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- 2026-03-19 08:09:25
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- Repatha’s options for ultra high risk patients extended
- by Eo, Yun-Ho Jan 28, 2020 06:13am
- Professor Hyeon Cheol Gwon Since statins, the coverage of the PCK9 inhibitor Repatha, an option for managing dyslipidemia, is expected to increase utilization. Amgen Korea(the CEO Noh) held a press conference at the Westin Chosun Hotel in Seoul on the 22nd to commemorate the reinforcement of health insurance benefits for Repatha’s atherosclerotic cardiovascular disease (ASCVD). Repatha has been applied to the treatment of patients with atherosclerotic cardiovascular disease at very high risk and patients with heterozygous familial hypercholesterolemia with hypercholesterolemia and statin intolerance patients from January 1 this year. The press conference centered on atherosclerotic cardiovascular disease among them. Professor Hyeon Cheol Gwon, Director of circulatory internal medicine dept., Samsung Medical Center, who presented as the first speaker at the meeting, announced the theme of 'the latest knowledge on the treatment of atherosclerotic cardiovascular disease with ultra high risk group using PCSK9 inhibitor'. Atherosclerotic cardiovascular disease, known as myocardial infarction, stroke, or peripheral artery disease, is a type of atherosclerosis caused by the accumulation of cholesterol in the vascular lining. Patients who have experienced at least one atherosclerotic cardiovascular disease have a high risk of clinical recurrence and a poor prognosis, with a mortality rate of up to 85%. Professor Hyeon Cheol Gwon said, "A patient who has experienced atherosclerotic cardiovascular disease is a serious disease whose mortality rate increases rapidly with the second and third recurrences, and LDL-C, a major risk factor for the ultra high risk group, must be thoroughly managed". He said, “Statin and Ezetimibe are already standard treatment regimens, but some patients with ultra high risk group are still unable to reach their treatment goals because the LDL-C baseline is high and the target is low in the ultra high risk group. We look forward to lowering LDL-C to prevent recurrence of cardiovascular disease in more patients. And, the indication expansion is expected to lower the LDL-C in the high-risk group to prevent recurrence of cardiovascular disease in more patients”. Meanwhile, domestic treatment guidelines recommend that patients with atherosclerotic cardiovascular disease should be adjusted to less than 70 mg / dL of LDL-C to prevent recurrence of cardiovascular disease. However, in 2019, the European Heart Association lowered the target LDL-C level of the ultrahigh risk group to less than 55 mg/dL. Accordingly, there is increasing interest in the field of PCSK9 inhibitors that are useful for patients at very high risk who do not reach target levels with existing treatment regimens.
- Company
- Last year, Tamiflu sales fell by half
- by Jung, Hye-Jin Jan 28, 2020 06:13am
- Last year, the flu treatment Tamiflu market dropped sharply. The size of the market has shrunk as the number of flu patients has decreased significantly from 2018. The share of generics in the market has been expanding. Outpatient prescription performance of Oseltamivir were down ₩17.2 billion, down 50.4% from last year, according to UBIST, a drug research agency. This is the result of a survey of 37 products with recent prescriptions. Oseltamivir is a drug used to treat flu, and Roche's Tamiflu is the original medicine. Prescriptions for 37 items from 2017 to 2018 rose 103% from ₩17 billion to ₩34.6 billion, but fell back to ₩17.2 billion last year. In the winter of 2018, the flu was a very common epidemic. According to the KCDC(Korea Centers for Disease Control & Prevention), the number of influenza patients per 1,000 outpatients last year were 19.5 at 49 weeks, 28.5 at 50 weeks, 37.8 at 51 weeks, and decreased by more than 30% less than 49.8 at 52 weeks. 34.1, 48.7, 71.9, and 73.3 in the week 49-52 of 2018. In the prescriptions for Oseltamivir ingredients, Tamiflu, the original drug, was still ranked first last year. Tamiflu's prescription amount was ₩5.2 billion. Hanmiflu followed with ₩4.1 billion. After that, Comyflu came in third with ₩1.5 billion in earnings. Tamiflu and Hanmiflu, both of which ranked top in prescription performance, also saw a sharp decline. Both original and generic prescriptions declined, but Tamiflu was the largest among the top five. Tamiflu's prescriptions for 2019 decreased 58.4% year-on-year, while Hanmiflu also decreased 54.2%. Kolon's Comyflu decreased 31%, Yuhan's Yuhan N Flu decreased 50.6%, and Arlico's Tamipro decreased 20.8%. In particular, Tamiflu's share in the overall market of Oseltamivir is decreasing. Tamiflu's 2017 market share continued to decline from 51.3% to 36.2% in 2018 and 30.4% in 2019. The share of generics in the Oseltamivir market soared to around 70%. Generics such as Hanmiflu are interpreted as a competitive effect. However, as this winter is not over yet, it is necessary to observe the first quarter 2020 results. In 2018, the most common cases of influenza were in December, while in 2019, the number of patients has increased since the end of December, and the number of patients continues in January. The KCDC announced that the number of suspected influenza patients increased sharply in late December and January this year after the influenza watch warning was issued on last November 15. Last year, the number of suspected influenza patients per 1,000 outpatients fell 53.1 per week, down sharply from last December, but this week increased to 49.1 per week.
