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- 2025-12-27 12:03:48
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- Belviq was withdrawn voluntarily by Ildong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.”
- Company
- Lipitor won the market in the 2010s
- by An, Kyung-Jin Feb 12, 2020 06:27am
- In the past decade, Lipitor, the hyperlipidemia drug, recorded the most outpatient prescriptions. Lipitor has been prescribed a total of ₩1.31 trillion since 2010. After the patent expiration in 2009, even in the offensive of generic drugs, Lipitor showed that it never fell below the second place in prescriptions. The hepatitis B drug 'Baraclude' has been priscribed an average of more than ₩100 billion per year from 2010 to last year and has been at the leading position for the longest time. In 2010, hepatitis B treatment drug Viread and hyperlipidemia medicine Crestor had accumulated over ₩800 billion in prescriptions. Pfizer's Lipitor(Atorvastatin), ranked first in 2010-2019 with a total prescription of ₩1.31 trillion. Pfizer Korea introduced Lipitor to the domestic market in 1999. In the 20 years since its launch, more than 130 generic products have poured into the market for Atorvastatin-based hyperlipidemia. The drug price of Lipitor 10mg was cut in half from ₩1,241 in 2007 to ₩644. Nevertheless, Lipitor's outpatient prescriptions increased by nearly 80% from 2010's ₩98.3 billion. In the past decade, the overall prescription drug ranking has never fallen below second place. Pfizer Pharmaceuticals has self-diagnosed that the prescription amount could be continuously increased by conducting a large-scale clinical study of Koreans and carrying out active marketing activities such as social contribution activities. It is also analyzed that co-selling with Jeil, which has been established for a long time, has generated synergies. Outpatient prescription performance by year for the top three products in 2010-2019 (Unit: ₩100 million, Source: UBIST) BMS's Baraclude has accumulated over ₩1.23 trillion in the past 10 years. This means that the company has recorded more than ₩100 billion in prescriptions over the past 10 years. There are only two products, Lipitor and Baraclude, that have recorded prescriptions worth ₩ one trillion over 10 years. Baraclude has been the leader in prescriptions for the longest period of 2010, with outpatient prescriptions soaring from ₩ 88.8 billion in 2010 to ₩193.1 billion in 2014. However, after the emergence of competitive drugs and generic patent expiration, it fell to ₩71.4 billion in 2019 due to the entry of generics. Outpatient prescriptions decreased 63% QoQ. The rival drug Viread has been ranked 3rd in terms of cumulative prescriptions, with prescriptions worth ₩847 billion for the past 10 years. Viread, which appeared in the domestic market in 2013, led the year with a record of ₩166 billion in 2017, but fell to ₩106.8 billion last year. Since the entry into the generics market, drug prices have dropped sharply. Baraclude and Viread, along with Lipitor, dominated the prescription drug market in the 2010s, but suffered the upswing in generics after the patent expiration. During the decade of the 2010s, the top spot for prescriptions was granted to only three items: Lipitor, Baraclude, and Viread. After Lipitor took the top spot in 2010, Baraclude took the lead for five years from 2011 to 2015. In 2016, Lipitor recaptured the first place in six years, but in 2017, gave the lead. Since then, due to drug price cuts and the general offensive, Viread's prescription performance has slowed down. In 2018, Lipitor returned to the top position and remained the number one for two consecutive years until last year. AstraZeneca's hyperlipidemia treatment, Crestor recorded a total prescription amount of ₩803.3 billion over the last 10 years. Sanofi's anti-thrombotic drug Plavix has accumulated cumulative prescriptions of ₩721.9 billion since 2010. Boehringer Ingelheim's Twynstar (Telmisartan/Amlodipine) has been prescribed for ₩711.8 billion over the last 10 years. Antihypertensive drugs, Exforge & Amosartan, Norvasc, and prostatic hyperplasia treatment, Harnal have been listed in the top 10 items with the highest prescription rates in the last decade. Over the past decade, the trend in prescription drug sales has been clear. Multinational pharmaceutical companies with patent-expired drugs implemented their market defense strategy by strengthening their sales force through joint sales agreements with domestic pharmaceutical companies. Crestor's outpatient prescriptions peaked at ₩100.8 billion in 2014 from ₩66.8 billion in 2010 and then turned downward. However, the company has continued its uptrend for the second straight year, reaching ₩74.1 billion in 2018 and ₩84 billion in 2019. AstraZeneca has been co-selling Crestor with Daewoong Pharmaceutical since 2016. Last year, prescription sales for Plavix increased by 17.3% year-on-year to ₩88.9 billion. In 2013, it fell to ₩46.4 billion in 2013 from ₩95.8 billion in 2010, but recovered ₩60 billion in the following year, up 48.2% in five years. Two years after launching joint sales with Dong-wha in 2017, the prescription performance jumped 28.1%, which is considered to be an effective defense against the generic offensive. More than 100 generic products for Twynsta have been poured to the market since its patent expiration in 2013, but there has been no change in prescription performance. After peaking at ₩97.7 billion in 2016, the market faltered to ₩81.2 billion in 2017 and ₩80.3 billion in 2018, but rebounded