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- 2025-12-27 05:14:55
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- Yuhan, sell anticancer drug 'Glivec' with Novartis
- by Chon, Seung-Hyun May 20, 2020 06:11am
- Yuhan jointly sells anti-cancer drug 'Glivec' with Novartis. While Glivec's patent expired seven years ago, its growth slowed, but it intends to secure stable sales and overcome its recent sluggish earnings. On the 19th, Yuhan announced that it had signed a domestic exclusive sales and joint promotion agreement for Glivec with Novartis. Glivec is an anticancer drug used to treat chronic myelogenous leukemia and gastrointestinal stromal tumors. Yuhan is responsible for joint sales of Glivec with Novartis under this agreement. Glivec had annual sales of ₩80 billion. However, since generics entered after patent expiration in 2013, sales have been somewhat reduced. Glivec Sales Trend by Year (Unit: ₩100 million, Source: IQVIA) According to drug research firm IQVIA, Glivec's sales last year recorded ₩46.9 billion. It has consistently generated sales of ₩40 billion, including ₩43.3 billion in 2015, ₩45.8 billion in 2016, ₩45.9 billion in 2017, and ₩43.3 billion in 2018. Currently, six companies including Hanmi, Chong Kun Dang, Boryung, and Dong-A ST are selling Glivec's generics. Yuhan is expected to benefit from Glivec's domestic copyright. Yuhan has recently performed poorly in the prescription market. Sales amount in the first quarter were ₩303.3 billion, down 11.3% from the previous year. The prescription drug division, which accounts for more than 60% of total sales, is showing a severe slump. In the first quarter, Yuhan's prescription drug sales fell 13.3% YoY to ₩193.7 billion. Compared to the previous quarter (₩255.3 billion), prescription drug sales fell 24.1%. It means that about a quarter of sales of prescription drugs disappeared in three months. As sales of Glivec amounted to about ₩50 billion a year, Yuhan could overcome the sluggish prescription drug sales. It is also evaluated that the sales of Glivec also provided an opportunity to accumulate anti-cancer drug sales know-how. Yuhan has some anticancer drugs, but has no experience in handling anticancer drugs with a large sales volume. Yuhan is conducting a clinical trial for commercialization of 'Lazertinib', an anticancer drug that has been transferred to Janssen. The company expects that after Yuhan boosts its anticancer drug sales capabilities, it will be able to create synergies if Lazertinib gets domestic approval.
- Company
- Daewon launches bone forming biosimilar Terrosa
- by Nho, Byung Chul May 20, 2020 06:11am
- On May 18, Daewon Pharmaceutical (CEO Baek Seung Ryel) announced the launch of a biosimilar treating patients with osteoporosis, Terrosa cartridge injection,. Richter-Helm BioTec, a joint venture between a German-based company Helm and a Hungarian-based company Gedeon Richter, has developed biosimilar Terrosa with an active ingredient teriparatide. Eli Lilly’s Forsteo (U.S. brand name Forteo) is the originator of the product. A recombinant human parathyroid hormone (PTH) drug, Terrosa is indicated to treat both postmenopausal women and men with osteoporosis in high risk of fracture. By increasing the number of osteoblasts in bones, the biosimilar forms bones and demonstrates outstanding effect of reducing risk in osteoporotic fracture. Phase 1 and 3 clinical studies conducted in Europe and Japan have confirmed the drug’s significant effect of increasing bone mineral density in lumbar, femoral neck and total hip. As a bone builder, the drug has effect of increasing bone mass superior than other bone absorption inhibitors and it received four years of post-marketing survey period after being listed as a bioequivalent biologic confirmed via bioequivalence test. The self-injected once-daily injection pen can be reused with replaceable cartridge. The sturdy aluminum body of the injection pen is intricately designed to protect the product from external damage. Daewon Pharmaceutical official stated, “Terrosa is a meaningful addition to Daewon Pharmaceutical’s line up not only as the company’s first bio drug, but also as the first teriparatide biosimilar to be released in the Korean market,” and “besides confirmed efficacy and safety, the biosimilar is expected to lessen the financial burden on patients with its competitive pricing.” With the approximate patient size of one million in Korea only, the osteoporosis treatment market in Korea is projected to be worth around 200 billion won and specifically the injectable market is worth about 70 billion won.
