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- 2025-12-23 20:46:04
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- Duloxetine shows strength in ₩30B antidepressant mkt
- by Nho, Byung Chul May 17, 2023 05:38am
- Last year, top-line sales of the antidepressant duloxetine recorded KRW 17.7 billion, taking a big lead ahead of venlafaxine, which achieved KRW 12.7 billion in sales, and is solidifying its position in the relevant prescription market. According to drug distribution data, sales of duloxetine drugs grew from KRW 15.5 billion to KRW 17.7 billion from 2019 to 2022, whereas sales of venlafaxine drugs showed a declining trend from KRW 13.1 billion to KRW 12.7 billion. The contrasting performance of the top two major antidepressant substances in the market is interpreted to be attributed to the difference in their indications. The duloxetine original, Lilly’s Korea’s Cymbalta Cap can be prescribed in a broader scope as its indications include the treatment of generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and musculoskeletal pain that does not respond appropriately to non-steroidal anti-inflammatory drugs (NSAIDs). On the other hand, the venlafaxine leader, the indication of Viatris Korea’s Efexor Xr Cap. Is limited to depression, such as social phobia and panic disorder, which fall under the category of generalized anxiety disorder. The unwavering lead in the duloxetine antidepressant market is Cymbalta, which has raised sales of KRW 8.6 billion in 2018, KRW 9.1 billion in 2019, KRW 9.3 billion in 2020, KRW 9.7 billion in 2021, then KRW 9.7 billion in 2022. The second duloxetine in line is Hanlim Pharm’s Duxela Cap., which raised sales of KRW 1.7 billion last year. Myung-In Pharm’s Droctin Cap ranked third has shown aa over twofold growth from KRW 0.74 billion in 2018 to KRW 1.35 billion last year. Top-line sales of the duloxetine drugs that followed are HR Inno. N’s Culocta, ‘Hwan-In Pharm’s Duloxeptol, Korea Celltrion Pharm’s Julotine, then Korea Pharm’s Duroprex. The respective drugs raised sales of KRW 0.85 billion, 0.77 billion, 0.53 billion, and 0.38 billion, respectively. The combined sales of the 18 other minor products in 2022 were in the KRW 1.4 billion range. The lead product among venlafaxine drugs is Efexor XR, which recorded KRW 4.4 billion last year. The rapid growth of generic versions of venlafaxine is noteworthy in the market. Korea Pharma’s Pharma Venlafaxine arose to become the second-most sold the drug in the venlafaxine market, making a 1800% growth from KRW 0.15 billion in 2018 to KRW 2.89 billion in 2022. The third was Hanlim Pharm’s Venexor XR, which recorded sales of KRW 2.1 billion last year. Sales of Myung-In Pharm’s Cofexor, which had been in the KRW 3 billion range until 2019, were reduced to sales of KRW 1.7 billion last year. Daewoong Bio’s Verakan and Sam Chung Dang Pharm’s Venlafect, Youngjin Pharm’s Venfaxine raised sales of KRW 0.26 billion, 0.53 billion, and KRW 6.8 billion last year. Meanwhile, observations show that Alvogen Korea’s Ivenxine withdrew from the prescription market after raising KRW 12 million in sales in 2019.
