Office of the Assistant Secretary for Preparedness and Response
Office of the Assistant Secretary for Preparedness and Response
News Article | April 17, 2017
Successful clinical trials to create drugs and vaccines for next pandemic disease will rely on building capacity, community engagement, and international collaboration before and during outbreak WASHINGTON - Mobilization of a rapid and robust clinical research program that explores whether investigational therapeutics and vaccines are safe and effective to combat the next infectious disease epidemic will depend on strengthening capacity in low-income countries for response and research, engaging people living in affected communities, and conducting safety trials before an epidemic hits, says a new report from the National Academies of Sciences, Engineering, and Medicine. Using key lessons learned from the Ebola epidemic in West Africa, the report outlines how to improve the speed and effectiveness of clinical trial research while an epidemic is occurring, especially in settings where there is limited health care and research infrastructure. The research and development of therapeutics and vaccines is a long, complex, and expensive process and cannot be compressed into the course of a rapidly progressing outbreak. The development of a drug "from bench to bedside" is estimated, on average, to take at least 10 years and cost $2.6 billion, with less than 12 percent likelihood of eventual licensing. Therefore, making progress on the research and development of products - such as therapeutics and vaccines - before an epidemic breaks is the only way to ensure that promising candidates are ready for trials once an outbreak occurs, said the committee that carried out the study and wrote the report. In addition, clinical trials could be more rapidly planned, approved, and implemented during an outbreak if promising products are studied through Phase 1 or Phase 2 safety trials in advance of an outbreak and if emergency response planning includes clinical research considerations and clinical researchers in the discussions from the beginning. The 2014-2015 Ebola epidemic was the longest and most deadly Ebola outbreak since the virus was first discovered in 1976, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. In August 2014, the World Health Organization declared the epidemic a public health emergency of international concern. Researchers discussed how to conduct clinical trials on potential Ebola therapeutics and vaccines in West Africa, and ultimately, several teams conducted formal clinical trials in the Ebola-affected countries during the outbreak. The clinical trial teams overcame immense logistical obstacles encountered while trying to design and implement trials in West Africa in the midst of a rapidly spreading epidemic of a highly dangerous contagious disease. However, none of the therapeutic trials ended with conclusive results on product efficacy, although limited evidence from the trial for the ZMapp treatment did trend toward a possible benefit. Given the resources, time, and effort put into these trials, they were not as successful as they could have been. The results of the vaccine trials were more fruitful. Two Ebola vaccine candidates have data that suggest they may be safe and produce an immune response, and one is most likely protective, but further data are needed. Planning and conducting clinical research during the Ebola epidemic also required confronting a number of ethical issues, such as whether it was ethical to conduct clinical trials at all in the midst of a public health emergency and whether the research activities drew effort away from providing clinical care to the most people possible. There was also disagreement among researchers over how clinical trials should be designed during the Ebola epidemic, particularly whether trials should use randomization and concurrent control groups. Randomized controlled trials are generally the preferred research design, because they allow researchers to directly compare the outcomes of similar groups of people who differ only in the presence or absence of the investigational agent. However, many argued that randomized controlled trials would be unethical during the Ebola epidemic, as this trial design would deprive patients of an agent that could potentially prevent or treat Ebola, given the high mortality rate and lack of known and available treatment options. The committee concluded that randomized controlled trials are both ethical and the fastest and most reliable way to identify the relative benefits and risks of investigational products, and except in rare circumstances, every effort should be made to implement them during epidemics. The issues that influenced choices about trial design during the Ebola epidemic - such as community mistrust, the feasibility of a standard-of-care-only arm, the high and variable mortality rate, limited product availability, and the potential conflicts between research and care - are likely to recur in future epidemics. Nevertheless, the perceived ethical or logistical hurdles that these issues present are not sufficiently compelling to override the benefits of randomized trials. Rather, randomized trials may be the most ethical trial design, because they offer the fastest route to identifying beneficial treatments while minimizing the risks of exposure to potentially harmful investigational agents. To improve the national and international clinical trial response to the next epidemic, the committee focused on three main areas - strengthening capacity, engaging communities, and facilitating international coordination and collaboration - both in the period of time before an outbreak strikes and during the epidemic itself. The committee found major capacity challenges that hindered and slowed the research response to the Ebola epidemic, and recommended developing sustainable health systems and research capabilities, improving capacity to collect and share clinical and epidemiological data, facilitating the mechanisms for rapid ethics reviews and legal agreements before an epidemic occurs, and incorporating research systems into emergency preparedness and response systems for epidemics. Affected