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News Article | February 17, 2017
Site: www.prweb.com

SPH Analytics will introduce its new MIPS Max solution at the 2017 HIMSS Conference and Exhibition taking place February 19-23 at the Orange County Convention Center in Orlando, Florida. The action analytics leader will also display its population health, predictive analytics, and patient experience solutions at booth 4587. With more than two decades of proven success at driving quality measure programs for its clients, SPH Analytics is launching its new MIPS Max suite of solutions to help providers maximize Medicare reimbursements and avoid negative penalties from the new Merit-Based Incentive Payment System (MIPS). MIPS went into effect January 1 as part of the CMS Quality Payment Program that combines existing programs such as PQRS, Meaningful Use, and Value-based Modifier into one performance payment system. SPH Analytics also offers MIPS Max clients its MIPS Penalty-Free Guarantee. With MIPS Max, SPHA clients will avoid any downward fee adjustments in 2019 from MIPS payment penalties. If any penalties are incurred, SPHA will credit all 2019 MIPS penalties from the 2017 submission year back to the client.* The MIPS Max solution helps minimize workload and administrative burden while enabling providers to improve their MIPS Composite Performance Score. Depending on provider readiness, MIPS Max clients can improve scores in any one or all four of the MIPS performance categories: Quality, Improvement Activities, Advancing Care Information, and Cost. At the core of the MIPS Max solution is SPH Analytics QCDR Plus™, a CMS Qualified Clinical Data Registry that can validate and aggregate clinical data from multiple EHR systems and benchmark the data against other registry clients. This data collection process alleviates labor-intensive manual processes for practices and providers, while allowing them to monitor quality measures throughout the year to proactively improve performance before annual submission to CMS. The MIPS Max solution features an intuitive performance dashboard with bimonthly data refresh and a large library of eCQMs and registry-based measures. QCDR Plus will automatically calculate the top six performing measures based on CMS benchmarks to maximize MIPS Quality Performance points. The dashboard can be set up at the provider level or at the network level with multiple TINs and displays measure performance across Medicare and non-Medicare patients to monitor quality performance across multiple payers. “We’re very excited to introduce MIPS Max at HIMSS,“ said Dr. Bill O’Connor, Chief Medical Officer and EVP Product for SPH Analytics. “We have been improving performance and submitting measures for healthcare clients for more than 24 years and want to partner with our MIPS Max clients to help them understand the new MACRA legislation and maximize their reimbursement. With our extensive experience with quality and experience measures providers can feel confident about their MIPS submission. Our unique solution will ensure that they receive no negative fee adjustments for the 2017 submission year, guaranteed.” To learn more about MIPS Max, visit SPH Analytics in Booth 4587 at HIMSS 2017. An interactive MIPS Financial Impact Calculator and a list of MIPS Max measures is available at http://www.SPHAnalytics.com/mips-max. About SPH Analytics SPH Analytics (SPHA) is a leader in healthcare quality measures, population health and predictive analytics, and experience measurement and engagement, providing best-in-class solutions and transformative technologies for health plans, providers, and healthcare networks. SPHA solutions help clients meet MACRA and MIPS regulations and lead the way for the next generation of healthcare through powerful applications and analytics, healthcare surveys, call center solutions, and consulting. SPHA’s intuitive analytics aggregate data and empower action, enabling clients to increase member and patient satisfaction, improve population health, drive patient engagement, and reduce overall cost of care. SPH Analytics serves clients in all 50 states and has been driving quality program success for more than 24 years. Company headquarters and healthcare call center are located in metro Atlanta. SPH Analytics is a member of the $3 billion Symphony Technology Group. For more information, call 1-866-460-5681 or visit SPHAnalytics.com.


