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- 2026-05-15 17:25:20
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- Handok has domestic copyright of Exelon & Trileptal
- by An, Kyung-Jin Nov 27, 2019 06:42am
- Exelon capsules Novartis Korea handed over copyrights of two neurology products including dementia medicine 'Exelon' to Handok pharmaceuticals. The intention is to organize copyrights for four medicines that were in charge of the department of neurology and concentrate sales marketing activities on the company's flagship products, including new products. According to the industry on Nov 26, Novartis Korea signed a domestic sales agreement for Alzheimer's dementia drug, 'Exelon' and anti-intermittent drug, 'Trepttal' with Handok pharmaceuticals. Handok will be in charge of sales activities next year, including the promotion of two products to medical staff and sales operational labor management. It is a condition that Novartis Korea continues to supply products while maintaining the license copyrights. The contract was made in accordance with the company's policy to clean up some of the drugs sold by the CNS department, including treatments for dementia, epilepsy and Parkinson's disease. The intention is to reduce the concentration of relatively unprofitable products and to focus sales marketing activities on the company's flagship products. It is said that the company will focus on promotion of SMA gene therapy drug named 'Zolgensma' and a follow-up product of Gilenia, 'ofatumumab' for relapsing multiple sclerosis. The CNS department in Novartis Korea's Specialty Pharmaceuticals Division, which was in charge of related products, was dissolved. Sales department employees in the department are in the process of transitioning to other departments. The anti-intervention drug 'Tegretol', except for two products signed by the copyright sale contract, will not be pushed forward. Novartis Korea has decided to continue supplying 'Tegretol' but will not deploy any promotion or sales marketing personnel. Parkinson's treatment drugs Stalevo and Comtan will continue to be available for the duration of the existing contract, as Novartis is not the original copyright holder, and will not renew the contract next year. An Novartis official said, “In the process of optimizing our product portfolio strategy, we decided to sell domestic sales marketing rights for some older products to Handok. It is the headquarters decision to increase the concentration of new drugs such as Zolgensma". "We're investigating departments wants to go for CNS staff and we're transitioning. Exelon and Trileptal have recorded prescription sales worth ₩10 billion as of last year. According to drug market researcher UBIST, In 2018, sales of outpatient prescriptions for `` Exelon '' and `` Trileptal '' are estimated at ₩1.7 billion and ₩8.2 billion, respectively. Both products received a six-month suspension from insurance payments for Aug 24 2017 ~ Feb 23 2018 due to illegal rebates for health care workers, which drastically reduced the size of prescriptions. In 2016, before the suspension of wages, the Exelon prescription dropped by 86.7% and 27.3%, respectively.
- Company
- Saxenda easily leads obesity market with KRW 32 bln by 3Q
- by Chon, Seung-Hyun Nov 27, 2019 06:41am
- Novo Nordisk’s Saxenda reaffirmed its unmatched leadership in obesity treatment market. Up to the third quarter this year, the treatment’s accumulated sales surpassed 30 billion won. And also Saxenda’s market share is stabilizing at over 30 percent. According to a pharmaceutical industry research firm IQVIA on Nov. 26, the overall obesity treatment market volume in the third quarter reached 35.4 billion won, about 45.4 percent increase from last year same time. In last two years, the obesity treatment market volume soared by 70 percent from 20.7 billion in the fourth quarter of 2017. Quarterly market volume trend in obesity treatment (Unit: KRW 100 million) Source: IQVIA Since its launch in Korean market, Saxenda has dominated the market and also seems to have elevated the overall market volume. In the third quarter, Saxenda made 11.9 billion won, a sevenfold growth from third quarter last year. Saxenda’s sales was more than a fivefold of Dietamins’, coming in second in the market. Saxenda generated accumulated sales amount of 32 billion won until the third quarter. Released in Korean market last year, Saxenda was the world’s first obesity treatment approved as a glucagon-like peptide 1 (GLP-1) analogue. The GLP-1 hormone is secreted by food intake and reaches activated neurons in brain to regulate