- Company
- Samsung Bioepis' SB11 has equivalence with Lucentis
- by Lee, Seok-Jun May 20, 2020 06:10am
- SB11 (Ranibizumab), Lucentis' Biosimilar by Samsung Bioepis has demonstrated equivalence with the original. This is a global phase III for 705 people. SB11 is Samsung Bioepis' first ophthalmic disease treatment. It is also the sixth antibody biosimilar following three autoimmune disease treatments (SB2, SB4, and SB5) and two tumor disease treatments (SB3, SB8). 'Lucentis', original for SB11 is a treatment for macular degeneration and diabetic macular edema developed by Genentech. Currently, multinational pharmaceutical companies Roche and Novartis are selling it, and last year they made a global sales of about ₩4.6 trillion. Samsung Bioepis conducted a comparative study of clinical efficacy between SB11 and Lucentis in clinical trials for a total of 705 neovascular age-related macular degeneration (nAMD) patients from March 2018 to December 2019. The primary efficacy evaluation index (primary endpoint) was set in two ways to determine whether the previously established equivalence margin was met. After the prescription, the maximum corrected visual acuity (BCVA) improvement value was measured for 8 weeks, and then the 90% confidence interval (CI) was checked. In addition, 95% confidence intervals were observed after 4 weeks of macular center thickness (CST) measurements. According to the study results, the BCVA Least Squares mean improved by 6.2 characters in SB11 and the original 7.0 characters. The 90% confidence interval interval (-1.827 ~ 0.219) of the mutual difference (-0.8) met the pre-established range of equivalence (± 3). The least square mean of the 4 week CST change was observed to be SB11 -108.4 micrometers (μm) and the original -100.1 micrometers. The 95% confidence interval interval (-19.446 ~ 2.747) of the inter-difference (-8.3) was included in the pre-established range of equivalence (± 36). Samsung Bioepis plans to start the product licensing phase by applying for sales authorization of SB11 in the US and Europe as early as this year. Samsung Bioepis is expanding the field of biopharmaceutical development with ophthalmic diseases, rare diseases, etc. along with existing autoimmune and oncology treatments based on its product portfolio expansion strategy. In addition to SB11, SB15 (Eylea’s Biosimilar, Aflibercept) is also being developed.
- Company
- Bispecific antibody by Yuhan & ABL BIO debuts at the AACR 20
- by An, Kyung-Jin May 19, 2020 06:06am
- YH32367/ABL-105, which Yuhan & ABL Bio are jointly developing, debuts on the international stage. Yuhan announced on the 15th that it will announce the results of the preclinical efficacy test of the bispecific antibodies for cancer immunotherapy 'YH32367 (ABL-105)' at the American Association of Cancer Research's 2nd online academic conference (AACR 2020). YH32367 / ABL-105 is a Pipeline drug under joint research by Yuhan & ABL Bio. By specifically binding to tumor cells and stimulating T-immune cell activation receptor 4-1BB, it increases the anticancer activity of immune cells and suppresses the growth of tumor cells. In September 2018, Yuhan Corporation secured global rights for two bispecific antibodies for cancer immunotherapy under preclinical stage through a contract with ABS Bio. The contract amount without obligation to return is ₩200 million, and the total contract size combined with milestones is up to ₩59 billion. This was achieved in one year and eight months of technology introduction. According to the abstract published on the 15th (local time) AACR website, YH32367 increased apoptosis cytokine secretion such as interferon gamma (IFN-γ) in human T-immune cells and induced tumor cell death. Animal experiments using humanized mice and human 4-1BB-expressing mice also showed superior anticancer efficacy compared to the control group. In particular, it explained that safety has been proven without identifying side effects of hepatotoxicity, which is one of the disadvantages of competitive drugs. Yuhan expects YH32367 to be effective against patients with resistance to existing anticancer drugs among a number of solid cancers such as breast cancer, stomach cancer, and lung cancer. The goal is to complete pre-clinical toxicity studies next year and start clinical trials.
