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- Hanmi’s diabetes pipeline still standing in the storm
- by Chon, Seung-Hyun Dec 11, 2019 06:47am
- Hanmi Pharmaceutical’s efpeglenatide with the title of the biggest license-out deal to date is going through harsh times before reaching the finish line. The company’s unbent commitment for the pipeline kept it alive, despite amending the license out agreement twice and the partner company shifting R&D pipeline focus. Although it seems to have international clinical trials on their way unaffected, the company is now concerned of change in global commercialization partner. Headquarters of Hanmi Pharmaceutical On Dec. 10, Hanmi Pharmaceutical’s stock price closed at 298,000 won with 6.88 percent drop from the day before. Hanmi Science also took a 4.57-percent fall. Experts see that news of Hanmi Pharmaceutical’s partner company, Sanofi looking for a partner to launch efpeglenatide may have intimidated the investors. ◆Efpeglenatide surviving albeit Sanofi’s R&D pipeline shake-up In fact, efpeglenatide’s development timeline has not been changed. Sanofi broke a news of acquiring a U.S.-based oncology R&D company Synthorx for USD 2.5 billion (approximately three trillion won) on Dec. 9, and elaborated its plan to shift the focus of R&D pipeline and management style. Sanofi official stated it would prioritize investment on oncology, rare disease, blood disorder and neurology, while it would cease researches on diabetes and cardiovascular disease. However, the multinational company’s news also included its plan to complete ongoing Phase 3 clinical trials of efpeglenatide, but not to pursue a efpeglenatide launch. At face value, Sanofi means to not commercialize efpeglenatide, but it also means the pipeline survived another major pivot in Sanofi’s R&D pipeline. The candidate drug is the only diabetes treatment pipeline among five investigational drugs the multinational company plans to submit the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) for in two years time. A Sanofi executive stressed “It was the best decision for the successfully launch of efpeglenatide while maximizing the productivity of our research engine. It was irrelevant to efficacy and safety of the substance, and it would make no changes on license-in agreement with Hanmi Pharmaceutical”. Technically, efpeglenatide proved its potential to Sanofi’s new CEO, Paul Hudson appointed last August, despite his firm commitment to reprioritize R&D pipeline. In the year, Sanofi suddenly stopped research in a trigonal GLP-1/GIPR/GCGR agonist, SAR441255. And the French company also has paid back upfront fee to exit a 300-million-dollar partnership deal over SGLT1/2 dual inhibitor Zynquista (sotagliflozin) signed in 2015. ‘New Drug Application Submission Timeline 2019-2023’ unveiled during 3Q performance presentation by Sanofi ◆Amending license-out agreement twice, two LAPSCOVERY medicines returned Starting with the license-out agreement, efpeglenatide has gone through a series of ups and downs. Efpeglenatide, a GLP-1 injection for type 2 diabetes, is a bio drug candidate that extended once-daily administration interval to once-weekly and even once-monthly. It incorporated Hanmi Pharmaceutical’s key platform technology, ‘LAPSCOVERY’. LAPSCOVERY, or Long Acting Protein/ Peptide Discovery platform technology prolongs the duration of biologics’ short half-life to reduce administration frequency and dose, which would ultimately reduce adverse reaction and improve efficacy. Chemically conjugated biologics and protein ‘LAPS-carrier’ amplifies duration of the substance’ effect in human body and maintains the effect for maximum one month even with a small amount. In November 2015, Hanmi Pharmaceutical signed a license-out agreement with Sanofi on efpeglenatide, which still to this date is the biggest deal in the history of Korean pharmaceutical industry. The 2015 deal transferred technology of a EUR 3.9 billion-worth Quantum Project (efpeglenatide, long-acting insulin, and efpeglenatide with long-acting insulin) to Sanofi. The upfront fee alone was 400 million euro. But after closing the deal, a number of unexpected changes were made. In December of 2016, Hanmi Pharmaceutical amended the agreement to drop one of the drug candidates from the ongoing technology transfer project. Out of three drug candidates, Sanofi decided to return license over the long-acting insulin. Agreement terms on the long-acting insulin combination was also changed so that Sanofi would acquire it after Hanmi Pharmaceutical develops it for a certain period of time. As a result, Hanmi Pharmaceutical paid back 196 million euro out of Sanofi’s 400-million-euro upfront payment. The milestone payments were also affected and the overall deal was shrunk by over one billion euro, down to 2.82 billion euro. Regardless of the reduction, the upfront fee and overall scale of the efpeglenatide deal is still historic record high within the Korean pharmaceutical industry. Hanmi Pharmaceutical-Sanofi agreement revised in June (Source: Financial Supervisory Service) In June, however, Hanmi Pharmaceutical and Sanofi agreed to amend the agreement once again. Hanmi Pharmaceutical lowered the maximum co-research expense from 150 million euro to 100 million euro with about 50 million euro (approximately 65 billion won) cut. The first amendment actually included a clause for Hanmi Pharmaceutical to contribute 