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- 2026-03-19 12:07:18
- Company
- Bayer Korea appoints Freda Lin as a new President
- by Eo, Yun-Ho Dec 13, 2019 10:59pm
- 프레다 린 대표 Bayer Korea has announced an appointment of Freda Ta-Ling Lin as a new President , starting from Jan. 1, 2020. The Korean branch’s top executive position has been vacant since the former President Ingrid Drechsel transferred to Bayer’s Turkish branch. From October, Bayer Korea’s Pharmaceuticals division has been managed by Lee Jina, a head of Cardiovascular Therapeutics Area. New President Freda Lin is a seasoned global leader in sales and marketing with 25 years of vast experience in the pharmaceutical industry. From 2013 to recent, Lin has been leading Bayer Taiwan as a head of Pharmaceuticals division and a President of the region. Previously, Lin has been building her career in the pharmaceutical industry as sales, market and strategic planning executive at GlaxoSmithKline’s Taiwan, China, Asia Pacific, and the U.K. branches. Moreover, Freda Lin is also to simultaneously serve as a head of Pharmaceuticals Division at Bayer Korea. New President Freda Lin said, “I am pleased to serve the role of President and to lead Bayer Korea in a country considered as one of the most innovative countries in the world”.
- Company
- Boryung Holdings appoints Kim Jung Gyun as New CEO
- by Eo, Yun-Ho Dec 13, 2019 10:59pm
- CEO Kim Jung Gyun Boryung Holdings recently convened a board meeting and appointed Chief Operating Officer Kim Jung Gyun as the new Chief Executive Officer. Joined Boryung Pharmaceutical in 2014 as a director, the new CEO Kim Jung Gyun served in Strategic Planning team, Production Management team, Human Resources team and was appointed as an executive director and COO at Boryung Holdings in January 2017. CEO Kim has contributed in increasing sales and improving profitability at Boryung Pharmaceutical by endeavoring on initiatives like ‘internal operational management system,’ ‘investment reprioritization,’ ‘generating open innovation-based new business like Vigen Cell’, and ‘building transparent and horizontal organizational culture’. As the COO of Boryung Holdings, Kim started establishing a holding company and subsidiary ‘Boryung Consumer’ since 2017, and shifted each business division to center board members for set a faster and transparent decision making process. Moreover, Kim reinforced collaboration system between board member executives to expand corporate value. Undergoing a series of changes, Boryung Pharmaceutical’s compound annual growth rate marked 7.1 percent in last three years, and its profitability has been significantly improved. The company is expected to make a record-high sales and operating profit this year. Besides, a vaccine manufacturer and biopharmaceutical R&D affiliate ‘Boryung Biopharma’ has also shown a steep growth and is expected to generate 100 billion won in 2019. CEO Kim stated, “As Korea is a part of top global markets, we should be the fastest to adapt to changes happening outside, constantly seek for opportunity in the global market, and invest on opportunity in future digital healthcare industry consisting of pharmaceutical industry, IT technology and healthcare”. Meanwhile, the current CEO of Boryung Pharmaceutical Ahn Jae-hyun resigned from his other position as a CEO of Boryung Holdings.
