GMP

Gyeonggi do, South Korea
Gyeonggi do, South Korea
SEARCH FILTERS
Time filter
Source Type

Dublin, May 12, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Regenerative Medicine Market Analysis & Forecast to 2021 - Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries" report to their offering. Current regenerative medicine market is worth $18.9 billion globally, and will hit over $53 billion by 2021 According to the report ‘due to the dominance of the bone and joint reconstruction market, the US currently has the biggest space, followed by Europe. However, due to recent positive legislation in Japan and Europe, the stem cell arena will grow more substantially in these regions over the next five years. By 2021, it is possible that Europe will surpass the US market with respect to stem cell applications, and this will become more likely if the Trump Administration restricts legislation and funding’. The regenerative medicine market has massive scope and can be applied to a wide range of diseases and indications including neurological, autoimmune, cardiovascular, diabetes, musculoskeletal, ocular, orthopedic and wound healing. To that end, the expanse of market opportunities is large as are the patient populations globally. Kelly indicates that ‘this study has extensively profiled all major players in the market, analyzed their financials, pipeline products and business strategy going forward. It is the most comprehensive analysis on the market, and stakeholders wanting to gain a significant insight would greatly benefit from this information’. Financial forecasts to 2021 are included with respect to: Interestingly, the report also takes a detailed look at the CAR-T industry and its impact on the healthcare space. The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? The report also addresses the following key points: Key stakeholder questions are answered in this 680 page analysis including: Key Topics Covered: 1.0 Report Synopsis 1.1 Objectives of Report 1.2 Executive Summary 1.2 Key Questions Answered in this Report 1.3 Data Sources and Methodology 2.0 Introduction 2.1 Gurdon and Yamanaka Share the Nobel Prize 2.2 Stem Cell Clinical Trials: Initiated in 2010 2.3 Types of Stem Cells 2.4 Adult (Tissue) Stem Cells 2.5 Pluripotent Stem Cells 2.6 Somatic Cell Nuclear Transfer (SCNT) 2.7 Induced pluripotent Stem Cells (iPSC) 2.8 Mesenchymal Cells 2.9 Hematopoietic Stem and Progenitor Cells 2.10 Umbilical Cord Stem Cells 2.11 Heart Stem Cells 2.12 Mammary Stem Cells 2.13 Neural Stem Cells 2.14 Stem Cell Applications in Retinal Repair 2.15 Liver Stem Cells 2.16 Gut Stem Cells 2.16 Pancreatic Stem Cells 2.17 Epidermal Stem Cells 3.0 Stem Cells and Clinical Trials 3.1 Introduction 3.2 Pluripotent Stem Cells 3.3 Limbal Stem Cells 3.4 Neural Stem Cells 3.5 Endothelial Stem or Progenitor Cells 3.6 Placental Stem Cells 3.7 Why Do Stem Cell Clinical Trials Fail? 3.8 What is the Future of Stem Cell Trials? 3.9 Cutting Edge Stem Cell Clinical Trials 3.10 Ocata Therapeutics Current Stem Cell Trials 3.11 CHA Biotech Current Stem Cell Trials 3.12 Pfizer Current Stem Cell Trials 3.13 GSK Current Stem Cell Trials 3.14 Bayer Current Stem Cell Trials 3.15 Mesoblast International Current Stem Cell Trials 3.16 Millennium Pharmaceutical Current Stem Cell Trial 3.17 AstraZeneca Current Stem Cell Trials 3.18 Merck Current Stem Cell Trials 3.19 Chimerix Current Stem Cell Trials 3.20 Eisai Current Stem Cell Trials 3.21 SanBio Current Stem Cell Trials 3.22 Celgene Current Stem Cell Trials 3.23 StemCells Current Stem Cell Trials 3.24 Genzyme (Sanofi) Current Stem Cell Trials 3.25 Teva Current Stem Cell Trials 3.26 MedImmune Current Stem Cell Trials 3.27 Janssen Current Stem Cell Trials 3.28 Seattle Genetics Current Stem Cell Trials 3.29 Baxter Healthcare Current Stem Cell Trials 3.30 InCyte Corp Current Stem Cell Trials 4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing 4.1 Introduction 4.2 Case Study: Genentech and Stem Cell Technology 4.3 3D Sphere Culture Systems 4.4 Stem Cells and