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- 2025-12-27 15:35:01
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- The third JAK1 inhibitor,↑competition in Korea
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- It is the third rheumatoid arthritis drugs that is expectecd to enter domestic market. According to the industry, Abbie recently filed an application for permission to use 'Upadacitinib' for JAK inhibitors. Given the approval from the FDA in US on the 16th of last month, it is rapidly knocking on the Korean market. Abbie demonstrated the efficacy and safety of 'Upadacitinib' in various patient groups through a SELECT clinical program comprising approximately 4,400 patients with rheumatoid arthritis and a total of five phase III clinical studies. In the SELECT-EARLY study of patients with no experience with MTX, 52% of the Ufadacytinib-treated group achieved ACR50 at 121th week and showed a significant improvement over 28% of the MTX-treated control group. In the SELECT-MONOTHERAPY study, which compared the administration of 'Upadacitinib' alone with MTX treatment in patients with insufficient MTX treatment, such as the approved indication, 68% of the Upadacitinib-treated group achieved ACR20 at 141th week . 41% of the improvement was proved. On the other hand, Xeljanz (Tofacitinib) and Olumiant (Baricitinib)) are approved in Korea. Olumiant, once daily, has a mechanism to block JAK1 and JAK2, and drugs such as Xeljanz, Upadacitinib, and Filgotinib, which block twice daily, block JAK1.
- Company
- Big5 hospitals adds Glead’s new HIV option Biktarvy
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- Glead’s new HIV combination drug, Biktarvy is landing its code on tertiary hospital’s prescription list. According to pharmaceutical industry source, Biktarvy has been passed by drug committee (DC) at the Big Five tertiary hospitals in Korea, including Seoul National University Hospital, Samsung Seoul Medical Center, Severance Hospital and others, after the drug passed the insurance listing in July. The main active agent of Biktarvy, bictegravir has been evaluated as a powerful second generation integrase inhibitor that displays a high resistance barrier lowering the risk of developing resistance. Tenofovir alafenamide is also a nucleoside reverse transcriptase inhibitor (NRTI) backbone that shows improved safety profile of tenofovir disoproxil fumarate (TDF). Biktarvy does not require HLA-B*5701 genetic screening and it is able to start treatment fast as it does not have restriction on patients’ viral load or CD4 count. The treatment regimen is an orally taken once-daily tablet, and a patient can take the tablet regardless of food intake. Biktarvy has high barrier to resistance, and it enhanced patient’s administration convenience presenting the smallest size of tablet among three-drug combination drug on HIV infection. Gilead confirmed Biktarvy’s safety and efficacy in four of Phase 3 clinical studies --Study 1489, Study 1490, Study 1844, and Study 1878-- on adult patients with HIV infection who had or not had antiretroviral treatment,. Professor Kim Yeon-Sook of virology department at Chungnam University Hospital explained, “The median age of HIV-infected patients who received antiretroviral treatment has reached 48. HIV infection accelerates development of renal, cardiovascular system, hepatic, bone, neurological and cancer diseases, as the therapy puts pressure on certain aging process.” “While the overall population’s number of death by cardiovascular disease has been going down, the number of death by cardiovascular disease in patients with HIV infection has gone up from seven percent to 13 percent. To reduce the risk of cardiovascular disease in HIV-infected patient, blood pressure and lipid managements are needed,” the professor added. In Study 1844 that compared 563 adult patients with HIV-1, who have undergone antiretroviral therapy for at least three months, the participants in respective arms were treated with ABC, DTG, 3TC and Biktarvy. The result found only 1 percent of 282 patients who switched to Biktarvy had virological failure at 48 weeks. The treatment arm demonstrated noninferior efficacy compared to ABC, DTG and 3TC arms (n=281), as the 94 percent of Biktarvy arm maintained virologic suppression. In both Study 1844 and Study 1878 of 48-week Phase 3 clinical trials, Biktarvy demonstrated no case of emergent drug resistance.
