- LOGIN
- MemberShip
- 2026-05-10 18:41:44
- Company
- Interview: More options in CDK4/6 inhibitor-Faslodex
- by Eo, Yun-Ho Oct 29, 2020 05:52am
- Professor Kim Ji Yeon The emergence of cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in treatment of patients with human epidermal growth factor receptor 2-negative (HER2-) breast cancer has brought a change in treatment pattern. Technically, chemotherapy was the only option in the hormone receptor-positive (HR+) and HER2- breast cancer. Ibrance (palbociclib), the first CDK4/6 inhibitor to be approved in South Korea in 2016, was already under the limelight from the R&D phase, and it firmly took root in the therapeutic scene as the healthcare reimbursement was granted on the aromatase combination therapy in post-menopausal female patients as the first-line treatment in November 2017. But still, there was an unmet medical needs—the Faslodex (fulvestrant) combination therapy as a second-line therapy. Regardless of relentless attempts to receive the healthcare reimbursement, the indication is yet to be listed for over two years. However, the restraint was lifted in last June. Now, the patients can fully take advantage of the benefits from CDK4/6 inhibitor. And as Verzenio (abemaciclib) and Kisqali (ribociclib) are either listed or to be listed soon, the patients have two more options besides Ibrance. Daily Pharm interviewed Professor Kim Ji Yeon at Samsung Medical Center Hematology-Oncology division and heard her story of the prospects in utilizing CDK4/6 inhibitor. -What is the significance in having the reimbursed option of Faslodex combination therapy? As for a healthcare provider, more than anything, CDK4/6 inhibitor is an option that lessens the concern of ‘relapse.’ Up until recently, the healthcare coverage was limited to the aromatase combination therapy for the first-line treatment. The reimbursement expanding to Faslodex combination therapy is providing benefits to more people, and healthcare providers are now treating the patients in peace. Being able to prescribe a CDK4/6 inhibitor in combination with Faslodex in patients whose cancer advanced after a tamoxifen adjuvant treatment is a blissful option for patients. -With the expanding coverage, follow-on drugs (Verzenio and Kisqali) have also won reimbursements. Especially, soon-to-be-listed Kisqali even covers pre-menopausal female patients. Which factors should patients consider when choosing a CDK4/6 inhibitor? Surely, Kisqali would be prevalently used among pre-menopausal patients. In the past, CDK4/6 inhibitor in combination with an aromatase inhibitor was the only option after prescribing tamoxifen adjuvant hormonal therapy following a bilateral salpingo-oophorectomy (BSO). But now patients skip BSO and simultaneously use Kisqali plus aromatase inhibitor and gonadotropin releasing hormone (GnRH) agonist. The healthcare providers also try to avoid BSO. However, patients using Ibrance or Verzenio after having a BSO do not have to get injected every month. Specifically, Ibrance is prescribed for two to three months’ worth at once as it rarely causes adverse reaction. On the contrary, patients using Kisqali would have to visit hospital to get injected once a month. -You have mentioned Ibrance is advantageous regarding adverse reaction. Does that mean between various CDK4/6 inhibitors, there are differences in adverse reactions? Apparently, the adverse reaction depends on whether the CDK4/6 inhibitor blocks ‘4’ or ‘6’ more, or other types of CDK including CDK2 or hinders cyclin activity. Verzenio and Kisqali tend to frequently cause stomach related adverse reaction. Patients usually complain about having diarrhea with Verzenio and having nausea or indigestion with Kisqali. On the other hand, Ibrance has reported barely any adverse reaction related to stomach. Nevertheless, reduction in neutrocyte and bone density, compared against Verzenio, were more frequently reported from Ibrance. Moreover, Kisqali and Ibrance share similar level of hematological adverse reaction like the reduction in neutrocyte. For instance, most of adverse reaction experienced from using Ibrance is reduction in neutrocyte, whereas Verzenio causes relatively insignificant changes in the neutrocyte level, but more prevalent adverse reactions in stomach are found. But, the patients directly feel the stomach related adverse reactions, when the reduction in neutrocyte level is almost unnoticeable for patients unless they have fever or a drop in immunity level. -It sounds like the preference on Ibrance would be up to patients’ situation It is so. An elderly patient over 70 would highly prefer Ibrance. Even patients in their 60s could prefer Ibrance, if they have underlying diseases like diabetes and hypertension, or not feel the best condition. -But the experts say the downside of Ibrance is no available data on overall survival (OS). Generally, an anticancer treatment clinical trial produces statistics based on a primary endpoint, and prioritizes in improving the Progression Free Survival (PFS) within the smallest group of patients. As a first CDK4/6 inhibitor, Ibrance’ statistics had to focus on PFS than any other endpoint. The first-in-class drugs tend to go through generically conventional design of clinical study. Kisqali’s study was designed to analyze OS and PFS by setting the OS as the key secondary endpoint. A latecomer can learn from the first-in-class drug and take a bolder step in a clinical study. Personally, the most integral factor would be the hazard ratio in PFS. All three of the drugs showed similar level of hazard ratio ranging from 0.5 to 0.6. When CDK4/6 inhibitors’ real world data accumulate in the future, more clear answer would be given. -The recent trend in the indication expansion among anticancer treatments seems to highlight adjuvant therapy after the release to diversify the indication. Do you think the adjuvant therapy is crucial in CDK4/6 inhibitors? To be honest, I am skeptical about the need of patients in stage 2 or earlier taking CDK4/6 inhibitor, while enduring the adverse reaction. As 40 percent to 50 percent of stage 3 patients would relapse, administering CDK4/6 inhibitor for two to three years would make sense when the OS benefit is significant. But, there is also concern about which medication to use when the cancer cells metastasize after using CDK4/6 inhibitor in adjuvant therapy.