appetite. Saxenda has a similar mechanism with the native GLP-1, and induces weight loss by suppressing appetite and food intake. Even before reaching the one year point, Saxenda generated 5.6 billion won in the fourth quarter last year and placed itself on the top of the market. The treatment has made at least 10 billion won each quarter this year. Saxenda and a diabetic treatment Victoza share the same active ingredient, liraglutide, but have different regimen and dosage. As Saxenda verified long-term use safety with Victoza and demonstrates similar mechanism as native hormone GLP-1, consumer’s high trust on the treatment would have affected the skyrocketing demand for it. Saxenda Saxenda’s market share in the overall obesity treatment market has shown steep increase. In the fourth quarter last year, its pie took up more than 20 percent, and in the first quarter this year, the pie expanded out to over 30 percent. By the last third quarter, the figure reached 33.7 percent. Following Saxenda’s strong lead, Daewoong Pharmaceutical’s Dietamin (2.5 billion won), Ildong Pharmaceutical’s Belviq (2.2 billion won), Huon’s Hutermine (1.6 billion won), Alvogen Korea’s Furing (1.3 billion won), and Huon’s Phendi (one billion won) have each generated over one billion won in the last quarter. However, their combined third quarter sales amount was about 8.6 billion won, far under Saxenda’s individual performance.
- Company
- Talking points on ‘Korea Passing’ in pharma industry
- by Eo, Yun-Ho Nov 27, 2019 06:36am
- The well-known expression ‘Korea Passing’, recently used to describe a phenomenon related to foreign affair discrepancies, does not mean the same in pharmaceutical industry. When it comes down to the Korean pharmaceutical industry, the expression does not indicate the U.S. and North Korea neglecting South Korea during the Korean peninsula nuclear talks. Rather, it indicates multinational pharmaceutical companies neglecting Korean market to protect certain level of pricing in other countries. This is why the South Korean health authority is offended by the industry using the expression, ‘Korea Passing’. However, there have been some clear signs of the phenomenon and a number of alarming cases has been reported. And the issue is around ‘drug’, a product that directly affects people’s health. Increasing number of ‘available but inaccessible drug’ is certainly an issue we need to be concerned of. ◆ The cause and irony of Korea Passing: ‘Drug price in Korea is low’. It’s agreeable to deduce the theory under a number of circumstances, but it cannot be defined as ‘truth’ at the moment. Despite the grievance, the industry also cannot exactly explain it. Countries around the world have different drug pricing systems according to respective calculation model. Tax, actual transaction price, retail price and many other factors play a part. As we are now in the day and age of high-cost drug, growing number of countries are adopting the dual pricing system. A research was criticized by the public because of it, as the research concluded ‘drug price in Korea is at around 45 percent of other OECD member countries’’. Of course, if a specific drug’s insurance listing in Korea has been delayed or withdrawn, then the reason is not because ‘the drug price was too high’. At least there is no doubt the drug price in Korea that more countries would refer to, is the black sheep multinational pharmaceutical companies want to keep it hidden. Multinational drug manufacturers point their fingers at Middle Eastern countries, Japan and even recently China as the biggest reason why Korea Passing is a relevant issue, because those countries take up significant pie in the overall international sales, but also refer to pricing in Korea. Then why are those countries peaking at drug pricing in Korea? It would be truer to say ‘because pricing is transparent’ instead of simply saying ‘pricing is low’. Under the single-payer health insurance system, or the National Health Insurance (NHI), Korean drug pricing system compares drug price with other alternative options, and conducts pharmacoeconomic analysis before a price for drug is set when listing the item on NHI. The system is surely convenient for other countries to use as a reference. Although the risk sharing agreement (RSA) system has been introduced, the ratio of dual pricing in Korea is comparatively lower. However, the actual volume of Korean pharmaceutical market is about 1.5 to 1.7 percent of the entire global market. Because of the transparent pricing system, multinational drug companies ironically started to neglect Korean market. And hence, the