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- 2026-05-16 04:49:53
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- New migraine preventive Emgality cleared in general hospital
- by Eo, Yun-Ho Feb 19, 2020 06:34am
- Korean general hospitals are swiftly implementing a new migraine preventive medication, Emgality, on their prescription drug code. According to a pharmaceutical industry insider, migraine-preventing calcitonin gene-related peptide (CGRP) antagonist Emgality (galcanezumab) has been launched last December. And it has been passed by Drug Committees in Seoul National University Hospital, Severance Hospital, Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. The drug is a humanized monoclonal antibody that binds to CGRP, causing migraine symptoms in brain, and blocks its binding to the receptor. The Korean government has approved the new drug has been as the first in its class. Designated as an orphan drug in last April, the drug has been approved to market in last September. Recently, the U.S. Food and Drug Administration (FDA) has additionally indicated the drug as a treatment for episodic cluster headache. Emgality’s approval was based on six-month long EVOLVE-1 and EVOLVE-2 trials with 1,773 patients with episodic migraine headache (monthly average four to 14 migraine headache days (MHD)), and three-month long REGAIN trial with 1,113 patients with chronic migraine headache (monthly average 15 headache days, more than eight MHD). The two trials treating patients with episodic migraine headache for six months compared mean changes of monthly average migraine headache days from baseline (9.2 MHD in Emgality group, 9.1 MHD in placebo group) and demonstrated improved treatment effect of the drug than the placebo. For six months time in the EVOLVE-2 trial, particularly with Korean participants, 226 patients in Emgality group has reduced monthly average MHD by 4.3 days, or two days more than placebo group (450 patients) that reduced MHD by 2.3 days. Among the Emgality-treated group, 59 percent of the patients had 50 percent less MHD, 34 percent of them had over 75 percent less MHD, and 12 percent of them had 100 percent less MHD. Whereas, 36 percent, 18 percent and 6 percent of placebo-treated group had 50 percent, more than 75 percent and 100 percent less MHD, respectively. Professor Chu Min Kyung of Neurology Department at Severance Hospital explained, “Migraine headache could unimaginably damage patient’s quality of life. Patients with average four to five MHD in a month could expect to improve their quality of life with preventive treatment. While anti-hypertension and anti-epileptic medications were recommended for migraine preventive treatment, Emgality’s launch is a hopeful news to the patients.” Meanwhile, a series of CGRP-class medications have been released throughout last year. Besides Emgality, Aimovig (erenumab) co-developed by Novartis and Amgen and Ajovy (fremanezumab) by Teva have entered the market.
- Company
- JW Holdings patent pancreatic cancer diagnostic kit in US
- by Nho, Byung Chul Feb 19, 2020 06:33am
- JW Holdings has also successfully patented an early-stage pancreatic cancer diagnostic technology in the U.S. JW Holdings (CEO Han Seong Gwon) announced on Feb. 17, the United States Patent and Trademark Office (USPTO) has granted a patent on source technology of the world’s first ‘multi-biomarker diagnostic kit’ that identifies pancreatic cancer in early stage through a simple blood test. From Professor Paik Young-k’s team at Yonsei University, JW Holdings licensed the innovative source technology in 2017, of a diagnostic platform testing each level of cancer with human body substance found in early and late-stage pancreatic cancer patients.. To this date, a diagnostic method of testing CA19-9, a common antibody expressed in late-stage pancreatic patient, has been used, frequently. But JW Holding is the only company in the world to own a source technology to diagnose pancreatic cancer by testing complement factor b (CFB) found in early-stage patient. After patenting the source technology in Korea in 2016, JW Holdings has patented the technology in Japan (2018) and in China and Europe (2019). With its subsidiary company JW Bioscience, JW Holdings has been developing multi-biomarker measuring kit and diagnostic algorithm, including CFB and CA19-9. And with Professor Kang Chang Moo’s research team at Severance Hospital, the Korean pharmaceutical company is to initiate an exploratory clinical trial from this year on 500 patients including pancreatic cancer patients. JW Holdings official stated, “Following the patent approval in Japan and Europe, the U.S. with highly complicated patent review standards have finally recognized the technology and rights of CFB-based early-stage pancreatic cancer diagnostic kit and completed the patent procedure. By continuing to work on the technology and commercializing it in the future, the company would lead the higher value-added global market of in-vitro diagnostics.” Taking the lives of a thousand patients a day in worldwide, pancreatic cancer is diagnosed in about 6,600 patients in Korea a year. Among all cancer types, early-stage diagnostics in pancreatic cancer is crucial as it has the lowest five-year relative survival rate of 11 percent. But, because pancreas is surrounded by other organs and early symptoms are barely noticeable, early diagnosis for the cancer has been significantly difficult. Academic societies, such as the American Association for Cancer Research, predict the pancreatic cancer would be ranked at second place for the cause of cancer patient’s death in 2020, because there is no early diagnostic marker is available until now. Market research company, Mordor Intelligence found the global pancreatic cancer treatment and diagnostics market was recorded at USD 1.73 billion (about 2 trillion won) in 2015. And they argue the market would grow up to 3.19 billion dollars (about 3.7 trillion won).