25 percent of efpeglenatide R&D expense, which was supposed to be covered entirely by Sanofi. And Hanmi Pharmaceutical set the research expense cap at 150 million euro. In just about two years, Hanmi Pharmaceutical was able to revise the clause added in 2016 to be more favorable to them. When amending the agreement for the second time, Hanmi Pharmaceutical also postponed its payment period of clinical trial expense. Initially, Hanmi Pharmaceutical was supposed to pay when Sanofi quarterly billed for efpeglenatide’s clinical expense. The additional expense of 40 million euro out of 68.5 million euro would be billed on an earlier date between September 2022 and submission date of Biologics License Application (BLA) to FDA. The bill is to be cleared by Hanmi Pharmaceutical within 15 days. The rest of 28.5 million euro would be paid on earlier date, either in September 2023 or the FDA approval date. Basically, Hanmi Pharmaceutical is to pay Sanofi whenever efpeglenatide development achieves a milestone. When Sanofi initiated large scale clinical trials on efpeglenatide, the expense soared more than expected. But then Sanofi seems to have accepted Hanmi Pharmaceutical’s request to lower its contribution in clinical expense. Meanwhile, risk factors in LAPSCOVERY technology have been raised. Janssen signed a technology transfer deal on JNJ-64565111, a candidate diabetic obesity drug, but it had to suspend clinical trial due to production delay. In July, Janssen returned its license on JNJ-64565111 and the license-out agreement covering two candidate drugs based on LAPDISCOVERY technology fell through. Spectrum Pharmaceutical’s in-licensed Rolontis, a neutropenia treatment, is the first LAPSCOVERY-applied medicine to get so close to commercialization. A U.S.-based Spectrum Pharmaceutical filed for FDA approval on Rolontis at the end of last year, but it dropped the BLA in March as the authority ordered for more supplementary data. The application was submitted again in October. ◆ Five out of two efpeglenatide clinical trials completed selecting participants Currently, the efpeglenatide development is going smoothly. Two years after signing the deal, Sanofi officially unveiled a detailed plan on efpeglenatide at the end of year 2017. By the end of 2017, Sanofi initiated the first Phase 3 clinical trial to compare efpeglenatide and placebo, and in April last year, the company initiated a large-scale Phase 3 trial to test efficacy and safety in treating cardiovascular diseases. Another Phase 3 trial was initiated since September last year to compare efpeglenatide and competing product Trulicity (dulaglutide) as a combination therapy with Metformin. In October last year, a protocol on combination therapy with efpeglenatide and basal insulin was registered, and in December same year, the fifth Phase 3 trial was initiated to confirm the drug treating Type 2 diabetic patients who cannot control glucose level either after Metformin single therapy or Metformin and sulfonylureas combination therapy. The overall target number of sample is 6,340. As of now, two out of five Phase 3 trials on efpeglenatide have gathered sufficient number of participants. Most recently, placebo-comparing Phase 3 trial AMPLITUDE-M has gathered targeted number of patients. The investigational drug’s key trial, AMPLITUDE-O testing effect of efpeglenatide on cardiovascular outcomes has registered more than planned number of participants of 4,076 patients in June. A Hanmi Pharmaceutical official stated, “Sanofi has promised to concentrate on completing numerous Phase 3 trials currently ongoing to develop efpeglenatide successfully”. Two Phase 3 efpeglenatide trials have registered enough number of patients (Source: ClinicalTrials.gov)
- Company
- MSD’s new labor union in talks for unpaid wage compensation
- by Kim, Jin-Gu Dec 11, 2019 06:39am
- MSD Korea employees have gathered again under a new umbrella. Majority of the members previously affiliated under Korea Democratic Pharmaceutical Union MSD Chapter left and established a new labor union of their own. ‘MSD Korea Laborers’ Union’ is the new name for the independent corporate labor union. On Dec. 5, the union convened its first general meeting and kicked off with a union representative election. MSD Korea’s labor union was formed for the first time as the 17th chapter of the Korea Democratic Pharmaceutical Union last year. Since then the union engaged in a single union talks with the corporate management over compensation of unpaid wages and other agenda. However, discrepancies loomed between the executive body and members during the process. Some members started complaining that the executive body is not properly speaking up for the compensation for weekend wage. As a result, the members started working on forming a new labor union from September last year. Except for the chairperson from the MSD Korea Chapter, most of the executive body left the union and formed a new one. 80 percent of the members also joined the new one. Currently, the new union has about 280 members. With the scale, the new union gained support of the majority and earned the representative bargaining rights. The new union is now in talks with the employer about compensation for weekend wage and reasonable salary raise negotiation. Since October 31, total five talks have been held. The labor union is specifically demanding for an immediate payment of five-year overdue weekend