- Company
- MFDS to wait and see self-test results on metformin
- by Chon, Seung-Hyun Dec 13, 2019 06:34am
- Ministry of Food and Drug Safety (MFDS) The government seems to have decided to encourage pharmaceutical companies to run their own impurity contamination test on metformin drugs. Unlike the ranitidine and nizatidine incidents, the government means to wait and see the companies’ self-investigation results, rather than to take an action by itself. Basically, metformin would be the first substance to be applied with the recently unveiled impurity risk management initiative. However, the possibility still exists for the government to immediately call for sales ban and other follw-up measures, when a exceeding level of impurity is found in a product, either in Korea or overseas. According to the industry source on Dec. 12, Korea’s Ministry of Food and Drug Safety (MFDS) has not made any official order to pharmaceutical companies regarding findings of cancer-causing impurity in metformin. On Dec. 4, Singapore’s Health Science Authority (HSA) has decided to recall three out of 46 metformin products tested. Apparently, the regulator found N-nitrosodimenthylamin (NDMA) exceeding an acceptable level of daily consumption in metformin products. Since then, the U.S. and European health regulators have also started probing on contaminated metformin products. The U.S. Food and Drug Administration (FDA) is reportedly investigating NDMA discovered in metformin products available in the U.S. It also stated it would recommend recalling products with exceeding levels of NDMA contamination. The European Medicines Agency (EMA) has ordered companies to conduct NDMA contamination testing. Japan’s Ministry of Health, Labor and Welfare recently ordered metformin containing product manufacturers and importers in Japan to analyze and report risk of NDMA contamination in the substance and complete products. So far, MFDS has only stated it would “review investigation results”, and no other specific orders have not been given to the companies. The ministry has not yet ordered the companies to investigate NDMA in metformin active agent or complete product, nor has it stated the ministry would directly collect and investigate the substance. The ministry’s reaction is contrasting from the follow-up measures it had with other pharmaceutical impurity risk incidents. When the European regulator announced it would recall all valsartan products, the Korean ministry immediately banned sales of products with the same active ingredient. And after the sales ban was ordered in the U.S., the ministry once said “nothing to worry about”, but soon after it ordered an all-product ban. Actions on nizatidine followed the ranitidine sales ban. After collecting and testing active ingredient and complete product with similar chemical structure as ranitidine, MFDS banned sales on 13 items with unacceptable level of NDMA. It could be interpreted that the authority is trying to encourage companies to voluntarily test their metformin products. Neither of the U.S. or Europe has called for a recall due to exceeding level of the contamination. And the complete products reported with the impurity to date are not available in Korea, yet. MFDS official explained, “We have already asked companies to test the impurity in all products themselves”. It also means the recently introduced active ingredient impurity risk management initiative would be applied on metformin. In fact, MFDS has already asked pharmaceutical companies to run NDMA-like impurity test on all synthetic active agents, when announcing the investigation result of nizatidine medicine. Accordingly, synthetic ingredient manufacturer and importers, as well as complete product companies, have to evaluate risk of impurity contaminated during the process of manufacturing or storing. Pharmaceutical companies suspecting a risk of discovering NDMA and other harmful impurity in their product should immediately conduct a voluntary test and has to report MFDS as soon as possible when it is actually found. The impurity risk evaluation and testing should be conducted voluntarily, and the result of risk evaluation should reported by May 2020, and the result of test by May 2021. Pharmaceutical impurity risk management initiative presented by MFDS last month Since MFDS has introduced the impurity management initiative, metformin basically became the first case of ‘medicine with high risk’. In other words, MFDS is unlikely to test metformin itself, as of now. Moreover, metformin being a commonly used agent seems to make MFDS hesitant about testing the products proactively. Metformin is the most commonly prescribed first-line treatment for patients with Type 2 diabetes to control glucose level. In Korea alone, 642 of approved complete products contain metformin. Practically, all pharmaceutical companies have at least one metformin medicine. Compared to valsartan and ranitidine market, metformin has a far larger market volume. Pharmaceutical industry research firm UBIST reported outpatient prescription market volume of metformin product reached 420 billion won last year. It soared 63.4 percent in four years from 257.1 billion won in 2014. Currently banned ranitidine products generated about 200 billion won as outpatient prescription, but metformin market easily doubles the ranitidine market. A single dose of metformin is priced at less than a hundred one with reimbursement. Considering the pricing, metformin’s usage volume is overwhelmingly bigger than ranitidine. Yearly trend of outpatient prescription volume of metformin product (unit: KRW 100 million) Source: UBIST If the testing confirms metformin is contaminated with NDMA during the process of storing, active agent and complete product should be reviewed by each serial number. In such case, millions of serialized products would have to be investigated. It is physically impossible for MFDS to directly investigate them all. However, the ministry may initiate a full investigation, depending on the updates from home and abroad. The ministry’s hands-on investigation would be inevitable when active ingredient or complete product in Korea is found with exceeding level of impurity is reported from overseas. And even when a Korean company reports any case of NDMA contamination exceeding an acceptable level, full investigation is likely follow.