- Company
- Localization of Korean pharmaceuticals in Vietnam is pouring
- by Nho, Byung Chul Nov 22, 2019 06:32am
- Recently, listed pharmaceutical companies are stepping up their efforts to localize Vietnam, which has been spotlighted as a Pharmerging market. Pharmaceutical companies investing in Vietnam include Chong Kun Dang (local branch), JW Pharmaceuticals(acquired Euvipharm), Korea United Pharm. Inc. (local plant), Ctcbio (joint plant),Shin Poong Pharm. Co.,LTD.,(Shin Poong Daewoo Vietnam Pharma), Seoheung Capsules (plant / corporation). The Vietnamese market is attracting attention because of: ▲ High growth potential due to population increase ▲ Generic consumption increase ▲ Specialty drug market expansion due to the aging / chronic diseases increase ▲ High investment refund due to continuous regulatory reform and FOL reduction Can be mentioned. As of 2018, the Vietnamese pharmaceutical market is estimated at ₩7 trillion, of which imports amount to ₩3.30trillion. Other than this, ₩3,6 trillion is the local production scale. Pharmaceutical spending per person is ₩71,000 per year, and it is gradually increasing. Exports are still weak at around ₩ 120billion. By product, the ETC market is about three times larger than OTC and occupies about 75% of the total market. The major importers of pharmaceuticals are European countries such as France (11.4%), Germany (11%), Switzerland (6.7%), Italy (6.7%), UK (4.8%) and Spain (2.8%). India and Korea are representative among Asian countries In particular, Vietnam's pharmaceutical market has high growth potential, It should not be overlooked where the entry of foreign companies is very difficult. The Vietnamese government considers the distribution of medicines to be directly related to national health and national security, and sets high barriers to entry into the Vietnamese pharmaceutical market for foreign companies. In particular, foreigners are not allowed to distribute or sell medicines in Vietnam For foreign companies to distribute and sell medicines in Vietnam, it is possible only through local agents and distributors Drug categorization of bidding for supply of drugs for public health facilities The bidding policy for the supply of medicines for public medical facilities is also worth noting. Vietnam bids on threeparts about generics, originals, and oriental pharmaceuticals in the public health sector. In the case of fiercely competitive generic drugs, bidding companies are divided into 5 groups, and since 1st and 2nd groups have high standards, it is difficult for Vietnamese companies to participate, so foreign pharmaceutical companies belonging to 1st and 2nd groups are advantageous for bidding competition. .Recently, Vietnamese pharmaceutical companies are increasing their investment in technology development to prepare for the increase in imported drugs .The Vietnam market competition is expected to increase due to Vietnam's imports of medicines from the entry into force of the CPTPP and the EU-Vietnam FTA .The removal of the foreign equity cap by local pharmaceutical companies valued a good thing .Vietnam's largest pharmaceutical company DHG (DHG Pharmaceutical Company) officially announced on its website in July 2018 that it will eliminate the foreign ownership limit (FOL) and allow up to 100% .Trapaco also said it plans to eliminate the foreign ownership limit, and Domesco (DMC), the third-largest pharmaceutical company, already owns more than 50% of Chile's Abbott (US Abbott subsidiary) .One of the reasons why Vietnam's major pharmaceutical companies remove foreign ownership limit is to increase R & D investment through foreign investment and gain an edge in the fierce market competition .Vietnam's No .1 pharmaceutical market leader is DHG, with sales of ₩210 billion as of 2017 .The head office is located in Can Tho, South Vietnam .Along with domestic sales, the company exports products to 13 countries including Ukraine, Romania, Myanmar, Russia, Mongolia, Cambodia, Laos and Singapore .In addition to over-the-counter drugs, the company also produces health functional food and attracted ₩120 billion in investment from Taisho Group, Japan's top five pharmaceutical company, in April 2019 .It is also partnering with Vinamilk, Vietnam's largest dairy company, to expand health functional food .Trapaco, the No .2 company, has sales of ₩100 billion and is building a portfolio of all areas including professional, general and health functional food .Another unique feature is having three production plants that meet GMP standards Daewoong Pharmaceuticals is participating in management through equity investment, and it is believed that it is cooperating in various fields, including local production, distribution, sales, business, and bidding .Recently, Vietnam's major companies are actively investing in the retail pharmaceutical distribution market .As a result, Vietnamese pharmacies are gradually transforming into modern distribution