communities had considerable fear, mistrust, and misunderstanding of national and international response and research staff. Community members feared going to health care facilities for the treatment of Ebola, rumors spread that Ebola was deliberately brought to the region by foreigners, and initial response efforts did not take into account community traditions and beliefs. For example, mandatory cremation policies countered deeply held religious beliefs. Successful clinical research is dependent on a community's understanding of, engagement in, and sense of involvement and respect in the process of planning and conducting research, the committee found. Community engagement should be prioritized during epidemic responses and be a continuous and evolving effort, starting at the onset of the epidemic. Research and response efforts were also greatly affected by the relationships among international stakeholders and their ability to coordinate and collaborate. For example, there were a few Ebola-specific therapeutic candidates with suggestive efficacy available at the beginning of the outbreak that could have been investigated in clinical trials, but the mechanism to prioritize which should be studied first was limited. The committee recommended the establishment of an international coalition of stakeholders to work between epidemics that would advise and prioritize pathogens to target for research and development, develop generic clinical trial design templates, and identify teams of clinical research experts who could be deployed to assist with research during an outbreak. The committee also highlighted seven critical steps to launching successful clinical trials when the next epidemic first strikes and before it peaks. The steps are to collect and share patient information and establish standards of care, engage communities and establish mutual trust, integrate research efforts into response and facilitate stakeholder coordination, prioritize vaccines and therapies and select trial designs, negotiate contracts, consult with regulators, and perform independent ethics reviews. The study was sponsored by the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, National Institutes of Health, and U.S. Food and Drug Administration. The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. The National Academies operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. For more information, visit http://national-academies. . A roster follows. Copies of Integrating Clinical Research Into Epidemic Response: The Ebola Experience are available from the National Academies Press at http://www. or by calling 1-800-624-6242. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above). Gerald T. Keusch, M.D.* (co-chair) Professor of Medicine and Global Health Boston University Schools of Medicine and Public Health Boston Keith McAdam, M.D. (co-chair) Emeritus Professor of Clinical and Tropical Medicine London School of Hygiene and Tropical Medicine London Abdel Babiker, Ph.D. Professor of Epidemiology and Medical Statistics Medical Research Council Clinical Trials Unit at University College London London Susan S. Ellenberg, Ph.D. Professor of Biostatistics Perelman School of Medicine University of Pennsylvania Philadelphia Roger J. Lewis, M.D., Ph.D.* Professor and Chair of the Department of Emergency Medicine Harbor-UCLA Medical Center Los Angeles Alex London, Ph.D. Professor of Philosophy, and Director of the Center for Ethics and Policy Carnegie Mellon University Pittsburgh Michelle M. Mello, Ph.D.* Professor of Law Stanford University School of Medicine and School of Law Stanford, Calif. Olayemi Omotade, M.D. Professor of Pediatrics and Child Health Institute of Child Health University College Hospital University of Ibadan Ibadan, Nigeria Fred Wabwire-Mangen, Ph.D. Associate Professor of Epidemiology and Public Health Makerere University School of Public Health Kampala, Uganda
News Article | May 17, 2017
"This study is intended as a step towards improving transfusion therapy and transfusion safety in the U.S.," said Sherrill Slichter, MD, principal investigator from Bloodworks Northwest and lead investigator for the MIPLATE clinical trial. "We're excited to be a part of this study that hopefully will lead to measures that could further protect the nation's blood supply from certain complications and threats of blood transfusions." MIPLATE is a multi-center, controlled, randomized, non-inferiority study designed to evaluate the clinical effectiveness of Mirasol-treated apheresis Platelets in Plasma versus standard apheresis Platelets in Plasma in patients with hypoproliferative thrombocytopenia. This condition is characterized by low platelet count in patients with compromised bone marrow due to hematologic malignancies or treatments such as chemotherapy. "In addition to being designed to support our PMA application for U.S. approval, this study is an important part of our ongoing efforts to advance blood safety and patient care," said Palani Palaniappan, Executive Vice President of Innovation & Development, Terumo BCT. "With a better clinical understanding of technologies like the Mirasol PRT system in the U.S., we can bring our customers a safe, simple and effective solution to help protect their patients from pathogens." About Mirasol PRT System The Mirasol PRT system is CE marked for platelets, plasma, and whole blood and is in use in approximately 20 countries and 140 blood centers throughout Europe, the Middle East, Africa, Asia and Latin America. The system is for investigational use only in the U.S. and Canada and is available in other select countries. About Terumo BCT Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600013C. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/terumo-bct-announces-enrollment-of-the-first-patient-in-its-us-clinical-trial-designed-to-study-platelets-treated-with-the-mirasol-pathogen-reduction-technology-prt-system-300458904.html
News Article | May 15, 2017