work wage, and affirmed seven percent raise in salary. According to the labor union, MSD Korea has not properly paid employees for the weekend work by calculating it as normal daily expenses. The union estimates the overall unpaid weekend wage is about five billion won. The management is holding on to the four percent salary raise. They have agreed on compensating for the overdue weekend wage, but they want to further discuss about the details of the payment later. As it is a matter of ‘unpaid wage’, the union is asking for a letter to affirm payment of the unpaid wage without further discussion. Apparently, both of parties have agreed to make decisions and resolve the said issues within this year. Shim Sang-nam, elected as a chairperson to lead the first general meeting explained the reason of forming a new labor union saying “The recently addressed issues needed a union with more democratic and ethical qualities. Also multiple problems reported constantly called for a new union urgently and solely for MSD employees”. “MSD Korea Laborers’ Union aims to resolve salary raise negotiation and unpaid payment issues in short term, but it would thrive to create the best working environment with MSD-appropriate levels of salary, benefits and guaranteed retirement age”, the chairperson added.
- Company
- Korean biosimilars carving out Herceptin market share
- by Chon, Seung-Hyun Dec 10, 2019 06:31am
- Korean-made biosimilars are gaining more market share in the anticancer treatment Herceptin (trastuzumab) market. The biosimilars have now taken over more than 25 percent of the market share. The total market size has recovered the previous level, before the original’s price fell with new launches of inexpensive biosimilars. Alhtough Celltrion’s Herzuma showed a steep uptrend, Samsung Bioepis’ Safenet was sluggish with the growth. According to pharmaceutical market research firm IQVIA on Dec. 9, the third quarter the total trastuzumab market reached 26.8 billion won. It soared 24.7 percent from the same period last year. Trastuzumab is a substance used for treating breast cancer and metastatic stomach cancer, and Roche’s Herceptin is the well-known brand name of the substance. In Korea, Herzuma and Samfenet are two available trastuzumab biosimilars. Quarterly market share trend of trastuzumab items (Unit: percentage) Source: IQVIA In the third quarter of 2017, the trastuzumab market plummeted by 30.5 percent to 19.1 billion won, compared to 27.5 billion won made a year before. But the figure climbed back up to the point of two years ago. The biosimilars entering the market triggered Herceptin’s price to drop and shrunk the whole market. When Celltrion’s Herzuma was listed for insurance reimbursement in April 2017, Herceptin’s maximum reimbursed price fell two months later from 517,628 won per 150 mg to 414,103 won by 20 percent in. By the principles of the Korean drug pricing system, a biosimilar itemcan be priced at maximum 70 percent of the original’s initial reimbursed price. From October 2016, a biosimilar item developed by a designated Innovative Pharmaceutical Company, a company passing the designation standard, or Korean and multinational companies in partnership can be priced at maximum 80 percent of the original’s price. The same condition applies to items either first approved in Korea or manufactured locally. The off-patent original item’s price is automatically dropped to around 70 to 80 percent of the initial price when biosimilars item is launched. The recent expansion of the trastuzumab market was leveraged by biosimilars. Herzuma generated 6.3 billion won in the third quarter, increasing the sales by 156.7 percent than same time last year. Herzuma started making sales profit from the third quarter 2017, and it grew consistently and surpassed five billion won mark in last second quarter. The accumulated sales in the third quarter reached 16.2 billion won. Samfenet, on the other hand, was not performing as well as Herzuma. In the third quarter, Samfenet generated about 500 million won. Its sales reached 700 million won in last second quarter, but the figure is coming down again. Daewoong Pharmaceutical is in charge of commercializing Samfenet at the moment. Although Samfenet did not show as satisfying growth, Herzuma’s steep growth took a big bite out of the overall trastuzumab market, expanding the general biosimilars’ pie. The biosimilars took over 25.7 percent of market share in the third quarter with Herzumab taking up 23.6 percent and Samfenet taking up 2.1 percent. In general, a highlight of the trastuzumab market was Celltrion and Samsung Bioepis leading the general growth of the market. 150 mg of Herzuma was listed for reimbursement in April 2017 at the maximum reimbursed price of 372,692 won, about 72 percent of Herceptin’s price before its patent expired. Samsung Bioepis’ Samfenet in 150 mg dose was granted with insurance reimbursement since February last year at the maximum reimbursed price of 291,942 won. It was about 56.4 percent of Herceptin’s initial price. Since then, Celltrion brought down its Herzuma’s reimbursed price by 21.7 percent to 291,942 won to match Samfenet’s price. Trastuzumab’s market volume is now about the same as three years ago. It could be analyzed that patients’ access has been improved and accordingly the medicine use has been increased significantly with reasonably priced biosimilars and the original’s lowered price.