channels .In April 2018, Vietnam's No.1 Vin Group announced its entry into the pharmaceutical industry, and in November of the same year, it launched the retail pharmacy brand 'VinFa' in Hanoi and established VinFa Drug Research and Production Center in Bac Ninh province in northern Vietnam .. Vietnam's leading electronics retailers, Mobile World and FPT Retail, also entered the pharmaceutical market through a stake acquisition. Mobile World acquired a 40% stake in Phuc An Khang, a local pharmacy chain, and FPT Retail also acquired Long Chau pharmacy chain and established FPT Long Chau Pharmaceutical JSC (FPT Pharma). Pharmacity, one of Vietnam's leading drugstores, expands its distribution network to major Vietnamese cities such as Ho Chi Minh City, Binh Duong, Can Tho and Hanoi, increasing the number of stores to 196 in June 2019, making it one of the largest pharmacy chain stores in Vietnam. Pharma City plans to increase the number of stores across Vietnam to over 1000 by 2021. Meanwhile, the number of Vietnamese pharmacies is about 57,000, most of them in small families, and the proportion of modern retail channels is only 1.5% of the total.
- Company
- Teva-Handok turns around and readies CNS for next year
- by Eo, Yun-Ho Nov 22, 2019 06:32am
- Teva-Handok is shooting for business expansion as it scores a turnaround. One of the most prominent multinational pharmaceutical companies, Israel-based Teva was the talk of the year 2013 in Korean pharmaceutical industry when it entered into a joint venture with a Korean pharmaceutical company, Handok. But, Teva-Handok’s performance was unexpectedly underwhelming, and for a while it has been operating in the red. Among all the other factors, Teva took a risk of operating new drug-centered portfolio, despite the new launch in the market takes time. In fact, 70 to 75 percent of Teva-Handok’s sales were from original items, and by 2018, it turned around as it planned with surge of sales in major new drugs, such as Parkin’s disease treatment Azilect, an opioid agonist for breakthrough pain in cancer Fentora, prolonged neutropenia treatment Lonquex, and severe asthma treatment Cinqair. ◆Teva-Handok’s successful turnaround: Teva-Handok, based on the successful turnaround, is currently operating four business sectors consisting of central nervous system (CNS), anticancer, primary care and respiratory. Above all, CNS disease treatments have been the star of the company leveraging Teva-Handok’s notable growth. Besides multiple sclerosis treatment Copaxone and Parkinson’s disease treatment Azilect, narcolepsy treatment Nuvigil launched September last year propelled the company’s expansion. Nuvigil, a new comer in the Korean narcolepsy treatment market after 15 years, is made of armodafinil, an R-enantiomer of modafinil. It shares same administration with modafinil, but armodafinil’s effect lasts longer. As narcolepsy’s major symptom is excessive daytime sleepiness, prolonged duration of effect could be a deciding factor for patients, who need to be active during the day. Launched in September last year, Nuvigil landed code-in deals at major tertiary hospitals and heightened expectation for next year’s sales growth. ◆ Future plan to reinforce CNS pipelines: Teva-Handok’s CNS portfolio build up plan for next year is to maintain the existing product’s stabilized position in respective markets, and also to rapidly grow new drugs after their launch in Korea next year. The new emerging stars are Huntington’s disease and tardive dyskinesia treatment deutetrabenazine (Austedo, trade name in the U.S.), and new migraine preventive drug, fremanezumab (Ajovy, trade name in the U.S. and EU). Duetetrabenazine, developed by Teva, is a new treatment option approved by the U.S. Food and Drug Administration (FDA) for chorea in Huntington’s disease patients or antipsychotic-induced tardive dyskinesia patients, who did not have a proper treatment option to date. Teva-Handok is currently busy preparing for duetetrabenazine’s release in Korea as Korean Ministry of Food and Drug Safety (MFDS) designated the medicine as an orphan drug for chorea in Huntington’s disease in last May. Fremanezumab is a new migraine-prevention medicine in recently emerging anti-CGRP class. Within the same class, the new medicine is the only option to provide quarterly or monthly choice of administration. So the company is expected to emphasize the administration convenience when promoting the follow-on drug in migraine treatment market for adults in Korea. “Teva-Handok’s mission is to provide as much benefit as possible to many more patients. Instead of strategically segregating new drug and generic lineup, the company stuck to a pipeline portfolio building to target patient’s unmet needs, and also steadily generated expected level of performance. And next year, in particular, the company’s distinctive pipeline in CNS sector would generate even more remarkable results”, the company official stated.