to ₩84.7 billion last year. Twynsta is co-sold by Yuhan. (Clockwise from top left) Lipitor, Baraclude, Viread, Albis, Stillen, & Hepsera The top prescriptions in 2010 and 2019 were also changed significantly. Dong-A ST's gastritis treatment Stillen, which was ranked fourth in 2010 with a prescription amount of ₩88.3 billion, disappeared from the top of 2019. In 2011, the prescription amount of Stillen, jumped to ₩93.3 billion, but its market position has declined significantly since the emergence of generics. In 2017, the reimbursement for prevention of gastritis was deleted, and even reimbursement benefit was cut in half. Last year, outpatient prescriptions amounted to ₩9.3 billion, which was only about one tenth of 2010. Chong Kun Dang's high blood pressure treatment, Dilatrend, Pfizer's Norvasc, Daewoong's brain function improver Gliatilin, and MSD's asthma treatment, Singulair disappeared from the top of 2019. On the other hand, Daewoong Bio's brain function improver Gliatamin, Boehringer Ingelheim's Twynsta, Hanmi's Rosuzet, Eisai's brain function improver Aricept, Hanmi’s Amosartan have newly ranked at the top.Top 10 Outpatient Prescription Products in 2010 and 2019 (Unit: ₩100 million, Source: UBIST)
- Company
- JAK-inhibiting oral antirheumatic drug market getting fuller
- by Eo, Yun-Ho Feb 11, 2020 06:31am
- Orally taken antirheumatic treatment, JAK inhibitor drug market in Korea would be soon led by four competitors. According to pharmaceutical industry, the close competition between Pfizer’s Xeljanz (tofacitinib) and Lilly’s Olumiant (baricitinib) would get even intensified as Astellas Pharma’s Smyraf (peficitinib) entered the competition last month and AbbVie’s upadacitinib is awaiting Ministry of Food and Drug Safety’s nod at the moment. Janus kinase (JAK) inhibitor has gotten the industry’s attention since its release, because it was first oral therapeutic option for autoimmune disease with equivalent treatment level as anti-TNF medicine. However, its position in the market is not as influential as other biologics. While anti-TNF drug and anti-interleukin drug have consolidated their positions in the market, JAK inhibitors’ indications have been too narrow except for rheumatoid arthritis. Global Sales Volume of Anti-TNF Drugs and JAK Inhibitor Drugs (Unit: KRW 100 million) In other words, JAK inhibitor still has much more potential. The first JAK inhibitor, Xeljanz was additionally indicated for treating ulcerative colitis and psoriatic arthritis, and other following drugs have ongoing trials to expand indications treating autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylsoing spondylitis. Once Smyraf and upadacitinib enter the market, and Gilead Sciences’ filgotinib, currently under review in the U.S. and Europe, is commercialized in Korea, JAK inhibitor market with convenience of oral administration option would naturally grow. But also there is a drawback. JAK inhibitor recently had an adverse reaction issue regarding cardiovascular system safety when administering high dose. Although direct relationship of cause-and-effect has not been fully confirmed, warning has been labeled on the high-dose prescription of the three drugs. High-dose of the drugs is prescribed for rheumatoid arthritis and other major indications. JAK inhibitors block inflammatory cytokine cell’s family of Janus kinase enzymes (JAK1, JAK2, JAK3, and TYK2). Different kinds of JAK inhibitors share the same mechanism of actions but with some intricate differences. Xeljanz inhibits JAK1 and JAK3, Olumiant blocks JAK1 and JAK2, whereas Smyraf blocks JAK1, JAK2, JAK3 and TYK2. Upadacitinib and filgotinib interferes activity of JAK1.
- Company
- Pfizer recalling Lipitor and Caduet in defective packaging
- by Jung, Hye-Jin Feb 11, 2020 06:29am
- Pfizer Korea is recalling some of Lipitor and Caduet stocks, not because of the drug itself but because of defective packaging. On Feb. 6, Pfizer Korea disseminated official notice to vendors and requested them to suspend shipping of Lipitor and Caduet. The shipping is halted for Lipitor 10 mg in 90-tablet packaging with manufacturer’s serial number DA1448 (expired by Apr. 15, 2022), CY0992 (expired by Apr. 15, 2022), and DA0505 (expired by Oct. 24, 2021), and Caduet 5/ 20 mg in 30-tablet packaging with serial number CR4181 (expired by Aug. 5, 2022). Pfizer Korea explained the company has found potential risk on product quality, and said it would voluntarily recall the products. The official notice stated, “Any healthcare institute or distributor with the said packaging in the stock should suspend shipping, and return the products to supplier when the recall is initiated.” Currently, Pfizer is discussing about the recall with Ministry of Food and Drug Safety (MFDS), and is also planning to notify related vendors and healthcare institutes about the recall method as soon as possible when it is decided. Pfizer Upjohn Korea official said, “The shipping suspension has been decided, because we found some bottled products with a crack on the rim of bottle opening. However, the ratio of products with the crack among the to-be-recalled products is estimated to quite low.” The company elaborated the potential risk on patient is low, but the preemptive steps are taken voluntarily to ensure safety of the patients.” Lipitor is hypertension-treating drug with atorvastatin that made 176.2 billion won in Korea last year. Caduet is a combination drug treating hypertension and dyslipidemia with atorvastatin and amlodipine. It has raised 24.1 billion won last year from prescription.