- Company
- Hemophilia drug Hemlibra coverage expansion
- by Chon, Seung-Hyun May 17, 2023 05:37am
- Hemlibra JW Pharmaceutical has laid the foundation for developing Hemlibra, a treatment for hemophilia, into a large-scale product. With the expansion of benefits, treatment benefits are provided to more patients, and expectations for sales growth are rising due to increased prescriptions. According to the Ministry of Health and Welfare on the 16th, Hemlibra will be covered for hemophilia A patients over the age of 1 who do not possess factor VIII antibodies from this month. Hemlibra is a routine prophylaxis for hemophilia A, which is caused by a deficiency of coagulation factor VIII. It is a product that applies bispecific antibody technology that simultaneously binds to blood coagulation factor 9 and factor 10. Unlike existing coagulation factor 8 preparations, it is the first non-coagulation factor preparation and can be administered subcutaneously once every 4 weeks at most. Hemlibra was developed by Chugai Pharmaceutical, a subsidiary of the global pharmaceutical company Roche. JW Pharmaceutical secured domestic development and sales rights for Hemlibra in 2017 and received permission from the Ministry of Food and Drug Safety in 2019. Chugai Pharmaceutical applied health insurance benefits to severe hemophilia A antibody patients in May 2020, and from this month, benefits were extended to non-antibody patients. According to JW Pharmaceutical, there are 1,746 patients with hemophilia A in Korea. Among them, severe hemophilia A patients were 1259, or 72%. Among patients with severe hemophilia A, 27 patients had antibodies and 1171 patients had non-antibodies. JW Pharmaceutical explained, “More than 60% of hemophilia A patients in Korea are covered by Chugai Pharmaceutical’s benefits.” JW Pharmaceutical expects that Hemlibra will provide great treatment benefits to patients based on the efficacy and safety proven by large-scale clinical trials. In the HAVEN1 clinical trial for antibody patients, it was confirmed that Hemlibra prophylaxis compared to the existing bypass therapy prophylaxis therapy reduced the annual bleeding rate (ABR) by 3.3 times by about 79%. In the HAVEN3 clinical trial for non-antibody patients, it proved an effect of reducing approximately 68% of the ABR (Annual Bleeding Rate) 1.5 times compared to prophylactic factor 8 therapy. The company explains that Hemlibra has also proven safety through clinical results. HAVEN 1~4 Clinical Results Among patients who received Hemlibra, most side effects were mild injection site manifestations. Quarterly Hemlibra sales (unit: million won, source: IQVIA) The company said, "Hemlibra has a long half-life of 28 days, so it increases patient convenience by reducing the number of administrations once every 4 weeks, compared to 2-3 times a week for conventional prophylaxis." In contrast to having to do intravenous injection, subcutaneous injection is possible, so it can help patients who have difficulty in intravenous injection or pediatric patients.” According to IQVIA, a pharmaceutical research institute, Hemlibra recorded sales of 7.6 billion won last year. In the first year of application in 2020, it raised 2.1 billion won, followed by 7.2 billion won in 2021, and showed an upward trend last year. Looking at quarterly sales, it recorded 2.2 billion won in the fourth quarter of last year, surpassing 2 billion won in sales for the first time. The cumulative sales of Hemlibra over the past three years were 17 billion won. The company expects that the amount of use will increase sharply as the target of benefit coverage expands significantly in the future. Last year, Hemlibra's global sales increased by 27% to CHF 3.823 billion. Currently, more than 20,000 patients in 144 countries around the world are using Hemlibra. “Hemlibra is an innovative new drug that can dramatically improve the quality of life of hemophilia patients with ease of administration and excellent efficacy,” said an official from JW Pharmaceutical. He said, "We expect that this new standard will expand the treatment accessibility of patients suffering from hemophilia and the choice of medicines for medical staff."
- Company
- Crysvita, the first fast-track drug by Yoon gov, is expected
- by Eo, Yun-Ho May 16, 2023 09:06pm
- It is now possible to prescribe 'Crysvita', the No. 1 rapidly registered drug of the Yoon government. This drug recently passed the Drug Committee (DC) of medical institutions such as SNUH. Kyowa Kirin Korea's (XLH rickets treatment Crysvita is a pediatric treatment that has been clinically proven effective in the field of diseases for which there is no equivalent drug or treatment. ) was listed on the list of insurance benefits. Since it is a drug that requires prior approval for reimbursement, it will take more time until the first prescription comes out. Crysvita's reimbursement criteria are for patients with X chromosome-linked hypophosphatemic (XLH) rickets aged 1 to 12 years who have not been controlled despite continuous administration of existing treatments (active vitamin D preparations, etc.) for more than 6 months. Symptoms such as growth retardation, dental abnormalities, lower extremity bone deformity, premature cranial fusion, and increased intracranial pressure are confirmed, and 'RSS level is 2 points or more, hypophosphatemia (less than 3.0 mg/dL) and loss of renal phosphorus (TmP/GFR reference value) less) must be proven. Until the registration of Crysvita, pediatric XLH rickets was treated with large doses of phosphate and vitamin D, but it was administered 4 to 6 times a day, and about 30% required surgery. Kang Hee-kyung, a professor of pediatrics at Seoul National University Hospital, said, "The existing treatment method of directly administering insufficient phosphate has a limit in that a vicious cycle occurs in which 'FGG23' is further activated and the degree of phosphate reabsorption further decreases. Crysvita is not a method of adding phosphate, It is a fundamental treatment that inhibits FGG23.”