High Throughput Screening 4.5 Genetic Instability of Stem Cells 4.6 Comprehensive in Vitro Proarrhythmia Assay (CiPA) & Cardiomyocytes 4.8 Coupling Precise Genome Editing (PGE) and iPSCs 4.9 Stem Cells & Toxicity Testing 4.10 Stem Cell Disease Models 4.11 Defining Human Disease Specific Phenotypes 4.12 Advantages of Stem Cell Derived Cells & Tissues for Drug Screening 5.0 Stem Cell Biomarkers 5.1 Pluripotent Stem Cell Biomarkers 5.2 Mesenchymal Stem Cell Biomarkers 5.3 Neural Stem Cell Biomarkers 5.4 Hematopoietic Stem Cell Biomarkers 6.0 Manufacturing Stem Cell Products 6.1 Manufacturing Strategies For Stem Cell Products 6.2 BioProcess Economics for Stem Cell Products 6.3 Capital Investment 6.4 Cost of Goods 6.5 Bioprocess Economic Drivers & Strategies 6.6 hPSC Expansion & Differentiation using Planar Technology 6.7 hPSC Expansion using 3D Culture 6.8 Microcarrier Systems 6.9 Aggregate Suspension 6.10 Bioreactor Based Differentiation Strategy 6.11 Integrated hPSC Bioprocess Strategy 6.12 GMP Regulations and Stem Cell Products 7.0 Investment & Funding 7.1 What do Investors Want from Cell & Gene Therapy Companies? 7.2 What Makes a Good Investment? 7.3 What Types of Companies do Not Get Investment? 7.4 Global Funding 7.5 Cell & Gene Therapy Investment Going Forward 7.6 What Cell & Gene Companies are the Most Promising in 2017? 7.7 Insights into Investing in Cell and Gene Therapy Companies 8.0 Regenerative Medicine Market Analysis & Forecast to 2021 8.1 Market Overview 8.2 Global Frequency Analysis 8.3 Economics of Regenerative Medicine 8.4 Market Applications & Opportunities for Regenerative Therapies 8.5 Global Financial Landscape 8.6 Regenerative Medicine Clinical Trial Statistics 8.7 Regenerative Medicine Market Forecast to 2021 8.8 Regenerative Medicine Geographic Analysis and Forecast to 2021 8.9 Regenerative Medicine Geographical Location of Companies 8.10 Regenerative Medicine Technology Breakdown of Companies 8.11 Commercially Available Regenerative Medicine Products 8.12 Major Regenerative Medicine Milestones 9.0 Stem Cell Market Analysis & Forecast to 2021 9.1 Autologous & Allogenic Cell Market Analysis 9.2 Stem Cell Market by Geography 9.3 Stem Cell Market Forecast by Therapeutic Indication 9.4 Stem Cell Reagent Market Trends 10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2021 10.1 Geographical Analysis and Forecast to 2021 10.2 Geographical Analysis by Company Share 10.3 Tissue Engineering Clinical Indication Analysis & Forecast to 2021 11.0 Biobanking Market Analysis 11.1 Increasing Number of Cord Blood Banks Globally 11.2 Global Biobanking Company Sector Analysis & Breakdown 11.3 Allogenic Versus Autologous Transplant Frequency 11.4 Biobanking Market Analysis & Forecast to 2021 11.5 Major Global Players 12.0 Global Access & Challenges of the Regenerative Medicine Market 12.1 Regenerative Medicine Market in the USA 12.2 Regenerative Medicine in Japan 12.3 Regenerative Medicine in China 12.4 Regenerative Medicine in South Korea 13.0 Cell and CAR T Therapy 13.1 Challenges Relating to Cell therapy and Chimeric Antigen Receptor T Cells in Immunotherapy 13.2 Regulations Pertaining to Immunotherapy, including Adoptive Cell Therapy (CAR-T and TCR) Immunotherapy Regulation in the USA 13.3 Regulations for Cell Therapy & Immunotherapy in Japan 13.4 European Regulation and Cell Therapy & Immunotherapeutics 13.5 Manufacturing of Immunotherapies 13.6 Supply Chain & Logistics 13.7 Pricing & Cost Analysis 14.0 Company Profiles 14.1 Astellas Institute for Regenerative Medicine (Ocata Therapeutics) 14.2 Athersys 14.3 Baxter International (Baxalta, Shire) 14.4 Caladrius Biosciences (NeoStem) 14.5 Cynata Therapeutics 14.6 Cytori Therapeutics 14.7 MEDIPOST 14.8 Mesoblast 14.9 NuVasive 14.10 Osiris Therapeutics 14.11 Plasticell 14.12 Pluristem Therapeutics 14.13 Pfizer 14.14 StemCells Inc 14.15 STEMCELL Technologies 14.16 Takara Bio 14.17 Tigenix 15.0 SWOT Industry Analysis For more information about this report visit http://www.researchandmarkets.com/research/ml94n2/global