- Company
- Yuhan talks plans after lazertinib L/O at JPM Conference
- by Jung, Hye-Jin Jan 28, 2020 06:12am
- Yuhan announced on Jan. 22, the company has participated in J.P. Morgan Healthcare Conference 2020 to talk about plans following the out-licensing lazertinib and to hold R&D recruiting event. Since 2018, Yuhan has signed 3.5 trillion won worth of out-licensing deals including lazertinib. And at the event in the U.S., the company representatives met with partner companies to share the details of this year’s scheduled plan and discussed about further research topics. Meetings were convened with global pharmaceutical giants to talk about possible licensing deals on Yuhan’s candidate medicine in clinical and preclinical phases, and also the Korean company had a partnering opportunity to reinforce pipeline by adopting anticancer treatments and NASH sector. Moreover, the company held a special event to recruit outstanding global R&D experts. The members of ‘Korean Life Scientists in the Bay Area (KOLIS)’ from three universities—UCSF, UC Berkeley and Stanford)—were invited for networking. Besides, the company also visited the university campuses to show the company introduction video, introduce its R&D facility and ImmuneOncia and provide a Q&A session. Head of Global Business Development Yoon Taejin participating in the conference explained “The J.P. Morgan Conference was our time to fine-tune Yuhan’s focus on achieving the ultimate vision, ‘Global Yuhan.’” He added, “Yuhan aims to leap as a global company by stepping out of simple notion of open innovation based on pipeline license-in deals, but by taking a step further in open innovation, where it covers not only technology and substance, but extends out to incorporate exceptional specialists of the field.” In this year, overall 25 representatives of Yuhan’s R&D, Global BD and Development departments and other corporate subsidiary and global offices participated in the event.
- Company
- Sanofi firing employee for playing golf is unfair dismissal
- by Eo, Yun-Ho Jan 23, 2020 06:16am
- A government organization has decided a salesperson fired by Sanofi Pasteur for playing golf with his colleagues during their working time was unfair dismissal. Following the decision made by Chungnam Regional Labor Relations Commission in 2019, National Labor Relations Commission (NLRC) has accepted “Manager A”’s request for unfair dismissal remedy claim on Jan. 20 regarding Sanofi Pasteur dismissing the employee for violating the Compliance Program. The Commission ordered, “Sanofi should immediately reinstate the employee as it was an unfair dismissal.” Manager A, who used to work at Chungcheong and Honam regional team of Sanofi Pasteur, went out to play golf with his colleagues as proposed by then sales executive director for two days in September 2018. And on the day of the rounding, the employee submitted a call report and received a daily pay of 36,000 won. In July 2019, Sanofi Pasteur sent a notice of termination to Manager A for violating the Global Code of Ethics. But Manager A argued the disciplinary action of termination was excessive and requested for unfair dismissal remedy to Regional Labor Relations Commission. The Labor Commission acknowledged the claim and accepted the remedy request. Although Sanofi Pasteur filed an appeal for the decision, NLRC also sided with Manager A. In the ruling, NLRC stated “Sanofi Pasteur’s Code of Ethics regulates disciplinary actions vastly ranging from training, verbal warning, written warning, change of assignment, termination of employment, and civil and criminal law suit. However, dismissing Manager A for violating the Code of Ethics and not considering other disciplinary actions is an abuse of power.” “The reason for termination is understandable, but it is difficult to say his action was intentional or ill-intended, and as he had good attitude at work, the company’s decision was abnormally unfair in the standard of social norm. Therefore, the Commission decided the company’s action was out of their discretionary power of human resource management,” the Commission elaborated.