- Company
- JAKi Cibinqo owns strengths in dosage adjustments
- by Jung, Sae-Im May 16, 2023 05:40am
- Pfizer's JAK inhibitor ‘Cibinqo (abrocitinib)' has embarked on a full-fledged journey to expand its prescriptions. After landing in major general hospitals at the end of last year, the drug is likely to be registered for reimbursement within the first half of this year. Cibinqo is a Janus kinase 1 (JAK1) inhibitor approved by the Ministry of Food and Drug Safety in November 2021. It is the 4th JAK inhibitor introduced to Korea and the second JAK inhibitor drug introduced by Pfizer after Xeljanz. Unlike Xeljanz, which is only used for ulcerative colitis, Cibinqo is used to treat severe atopic dermatitis. Treatment options have increased significantly for severe atopic dermatitis starting with the introduction of the injection-type biologic medication and oral JAI inhibitors. In particular, a total of 3 oral JAK inhibitors are available for patient use in Korea. Olumiant (baricitinib) and Rinvoq (upadacitinib) have first entered the market and are being used with reimbursement, followed by Cibinqo. Although Cibinqo is a latecomer, it owns a differentia table property from existing drugs. Dailypharm met with Jung-Im Na, Professor of Dermatology at Seoul National University Bundang Hospital to hear about its differentiable properties in the field. Jung-Im Na, Professor of Dermatology at Seoul National University Bundang Hospital Its first advantage is in its free dose control. Cibinqo comes in three doses: 50, 100, and 200mg. Although the recommended starting dose is 200mg, the dosage can be adjusted to 100 mg or 50 mg depending on the progress of treatment. If symptoms worsen with dose reduction, the doctor can increase treatment response again by increasing the dose and using local treatment together (JADE REGIMEN study). Professor Na said, “JAK inhibitors are fast and effective, but its exit strategy is considered a problem after the patient’s condition improves. In other words, ending treatment after seeing an effect is difficult with the use of JAK inhibitors. However still, due to its free dosage adjustments, it is attractive that the dosage can be reduced step by step from 200mg to 50mg.” He added, “No drug can be used for the rest of one’s life. Therefore, how to complete the treatment well is an important factor, and dose plays an important role. In particular, JAK inhibitors generally have a short half-life, and therefore disappear quickly from the body, leading to recurrence. Therefore, you cannot terminate treatment at once,” emphasizing the importance of dosage control. Major efficacy endpoint results in the JADE DARE trial Another advantage is in how it holds grounds based on a head-to-head trial for switching to the biological drug Dupixent. Among Cibinqo’s 7 Phase III clinical trials, the JADE DARE study is a head-to-head clinical trial comparing Cibinqo with Dupixent. As a result of separately administering Cibinqo 200mg and dupilumab 300mg in combination with a topical treatment for 26 weeks, the proportion of patients who achieved an improvement of 4 points or larger in the Peak Pruritus Numerical Rating Scale (PP-NRS4) at 2 weeks was 48.2% in the Cibinqo group, higher than the 25.5% of the Dupixent group. The proportion of patients who achieved a 90% improvement in the Eczema Area and Severity Index (EASI-90) at Week 4 was also significantly higher in the Cibinqo group (28.5%) than in the Dupixent group (14.6%). Moreover, the company also conducted the JADE EXTEND study, which studied the effect of switching patients who used Dupixent to Cibinqo. Patients were divided into those who were responsive to Dupixent and those that were non-responsive to Dupixent. 93.5% and 90.2% of patients who showed a response to Dupixent achieved EASI-75 after switching to Cibinqo 200mg and 100mg, respectively. PP-NRS4 was 89.7% and 81.6%, respectively. Among patients who did not respond to Dupxient, the proportion of those that reached EASI-75 was 80% and 67.7%, respectively, and PP-NRS4 was 77.3% and 37.8%, respectively. Efficacy of switchin gto Cibinqo(Abrocitinib) among patients thatresponsive to Dupxient(left) and those that were unresponsive (Data: Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab). The study provided evidence that patients who did not see an effect with Dupixent can expect an effect when they switch to Cibinqo. Previously, a clinical trial was also conducted with the JAK inhibitor Rinvoq on switching therapy from Dupixent. However, Cibinqo is the only drug that analyzed the effect of switching administration according to the patient’s presence or absence of an effect with Dupixent. This is why the trials have raised expectations of JAK inhibitors receiving expanded reimbursement as a replacement therapy when switching from Dupixent. Professor Na said, “The reason why the JADE EXTEND clinical trial is significant is that there are many patients who do not see an effect while using Dupixent, even though it is a good drug. However, these patients have to discontinue treatment and use immunotherapies for 3 months and see a deterioration in their condition before switching to a different treatment to receive reimbursement due to limited reimbursement standards. As Cibinqo has evidence prepared with clinical trials, the trials may be grounds to extend the drug’s reimbursement to switching medications. Also, For those who have not seen any effect after using Dupixent, the evidence is there to switch to Civinco.”
