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- 2026-05-20 22:12:20
- 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.
- Policy
- Unfair profit of orphan drugs will be readjusted
- by Lee, Jeong-Hwan Jan 23, 2020 06:15am
- The KOEDC (Korea Orphan & Essential Drug Center) took the first step toward improving the 'profit for difference' of urgently imported drugs, which had been disputed for over 20 years. The KOEDC will soon discuss the detailed procedures for drug price adjustments with the Ministry of Health and Welfare & the HIRA, for the purpose of permanently eliminating the profits from urgently imported drugs. In particular, The KOEDC are considering not only one-time drug price adjustment, but also regularizing the re-adjustment system every six months or one year. An official of the KOEDC said on the 20th, “We are currently selecting drugs that need to adjust the price due to the large difference in profits, and apply for collective price adjustment by next month after meeting with the Ministry of Welfare and the HIRA”. The problem of unfair profit of orphan drugs is regarded as chronic disease. If the KOEDC unveils the policy of price restructuring, the illegal disputed earnings will soon disappear. In last year's National Assembly audit, many members of the parliament have pointed out that the KOEDC spent about ₩6.5 billion on unfair profits for the past five years and spent it on institutional expenses. In response, Young-mi Yoon, the president of the KOEDC, embarked on a discussion on rebalancing of drug costs with the HIRA to fundamentally solve the problem of drug price gaps and delivered a plan to eliminate the proceeds. Proceeds will be generated when the center purchases insurance contracts of emergency drugs from abroad and imports them into Korea. For example, the profit generated when the center buy ₩10,000 abroad for a orphan drug with a domestic insurance price of ₩20,000 is ₩10,000. Indeed, the difference between the import price of a drug and the high insurance price is the profit, but there is a problem that the national budget and national tax, the cost of health and pharmaceutical drugs, are unnecessarily wasted. There are a total of 17 insurance-listed items in Korea. The KOEDC will select the item with the largest drug price difference, apply for the drug price adjustment to the Ministry of Health and Welfare and is to eliminate controversial proceeds. In detail, the center plans to complete the request for price re-adjustment next month after a selection of drug price-adjusted items reflecting the changes in the total price of drugs and the VAT for each item through the meeting with the HIRA related officials. Drug rebalancing is the process by which the KOEDC re-adjust urgent import drug prices that is out of the range. In addition, the center also planned to regularize the drug price adjustment system. It is a policy to enforce the price adjustment repeatedly for all of the urgent imported drugs handled every six months or one year. The center official said, "We will re-adjust drug prices sequentially from items with large difference in profits as discussed with the Ministry of Health and Welfare, and currently reorganizing the entire 17 listed urgent imported drugs, as well as planning regular realignment procedures for 6 months or 1 year".
- 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".
- Policy
- SK Chemicals’ hemophilia drug Afstyla wins MFDS approval
- by Lee, Tak-Sun Jan 23, 2020 06:15am
- Hemophilia treatment Afstyla, developed by SK Chemicals, has won an approval for sales in Korea. The drug has licensed out its technology to Australia-based CSL in 2009. Ministry of Food and Drug Safety (MFDS) has authorized commercialization of Afstyla (lonoctocog Alfa (recombinant Factor VIII)) on Jan. 20. The licenser is Zanovex Korea, a subsidiary of global pharmaceutical distributor Zuellig Pharma. SK Chemicals’ blood product-manufacturing subsidiary, SK Plasma would be in charge of the sales in Korea. The U.S. Food and Drug Administration (FDA) granted approval on Afstyla in May 2015, and European Medicines Agency (EMA) also approved the treatment in January 2017. In Australia, where CSL is based, the treatment received the approval in April 2017. The Korean-developed treatment was approved first in overseas and entering the Korean market later. The drug is a recombinant factor VIII single-chain therapy for hemophilia A, developed by SK Chemicals. After the preclinical phase, the technology was licensed to Australia’s biotechnology firm CSL for all clinical trials. Existing hemophilia A treatments had two separate proteins combined, but Afstyla forms one whole structure with two proteins that improves stability of the treatment significantly and provides an option of twice-weekly dose. Compared to existing treatment options, the treatment apparently has enhanced productivity by ten-fold and doubled the stability. Specifically, Afstyla has doubled the duration of action of alternative options, and shows effect with only administration of twice or three times a week. Most of other hemophilia treatments are administered three to four times a week. However, some say Afstyla’s launch in Korea is late in the game as a once-weekly subcutaneously injected hemophilia treatment was approved in Korea last year and other Korean pharmaceutical companies like GC Pharma are developing investigational drugs. The hemophilia A treatment market in Korea is estimated to be around 150 billion won. While CSL is in charge of Afstyla’s global sales, SK Chemicals receives royalty on global sales and payment for agreed sales milestones. The Korean company is estimated to have earned approximately 6.5 billion won from Afstyla royalty last year.