- Company
- Metformin Self Test, undetected cases also listed
- by Lee, Tak-Sun Dec 10, 2019 06:31am
- The domestic pharmaceutical industry is responding quickly to the issue of Metformin impurities. In some cases, the MFDS has already completed testing, instructing its own testing of raw materials and finished products that may generate impurities. The rest of the companies are considering pushing the test through their own research institute or entrusting the test to outside the university research institute. According to the pharmaceutical industry on the 9th, the Korean pharmaceutical industry conducted its own investigation last Friday (December 6) as the US FDA tests whether it detects carcinogen NDMA (N-Itrosodimethylamine) in the diabetes drug Metformin. The issue began with the detection of more than daily NDMA on three Metformin products in Singapore. The MFDS is investigating the influx of finished Singapore products and raw materials into the country. In addition, it is reported that self-investigation is in the future. Prior to this, domestic pharmaceutical companies began their own tests. The MFDS immediately followed its own investigation of raw materials and finished products that are highly likely to detect impurities, and immediately reports any abnormalities detected. An official from a mid-sized pharmaceutical company said, "We have already tested NDMA for pharmaceutical raw materials through a university lab, and there were no detection results as a result of testing on 3 lots of raw materials using a similar method to the Nizatidine method". Large pharmaceutical companies with high sales of Metformin are also in a hurry to promote their own tests. An official from the company said, "We are planning a test through our own laboratory". Other companies are also making rapid progress, including hearing about the detection of metformin's impurities and promoting their own tests. However, the MFDS does not have any further instructions so it is reported that they are struggling over the countermeasure and test result report. A mid-sized company official said, "We do not know how to report the undetected test results to MFDS and there are no directions from MFDS yet".
- Company
- MedPacto: “license out co-developed vactosertib in 2021”
- by Lee, Seok-Jun Dec 10, 2019 06:30am
- CEO Kim Seong-jin of MedPactoMedPacto predicts to sign license out deals on its star pipeline vactosertib in around 2021. Particularly, the company anticipates the license out deal would highly likely to be for the indications on colorectal, stomach and non-small cell lung cancers that are currently in co-development with MSD and AstraZeneca. Vactosertib (TEW-7197) selectively inhibits Transforming Growth Factor (TGF) beta’s signaling pathway as it disrupts immunotherapy’s treatment effect. The substance improves surroundings of tumor for immunocytes to effectively eliminate cancer cells. At a press conference held on Dec. 6, MedPacto CEO Kim Seong-jin stated “Results of two clinical trials, Phase 1b and 2a, collaborating with MSD and AstraZeneca, would be out next year. The trials with about 40 participating patients each is at a globally recognized level of sampling. When the results are out, we expect a couple of global pharmaceutical companies to offer us the license out deals”. “Considering the overall timeline, the vactosertib license out deals would be signed around 2021. When the deal closes, we are not only expecting sales profit, but also a turnaround”, the CEO added. Reportedly, MedPacto is currently conducting Phase 1b and 2a clinical trials on combination therapy indications for colorectal/stomach cancers and non-small cell lung cancer with MSD’s Keytruda and AstraZeneca’s Imfinzi, respectively. While collaborating with MSD and AstraZeneca, MedPacto is provided with their