- Company
- Samil, a series of love calls from multinational companies
- by Lee, Seok-Jun May 16, 2023 12:16am
- Samil Pharmaceutical is receiving a series of love calls from multinational companies. This time, it has decided to exclusively distribute and sell all Sandoz products, including the central nervous system (CNS). The CNS division, which was newly established in 2021, will gain momentum for business expansion. It is evaluated that Samil Pharmaceutical's expansion of partners is because it has met global standards in sales and marketing. Even before Sandoz, the company has partnered with global pharmaceutical companies such as GSK, Abbott, AbbVie, Mundipharma, and Beatrice. It is also affiliated with domestic companies such as Samsung Bioepis. Samil Pharmaceutical exclusively distributes and sells all products, including Sandoz CNS (Central Nervous System). The two companies recently signed such an agreement. Sandoz changed its Korean business to a 100% third-party distribution model. Sandoz is a subsidiary of Novartis in the generic and biosimilar business. Samil Pharmaceutical plans to strengthen the recently expanding CNS field while holding Sandoz products. In order to broaden the CNS lineup in 2021, the company established a new CNS division for sales of the existing neurology team and psychiatric products. In the same year, it signed an exclusive distribution and sales contract for Beatrice's Xanax, Zeldox, and Zoloft in the Korean market. A company official said confidently, "Samil Pharmaceutical will provide the best treatment options for domestic patients by further strengthening its powerful central nervous system disease lineup through the distribution and sales of Sandoz medicines." Sandoz currently has about 40 items in stock. In addition to CNS, it deals with chronic disease products such as Sandoz Amlodipine and Sandos Atorvastatin. This is also exclusively distributed and sold by Samil Pharmaceutical. This is where Samil Pharm's external expansion is expected. The company's sales last year were 179.7 billion won. It is expected to break through 200 billion won this year. Samil Pharmaceutical’s factory in Vietnam Samil Pharmaceutical is receiving a series of love calls from multinational companies in addition to Sandoz. Prior to Sandoz, it partnered with global pharmaceutical companies such as GSK, Abbott, AbbVie, Mundipharma, and Beatrice. There are also domestic companies such as Samsung Bioepis. It is evaluated that it is because it has met global standards in sales, marketing, and distribution. Sandoz Korea also explained that the decision to partner with Samil Pharmaceutical was made considering △company size, △professionalism in supplying medicines in ophthalmology, liver and stomach, musculoskeletal system, and CNS areas, and long-term collaboration experience and capabilities with many global companies. Samil Pharmaceutical has been making efforts to grow into a global company for several years. △ Established a subsidiary in Vietnam in 2018, △completed the construction of a CDMO plant for eye drops in Vietnam in 2022, △Established a North American subsidiary in Canada in 2022, and △Secured future growth engines by signing contracts for new drug candidates in the global phase 3 clinical trials such as Aramchol and Lorecivivint △ Domestic introduction of excellent foreign medicines, etc. In particular, the Vietnam global eye drop CDMO plant, which had a completion ceremony in November last year, is expected to serve as a stepping stone for global expansion. The factory can produce about 330 million eyedrops per year. It is aiming to obtain GMP approval for DAV in Vietnam and MFDS in Korea by the end of the year at the earliest. Within the next two to three years, the company plans to supply high-quality medicines to the global market through US FDA cGMP, European EMA EU GMP, and Health Canada GMP approvals.