- Company
- AstraZeneca takes back local sales from GC and Daewoong
- by Eo, Yun-Ho Nov 21, 2019 11:40pm
- AstraZeneca is taking back some local sales rights from GC Pharma and Daewoong Pharmaceutical. According to pharmaceutical industry source on Nov. 1, AstraZeneca Korea has recently decided to retrieve local sales and distribution rights of a high blood pressure treatment, Atacand (candesartan) from GC Pharma, and of chronic obstructive pulmonary disease (COPD) treatment, Eklira (aclidinium) and Duaklir (formoterol and aclidinium) from Daewoong Pharmaceutical. So from next year at latest, AstraZeneca would directly operate marketing and sales of the three items in Korea. Cardiovascular, Renal and Metabolism (CVRM) Department, currently responsible for antidiabetic treatment Farxiga (dapagliflozin), would probably take in Atacand, and Respiratory Department with Daxas (roflumilast) and Symbicort (budesonide and formoterol) would absorb Eklira and Duaklir back. The two types of medicines are under different circumstances. Atacand, under angiotensin receptor blockers (ARBs) class, has an expired patent, but it sold around 25 billion won as outpatient prescription drug last year. AstraZeneca had a joint local sales and distribution deal with GC Pharma since 2011. Eklira and Duaklir’s actual sales figures are not too significant. But retrieving those back would reinforce single-component long-acting muscarinic antagonists (LAMA) and long-acting beta-agonist (LABA) and LAMA combination pipelines at AstraZeneca’s Respiratory Department. The two COPD medicines entered the Korean market as Daewoong Pharmaceutical signed a local sales deal with Spain-based pharmaceutical company, Almirall, in 2004. But AstraZeneca now owns the medicine as it acquired the respiratory pipeline later. Meanwhile, domestic sales contract on Farxiga and a hyperlipidemia treatment, Crestor (rosuvastatin), with Daewoong Pharmaceutical would be maintained as they are.