- Company
- Lilly releases first non-reimbursed 'Emgality'
- by Eo, Yun-Ho Dec 13, 2019 06:34am
- Eli Lilly's migraine new drug 'Emgality' was released in Korea. Lilly Korea announced on the 12th that it will release non-reimbursed CGRP-targeted migraines prevention drug, Emgality (Galcanezumab). This drug is a humanized monoclonal antibody that binds to the Calcitonin gene-related peptide (CGRP) molecule which plays a key role in causing migraine symptoms in the brain and blocks binding to receptors. .This is the first drug in Korea .Last year, after being approved for migraine treatment, it recently acquired additional FDA approval for episodic cluster headache treatment .The permission was granted for the EVOLVE-1 and EVOLVE-2 studies in which 1,773 people with migraine headaches (average migraine days 4-14 days per month) participated for 6 months, and chronic migraine patients (average headache days 15 days, migraine days 8 months or more) .The study was based on a REGAIN study involving 1113 people over 3 months .Through two clinical trials for episodic migraine patients, placebo of Emgality-treated patients for migraine treatment compared to baseline (9.2 days for Emgality group, 9.1 days for placebo group) across six months of clinic compared to average monthly migraine incidence for 6 months .Therapeutic benefit was proved .In particular, in the EVOLVE-2 clinical study involving Koreans, the average number of migraine headaches for 6 months in the Emgality group (226 patients) was reduced by 2 days (4.3 days in the Emgality group, 2.3 days in the placebo group) compared to the placebo group (450 patients) .Amgelity-treated patients who had 50% reduction in the number of days of migraine headaches over 6 months were 59% (36% placebo), 75% reduction were 34% (18% in the placebo group), and 100% reduction were 12% (6% in the placebo group) .Min-kyung Chu, neurology professor of Severance hospital, said “Migraine is a pain beyond our imagination that impairs the quality of life of patients, Patients who experience migraines more than four to five days a month can expect to improve their quality of life through preventive care .Emgality's launch is encouraging, with high blood pressure and epilepsy drugs being recommended for preventive treatment .Until now, high blood pressure medications and epilepsy medications have been recommended for preventive treatment” .Meanwhile, commercialization of CGRP-based therapeutics has been ongoing since last year .In addition to Emgality in the United States, drugs such as Aimovig (Erenumab) and Teva's Ajovy (Fremanezumab), which have been jointly developed by Novartis and Amgen, have entered the market.
- Company
- China okays Samsung’s Herceptin biosimilar Phase 3 trial
- by Lee, Seok-Jun Dec 11, 2019 10:20pm
- The Chinese health authority has green lit Samsung Bioepis’ first clinical trial in China. On Dec. 10, Samsung Bioepis announced China’s National Medical Products Administration (NMPA) has approved the company’s Phase 3 investigational new drug protocol on SB3, a biosimilar version of Hercpetin with trastuzumab. The first patient of Samsung Bioepis’ first clinical trial is scheduled to get treated in the first quarter of next year. The Phase 3 trial is planned treat 208 Chinese patients with breast cancer. Samsung Bioepis to initiate its first clinical trial in China (indicated in red) In February, Samsung Bioepis has signed a partnership contract with Chinese private equity firm C-Bridge Capital for clinical trial, government approval and commercialization in China. The recently approve clinical trial would be conducted along with C-Bridge Captial’s biopharmaceutical company, ‘AffaMed Therapeutics.’ Established in 2014, C-Bridge Capital is China’s topline healthcare-dedicated private equity firm. The company’s portfolio covers general healthcare service sectors including biopharmaceutical, medical device and diagnostics, and its current assets under management is approximately two trillion won. Besides SB3, Samsung Bioepis is to collaborate with C-Bridge Capital on conducting clinical trials, processing approval applications and launching SB11 (ranibizumab biosimilar, referencing Lucentis), SB12 (eculizumab biosmilar, referencing Soliris) and SB15 (aflibercept biosimilar, referencing Eylea) in Chinese market. Before inking the partnership with C-Bridge Captial, Samsung Bioepis has also inked another partnership with China-based biopharmaceutical company ‘3S Bio’ in last January to market SB8 (bevacizumab biosimilar, referencing Avastin) and some other pipelines.
- Company
- 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.