TORONTO, ON--(Marketwired - February 17, 2017) - Axiom Real-Time Metrics, the premier provider of eClinical software solutions and services to small to mid-sized life sciences organizations, will be exhibiting at the Outsourcing in Clinical Trials event on the West Coast taking place in Burlingame, California on February 22-23, 2017. Axiom invites attendees to join them for gourmet coffee and a conversation at Booth 36. OCT West 2017 will bring together over 700 clinical professionals, including senior level executives from the pharmaceutical, biotech, and medical device sectors to discuss clinical outsourcing strategies and address key challenges within clinical operations. Axiom's Fusion eClinical suite and the unified modules Randomization, Inventory Management and Safety Management will be showcased at the conference. "Our team is excited to meet with attendees and share information about the benefits and value of our award winning product suite. Fusion delivers powerful, enterprise level software made for small to mid-size organizations. We provide a truly Unified eClinical suite and are always excited to share and illustrate what this distinction of being 'Truly Unified' really means and what sets us apart," says Andrew Schachter CEO and Founder. Christopher Kata, Axiom's CIO further offers, "Fusion, Axiom's product suite has been engineered with our design & programming teams, and directed through years of client input. All of our technology is delivered from a single source. We provide our 'peerless' Unified product and services to leading edge life science organizations around the world, and, true to our Mission we are partners in this journey together. This means that it eliminates having a separate EDC, randomization and adjudication vendor -- Fusion does it all!" Headquartered in Toronto, Canada, Axiom delivers intuitive, powerful and cost-effective eClinical solutions and services focused around your entire study. Services include: DM, Biostatistics and Pharmacovigilance. Axiom's eClinical suite, Fusion, delivers a powerful range of innovative end-user focused, unified functionality and 15 modules. Axiom serves as the Connected Hub for your entire clinical study data and operational needs. Fusion Delivers: EDC, DM, IWRS, CTMS, Inventory Management, IVR, Patient Portal, AE/SAE Tracking, Safety Database, Central Lab, Imaging, eTMF, and 24/7 Project and Clinical Data Reporting. For more information, please visit http://www.axiommetrics.com/.


The International Nurses Association is pleased to welcome Lorna E. Taylor, RN, MSN, to their prestigious organization with her upcoming publication in the Worldwide Leaders in Healthcare. Lorna E. Taylor is a Registered Nurse (RN) who is currently an Inpatient Care Manager at one of the leading managed care corporations in the United States. She is responsible for the day-to-day process of acute care bed-day management. With over 16 years of experience in nursing which collectively includes the specialty areas of organ transplantation and orthopedics in the Acute care setting; home health care; skilled nursing or long-term care; telephonic case management; telephonic nurse triage, US military treatment facilities and managed care commercial and Medicare. Lorna is also affiliated to Hartford Hospital, and the University of Connecticut Health Center. She has worked as a Clinical Data Analyst for the Senior Market Medicare Unit at Blue Cross Blue Shield of NC. She was responsible for the day-to-day processes of data acquisition, data reconciliation and data management. Lorna was also responsibility for Collaborating with Medicare Part C leadership toward the Medicare Quality Improvement Process (QIP) and ensuring accuracy, consistency and completeness for Medicare Data Validation Audit (DVA) reports. Lorna E. Taylor holds a Master of Nursing Science (MSN) degree with a specialization in Nursing Informatics; Magna Cum Laude, from Walden University, a Bachelor of Science in Nursing (BSN) from University of Hartford, an Associates Degree in Nursing (ADN) from Capital Community College and an Associates Degree in Liberal Arts (AA). She is currently pursuing her certification in Nursing Informatics and holds her certification in  Lean Six Sigma Yellow Belt. Her professional affiliations include Walden University Alumni Association, University of Hartford Alumni Association, American Nursing Informatics Association (ANIA), Honor Society of Nursing: Sigma Theta Tau International (STTI), Connecticut Nurses Association (CTNA), Healthcare Information and Management Systems Society (HIMSS), and American Nurses Association (ANA). Her professional interests expand to the methodology of project management, quality improvement, policy and regulation compliance and medical/nursing informatics. Learn more about Lorna E. Taylor here: http://inanurse.org/network/index.php?do=/4133736/info/ and read her upcoming publication in Worldwide Leaders in Healthcare.


