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- 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.
- Company
- The 38th JP Morgan Healthcare Conference ended
- by Kim, Jin-Gu Jan 21, 2020 06:24am
- Se-chang Kwon, president of Hanmi Pharmaceutical, who attended the 38th JP Morgan Healthcare Conference, announces the vision of Hanmi Pharmaceutical and its 2020 R&D strategy The 38th JP Morgan Healthcare Conference ended. This year, more than 30 Korean pharmaceutical bio companies visited San Francisco, USA. Seven companies, including Samsung BioLogics, Celltrion, Hanmi Pharm, and LG Chem, made public announcements. Other pharmaceutical companies also had a competition behind the curtains There are three keywords that summarize the performance of Korean companies who attended this year's JP Morgan Healthcare Conference: ▲overseas expansion, ▲metabolic disease, and ▲global clinical launch. Samsung Biologics and Celltrion, two of the largest 'guests' of Korean companies, announced their plans to directly target overseas markets. Hanmi Pharm, LG Chem, and Daewoong Pharm introduced plans to develop metabolic diseases such as diabetes and obesity. The world's first non-alcoholic steatohepatitis (NASH) drug under development by Hanmi and Daewoong's next-generation gastroesophageal reflux disease drug have once again announced that global clinical trials are going well. SK Biopharm's Excopry and Sunosi announced their launch and full-scale sales in the US and Europe respectively. The presentations and activities of each company's JP Morgan Healthcare Conference are as follows. ◆Samsung Biologics = Samsung Biologics announced in April that it will establish a R&D Center for Biopharmaceutical Development (CDO) in San Francisco. Samsung Bio is the first US subsidiary. The strategy is to establish a forward base in the US, the largest market. First, the company aims to increase contract development orders, and eventually expand the scope to consignment production (CMO). Samsung Biologics' number of CMO items increased to 27 in 2018 and 35 in 2019. This year, the plan is to increase the number to 47. For this, it said that it is considering the construction of a fourth plant in Songdo, Incheon. At present, the 3 plants of 364,000 liters are said to be in full operation. What Samsung Biologics expects is Biogen's Alzheimer's drug. At the conference, Biogen said it is pushing for a US product license to launch the Alzheimer's drug, Aducanumab. Samsung Biologics and Biogen are deeply connected as the first and second shareholders of Samsung Bioepis. ◆Celltrion = Celltrion announced that it will launch into China after Europe and the US. Celltrion plans to enter the Chinese market by itself, not in the form of a joint venture (JV). This goal was announced directly by Chairman Jung-jin Suh. "We are working on a business agreement with the provincial government of China to build 4 plants of 120,000 liters locally, and we are going to make an agreement this month, and we will start construction in April". He also introduced plans for the development of an insulin biosimilar. Through self-development and co-development, he has succeeded in the diabetes treatment market of ₩47 trillion worldwide. Chairman Jung-jin Suh also announced the possibility of the merger of Celltrion Group. In the Q&A process, he mentioned the possibility of merging Celltrion, Celltrion Healthcare, and Celltrion Pharmaceuticals. The merger's market cap is estimated at ₩23 trillion. However, Celltrion is conducting an internal review of the merger on the premise that the share of shareholders of the company and its affiliates is high on the following day, but there are no specific details such as the method and timing of the merger. ◆Hanmi Pharm = Hanmi Pharm has focused on the introduction of NASH drugs and obesity drugs returned from Janssen. HM15211, which is being developed as a NASH treatment, said it plans to launch a global