- Company
- Will Hanmi also target Stivarga's patent?
- by Kim, Jin-Gu May 19, 2020 06:06am
- Hanmi's generic launch of Nexavar (Sorafenib) is imminent. Hanmi is considering internally reviewing a plan to target the patent of 'Stivarga (Legorafenib)', a secondary target treatment for liver cancer. If Hanmi succeeds in overcoming patents to Nexavar and Stivarga, it is expected that a lineup of targeted treatments for liver cancer will be established. According to the pharmaceutical industry on the 14th, Hanmi recently submitted an application of generic for Nexevar to the MFDS. Unless there is a special variable, the approval of an item for “Hanmisorafenib (tentative name)” is expected to be made soon. It is confirmed that Hanmi is already in the process of planning for the next step as the launch of Generic for Nexavar is imminent. Hanmi intends to target the patent of Stivarga, following to Nexava. Stivarga is a targeted anticancer drug that can be used as a secondary treatment for patients who fail to treat Nexavar. Bayer has a patent right. An official from Hanmi said in a call with Dailypharm, "With the imminent approval of generic for Nexavar, we are considering a new way to re-challenge the patent in the next step." In fact, Hanmi had previously tried the patents. However, the results were not good. It ended in defeat or self-dismissal. In April 2015, Hanmi, together with Huons, Yuhan, and Chong Kun Dang, requested invalidated trials for Stivarga's material patent (expired in March 2025), formulation patent (expired in August 2025), and hydrate patent (expired in September 2027). In June 2017, the Patent Tribunal sided with the original company on a trial of “partial dismissal” against the invalidation trial for a formulation patent. Subsequently, in August, domestic companies voluntarily canceled the trial for invalidating a patent. Although domestic companies seemed to have failed to acquire Stivarga's patent, Boryung requested a judgment to confirm the scope of passive rights alone in the hydrate patent. In the end, after two years of fighting, Boryung succeeded in pursuing patents in April 2019, leading to a trial. The decision was confirmed in May of the same year. Hanmi's strategy is no different from Boryung. It intends to re-challenge by raising a judgment on the passive scope of rights to Stivarga's hydrate patent. If Hanmi targets patents following Nexavar and Stivarga, it is expected to generate considerable synergy in that it will have both generics of primary targeted treatments for liver cancer. The original company, Bayer, also has the advantage of being able to perform continuous treatment and has an advantage over Lenvima. According to drug research agency IQVIA, sales of each drug amounted to ₩25.4 billion in Nexavar and 23.6 billion in Stivarga as of last year.
- Company
- Pfizer launches Vyndaqel followed by Vyndamax in Korea
- by Eo, Yun-Ho May 18, 2020 06:16am
- Pfizer is expecting to introduce 'Vyndamax' following 'Vyndaqel'. According to the related industry, Pfizer is in the process of approving for Vyndamax (Tafamidis meglumine) by the MFDS, a treatment for cardiomyopathy caused by hereditary transthyretin amyloid polyneuropathy (hATTR-PN) and transthyretin mediated amyloidosis (ATTR-CM). It is expected in the second half of the year. Vyndaqel (Tafamidis meglumine) and Vyndamax have the same active ingredients but differ in indication and dosage. In the case of Vyndaqel, it was already approved in Korea in 2015, and it is currently undergoing an expanded indication for cardiomyopathy indications by ATTR-CM. Both drugs added an indication for cardiomyopathy caused by ATTR-CM following hATTR-PN from the US FDA last year. The efficacy of ATTR-CM has been demonstrated in a phase III study. The primary endpoint of the study was a comprehensive assessment of mortality for all causes and frequency of hospitalization for cardiovascular disease, and the secondary endpoint was a Kansas City survey of 6-minute walking distance tests and quality of life for patients with heart failure. As a result of the study, the two drugs showed statistically significant results in both the mortality rate according to all causes and the hospitalization period due to heart disease compared to the placebo. On the other hand, hATTR-PN is a genetic disease, whereas ATTR-CM is not the only cause. There is a non-genetic factor, and it is more common in men than in women as age increases. The incidence of non-genotype hATTR-CM is higher than that of PN. It is estimated that there are more patients in the world.