- Company
- New diabetes treatment guidelines released
- by Kim, Jin-Gu May 15, 2023 05:41am
- The status of GLP-1 analogues and SGLT-2 inhibitors has risen further in Korea’s new diabetes treatment guidelines. In the revised guidelines, when considering options to use in combination with injection therapy, GLP-1 analogues were recommended over basal insulin, and SGLT-2 inhibitors were recommended first for diabetic patients with heart failure, kidney disease, or cardiovascular disease. Kyu-Chang Won, Chairman of KDA (Endoctriology, Yeungnam University Hospital) is introducing KDA On the 12th, Korean Diabetes Association introduced the key contents of its ‘KDA clinical practice guidelines for diabetes: 8th edition’ at the 2023 Spring Conference of the Korean Diabetes Association that was held at the Kimdaejung Convention Center in Gwangju. The KDA publishes treatment guidelines for diabetes every 2 years. The association organized a clinical practice guideline committee around Director Min Kyong Moon (Internal Medicine, Seoul National University Medical School) and developed the new practice guidelines from January last year to April this year. The most notable change observed in the new guideline is the use of GLP-1 analogues and SGLT-2 inhibitors. In general, the two classes of drugs were more strongly recommended. GLP-1 analogues currently available in Korea include Trulicity (dulaglutide) and Ozempic (semaglutide), and SGLT-2 inhibitors include Forxiga (dapagliflozin) and Jardiance (dapagliflozin). ◆GLP-1 analogues = The new clinical practice guidelines ‘recommend GLP-1 analogues over basal insulin when considering injection-based combination therapy.’ Previously, treatments in combination with injection therapy were recommended as priority for potent blood sugar-lowering effect. In addition, GLP-1 analogues in combination with basal insulin were recommended to enhance blood sugar control. The newly revised guidelines went a step further from the previous guidelines to recommend GLP-1 analogues first. Jung-Hyun Noh, professor of internal medicine at Inje University, said, “In a study that directly compared the results of using GLP-1 analogues+oral medications to separate use of GLP-1 analogues or insulin, there was no significant difference in their HbA1c level reduction effect. However, the use of GLP-1 analogues was found to maintain the lowering effect longer.” In addition, the content that if the target blood sugar level cannot be achieved with either the GLP-1 analogue or basal insulin alone, the two drugs shall be used together, was newly added to the guideline. It was also added that if the target blood sugar level is not reached even with GLP-1 analogue or basal insulin treatment, insulin potentiation therapy should be attempted. ◆SGLT-2 inhibitors = SGLT-2 inhibitors were also more strongly recommended. The revised guideline recommends, "'in case of accompanying heart failure, the use of SGLT-2 inhibitors with proven heart failure benefits is recommended in priority regardless of HbA1c level, and the treatment should be continued unless contraindications or side effects arise.' In the case of renal disease as well, the revised guideline recommend 'in case of albuminuria or decreased estimated glomerular filtration rate, SGLT-2 inhibitors with proven renal benefits should be used first regardless of HbA1c level, and be maintained unless contraindications or side effects arise." Previous guidelines have recommended ‘treatment including SGLT-2 inhibitors to be considered first in patients with heart failure.’ Here, the phrase 'regardless of the HbA1c level’ was newly added with the revision. Professor Noh said, “New studies have demonstrated the benefit of SGLT-2 inhibitors in heart failure and renal disease. The effect was consistent in patients without diabetes. This is why we recommended the use of SGLT-2 inhibitors if there is a risk of disease, regardless of HbA1c level." In addition, it was recommended that "treatment including GLP-1 analogues or SGLT-2 inhibitors with proven cardiovascular benefits should be prioritized in patients with atherosclerosis cardiovascular disease. Previously, SGLT-2 inhibitors were recommended as monotherapy for such patients, but this time, GLP-1 analogues were added to the recommendations."
- Company
- MSD Korea begins voluntary retirement
- by Jung, Sae-Im May 15, 2023 05:40am
- MSD Korea, which announced a reduction in manpower due to the abolition of the Januvia division, has begun a full-fledged reduction in personnel by disclosing the conditions for ERP. The labor union of MSD Korea warned of a tough response, saying, "We cannot accept the company's attempt to reduce manpower." On the 12th, MSD Korea announced the conditions for voluntary retirement for GM division employees. Employees who apply for voluntary retirement are paid a monthly basic wage equal to the number of months equivalent to the value of adding 10 to twice the number of years of service as a basic severance pay (2n+10). The payment limit is limited to a maximum of 48 months. In addition, an additional 20 million won is paid as severance compensation. For example, if an employee with 10 years of service applies for voluntary retirement, he or she will receive a monthly base salary equivalent to 30 months and an additional 20 million won. However, if the total severance pay exceeds the 'amount calculated by multiplying the number of remaining months until retirement by the monthly basic salary', the excess amount is deducted. This voluntary retirement program is aimed at about 100 employees in the GM division. The company began reorganization by handing over all rights of the diabetes treatment 'Januvia series' sold by the GM division to the domestic pharmaceutical company Chong Kun Dang. The plan is to get rid of the GM division, which mainly sold chronic disease treatments, and leave only three divisions: anticancer drugs, vaccines, and hospital specialties. The downsizing of the division was also accompanied by a reduction in personnel. The labor union strongly opposed the company's attempt to cut personnel. Since there was no urgent management problem to abolish the business unit, it is a position that it cannot agree to all attempts to reduce personnel, such as ERP, individual meetings, external career support programs, and layoffs. The union said, "According to the Labor Standards Act and Article 18 of 'Employment Security' of the MSD Korea Collective Agreement, the union and all members will not participate in any sessions, including one-on-one meetings scheduled for the future." In addition, the union said, "The union and all union members will fight strongly by mobilizing all available capabilities to defend the right to live."