clinical phase II in the second quarter of this year. According to the phase I of clinical trials, various effects, including rapid and strong fatty liver reduction, were confirmed. Another key challenge, the HM12525A, was also introduced. Last year, Janssen returned the rights to Hanmi after completing Phase II clinical trials. Janssen has been conducting Phase II clinical trials to develop drugs that treat obesity and diabetes. Unlike Jansen, Hanmi Pharm plans to develop this drug as a dual-mechanism for obesity, which is superior to existing drugs. Hanmi Pharm explained that it is the world's first once-weekly anti-obesity drug, and demonstrated the superior weight loss effect compared to the existing daily anti-obesity drug through Global Phase II. ◆Daewoong Pharmaceutical has unveiled its global development roadmap for 'Fexuprazan', the next-generation gastroesophageal reflux disease treatment. Last year, Phase III clinical trials were completed, and a product license was applied to the MFDS. In particular, it plans to enter clinical trials in the US and China within this year. Through this, it announced that it would enter the global market worth ₩40 trillion. In addition, Daewoong introduced the positive results in Phase III clinical trials of HL036, a new dry eye treatment drug under development with Hanall Biopharma. ◆LG Chem = Ji-woong Sohn, head of the Life Sciences Division, explained the anticancer, immune, diabetes, and metabolic disease pipelines. According to LG Chem, the drug, gout treatment entered the US Phase II trial, inhibits xanthine oxidase which is a protein involved in the excessive production of uric acid. In the previous phase I, the possibility of side effects of cardiovascular disease indicated as a disadvantage of the existing uric acid inhibitors was low. ◆SK Biopharm has updated its sales plans for the new epilepsy drug, Excopry, and the sleep disorder, Sunosi. In case of Excopry, it plans to start negotiations on drug prices and full-scale marketing activities for Excopry from March after the US DEA review. Sunosi expects to be approved for a European marketing license as early as next week. Jazz Pharmaceuticals, which bought Sunosi's technology, said Sunosi's European Drug Administration's product licensing is expected next week. Through this, in June, it announced plans to launch in Germany throughout Europe. ◆Genexine = HPV vaccine GX-188E has been released. GX-188E is undergoing phase 2a clinical trial with Kitruda in patients with recurrent or metastatic cervical cancer. Genexine explained that it achieved the planned target response rate early. ◆SCM Life Sciences reportedly focused on finding clinical partners in the field of kidney cancer. The company announced last week that it has applied for a phase 2b trial with the US FDA. ◆Genome&Company = Genome & Company, a microbiome company, said it has signed a combined clinical contract with Merck and Pfizer, a global pharmaceutical company. Phase I clinical trial for the combination of Merck and Pfizer's anticancer drugs, Bavencio and Genome&Company, for GEN-001. ◆HLB said it had concurrent meetings with multinational pharmaceutical companies for licensing in and out agreements. The company said it had a meeting with a Japanese and European partner to license out Rivoceranib, which is being developed for gastric cancer treatment. However, the sales schedule for Rivoceranib scheduled for the fourth quarter was explained as "The FDA continues to discuss." ◆Eubiologics announced that it has signed a Term Sheet agreement with POP Biotech in the US to establish a joint venture. It is a combination of Eubiologics' EuIMT(immune enhancer) technology and POP Biotech's SNAP platform (antigen delivery) technology. The company announced that it reported establishment in the US within March of this year and develop vaccines against respiratory syncytial virus (RSV), shingles virus (VZV) and Alzheimer's as its primary targets.
