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- 2026-04-17 13:48:12
- 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).
- Policy
- Naglazyme RSA ends, 20.6% price cut from March
- by Kim, Jung-Ju Jan 22, 2020 06:27am
- Insurance prices have fallen by more than 20% since March, when Naglazyme (Galsulfaze) by Samoh Pharmaceutical has concluded a risk-sharing contract (RSA) agreement. According to pharmaceutical companies' strategies, such as price competition, there are a total of eight products that will be lowered on their own benefits next month. According to the industry on the 19th, the Ministry of Health and Welfare is pursuing ‘the revision of drug reimbursement list and the upper price limits’. The criteria for application are as follows, but the timing of application differs depending on the product. ◆Naglazyme’s RSA terminated= Samoh’s Naglazyme with the end of the RSA, is applied as regular reimbursement. The drug was not easily covered because it was expensive until now. In the past, the government increased the accessibility by registering the drug in insurance as a refund pharmacy negotiation pilot project, and introduced the RSA in Korea, and maintained the drug access on the RSA track in March 2016 after the end of the project. The RSA contract lasted for four years, and in preparation for the termination of the drug contract, the NHIS negotiated a drug price on a general track with the company. Negotiations were priced at ₩1,492,815 per 5mg/ml, 20.6% lower than RSA price. The new drug price starts in March shortly after the RSA contract expires. ◆Lowered the upper limit due to the price-volume agreement negotiation conclusion= This time, there are a total of 1 drug for which the price is lowered after negotiating with the NHIS. The government is conducting post management of drug prices through Price-Volume agreement linkage, which lowers drug prices by re-negotiating drugs with higher anticipated dosages and claims compared to those listed on drug insurance. Samoh's Vimizim is a new drug that is listed as a drug price negotiation, and the same product group charges are more than 30% higher than the expected billing amount. Price-Volume agreement system(Type Ka) has been applied. Here, the same product group means a drug having the same company name, route of administration, ingredient, and dosage form. The closing price of the negotiations was ₩995,661, 2.3% lower than the previous price. New drug price will be effective from June 1. ◆Voluntary upper limit adjustment (voluntary lowering)= A total of eight items will be lowered as the pharmaceutical company voluntarily decides to lower its insurance price. The government calculates and re-adjusts a manufacturer, a consigned manufacturer, or an importer to apply for a price cut at a price lower than the listed maximum drug price. In general, it is a measure of cuts in line with its policies following market competition. Looking at the items, Chong Kun Dang's Esoduo 40/800mg drops by 14.7% from ₩1,078 to ₩920, and Huon's Cinacal from ₩2,267 to ₩2,020 by 10.9%, respectively. Celltrion’s Truxima dropped 6.1% from ₩871,323 to ₩817,823, and Jinyang Pharmaceutical's Jinicough drops 2.9% from ₩102 to ₩99. New drug pricing will begin next month. ◆Preservation of production cost of shortage prevention drugs= A total of two drugs are designated as shortage prevention drugs or the price has been preserved. The government designates drugs that are necessary for patient care or are not profitable and that manufacturers, consigned manufacturers, or importers avoid production or import, drugs that require the preservation of production and import costs as a shortage prevention drug and preserves production costs. Myung In Pharm’s Vivaquin is the drug that raised the upper limit due to the conservation of production cost, It is up 21.2% from ₩255 to ₩309. In addition, Shin Poong’s Malafree was designated as a cost-preserving drug. The drug price is ₩309 per tablet. New drug prices will be applied from next month.
- InterView
- “Changing the public’s view on psoriasis patients”
- by An, Kyung-Jin Jan 22, 2020 06:27am
- (From upper left in clockwise) Manager Hwang Chae-rin, Reward Manager Kim Ye-ji, Public Relations Manager Jeon Se-bin, President Park Hye-won) “Too many people had no or wrong idea about psoriasis. We opened the crowd funding to raise awareness of psoriasis and to improve the public’s perception on the disease.” A university student-centered crowd funding union, ‘Wishtree’ opened a new funding project this month. The project aims to help patients with psoriasis. Although the non-infectious disease can get better with constant care, many psoriasis patients struggle with public’s inaccurate knowledge of the disease. Their small wish is for the people to see psoriasis as normally as they see atopic dermatitis. Daily Pharm interviewed Wishtree administration members—Park Hye-won (23, Sookmyung Women’s University), Kim Ye-ji (21, Sookmyung Women’s University), Jeon Se-bin (22, Dongguk University), and Hwang Chae-rin (22, Hongik University)—actively campaigning for a better social view on psoriasis. Met through crowd funding related class, the union has been operating for two years Wishtree is a university student group union formed in 2018 to create and operate crowd funding projects. Initially, the students taking crowd funding class came together to make a crowd funding project for a social cause. The first year of Wishtree funded for firefighters, patients with retinal degeneration and raising awareness of the East Sea. And the second year followed with funding for various social class including patients with complex regional pain syndrome (CRPS). The crowd funding project for psoriasis patient consists of 15 students including four administration members (President Park Hye-won, Reward Manager Kim Ye-ji, Public Relations Manager Jeon Se-bin, and Story Manager Hwang Chae-rin). The rest of the eleven members are participating under the following three teams; Reward Team in charge of selecting, making and pricing rewards; Story Team in charge of planning and setting up projects; and Public Relations Team in charge of promoting the funding project to reach the target amount. Members of Wishtree Regularly meeting every Saturday, the members learn about crowd funding in class and discuss about project topics first. And when the next topic