriptions within the therapeutic area (TA) and accelerate its business growth. SK Biopharm has established the U.S. direct sales system and inventory adjustment in advance, anticipating “a high gross profit margin” SK Biopharmaceuticals expects that the steady growth in Cenobamate’s sales in the United States, which led to the operating profit achieved in Q4 of last year, will continue throughout this year. The U.S. direct sales system is the rooting force behind this positive outlook. Before the launch of Cenobamate, SK Biopharmaceuticals established its U.S. subsidiary, SK Life Science, and established an extensive distribution network nationwide. They have also recruited specialized CNS sales professionals throughout the United States to directly promote Cenobamate. SK Biopharmaceuticals explained that the company can achieve a high gross profit margin with this direct sales system. Unlike selling through local partners, SK Biopharmaceuticals can achieve a high profit margin as it doesn't have to pass on approximately 30% of its revenue as commissions. SK Biopharmaceuticals anticipates that its future gross profit margin will remain in the mid-90s range. Another attributing factor for expecting a high gross profit margin is blocking any possibilities of operating losses in advance. At the end of the previous year, SK Biopharmaceuticals adjusted their inventory to prevent excessive accumulation by local wholesalers. This helps to reduce adverse impacts on operational performance resulting from inventory depletion. SK Biopharm is planning to expand indications for Cenobamate and develop a new pipeline as part of its mid-to-ling-term strategy The mid-to-ling-term strategy focuses on expanding indications and age groups and developing a follow-up new product. For Cenobamate's indications, SK Biopharmaceuticals plans to expand its approval from partial seizures to generalized seizures. The expected timeline for approval of this expanded indication is between 2025 and 2026. Additionally, SK Biopharmaceuticals intends to expand the age range of use from adults to pediatric and adolescent patients. SK Biopharmaceuticals’ Pipeline (Source: SK Biopharmaceuticals). Furthermore, SK Biopharmaceuticals plans to present strategies for introducing a follow-up new product this year, intending to conclude acquisitions of new commercial products by 2025. Last year, SK Biopharmaceuticals selected the development of radiopharmaceutical therapy (RPT), targeted protein degradation (TPD), and cell-gene therapy (CGT) as the ‘Three New Modality.’ Among these three, targeted protein degradation (TPD) is a potential candidate product. Led by SK Life Science Labs, the company plans to provide information on the pipeline in the TPD area and the development schedule this year. SK Life Science Labs owns a platform called ‘MOPED’ for discovering the molecular glue (MG).
Company
Oral plaque psoriasis drug Sotyktu in final stages of reimb
by
Kim, Jin-Gu
Feb 01, 2024 12:38pm
The oral plaque psoriasis treatment ‘Sotyktu’ has entered its final stages to reimbursement in Korea. According to Dailypharm’s coverage, BMS Korea accepted the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee’s deliberation results and accepted the condition of setting the price of its TYK2 inhibitor ‘Sotyktu (deucravacitinib)’ ‘below the evaluation amount’ that was made in DREC’s December meeting and is currently in drug pricing negotiations with the National Health Insurance Service. As the first oral treatment option introduced for tie indication in 10 years, Sotyktu is designed to selectively target TYK2, inhibiting signaling of interleukin (IL)-23, IL-12. TYK2 is an important link between IL-23 and IL-17, key inflammatory cytokines in psoriasis. By binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. In Korea, Sotyktu was approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in August last year. The drug demonstrated its efficacy through the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which evaluated the safety and efficacy of Sotyktu compared to placebo and twice-daily Otezla(apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis.' In the POETYK PSO-1 trial, 58.4% of patients on Sotyktu achieved a PASI 75 response at week 16, which was significantly higher compared with the 35.1% of patients on Otelza and 12.7% of patients on placebo. Also, the proportion of patients achieving sPGA 0/1 was significantly higher, at 53.6% compared with 32.1% in patients on Otelza and 7.2% in patients on placebo. Sotyktu achieved a significantly higher PASI 75 response at week 16 in the POETYK PSO-2 trial as well, achieving a PASI 75 response at week 16, compared with the 39.8% of patients on Otelza and 9.4% of patients on placebo. Also, the proportion of patients achieving sPGA 0/1 was significantly higher, at 49.5% compared with the 33.9% of patients on Otelza and 8.6% of patients on placebo, and the higher response rate was maintained through week 52. Yong-beom Choe, president of the Korean Society of Psoriasis, said, “Considering the various limitations psoriasis patients in Korea face, by those who are unable to achieve sufficient therapeutic benefit from existing therapies such as systemic therapy and phototherapy, those who experienced adverse events using existing therapies, and due to the lack of options other than injectable biologics in later-line stages of treatment, we expect Sotyktu will address these unmet needs of psoriasis patients in Korea based on its convenient once-daily oral dosing method.”
Company
HK Inno.N will copromote Xigduo and Sidapvia with AZ
by
Kim, Jin-Gu
Feb 01, 2024 12:38pm
HK Inno.N and AstraZeneca Korea announced on the 31st that they held a signing ceremony at HK Inno.N's Seoul office to mark their strategic collaboration of their diabetes portfolio. Under the agreement, HK Inno.N will jointly market and sell Xigduo (dapagliflozin + metformin) and Sidapvia (dapagliflozin + sitagliptin) with AstraZeneca Korea. HK Inno.N had signed a co-promotion agreement for Sidapvia in October last year. The co-promotion agreement was expanded this time to include Xigduo. At the same time, the company will be responsible for the domestic supply and distribution of the single-agent drug ‘Forxiga.’ At the end of last year, AstraZeneca Korea decided to withdraw Forxiga from the Korean market, and HK Inno.N will be responsible for the domestic supply of Forxiga until the second half of this year. Both companies assured that they will fully commit to ensuring a stable supply for patients using Forxiga, including those with type 2 diabetes, chronic heart failure, and chronic kidney disease, so they do not experience any inconvenience. HK Inno.N has previously been in charge of the domestic sales of Dong-A ST’s Suganon series for 5 years. Based on the market understanding and know-how accumulated through the experience, the company plans to focus on marketing and sales of Xigduo and Sidapvia at general hospitals, semi-general hospitals, and clinics. Dalwon Kwak, CEO and President of HK Inno.N, said, “Building on the strong network and co-marketing experience HK Inno.N owns in the diabetes market, we will focus our sales and marketing capabilities to ensure that AstraZeneca's excellent treatments are stably supplied to healthcare providers and patients in Korea, We will make our best efforts to supply the drugs we co-market through healthcare providers in general hospitals and clinics nationwide and establish the drugs as solid treatment options for patients with type 2 diabetes in Korea. Sewhan Chon, Country President of AstraZeneca Korea, said, “Through our partnership with HK Inno.N, AstraZeneca Korea will continue to work to drive the expansion of the diabetes combination market and provide various treatment options for patients and healthcare providers in Korea. In particular, we will do our utmost to ensure a stable supply of Forxiga in Korea so that patients with type 2 diabetes, chronic heart failure, and chronic kidney disease do not experience any inconvenience.” Sidapvia is manufactured in Korea under an agreement between AstraZeneca and SK Chemicals. As the Marketing Authorization Holder (MAH) for Sidapvia, AstraZeneca is responsible for its commercialization in Korea and abroad, while SK Chemicals is responsible for the manufacture and supply of the product. According to the market research institution UBIST, prescriptions for Xigduo amounted to KRW 47.2 billion last year, up 2% YoY. Sidapvia posted sales of KRW 200 million last year.
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