- Company
- MSD has appointed So-eun Kim as the first CEO of Organon
- by Oct 29, 2020 05:51am
- So-eun Kim, the first CEO of Organon & Co. MSD announced on the 27th that it has appointed So-eun Kim (49 years old), currently managing director of MSD Korea, as the new CEO of Organon & Co, which will be newly established through the spin-off in the first half of 2021. Organon & Co's term of office begins on February 1, 2021, when the division of the company in Korea is completed. Since joining MSD Korea in 1998, the new CEO So-eun Kim has played various roles in MSD domestic and overseas for about 23 years. She has served as Head of the External Affairs, Primary Care, and Commercial Operations divisions, and has led Marketing and Sales Excellence (MSE) in Asia Pacific. She has been in charge of the division of the company as a transition lead at MSD Korea since last February. New CEO So-eun Kim said, "Organon & Co. will grow into a global healthcare company that provides specialized solutions for women's health based on the continuous growth of various products such as cardiovascular, respiratory, dermatological, and musculoskeletal systems." She added, "In the case of the Korean branch, we will build a corporate culture so that employees can enjoy various opportunities for growth in a horizontal and flexible environment while pursuing the company's continuous growth and leadership."
- Company
- Evrysdi is expected to enter Korea
- by Eo, Yun-Ho Oct 28, 2020 06:03am
- The third SMA treatment is expected to enter Korea following Biogen's Spinraza approved in 2017 and Novartis' Zolgensma, which is currently undergoing approval review. According to related industries, Roche also submitted an application for Evrysdi (Risdiplam) to the MFDS after approval from the US FDA in August. All of these drugs are treatments for Spinal Muscular Atrophy (SMA), and detailed indications, formulations, dosages, and dosages are different. Zolgensma (Onasemnogene abeparvovec), a gene therapy drug and an expensive drug with a concept of 'one-time treatment', is still under review, and Evrysdi, which is an oral drug and continuously administered, is considered to have relatively shortened the screening period. Evrysdi's indications are for 'adult and infant SMA patients over 2 months'. Evrysdi's FDA approval was based on the results of a FIREFISH study in infants aged 2 to 7 months and SUNFISH in children and adults aged 2 to 25 years. In SUNFISH conducted in 180 SMA type II or III patients, Evrysdi demonstrated motor function improvement at 12 months as measured by MFM-32, a motor function evaluation scale. In addition, in the FIREFISH of infant SMA patients 2-7 months of age after type I, 88% of patients receiving Evrysdi for 2 years continued to survive without a ventilator for 2 years. Over two years, 59% of infants were able to sit without assistance for at least 5 seconds on the basis of the Bailey Infant and Toddler Development Test (BSID-III), which measures total infant and toddler developmental exercise. In addition, 65% of infants were able to hold their neck for 1 year, 29% were able to turn themselves over for 1 year, and 30% were able to stand using supports. Meanwhile, Spinraza (Nusinersen) was listed on the insurance benefit list in April last year, accepting the Refund type and the Expenditure Cap type of the total amount limit of the Risk Sharing Agreement (RSA). At the time, due to the efforts of both the government and pharmaceutical companies, the maximum amount of domestic insurance coverage in Spinraza was set at ₩92,359,131 per bottle. It is unclear how long Zolgensma and Evrysdi will take from domestic approval to reimbursement list.