- Company
- Advate leading hemophilia treatment
- by Nho, Byung Chul May 12, 2023 05:45am
- In the field of hemophilia non-antibody and antibody treatment, Takeda Korea Pharmaceutical and JW Pharmaceutical are gaining attention as they are strengthening their positions. Korea Takeda Pharmaceutical's 'Advate/Adynovate', and JW Pharmaceutical's Hemlibra's sales last year were 26.2 billion won and 7.6 billion won, respectively, ranking first in related markets. Of particular note is that the hemophilia antibody treatment market is fluctuating in line with the launch of Hemlibra in 2020. Due to the emergence of strong competing products, the external expansion of traditional powerhouses Novoseven RT and Faiva is drawing a steep downward curve. Novoseven RT·Faiva's sales from 2018 to 2022 show a decreasing trend from '19.5 billion - 5.4 billion won' to '6.1 billion - 3.6 billion won'. In the non-antibody treatment market, six domestic and foreign pharmaceutical companies, including GC Green Cross, Pfizer Korea, Sanofi, and Bayer Korea, are competing fiercely with Takeda at the forefront. Based on the sum of pharmaceutical product lines, Takeda's 'Advate/Adynovate -19.4 billion won/6.7 billion won' and GC Pharma's GreenMono/Greengene F -6.5 billion won/2.7 billion won' ranked first and second, respectively. Pfizer's Xyntha Solofuse, Sanofi's Eloctate, and Bayer's Kogenate FS achieved 5.1 billion won, 3 billion won, and 1.8 billion won last year. The newly released CSL Bering Korea Afstyla in 2021 showed a performance of 40 million won in the first year and about 100 million won last year. The peculiarity is that except for Adynovate and Eloctate, the performance of most non-antibody treatment products is showing a downward trend, and the market also decreased by nearly 5 billion won last year compared to 50 billion won in 2018, five years ago. The antibody treatment market also recorded a sales peak of 25.7 billion won in 2018, followed by a 35% decline with sales worth 16.7 billion won in 2022. Hemophilia is largely divided into hemophilia A (factor VIII deficiency), hemophilia B (factor IX deficiency, also known as 'Christmas disease'), hemophilia C (factor XI deficiency), para hemophilia (factor V deficiency), and pseudo hemophilia. (pseudo hemophilia) or von Willebrand disease (von Willebrand factor deficiency). The incidence of hemophilia A patient is about 1 in 5,000 to 10,000 normal-born males, and hemophilia B is about one-fifth of this. Von Willebrand disease occurs in both men and women and occurs in about 1 in 1000 cases. It is estimated that there are 600,000 hemophilia patients worldwide, and about 12% of all hemophilia patients are hemophilia B patients. In Korea, the number of patients with hemophilia A is the highest at 2,000, followed by 400 patients with hemophilia B, 100 patients with von Willebrand disease, and 20 patients with hemophilia C.