- Company
- Lilly Korea, certified as a family-friendly company
- by Eo, Yun-Ho Jan 23, 2020 06:15am
- Lilly Korea (CEO Alberto Riva) said it has succeeded for receiving the family-friendly company certification, which is given to companies that run family-friendly models, for 10 consecutive years by the Ministry of Gender Equality and Family. The Family-Friendly Certification System, through the screening of the Ministry of Gender Equality and Family, provides certification to companies and public institutions that run family-friendly models to balance work and family with workers, including childbirth and nurturing of children, flexible working hours, and the creation of a family-friendly workplace culture. Lilly has been certified as a family-friendly company for 10 consecutive years, beginning with the first certification in 2011 and continuously receiving excellent evaluations every three years. In last December, the recertification audit was conducted to receive family scores for management awareness of the family-friendly culture, high scores for childbirth and childcare, and to continue to be certified as a family-friendly company. On the other hand, Lilly Korea is operating various in-house systems that provide a flexible working environment such as ▲family day, ▲male parental leave, and ▲at-home job. Alberto Riva, the CEO said, “Korea Lilly will continue to lead the creation of a healthy working environment where employees' work and life are balanced, as has been practiced for the past 10 years. Furthermore, it will be an example of a family-friendly company that strives for healthy living and happiness of community members".
- Company
- BMS-Celgene to maintain independent offices this year
- by Eo, Yun-Ho Jan 22, 2020 06:29am
- Bristol-Myers Squibb (BMS) and Celgene have agreed to maintain the independent administrative system until the end of the year. According to pharmaceutical industry sources, BMS Korea Pharmaceutical and Celgene Korea have recently convened a town hall meeting to discuss the post-merge operational plan for the Korean offshoots, and have decided to postpone the office and departmental integration procedure until the end of the year and to keep the current board of directors of respective companies. The plan is not for all offshoots of BMS Global. Some of offshoots in other countries are in typical merging process like reshuffling the organization and appointing new heads for each department. The tentative decision was made because the two Korean offices are comparatively larger in scale than other regional offices, and have significant number of actively promoted products. However, the legal proceedings are to be carried out as planned. Currently, the two companies are working on registering the newly appointed CEO Kim Jinyoung (43) as their shared CEO. Sources confirmed the former CEO of Celgene Korea, Ham Tae-jin (47) has resigned last year. Moreover, new heads would be appointed for newly forming commercial departments, including marketing and sales, under the integrated office. The commercial sector would include in-office departments like Market Access and Government Access. In January last year, BMS has decided to acquire Celgene for USD 74 billion (86.4 trillion won). The acquisition was executed in cash and stock transaction and related legal proceedings are ongoing after the deal has been closed. BMS now owns anticancer treatment Revlimid and a next generation chimeric antigen receptor T (CAR-T)-based cellular immunotherapy option, which Celgene acquired in 2018 from Juno Therapeutics.