- Company
- Sanofi launches Dupixent '200mg' in Korea
- by Oct 28, 2020 06:02am
- Sanofi-Aventis Korea (CEO Kyung-eun Bae) announced that it will release Dupixent PFS 200mg (Dupilumab), a biologic drug for atopic dermatitis and asthma on the 26th. Accordingly, Dupixent is available in two doses, 200mg in addition to the 300mg previously released. According to the MFDS, Dupixent 200mg can be used for moderate-severe atopic dermatitis patients aged 12 years or older, weighing less than 60kg. After the initial administration of 400mg, it has been approved as a maintenance dose of 200mg every two weeks. Atopic dermatitis is characterized by the intensity of symptoms such as severe itching, rash, dry skin, cracked skin, crusts, and sores during adolescence. Atopic dermatitis patients with adolescents experience difficulties in school life, such as exclusion and harassment of their peers due to outward symptoms, and negatively affected academic performance. In fact, 46% of adolescent patients answered that symptoms of atopic dermatitis affect their school life, and about 26% of patients said they felt a high level of anxiety disorder. Dupixent 200mg has been tested for efficacy and safety profile in LIBERTY AD ADOL clinical trials. In this study involving 251 patients with moderate-severe atopic dermatitis, the Dupixent 200mg and 300mg groups showed a 66% improvement in lesion size and severity at 16 weeks. There was a clinically significant improvement in the quality of life index. Hee-kyung Park, president of Sanofi Genzyme, a specialty care division of Sanofi-Aventis Korea, said, "We are pleased to be able to introduce all of the new doses of Dupixent in Korea." "We look forward to improving their accessibility, and we will do our best to make Dupixent an innovative treatment option for suffering patients in the future."
- Company
- Ilyang's leukemia treatment Supect, approved by Russian GMP
- by Oct 28, 2020 06:02am
- The factory that manufactures Ilyang's Supect has passed the GMP (Manufacturing, Processing, Packing or Holding of Drugs) due diligence conducted by the Russian government. According to the pharmaceutical industry on the 26th, the Ministry of Industry and Trade of Russia determined that Ilyang’s plant located in Jecheon-si, Chungcheongbuk-do on the 20th (local time) was suitable for manufacturing and quality control standards, and approved GMP compliance. This plant is where Ilyang manufactures Supect, which was completed in 2015. The validity period for GMP conformity approval is until September 25, 2023. The Russian government conducted due diligence on the Ilyang Biopharm’s plant from September 21 to 25. The due diligence was conducted by video conference due to COVID-19. This GMP due diligence was carried out by Ilyang for Supect's entry into Russia as a leukemia treatment, but as it is combined with the COVID-19 clinical trial, expectations of shareholders are growing together. Supect is a Korean new drug No. 18 developed by Ilyang. Ilyang initially attempted to advance Supect into Russia as a treatment for leukemia. Targeting leukemia, it was approved for Phase III clinical trials and conducted GMP due diligence. It has not yet entered the leukemia clinical trial. At the same time, Ilyang also explored the possibility of Supect as a treatment for COVID-19. Ilyang , which confirmed the inhibitory effect of the COVID-19 in an in vitro experiment in March, was approved by Russia on May 28 and is undergoing clinical trials. In the pandemic, the clinical progression of COVID-19 was faster than that of leukemia. The industry is speculating that it will be able to speed up commercialization with rapid production if only the effectiveness of COVID-19 treatment is proved in phase III as it has been approved for GMP compliance. It is predicted that the GMP due diligence will be exempted because the Corona 19 clinical trial is a drug repositioning method. However, Ilyang has expressed concern about the direct link between the GMP compliance approval and COVID-19 clinical trial. Another variable is that it is difficult for Ilyang to grasp the progress as the local pharmaceutical company 'R-Pharm' is entirely leading COVID-19 clinical trial. Ilyang has delegated all authority to R-Pharm for the Russian clinical trial of COVID-19. R-Pharm signed an export contract with Ilyang in December 2014 for Supect. R-Pharm is conducting clinical trials for 185 mild and severe COVID-19 confirmed patients at 29 institutions in Russia and Republic of Belarus. An official at Ilyang said, "This GMP due diligence was done on the manufacture of Supect as a leukemia treatment, and was planned from the beginning of this year." He added, "If Supect is commercialized as a treatment for COVID-19, there is a possibility that due diligence may be exempted, but this is something the Russian government will judge."