- Company
- Oral GLP-1 competitiveness depends on price and convenience
- by Nho, Byung Chul Nov 20, 2019 11:50pm
- Although an oral GLP-1 drug, Rybelsus has attracted heightened attention from its market since its recent approval by the U.S. Food and Drug Administration (FDA), it faces some barriers to overcome like inconvenient high-dose regimen and expensive price. Reportedly, once-daily Rybelsus’ effect of glucose control and weight loss is not as effective as once-weekly injection, despite the oral drug’s dosage is hundred times higher than the injection. And also the drug’s price is expected to be higher than other existing oral drugs. Well aware of the concerns, Novo Nordisk (“Novo”) official spoke at a recently held third quarter 2019 earnings presentation and explained that competitors of Rybelsus would not be an once-weekly injection, but other existing oral antidiabetic treatments and Novo’s own once-daily injection, Victoza. Rybelsus is an oral version of Novo’s once-weekly GLP-1 injection, Ozempic, and 7mg and 14mg doses of Rybelsus were approved by FDA in last September for type 2 diabetic patients, who needs to control glucose level with drug as they cannot self-control it by diet or exercise. The biggest risk factor of Rybelsus is in effectiveness. Rybelsus’ glycated hemoglobin reduction rate, which measures treatment effect on diabetic patients, demonstrated similar level of effectiveness as Novo’s own once-daily injection, Victoza. However, the rate was less promising than Novo’s other once-weekly antidiabetic injection Ozempic. According to Novo’s clinical data, taking 14mg of Rybelsus daily for 52 weeks would reduce 1.3 percent of hemoglobin level, whereas 26 weeks of taking 1.8mg of Victoza daily reduces 1.3 percent, and 40 weeks of 1mg of Ozempic weekly reduces 1.8 percent. Treatments in GLP-1 class take a certain period of time to find patient’s adequate dose to minimize the treatment’s well-known adverse reaction, gastrointestinal side effects. For Rybelsus, it takes about eight weeks. Other injectable Saxenda by Novo, Trulicity by Eli Lilly, and efpeglenatide by Sanofi take about four weeks or less. Unlike the Korean market, market expectation on Rybelsus is also lowered by diabetic patients in the U.S. and other European countries not minding so much of pen-type injection device. Clinical trial on single-dose prefilled pen-type injection conducted by Eli Lilly found 99 percent of subject patients completed administration for the target period of four weeks, and 97 percent of them were positive about continuous use of the treatment type. Moreover, Rybelsus’ 14mg high-dose daily regimen is another issue the treatment faces, because such high dosage could lead patient’s pharmaceutical expense to rise. In fact, Rybelsus’ injectable version, Ozempic’s treatment dosage is 1mg per week, but patients taking Rybelsus has to take 98mg (14mg per day) a week of the exact same substance, which is close to a hundredfold of Ozempic. The industry accordingly expects the extensively higher dosage of the drug would inevitably increase patient’s drug expense. “Rybelsus is ‘just another option of oral antidiabetic treatments’ and it is expected to take its unique place in the market. But it has some problems to overcome, compared to an existing once-weekly injection. Rybelsus’ competitors would likely to be other options of oral antidiabetic treatments or once-daily injection like Victoza. Whichever product demonstrates the most outstanding effect, benefit, convenience and safety among once-weekly injections would lead the market, eventually,” a pharmaceutical industry insider commented.
- Company
- JW Pharmaceutical’s R&D generates fruitful return
- by Chon, Seung-Hyun Nov 20, 2019 06:14pm
- For this year’s third quarter, JW Pharmaceutical recognized total 6.6 billion won made from exporting drug candidate technology. The amount includes upfront fees received from technology transfer deal from last year over atopic dermatitis drug candidate, and from technology export deal on anti-gout drug candidate made last September. The industry evaluates it was fruitful return from R&D investment. JW Pharmaceutical reported on Nov. 19 that the company’s accumulated profit from technology export payment in the third quarter reached 6.6 billion won. The figure reflects upfront payment from two technology transfer deals signed last year and this year. In August last year, JW Pharmaceutical shook hands with Demark-based multinational pharmaceutical company, Leo Pharma agreeing to export atopic dermatitis pipeline, 'JW1601'. Including USD 17 million upfront payment, the deal is worth total 402 million