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Market growth can be attributed to factors such as rising incidence of neurological disorders, growing disease awareness, introduction of novel antiepileptic drugs (AEDs), strong government support and initiatives. Moreover, increasing R&D investment and launch of extended-release formulations are further expected to fuel the market growth. However, high cost of patented drugs, concerns over decreasing healthcare costs as part of government austerity measures, particularly in Europe and low accessibility to antiepileptic drugs in low and middle income countries, are likely to restrict the market growth. Vimpat is the undisputed leading drug of Global Epilepsy Drugs Market. It has a market share of nearly 22% in 2016 and is expected that Vimpat will gain its momentum till the forecasting period. Keppra was the second highest market share taker with more than 19% share in 2016 but the prospect of this drug will change due to the patent expiration in 2018 and its share decline to XX% by 2021. It is expected that Lamictal will be second leading drug with nearly XX% share by 2021. Onfi will hold the third highest share of the Epilepsy Drugs market, being followed by Depakine by the year end of 2021. To get a sample of the report visit: https://www.bharatbook.com/drugs-market-research-reports-836912/epilepsy-drugs-global.html The research report titled "Epilepsy Drugs Market: Global Demand, Growth Potential & Opportunity Outlook 2021" examines the market, competitive landscape and trends of the Global Epilepsy Drug Market. This report analyzes market data and provides a better understanding of Epilepsy Drugs sales value and demand in the Global Market. Market outlook in value terms for the forecasted period for Epilepsy Drugs Market has been detailed in the report. Key trends in terms of collaborations, partnerships and licensing agreements are analysed with details. The report also explores detailed description of growth drivers and inhibitors of the Global Epilpesy Drugs Market. The report concludes with the profiles of major players in the Epilepsy Drugs Market such as UCB, EISAI, Pfizer, Sanofi and Lundbeck. The major market players are evaluated on various parameters such as company overview and latest development and trends in the Epilepsy Drugs Market • Key Drivers and Inhibitors of the Epilepsy Drugs Market Key Epilepsy Drugs Covered in the Report are as follows: Key Companies Covered in the Report are as follows: Bharat Book Bureau established in 1989 is the leading market research information aggregator that provides market research reports, industry analysis, company profiles, business reports, Country Reports, newsletters and online databases. Bharat Book Bureau provides over a million reports from more than 400 publishers around the globe.


Receive press releases from iHealthcareAnalyst, Inc.: By Email Monoclonal Antibody Therapeutics Market by Sources, Therapies, Applications, End Users and Forecast to 2021, Upcoming Research by iHealthcareAnalyst, Inc. Monoclonal Antibody Therapeutics Market by Source Type (Chimeric and Humanized, Human, Murine, Others), Therapy Type (Antibody-Directed Enzyme Prodrug Therapy, Antibody-Drug Conjugates, Radioimmunotherapy), Application (Autoimmune Diseases, Cancer, Hematological Diseases, Infection, Ophthalmological Diseases, Others), and End User (Hospitals, Private Clinics, Research Institutes) and Forecast 2017-2021 Maryland Heights, MO, May 12, 2017 --( Visit Monoclonal Antibody Therapeutics Market by Source Type (Chimeric and Humanized, Human, Murine, Others), Therapy Type (Antibody-Directed Enzyme Prodrug Therapy, Antibody-Drug Conjugates, Radioimmunotherapy), Application (Autoimmune Diseases, Cancer, Hematological Diseases, Infection, Ophthalmological Diseases, Others), and End User (Hospitals, Private Clinics, Research Institutes) and Forecast 2017-2021 at https://www.ihealthcareanalyst.com/report/monoclonal-antibody-therapeutics-market/ The global monoclonal antibody therapeutics market segmentation is based on source type (chimeric and humanized, human, murine, others), therapy type (antibody-directed enzyme prodrug therapy, antibody-drug conjugates, radioimmunotherapy), application (autoimmune diseases, cancer, hematological diseases, infection, ophthalmological diseases, others), and end user (hospitals, private clinics, research institutes). The global monoclonal antibody therapeutics market report provides market size (Revenue USD Million 2014 to 2021), market share, trends and forecasts growth trends (CAGR%, 2017 to 2021). The global monoclonal antibody therapeutics market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global monoclonal antibody therapeutics market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and also tracks the major competitors operating in the market by company overview, financial snapshot, key products, technologies and services offered, market share analysis and recent trends in the global market. Major players operating in the global monoclonal antibody therapeutics market and included in this report are AbbVie, Inc., Alexion Pharmaceuticals, Amgen, Inc., Bayer Healthcare Pharmaceuticals, Biogen. Inc., Bristol-Myers Squibb Company, Eli Lilly and Co., F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc., Johnson and Johnson, Merck and Co., Inc., Novartis Pharmaceuticals, Pfizer, Inc., Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, Takeda Pharmaceutical Co., and UCB. 1. Source Type 1.1. Chimeric and Humanized 1.2. Human 1.3. Murine 1.4. Others 2. Therapy Type 2.1. Antibody-directed enzyme prodrug therapy 2.2. Antibody-drug conjugates 2.3. Radioimmunotherapy 