- Company
- The Rx rate of Lipitor and Plavix is high
- by Chon, Seung-Hyun Jan 20, 2020 06:27am
- Last year, the strength of patent expiration drugs stood out in the top domestic outpatient drug market. Lipitor, a hyperlipidemia treatment drug, continued to rise and remained No.1 in the prescription market for two consecutive years. The antithrombotic drug Plavix has grown by about 50% in five years. 'Twynsta', 'Crestor', and 'Aricept' also increased the amount of prescriptions despite the generics. Among the products developed by domestic companies, 'Gliatamin' and 'Rosuzet' showed a remarkable progress. Last year, Lipitor took the lead in outpatient Rxs of ₩176.2 billion, according to drug research agency UBIST. It was 8.4% higher than the previous year, winning the Rx market for two consecutive years. In 2017, Gilead's hepatitis B treatment, Viread, ranked first. Outpatient Rx Performance Rank by item in 2019 (Unit: ₩100 million,%, Source: UBIST) Lipitor is clearly ranked first in the outpatient Rx market with a gap of ₩69.4 billion from the second-largest Viread. Hyperlipidemia drug Lipitor by Pfizer Lipitor, which was released in Korea in 1999, is exceptional. More than 100 generic products have entered since 2009, and insurance prices have fallen by half compared to before patent expiration. Pfizer recently received a series of large-scale clinical studies on Koreans, engaged in a variety of social contribution activities, and is said to have concentrated on Lipitor. Last year, the prescription market showed the most notable increase in patent expired drugs. .Sanofi's Plavix last year recorded prescription results of ₩88.9 billion, up 17.3% from the previous year .Rx amount of Plavix increased 28.1% in two years from ₩69.4 billion in 2017 .Prescription performance of Plavix has risen by 48.2% in five years from ₩60 billion in 2014 .The patent expired in 2007 and has entered more than 120 generics .The accompanying rise in patent expired drugs is a very unusual phenomenon .In general, the market share drops rapidly after the release of drugs such as generics or salt-changed generics .In the domestic market, the market share is increasing .Prescriptions also increased last year, compared to last year's generic competition, including Boehringer Ingelheim's Twynsta, Eisai's Aricept and Novartis' Exforge .Due to the domestic drug price system, original drugs are said to be favorable for market share expansion .In Korea, when generics are released, the drug price of original drugs drops to the previous 70% level .After one year, the price will drop to 53.55% before patent expiration .The upper limit of the generic drug can be up to 59% of the original drug before the patent expires, and after one year, the price goes down to 53.55% like the original .After the patent expiration of new drugs, drug prices were similar to those of generics, and it is analyzed that the prescription of the original drug has increased in the prescription field .It is estimated that the market defense of patent expired drugs is firmly established by strengthening sales activities of domestic pharmaceutical companies .Lipitor is sold jointly by Jeil Pharm, while Plavix and Twynsta are sold by Dong-wha and Yuhan .Domestic patented new drug products such as Crestor (Daewoong), Aricept(Chong Kun Dang), and Harnal(Boryeong) also joined the business .Viread, which ranked No .1 in prescription drugs in 2017, fell outpatient prescriptions at ₩106.4 billion last year, down 30.5% YoY .The gap with leading Lipitors widened sharply due to drug price cuts and a decline in market share .Daewoong Bio's “Gliatamin,” a brain function improving agent of “Choline Alfoscerate”, recorded the most of ₩91.6 billion of outpatient prescriptions last year .It is up 19.5% from ₩76.7 billion in 2018 .Chong Kun Dang's “CKD Gliatilin Soft Cap” of the same ingredient also posted a prescription of ₩72.3 billion, up 14.9% from the previous year .Last year, the effectiveness of choline alfoscerate was debated, but it still rose sharply .'Rosuzet', launched by Hanmi in late 2015, recorded ₩77.3 billion, up 36.4% from last year .Rosuzet is a hyperlipidemic complex consisting of Rosuvastatin and Ezetimibe .Hanmi entered the market earlier than its competitors by securing the right to use Ezetimibe from the patent holder MSD and ranks first in the same ingredient market .Hanmi's hypertension complex, Amosartan, was listed at the top of last year with a prescription of ₩74.1 billion .Amosaltan, released in 2009, is a hypertensive complex that combines calcium channel blocker (CCB) 'Amlodipine' and angiotensin II receptor blocker (ARB) 'Losartan'.