- Company
- Tecentriq as 1st reimbursed immunotherapy for TNBC and HC
- by Eo, Yun-Ho Oct 27, 2020 06:12am
- An immunotherapy Tecentriq (atezolizumab) is seeking for the National Health Insurance (NHI) reimbursement in treating patients with either triple-negative breast cancer (TNBC) or hepatocellular carcinoma. A pharmaceutical industry source reported Roche Korea has recently submitted an application to expand reimbursement for indication to treat patients with TNBC and also hepatocellular carcinoma. In early this year, Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, won the health authority’s approval to treat patients with TNBC as a first-line treatment, and it also earned an approval to treat liver cancer as a first-line treatment through Avastin (bevacizumab) combination therapy. Once it successfully expands its coverage, Tecentriq would be the first immunotherapy option for the two cancer types. However, it is still unknown how long the listing procedure would take. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government as the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. Meanwhile, the two indications barely had any treatment option and an emerging option of an immunotherapy heightened the interest of medical academics. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy marked the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.” The efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 41 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. Professor Kim Doyoung of Gastroenterology Department at Severance Hospital noted, “Beside the OS, the improvements in the response rate and PFS were positive findings. We are glad to have found an immunotherapy option in the liver cancer area that has no other alternative than Nexavar. Hopefully, the drug can meet the highly unmet medical needs in the future.”
- Company
- Domestic supply of Nimbex has been discontinued
- by Oct 27, 2020 06:11am
- NimbexAccording to the distribution industry on the 23rd, 'Mitsubishi Tanabe, which is in charge of distribution and sales of Nimbex in Korea, sent an official letter to the wholesale industry and announced that Nimbex will cease distribution in Korea on November 3rd. Mitsubishi Tanabe said, "Due to internal circumstances such as the productivity problem of the manufacturer Aspen, there is no additional supply and demand plan since the imported volume in May." The company said that it can only be sold until November 3rd. Nimbex was changed once from GSK to Aspen. In June 2018, GSK transferred the Nimbex rights to South African pharmaceutical company Aspen, and the domestic seller was changed to Mitsubishi Tanabe. Mitsubishi Tanabe has been distributing the product for two years, but this time Aspen decided to stop supplying it. It is believed that there are no plans to resupply in the future. Nimbex's inventory is 1,542 cases for 10ml/5amp and 20 cases for 2.5ml/5amp. The validity period is December 1, 2021 and January 23, 2022, respectively. Nimbex is a drug with two or less identical ingredients (No. 3) among drugs with production and import records in the previous year, and a drug with a market share of 50% or more (No. 4) among product groups with the same ingredient. Mitsubishi Tanabe recently reported the discontinuation to the MFDS. MSD's Esmeron and Hana Pharm's Atra are mentioned as generics for Nimbex.
- Company
- Pfizer’s EGFR TKI Vizimpro to get listed by the year-end
- by Eo, Yun-Ho Oct 26, 2020 06:15am
- Pfizer’s epidermal growth factor receptor (EGRF) tyrosine kinase inhibitors (TKI) Vizimpro (dacomitini) is predicted to get listed for National Health Insurance (NHI) reimbursement within this year. The pharmaceutical industry sources reported the fifth ERGR TKI Vizimpro is to begin the pricing negotiation with National Health Insurance Service (NHIS) soon. As the negotiation is due within 60 days, the drug could receive reimbursement by the end of the year if the administration procedure is processed promptly. Currently, the first generation EGFR TKI ‘Iressa (gefitinib)’ by AstraZeneca and Tarceva (erlotinib) by Roche, and the second generation Giotrif and the third generation Tagrisso (osimertinib) by AstraZeneca are prescribed in South Korea. The key competition takes place in the non-small cell lung cancer (NSCLC)-treating indication. As the direct competitor Giotrif has already taken root in the market, Vizimpro decided to take the weighted average pricing as an alternative drug and took the fast-track review route. Without the burden of setting the upper limit pricing, the negotiation with NHIS is expected to cruise on without much of issue. Vizimpro’s efficacy has been confirmed in Phase III ARCHER 1050 trial. The study compared Vizimpro and the first-generation Iressa head-to-head with total 452 patients fighting against NSCLC. In the trial, the medicine reduced the risk of progression-free survival (PFS) by 41 percent compared to Iressa, as Vizimpro patient group’s median PFS was at 14.7 months and Iressa group’s was at 9.2 months. Nevertheless, Vizimpro showed worse cases of adverse reactions. In the Vizimpro group, the frequently demonstrated severe adverse reactions included dermatological issues with pimple (14 percent) and diarrhea (8 percent), whereas changes in liver enzymes (8 percent) were significant in the Iressa group. Around 60 percent of Vizimpro patient group had to adjust their medication dose due to adverse reaction. Vizimpro is a second-generation targeted therapy indicated to treat patients with EGRF-mutation-positive NSCLC. The U.S. Food and Drug Administration (FDA) approved the anticancer treatment in September 2018 after granting Priority Review in January same year. Currently, the drug is approved and used in the U.S., EU and Japan. In South Korea, the medication has been approved as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, and it is also indicated to treat patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, who have not been treated before.