immunotherapy medicines, Keytruda and Imfinzi. So far, the company has been provided with 15 billion won worth of the medicines. In addition, MedPacto is collaborating with the global pharmaceutical companies on clinical strategies and designs. The Korean company is planning to transfer all rights of development for the pipeline license out deal. CEO Kim explained, “While we see the license out deals to be signed in 2021, we are considering on transferring all development rights of the substance. From 2021, when the license out deals are supposed to happen, we would not put down any more clinical trial cost. It is informed that the December public offering fund would cover only up to next year’s vactosertib clinical trial”. “Although the license out deals would transfer all development rights, commercialization in Asian region could be maintained. In such case, clinical trial in Korea could be possible. Profits from vactosertib would used for clinical trial on MA-B2”, the CEO further elaborated. CEO Kim stressed the talks on vactobsertib license out deals would be led independently, regardless of the current pipeline partnership with MSD and AstraZeneca. “Because the pipeline is co-developed with MSD and AstraZeneca, it is highly likely to be licensed out to them. But other pharmaceutical companies are interested in those indications for colorectal, stomach and non-small cell lung cancers. When we are to negotiate license out deals with other companies, MSD and AstraZeneca would not have the rights to refuse”, CEO Kim pin pointed. MedPacto projects it would generate profit of 165.5 billion won until 2022 with pipeline license out deals on vactosertib and MA-B2. The company is predicted to generate profit from 2021. Previously a subsidiary of Theragen Etex, MedPacto split from the company and was established as an independent company in July 2013. As of the first half of the year, Theragen Etex owns 18.1 percent of the company share. The sum of share including specially related person share is 40.34 percent. A former vice president and the largest shareholder of Theragen Etex, Kim Seong-jin is the current CEO of MedPacto.
- Company
- Samil to release FDA-approved conjunctivitis treatment
- by Lee, Seok-Jun Dec 10, 2019 06:30am
- On Dec. 6, Samil Pharm announced it signed a manufacturing and commercialization license with a France-based ophthalmic R&D company, Nicox S.A. for the exclusiv rights of allergic conjunctivitis treatment Zerviate (cetirizine) in Korea. By closing the deal, Samil Pharm would receive the exclusive rights to manufacture and commercialize the ophthalmic solution and start preparing for the release in 2022. The U.S. health regulator granted an approval on Zerviate for preventing ocular itching associated with allergic conjunctivitis in 2017. The treatment is preparing for a launch in early next year. It is the first and only ophthalmic solution to be made with cetirizine. A Phase 3 clinical study in the U.S. demonstrated significantly less ocular itching within a short period of time. The trial also confirmed safety of the solution so that it could be prescribed to a child aged at two and up. Allergic conjunctivitis is an allergic reaction causing conjunctivitis, an inflammation of the thin layer on the surface of the eye. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge and blurred vision. With its headquarters in France, Nicox S.A. is an international ophthalmology company focused on development and commercialization of ophthalmic pipeline. Other than Zerviate, Nicox S.A.’s ophthalmic pipeline cover glaucoma and other ocular diseases, developed with the company’s novel nitric oxide-donating R&D platform. Based on the technology, a glaucoma treatment Vyzulta (latanoprostene bunod ophthalmic solution) has been commercialized in the U.S. since December 2017.