- Company
- Novartis holds the most number of drug patents in Korea
- by Kim, Jin-Gu Jan 20, 2020 06:26am
- Sources confirm a pharmaceutical company with the highest number of pharmaceutical patent in Korea is Novartis Korea. The company owns the rights of 153 patents related to total of 29 drug items. While multinational drug companies are mostly dominating the top ten list of patent holders, Hanmi Pharmaceutical with incrementally modified drug (IMD) patents is the only Korean company in the list. On Jan. 17, Daily Pharm analyzed Ministry of Food and Drug Safety’s (MFDS) statistics on patents and found there are overall 1,881 drug patents in effect as of January 2020. The patents affect 1,093 drug items. Top 30 drug patent-holding companies in Korea Currently, 116 companies own at least one or more patents. Novartis Korea own the most with 153 patents related to 79 items. The company’s major line-up consists of Galvus, Galvus Met, Tasigna, Cosentyx, Jakavi, Glivec, Entresto, Afinitor, Stalevo, Exjade, Xolair and more. And recently, patents on Galvus and Galvus Met had been challenged fiercely by Korean pharmaceutical companies. Centering Hanmi Pharmaceutical and Ahn-gook Pharmaceutical, the Norvatis’ patent has been challenged by Korean companies’ defensive confirmation trial for the scope of patent right. The industry expects to see the original’s generics launched by August 2021 at earliest. Janssen Korea takes the second place, but has a significant gap with Novartis. Janssen holds 83 patents for 47 items, including Darzalex, Stelara, Prezista and more. Hanmi Pharmaceutical follows next on the list with 66 patents registered for 43 items. Most of them are IMDs like Amodipin, Amosartan, and Hanmi Flu. The rest of the list includes MSD Korea, GSK Korea, Takeda Pharmaceuticals Korea, Pfizer Pharmaceutical Korea, Korea Boehringer Ingelheim Korea, AstraZeneca Korea, and Bayer Korea. Hanmi Pharmaceutical is the only Korean company in the top-ten list. Expanding out the list down to top 20, there are total seven Korean pharmaceutical companies. LG Chem (27 patents), Chong Kun Dang Pharmaceutical (27 patents), Dong-A ST (24 patents), JW Pharmaceutical (22 patents), Daewoong Pharmaceutical (20 patents), and SK Chemicals (19 patents) have their places in the top 20 list. Interestingly, the top sales revenue list and the top patent-holders list do not match. As of 2018, Yuhan is the top selling Korean pharmaceutical company, but the company sits on the 13th place on the top Korean patent-holding companies’ list. The second top selling company GC Pharma is on the 21st place on the patent-holder’s list. Whereas the top selling global pharmaceutical company Pfizer is actually on the sixth place on the top patent holder’s list. Janssen is within the top ten selling pharmaceutical companies’ list, but it is on the second place for the patent holder’s list. Top 20 patent-holding multinational companies 50 multinational pharmaceutical companies’ patents affect 63.6 percent of drugs in the Korean market. The global companies hold 72.8 percent of all drug patents in Korea, which means each global company owns average of 13.9 patented drugs. Among 66 Korean companies, each one holds average of six patented drugs. However, most of the Korean companies (46 companies) own less than five patented items. 21 companies have only one item patented. Patent-holding ratio of multinational and Korean pharmaceutical companies in Korea As far as patented substance goes, metformin hydrochloride had the most number of related patented drugs with 47 items. Following the list, rosuvastatin calcium (29 drugs), amlodipine besylate (25 drugs), hydrochlorothiazide (20 drugs), losartan potassium (16 drugs), telmisartan (16 drugs), amlodipine camsylate (15 drugs), and pregabalin (15 drugs) have the most number of related patented drugs. Mostly, the patented drugs treat chronic diseases like hypertension and diabetes.