- Policy
- Pfizer, challenges Velcade’s generic market
- by Lee, Tak-Sun Jan 22, 2020 10:47pm
- Pfizer will show anticancer generics (Pfizer Bortezomib, generic for Velcade) used in multiple myeloma. It is expected to compete with the original drug by Janssen and six domestic generics. The MFDS approved the Pfizer Bortezomib 3.5 mg of Pfizer Korea on the 21st. It is the same ingredient of Janssen Korea’s Velcade (Bortezomib). The difference is that the velcade is attached to the trimer, while the Pfizer’s Bortezomib has monohydrate attached to the main component. In conclusion, the same effectiveness is shown for multiple myeloma and mantle cell lymphoma. The original 'Velcade' is a blockbuster drug that generates about ₩10 billion in sales in Korea. In December 2015, the generic market was opened due to patent expiration, but it has maintained its market share due to the characteristics of the cancer drug market that prefers the original. Moreover, it is licensed as a first-line treatment for patients with multiple myeloma. About 8000 patients with multiple myeloma are known in Korea. Multiple myeloma is a type of blood cancer that occurs in plasma cells, the final stage of maturation of B lymphocytes, a type of white blood cell. Symptoms such as bone pain, and symptoms caused by bone marrow dysfunction. Janssen's Darzalex and Celgene’s Revlimid are available. As Velcade's patent expired in December 2015, generics for Belcade by Chong Kun Dang and Samyang Biofarm launched at a low price. Since then, generics for Boryung, ACE Pharma, Korea United Pharm, and Alvogen Korea have been approved. Seven companies are competing, including the original Janssen. Although there are few competitors, generic sales are still small enough to compete the original. An official of the related company said, "Even if there are few competitors because of the original loyalty in the anticancer drug market, there is no room for generics to enter the market." In this situation, Pfizer has challenged the generic market with imported products. Pfizer is showing a variety of anticancer drugs such as Sutene, Xalkori and Ibrance, and is expected to show its competitiveness as a generic because of the high reliability of domestic medical institutions. It is noteworthy that Pfizer will use the success story as generics in the anticancer market.
- 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.”
- Policy
- The leukemia drug 'Venclexta', formulary approved
- by Lee, Hye-Kyung Jan 22, 2020 06:27am
- Venclexta (Venetoclax), a drug used to treat chronic lymphocytic leukemia (CLL) that by Abbvie Korea, got formulary approval. The HIRA announced in December last year that Venclexta 10 mg, 50 mg and 100 mg were adequate for their benefits. Abbvie received Venclexta’s permission from the Ministry of Food and Drug Safety on May 29, and filed a formulary request with the HIRA. Venclexta has been approved as a monotherapy for the treatment of patients with chronic lymphocytic leukemia who are relapsed or refractory to chemoimmunotherapy and B cell receptor pathway inhibitors. CLL is a blood cancer caused by abnormally increased lymphocytes in the blood. In the West, CLL is the most prevalent leukemia, but in Korea, it is a rare disease that accounts for only 0.4-0.5% of all leukemias. On the other hand, the HIRA evaluates the reimbursement adequacy of drugs after deliberation by the drug reimbursement and evaluation committee in accordance with Article 11-2 of the regulation for criteria for providing reimbursed services in the NHI. The final evaluation result may be changed in the event of changes in the specific reimbursement range and standard items of the drug, changes in the permission of the item requested for decision, and withdrawal (cancellation).