North America is estimated to hold a whopping 45.3% value share in the global GMP cell banking services market by the end of 2017 and will witness an increase of 231 basis points in market share by 2025 over 2017. The North America regional market will create absolute $ opportunity of US$ 23 Mn in 2018 over 2017. In a new report titled "Global Market Study on GMP Cell Banking Services: Mammalian Cell Type Segment Revenue Projected to Grow 3.2x by 2025 End as Compared to that in 2017," Persistence Market Research forecasts revenue from the North America market to grow 3.1x by 2025 end as compared to that in 2017. This will directly impact the global GMP cell banking services market, which will likely grow from US$ 346.6 Mn in 2017 to US$ 1,012.4 Mn by the end of 2025, translating into a CAGR of 14.3% during the eight year forecast period 2017 - 2025. Strategic industry consolidations and increase in demand for Ready-to-Use (RTU) Bioassay Banks is trending the global GMP cell banking services market One of the key objectives of the report is to identify the key trends governing the global GMP cell banking services market and present a clear picture of the various forces impacting the market at a micro and macro level. A sustained growth of the market can be attributed to macro-economic drivers such as increased public and private sector funding for disease research, which is expected to bring newer therapies to the market; high costs of clinical development; and various collaborative initiatives to identify therapies for difficult-to-treat illnesses. On the supply side, an expansion of production facilities by key players to meet growing customer demand besides offering customized solutions based on specific customer needs (this involves strategic tie-ups between biopharmaceutical companies and cell banking service providers) are some of the factors likely to push the global GMP cell banking services market ahead in the coming years. The report also identifies certain demand side drivers boosting the market such as a growing number of biologics in development currently, limited in-house storage and testing capabilities and a rise in the demand for outsourcing and contract manufacturing. While the above growth factors are indicative of a mature market, Persistence Market Research identifies certain pull factors likely to restrain the market to a certain extent in the coming years. First off, the global GMP cell banking services market is highly fragmented with multiple vendors offering a variety of services - resulting in limited global reach. Besides, complexities in the production and manufacturing processes, a constantly evolving technology landscape, and inconsistent demand for services are likely to restrain revenue growth of the global GMP cell banking services market during the forecast period. Persistence Market Research predicts a large opportunity for key players in the fast growing Asia Pacific region. It must be noted that there has been a shift of R&D and technology investments in the healthcare industry from North America and Europe to Asia Pacific with developing APAC economies such as India offering increased scope for outsourcing of biotech projects owing to ample skilled and qualified manpower at optimal costs. A sample of this report is available upon request@ http://www.persistencemarketresearch.com/samples/13735 Mammalian cell type segment to retain its pole position throughout the forecast period Among the cell type segments, the Mammalian segment was the dominant segment in 2016 and is expected to retain its dominance through 2025. From an estimated US$ 216 Mn in 2017 to a market valuation in excess of US$ 680 Mn by the end of the forecast period, the Mammalian segment will register the highest CAGR of 15.6% among the other cell type segments. The Microbial segment is the second most attractive cell type segment in the global GMP cell banking services market in terms of revenue. Registering a value CAGR of 12.9% between 2017 and 2025, the Microbial segment will hold the second position among the cell type segments of the global GMP cell banking services market. Biopharmaceutical Companies will be the largest end users of GMP cell banking services Among the end user segment of the global GMP cell banking services market, the Biopharmaceutical Companies segment will emerge the undisputed leader both in terms of market share (estimated to hold almost 69% share by 2017 end) and CAGR (an impressive 15.4% during 2017 - 2025). In comparison, the Contract Manufacturing Organizations segment will come a pale second, recording a market attractiveness index of 0.5 during the forecast period. Request to View Report Table of Contents, Figures, and Tables @ http://www.persistencemarketresearch.com/market-research/gmp-cell-banking-service-market/toc The top companies profiled in the report include Wuxi AppTec, Charles River Laboratories International Inc, Eurofins Scientific, Merck KGaA, Lonza Group Ltd., SGS Ltd., ViruSure GmbH, Austrianova, Goodwin Biotechnology Inc., and Paragon Bioservices Inc. Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance. To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.