3. Application 3.1. Autoimmune Diseases 3.2. Cancer 3.3. Hematological Diseases 3.4. Infection 3.5. Ophthalmological Diseases 3.6. Others 4. End User 4.1. Hospitals 4.2. Private Clinics 4.3. Research Institutes 5. Company Profiles 5.1. AbbVie, Inc. 5.2. Alexion Pharmaceuticals 5.3. Amgen, Inc. 5.4. Bayer Healthcare Pharmaceuticals 5.5. Biogen. Inc. 5.6. Bristol-Myers Squibb Company 5.7. Eli Lilly and Co. 5.8. F. Hoffmann-La Roche Ltd. 5.9. GlaxoSmithKline plc. 5.10. Johnson and Johnson 5.11. Merck and Co., Inc. 5.12. Novartis Pharmaceuticals 5.13. Pfizer, Inc. 5.14. Regeneron Pharmaceuticals 5.15. Sanofi 5.16. Spectrum Pharmaceuticals 5.17. Takeda Pharmaceutical Co. 5.18. UCB To request Table of Contents and Sample Pages of this report visit: https://www.ihealthcareanalyst.com/report/monoclonal-antibody-therapeutics-market/  About Us iHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals. In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study. Contact Us iHealthcareAnalyst, Inc. 2109, Mckelvey Hill Drive, Maryland Heights, MO 63043 United States Email: sales@ihealthcareanalyst.com Website: https://www.ihealthcareanalyst.com Maryland Heights, MO, May 12, 2017 --( PR.com )-- Monoclonal antibody therapy is a form of immunotherapy that uses monoclonal antibodies (mAb) to bind monospecifically to certain cells or proteins. This may then stimulate the patient's immune system to attack those cells. It is possible to create a mAb specific to almost any extracellular/ cell surface target. Research and development is underway to create antibodies for diseases (such as rheumatoid arthritis, multiple sclerosis, Alzheimer's disease, Ebola and different types of cancers). Chimeric antibodies are composed of murine variable regions fused onto human constant regions. Humanized antibodies are produced by grafting murine hypervariable regions on amino acid domains into human antibodies. Human monoclonal antibodies are produced using transgenic mice or phage display libraries by transferring human immunoglobulin genes into the murine genome and vaccinating the transgenic mouse against the desired antigen, leading to the production of appropriate monoclonal antibodies. Murine antibodies have short half-life in vivo, limited penetration into tumor sites and inadequately recruit host effector functions.Visit Monoclonal Antibody Therapeutics Market by Source Type (Chimeric and Humanized, Human, Murine, Others), Therapy Type (Antibody-Directed Enzyme Prodrug Therapy, Antibody-Drug Conjugates, Radioimmunotherapy), Application (Autoimmune Diseases, Cancer, Hematological Diseases, Infection, Ophthalmological Diseases, Others), and End User (Hospitals, Private Clinics, Research Institutes) and Forecast 2017-2021 at https://www.ihealthcareanalyst.com/report/monoclonal-antibody-therapeutics-market/The global monoclonal antibody therapeutics market segmentation is based on source type (chimeric and humanized, human, murine, others), therapy type (antibody-directed enzyme prodrug therapy, antibody-drug conjugates, radioimmunotherapy), application (autoimmune diseases, cancer, hematological diseases, infection, ophthalmological diseases, others), and end user (hospitals, private clinics, research institutes).The global monoclonal antibody therapeutics market report provides market size (Revenue USD Million 2014 to 2021), market share, trends and forecasts growth trends (CAGR%, 2017 to 2021). The global monoclonal antibody therapeutics market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global monoclonal antibody therapeutics market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and also tracks the major competitors operating in the market by company overview, financial snapshot, key products, technologies and services offered, market share analysis and recent trends in the global market.Major players operating in the global monoclonal antibody therapeutics market and included in this report are AbbVie, Inc., Alexion Pharmaceuticals, Amgen, Inc., Bayer Healthcare Pharmaceuticals, Biogen. Inc., Bristol-Myers Squibb Company, Eli Lilly and Co., F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc., Johnson and Johnson, Merck and Co., Inc., Novartis Pharmaceuticals, Pfizer, Inc., Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, Takeda Pharmaceutical Co., and UCB.1. Source Type1.1. Chimeric and Humanized1.2. Human1.3. Murine1.4. Others2. Therapy Type2.1. Antibody-directed enzyme prodrug therapy2.2. Antibody-drug conjugates2.3. Radioimmunotherapy3. Application3.1. Autoimmune Diseases3.2. Cancer3.3. Hematological Diseases3.4. Infection3.5. Ophthalmological Diseases3.6. Others4. End User4.1. Hospitals4.2. Private Clinics4.3. Research Institutes5. Company Profiles5.1. AbbVie, Inc.5.2. Alexion Pharmaceuticals5.3. Amgen, Inc.5.4. Bayer Healthcare Pharmaceuticals5.5. Biogen. Inc.5.6. Bristol-Myers Squibb Company5.7. Eli Lilly and Co.5.8. F. Hoffmann-La Roche Ltd.5.9. GlaxoSmithKline plc.5.10. Johnson and Johnson5.11. Merck and Co., Inc.5.12. Novartis Pharmaceuticals5.13. Pfizer, Inc.5.14. Regeneron Pharmaceuticals5.15. Sanofi5.16. Spectrum Pharmaceuticals5.17. Takeda Pharmaceutical Co.5.18. UCBTo request Table of Contents and Sample Pages of this report visit:https://www.ihealthcareanalyst.com/report/monoclonal-antibody-therapeutics-market/About UsiHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals.In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study.Contact UsiHealthcareAnalyst, Inc.2109, Mckelvey Hill Drive,Maryland Heights, MO 63043United StatesEmail: sales@ihealthcareanalyst.comWebsite: https://www.ihealthcareanalyst.com Click here to view the list of recent Press Releases from iHealthcareAnalyst, Inc.