dollars. And in August, the company made a deal with China-based Simcere Pharmaceutical for exporting an anti-gout drug candidate 'URC102'. The deal is worth 70 million dollars, including five-million-dollar upfront payment. But it is quite different as to how these two deals were reflected on the account. The upfront fee on JW1601, 17 million dollars (about 19 billion won), was received September last year. But JW Pharmaceutical decided to recognize 17 billion won at once in August last year, and recognize the rest of 1.3 billion won in 20-month installment from August last year to March next year. So payment of 66.41 million won would be reflected on the account every month until March next year. And up to September this year, payment of about 600 million won (66.41 million won reflected for nine months) was recognized. On the other hand, payment from URC102 deal was recognized all at once. The payment of six billion won was reflected on the third quarter account. However, the actual payment was not transferred in the third quarter. JW Pharmaceutical clarified on the quarterly report that “The payment is to be received in November”. The company, in fact, stated early this month that it has received the payment. A JW Pharmaceutical insider commented, “The payment from the August deal was reflected on the third quarter account as the agreement was finalized then”. Reflecting payments from the two drug candidate technology deals, JW Pharmaceutical has made total of 6.6 billion won profit in the third quarter. The profit from the deals actually helped the company’s overall performance. JW Pharmaceutical generated operating profit of 2.6 billion won in the third quarter, which means it would have made deficit if the technology transfer deal was not reflected. The company may have risked overall earnings with increased R&D expense, but R&D performance is also contributing back to the company’s earnings. JW Pharmaceutical’s earnings were recently worsened due to increased R&D expense. The accumulated R&D expense up to the third quarter was 29.7 billion won, surged by 23.5 percent than the same time year before. The company insider commented, “R&D investment amount was significantly increased recently, as clinical trials for the exported drug candidates have initiated”. The industry sees that the company is well on its way to create a positive cycle of dedicated R&D effort contributing back to the company’s return. Also in last year, JW Pharmaceutical received payment of 4.8 billion won for exporting total parenteral nutrition (TPN) product. JW Holdings signed a licensing-out and export contract with Baxter in July 2013, granting the multinational company rights to supply the TPN product, Winuf to the U.S., Europe and all around the world. The contract is worth total of 35 million dollars, including 25-million-dollar upfront payment and ten-million-dollar milestone payment. With European health regulator giving a green light on Finomel (Winuf’s brand name in Europe), JW Holdings received promised milestone payment of four million dollars last year. The rest of milestone payment, six million dollars is expected to be paid out when the product gets approved in other regions.
- Company
- Boycott against Japan makes no impact on drug sector
- by Kim, Jin-Gu Nov 20, 2019 06:33am
- Although this year’s deficit generated from trade with Japan is expected to hit the lowest point, the pharmaceutical sector has not been affected on a notable level. For last six years, Japanese drug import volume skyrocketed by around 57 percent. The import volume easily overwhelmed the Korean export volume, resulting in inevitable heavy deficit. In general, Korean boycott movement against Japanese goods, started spreading since June, seems not to have affected Japanese drug as much. According to Ministry of Trade, Industry and Energy (MOTIE) and Korea Customs Service (KCS) on Nov. 18, South Korea’s total trade deficit with Japan from January to October this year was USD 16.37 billion, which has gone down by 20.6 percent than same time last year at 20.61 billion dollars. As far as total deficit made from January to October goes, this year’s deficit has been the least ever since 2003 with 15.57 billion dollars. If the trend continues until the end of the year, Korea’s total deficit with Japan would be under 20 billion dollars for the first time in 16 years. It would be about the half of highest volume marked in 2010 at 36.12 billion dollars. However, the pharmaceutical sector seems to be an exception to the trend. Until last October, Korea marked trade deficit with Japanese pharmaceutical products of 132.3 million