News Article | May 11, 2017
Site: globenewswire.com

SAN DIEGO and TORONTO, May 11, 2017 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, today announced financial results for the three months ended March 31, 2017 and reported on corporate developments. Unless specified otherwise, all amounts are in Canadian dollars. The net loss for the quarter ended March 31, 2017 was $4.4 million ($0.25 per share) compared with $5.1 million ($0.42 per share) in the quarter ended March 31, 2016. Total cash and cash equivalents and investments as of March 31, 2017 were $12.0 million (or $9.0 million US dollars) which, based on information currently available, provides the Company with sufficient resources to fund research and development and operations into Q2 2018. “We, along with some of the nation’s leading hematology researchers, continue to generate compelling data on CG’806, an oral first-in-class pan-FLT3/BTK inhibitor that we plan to develop for patients with FLT3-driven acute myeloid leukemia and certain B-cell malignancies,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. “Preclinical data presented at AACR this past week demonstrated the ability of CG’806 to potently inhibit all mutant forms of FLT3 tested and to completely eradicate tumors in AML xenograft models in the absence of toxicities. Though early, we believe these data begin to position CG’806 as a best-in-class pan-FLT3 inhibitor for the treatment of AML. In addition, CG’806 is a potent non-covalent inhibitor of the wild type and C481S mutant forms of BTK, and we plan to develop CG806 in parallel for patients with B cell malignancies resistant and intolerant to covalent BTK inhibitors. We are working towards advancing this molecule into clinical trials within a year.” Our net loss for the three months ended March 31, 2017 was $4.4 million ($0.25 per share) compared with $5.1 million ($0.42 per share) during the three months ended March 31, 2016. The decrease in the net loss during the three months ended March 31, 2017 compared with the three months ended March 31, 2016 is primarily related to savings from cancelling the LALS/Moffitt collaboration, lower stock-based compensation, and offset by development activities related to the CG’806 development program which started in the second half of 2016. We utilized cash of $3.5 million in our operating activities in the three months ended March 31, 2017 compared with $4.5 million in the three months ended March 31, 2016. The decrease in cash used in operating activities in the current period is due mostly to increased accounts payable and accrual balances during the three months ended March 31, 2017. Research and Development Research and development expenses totaled $2.3 million in the three months ended March 31, 2017 compared with $2.3 million in the three months ended March 31, 2016. Research and development costs consist of the following: Expenditures for the three months ended March 31, 2017 were comparable to the expenses incurred in the three months ended March 31, 2016.  Higher program costs associated with the Company’s CG’806 program were offset by lower costs associated related to the cancellation of the LALS/Moffitt collaboration. Lower salaries expense was primarily related to severance payments made in the three months ended March 31, 2016 due to a reduction in Research & Development FTE. General and Administrative General and administrative expenses totaled $2.1 million in the three months ended March 31, 2017, compared to $2.6 million in the three months ended March 31, 2016. General and administrative costs consist of the following: General and administrative expenses excluding salaries, decreased in the three months ended March 31, 2017, compared with the three months ended March 31, 2016, mostly the result of lower travel, consulting and rent costs in the current year related to cost containment initiatives taken