Scientific Findings Reveal that Cellular Damage Alters Trafficking for Key Proteins Involved in Muscle Membrane Integrity and Muscle Repair Preclinical Studies Demonstrate Reversal of Cellular Damage and Significant Improvements in Muscle Strength in GAA Knock-out Mice After Treatment with Amicus Novel Pompe Treatment Paradigm Additional Phase 1/2 Clinical Data to be Presented at Wednesday Afternoon Poster Session (4:30pm PT) CRANBURY, N.J. and SAN DIEGO, Feb. 15, 2017 (GLOBE NEWSWIRE) --  Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company at the forefront of rare and orphan diseases, today presented new scientific findings and preclinical data on functional outcomes in an oral presentation and poster1 at the 13th Annual WORLDSymposium™ in San Diego, CA. ATB200/AT2221 is a novel treatment paradigm that consists of ATB200, a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly mannose-6 phosphate (M6P), to enhance uptake in muscles, co-administered with AT2221, a pharmacological chaperone designed to stabilize ERT in circulation. In previously reported preclinical studies, ATB200 was associated with increased tissue enzyme levels and reduced glycogen levels in muscle, which was further improved when AT2221 was co-administered with ATB200. For the first time at WORLDSymposium, Hung Do, PhD, Chief Science Officer of Amicus Therapeutics, presented results from preclinical studies that showed ATB200/AT2221 reversed cellular dysfunction and progressively increased muscle strength following every-other-week administration at 20 mg/kg over a five month period in an animal model of Pompe disease (GAA knock-out mice). Key Highlights on New Preclinical Data for ATB200/AT2221 in GAA Knock-Out Mice Dr. Do stated, “Our latest preclinical studies give us further confidence that ATB200/AT2221 has been optimally designed for efficient targeting to muscles. The results build upon our prior preclinical studies showing that ATB200/AT2221 not only clears accumulated glycogen but importantly, significantly reversed muscle damage and increased muscle function. These studies have also been invaluable for gaining important insights into the role of protein mistrafficking as contributing factors towards muscle weakness and disrepair in Pompe disease, and the potential for ATB200/AT2221 to reverse cellular dysfunction to restore muscle structure and increase muscle strength.” Grace K. Pavlath, Ph.D., Senior Vice President, Scientific Program Director of the Muscular Dystrophy Associated stated, “The scientific findings and preclinical data presented today are profound and shed new light on questions about the underlying cause of muscle damage and weakness in Pompe patients.  Furthermore, these results provide a window into a potential underlying link among key muscular dystrophies, such as Pompe, Limb Girdle, and Duchenne. Amicus has been a pioneer in advancing the scientific understanding of Pompe disease and in developing next-generation therapies for patients.” About ATB200/AT2221 ATB200/AT2221 is a novel treatment paradigm that consists of ATB200, a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly mannose 6-phosphate (M6P), to enhance uptake, co-administered with AT2221, a pharmacological chaperone. In preclinical studies, ATB200 was associated with increased tissue enzyme levels and reduced glycogen levels in muscle, which was further improved when AT2221 was co-administered with ATB200. Amicus Therapeutics is currently conducting a global Phase 1/2 study (ATB200-02) to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of ATB200/AT2221. About Pompe Disease Pompe disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called acid alpha-glucosidase (GAA). Reduced or absent levels of GAA lead to the accumulation of the substrate glycogen in the lysosomes of muscles and other tissues. Progressive accumulation of glycogen is believed to lead to the morbidity and mortality associated with Pompe disease, including muscle weakness and respiratory insufficiency. About Amicus Therapeutics Amicus Therapeutics (Nasdaq:FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases. 1Do, et. al, WORLDSymposium 2017, ATB200/AT2221 Cleared Accumulated Glycogen and Reversed Cellular Dysfunction to Increase Functional Muscle Strength in Mouse Model of Pompe Disease Forward-Looking Statements This press release contains "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to encouraging pre-clinical data from a study to investigate ATB200/AT2221 in a knock-out mouse model and the potential implications on these data for the future advancement and development of ATB200/AT2221 in humans.  Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements.  The forward looking statements included in this press release are based on management's current expectations and belief's which are subject to a number of risks, uncertainties and factors,  including that the pre-clinical data will not be predictive of future results in humans, and that preliminary human clinical data based on a small patient sample and reported before completion of the study  will not  be predictive of future results,  that results of additional preliminary data or data from  the completed study or any future study will not yield results that are consistent with the pre-clinical or preliminary data presented, that the Company will be not  able to demonstrate the safety and efficacy of ATB200/AT2221, that later  study results will not support  further development, or even if such later  results are favorable, that the Company will not be able to  successfully complete the development of, obtain regulatory approval for, or successfully commercialize  ATB200/AT2221.  In addition, all forward looking statements are subject to the other risks and uncertainties detailed in our Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on 10-Q for the Quarter ended September 30, 2016.  As a consequence, actual results may differ materially from those set forth in this press release or the accompanying conference call or webcast.  You are cautioned not to place undue reliance on these forward looking statements, which speak only of the date hereof.  All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise this press release to reflect events or circumstances after the date hereof.