industry argues drug prices should be kepts undisclosed. In the same sense, some are demanding ratio of dual pricing should be increased with RSA subject expansion. A market access (MA) expert from a multinational pharmaceutical company stated “Each drug has different circumstances, but the Korean office is feeling the strain as increasing number of foreign countries are referring to drug pricing in Korea. Korea Passing is an issue that the Korean industry and government should talk and seek for solutions”. ◆ Not all Korea Passings are the same: Definitely, Korea should be concerned of and counteract to the Korea Passing phenomenon. But justification for each case should be thoroughly reviewed. The government cannot shrug shoulders every time when multinational companies pull out reimbursement application or give up on their reimbursement listing. For instance, Novartis’ allergic asthma treatment Xolair (omalizumab) is a typical example of Korea Passing the industry is complaining about. In December last year, Novartis pulled out Xolair from drug pricing negotiation with National Health Insurance Service (NHIS) when it was finally passed by Drug Reimbursement Evaluation Committee (DREC) under Health Insurance Review and Assessment Service (HIRA) after being approved in Korea for 11 long years. It was actually China triggering the company’s action. Right around then, China added Korea as one of external reference pricing countries. Novartis headquarters decided to avoid risk of lowering drug price in a market potentially 20 times bigger than Korean market. Some of the Korean industry people named the incident as ‘China Shock’. It wasn’t to say what was a righteous or justifiable. It was simply a good example of what the industry fears—a global company giving up on Korea for a bigger market. Within the business logic, it would be considered as a reasonable case of Korea Passing. However, another case with Mitsubishi Tanabe’s amyotrophic lateral sclerosis (ALS) treatment Radicut (edaravone) was different. The company suddenly withdrew application for refund type RSA on Radicut in last June. It was Canada this time. The refund type RSA was considered Korean industry’s solution to Korea Passing. Some are even arguing the refund type should be excluded from RSA types and shift it as a type of general insurance listing. Mitsubishi Tanabe gave up on listing the drug in Korea, because it was afraid drug price in Canada would be affected by labeled price and not by the actual transaction price. Labeled price is usually proposed by pharmaceutical company. In fact, many multinational companies have their Korean office to go through a process of conducting its own internal and external feasibility evaluation on the labeled price set with DREC, and reporting the result to the headquarters for their confirmation. During the process, the company also keeps track of drug listing schedule in other countries and the foreign country’s external reference pricing system as well. In May 2017, Canada announced it would add Korea on to their list of countries of external reference pricing, and enforced it from the beginning of this year. It was well-known news ever since the global company initiated a talk on RSA in Korea. And actually, Canada dropped Korea from its list recently. The case of Ono Pharmaceutical’s cancer immunotherapy Opdivo (nivolumab) was even worse. The item was listed as both refund and expenditure cap type RSA in August 2017, but the company technically gave up on the Korean market after the pre-negotiation on expanding reimbursed indication for lung cancer second-line therapy fell apart. The negotiation started from last year but it broke down in the first quarter of this year. The Korean health authority proposed for a renegotiation, but Ono Pharmaceutical refused. “The headquarters has made up their mind”, was their answer. A drug, listed with RSA and initially engaged in an indication expansion talk, refused to even negotiate. It was certainly not because of external reference pricing. Xolair, Raicut and Obdivo are all cases of Korea Passing. But they are all different. Xolair was a concerning case, but Radicut and Obdivo were not. They should rather be reprehended. “Without company’s will, there isn’t anything the government can do. The government is also internally reviewing various means to improve new drug accessibility. But a company unilaterally announcing withdrawal of listing and blaming everything on the government is unacceptable”, said Ministry of Health and Welfare official.
- Company
- 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.