in the prior fiscal year. Salary charges in the three months ended March 31, 2017, increased slightly in comparison with the three months ended March 31, 2016, due to severance payments made in the current period that will result in savings in the following fiscal quarters. Stock-based compensation decreased in the three months ended March 31, 2017, compared with the three months ended March 31, 2016, due to large forfeitures in the current period and also due to grants in prior periods having a greater fair value than the grants issued in the three months ended March 31, 2017, and therefore contributing to higher stock-based compensation in the prior year period. Foreign exchange loss in the three months ended March 31, 2016, is the result of a decrease in the value of US dollar denominated cash and cash equivalents balances during the period due to an appreciation of the Canadian dollar compared to the US dollar. During this period the Company’s functional currency was the Canadian dollar. Interest income represents interest earned on our cash and cash equivalent and investment balances.  Foreign exchange gains in the three months ended March 31, 2017, are the result of an appreciation of the Canadian dollar compared to the US dollar. During this period the Company’s functional currency was the US dollar. Effective January 1, 2017, the Company changed its functional currency to US dollars given the prevalence of US dollar denominated activities over time. The Company’s historic source of financing, with the exception of the recent at-the-market equity facility, has been in Canadian dollars and the Company still has a majority of its shareholders in Canada.  For this reason the Company has chosen to keep the presentation currency as Canadian. The press release, the financial statements and the management’s discussion and analysis for the quarter ended March 31, 2017 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml Aptose will host a conference call to discuss results for the three months ended March 31, 2017 today, Thursday May 11, 2017 at 5:00 p.m. EDT. Participants can access the conference call by dialing (844) 882-7834 (North American toll free number) and (574) 990-9707 (International) and using passcode 13003413.  The conference call can also be accessed at http://edge.media-server.com/m/p/bfhzuofp and will also be available through a link on the Investor Relations section of Aptose’s website at ir.aptose.com.  Please log onto the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required.  An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days.   An audio replay of the webcast will be available approximately two hours after the conclusion of the call for 7 days by dialing (855) 859-2056, using the passcode 13003413. The information contained in this news release is unaudited. Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology. Aptose is advancing new therapeutics focused on novel cellular targets on the leading edge of cancer. The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. For further information, please visit www.aptose.com. This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws, including, but not limited to, statements relating to the expected cash runway of the Company, the clinical potential and favorable properties of CG’806, the clinical trials for CG’806, the clinical development and potential partnering of APTO-253, the focus of resources on CG’806, and statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “should”, “would”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such factors could include, among others: our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market and economic conditions; inability of new manufacturers to produce acceptable batches of GMP in sufficient quantities; unexpected manufacturing defects; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.