is decided, the members specify activities in back story planning, reward selection, and PR activity planning. Further discussion flows as they each designate role in respective teams and share feedbacks on the team’s activities. Jeon Se-bin, a Public Relations Manager, explained “Wishtree’s crowd funding projects are not for profit, but for public interest and social cause. When recruiting for the group members, we value not only the students’ interest in crowd funding, but also their interest in social issues.” People misunderstanding the condition as an infectious disease, “Heart breaks as the patients feel isolated from the society " So what motivated them to select psoriasis as their funding topic out of all candidate diseases? The students answered, “Compared to other diseases we’ve talked about, psoriasis needed the most attention from the public. Even many of us did not know much about the condition, and some heard about the disease for the first time.” Psoriasis is a non-infectious chronic skin disease causing raised, red, scaly patches on skin and repeatedly worsens and recovers. With continuous care, a patient with the disease can improve the condition, but many miss their treatment timing because most of the people are clueless that it requires constant treatment. And majority of the patients are having difficulties in their social life due to people’s misunderstanding of the disease being infectious. Typically, a crowd funding project selects more popular topics to raise the funding success rate, but Wishtree saw the grave issue in the public’s inaccurate view about the disease. Apparently, the students interviewed psoriasis patients and truly felt the need to correct the common misunderstandings, when they heard a patient answering ‘We wish psoriasis would be taken as normally as atopic dermatitis.’ Manager Jeon said, “It broke our hearts when we studied about psoriasis from news articles and statistic data, and found how a lot of patients feel isolated from the society because of the people’s fear of the disease being infectious by judging if from visible condition.” She added, “We have decided to fund the patients as we discovered poor public awareness is hurting the psoriasis patients the most.” Personally designed mug as a reward for funding The crowd funding project has started calling for funders from Jan. 2 through a social venture, ‘Oh My Company.’ The funding participants would be rewarded with a personally designed mug, cup coaster, and sticker sets with hopeful messages. The fund raised via the project would be entirely donated to Korea Psoriasis Association, and used for survey research and publishing news articles through ‘Oh My Company’. President Park Hye-won of Wishtree showed her ambition for the project saying “We hope the funding raising project would help change the people’s inaccurate views about psoriasis patients,” and “in the long run, we also hope that Wishtree’s good influence would expand on in the future.”
- 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.
- Policy
- Nabota, Phase III clinical trial will be conducted
- by Lee, Tak-Sun Jan 21, 2020 06:25am
- Daewoong's botulinum toxin preparation 'Nabota' is speeding up the indication of treatment as well as improving the wrinkles of the glans. Nabota, which has four indications, is in the final phase of clinical trials to prove the effectiveness of improving the square jaw. The Ministry of Food and Drug Safety approved the Phase III clinical trial plan to demonstrate the efficacy of improving Nabota's bilateral hypertrophy (square jaw). The clinical trial will be conducted at Chung-Ang University Hospital, which has undergone Phase II. When Nabota acquires the indication, there will have five effectiveness. Currently, Nabota is can be used to treat ▲a temporary improvement in moderate to severe severe glabellar wrinkles associated with corrugator muscle and/or proerus muscle activity in adults aged 20 to 65 years, ▲treatment of upper limb muscle stiffness associated with stroke in adults 18 years and older, ▲temporary improvement of moderate to severe external angular wrinkles (eye wrinkles) associated with orbicularis oculi activity in adults 18 years and over 65 years ▲ treatment of benign essential eyelid spasms in adults 18 years and older. Of these, eyelid spasm indications were obtained last June, the most recent. For 230 adults, Nabota demonstrated non-inferiority by comparison with Botox. After 4 weeks of administration, 96.15% of the Nabota group and 96.12% of the Botox group showed improvement of eyelid spasms. Daewoong expects that botulinum toxin has great potential not only in the beauty market but also in the therapeutic market, and thus, the acquisition of indications will increase competitiveness on the global stage. For reference, Botox (Allergan), which Nabota used as a reference, has eight indications. It has been recognized for its effects in various areas including strabismus and eyelid spasms, spinal malformations, treatment of cirrhosis, primary hyperatrophic hypertension, muscle stiffness, temporal improvement of worry lines, headache relief in migraines, and bladder dysfunction. Meditoxin of Medytox, which is fighting a legal battle on Daewoong about technology infringement, has five indications. Meditoxin targets domestic and international markets with the effects of benign essential eyelid spasms, treatment of acute malformations, temporal improvement of glacial wrinkles, local muscle stiffness associated with stroke, and temporary improvement of eye wrinkles. Botulinum preparations are expanding into treatment areas as well as basic wrinkle improvement. Daedal Research, a global market analyst firm, predicts that the global botulinum toxin market will reach $5.9 billion (about ₩7 trillion) in 2021, and the therapeutic market will account for about $3.2 billion (about ₩3.8 trillion). In Korea, more than 90% is used for cosmetic purposes, but in the US and overseas markets, it is known that botulinum toxin is used more for therapeutic purposes. Nabota is also investigating its potential as a treatment for male hair loss, triangular hypertrophy and tearing symptoms. Nabota was introduced to the US market last year through Evolus. Evolus reported that the first year of performance in the overseas market has raised about ₩40 billion.
- 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.