- Company
- GSK and Pfizer intensify treatment conflicts after merger
- by An, Kyung-Jin Feb 18, 2020 06:34am
- There is a friction over the integration process of Pfizer Korea and GlaxoSmithKline's Consumer Health Division. Pfizer Pharmaceutical's union raises suspicions that GSK will endorse unfair changes in working conditions in the process of employee succession. There are ten days left to launch an integrated corporation, and a possibility that variables may arise during the merger process if employees refuse to transfer largely. According to the related industry on the 14th, Pfizer Korea’s labor union had an emergency meeting with about 50 employees of Consumer Health Division in the afternoon. The intent is to seek a response to GSK's notification that Pfizer's Consumer Health Division employees must submit a written consent by this coming 17th to agree to transfer to GSK on the condition that they agree to change the disadvantage of working conditions. Pfizer and GSK Korea have been pursuing related procedures since the merger with Consumer Healthcare in 2018. As GSK establishes a joint venture with 68% of the joint venture and Pfizer's remaining 32%, GSK is committed to 100% succession of Pfizer employees. The organization of the headquarters has already completed the establishment of a joint venture and transfer of its employees in August last year, and GSK & Pfizer Consumer Health Korea is expected to launch a corporation on the 24th as the related procedure has reached its final stage. The problem arises from the fact that labor negotiations over working conditions have not progressed even though the date of incorporation is approached ten days in advance. Pfizer's union argues that GSK, the owner of the negotiating bargaining agreement, has asked Pfizer employees to change their working conditions to be 100% identical to GSK, and the gap has not narrowed. It is pointed out that the employee's options were limited because the company insisted employees should approve changes of disadvantages in working conditions if employees want to transfer with GSK for more than two months since last December On the 10th, Pfizer's labor union, Pfizer's human resources officers and GSK's human resources officers agreed that even if employees want to transfer, whether they agree to changes of disadvantages in working conditions are left to the opinion of individuals. But, they took back their words in four hours. It also uncovered that employees of Pfizer Pharmaceutical Consumer Business Division of Korea had to submit an agreement by e-mail by the 17th that they would agree to change the disadvantage of working conditions and change the retirement pension system if they want to transfer work. Yun-gyu Park, the chairman of Korea Pfizer labor union, said, “It is a serious offense to allow GSK transfers under the conditions of work conditions and retirement pension, and employees who were unilaterally notified by e-mail are not able to get out of shock”. Pfizer Korea's HR team tipped off that GSK had an attitude problem and raised objections to the headquarters. According to Park, most employees complain about the wide difference in working conditions such as benefits and ranks. For example, Pfizer has six ranks and GSK has three levels. According to the GSK standard, even if there are paid health leave, sick leave and other leave, medical expenses support, and retirement pension system, the company must bear a considerable disadvantage. Apart from the difference in the basic labor system, he also pointed out that the entire agreement contained many poisonous clauses. It was also predicted that confusion would be inevitable if the majority of the 53 members of the Consumer Health team refused to do so. It is pointed out that the launch of an integrated corporation may have a problem. The two companies have not disclosed their official position. Pfizer and GSK officials said, "There is currently no formal issue that can be revealed, except that the two companies are in the process of merging the consumer healthcare business".