- Company
- Despite No Japan movement, Japanese companies performed well
- by An, Kyung-Jin Jan 22, 2020 06:28am
- (From left) Lixiana, Aricept, & Harnal D In the prescription drug market, there was no aftermath of a Japanese boycott. Since July, when the Japanese government began to regulate exports, outpatient prescriptions by Japanese pharmaceutical companies have increased. The high severity of disease and the proportion of original drugs have unaffected by the boycott. According to UBIST data on the 22nd of the pharmaceutical market research institute, outpatient prescription performances of six major Japanese pharmaceutical companies, including Astellas Korea, Daiichi Sankyo Korea, Korea Eisai, Korea Takeda Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Co. The six companies increased 12.6% from the previous year's ₩321.6 billion by jointly acquiring outpatient prescriptions of ₩362.2 billion. This is an increase of 8.1% compared to ₩335.1 billion in the first half of last year. Cumulative prescriptions last year were ₩697.2 billion, up 12.8% year-on-year. Monthly outpatient prescriptions of six major Japanese pharmaceutical companies in 2017-2019 (Unit: ₩ million, Source: UBIST) The increase in prescription of Daiichi Sankyo Korea was most noticeable. Outpatient prescriptions for Daiichi Sankyo in the second half of last year increased 17.9% YoY to ₩81.9 billion. The outpatient prescription growth rate is 9.1%. Anticoagulant Lixiana, launched in 2016, drove up the performance of prescription drugs. Lyxiana was prescribed for₩30.7 billion in the second half of last year. This is an increase of 60.0% compared to the same period last year. Cumulative prescriptions last year amounted to₩56 billion, up 64.6% from last year Lyxiana is a non-vitamin K antagonist family oral anticoagulant (NOAC). It is prescribed for the prevention of stroke in patients with nonmembranous atrial fibrillation. Lixiana was the latest of the four NOACs, but was updated every quarter, making it the No. 1 prescription formula. Astellas Korea has the largest outpatient prescription effect among Japanese pharmaceutical companies included in the report. Outpatient prescriptions for Astellas in the second half of last year rose 12.1% YoY to ₩16.6 billion. It rose 6.6% over the first half. The performance of Astellas was boosted by two major urological products, including prostate hypertrophy treatment Harnal D and overactive bladder treatment Betmiga. In the second half of the year, outpatient prescriptions rose 8.3% YoY to ₩38.3 billion. During the same period, outpatient prescriptions for Betmiga stood at ₩33.3 billion, up 17.3% YoY. Monthly outpatient prescriptions of major specialty drugs sold by Japanese pharmaceutical companies (Unit: ₩ million, Source: UBIST) Korea's Eisai Pharmaceutical posted an outpatient prescription performance of ₩59 billion, up 12.3% YoY in the second half of last year. Aricept, a flagship product that improves brain function, was prescribed at ₩40.1 billion in the second half of last year, increasing the market size by 12.5%. Outpatient prescriptions for Korea's Takeda Pharmaceutical in the second half of last year are estimated at ₩39.7 billion, up 6.4% YoY. The outpatient prescription of Actos, an anti-diabetes drug, rose 11.1% YoY to ₩10.4 billion, and the prescription amount of the new high blood pressure drug 'Edarbi' released in 2017 was ₩2.8 billion, up 61.1% YoY. In the industry, most of Japan's specialty medicines are original medicines, and there are many cases where there are no alternative drugs, which suggests that they are out of boycott. It is pointed out that it is difficult to change prescription for boycott because of high severity of disease compared to general medicine. In fact, unlike the pharmaceutical associations that have been active in boycotts, associations of doctors have not publicly declared boycotts.