-Submissions for CIMZIA® (certolizumab pegol) and glycopyrronium tosylate remain on schedule for later this year MENLO PARK, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today reported financial results for the quarter ended March 31, 2017 and provided an update on its clinical development programs. “We are off to a great start in 2017, including the successful completion of our third Phase 3 clinical trial for CIMZIA, a pre-NDA meeting with the FDA for glycopyrronium tosylate and the closing of a successful follow-on offering,” said Tom Wiggans, chairman and chief executive officer of Dermira. “As we prepare for the remainder of the year, we anticipate UCB submitting marketing applications for CIMZIA for the treatment of chronic plaque psoriasis in the United States, Europe and Canada in the third quarter and we expect to submit a new drug application for glycopyrronium tosylate for the treatment of axillary hyperhidrosis in the second half of this year. We also continue to work on expanding our product portfolio and have made progress on building our commercial operations, which we plan to provide an update on later in the year.” About Dermira Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s product pipeline includes three late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com. In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts. Forward-Looking Statements The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to: the completion of, and timing expectations for the receipt and announcement of topline results from, Dermira’s CLAREOS-1 and CLAREOS-2 trials; the timing and submission of marketing applications in the United States, Europe and Canada for CIMZIA; the timing and submission of an NDA to the FDA for glycopyrronium tosylate; and estimates of 2017 collaboration and license revenue, operating expenses, stock-based compensation expense and 2017 year-end cash, cash equivalents and short- and long-term investments. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcome of Dermira’s clinical trials; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.


Market growth can be attributed to factors such as rising incidence of neurological disorders, growing disease awareness, introduction of novel antiepileptic drugs (AEDs), strong government support and initiatives. Moreover, increasing R&D investment and launch of extended-release formulations are further expected to fuel the market growth. However, high cost of patented drugs, concerns over decreasing healthcare costs as part of government austerity measures, particularly in Europe and low accessibility to antiepileptic drugs in low and middle income countries, are likely to restrict the market growth. Vimpat is the undisputed leading drug of Global Epilepsy Drugs Market. It has a market share of nearly 22% in 2016 and is expected that Vimpat will gain its momentum till the forecasting period. Keppra was the second highest market share taker with more than 19% share in 2016 but the prospect of this drug will change due to the patent expiration in 2018 and its share decline to XX% by 2021. It is expected that Lamictal will be second leading drug with nearly XX% share by 2021. Onfi will hold the third highest share of the Epilepsy Drugs market, being followed by Depakine by the year end of 2021. To get a sample of the report visit: https://www.bharatbook.com/drugs-market-research-reports-836912/epilepsy-drugs-global.html The research report titled "Epilepsy Drugs Market: Global Demand, Growth Potential & Opportunity Outlook 2021" examines the market, competitive landscape and trends of the Global Epilepsy Drug Market. This report analyzes market data and provides a better understanding of Epilepsy Drugs sales value and demand in the Global Market. Market outlook in value terms for the forecasted period for Epilepsy Drugs Market has been detailed in the report. Key trends in terms of collaborations, partnerships and licensing agreements are analysed with details. The report also explores detailed description of growth drivers and inhibitors of the Global Epilpesy Drugs Market. The report concludes with the profiles of major players in the Epilepsy Drugs Market such as UCB, EISAI, Pfizer, Sanofi and Lundbeck. The major market players are evaluated on various parameters such as company overview and latest development and trends in the Epilepsy Drugs Market • Key Drivers and Inhibitors of the Epilepsy Drugs Market Key Epilepsy Drugs Covered in the Report are as follows: Key Companies Covered in the Report are as follows: Bharat Book Bureau established in 1989 is the leading market research information aggregator that provides market research reports, industry analysis, company profiles, business reports, Country Reports, newsletters and online databases. Bharat Book Bureau provides over a million reports from more than 400 publishers around the globe.