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that the first patient has been transfused in Puerto Rico for the “INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS)” clinical trial to assess the safety and efficacy of the INTERCEPT Blood System for Red Blood Cells (RBCs) when compared to conventional RBCs in regions impacted by the Zika virus epidemic. RedeS is a two-stage study being conducted initially in Puerto Rico, a region significantly impacted by the Zika virus epidemic. The study is expected to be expanded to other areas at risk for transfusion-transmitted infections due to the Zika virus, such as Florida. The first stage of the trial is a double-blind, controlled, parallel group trial where 600 adult patients will be randomized to receive up to 28 days of transfusion support with INTERCEPT-treated RBCs or conventional RBCs, with a primary endpoint of hemoglobin increment following transfusion. In a second optional stage, up to 20,000 patients would receive RBC transfusion support with up to 50,000 RBC units in an open-label, single-arm treatment use study. The objective of the second stage is to provide early access to the INTERCEPT pathogen reduction system for RBCs in regions where a substantial proportion of the population has been infected or is at risk of infection by the Zika virus, and the risk of asymptomatic infection among qualified blood donors is recognized. “RedeS marks the first of three pivotal trials expected to support our planned submission to FDA for US licensure of the INTERCEPT Blood System for red cells,” said Richard Benjamin, Cerus’ chief medical officer. “It will lay the ground work for our subsequent anticipated U.S. Phase III trials designed to demonstrate safety and efficacy of INTERCEPT RBCs in cardiovascular surgery patients (the ReCePI study) and chronically transfused patients.” Study RBCs are currently being manufactured and supplied to participating Puerto Rican hospitals by Banco de Sangre de Servicios Mutuos. “We are proud to partner with Cerus by participating in the RedeS study to help move pathogen reduction technology one step closer for red cells,” said Jose O. Alsina, vice president and chief operating officer of Banco de Sangre de Servicios Mutuos, Puerto Rico’s largest blood bank. “Implementing the INTERCEPT Blood System for platelets and plasma allowed us to safely continue to accept donations from our local donor network during the Zika outbreak last year.” RedeS is funded as part of an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Blood System for Red Blood Cells is in clinical development. See www.cerus.com for information about Cerus. INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation. Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements concerning potential expansion of the RedeS study to other areas at risk for transfusion-transmitted infections due to the Zika virus, and potential future manufacturing scale-up activities, in vitro studies and preparedness for a Phase III clinical trial in the continental U.S clinical trial activity and regulatory submissions. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the uncertain nature of BARDA’s funding over which Cerus has no control as well as actions of Congress and governmental agencies which may adversely affect the availability of funding under the BARDA contract and/or BARDA’s exercise of any potential subsequent option periods, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be delayed or halted; the uncertain and time-consuming research and development processes that may be necessary prior to the commencement of a Phase III clinical trial; the risks that Cerus may be unable to meet FDA requirements to commence any Phase III clinical studies; the time-consuming clinical trials and regulatory processes that must be completed to obtain regulatory approval of the red blood cell system in a timely manner or at all; as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including in Cerus‘ Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the SEC on May 4, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
News Article | May 10, 2017
GAITHERSBURG, Md., May 10, 2017 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today held a ribbon-cutting ceremony led by Dr. Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), and Daniel J. Abdun-Nabi, Emergent’s president and chief executive officer, to mark the formal opening of the company’s newly expanded Center for Innovation in Advanced Development and Manufacturing (CIADM) at its Bayview Campus in Baltimore. The facility is one of three centers designated by the U.S. Department of Health and Human Services to provide advanced development and manufacturing of medical countermeasures to support the U.S. government’s national security and public health emergency needs. “With the expansion of our Bayview campus, Emergent is pleased to directly support BARDA’s vision of enhancing the nation’s capability to respond quickly to both known and emerging public health threats,” said Abdun-Nabi. “This milestone strengthens our manufacturing infrastructure, which is one of our core competencies, and symbolizes Emergent’s commitment to the City of Baltimore and the State of Maryland, where we are proud to meaningfully contribute to economic activity and job growth.” “The Centers for Innovation in Advanced Development and Manufacturing were designed as public-private partnerships to provide greater speed, flexibility, and domestic capacity to produce medical countermeasures to address public health emergencies,” said Bright. “The work that we do in BARDA – and that we do together with industry partners at our CIADMs – is critical to protecting Americans’ health in emergencies and is fundamental to our nation’s security.” Emergent has doubled the Bayview facility’s footprint to 112,000 square feet with investments to the original 56,000-square-foot facility purchased by the company in 2009. The facility, comprised of laboratory, manufacturing and office space, offers flexible manufacturing of drug substance from microbial, cell culture or viral production platforms and is equipped with disposable manufacturing technology to enable Emergent to meet the government’s domestic preparedness priorities on a cost-effective, reliable and sustainable basis. The new suite within the expanded facility is expected to come online with cGMP production capabilities in late 2018. Since its inception, the Emergent CIADM has