- Company
- Belviq was withdrawn voluntarily by Ildong
- by Chon, Seung-Hyun Feb 18, 2020 06:34am
- Ildong Pharmaceuticals voluntarily discontinued the sale of its obesity drug, Belviq. In the United States, it was advised to withdrawal of permission because of the risk of developing cancer, and it has preemptively discontinued sales in Korea. According to the industry on the 14th, Ildong Pharmaceutical decided to stop selling Belviq in Korea. Ildong Pharmaceutical said, “The FDA recommended discontinuing sales in the US because of the increased incidence of cancer,and we are proactively discontinuing Belviq's sales and are discussing with MFDS for further actions”. In this regard, the US FDA recommended Belviq’s withdrawal. Due to the increased risk of developing cancer, and has asked Belgian developer Belviq’s developer, Eisai to withdraw of the market. The FDA said last month that the results of Belviq's safety assessment trials indicate a new increased risk of cancer during the trial. In a clinical trial involving 12,000 patients in a five-year trial to evaluate heart-related problems by Eisai, patients taking Lorcaserin(generic for Belviq) were more likely to be diagnosed with cancer than those taking placebo. .In Korea, the official position of the Food and Drug Administration has not been determined in relation to Belviq's sale or discontinuation of prescriptions .Although the MFDS has not decided, Ildong plans to discontinue its sales and follow up with safety verification .Belviq was the drug that had been expected to be a safe obesity drug since its introduction to the market .Belviq, which was domestically licensed in February 2015, is a new drug approved for weight control by the FDA in 13 years .Belviq is a drug that selectively acts on the serotonin receptor, a neurotransmitter that regulates appetite and emotions, suppressing appetite and improving satiety .According to drug research institution IQVIA, Belviq ranked No.1 in obesity treatments with 2018 sales of ₩9.8 billion in Korea .After the emergence of Saxenda in the second quarter of 2018, it was handed over to the top spot for obesity treatment, but it was still regarded as a highly preferred obesity treatment .Cumulative sales for the third quarter of last year stood at ₩6.6 billion .However, the sale was put into the worst crisis due to this withdrawal .Ildong Pharmaceuticals official said, “We will implement further measures as soon as consultation with MFDS is completed, and will faithfully do all measures with the patient's health first”.
- Company
- Delstrigo by MSD was approved
- by Eo, Yun-Ho Feb 14, 2020 06:36am
- MSD aims to expand market share in AIDS According to the industry, the MFDS recently approved a fixed-dose HIV complex, Delstrigo (Doravirine, Lamivudine, Tenofovir), once daily. Delstrigo has been approved for the treatment of human immunodeficiency virus (HIV-1) infections in adults without prior antiretroviral treatment. Doravirine 100mg is approved by the MFDS on November 22 2019 under the brand name 'Pifeltro' and is intended to be used in combination with other antiretroviral drugs. Both Pifeltro and Delstrigo approved indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients without previous antiretroviral treatment. This drug has been validated through the DRIVE-AHEAD trial. In this trial, Delstrigo demonstrated non-inferiority to Efavirenz, Emtricitabine, and Tenofovir such as Atripla. At 48 weeks, the percentage of patients who reached virological inhibition (less than HIV-1 RNA 40copies/mL) was 84% in the Delstrigo treatment group and 80% in the EFV/FTC/TDF treatment group. The rate of discontinuation due to adverse events was 3% and 6.6%, respectively, which was lower in the Delstrigo treatment group. An MSD official said, "The company is currently preparing for Deltrigo's insurance coverage and launching. We are also planning to expand further indications".
- Company
- Celebrex, resupplied as bottles of 100 capsules
- by Jung, Hye-Jin Feb 14, 2020 06:35am
- Cerebrex capsules, which are widely prescribed for rheumatoid and osteoarthritis pain medications, run out of stock. Pfizer Upjohn Korea recently announced that Celebrex 100mg 30 unit doses were sold out to distributors and medical institutions. Pfizer Korea explained that it will be resupplyed in early April and that Celebrex 100mg bottles of 100 capsules are normally supplied This is not the first time that Cerebrex is out of stock. Pfizer announced last June that Celebrex 100mg bottles of 100 capsules were out of stock. Out-of-stock period was for 6 months, and it has been resupply since early this year. However, as soon as Celebrex 100mg bottles of 100 capsules are resupplied, Celebrex 100mg cartons of 30 capsules are running at this time. Pfizer said the reason for the out of stock was a delay in production schedule.