dollars. Deficit from January to October has hit the lowest figure since three years ago in 2016 (deficit of 120.63 million dollars). But considering average deficit in five years from 2014 to 2018 (accumulated from January to October) was around 95.71 million dollars, this year’s improvement on deficit is hardly remarkable. In the same time, Korea’s export volume to Japan has surged by 51.6 percent from 127.69 million dollars to 197.83 million dollars, but the import volume also surged by 56.6 percent from 185 million dollars to 330.13 million dollars. The increase in import rose over the increase in export, generating the total net deficit as a result. Jan. to Oct. drug trade trend by year (unit: USD 1,000). Red shows this year’s trade volume. Figure improved the most since last 3 years (2017-2019) but still deficit reached higher than before. Even when the boycott movement took off July, the changes of pharmaceutical import and export volume by month did not leave a notable change in trend. As for July, Korea made a deficit of 22.19 million dollars. The country exported 23.97 million dollars of pharmaceutical products and imported 46.16 million dollar-worth of goods. July had the heaviest deficit of the year. The deficit was lowered to 5.56 million dollars in August, but it is getting larger again after generating 10.11 million dollars and 14.57 million dollars of deficit in September and October, respectively. Analyzing last three years of monthly trade deficit, the boycott movement did not make a clear mark on the graph. The result is quite contrasting from major consumer goods, such as automobile, apparel, alcohol beverages and electronics that got struck by the boycott against Japanese goods. Drug trade volume trend by month in last 3 years (unit: USD 1,000) Red shows trade volume in July-Oct. after boycott, but no special tendency found
- Company
- Ferinject for bloodless surgery, reimbursement started up
- by Nho, Byung Chul Nov 20, 2019 06:19am
- It is noted whether high dose iron injection, Ferinject may be included as insurance reimbursement for bloodless surgery (Minimal Transfusion). According to the industry, JW Pharmaceutical applied for a non-reimbursement item, Ferinject, to HIRA on the 18th. High-dose iron is effective as a transfusion replacement therapy for surgical patients who need to increase hemoglobin levels in a short time, and for mothers who have bleeding from childbirth. Introduced by Swiss company, Vifor in 2011, JW Pharmaceutical is currently generating sales of about ₩10 billion. This product is a 500mg high iron injection that can be replenished quickly by administering up to 1000mg of iron per day for 15 minutes. Conventional intravenous iron injections are difficult to administer high doses, so many visits are needed to the hospital. It took more than 40 minutes in a single dose, but Ferinject can be administered up to 5 times faster (in 3 to 5 minutes). Clinical data shows that Ferinject 500mg high-injection iron injection has the same effect as 2 packs of blood 420ml. In addition, it has been evaluated as a safe iron with reduced side effects and vascular pain compared to conventional intravenous iron injection. Ferinject is an effective iron deficiency treatment that can improve the side effects of oral iron containing products with high absorption rate and stability of 99%, and can be administered faster than the existing intravenous iron products. It elevates patient compliance and reduces overload of nurse and hospital work. It is also a safe, high-dose iron infusion that can be used for patients 14 years of age and older, demonstrating safety in pregnant women. Therefore, iron, which is lacking in blood with minimal blood transfusion to surgery patients or anemia patients, has recently emerged as a minimal transfusion treatment supplemented with iron injections, which will greatly contribute to improving the quality of life of patients. High-capacity iron injections are priced at ₩150,000 ~ 200,000 per 500mg of 1 ampule. The reimbursement price is expected to be around ₩70,000 ~ 90,000. The single daily dose is 1000 mg and the maximum maximum dose is 1000 mg or 20 mg / kg. It is contraindicated as follows. Patients with hypersensitivity to Ferinject or its components, patients with known significant hypersensitivity to other parenteral iron preparations, patients with anemia other than iron deficiency (microcytic anaemia), iron overdose or iron impairment. or patients with bacteraemia should be avoided. Adverse events (1% to 10%) are usually headache, dizziness, high blood pressure, nausea, injection site reactions, increased ALT, and hypophosphatemia.