- Company
- Whanin·Myung In successfully evaded patent for Fycompa
- by Kim, Jin-Gu Oct 26, 2020 06:15am
- Fycompa Myung In and Whanin succeeded in circumventing some of the patents of 'Fycompa (Perampanel anhydrous)', an epilepsy treatment. The two companies will be able to launch generics as early as October 2023. On the 21st, the Intellectual Property Trial and Appeal Board issued a trial decision for ``establishment of claim'' at the judgment on the passive scope of rights for crystal patent of Fycompa (October 14, 2026), which Myung In and Whanin claimed against Eisai. As a result, the two companies met two of the three requirements for the early release of generics (first request for trial and trial decision for claim establishment). One of the remaining requirements is 'application for approval for the first generic'. For now, it is very likely that both companies will achieve this requirement at the same time. The two companies are conducting bioequivalence tests for the generic for Fycompa. Whanin has started bioequivalence tests in May of this year and Myung In in July. Fycompa's PMS expires July 9, 2021. Considering that it is possible to apply for an item permission after the expiration of the PMS, this means that about 9 months will be given. It's time to end the bioequivalence test. Assuming that the two companies apply for product license at the same time, the generic release is expected to be on or after October 14, 2023. It is when Fycompa's material patent expires. The two companies did not file a separate patent trial for material patents. Fycompa is a new drug for epilepsy that was launched in Korea in February 2016. In particular, it can be used as a monotherapy for adolescents 12 years of age or older with partial epilepsy seizures, and prescription performance is increasing. According to UBIST, Fycompa's annual prescription amount increased more than three times in three years to ₩1.3 billion in 2016, ₩3 billion in 2017, ₩3.7 billion in 2018, and ₩4 billion in 2019. Fycompa's prescription amount was worth ₩3.2 billion until September this year.
- Company
- CKD top candidate for Amgen’s Evenity co-promotion partner
- by Oct 26, 2020 06:14am
- A product image of Amgen Evenity. As Amgen’s novel osteoporosis drug Evenity (romososumab) is expected to get listed for reimbursement by the end of the year, the multinational company is reportedly seeking for a co-promotion company. The current partner company for Prolia (denosumab) co-promotion, Chong Kun Dang, is considered as the strongest candidate. According to pharmaceutical industry sources on Oct. 22, Amgen is in process of searching for a South Korean co-promotion partner as they aim to receive the National Health Insurance (NHI) reimbursement within this year. The sources claim Chong Kun Dang is on top of the list. In September 2017, Chong Kun Dang signed a co-promotion deal with Amgen for other osteoporosis drug Prolia, which is still effective to this date. Prior to its reimbursement listing in October 2017, Amgen shook hands with the South Korean company to leverage the sales in Prolia. Boosted by the coverage approval and the co-promotion deal, Prolia’s sales surged soon after. The sales marked 2.4 billion won in the fourth quarter of 2017, almost doubling the initial quarterly sales at launch of 1 billion won. The quarterly sales skyrocketed to 12.3 billion won in April last year, after its reimbursement standard was expanded to first-line therapy. The cumulative sales up to the first half of 2020 reached 100.6 billion won. And because Amgen is to take the marketing strategy of introducing Evenity as a sequential combination therapy with Prolia, Chong Kun Dang is the most likely candidate. Prolia is a bone resorption inhibitor, launched earlier, and Evenity is a bone-builder and a bone resorption inhibitor. Amgen set down a therapeutic strategy to administer Evenity first to postmenopausal women fracture and men with osteoporosis at high risk for fracture (maximum 12 months), and to continue on with Prolia as maintenance therapy. In fact, their clinical trial has been conducted as a sequential therapy. Compared to the placebo group after 12 months, the Evenity group had 73 percent lower risk of new vertebral fracture. The patient group that switched to Prolia (denosumab) at year 2 after 12 months of using Evenity showed 75 percent lower risk of new vertebral fracture, compared to the placebo group switching to Prolia. Considering Evenity’s marketing strategy has to be in accordance with Prolia’s, the existing co-promotion partner Chong Kun Dang would be the most efficient option. Sources confirmed, the two companies are already in talks to expand their deals to also cover Evenity. When the final contract is inked, Chong Kun Dang is expected to initiate the co-promotion activities from next year after the novel osteoporosis drug is listed. The industry source commented, “We are anticipating to a see a positive level of synergy effect created from Evenity as Amgen and Chong Kun Dang are already in a good collaboration for Prolia.”