- Company
- 4th IL inhibitor Skyrizi takes steps towards reimbursement
- by Eo, Yun-Ho Feb 13, 2020 06:29am
- The fourth interleukin medicine in Korean market, Skyrizi has started its reimbursement listing procedure. Pharmaceutical industry sources reported AbbVie Korea recently submitted an application for reimbursement on interleukin-23 (IL-23) inhibitor Skyrizi prefilled syringe (risankizumab). As a follow-on drug, the medication is predicted to accept the alternative drug weighted average price and promptly complete the listing process by the end of coming June. When the syringe receives reimbursement, the interleukin medicine market would be led by four competitors. Besides Skyrizi, Novartis’ IL-17A inhibitor Cosentyx (secukinumab), Lilly’s IL-17 inhibitor Taltz (ixekizumab), and Janssen’s IL-23 inhibitor Tremfya (guselkumab) are available in Korean market with reimbursement. All four medications are indicated for treating psoriasis and they are expanding indications on other autoimmune disease-treating fields. Professor Youn Sang Woong of Seoul National University Bungdang Hospital explained, “Severe psoriasis can seriously affect patient’s quality of life with physical, mental and social difficulties and pain. Each patient differs vastly in treatment response, and experiences various adverse reactions due to long-term treatment.” “During a Phase III trial, 90 percent of patient group administered with Skyrizi improved symptoms at over week 16, and 80 percent of them still maintained the improved state even after a year. The medication would be a new treatment option to improve symptoms of severe psoriasis and for maintenance therapy,” the professor added. In last December, MFDS indicated Skyrizi for treating adult patient, who needs phototherapy or systemic therapy (including biological therapy), with severe-level plaque psoriasis. Its indication was approved based on UltMMa-1 and UltMMa-2 trials, where patient group treated with Skyrizi showed high level of condition improvement at 16 weeks. 82 and 82 percent of the patients achieved Psoriasis Area and Severity Index (PASI) 90 at one year (52 weeks), and 56 and 60 percent of the patients achieved PASI 100, respectively. PASI 100 indicates the patient’s condition has achieved a complete resolution. Skyrizi administration starts with 150 mg initiation dose injected subcutaneously at week 0 and 4, followed by injection at every 12 weeks. Among the biologic IL-23 inhibitor class medicines approved in Korea, the treatment has the minimum administration frequency of four times a year, and it can be injected at a hospital or a patient can self-inject after training.
- Company
- Who will distribute Lamisil?
- by Jung, Hye-Jin Feb 13, 2020 06:28am
- GlaxoSmithKline Consumer Health's 'Lamisil' distribution network is distant. All rights reserved by Dong-wha have been transferred to Ildong. Only Lamisil has been missing and haven't found a supplier for over a month. Wholesalers and medical institutions are holding back their existing inventory and are very nervous about their short expiration dates. Lamisil has not been available since January, according to retailers and pharmacies. GSK products supplied by Dong-wha until last year are 10 items including Lamisil, Otrivin, Voltaren, Nicotinell, Theraflu, Sensodyne, Brethe Right, Zantac, Polident, and Diclor. Ildong signed a co-promotion agreement on only nine items except Lamisil. As the rights were transferred from Dong-wha to Ildong, only Lamisil has been lost. The distribution industry believes that Ildong Pharm has already given up the products because of its similar efficacy. Ildong signed a co-promotion agreement with Bayer in 2013 to supply Canesten creams, vaginal tablets and powders. Canesten cream is an antifungal agent for infectious diseases, and is widely prescribed for vaginitis and athlete's foot. The two products have different ingredients, but they are both cream-type athlete's foot treatments and both are classified as 'parasitic skin disease agents'. From the standpoint of Ildong, it is likely that a pharmaceutical company would be difficult to sell two similar items, and the decision could be a violation of the contract for two companies that signed a co-promotion agreement. The problem is that the company that distributes Lamisil has not been confirmed until mid-February. Wholesaler Zuellig Pharma Korea has been negotiating with GSK since last year for a sales contract, but it is reported that it has not reached an agreement on margin. wholesalers and pharmacies suffer from Lamisil’s short stocks. Most wholesalers and pharmacies have stocks of Dong-wha, but they are in danger because they have short expiration dates. An pharmacy official said, "Because imported goods take 5~6 months from customs clearance, even if they are produced at the same time, the expiration date is 6 months shorter than domestic products and there aren't a lot of Lamisil stocks available for sale". In response, GSK explained that Lamisil will soon be resupply. GSK officials said, "The internal process related to the contract is in progress, and it is possible to resume supply as soon as the related contract is concluded. We are making every effort to minimize the impact on the market demand".