- Company
- SK Biopharm’s cenobamate secures KRW 700 billion
- by Chon, Seung-Hyun May 12, 2023 05:45am
- Cumulative sales of SK Biopharmaceutical’s epilepsy treatment cenobamate exceeded KRW 300 billion in the US. It had continued to show growth every quarter ever since its release. Combined with the upfront payment and milestone payments cenobamate has earned more than KRW 700 billion over the past 4 years. According to SK Biopharm on the 11th, cenobamate posted sales of KRW 53.9 billion in the United States in Q1 last year. This is a 70.0% increase from the KRW 31.7 billion made in the same period last year. This also surpassed the previous record of KRW 49.8 billion recorded in the previous quarter by 8.2%, and the sales showed continued growth every quarter since its release. The total number of prescriptions for cenobamate in the United States is also on the rise. The total number of prescriptions in the first quarter was about 55,000, up 10% from the previous quarter. Quarterly sales of cenobamate in the US (Unit: KRW 100 million, Data: SK Biopharm). Cenobamate is a new anti-epileptic developed solely by SK Biopharmaceuticals from its initial development to US FDA approval as a treatment for partial-onset seizures in adults. It simultaneously regulates 2 targets related to excitatory/inhibitory signaling that are known to cause epilepsy to reduce seizure frequency. SK Biopharmaceuticals received approval for cenobamate under the brand name ‘Xcopri’ from the US FDA in November 2019, and has been directly selling the drug through its US subsidiary, SK Life Science since May 2020. Cenobamate has been growing every quarter since generating initial sales of KRW 2.1 billion in Q2 2020. In Q1 2021, sales exceeded KRW 10 billion, and quarterly sales exceeded KRW 50 billion this year. Cumulative sales of cenobamate in the US totaled KRW 314 billion. Also, Cenobamate has secured over KRW 400 billion as technology fees over the past 4 years. SK Biopharmaceuticals entered into an exclusive licensing agreement in February 2019 with the Swiss pharmaceutical company Arvelle Therapeutics to transfer technology on cenobamate for up to USD 530 million. At the time, SK Biopharmaceuticals received an upfront payment of USD 100 million with no obligation of return. In October 2020, the company entered into an exclusive licensing agreement with Ono Pharmaceutical for Ono to develop and commercialize Xcopri in Japan. Under the agreement, SK Biopharmaceuticals received an upfront payment of ¥5 billion with no obligation of return, and will also be eligible to receive up to ¥48.1 billion based on the achievement of certain regulatory and commercial milestones, as well as over 10% royalties on net sales generated in Japan. In November 2021, SK Biopharmaceuticals licensed out 6 new central nervous systems (CNS) drugs including cenobamate to Ignis Therapeutics. Under the deal, SK Biopharmaceuticals received an upfront payment of USD 20 million, a milestone payment of USD 15 million, and royalties on net sales in the future. Through the technology export, SK Biopharmaceuticals acquired 150 million shares of Ignis (share amounts to 44.9% including common stock). And in December 2021, SK Biopharmaceuticals signed a licensing deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada. Under the deal, SK Biopharmaceuticals an upfront payment of USD 20 million. The company will also be able to receive up to USD 21 million in Canadian dollars based on the achievement of certain regulatory and commercial milestones in the future. Paladin Labs Inc., a Canada-based operating subsidiary of Endo, will be responsible for all commercial activities related to cenobamate in the region, including its release. Endo is a global healthcare company headquartered in Ireland. In July last year, SK Biopharmaceuticals signed a licensing out deal with the Brazilian pharmaceutical company Eurofarma Laboratorios SA for cenobamate. Under the agreement, SK Biopharmaceuticals will receive an upfront payment of USD 15 million and up to USD 47 million in milestone payments. Under the licensing out agreement, Eurofarma will be selling cenobamate in 17 Latin American countries including Brazil and Mexico In addition to upfront payments, the company has also received milestone payments upon cenobamate’s approval abroad. SK Biopharmaceuticals received USD 123.22 million from its European partner Angelini Pharma as milestone payments last year. Angelini Pharma (formerly Arvelle Therapeutics UK) has collected additional milestone payments after receiving marketing authorization from the European Commission in March last year. SK Biopharmaceutical’s cash inflow from upfront payments and further milestones from the technology transfer of cenobamate is USD 278.22 million and ¥5 billion. Based on recent exchange rates, the company had secured about KRW 400 billion through upfront and milestone payments through technology transfer with cenobamate. Combined with US sales, the drug had brought in over KRW 700 billion. The company is seeking to expand its sales in the global market. After its approval in Europe in March 2021, the company released its drug under the product name ‘Ontozry.’ So far, it has been released in 18 European countries, including Germany, England, Italy, Spain, and France. The company is also speeding up development to expand indications for cenobamate as well as its pipeline. Cenobamate is undergoing multinational clinical trials to extend its indication to generalized seizures and expand the age group that can be administered from adults to adolescents, and the study has entered Phase III trials in Korea. An SK Biopharmaceuticals official said, “We plan to conduct aggressive sales activities including improving the incentive system for our sales representatives to encourage sales in the US and by expanding the clientele from epilepsy specialists to general neurologists.”