News Article | May 11, 2017
Site: www.rdmag.com

Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery and development, today announces it has signed a non-exclusive licensing agreement with ERS Genomics to access its foundational intellectual property related to CRISPR/Cas9 gene editing technology. The agreement grants Oxford Genetics the rights to use the technology for the provision of genome engineering services, and as part of it ongoing R&D for cell line development and gene therapy viral vector improvement. The license also allows the development and commercial sale of research tools and reagents, and the use of CRISPR edited cell lines for the GMP manufacturing of bio-therapeutics. According to BCC Research, the global market for genome editing is estimated at $206 million in 2014, and is expected to grow to reach over $2.0 billion by 2020. The availability of the latest technologies is vital to supporting this rapid growth within the industry. "Oxford Genetics is committed to driving innovation in the biopharmaceutical industry. Licensing the CRISPR gene editing technology from ERS Genomics is another step on our journey to establishing the most efficient and integrated service portfolio in this sector," commented Dr. Paul Brooks, Ph.D., CCO, Oxford Genetics. "We are excited to be adding this technology to our existing portfolio in the synthetic biology space and supporting the rapidly expanding market for products and services that utilise genome engineering technologies.” The licensing of this technologies comes just two months after Oxford Genetics announced the award of a £1.61M Innovate UK government grant aimed at optimising the bioproduction of complex biologics via screening methodologies. The licensing of the CRISPR genome engineering technology will enable the business to explore and answer a diverse set of previously unaddressed biological questions via automated high-throughput screening approaches. Eric Rhodes, CEO at ERS Genomics added, “We’re pleased to add Oxford Genetics into our portfolio of licensees as they provide important tools and services to support the needs of the life science and pharmaceutical research and manufacturing communities. This further supports ERS’ goal of making the CRISPR technology broadly available.”


SAN DIEGO--(BUSINESS WIRE)--Batu Biologics, an immuno-oncology company dedicated to studying blood vessel formation within tumors, announced today the launch of an equity crowdfunding campaign on EquityNet. This investment offering, which is open to accredited investors, is seeking to fund the upscaling of GMP manufacturing for the ValloVax platform in preparation for our planned Phase I study in advanced lung cancer. ValloVax is a cellular immunotherapy that trains the body to target and kill pathological blood vessels specific to the tumor. Antigens found preferentially on the tumor endothelium are ideal targets for cancer therapeutics because a.) they are in direct contact with the immune system via the blood and are therefore easier to access b.) an immune response against the tumor vasculature may increase lymphocyte infiltration into tumors and c.) by killing the blood vessels we are seeking to starve the tumor of its food supply. Angiogenesis is a biological process that is commonly found in all solid tumors. Instead of targeting the tumor itself, which can be a difficult strategy due to cancer’s propensity to mutate, ValloVax trains the body to initiate a cellular and antibody response against several targets associated with tumor angiogenesis. To date, ValloVax has demonstrated strong inhibition of melanoma, lewis lung carcinoma, colorectal cancer, breast cancer, and glioblastoma in animal models. By facilitating better drug delivery and lymphocyte penetration into the tumor, ValloVax may be an ideal candidate for combination therapies with some of the latest immuno-oncology drugs in late stage clinical development or on market. “Batu has gained significant traction in our partnership efforts for ValloVax in the past couple months, and we are confident that the clearance of our IND application with the Food and Drug Administration will be a critical value inflection point for the company,“ stated Samuel C. Wagner, Chief Executive Officer of Batu Biologics. “We are looking to leverage the FDA’s approval of our IND application to push forward with an international clinical development plan. This is an exciting time for the Company and I would welcome prospective investors to reach out to learn more about our plans for commercialization and the opportunity.” Batu Biologics is holding a press conference located in the lobby of the ResMed facilities that will be open to the public on Thursday, May 11th, at 10:00AM (PST). The meeting will be located at the following address: Visit our campaign today to learn more about Batu Biologics at: www.equitynet.com/c/batu-biologics-inc