SANTA CLARA, Calif.--(BUSINESS WIRE)--Renesas Electronics Corporation (TSE:6723), a premier supplier of advanced semiconductor solutions, today announced that Automotive Grade Linux (AGL) has adopted the Renesas R-Car Starter Kit as one of its standard reference platforms for software development. AGL is a collaborative open source project that is bringing together automakers, suppliers and technology companies to build a Linux-based, open software platform for automotive applications that can serve as the de facto industry standard. Its adoption of the Renesas R-Car Starter Kit makes it easy for software developers to acquire the hardware environment that runs software developed by this project and allows them to quickly and easily develop in-vehicle infotainment (IVI) application software for next-generation connected cars. The R-Car Starter Kit supports the Unified Code Base (UCB) 3.0, which the AGL project released in January 2017. The R-Car Starter Kit enables the up-to-date 64-bit software development environment, which unlike the earlier 32-bit environment, allows the latest IT solutions, including container technology (Note 1), to be applied seamlessly to automotive applications. In addition, two IVI development expansion boards from a Renesas partner (Note 2) that can be used with the R-Car Starter Kit will be available in July 2017. The standard expansion board includes multiple displays and a wide range of network interfaces and the advanced model provide interfaces that can be expanded to up to eight channels of camera input as well as high-speed/large-capacity storage. Software developers can easily maintain IVI software development with the latest software development environment platform that will serve as the industry standard, and the expansion boards optimized for IVI development. This platform and board access, along with the support provided by the free-of charge Renesas libraries and the R-Car ecosystem that consists of over 190 companies, allows software developers to quickly develop IVI application software and reduce costs. Renesas will participate as a gold sponsor, in the Automotive Linux Summit (ALS) to be held from May 31, 2017 at the Tokyo Conference Center. In addition to an exhibition of the latest AGL development environments, Renesas will demonstrate its state-of-the-art connected car cockpit that connect to cloud IT services. "Renesas is a passionate and active supporter of open source and understands the impact that Automotive Grade Linux will have on development and enabling rapid innovation across the industry,” said Dan Cauchy, Executive Director of Automotive Grade Linux, The Linux Foundation. “By adopting the Renesas R-Car Starter Kit as one of our standard reference platforms, developers will be able to quickly and easily develop applications using the AGL Unified Code Base.” "We are pleased that our R-Car Starter Kit has been adopted as one of the standard reference platforms by the AGL project dedicated to creating industry-standard advanced open source software," said Masahiro Suzuki, Vice President, Head of Automotive Information Solution Business Division, Renesas Electronics Corporation. "Software developers will now have access to both R-Car Starter Kit hardware and AGL Unified Code Base, which allows them to put all their efforts into developing even higher level specialized software. Renesas hopes to contribute to increasing the pace of innovation of new IVI developments across the industry.” (Note 1) Containers are a type of virtualization technology that are incorporated into systems where they are combined with the execution environment that the applications require. This technology has received much attention in recent years from the IT industry since it can significantly reduce software management costs. For more information on Renesas, follow Renesas Electronics America at @RenesasAmerica on Twitter and http://www.facebook.com/RenesasAmerica. Renesas Electronics Corporation (TSE: 6723) delivers trusted embedded design innovation with complete semiconductor solutions that enable billions of connected, intelligent devices to enhance the way people work and live—securely and safely. The number one global supplier of microcontrollers, and a leader in Analog & Power and SoC products, Renesas provides the expertise, quality, and comprehensive solutions for a broad range of Automotive, Industrial, Home Electronics (HE), Office Automation (OA) and Information Communication Technology (ICT) applications to help shape a limitless future. Learn more at renesas.com. (Remarks) All registered trademarks or trademarks are the property of their respective owners.


Market research and strategy will also be on the agenda for the anticipated 13-14 July forum -- A keynote on "Competitive Intelligence Excellence" will help set the stage for two days of industry discussion at the 2017 Pharma CI Asia Conference & Exhibition, held 13-14 July at the Hilton Singapore, Singapore. Osamu Karita will lead the talk, drawing from his experience as Senior Partner and Managing Director at The Boston Consulting Group. This talk will follow a special keynote from Ana Cerdeira, VP of Strategy at Takeda Pharmaceuticals.Pharma CI Asia puts the focus on the particular needs of this region, while also taking a look at the global picture, which is why the Pharma CI Asia Conference is the standard-bearer for intelligence forums in Asia and worldwide. With the multiple talks, networking opportunities, and deep-dive sessions, there's simply no better venue to gain access to the ideas and experts at the center of the next wave of progress.Other agenda topics include:•          Building a Community of Insights•          HCP's Social Media Tracking in China•          CI Strategies in Niche Therapeutic Segments•          Competitive Intelligence Framework for Organization Readiness – Pharma / Innovation Centric Industries•          and more!View the agenda here: http://www.pharmaciconference.com/ Register by Friday 9 June to take advantage of the Early Bird rate and secure the best possible price.For the last decade and going strong today, the Pharma CI Conference & Exhibition is the best and largest assembly of pharmaceutical competitive intelligence executives in the world!The Pharma CI Conference features the participation of the world's top companies, including: A. Menarini Asia-Pacific, Abbott, Astellas, Bristol-Myers Squibb, Daiichi Sankyo, Deallus Consulting, Harvest Moon Pharmaceuticals, Lifescience Dynamics Limited, Medtronic, Novartis, Roche, SAI Asia, Sanofi China, Sanofi Genzyme, Shionogi, Takeda Pharmaceuticals, The Boston Consulting Group, UCB, and more.To register to attend the conference, go to: http://www.pharmaciconference.com/To view the detailed agenda, go to: http://www.pharmaciconference.com/For more information, call +1-212-228-7974 or email info@pharmaciconference.com