- Company
- Power of Innovative Drugs, Keytruda & Spinraza Shake Market
- by Chon, Seung-Hyun Nov 19, 2019 06:34am
- New products, which are regarded as innovative new drugs in the domestic pharmaceutical market, are shaking the upper hand. Keytruda, an immunocancer drug, spearheaded Lipitor to the chin with a steep rise. Rare disorder treatment “Spinraza” presented a remarkable quarterly sales of ₩20 billion immediately after applying for health insurance reimbursement. According to IQVIA,the health information technology and clinical research on the 18th, Pfizer's Lipitor, medicine that lowers cholesterol in the blood, posted the highest sales of ₩36.3 billion in the third quarter. It rose 5.5% over the same period in the previous year. Lipitor, which was released in Korea in 1999, is still well despite the entry of more than 100 generic products after the patent expiration in 2009. Top 10 sales medications in third quaeters 2019 (Unit: KRW million, %, Source: IQVIA) Keytruda's propaganda was noticeable. Keytruda's the third-quarter sales grew 78.9% over the same period in the previous year to ₩33 billion ranking second after Lipitor. The company's quarterly sales gap with Lipitor is narrowed to ₩3.3 billion threatening its lead. Keytruda binds to the PD-1 receptor, blocking both immune-suppressing ligands, PD‑L1 and PD‑L2, from interacting with PD-1 to help restore T-cell response and immune response. When functioning properly, T cells are activated and can attack tumor cells. Since August 2017, insurance reimbursement has been applied as a secondary treatment for non-small cell lung cancer. Quarterly sales of Keytruda jumped from ₩4.9 billion in the fourth quarter of 2017 to ₩13.6 billion in the first quarter of 2018. Keytruda exceeded sales of ₩ 20billion in the fourth quarter of last year and has recorded sales of ₩30 billion since the second quarter of this year. Keytruda has booked a record-breaking ₩100 billion in sales in the third quarter of this year. It also attempt to get top position of Lipitor. The sales gap between Lipitor and Kitruda is ₩19 billion based on cumulative sales in third quarter Quarterly Sales Revenue by Quarter (Unit: KRW million, Source: IQVIA) Biogen's Spinraza made a surprise blast with sales of ₩20.4 billion in the third quarter. The company did not generate sales until the second quarter, but sold more than ₩20 billion at a stretch. Spinraza is a rare disease treatment that treats hereditary diseases of the neuromuscular system, in which the muscles are contracted by damage to the spinal cord and brain stem motor neurons, called spinal muscular atrophy (SMA). Cognitive function is normal, but muscle tension is poor, tongue muscle contractions, such as normal life is difficult. Spinraza, which was approved in Korea in December 2017, was listed on the health insurance list at the maximum price of ₩92.3 million in one bottle (5ml) in April after drug pricing negotiating with National Health Insurance Service. Spinraza does not have a large number of patients and must undergo a rigorous procedure that requires prior review before administration. However, due to the high price, it made ₩20 billion in sales. Roche's anti-cancer drug 'Avastin' was ranked 3rd overall with sales of ₩30.7 billion, up 18.1% from the previous year. Avastin, which is used for metastatic colorectal cancer, metastatic breast cancer, and non-small cell lung cancer, surpassed the annual sales of ₩100 billion for the first time since its domestic approval last year. Cumulative sales for the third quarter of this year stood at ₩89.2 billion, which is likely to exceed ₩100 billion for two consecutive years. Abbvie's autoimmune disease treatment product, Humira, recorded ₩24.4 billion in sales in the third quarter up 12.4% from the previous year. Humira is a TNF-alpha inhibitor that inhibits the expression of tumor necrosis factor (TNF-α). and continues to rise due to the merits which has the most indications among the TNF-alpha inhibitors. Humira's 3rd quarter cumulative sales increased 15.1% year-on-year to ₩71.3billion. AstraZeneca's anti-cancer drug Tagrisso jumped to fifth place in the third quarter with sales of ₩21.1 billion. The growth rate was 42.0% year-on-year. Tagrisso is a second-line treatment prescribed for patients with non-small cell lung cancer (NSCLC) who developed resistance after conventional EGFR tyrosine kinase (TKI), such as Iressa, Tarceva, and Gilotrif. It is called a third generation drug because it overcomes the resistance of the existing EGFR-TKI. Tagrisso, which was launched in December 2017, received nearly ₩60 billion in sales last year, making it the leading EGFR anticancer drug. Revenue continued to rise after exceeding ₩20 billion in the previous second quarter. Gilead's hepatitis B treatment, Viread, which was once the leader in overall sales, recorded only ₩20.7 billion in the third quarters sales, down 29.3% from the previous year. After patent expiration, market share dropped sharply due to drug price cuts and generic emergence.