- Company
- Hanmi on legal action against Sanofi returning efpeglenatide
- by Chon, Seung-Hyun May 18, 2020 06:14am
- A multinational pharmaceutical company Sanofi has decided to return the rights on antidiabetic candidate medicine efpeglenatide back to Hanmi Pharmaceutical. Apparently, the French-based company is putting an abrupt brake on the development of efpeglenatide, licensed out as the biggest Korean-developed pipeline in 2015. Hanmi Pharmaceutical explains “The decision was solely made by Sanofi with their shift in business plan,” and stated it would review taking a legal response. A view over Hanmi Pharmaceutical headquarters On May 14, Hanmi Pharmaceutical released news that Sanofi has notified the intention to return the licensed out efpeglenatide, currently undergoing a series of phase 3 clinical trials. According to the contract terms, the two companies are to finalize the decision on the retuning of the rights after 120 days of negotiation. Even if the French company returns the right, the Korean company is not subjected to return EUR 200 million (approximately 260 billion won) already received from the partner company. Hanmi Pharmaceutical official elaborated, “We have decided to negotiate with Sanofi to complete the ongoing phase 3 global study on efpeglenatide as it is close to the end,” and said the company “plans to seek for a new global partner company.” A glucagon-like peptide-1 (GLP-1) receptor agonist, efpeglenatide is an innovative bio drug candidate to treat patients with diabetes by administering the drug once-weekly or once-monthly at most. The candidate drug is based on Hanmi Pharmaceutical’s core platform technology ‘Labscovery,’ which prolongs the short half-life period of biologics and reduces administration frequency and dose to lessen the adverse reaction and improve effect. In November 2015, Hanmi Pharmaceutical and Sanofi had signed a license-out deal valued at 390 million euros on the Quantum Project (efpeglenatide, long-acting insulin, efpeglenatide plus long-acting insulin combination). Although the contract terms have been revised twice since then, the deal is still the biggest license out deal a Korean pharmaceutical company holds to the date. Hanmi Pharmaceutical claims Sanofi’s decision to return their rights over efpeglenatide were unreasonable, because the global company is dropping the already agreed upon phase 3 clinical study. Intending to take a legal action, Hanmi Pharmaceutical official said, “Sanofi’s decision was made without discussing with Hanmi Pharmaceutical.” After a new CEO took over the office in last September, Sanofi has unveiled a widely reformed R&D plan to halt diabetes and cardiovascular related research but to strategically concentrate on four main sectors including oncology, hematology, rare disease and neurology. When the announcement was made, Sanofi officially noted the multinational company would give up the rights to commercialize and distribute the antidiabetic pipeline efpeglenatide and search for a new partner, however, the ongoing phase 3 clinical trials would be completed with the company. At the moment, Sanofi is conducting five global phase 3 clinical trials related to efpeglenatide. Hanmi Pharmaceutical stressed Sanofi giving up on the efpeglenatide rights is unrelated to the medicine’s efficacy and safety. Hanmi Pharmaceutical official stated, “As Sanofi has publicly promised affected patients, investigators and Hanmi Pharmaceutical that the global phase 3 clinical trials would be fully conducted, we would demand Sanofi to keep their word,” and “Further legal actions pursuing litigation would be reviewed, if need be.” The Korean company official stressed, “Efpeglenatide is a promising pipeline, as the global GLP-1 receptor agonist market would be worth approximately USD 10 billion by the time the candidate medicine is commercialized,” and “the biologic would be able to find a new global partner at around the end of the year or the beginning of next year, when the outcomes of the superiority trial against efpeglenatide’s competitor Trulicity would be released.”