"The practice of helping babies by providing stem cells at birth has been around for a long time; it makes sense for the sickest infants," said Anup Katheria, MD, director of the Neonatal Research Institute. "We're focused on producing evidence that shows the benefits. We think this could become the foundation for practice-changing birthing techniques, transforming outcomes for the most critical of newborns nationwide." As a California-based public/private cord blood banking company and with a strong research focus, StemCyte stands ready to help efficiently and effectively to support the partnership with Sharp HealthCare to educate expecting parents of their options, to ensure the information is delivered accurately and consistently, and to collect the cells in cord blood and process and store them with the highest quality standards in the industry. "We are excited to work with the Sharp Mary Birch Neonatal Research Institute, and we are looking forward to maximizing the capacity for cord-blood banking. Residents of California and people around the world will benefit from the research and increased availability of umbilical cord blood stem cell transplant units." said Jonas C. Wang, Ph.D., CEO/ Chairman of StemCyte Group. About StemCyte StemCyte's rich history started with a mission of being dedicated to helping the world's physicians save more lives by providing high quality, safe and effective stem cell transplantation and therapy to all patients in need. Located in the US, India and Taiwan, StemCyte has supplied over 2100 cord blood products for over 40 life-threatening diseases to over 300 leading worldwide transplant centers.  StemCyte is actively involved in the development of stem cell therapies. StemCyte was the first to donate umbilical cord blood units (UCB) to Dr. Jaing of Chung Gung Memorial Hospital for his clinical trial to use UCB to treat and cure Beta Thalassemia.  More excitingly is the work and accomplishments of Prof Wise Young, MD, PhD.  Prof. Young has completed Phase II clinical trials on patients with chronic spinal cord injury with UCB and the results are extremely encouraging. StemCyte is chosen by the US Department of Health and Human Services to help establishing a public National Cord Blood Inventory. Its headquarters are located in Baldwin Park, CA.  To learn more visit www.StemCyte.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/stemcyte-renewed-strategic-partnership-with-the-neonatal-research-institute-at-sharp-mary-birch-hospital-for-women--newborns-300464844.html


-- The CRADLE study found minimal to no transfer of CIMZIA through breast milk -- These studies provide complementary information that is important for the management of women of child bearing age with active chronic inflammatory diseases who face limited options during pregnancy and lactation. Adequate disease control is crucial for these women to ensure optimal infant and maternal health and to reduce adverse pregnancy outcomes BRUSSELS, June 14, 2017 /PRNewswire/ -- UCB today presented results from CRIB, a pharmacokinetic study designed to assess if CIMZIA® (certolizumab pegol) is transferred across the placenta from pregnant women to their infants. The study used a sensitive immunoassay designed specifically to measure CIMZIA and found no measurable levels in 13 out of 14 infant blood samples at birth, and in all infant samples at weeks four and eight after birth. The CRIB study results were presented as an oral presentation at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.1 The studies included women with rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS), and Crohn's disease (CD) – chronic inflammatory diseases (CID) that often affect women of child bearing age. Adequate disease control is crucial to ensure optimal infant and maternal health and to reduce adverse pregnancy outcomes. Yet, many women with CID face inadequate disease control before pregnancy and disease flare during and after pregnancy.2 These women have limited options when considering whether to continue treatment during pregnancy and lactation due to the potential associated health risks for fetuses and infants. They often face uncertainty regarding the use of biologics during pregnancy and breastfeeding.3 Data from the CRIB study offer important, new information for women with CID and their doctors. Results from the CRADLE study (NCT02154425) are also relevant for these patients. Presented this year at EULAR 2017, the study evaluated CIMZIA concentrations in human mature breast milk and found minimal to no transfer of CIMZIA to breast milk.4 "Tumor necrosis factor inhibitors (anti-TNFs) represent one of the most significant advances in the treatment of inflammatory diseases like rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis/ankylosing spondylitis, but research suggests that most of these drugs cross the placenta, so they are usually discontinued during pregnancy," said Xavier Mariette, MD, PhD, Head of Rheumatology, Bicetre Hospital, Paris-Sud University, and lead author of the study. "The CRIB study is the only clinical research that demonstrates how an effective anti-TNF, CIMZIA, shows minimal to no placental transfer from mother to infant. This is very encouraging news for female patients who have an active inflammatory disease." "By partnering with expert researchers, UCB has uncovered and responded to the largely unrecognized needs of women of child bearing age who have active inflammatory diseases. In response to this need, we conducted the CRIB and CRADLE studies which have shown that CIMZIA, the only Fc-free, PEGylated anti-TNF, has minimal to no transfer through the placental barrier, and minimal to no transfer through lactation," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB. CRIB (NCT02019602) was a pharmacokinetic study with a safety evaluation designed to measure the potential level of placental transfer of CIMZIA from pregnant women to their infants. Sixteen women (≥ 30 weeks gestation) who were already receiving CIMZIA for approved indications (RA [N=11], CD [N=3], PsA [N=1] and axSpA/AS [N=1]), were followed in the study.1 To determine CIMZIA plasma levels, blood samples were collected from each woman, the umbilical cords, and their infants at delivery and again from infants at weeks four and eight post-delivery. The study evaluated CIMZIA concentration in the blood using a sensitive, CIMZIA-specific electrochemiluminescence immunoassay with a lower level of quantification (LLOQ) of 0.032ug/mL, which is 10 times more sensitive than prior CIMZIA assays.1 The study found that CIMZIA levels were below LLOQ in 13 out of 14 infant blood samples at birth, and in all samples at weeks four and eight. One infant had a minimal CZP level of 0.042ug/ML (infant/mother ratio of 0.009). No anti-CIMZIA antibodies were detected in mothers, umbilical cords, or infants, and the infants of CIMZIA-exposed mothers had a safety profile consistent with that of unexposed similar-age infants. These data indicate no to minimal placental transfer of CIMZIA from mothers to infants, suggesting lack of in utero fetal exposure during the second and third trimesters.1 In CRIB, adverse events experienced by the infants did not show any patterns or clusters of events suggesting a specific safety signal in children. Safety data in the mothers were in line with the known safety profile of CZP and pregnancy profile of these underlying diseases. The objective of CRADLE (NCT02154425), a pharmacokinetic study with a safety evaluation, was to determine the concentration of CIMZIA in human breast milk and to calculate the average daily infant dose (ADID), an estimation of the dose of maternal CIMZIA ingested by the infant every day over the dosing interval. A post-hoc analysis also calculated the relative infant dose (RID) of CIMZIA in breast milk to provide relative context of CIMZIA data to literature available for other drugs documented during breast feeding. In CRADLE, adverse events in the infants of mothers exposed to CIMZIA were consistent with those occurring in unexposed infants of similar age. Adverse events in mothers exposed to CIMZIA were consistent with the known safety profile of CIMZIA.1 In the US, CIMZIA is not indicated for axial spondyloarthritis. In the EU, Cimzia is not indicated in Crohn's disease. CIMZIA is not recommended during pregnancy. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with CIMZIA should be made taking into account the benefit of breastfeeding to the child and the benefit of CIMZIA therapy to the woman. About CIMZIA® in the EU/EEA In the EU, CIMZIA in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX. CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. CIMZIA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX. CIMZIA, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising: Important Safety Information about CIMZIA® in the EU/EEA CIMZIA® was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with CIMZIA® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking CIMZIA® due to adverse events vs. 2.7% for placebo. CIMZIA® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate-to-severe heart failure. Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving CIMZIA®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with CIMZIA®. Treatment with CIMZIA® must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop CIMZIA® if infection becomes serious. Before initiation of therapy with CIMZIA®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, CIMZIA® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with CIMZIA®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with CIMZIA®. Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including CIMZIA® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with CIMZIA®. Carriers of HBV who require treatment with CIMZIA® should be closely monitored and in the case of HBV reactivation CIMZIA® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. TNF antagonists including CIMZIA® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, CIMZIA® should be discontinued and appropriate therapy instituted. With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with CIMZIA®. Adverse reactions of the hematologic system, including medically significant cytopaenia, have been infrequently reported with CIMZIA®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA®. Consider discontinuation of CIMZIA® therapy in patients with confirmed significant haematological abnormalities. The use of CIMZIA® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, CIMZIA® should not be administered concurrently with live vaccines. The 14-day half-life of CIMZIA® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on CIMZIA® should be closely monitored for infections. CIMZIA® was studied in 325 patients with active axial spondyloarthritis (axSpA) in a placebo-controlled clinical trial for up to 30 months and in 409 patients with psoriatic arthritis (PsA) in a placebo-controlled clinical trial for up to 30 months. The safety profile for axSpA and PsA patients treated with CIMZIA® was consistent with the safety profile in RA and previous experience with CIMZIA®. Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision May 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf About CIMZIA® in the US CIMZIA® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. CIMZIA® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below. Important Safety Information about CIMZIA® in the US Risk of Serious Infections and Malignancy Patients treated with CIMZIA® are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA® should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: The risks and benefits of treatment with CIMZIA® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA® is a member. CIMZIA® is not indicated for use in pediatric patients. Patients treated with CIMZIA® are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease. Treatment with CIMZIA® should not be initiated in patients with an active infection, including clinically important localized infections. CIMZIA® should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with CIMZIA® should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic. During controlled and open-labeled portions of CIMZIA® studies of Crohn's disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 CIMZIA®-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of CIMZIA® for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 CIMZIA®-treated patients and one case of Hodgkin's lymphoma among 1,319 placebo-treated patients. In CIMZIA® RA clinical trials (placebo-controlled and open label), a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known. Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤18 years of age), of which CIMZIA® is a member. Approximately half of the cases were lymphoma (including Hodgkin's and non-Hodgkin's lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants. Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA®. The majority of reported TNF blocker cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis. Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with CIMZIA®, especially in these patient types. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. CIMZIA® has not been formally studied in patients with CHF. Exercise caution when using CIMZIA® in patients who have heart failure and monitor them carefully. Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA® administration. Some of these reactions occurred after the first administration of CIMZIA®. If such reactions occur, discontinue further administration of CIMZIA® and institute appropriate therapy. Use of TNF blockers, including CIMZIA®, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Test patients for HBV infection before initiating treatment with CIMZIA®. Exercise caution in prescribing CIMZIA® for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue CIMZIA® and initiate effective anti-viral therapy with appropriate supportive treatment. Use of TNF blockers, including CIMZIA®, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA®. Exercise caution in considering the use of CIMZIA® in patients with these disorders. Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with CIMZIA®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA®. Consider discontinuation of CIMZIA® therapy in patients with confirmed significant hematologic abnormalities. An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of CIMZIA® in these combinations. Therefore, the combination of CIMZIA® with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with CIMZIA®. There is no evidence that CIMZIA® therapy has an effect on in vivo coagulation. CIMZIA® may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities. Treatment with CIMZIA® may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop. Do not administer live vaccines or live-attenuated vaccines concurrently with CIMZIA®. In controlled Crohn's clinical trials, the most common adverse events that occurred in ≥5% of CIMZIA® patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% CIMZIA®, 13% placebo), urinary tract infection (7% CIMZIA®, 6% placebo), and arthralgia (6% CIMZIA®, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA® and 7% for placebo. In controlled RA clinical trials, the most common adverse events that occurred in ≥3% of patients taking CIMZIA® 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% CIMZIA®, 2% placebo), headache (5% CIMZIA®, 4% placebo), hypertension (5% CIMZIA®, 2% placebo), nasopharyngitis (5% CIMZIA®, 1% placebo), back pain (4% CIMZIA®, 1% placebo), pyrexia (3% CIMZIA®, 2% placebo), pharyngitis (3% CIMZIA®, 1% placebo), rash (3% CIMZIA®, 1% placebo), acute bronchitis (3% CIMZIA®, 1% placebo), fatigue (3% CIMZIA®, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA® than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving CIMZIA® 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA® 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA® and 2.5% for placebo. The safety profile for patients with psoriatic arthritis (PsA) treated with CIMZIA® was similar to the safety profile seen in patients with RA and previous experience with CIMZIA®. The safety profile for AS patients treated with CIMZIA® was similar to the safety profile seen in patients with RA. CIMZIA® is a registered trademark of the UCB Group of Companies. UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.