- Company
- Takeda's Kynteles indicated for first-line treatment
- by Eo, Yun-Ho Jan 20, 2020 06:26am
- Kynteles would be rubbing shoulders with tumor necrosis factor-alpha (TNFα)-antagonist in treating ulcerative colitis and Crohn’s disease. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated on Jan. 15, ulcerative colitis and Crohn’s disease treatment Kynteles (vedolizumab) won Korean Ministry of Food and Drug Safety’s (MFDS) approval on an indication for a first-line treatment. According to the approval, Kynteles would be available from Jan. 15 for prescription on treating patients with ulcerative colitis and Crohn’s Disease after having to fail in remission by conventional treatment (with corticosteroid or immune therapy). This means the treatment can be used, on the same treatment level as TNFα-antagonist and other biological drugs, to treat patients with inflammatory bowel diseases. The two most common forms of inflammatory bowel diseases, ulcerative colitis and Crohn’s disease, tend to relapse and remit repetitively. Studies found half of patients with inflammatory bowel diseases faced limits to their treatment so far having chronic, relapsed or worsened symptoms, damaged digestive systems and induced complications. Besides clinical remission, intestinal mucosal healing is globally emerging as a new treatment target for inflammatory bowel disease. Kynteles is a gut-selective treatment designed to specifically antagonize the α4β7 integrin, a cause of intestinal inflammation, and to inhibit the binding of α4β7 integrin. Unlike existing treatments possibly increasing risk of tuberculosis and infection, Kyntelels’ efficacy as systemic immunosuppressant has not been confirmed. According to GEMINI LTS study result, the vedolizumab drug demonstrated long-term effectiveness and safety profile in patients with ulcerative colitis and Crohn’s disease, observing clinical remission maintained up to 152 weeks. And in Phase 3b VERSIFY study testing the treatment’s efficacy in 101 patients with severe Crohn’s disease, 15 percent and 12 percent of patients treated with Kynteles showed complete mucosal healing and endoscopic remission, respectively. In a recent study, Kynteles demonstrated statistically superior clinical remission compared to conventional TNF-α antagonist. Comparing patient groups either intravenously injected with Kynteles or subcutaneously injected with Humira (adalimumab), VARSITY study found 31.3 percent of Kynteles group reached clinical remission at week 52, but only 22.5 percent of Humira group did. President of Korean Association of the Study of Intestinal Diseases (KASID), Kim Joo Sung claimed, “In Korea as of 2018, over 40,000 people were diagnosed with ulcerative colitis and 20,000 people with Crohn’s disease, and their prevalence rates have been soaring fast lately in Asian region including Korea. As the diseases require long-term treatment, alleviating symptoms are not sufficient, but rather the patients should also improve mucosal healing and treat their inflammatory bowel diseases considering safety profile of drugs.”
- Company
- Samsung BioLogics opens new CDO lab in San Francisco
- by Lee, Seok-Jun Jan 20, 2020 06:25am
- Samsung BioLogics will establish a CDO R&D Lab in San Francisco in the first half of this year. The company is the first US corporation. Samsung BioLogics plans to further expand to other regions of the US and Europe. Samsung Biologics President Tae-han Kim and Vice President John Lim announced the plan at the JP Morgan Biohealth Conference in San Francisco. Tae-han Kim, President & CEO, Samsung BioLogics (left) & Vice President John Lim(Right) President Tae-han Kim shared the business status. President Tae-han Kim said, "We are currently conducting 35 CMO products, 47 product approvals, 42 CDO projects and 10 CRO projects, & expanding our global business with 47 product approvals". As the project accumulates, the plant utilization rate is rising. Kim said, “The first plant is nearing its maximum utilization rate and the second plant is currently in full operation, the third plant has 35% of its production capacity and will raise it to 60% this year”. Vice President John Lim announced the entry into the CDO R&D Lab in San Francisco, USA in 2020. This is to create synergy with customer satisfaction and production base in Korea through overseas expansion. "We are looking into the CDO R&D lab in San Francisco in 2020 and further expansion in other parts of the United States and Europe," said John Lim. He said, “Samsung BioLogics began expanding its value chain to CDO/CRO in 2017, and established a one-stop service from cell line development to clinical material production through sCMO, quality control/analysis, and commercial mass production. Biotech and Big Pharma have more than 9,000 locations".