- Company
- Anti-obesity drug market stirred by lorcaserin safety issue
- by Jung, Hye-Jin Jan 22, 2020 06:27am
- Anti-obesity drug companies are on high alert as a safety issue has surfaced regarding lorcaserin, an active ingredient used for in anti-obesity medication.. Lorcaserin competitors are also getting busy anticipating doctors and pharmacists to avoid Ildong Pharmaceutical’s Belviq (locarserin), which was considered a safe anti-obesity drug. However, the industry experts note the lorcaserin safety issue would not significantly affect the anti-obesity drug market, as it has been generally stagnant except for Saxenda. According to pharmaceutical industry sources on Jan. 19, a pharmaceutical company in Korea supplying an anti-obesity medication has ordered their salespeople to collect information of Belviq-prescribing hospitals and clinics in their designated regions. The company seems to try using Belviq’s safety issue to leverage sales of their own anti-obesity drug. The safety warning notice on Belviq could be game changer in the anti-obesity drug market, because the competition is saturated with Alvogen Korea, Huon, Kwang Dong Pharmaceutical, Chong Kun Dang Pharmaceutical, as well as Ildong Pharmaceutical. Ministry of Food and Drug Safety (MFDS) have issued a notice on Jan. 17 advising pharmaceutical experts to consider if Belviq’s benefit outweighs the potential risk after the U.S. Food and Drug Administration’s (FDA) warning issued on Jan. 14 about possibility of Belviq causing cancer. Although a direct correlation of Belviq causing cancer has not been fully investigated, the Korean ministry warned doctors and pharmacists to consider the risk of cancer when prescribing the drug as a clinical trial testing safety of the drug found issues. MFDS plans to review clinical data and change indications on Belviq. Since the launch in February 2015, Belviq has attracted a huge attention. The anti-obesity drug market did not have a sufficient option after sibutramine was dropped out of the market due to adverse events. Approved for Korean market in February 2015, obesity-treating Belviq was developed by the U.S.-based Arena Pharmaceutical and has been supplied by Ildong Pharmaceutical in Korea. First time after 13 years, FDA cleared the drug as a weight loss treatment. After signing an exclusive marketing deal in 2012, Ildong Pharmaceutical has conducted clinical trials for two years with Arena Pharmaceutical. In the first year of launch, Belviq generated 13.6 billion won and topped the anti-obesity drug market. But its golden days did not last long. Belviq sales peaked in the second quarter of 2013 making 4.1 billion won but started descending right after. Its growth was blocked by launch of other competitors like Kwang Dong Pharmaceutical’s Contrav and Novo Nordisk’s Saxenda. In last third quarter, Belviq generated 2.2 billion won according to IQVIA. It took an 11.8 percent fall compared to 2.5 billion won made in same period the year before. Meanwhile, the anti-obesity medication market has been growing exponentially. IQVIA reported, the market volume marked 97.0 billion won in 2018. The overall volume in 2019 is expected to surpass 120 billion won as the market made 32.3 billion won, 33.1 billion won and 35.4 billion won in the first, second and third quarter last year, respectively. The exponential growth in the anti-obesity drug market was mostly led by Saxenda. The drug generated 11.9 billion won in the last third quarter, a seven-fold of what it has made in the same time previous year. The third quarter sales was a five-fold of Dietamin’s sales, the second in the market. Saxenda accumulated sales marked 32.0 billion won up to the last third quarter. It took the first place in the market right when it was launched and has been widening the gap with the second top seller in the market. On the other hand, the rest of the products’ market shares have been shrinking. Belviq has been on the second place ever since Saxenda was released, but Dietamin took it over in the fourth quarter of 2018. Contrav, slowly absorbing Belviq’s pie since its release in 2016, did not even sell over one billion won last quarter. Except for Saxenda, the anti-diabetic drugs—Belviq, Dietamin, Hutermin, Furing, Fendy, Xenical, Contrav, Adipex, and Furimin—are fluctuating in the market ranking without much of difference. Accordingly, experts do not expect one of them having a safety to cause a big shift in market. Also, the experts’ prediction of the safety issue unaffecting the market sounds more credible as the uncertainty in the safety notice cannot conclude a major shift in market. A pharmaceutical company insider elaborated, “As some of anti-obesity drugs are categorized as psychoactive drugs, not all pharmaceutical companies would take aggressive marketing strategy. Because Saxenda has prominent market presences, it is highly likely that a safety notice on Belviq would shake up the market.”