Data from the CRIB study offer important, new information for women with CID and their doctors. Results from the CRADLE study (NCT02154425) are also relevant for these patients. Presented this year at EULAR 2017, the study evaluated CIMZIA concentrations in human mature breast milk and found minimal to no transfer of CIMZIA to breast milk.4 "Tumor necrosis factor inhibitors (anti-TNFs) represent one of the most significant advances in the treatment of inflammatory diseases like rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis/ankylosing spondylitis, but research suggests that most of these drugs cross the placenta, so they are usually discontinued during pregnancy," said Xavier Mariette, MD, PhD, Head of Rheumatology, Bicetre Hospital, Paris-Sud University, and lead author of the study. "The CRIB study is the only clinical research that demonstrates how an effective anti-TNF, CIMZIA, shows minimal to no placental transfer from mother to infant. This is very encouraging news for female patients who have an active inflammatory disease." "By partnering with expert researchers, UCB has uncovered and responded to the largely unrecognized needs of women of childbearing age who have active inflammatory diseases. In response to this need, we conducted the CRIB and CRADLE studies which have shown that CIMZIA, the only Fc-free, PEGylated anti-TNF, has minimal to no transfer through the placental barrier, and minimal to no transfer through lactation," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB. CRIB (NCT02019602) was a pharmacokinetic study with a safety evaluation designed to measure the potential level of placental transfer of CIMZIA from pregnant women to their infants. Sixteen women (≥ 30 weeks gestation) who were already receiving CIMZIA for approved indications (RA [N=11], CD [N=3], PsA [N=1] and axSpA/AS [N=1]), were followed in the study.1 To determine CIMZIA plasma levels, blood samples were collected from each woman, the umbilical cords, and their infants at delivery and again from infants at weeks four and eight post-delivery. The study evaluated CIMZIA concentration in the blood using a sensitive, CIMZIA-specific electrochemiluminescence immunoassay with a lower level of quantification (LLOQ) of 0.032ug/mL, which is 10 times more sensitive than prior CIMZIA assays.1 The study found that CIMZIA levels were below LLOQ in 13 out of 14 infant blood samples at birth, and in all samples at weeks four and eight. One infant had a minimal CZP level of 0.042ug/ML (infant/mother ratio of 0.009). No anti-CIMZIA antibodies were detected in mothers, umbilical cords, or infants, and the infants of CIMZIA-exposed mothers had a safety profile consistent with that of unexposed similar-age infants. These data indicate no to minimal placental transfer of CIMZIA from mothers to infants, suggesting lack of in utero fetal exposure during the second and third trimesters.1 In CRIB, adverse events experienced by the infants did not show any patterns or clusters of events suggesting a specific safety signal in children. Safety data in the mothers were in line with the known safety profile of CZP and pregnancy profile of these underlying diseases. The objective of CRADLE (NCT02154425), a pharmacokinetic study with a safety evaluation, was to determine the concentration of CIMZIA in human breast milk and to calculate the average daily infant dose (ADID), an estimation of the dose of maternal CIMZIA ingested by the infant every day over the dosing interval. A post-hoc analysis also calculated the relative infant dose (RID) of CIMZIA in breast milk to provide relative context of CIMZIA data to literature available for other drugs documented during breast feeding. In CRADLE, adverse events in the infants of mothers exposed to CIMZIA were consistent with those occurring in unexposed infants of similar age. Adverse events in mothers exposed to CIMZIA were consistent with the known safety profile of CIMZIA.1 In the US, CIMZIA is not indicated for axial spondyloarthritis. In the EU, Cimzia is not indicated in Crohn's disease. CIMZIA is not recommended during pregnancy. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with CIMZIA should be made taking into account the benefit of breastfeeding to the child and the benefit of CIMZIA therapy to the woman. About CIMZIA® in the US CIMZIA® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. CIMZIA® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below. Important Safety Information about CIMZIA® in the US Risk of Serious Infections and Malignancy Patients treated with CIMZIA® are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA® should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: The risks and benefits of treatment with CIMZIA® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA® is a member. CIMZIA® is not indicated for use in pediatric patients. Patients treated with CIMZIA® are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease. Treatment with CIMZIA® should not be initiated in patients with an active infection, including clinically important localized infections. CIMZIA® should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with CIMZIA® should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic. During controlled and open-labeled portions of CIMZIA® studies of Crohn's disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 CIMZIA®-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of CIMZIA® for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 CIMZIA®-treated patients and one case of Hodgkin's lymphoma among 1,319 placebo-treated patients. In CIMZIA® RA clinical trials (placebo-controlled and open label), a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known. Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤18 years of age), of which CIMZIA® is a member. Approximately half of the cases were lymphoma (including Hodgkin's and non-Hodgkin's lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants. Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA®. The majority of reported TNF blocker cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis. Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with CIMZIA®, especially in these patient types. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer. Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. CIMZIA® has not been formally studied in patients with CHF. Exercise caution when using CIMZIA® in patients who have heart failure and monitor them carefully. Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA® administration. Some of these reactions occurred after the first administration of CIMZIA®. If such reactions occur, discontinue further administration of CIMZIA® and institute appropriate therapy. Use of TNF blockers, including CIMZIA®, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Test patients for HBV infection before initiating treatment with CIMZIA®. Exercise caution in prescribing CIMZIA® for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue CIMZIA® and initiate effective anti-viral therapy with appropriate supportive treatment. Use of TNF blockers, including CIMZIA®, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA®. Exercise caution in considering the use of CIMZIA® in patients with these disorders. Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with CIMZIA®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA®. Consider discontinuation of CIMZIA® therapy in patients with confirmed significant hematologic abnormalities. An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of CIMZIA® in these combinations. Therefore, the combination of CIMZIA® with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with CIMZIA®. There is no evidence that CIMZIA® therapy has an effect on in vivo coagulation. CIMZIA® may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities. Treatment with CIMZIA® may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop. Do not administer live vaccines or live-attenuated vaccines concurrently with CIMZIA®. In controlled Crohn's clinical trials, the most common adverse events that occurred in ≥5% of CIMZIA® patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% CIMZIA®, 13% placebo), urinary tract infection (7% CIMZIA®, 6% placebo), and arthralgia (6% CIMZIA®, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA® and 7% for placebo. In controlled RA clinical trials, the most common adverse events that occurred in ≥3% of patients taking CIMZIA® 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% CIMZIA®, 2% placebo), headache (5% CIMZIA®, 4% placebo), hypertension (5% CIMZIA®, 2% placebo), nasopharyngitis (5% CIMZIA®, 1% placebo), back pain (4% CIMZIA®, 1% placebo), pyrexia (3% CIMZIA®, 2% placebo), pharyngitis (3% CIMZIA®, 1% placebo), rash (3% CIMZIA®, 1% placebo), acute bronchitis (3% CIMZIA®, 1% placebo), fatigue (3% CIMZIA®, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA® than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving CIMZIA® 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA® 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA® and 2.5% for placebo. The safety profile for patients with psoriatic arthritis (PsA) treated with CIMZIA® was similar to the safety profile seen in patients with RA and previous experience with CIMZIA®. The safety profile for AS patients treated with CIMZIA® was similar to the safety profile seen in patients with RA. CIMZIA® is a registered trademark of the UCB Group of Companies. About CIMZIA® in the EU/EEA In the EU, CIMZIA in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX. CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. CIMZIA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX. CIMZIA, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising: Important Safety Information about CIMZIA® in the EU/EEA CIMZIA® was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with CIMZIA® and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking CIMZIA® due to adverse events vs. 2.7% for placebo. CIMZIA® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate-to-severe heart failure. Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving CIMZIA®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with CIMZIA®. Treatment with CIMZIA® must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop CIMZIA® if infection becomes serious. Before initiation of therapy with CIMZIA®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, CIMZIA® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with CIMZIA®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with CIMZIA®. Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including CIMZIA® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with CIMZIA®. Carriers of HBV who require treatment with CIMZIA® should be closely monitored and in the case of HBV reactivation CIMZIA® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. TNF antagonists including CIMZIA® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, CIMZIA® should be discontinued and appropriate therapy instituted. With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with CIMZIA®. Adverse reactions of the hematologic system, including medically significant cytopaenia, have been infrequently reported with CIMZIA®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA®. Consider discontinuation of CIMZIA® therapy in patients with confirmed significant haematological abnormalities. The use of CIMZIA® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, CIMZIA® should not be administered concurrently with live vaccines. The 14-day half-life of CIMZIA® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on CIMZIA® should be closely monitored for infections. CIMZIA® was studied in 325 patients with active axial spondyloarthritis (axSpA) in a placebo-controlled clinical trial for up to 30 months and in 409 patients with psoriatic arthritis (PsA) in a placebo-controlled clinical trial for up to 30 months. The safety profile for axSpA and PsA patients treated with CIMZIA® was consistent with the safety profile in RA and previous experience with CIMZIA®. Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision May 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/results-from-crib-study-on-cimzia-certolizumab-pegol-demonstrate-minimal-to-no-placental-transfer-of-drug-from-mother-to-infant-during-third-trimester-of-pregnancy-300473464.html


Taylor R.D.,UCB | Maccoss M.,Bohicket Pharma Consulting LLC | Lawson A.D.G.,UCB
Journal of Medicinal Chemistry | Year: 2014

We have analyzed the rings, ring systems, and frameworks in drugs listed in the FDA Orange Book to understand the frequency, timelines, molecular property space, and the application of these rings in different therapeutic areas and target classes. This analysis shows that there are only 351 ring systems and 1197 frameworks in drugs that came onto the market before 2013. Furthermore, on average six new ring systems enter drug space each year and approximately 28% of new drugs contain a new ring system. Moreover, it is very unusual for a drug to contain more than one new ring system and the majority of the most frequently used ring systems (83%) were first used in drugs developed prior to 1983. These observations give insight into the chemical novelty of drugs and potentially efficient ways to assess compound libraries and develop compounds from hit identification to lead optimization and beyond. © 2014 American Chemical Society.

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