News Article | November 30, 2016
Site: www.prweb.com

The Clinical Data Interchange Standards Consortium (CDISC) would like to remind the clinical research community that the FDA Binding Guidance goes into effect next month. Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog. The current FDA Data Standards Catalog specifies the use of CDISC standards: SDTM, SEND, ADaM and Define-XML as well as Controlled Terminology. The FDA’s Guidance on Standardized Study Data states . . . "After the publication of this guidance, all studies with a start date 24 months after the publication date must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions.” Implementing CDISC standards offers a number of benefits, including fostering efficiency, improving data quality, enhancing innovation, streamlining processes, increasing the ability to share information among systems and organizations, and reducing costs. Additionally, submitting standardized data helps regulatory reviewers receive, process, review, and archive submissions more effectively. About CDISC - CDISC is a 501(c)(3) global, non-profit charitable organization that develops clinical research data standards to streamline research and enable connections to healthcare. The CDISC suite of standards supports the complete clinical research lifecycle from protocol through analysis and reporting by allowing data to speak the same language, making the most of the valuable information offered by patients participating in research studies around the globe. Implementing CDISC standards from the start of studies enables Smarter Research to Unlock Cures, saving 70-90% start-up time and ~60% overall in time and resources to conduct clinical research. CDISC is funded through the generous support of over 400 member organizations, as well as through grants, authorized Education courses and CDISC events. To find out more about how to support CDISC, please visit http://www.cdisc.org.


News Article | February 17, 2017
Site: www.businesswire.com

DURHAM, N.C.--(BUSINESS WIRE)--Cmed, an innovative technology-led CRO, has been invited to share its expertise in bringing innovation to the design and conduct of clinical trials at three leading industry events in February and March. Ami Israel, Cmed’s Vice President of Clinical and Regulatory Operations, will present at eyeforpharma’s Data and Technology in Clinical Trials Summit (February 21-22, 2017, Philadelphia) in a session titled “Move towards more flexible and cost-effective trials. The Power of Technology Driven Applications”. The presentation will take place on Wednesday, February 22, at 10.15am and will explore ways to improve patient safety and compliance whilst maximizing the speed and quality of trial data. She will touch upon several themes, including how eSource and real-time clinical data analytics can improve data visibility and reduce the number of protocol violators in a trial. Sammie Rivera, Cmed’s Senior Client Services Manager, will speak at the CROWN Congress (March 7-9, 2017, Philadelphia). She will introduce Cmed’s App based new generation clinical data suite, encapsia™, in the Technology Showcase at 11:15am on Thursday March 9, 2017. The session titled “encapsia™ - Improving Patient Safety and Compliance, Reducing the Cost and Complexity of Clinical Trials” will highlight how a truly flexible, new seamless approach can simplify and streamline clinical trials. Attendees will also have the opportunity to visit Cmed in the exhibit hall to learn more. In addition, Cmed will showcase the capabilities of encapsia™ for increasing trial efficiency, improving timelines and reducing cost at its booth during the Clinical Data Integration and Management conference (March 21-22, 2017, Princeton). Attendees will also be able to discover more about Cmed’s portfolio of CRO service offerings, which includes full service and functional service provision, such as biometrics. To schedule a meeting with the Cmed team at these upcoming events, contact Jessi Lanuza, Associate Director, Business Development, at jlanuza@cmedresearch.com. Cmed is an innovative, full service technology-led CRO. Cmed brings together experienced people and technology, providing customers with a friendly, proactive service, and delivers this service using advanced clinical data capture, management and reporting software and processes. Cmed’s new generation clinical data suite, encapsia™, streamlines the capture, management and reporting of clinical data, saving customers time and money. Clinical data can be captured flexibly by eSource, multi-media and web eDC, while being displayed in live visual insights, providing live analytics, and allowing within suite audit trailed actions. It is fully compliant with regulatory guidelines, and allows integration with existing systems. For more information visit www.cmedresearch.com.