- Company
- AstraZeneca retries expanding Tagrisso's reimbursement
- by Eo, Yun-Ho Jan 21, 2020 06:25am
- Target therapy Tagrisso is trying to resume the reimbursement review procedure for its indication as a first-line lung cancer treatment. According to pharmaceutical industry source, AstraZeneca Korea has submitted a reimbursement expansion application at the end of last year for the first-line indication of its epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) treating EGFR-mutated non-small cell lung cancer (NSCLC). In last October, Health Insurance Review and Assessment’s (HIRA) Cancer Disease Deliberation Committee hase ‘deferred’ the decision to list the drug for reimbursement but the company has promptly compiled supplementary materials to receive the reimbursement. The Cancer Committee deferred the decision, because “The Phase 3 FLAURA study, confirming the overall survival (OS) of patients treated with Tagrisso as a first-line treatment, did not fully disclose the collected data.” Accordingly, AstraZeneca submitted the complete data set officially published in the New England Journal of Medicine (NEJM), and is expecting the committee to resume the deliberation in February at earliest. The industry is closely watching the Korean health authority reviewing the reimbursement feasibility on the third generation EGFR TKI, Tagrisso based on the clinical efficacy. Currently, Iressa (Gefitinib), Tarceva (erlotinib), and Giotrif (afatinib) are reimbursed first-line options for NSCLC. But, Tagrisso, when listed, would be the only reimbursed EGFR TKI option to treat NSCLC with brain metastasis. Based on the confirmed progression free survival (PFS) data, Tagrisso nabbed market authorization as a first-line treatment in Korea as of December 2018, following the approval in the U.S., Europe and other regions. The Korean health authority listed the drug for reimbursement in December 2017 with risk sharing agreement (RSA). The reimbursement is limited to patients qualifying conditions like disease advancing after being treated with other EGFR TKI, feasibility of biopsy and mutated T790M.
- Company
- Prostate cancer: New battlefield for global companies
- by Eo, Yun-Ho Jan 21, 2020 06:24am
- Prostate cancer market is predicted to emerge as another tight battleground for multinational pharmaceutical companies. Pharmaceutical industry sources reported on Jan. 20, two new drugs are to compete head-to-head with the world’s first oral option of androgen receptor (AR) inhibitor Xtandi (enzalutamide) supplied by Astellas Pharma Korea. Apparently, both of the new drugs have submitted approval application to Korea’s Ministry of Food and Drug Safety (MFDS), and they are expecting the process to be completed within this year. Janssen’s Erleada (apalutamide) and Bayer’s Nubeqa (darolutamide) are the investigational drugs to be indicated for treating patients with non-metastatic castration-resistant prostate cancer (nmCRPC), a same indication as Xtandi’s. The medical needs for nmCRPC had not been fully met as the specific condition lacks various treatment options and has high risk of death among all prostate cancer conditions. ◆ Following the success of Zytiga, Janssen to expand prostate cancer market presence: Already supplying an androgen biosynthesis inhibitor blocking 17α-hydroxylase/C17, 20-lyase (CYP17), Zytiga (abiraterone), Janssen has been predicted to tackle a variety of prostate cancer indications, including nmCRPC, with Erleada. In last September, the U.S. health authority has approved Erleada’s indication to treat metastatic castration-sensitive prostate cancer (mCSPC). During the Phase 3 SPARTAN trial, Erleada confirmed its efficacy. The international study evaluated and compared the safety and efficacy between Erleada plus androgen deprivation therapy (ADT) combination therapy and placebo plus ADT on patients with nmCRPC, who had rapidly rising prostate-specific antigen (PSA) level despite continuous ADT. As a result, the Erleada patient group’s risk of metastasis or death was reduced by 72 percent compared to the placebo group, while the Erleada group’s median metastasis-free survival (MFS) was 40.5 months, or over two years longer than the placebo group. ◆ Bayer’s comeback after Xofigo’s staggering performance: Nubeqa has gotten a spotlight as an emerging growth engine for Bayer’s future. Bayer entered the global and Korean prostate cancer treatment market with Xofigo (radium-223 dichloride) in 2013 and 2014, respectively, but the outcome was rather disappointing. Since then the company conducted a trial to confirm Xofigo’s effect as a combination therapy, but the company has failed to turn around. As for Nubeqa, it confirmed its efficacy during the Phase 3 ARAMIS trial. Administering a combination therapy with Nubeqa and ADT, the patient group demonstrated a significant improvement in MFS, a primary efficacy endpoint of the study. The Nubeqa arm’s MFS was 40.4 months, whereas the placebo arm’s was 18.4 months. The investigational drug demonstrating low blood-brain barrier permeability than any other AR inhibitor in every clinical trial phase is its highlighted strength. This could mean patients could expect reduced adverse reaction in central nervous system. Meanwhile, none of treatment options for nmCRPC has been listed for reimbursement. In November 2014, reimbursement on Xtandi was approved with risk sharing agreement (RSA) for treating patients with mCRPC, who has been treated with docetaxel before. The drug renewed the agreement and extended listing in last February to January 2023.