News Article | May 12, 2017
Site: www.businesswire.com

INCHEON, South Korea--(BUSINESS WIRE)--Detailed results from NOR-SWITCH, a randomized, double-blind, switching study of biosimilar infliximab, CT-P13 (Remsima®/ Inflectra™) were published in the prestigious journal The Lancet. Sponsored by the Norwegian government, the study explored the impact of switching adult patients who were stable on reference infliximab to Celltrion Healthcare’s biosimilar CT-P13. The results demonstrate that CT-P13 is not inferior to continued treatment with the reference product and that patients can be safely switched. 1 Dr Kwon, Medical Director at Celltrion Healthcare said: “ The publication of the NOR-SWITCH data in The Lancet marks another important milestone on the path to increasing physician confidence in using biosimilar infliximab when looking to switch their patients.” Following presentations at both the 2016 United European Gastroenterology (UEG) Week and the American College of Rheumatology (ACR) Annual Meeting, the findings from the study revealed that out of the 50% of patients switched to CT-P13, the proportion of patients with disease worsening were comparable to those who remained on reference infliximab (29.6 and 26.2% respectively.) The data discontinuation rates due to a lack of efficacy for reference infliximab and biosimilar infliximab were eight and three respectively. The time to study drug discontinuation was almost identical between the two groups, with similar overall remission rates and frequencies of adverse events also observed. 1 Tore K. Kvien, Head of Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, and the lead author of the NOR-SWITCH study, also said: “ NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13. As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.” The Norwegian government wanted to determine the impact of switching adult patients who were stable on reference infliximab to biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved (Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis). Involving nearly 500 patients, the study was designed by a multidisciplinary and multiregional project group with special competence in performance of strategy trials, immunogenicity, and statistics led by Professor Tore Kvien at the Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Additionally, the group consisted of representatives from the three relevant patient organisations.2 CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ The Lancet is one of the world's leading independent general medical journal. The peer-reviewed journal publishes medical news, original research, and reviews on all aspects of clinical medicine and International Health. The Lancet has an Impact Factor of 44.002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Available at: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [accessed May 2017]. 2 GAFPA. NOR-SWITCH. Available at: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/GAfPA_Norswitch_Sept.-2016.pdf [accessed May 2017].


Dr Kwon, medisch directeur bij Celltrion Healthcare, verklaarde: “ De publicatie van de NOR-SWITCH-gegevens in The Lancet markeert opnieuw een belangrijke mijlpaal voor het vergroten van het vertrouwen van artsen om biosimilar infliximab te gebruiken als overwogen wordt om hun patiënten over te schakelen.” Na presentaties tijdens zowel de 2016 United European Gastroenterology (UEG) Week als de jaarlijkse bijeenkomst van het American College of Rheumatology (ACR) bleek uit de bevindingen van de studie dat van de 50% van de patiënten die overgeschakeld waren naar CT-P13, het percentage patiënten met verslechtering van de ziekte vergelijkbaar was met die patiënten die referentie infliximab bleven gebruiken (respectievelijk 29,6 en 26,2%). De datadiscontinueringspercentages door een gebrek aan werkzaamheid voor referentie infliximab en biosimilar infliximab waren respectievelijk acht en drie. De tijd om de stopzetting van de medicijnen te onderzoeken was bijna identiek tussen de twee groepen, waarbij ook vergelijkbare totale remissiecijfers en frequenties van bijwerkingen waargenomen werden. 1 CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ The Lancet is een van 's werelds grootste onafhankelijke algemene medische tijdschriften. Het intercollegiaal getoetste tijdschrift publiceert medisch nieuws en origineel onderzoek en biedt evaluaties over alle aspecten van klinische geneeskunde en internationale gezondheid. The Lancet heeft een impactfactor van 44,002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, beschikbaar op: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [geraadpleegd in mei 2017]. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.


Celltrion Healthcare dirige la comercialización, las ventas y la distribución global de los medicamentos biológicos desarrollados por Celltrion, Inc. a través de una red global que engloba a más de 120 países. Los productos de Celltrion Healthcare se fabrican en las modernas instalaciones de cultivos celulares de mamíferos, diseñadas y construidas para cumplir con los requisitos de la Administración de Alimentos y Fármacos de EE. UU. (US Food and Drug Administration [FDA]) cGMP y de la EU GMP. Para más información, visite la página web: http://www.celltrionhealthcare.com/ 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, disponible en: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [última visita: mayo de 2017].

Loading GMP collaborators
Loading GMP collaborators