been awarded four task orders by BARDA to develop Ebola and Marburg therapeutics and a Zika vaccine. Emergent also successfully manufactured some of its product candidates at the CIADM and an Ebola vaccine candidate as part of a third-party collaboration. Emergent employs approximately 1,200 employees worldwide. More than 500 employees are located across four sites in Maryland, including its Bayview Campus, Camden manufacturing facility, and corporate headquarters and product development site in Gaithersburg. BARDA contract HHSO100201200004I, awarded to Emergent in June 2012 to establish a CIADM, consists of an eight-year base period of performance valued at approximately $220 million (cost-shared between the government and Emergent) and up to 17 additional one-year option periods. BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. Sen. Chris Van Hollen (D-Md.) “Maryland’s biopharmaceutical industry continues to grow and create good-paying jobs. Emergent's new Bayview facility is an exciting addition to their statewide footprint, and people across the nation could benefit from their vaccines and therapeutic treatments like those for anthrax and Zika. A successful biopharmaceutical industry requires a coordinated strategy to both expand job opportunities and ensure our next generation of workers has the skills needed to fill these jobs. I will continue to work on the federal level to help the industry grow in Maryland so the lifesaving innovations made in this sector also provide an economic boost to our state.” Rep. John Sarbanes (D-3rd District) “Maryland is home to a vibrant biotechnology industry that supports thousands of good-paying jobs. The expansion of Emergent BioSolutions’ Bayview facility in Baltimore will help ensure that Maryland remains a leader in biotechnology innovation and will help boost our state’s economy for many years to come.” Rep. Andy Harris (R-1st District) “I congratulate Emergent BioSolutions today on the expansion of their Center for Innovation in Advanced Development and Manufacturing that fulfils such a critically important component of America’s countermeasure development and biosecurity enterprise.” Rep. C.A. Dutch Ruppersberger (D-2nd District) “Emergent BioSolutions’ expansion was a public-private investment in the welfare of all Americans through the development of vaccines and treatments for diseases from the flu to Ebola. For us Baltimoreans, it’s also exciting because it means more high-quality manufacturing jobs in the cutting-edge biosciences sector. I congratulate Emergent and thank them for their commitment to Maryland and our great city.” Maryland Governor Larry Hogan “Emergent BioSolutions plays a critical role in addressing many of our nation’s emerging public health threats and we are proud they are continuing to do that important work right here in Maryland. Doubling the size of its Bayview facility and adding new jobs to meet its increased capabilities is further confirmation that Maryland offers an outstanding environment for life sciences companies to thrive.” Baltimore Mayor Catherine E. Pugh “It’s exciting to witness the continued growth of Emergent BioSolutions in Maryland and Baltimore City. I am encouraged by so many businesses investing and expanding in Baltimore. Not only does Emergent make meaningful products, which improve public health, the company is bringing and keeping manufacturing jobs in the city – jobs that provide family-sustaining wages.” Baltimore City Council President Bernard C. “Jack” Young “I am extremely pleased to see Emergent expanding its manufacturing capabilities in Maryland. They are at the forefront of innovation, and represent everything we want in a Baltimore area company. Emergent also continues to emphasize local hiring, which I have fought hard to promote so we can increase job opportunities and put our city to work. I commend Emergent for its commitment to our city schools where they teach students about manufacturing and expose them to potential career paths in science. I am confident Emergent will continue to be an asset to Baltimore.” About Emergent BioSolutions Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at emergentbiosolutions.com. Follow us @emergentbiosolu.
News Article | February 22, 2017
Thermo Fisher Scientific to develop and then commercialize its assay for measuring the concentration of plazomicin SOUTH SAN FRANCISCO, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that they have achieved a strategic milestone in their ongoing efforts to develop an assay enabling therapeutic drug management (TDM) of plazomicin. Achaogen is developing plazomicin for the potential treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). In Achaogen’s Phase 3 CARE trial in patients with serious infections due to CRE, an investigational assay enabling plazomicin TDM was used to help ensure that targeted exposures of plazomicin were achieved in the critically ill patients enrolled in the trial. If plazomicin is approved, Achaogen and Thermo Fisher plan to develop and have a commercial assay for plazomicin available at product launch. Achaogen plans to submit a New Drug Application (NDA) for plazomicin to the Food and Drug Administration (FDA) in the second half of 2017. Achaogen also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. “Thermo Fisher is a world leader in developing and providing high-quality commercial assays to achieve precise and accurate quantitative results crucial for monitoring drug levels. We are pleased with the progress made in our collaboration with Thermo Fisher and with achieving this important milestone of demonstrating assay feasibility, a key step toward enabling therapeutic drug management of plazomicin for those patients most likely to benefit from TDM,” said Blake Wise, Achaogen’s Chief Operating Officer. “In certain high-risk patient populations, such as the critically ill, we believe TDM has the potential to provide significant utility in optimizing plazomicin dosing.” The two companies have been collaborating on assay development since 2015. Under terms of their collaboration agreement, Thermo Fisher leads the development, regulatory approval, and commercialization of an assay for measuring plazomicin drug