- Company
- Pharmaceutical industry focuses on Spread of COVID-19 again
- by An, Kyung-Jin May 15, 2020 06:05am
- Pharmaceutical companies are also nervous again as the spread of COVID-19 from Itaewon Club in Seoul. Pharmaceutical companies seem to be cautious about unexpected situations when they tried to earnestly engage in sales marketing activities with the government's distancing in daily life. According to the industry on the 13th, a domestic pharmaceutical company e-mailed to all employees to inform the personnel team that they have visited a entertainment area in Itaewon, Seoul, and Gyeonggi Province, or immediately contact a personnel team after the visit to the entertainment district, individuals with personal health problems were notified immediately to contact the human resources team. Most companies recommend self-isolation for 2 weeks after self-examination to employees who have visited Itaewon entertainment store or suspected of symptoms related to corona19 such as fever, cough, sore throat. Samsung Bioepis asked to check the visit to Itaewon through a mobile interview last weekend. During this period, employees who visited nearby Itaewon also made strong preventive measures, such as recommending self-examination. Korean corporations of some multinational pharmaceutical companies such as AstraZeneca Korea and Janssen Korea plan to continue working for a long time with flexible operation of autonomous hours, such as every other day. Panoramic view of an office building lobby in Jung-gu, Seoul with a lot of floating Pharmaceutical companies are keen on the further spread of COVID-19 by employees who recently visited the Itaewon Club. If the spread of COVID-19 was concentrated in Daegu, Gyeongbuk 3 month ago, it is concentrated on young people in the metropolitan areas such as Seoul and Incheon, which intensifies the anxiety in the industry. In the case of COVID-19 confirmed patients in departments with high proportions of young employees, such as production facilities, research institutes, and sales departments, it is fatal to the operation of the company. In particular, in buildings where it is not possible to work from home, such as production facilities and research institutes, pharmaceutical companies become more nervous in that they have to stop operating for a while if there is one confirmed patient. In fact, a bio company that has a production facility in the metropolitan area said that employees who visited the area near Itaewon were suspicious until they received a negative result for COVID-19. The two companies in Seoul Square building where corona19 confirmed patients visited Itaewon were also nervous. MSD Korea and Mundipharma entered emergency telecommuting on the 11th after receiving a notice that Pernod Ricard Korea’s employee was confirmed on the 10th floor of the same building after visiting a local area near Itaewon in Seoul. Both companies seemed to be confused after ending their three-month telecommuting job and trying to approach work normalization. MSD Korea only started working at the office for only two weeks, but decided to switch to telecommuting and watch the trend. On the evening of the 11th, a management meeting decided to extend telecommuting until the 13th, and instructed employees not to stay in the office. Mundipharma also banned working at the office. Although building disinfection has been completed, it maintains a conservative position to set the time for resumption of work while paying close attention to the guidelines of the quarantine authorities. Companies are strengthening their guidelines to refrain from entering enclosed spaces The Yonsei Severance Building, where Boeringer Ingelheim of Korea resided, suffered a tumult on the news that the employee on the 11th was in close contact with COVID-19 confirmed patient. It turned out that Hyundai Shell Base Oil executive, the resident of the 7th floor of Yonsei Severance Building, ate with COVID-19 confirmed patient last weekend. Some of the companies in the same building immediately noticed the news and immediately left the company to work and urgent telecommuting was conducted for a day on the 12th, and Boeringer Ingelheim, who resided on the 16th floor, continued normal work. Although the close contact employee finally ended in happening after receiving a negative result, Boeringer Ingelheim, which resumed normal work from the 11th, passed the crisis of returning to home work in one day. An official from the pharmaceutical industry said, "The companies that tried to normalize the management after social distance was relieved by distancing in daily life was again in state of emergency and worried because there were a lot of young employees. but it is also not easy to recommend. The greater the psychological anxiety, the more the business disruption will continue. ”