- Company
- Yuhan and Eisai ink co-marketing deal for PPI Pariet
- by Eo, Yun-Ho Feb 12, 2020 06:31am
- Yuhan is to join the effort to market PPI medication Pariet in Korea. According to pharmaceutical industry sources, Pariet supplier Eisai Korea and Yuhan have signed a co-marketing contract on marketing and sales in Korea for proton pump inhibitor (PPI) medication Pariet (rabeprazole sodium) 5 mg as it has been listed for reimbursement since last September. Currently, the co-marketing deal is limited to low-dose (5 mg) tablet of Pariet, and the two companies are reportedly in discussion to expand the contract to cover all doses (10 mg and 20 mg) of the Pariet brand. With Yuhan’s powerful sales capacity, Pariet could further consolidate its position in the PPI market in Korea. UBIST reported, Pariet has generated 10.4 billion won and 12.5 billion won in 2017 and 2018, respectively, and recorded up to 20 percent of growth so far. The newly launched Pariet 5 mg is the lowest dose of PPI or rabeprazole medication available in Korea. Pariet 5 mg, the only rabeprazole medication indicated for low-dose aspirin in Korea, differentiates itself from high-dose PPI mediation as lowest-dose PPI medication, and it was released in Korea following the first global release in Japan. Randomized, double-blind, multicenter PLANETARIUM study confirmed the efficacy and safety of Pariet 5 mg. Over 24 weeks, 472 patients receiving low-dose aspirin for cardiovascular or cerebrovascular protection, but also has a history of peptic ulcers, were divided into three groups each treating them with Pariet 5 mg, Pariet 10 mg, and mucosal protective agent teprenone 50 mg. As a result, Pariet 5 mg, Pariet 10 mg, and teprenone 50 mg patient groups showed cumulative recurrence rates of 2.8 percent, 1.4 percent, and 21.7 percent, respectively, and confirmed meaningful treatment effect in Pariet patient groups. In the extension phase of PLANETARIUM, teprenone-treated patient group was randomly switched to rabeprazole for 28 weeks to maximum 52 weeks. The group administered with 5 mg of Pariet demonstrated cumulative recurrence rate of peptic ulcers of 3.7 percent, showing continuous peptic ulcer preventive effect. No bleeding ulcers were reported during the trial period.
- Company
- Baxter-Boryung shake hands on comarketing PN in Korea
- by Eo, Yun-Ho Feb 12, 2020 06:28am
- GM Hyun Dong-wook of Baxter (left) and CEO Lee Sam-soo of Boryung Pharmaceutical Boryung Pharmaceutical is to reinforce the sales capacity in Korea for Baxter’s nutrition solution pipeline. Baxter (GM Hyun Dong-wook) announced on Feb. 10 of signing a business partnership agreement with Boryung Pharmaceutical (Co-CEO Ahn Jae-hyun, Lee Sam-soo) on co-marketing the company’s Olimer and two other major nutrition solution products in Korea. Under the agreement, Boryung Pharmaceutical would be in charge of the marketing Olimel and Periolimel, Clinoleic, and Primene in Korean hospitals and clinics from January. Baxter’s star intravenous nutrition solution Olimel is parenteral nutrition in triple-chamber bag providing fluid, electrolytes, amino acids and calories to adult and infant patient age under two, who needs parenteral nutrition due to issues in gastrointestinal tract. In particular, the solution provides sufficient amount of protein to patients wasting nutrition, due to burn, blood poisoning, severe injury or cancer, for them to recover and sustain life with balanced nutrition. Clinoleic provides calories and essential fatty acid to premature or low birth-weight infant, pediatric and adult patients in need of parenteral nutrition. Primene provides parenteral nutrition to normal or low birth-weight infant, premature infant or infant and pediatric patients who cannot sufficiently consume nutrition orally or enterally. General Manager of Baxter, Hyun Dong-wook stated, “By signing the business partnership agreement with Boryung Pharmaceutical, we hope to stabilize supply of Baxter’s top nutrition solution line-ups to patients in Korea.” CEO Lee Sam-soo of Boryung Pharmaceutical said, “We expect to create good synergy effect between Baxter’s outstanding products and Boryung Pharmaceutical’s excellent sales infrastructure in Korea.”