levels. Achaogen brings plazomicin expertise to the collaboration, including the discovery of plazomicin-specific antibodies utilizing their state-of-the-art antibody discovery platform. “The agreement reflects our mutual commitment to providing a broadly-available plazomicin assay at launch so that healthcare providers can measure plazomicin drug levels in critically ill patients with bacterial infections,” said John Kody, Vice President/General Manager Clinical Diagnostics - Niche Products at Thermo Fisher Scientific. “During the feasibility period, our two teams have developed an assay that compares very well to traditional analytical chemistry techniques. Thermo Fisher’s QMS™ TDM assays are conveniently ready-to-use, with excellent precision and accuracy, and are optimized for performance on a wide range of analyzers.” In December 2016, Achaogen announced positive results from its plazomicin Phase 3 clinical trials in complicated urinary tract infections (cUTI) and infections due to CRE. In the Phase 3 EPIC registration trial in patients with cUTI and acute pyelonephritis (AP), plazomicin met the objective of non-inferiority compared to meropenem for FDA-specified primary efficacy endpoints, and achieved superiority for the EMA-specified primary efficacy endpoints. In addition, in the Phase 3 CARE trial in patients with serious infections due to CRE, a lower rate of mortality or serious disease-related complications was observed for plazomicin-treated patients compared with those on colistin therapy. In the Phase 3 CARE trial, TDM with an investigational assay helped to confirm that the targeted-exposure of plazomicin was achieved in these critically ill patients. About Therapeutic Drug Management and Plazomicin Therapeutic Drug Management is the practice of measuring the concentration of medication in blood and adjusting the dose of that drug based on the results. Healthcare providers routinely use TDM for certain drugs to help improve patient care by individually adjusting the dose as appropriate. Critically ill patients with bacterial infections often have abnormal and fluctuating renal function as well as an altered volume of drug distribution in the body. This can lead to these patients being either under or over-dosed with what are potentially life-saving therapies. Initial data from Achaogen’s plazomicin CARE study in critically ill patients with CRE infections confirmed drug concentration variability within and among patients and importantly, showed that TDM helped to ensure that the targeted-exposure of plazomicin was achieved in these patients. About Achaogen Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. Achaogen's LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. LpxC inhibitors are the second class of molecules from Achaogen's gram-negative antibiotic discovery engine. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
News Article | February 21, 2017
PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s new drug application (NDA) filing for Carbavance® (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTIs). The FDA does not currently plan to hold an advisory committee meeting to discuss the application. The NDA filing is based on results from the pivotal Phase III TANGO 1 clinical trial in patients with cUTIs. As previously announced, the TANGO 1 trial met both FDA and European Medicines Agency (EMA) pre-specified primary endpoints. Carbavance also demonstrated statistical superiority over piperacillin-tazobactam with overall success in 98.4% of patients. Supporting the NDA are interim data from the ongoing TANGO 2 Phase III trial, which compares the safety, tolerability and efficacy of Carbavance with best available therapy in patients with selected serious infections due to confirmed or suspected carbapenem-resistant Enterobacteriaceae (CRE). The TANGO 2 trial is ongoing and the Company expects results to be available before the end of the third quarter of 2017. “The exceptionally rapid development of Carbavance demonstrates the strong product discovery and development capabilities of The Medicines Company’s Infectious Disease Business, and reflects our commitment to making innovative antimicrobial products available to patients with the most serious drug-resistant infections,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “We believe that Carbavance could be a promising and highly-differentiated treatment option for these patients and we look forward to continuing our dialogue with the FDA during its review process.” Tony Kingsley, President and Chief Operating Officer of The Medicines Company added, “Reaching this point in the development of Carbavance reflects the focus, commitment and expertise of our Infectious Disease Business. Multiple studies support the potential for Carbavance to make a meaningful difference in the treatment of serious infections. If approved by the FDA, we will leverage our existing sales and distribution infrastructure to launch Carbavance in the U.S. market.” Carbavance, an investigational agent not approved for commercial use in any market, is a combination of the carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), administered as a fixed combination by IV infusion. It is being developed to treat serious gram-negative infections, such as cUTI, including those infections caused by bacteria resistant to currently-available carbapenems. Carbavance has been granted Fast Track status by the FDA for the treatment of cUTI and has been designated by the FDA as a Qualified Infectious Disease Product (QIDP), as authorized under the GAIN Act. Carbavance was designed to address gram-negative bacteria that produce new beta-lactamase enzymes that have spread in the United States and Europe, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant form of CRE in the United States and are classified by the U.S. Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat. In February 2014, the Company’s Infectious Disease Business was awarded a cost-sharing contract from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS), of which $55.8 million in federal funds have been obligated to date to support the development of Carbavance. In September 2016, The Medicines Company entered into a new strategic partnership with BARDA that will provide the Company with up to $132 million to support the development of new antibiotics to fight drug-resistant, gram-negative infections. The partnership was established under HHS’s Other Transactional Authority (OTA) and is a distinctive, flexible, portfolio-based approach to funding drug development. The Medicines Company was awarded $32 million in initial funding, and up to an additional $100 million (pending the availability of funding) over approximately five years, if all options to extend the partnership are exercised by BARDA. The initial $32 million award support a Phase IIIb trial of the Carbavance, for the treatment of gram-negative infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The initial award, as well as funding provided under any subsequent options exercised by BARDA, will also support the advancement of additional antibiotics in The Medicines Company’s leading portfolio of new antibiotic drug candidates targeting drug resistant bacteria. The Medicines Company’s Infectious Disease Business is committed to bringing life-saving antimicrobial products to patients with the most serious drug-resistant infections – infections caused by “super bugs” which are no longer treatable with available antibiotics. The Infectious Disease Business encompasses basic research and drug discovery focused on bacterial mechanisms of drug resistance; drug development focused on the most threatening bacterial diseases; and a distribution and commercial infrastructure that serves the leading hospitals and healthcare facilities in the United States. The business is currently developing Carbavance to treat serious gram-negative infections, such as complicated urinary tract infections, including those infections caused by bacteria resistant to currently available carbapenems. A pivotal Phase III clinical trial for Carbavance was successfully completed in 2016. Since 2014, our team has successfully developed and launched two antibiotics against serious infections: Orbactiv® (oritavancin) for treatment of acute bacterial skin and skin-structure infections in adults, including those due to methicillin-resistant Staphylococcus aureus (MRSA), and a new formulation of Minocin® (minocycline) for Injection, which is among the few FDA-approved agents for the treatment of infections due to Acinetobacter sp., a serious antimicrobial resistance threat. For more information on these products, including their respective prescribing information, please see www.orbactiv.com and www.minociniv.com. The Infectious Disease Business also has a leading pipeline of novel agents directed towards existing and emerging multidrug-resistant bacteria. The Medicines Company is a biopharmaceutical company driven by an overriding purpose – to save lives, alleviate suffering and contribute to the economics of healthcare. The Company’s mission is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians and providers in three critical therapeutic areas: serious infectious disease care, cardiovascular care and surgery and perioperative care. The Company is headquartered in Parsippany, New Jersey, with global innovation centers in California and Switzerland. Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," “potential,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include: whether the Company will make regulatory submissions for Carbavance on a timely basis, or at all; whether the Carbavance NDA and other regulatory submissions will receive approvals from regulatory agencies on a timely basis, or at all; whether clinical trials for Carbavance will advance in the clinical process on a timely basis, or at all, or succeed in achieving their specified endpoints; whether physicians, patients and other key decision makers will accept clinical trial results; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission, including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 27, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
News Article | March 1, 2017
-- Plazomicin NDA submission planned for the second half of 2017 -- -- Plan to initiate clinical trial of orally-administered antibacterial candidate for ESBL+ infections, C-Scape, in 2017 -- -- Advances in research expand unique pipeline of therapeutic candidates targeting the most critical priority pathogens -- SOUTH SAN FRANCISCO, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, held an R&D Day to provide an overview of its Research and Development programs including the Company's new orally-administered antibacterial candidate, C-Scape. The meeting consisted of presentations from members of Achaogen’s leadership team and medical community key opinion leaders. "We aspire to solve the growing issue of antimicrobial resistance and we are very pleased to announce that we now have two potential development candidates to further this vision,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. "We believe that with plazomicin, a pre-NDA candidate, and C-Scape, a 2017 Phase 1 candidate with potential for rapid development, we are positioned to advance our leadership in discovering, developing, and commercializing innovative antibacterials to treat the critical priority pathogens that cause highly resistant gram-negative infections.” The Achaogen R&D Day focused on the Company's antibacterial development pipeline to support the following corporate objectives: Plazomicin: The R&D Day provided an overview of the plazomicin program, including a review of the Phase 3 results, progress towards the planned New Drug Application (NDA) submission and preparation for commercialization: C-Scape: An overview of Achaogen’s newly announced, orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, was provided. Key highlights were as follows: Research Discovery and Development: Achaogen’s research and early development overview focused on novel approaches to address infections caused by MDR gram-negative pathogens. The early stage pipeline consists of the following research candidates: An audio webcast of the 2017 Achaogen R&D Day is available in the "Investors" section of Achaogen’s website, www.achaogen.com. A replay of the presentation will be available until April 2, 2017. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