- Company
- SU's strengths maximized through combined use with SGLT-2is
- by Kim, Jin-Gu May 12, 2023 05:44am
- New opportunities have emerged for the use of the diabetes treatment sulfonylurea (SU). It is claimed that its combined use with SGLT-2 inhibitor drugs can offset the existing disadvantages such as hypoglycemia and weight gain, while fully utilizing the strong blood sugar lowering effect of SU drugs. Jin Hwa Kim, Professor, Department of Endocrinology and Metabolism, Chosun University Hospital Professor Jin Hwa Kim of the Department of Endocrinology and Metabolism at Chosun University Hospital claimed so at the 2023 Spring Conference of the Korean Diabetes Association held at the Kimdaejung Convention Center in Gwangju on the 11th, where he made his theme presentation during the special session. In his presentation on 'Expected Effects of Combined Use of Sulfonylurea and SGLT-2 Inhibitor in Type 2 Diabetes', he said, "The commonly known disadvantages and side effects of SU class drugs can be overcome by combining them with SGLT-2 inhibitor class drugs." "A recent study cleared the misconception that SU class drugs increase cardiovascular risk" SU-class antidiabetics were known to have clear advantages and disadvantages. Although it has an excellent blood sugar lowering effect, its risk of hypoglycemia and weight gain were pointed out as disadvantages. Also, there had been rising concerns about how it may increase the risk of cardiovascular disease. Due to such reasons, the use of SU-class drugs had been gradually decreasing in practice. In the past, other than metformin, SU was the most commonly used drug, but its prescriptions had decreased since the release of DPP-4 class drugs that have a lower risk of hypoglycemia. However, Professor Jin Hwa Kim cleared the misconception that SU-class drugs have a high cardiovascular risk with a recent study. According to Kim, the CAROLINA trial that was published in 2019 compared the cardiovascular safety of glimepiride, an SU drug, and linagliptin, a DPP-4 inhibitor. Results of the CAROLINA trial, which studied 6,000 people in 43 countries around the globe for 8 years, showed that the cardiovascular safety of the two drugs was similar. With glimepiride demonstrating safety similar to linagliptin, a drug proven to have cardiovascular safety, U-class drugs can be cleared of the misconception that it increases cardiovascular risk. In the 'GRADE' study that compared glimepiride’s cardiovascular safety with liraglutide, a GLP-1 analog, results showed that glimepiride had a similar level of cardiovascular risk as liraglutide. In addition, in another meta-study that compared SU class drugs with DPP-4 inhibitor class drugs or TZD class drugs, there was no significant difference in cardiovascular events and mortality between different classes overall. With such research results coming out one after another, Professor Kim explained that the American Diabetes Association (ADA) issued a 'neutral' opinion on the cardiovascular risk of SU-class drugs in its diabetes treatment guidelines this year. Professor Kim said, "The studies reduced overall concerns about cardiovascular risk. Also, when used in combination with SGLT-2 inhibitors, which have cardiovascular benefits, its use will become much safer." "The risk of hypoglycemia and weight gain of SU class drugs can be offset by SGLT-2 inhibitors" Professor Kim claimed that the risk of hypoglycemia and weight gain, which were pointed out as other disadvantages of SU class drugs, can be sufficiently offset by combining the use of SGLT-2 inhibitor class drugs. According to Kim, a recent meta-analysis showed that the risk of hypoglycemia increased when SU-class drugs were used in combination with SGLT-2 inhibitors. On this, Professor Kim said, "However, specifics showed that results differed depending on the dosage of the SU class drugs. When using SU drugs with SGLT-2 inhibitors, you can reduce the dose of the SU drug to reduce the risk of hypoglycemia.” Regarding the weight gain side effect, he added “There are concerns that SU drugs may cause weight gain, but it can be offset with SGLT-2 inhibitors.” Professor Kim added, “The concerns held by SU class drugs can be offset by combining its use with SGLT-2 inhibitors. This will allow patients to fully enjoy the strong blood sugar lowering effect of SU class drugs.” Kang-Seo Park, professor of Endocrinology at Eulji University Hospital, who chaired the session, added, “For patients with high blood sugar, SU class drugs can be used to help lower blood sugar safely through combined use with SGLT-2 inhibitors.”