- Company
- Reimbursement expansion of osteoporosis drug 'Prolia'
- by Chon, Seung-Hyun Dec 09, 2019 06:27am
- In the domestic osteoporosis treatment market, the prosperity of 'Prolia' continues. In the six months since the increase in health insurance benefits in April, the company has built a solitary system in the market with sales of about ₩25 billion. Amgen's Prolia, on the 6th, reported sales of ₩13.5 billion in the third quarter, more than three times the previous year's ₩3.7 billion. It is slightly lower than the previous quarter's ₩12.3 billion, but it is showing a rapid growth of Prolia. AmgenProlia's recent upsurge is driven by increased reimbursement expansion. Prolia, released in Korea in November 2016, was the first product to receive attention as a biologic for treating osteoporosis. Prolia is the only biopharmaceutical osteoporosis treatment that targets the receptor activator of nuclear factor Kappa-B Ligand (RANKL), which is essential for the formation, activation, and survival of bone-breaking osteoclasts. Prolia has not received much response from the market, with sales of less than ₩1 billion in the early quarter. However, after reaching ₩2.4 billion in the fourth quarter 2017 when health insurance benefits began to be recognized, sales increased to ₩4.9 billion in this first quarter . Prolia was approved as a first-line therapy for the treatment of postmenopausal women with osteoporosis and for increasing bone density in men with osteoporosis. Since 2017, reimbursement has been applied to secondary therapy only. Quarterly Sales Revenue Trend (Unit: ₩ million, Source: IQVIA) Since April, insurance coverage has been approved for primary care. Prolia is entitled to pay ▲ twice a year if the T-score is -2.5 or less in bone mineral density measurements, and ▲ six times for three years if osteoporotic fractures are found on radiographs.▲After the administration period, benefits will be provided if follow-up continues to require medication with a T-score of -2.5 or less. After Prolia's approval of the first treatment benefit, sales reached nearly ₩25 billion in six months, causing a blast in the market. Prolia surpassed Lilly's “Forsteo”, which had previously ranked first in sales of osteoporosis treatments, from the second quarter. In the third quarter, Forsteo's sales were ₩5.5 billion, less than half of Prolia's. Sales force growth is also a factor for growth in Prolia. Amgen has been selling Prolia in partnership with Chong Kun Dang since September 2017. Amgen Korea is in charge of sales and marketing of Prolia at general hospitals and Chong Kun Dang at semi general hospitals and Clinics. Chong Kun Dang has developed synergies with its sales know-how combined with prolia sales in the musculoskeletal drug market with products such as Osteoarthritis treatment, ‘Imotun’ and anti-inflammatory analgesics, ‘Coxbito’.
- Company
- AbbVie Skyrizi approved, a new option for psoriasis
- by Eo, Yun-Ho Dec 09, 2019 06:26am
- Patients with plaque psoriasis now has another interleukin inhibitor option. On Dec. 3, AbbVie Korea announced Korean Ministry of Food and Drug Safety (MFDS) approved its interleukin-23 (IL-23) inhibitor Skyrizi Prefilled Syringe (risankizumab) for the treatment of moderate to severe psoriasis in adult patients who are candidates for systemic therapy (whole-body therapy including biologic treatment) or phototherapy. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, which AbbVie is managing development and global sales. The ministry’s approval was based on ultIMMa-1 and ultIMMa-2 clinical trials, where patients were treated with Skyrizi showed high level of condition improvement at 16 weeks. And during ultIMMa-1 and ultIMMa-2 trials, 82 and 82 percent of the patients achieved Psoriasis Area and Severity Index (PASI) 90 at one year (52 weeks), and 56 and 60 percent of the patients achieved PASI 100, respectively. PASI 100 indicates the patient’s condition has achieved a complete resolution. Skyrizi administration starts with 150 mg initiation dose injected subcutaneously at week 0 and 4, followed by injection at every 12 weeks. Among the biologic IL-23 inhibitor class medicines approved in Korea, the treatment is has the minimum administration frequency of four times a year, which can be injected at a hospital or self-injected after training. Professor Youn Sang Woon at Dermatology Department of Seoul National University Bundang Hospital explained “Severe psoriasis can gravely affect patient’s quality of life physically, mentally and socially. Respective case has widely different treatment reaction, and patients usually experience various adverse reactions during a long period of treatment”. “In a Phase 3 clinical trial, patients treated with Skyrizi showed over 90 percent of improvement at 16 weeks, and 80 percent of the patients maintained the state even after a year. Such positive findings confirm Skyrizi to be a new competitive treatment option for treating severe psoriasis condition and maintaining recovered state”, the professor elaborated. Skyrizi also reaffirmed its treatment effect and safety in four clinical studies conducted with 2,109 patients (ultIMMa-1, ultIMMa-2, IMMhance and IMMvent). During the ultIMMa-1 and ultIMMa-2 trials, 74 percent of Skyrizi-treated patients demonstrated 90 percent of recovery rate (PASI 90) at week 16, and 36 and 51 percent of patients achieved 100 percent recovery (PASI 100) in the trials, respectively. In fact, an integrated analysis of ultIMMa-1 and ultIMMa-2 showed most patients treated with Skyrizi who recovered 90 and 100 percent (PASI 90 and 100) at week 16 maintained the state at one year point.