News Article | February 22, 2017
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) Therapeutics™ to create a new generation of transformative medicines for patients, announced today the appointment of Israel Ruiz, Executive Vice President and Treasurer of the Massachusetts Institute of Technology (MIT), to the company’s Board of Directors, where he will serve as Audit Committee Chair. Mr. Ruiz serves as MIT’s Chief Financial Officer and, as a Trustee of the MIT Corporation and a member of its Executive Committee, is the chief steward of over $17 billion of financial assets, $3.4 billion in operating revenues and is responsible for administering MIT’s $5 billion capital plan through 2030. In addition, Mr. Ruiz currently serves as Audit Committee Chair on the Board of Directors of Fortive (NYSE: FTV), a diversified industrial growth company with 24,000 global employees and more than $6 billion in annual revenue. In 2015, Fortive was spun out from Danaher (NYSE: DHR), a Fortune 150 company and global science and technology innovator. “We are delighted to welcome Israel to Moderna’s Board of Directors. His progressive leadership at MIT has helped ensure the continued, unparalleled contributions of the Institute on a regional, national and global scale, through education, innovation and entrepreneurship,” said Noubar Afeyan, Ph.D., co-founder and Chairman, Moderna Therapeutics, and CEO of Flagship Pioneering. “We look forward to leveraging Israel’s insights as Moderna evolves into a leading, clinical stage biotechnology company by harnessing the promise of messenger RNA science to improve lives.” With a strong understanding of MIT’s innovation ecosystem and future technology trajectories, Mr. Ruiz was instrumental in leading the re-zoning efforts of Kendall Square in Cambridge, Mass. in 2013 to enable mixed-use development and accelerate the process of moving ideas from lab to market. Mr. Ruiz continues to actively co-lead the development of the process through its complex execution phase, expected to last beyond 2020. “A critical component of Moderna’s success to date has been our ability to tap into a breadth of viewpoints and guidance from leading experts across the corporate and academic worlds. To that end, we are thrilled that Israel is joining the Moderna board,” said Stéphane Bancel, Chief Executive Officer at Moderna. “Israel’s proven track record at MIT, one of the world’s leading incubators of innovation, as well as his active role in advancing Kendall Square as a world-class innovation hub, afford him a unique perspective on how Moderna can drive innovation on behalf of patients, and also advance change through broader contributions to society. In addition, Israel’s experience as Audit Committee Chair on Fortive’s Board of Directors well positions him to help us continue to ensure Moderna’s financial strength and establish a framework for long-term success.” “At MIT, we are driven to bring knowledge to bear on the world’s great challenges, and I see this same spirit of intellect and impact embodied by the Moderna team. They are working with rigor and intensity to drive breakthroughs in both science and technology with the goal of delivering a new class of medicines to address significant medical challenges and unmet needs around the world,” said Mr. Ruiz. “I am extremely honored to join Moderna’s Board, and look forward to lending my support to help further advance the mission and vision of this unique and immensely exciting company.” At MIT, Mr. Ruiz is responsible for financial and debt strategy development, budget and capital planning, and the integrity of financial information. His other areas of responsibility include human resources, information systems, campus facilities, security and safety, compliance, government relations, international support, sustainability and medical. Prior to becoming Executive Vice President and Treasurer in 2011, Mr. Ruiz held several roles of increasing responsibility at MIT, most recently serving as Vice President of Finance. Involved since the early 2000s with digital education, Mr. Ruiz was instrumental in launching a group to evaluate e-learning opportunities in 2009-2010 in response to the global financial crisis. The work of this group ultimately led MIT to launching its online efforts, MITx in 2011 and edX in 2012, in partnership with Harvard University. In 2014, Mr. Ruiz co-led the Task Force that published the “Future of MIT Education” outlining the tremendous opportunities that digital learning technologies bring to residential education and to the global market for education. Mr. Ruiz previously held management and engineering roles at Hewlett-Packard and Nissan Automotive. Mr. Ruiz serves on the MIT-related Board of Directors of edX (an MIT and Harvard on-line learning initiative), MIT Endicott House and MIT Technology Review. He is a director of Fortive (NYSE: FTV). He is also a director of the Governing Board of the Eliot Innovation School and very active in the Boston Public Schools. Mr. Ruiz holds a master’s degree from the MIT Sloan School of Management and a six-year degree in industrial and mechanical engineering from the Polytechnic University of Catalonia, in his native Barcelona. Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that directs the body’s cells to produces human proteins, antibodies and novel protein constructs, which are in turn secreted or active intracellularly. With its breakthrough platform, Moderna is developing mRNA vaccines and therapeutics to address currently undruggable targets and deliver a new class of medicines for a wide range of diseases and conditions. Moderna is developing its innovative mRNA medicines for infectious diseases, cancer (immunooncology), rare diseases, cardiovascular disease and pulmonary disease, through its ecosystem of internal ventures and strategic partners. Founded by Flagship Pioneering, Cambridge-based Moderna is privately held and has strategic agreements with AstraZeneca, Merck, Alexion Pharmaceuticals and Vertex Pharmaceuticals, as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS); and the Bill & Melinda Gates Foundation. To learn more, visit www.modernatx.com.