- Company
- Sanofi Pasteur GM Baptiste de Clarens to leave Korean office
- by Eo, Yun-Ho May 15, 2020 06:04am
- The General Manager at Sanofi Pasteur Korean office, Baptiste de Clarens is to leave the office at the end of May. According to pharmaceutical industry sources, the resignation of General Manager Baptiste de Clarens has been decided by the headquarter. The decision was apparently made as his term in Korea is ending and a new general manager would be take charge of the Korean office from July. Like the other previous general managers of Sanofi Pasteur Korean office, the new general manager has reportedly led the Asian-Pacific regional office. After leaving the Korean office, General Manager Baptiste de Clarens would be appointed at the Sanofi Pasteur headquarter in Lyon, France to oversee the vaccine business. Since joining the French-based company in 2006, the general manager has worked on enhancing efficiency in general marketing and sales at the Lyon headquarter office and developed his global expertise. He has also supervised the company’s business operation in Asia in Singapore, before he was appointed as a general manager in offices in Malaysia, Singapore, Brunei, and in South Korea from July 2017. Currently, Sanofi Pasteur supplies various vaccines to Korea, including influenza vaccine, diphtheria plus tetanus plus pertussis vaccine, DTaP-IPV Combo vaccine, meningococcal vaccine, live attenuated virus vaccine against Japanese encephalitis, hepatitis A vaccine, and yellow fever vaccine.
- Company
- Ibrance and Verzenio settle pricing for Faslodex combination
- by Eo, Yun-Ho May 14, 2020 06:24am
- At last, Faslodex plus CDK4/6 inhibitor combination therapy would be accessible as an actual treatment option for patients. According to Korean pharmaceutical industry sources, two cyclin-dependent kinases 4/6 (CDK4/6) inhibitors including Pfizer’s Ibrance (palbociclib) and Lilly's Verzenio (abemaciclib) treating patients with HER2-negative breast cancer have successfully settled on drug pricing with National Health Insurance Service (NHIS) as combination therapy with AstraZeneca’s Faslodex (fulvestrant). The listing would be finalized in June, if the Health Insurance Policy Deliberation Committee (HIPDC) would approve of it. Since the first reimbursement expansion, Pfizer took two years and Lilly took a year for the Faslodex combination therapy to get listed. The demand for the combination therapy has been present since the so-called Ibrance incident from 2017. However, Ibrance was freshly listed as a first-line therapy in Nov 2017, and individual listing for Faslodex was not even cleared. In fact, Faslodex has been approved in the Korean market for over a decade. The Korean health authority and the drug maker have struggled to find a middle ground on the cost-effectiveness of the monotherapy. However, the demand on the providing reimbursement on the drug has surged since the Ibrance combination therapy started receiving the public’s interest. Despite the challenges, the first attempt to list the combination therapy has been submitted in 2018. AstraZeneca applied for reimbursement on the Ibrance-plus-Faslodex combination therapy, while Pfizer also requested for reimbursement expansion. As the monotherapy of Faslodex has not been listed, the Korean health authority, however, requested AstraZeneca to withdraw the reimbursement application and rejected Pfizer’s application. Since then, AstraZeneca has decided to accept the pricing below the weighted average of alternative options to list Faslodex’ monotherapy, and successfully listed the drug in April last year via negotiation-exemption track. Pfizer then jumped on and submitted the second application to expand reimbursement for the Faslodex combination therapy, as soon as the drug’s listing was finalized in March. Lilly also submitted the listing application in May last year, immediately after its marketing approval. Verzenio was able to apply for the healthcare reimbursement via the risk sharing agreement (RSA) track as CDK4/6 inhibitor-plus-Faslodex combination therapy as a main indication has not been listed by any other drug.