- Company
- 'Jardiance' reaffirms CV benefits over DPP-4 inhibitors
- by Eo, Yun-Ho Dec 09, 2019 06:26am
- Research shows that SGLT-2 inhibitor ‘Jardiance’ has more cardiovascular benefits than DPP-4 inhibitors. Boehringer Ingelheim and Lilly are the first to analyze Jardiance’s effectiveness of the EMPRISE (Empagliflozin Comparative Effectiveness and Safety) Asia study at the International Diabetes Federation, IDF presented at the General Assembly site. The EMPRISE Asia study included approximately 57,000 adults with type 2 diabetes in Japan, Korea, and Taiwan, with or without cardiovascular disease. The first validity analysis of the study showed that Jardiance has benefits in hospitals due to lower heart failure, end-stage renal failure, and all-cause mortality risks compared to DPP-4 inhibitors in real clinical settings. According to the analysis, Jardiance reduced the risk of death from heart failure by 18%, the risk of developing end-stage renal failure by 63% and the risk of death by all causes by 36% in adults with type 2 diabetes. According to the analysis, Jardiance reduced the risk of death from heart failure by 18%, the risk of developing end-stage renal failure by 63% and the risk of death by all causes by 36% in adults with type 2 diabetes. Daejoong Kim, a professor of endocrine medicine at Ajou University Hospital, a researcher at EMPRISE Asia said “"Jardiane has been shown to reduce the incidence of deaths in people with type 2 diabetes compared to DPP-4 inhibitors, and it is a convincing result that the reduction in death of Jardiance, identified through the EMPR-REG OUTCOME study, can be consistently provided to Korean patients in a real clinical setting”. The results of the EMPRISE Asia study complement the findings of the EMPA-REG OUTCOME study, which shows that Jardiance provides cardiovascular and renal benefits in addition to metabolic effects in patients with type 2 diabetes with cardiovascular disease. In the EMPA-REG OUTCOME study and sub-analysis, Jatdiance reduced the relative risk of hospitalization due to heart failure by 35%, the relative risk of death from all causes by 32%, and the relative risk of developing or worsening kidney disease by 39%.
- Company
- Celltrion, achieved first $1 billion exports in Korea
- by Chon, Seung-Hyun Dec 09, 2019 06:26am
- Celltrion Healthcare announced on the 5th that it won '$1 Billion Export Tower award ' at the 56th Trade Day Ceremony hosted by the Korea International Trade Association. Whole view of Celltrion Healthcare HeadquartersCelltrion Healthcare is the first Korean pharmaceutical bio company to surpass $1 billion in annual exports. Only five companies have received more than $1 billion towers. SK Trading International won $10 billion tower, and Hyundai Construction Equipment, Kumho P&B Chemicals, Nexen Tire received the $1 billion tower with Celltrion Healthcare. Celltrion Healthcare is an affiliate of Celltrion and Chairman Seo, Jung-jin, Celltrion, is the largest shareholder (35.69% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltrion Healthcare's sales represent the export of biosimilars developed by Celltrion. Celltrion sells a total of three biosimilars in Europe and the United States, including ‘Remsima’, ‘Truxima’ and ‘Herzuma’. Remsima's original drug is Janssen's Remicade. 'Truxima' and 'Herzuma' are Mabthera’s and Herceptin’s biosimilar products, respectively. Celltrion Healthcare received a $1 billion export tower four years after winning the $300 million export tower in 2015 as biosimilar sales increased. According to Celltrion Healthcare's quarterly report, the cumulative exports of the three biosimilars in the third quarter totaled ₩7,828 billion. It was 57.9% higher than ₩4,956 billion in the same period last year. Remsima's exports increased 60.1% yoy to ₩399 billion, and Truxima's exports soared 148.3% to ₩34.6 billon. Although Herzuma's exports fell by 42.2%, Remsima's and Truxima's propaganda boosted exports. According to the Ministry of Food and Drug Safety, ‘2018 Domestic Drug Production Imports and Exports’, total drug exports last year totaled $4.67 billion. Celltrion Healthcare accounts for about 20% of annual drug exports. On this day, Hyeong-ki Kim, the CEO of Celltrion Healthcare, received the prize of the Minister of Trade, Industry and Energy's commendation for leading Korea's pharmaceutical exports. The CEO said, “Three biosimilar products have achieved great results in the global market, opening the era of ₩1 trillion in exports of pharmaceuticals to biopharmaceutical companies, and we will focus on expanding exports with the goal of winning the $ 2 billion Export Tower within the next 1-2 years”.