News Article | February 20, 2017
Site: www.prweb.com

ReportingMD, a Population Health Software Company, is pleased to announce a move to a larger office building to accommodate the rapid growth of the company. The new location will triple the size of the previous location while bringing life back to a medical practice building that was a historic location for the town of Sunapee, NH. “We are excited to expand our footprint to better serve our growing client base. We are also pleased to give back to the town of Sunapee in a way of rehabilitating a beautiful historic building for the town. The new location will allow for our growing employee base to better develop cutting edge solutions of the new era of healthcare.“ – Michael Deyett, President ReportingMD. ReportingMD’s new address will be 6 Holmes Lane, Georges Mills, NH. The organization plans to occupy the new building as of March 30, 2017, once renovations are complete. About ReportingMD: ReportingMD, a Population Health Software company, CMS qualified registry, an ONC certified company, and Qualified Clinical Data Registry is a national leader in quality and population health solutions. The company has successfully managed quality outcomes data for thousands of providers under various quality programs including ACO, PQRS, VBM, HEDIS (STARS), and MU. ReportingMD and ARCO are devoted to helping clients excel in an increasingly data-centric and value-focused environment. ReportingMD is able to submit quality performance program information via Registry and as a Data Submission Vendor to meet pay-for-performance program requirements. To learn more, visit http://www.ReportingMD.com.


News Article | March 1, 2017
Site: www.prnewswire.com

PRINCETON, N.J., March 1, 2017 /PRNewswire/ -- Quartesian, a leading data clinical research organization (CRO) known for delivering "Clinical Data Your Way" from early and late stage clinical studies for virtual, biotechnology, and small to mid-sized pharma as well as from generic...


News Article | February 22, 2017
Site: www.prweb.com

TAKE Supply Chain (TSC), a division of TAKE Solutions Ltd., today announced that it has formally launched the TAKE Digital Supply Chain Initiative in partnership with Nick Vyas, Executive Director and Professor of Clinical Data Science and Operations, USC Marshall Center for Global Supply Chain Management. This joint research project aims to evaluate the impact of key emerging technologies identified by Gartner at its 2016 Supply Chain Conference in Phoenix. Through this initiative graduate students at the USC Marshall Center for Global Supply Chain Management will apply Six Sigma practices and techniques to determine if and how transformative new technologies such as Blockchain, Augmented Reality, Predictive Analytics, the Internet of Things (IoT), Digital Supplier Networks, and Conversation Based User Interfaces can be effectively applied to remove data silos across supply chain organizations. “In today’s world, supply chains typically rely on multiple technology systems to manage their procurement processes, warehouses, logistics, and enterprise resource planning processes in addition to the manual, or paper-based, business processes. These are typically spread across multiple functional and geographic silos. Despite attempts at system convergence, these silos still do not share information well, and that continues to challenge supply chain performance and efficiency,” explained Steve Rice, director, product group at TAKE Supply Chain. “However, at TSC we believe that these information silos can be removed via the Digital Supply Chain initiative to provide full data transparency and real-time accessibility across entire operations, thus improving agility and cost effectiveness of entire supply chains as market economics change.” Throughout the duration of the project, USC students will evaluate whether or not these emerging technologies are potentially transformative and how they can drive improved collaboration and decision making across supply chain environments. At the conclusion of this project, TAKE will introduce a new Digital Supply Chain Roadmap that aligns with the USC team’s findings. The company will then commit a set of global resources to the development of globally relevant solutions that will deliver increased accuracy, visibility and responsiveness across its customers supply chains. “For 20 years, TAKE has been on the cutting-edge of supply chain innovation and we have a clear understanding of the challenges facing global supply chains today. We are excited to partner with the USC Marshall Center for Global Supply Chain Management to prove the viability of emerging technologies. We’re confident this project will help us quickly define new solutions to address our customers’ supply chain challenges,” added Brad Huff, executive vice president and general manager, TAKE Supply Chain.