News Article | February 17, 2017
Vaccine developers have successfully protected mice against Zika by injecting synthetic messenger RNA that encodes for virus proteins into the animals. The cells of the mice then build parts of the virus, training the immune system to recognize a future infection. The research, published February 17 in Cell, follows a February 2 Letter in Nature (doi:10.1038/nature21428) that showed similar positive results for a messenger RNA vaccine for Zika in mice and monkeys. "We measured virus in the blood, virus in the brain, virus in the spleen, virus in the uterus for the female mice, and in one group of our vaccines we saw no viral replication at all in 95% of the mice," says study senior co-author Michael Diamond, infectious disease researcher at the Washington University School of Medicine in St. Louis. Instead of training the immune system with weakened viruses or viral fragments, RNA vaccines trick cells into building pieces of virus, much the way viruses coerce cells into building more viruses. "Zika viruses inject their RNA into the cytoplasm and then they hijack the cell's translation machinery to produce their antigen," says study co-senior author Giuseppe Ciaramella, the Chief Scientific Officer at Valera LLC, a Moderna Venture focusing on the development of therapeutic approaches for infectious diseases. "With our vaccines, we direct cells to do exactly the same." While viruses inject RNA instructions to build an entire virus, the vaccine contains RNA with instructions for just two Zika proteins. When the vaccine RNA enters the mouse cells, the ribosomes pick it up, build the protein, and release it. The two proteins can't infect any other cells, but they're enough for the immune system to learn to recognize Zika and build immunity. Researchers have been hesitant to use weakened viruses of Zika to immunize against the virus, because Zika viruses can enter the brain. Even with weakened Zika, some scientists are concerned that attenuated viruses might still cause some damage in the brain. However, with RNA vaccines, cells quickly uptake the RNA, which never reaches the brain. Another key advantage of using RNA vaccines is their adaptability. Biologists have had a lot of practice at altering RNA strands, making it easier to customize the vaccine. The researchers demonstrated the vaccine's flexibility by addressing one possible concern in the Zika vaccine development community. Zika virus looks an awful lot like its close relative, the dengue virus. In fact, they look so much alike that the immune system's antibodies against Zika might latch onto dengue viruses without actually killing the dengue virus. If that occurred, anti-Zika antibodies might worsen dengue infections. However, slightly modifying the RNA in the vaccine allowed the researchers to induce a Zika-killing antibody that minimized its ability to bind to dengue. The researchers stressed that there haven't been epidemiological studies reporting especially vicious dengue infections in people who have had Zika. "It is a theoretical concern. We do not know yet if it's going to be a major concern or not. Because you need to have Zika first and then get dengue," says Diamond. Lots of people have gotten dengue first and later caught Zika, but since Zika is a relatively new addition to most locales, there haven't been enough Zika-first, dengue-second cases to lay the concern to rest. "We just don't know yet," says Diamond. Next steps for the Zika RNA vaccines include a human clinical trial (which is currently recruiting) and mouse studies that test whether the vaccine can prevent mother-to-fetus transmission. This work was supported by grants from the NIH-NIAID and by a research grant from Moderna. Michael Diamond is a consultant or scientific advisor for several pharmaceutical companies, including Moderna. Giuseppe Ciaramella and two co-authors are employees of Valera LLC, a Moderna venture. Pre-clinical funding for Moderna's development of its Zika mRNA vaccine was provided by the Defense Advanced Research Projects Agency (DARPA). Funding for the clinical trials of Moderna's Zika mRNA vaccine is provided by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Cell, Richner and Himansu et al.: "Modified mRNA vaccines protect against Zika virus and minimize antibody enhancement of dengue virus infection" http://www.cell.com/cell/fulltext/S0092-8674(17)30195-2 Cell (@CellCellPress), the flagship journal of Cell Press, is a bimonthly journal that publishes findings of unusual significance in any area of experimental biology, including but not limited to cell biology, molecular biology, neuroscience, immunology, virology and microbiology, cancer, human genetics, systems biology, signaling, and disease mechanisms and therapeutics. Visit: http://www. . To receive Cell Press media alerts, contact firstname.lastname@example.org.
News Article | February 13, 2017
GAITHERSBURG, Md., Feb. 13, 2017 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has received a task order from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $30.5 million to develop monoclonal antibody therapeutics for viral hemorrhagic fever. This task order will utilize the company’s Center for Innovation in Advanced Development and Manufacturing (CIADM) facility located in Baltimore, Maryland. Using monoclonal antibodies from Mapp Biopharmaceutical Inc., the company will conduct technology transfer of process materials and information, perform process and analytical method development, execute small-scale production runs, and perform cGMP cell banking leading to cGMP manufacture of bulk drug substance. The task order consists of a 36-month period of performance with a base task order valued at $7.4 million and options that, if executed, will bring the total task order value over three years to up to $30.5 million. “Protecting and enhancing life is at the core of Emergent’s mission, and one of the ways by which we are able to fulfill this mission is in partnership with BARDA as it addresses emerging public health threats,” said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions. “Emergent’s CIADM is a great example of a public-private partnership that works towards a shared goal. We look forward to successfully executing this task order in collaboration with all parties involved.” This is the fourth BARDA Task Order awarded to Emergent under the CIADM program. Since its inception in 2012, Emergent’s CIADM facility has been utilized to respond to public health emergencies including Ebola and Zika. This Task Order Number HHSO10033004T under contract HHSO100201200004I is funded by BARDA, within the Office of the Assistant Secretary for Preparedness and Response in HHS. About Emergent BioSolutions Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at emergentbiosolutions.com. Follow us @emergentbiosolu. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the exercise of options under the task order, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the availability of funding and BARDA’s exercise of options under the task order; the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; and commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.