2016 Clinical Data Support Eptinezumab’s Potential to Deliver a Unique Combination of Speed to Clinical Benefit and Effectiveness That Persists for at Least Three Months After a Single Administration Top-Line Data from First Pivotal Phase 3 Study, PROMISE 1, On Track for First Half 2017 BOTHELL, Wash., Feb. 23, 2017 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced financial results for the fourth quarter and full year ended December 31, 2016 and provided a corporate update. “2016 was a year of clinical validation and advancement for eptinezumab, a unique and potentially transformative migraine prevention therapy,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “We are excited about our Phase 2b data demonstrating clinically meaningful benefits to patients in as little as 48 hours, and persistent migraine prevention for at least three months from a single dose. Importantly, we remain on track to announce top-line data from PROMISE 1, our first pivotal study, in the first half of this year as we continue with enrollment of PROMISE 2. With our BLA submission planned for the second half of 2018 with positive data, we remain highly focused on advancing our pivotal development program and leveraging opportunities to maximize eptinezumab’s differentiated profile to optimize the compelling potential we believe it holds to positively impact the lives of patients living with migraine.” Eptinezumab: Pivotal-stage novel monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) for the prevention of migraine ALD1910 — Preclinical monoclonal antibody targeting pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), a protein that is active in mediating the initiation of migraine. Alder believes ALD1910 holds potential as a new preventive option for migraine patients who have an inadequate response to therapeutics directed at CGRP or its receptor Alder had $351.9 million in cash and cash equivalents, short-term and long-term investments as of December 31, 2016, compared to $403.4 million as of September 30, 2016, and $381.0 million as of December 31, 2015. Alder did not record any revenues for the 2016 fourth quarter and for the same period in 2015. For the full year 2016, Alder recorded $0.1 million of revenue under its license agreement with Vitaeris relating to a sale of clazakizumab inventory to Vitaeris at cost. Alder recorded no revenues for the full year 2015. Research and development expenses for the 2016 fourth quarter totaled $41.8 million, compared to $21.6 million for the same period in 2015. For the full year 2016, research and development expenses totaled $132.8 million, compared to $69.6 million for 2015.  The increase in 2016 expenses was primarily due to the company’s investment in eptinezumab for clinical trial costs and manufacturing costs for drug supply in support of planned and ongoing pivotal clinical trials. The company also had an increase in salaries and stock-based compensation expenses because of an increase in research and development headcount to support programs under development. General and administrative expenses for the fourth quarter totaled $7.4 million, compared to $4.8 million for the same period in 2015. For the full year, general and administrative expenses totaled $26.1 million, compared to $16.7 million for 2015. The increase in 2016 expenses was primarily due to an increase in stock-based compensation expense and salaries expense due to an increase in headcount, as well as increases in commercial readiness activities. Net loss for the fourth quarter totaled $48.9 million, or $0.97 per share, compared to net loss of $26.2 million, or $0.60 per share on a fully-diluted basis, for the same period in 2015. For the full year, net loss totaled $156.3 million, or $3.23 per share on a fully-diluted basis, compared to net loss of $85.5 million, or $2.11 per share, for 2015. Alder will host a conference call and live audio webcast at 5:00 p.m. ET today to discuss these financial results and provide a general business update. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 60771333. The webcast will be broadcast live and may be accessed from the Events & Presentations page in the Investors section of Alder's website at www.alderbio.com. A replay will be available following the call for 30 days. Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize genetically engineered therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder's lead pivotal-stage product candidate, eptinezumab, is being evaluated for migraine prevention. Eptinezumab is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), a protein that is active in mediating the initiation of migraine. Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine. Clazakizumab, Alder's third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc. For more information, please visit http://www.alderbio.com. This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of eptinezumab and ALD1910; the availability of results from clinical trials; the initiation and enrollment of future clinical trials; future regulatory filings and the potential regulatory approval of eptinezumab; the anticipated commercialization of eptinezumab; actions to positively impact the lives of patients living with migraine; and Alder's potential receipt of royalties and other payments under the license agreement with Vitaeris.  Words such as “supports,” “potential,” “excited,” “on track,” “continue,” “planned,” “remain,” “advance,” “maximize,” “opportunities,” “compelling,” “impact,” “deliver,” “believe,” “eligible,” “expected,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: risks related to the potential failure of eptinezumab and ALD1910 to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab and ALD1910 sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab and ALD1910; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with the development of eptinezumab and ALD1910; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption "Risk Factors" in Alder's Quarterly Report on Form 10-K for the year ended December 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on February 23, 2017, and is available on the SEC's website at www.sec.gov.  Additional information will also be set forth in Alder's other reports and filings it will make with the SEC from time to time.  The forward-looking statements made in this press release speak only as of the date of this press release.  Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Alder's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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