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 | 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 | November 18, 2016
YAVNE, Israel, Nov. 18, 2016 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces that an abstract highlighting the merits of NexoBrid® in the management of burns in mass casualty incidents was selected as “Best Poster” at the International Disaster and Military Medicine (DiMiMED) 4th Annual Conference, held November 15-16 in Dusseldorf, Germany. The poster, titled “The role of rapid & effective enzymatic debridement/escharotomy in burn mass casualties' incidents,” was delivered by Prof. Lior Rosenberg, MediWound's Chief Medical Officer and former head of the International Society of Burn Injury disaster committee. The prize was awarded by the co-chairmen of the conference, Dr. Christoph Büttner, MC Dr, Rear Admiral uh (ret), Editor-in-chief of Medical Corps International Forum, Germany and Dr. Rob van der Meer, MD, Brigadier General (ret), Former Surgeon General of the Netherlands Armed Forces. The poster highlights how NexoBrid's debridement and enzymatic escharotomy can reduce surgical burden, dependency on highly trained surgeons and scarce surgical facilities. NexoBrid provides rapid and selective, nonsurgical removal of the eschar at the patient's bedside, resolves or possibly prevents Burn Induced Compartment Syndrome (BICS), which currently requires immediate surgical intervention, and enables early visual diagnosis of burn severity. Collectively these contribute to increased surge capacity, and possibly reduced mortality and morbidity as well as faster resilience. “We are delighted that the role of NexoBrid in the management of mass casualty incidents continues to be acknowledged by thought-leading organizations such as the DiMiMED and the International Conference on Healthcare System Preparedness and Response to Emergencies and Disasters. Recognition has also come from important government agencies and officials such as the U.S. Biomedical Advanced Research and Development Authority and the president and government officials of Romania, following the Colectiv nightclub disaster,” noted Gal Cohen, President and Chief Executive Officer of MediWound. "Unfortunately, mass casualty incidents are not limited to acts of war or urban terror. There are civilian mass casualties as we have seen recently with the explosions at a Chinese chemical plant, and at an amusement park in Taiwan, each of which resulted in hundreds of burn victims. Even a multivehicle road accident could challenge burn treatment capacity and turn into a mass casualty incident. We look forward to working with various international agencies and with governments to advance the use of NexoBrid for mass casualty and disaster preparedness, as well as in military medicine,” added Mr. Cohen. According to Prof. Rosenberg, "Burn Induced Compartment Syndrome is characterized by severe high pressure in the compartment, which results in insufficient blood supply to muscles and nerves. It is a medical emergency that requires immediate surgical intervention. On one hand, if left untreated, the lack of blood supply leads to permanent muscle and nerve damage and can result in the loss of limb function. On the other hand, if escharotomy is not done by highly trained personnel, it could result in permanent damage to vital structures such as nerves and tendons, leading to impaired long-term functionality and permanent long linear scars. “During the NexoBrid Phase 3 study, no escharotomies were done in deeply burned hands treated with NexoBrid, versus 9.8% in deeply burned hands treated by standard of care. In fact, during NexoBrid’s clinical development more than 130 extremities treated with NexoBrid did not require escharotomies,” added Prof. Rosenberg. “This is imperative in the management of mass casualty incidents as extremities are the most frequently burned area, and if deeply burned are most likely to develop BICS. Not only can NexoBrid rapidly remove eschar and allow burn severity diagnosis, but it may avoid the need for immediate escharotomy. It is important to note that in routine burn care as well, surgical debridement and escharotomy are among the most traumatic surgical procedures and are challenging for both the care provider and patient. As demonstrated, NexoBrid nonsurgical debridement can significantly reduce such surgical burden.” DiMiMED is the International Conference on Disaster and Military Medicine focussing on current issues in military medicine and disaster medicine. The disasters taking place all over the world have shown that it is absolutely essential for civilian medical services and the military medical services to join forces to provide optimum on-site medical care. In addition to civilian medical services, the medical services of the armed forces are increasingly used to deal with disasters. DiMiMED provides a platform for exchanging experiences, holding discussions and for promoting global cooperation. The DiMiMED conference is organized by the Beta Group / Beta Verlag & Marketinggesellschaft mbH, under the auspices of the Medical Corps International Forum and powered by MEDICA / Messe Düsseldorf GmbH. NexoBrid is an easy-to-use, topically-applied product that removes dead or damaged tissue, known as eschar, in approximately four hours without harming the surrounding healthy tissues. NexoBrid received marketing authorization from the European Medicines Agency for the removal of eschar in adults with deep partial and full-thickness thermal burns, is commercially available in Europe and Israel and will be launched in Argentina in the coming months. Representing a new paradigm in burn care management, NexoBrid demonstrated in clinical studies, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier than other modalities, without harming viable tissues. The removal of eschar or “debridement” is a critical first step in the successful healing of severe burns and chronic and other hard-to-heal wounds. With the current standard of care, burn eschar is removed either with existing topical agents that have been found to be minimally effective or that take a significantly longer period of time to work, or by resorting to non-selective surgery, which is traumatic and may result in loss of blood and viable tissue necessitating further surgical treatments. The U.S. Phase 3 clinical trial and registration process for NexoBrid is being funded in whole or in part with federal funds under a contract with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority. MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency as well as the Israeli and Argentinian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns and was launched in Europe and Israel, with plans for a launch in Argentina. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. MediWound's second innovative product, EscharEx® is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds and is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx® contains the same proteolytic enzyme technology as NexoBrid®, and benefits from the wealth of existing development data on NexoBrid®. In two Phase 2 studies, EscharEx® has demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com. This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to the regulatory authorizations and launch dates. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2015 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
News Article | November 10, 2016
MEDFORD, N.Y., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (“POC”) diagnostic tests for infectious diseases, today reported financial results for the three and nine months ended September 30, 2016. John J. Sperzel III, Chief Executive Officer, stated, “The Company made important advances in multiple areas during the third quarter of 2016, intended to prepare the Company for growth: commercialization, regulatory approvals, product development grants, and equity financing. With respect to Chembio's commercial infrastructure, the Company appointed two seasoned executives to build our worldwide sales and marketing capabilities, with immediate focus on the United States, Latin America, Asia Pacific and Africa. The Company expanded its distribution network by appointing Isla Lab, the largest distributor of diagnostic products in the Caribbean, as its exclusive distributor in that region. “Chembio recently secured two important regulatory approvals. In July 2016, the Company obtained a CE mark for the DPP® Zika IgM/IgG Assay and DPP® Micro Reader, allowing the products to be marketed and sold in 17 European countries, including the United Kingdom, Germany, and France, as well as a majority of the Caribbean nations. In late October 2016, the Company received approval by Brazil’s health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA) for DPP® Zika IgM/IgG Assay. These regulatory achievements follow the milestone which occurred at the end of the second quarter of 2016, when Chembio’s DPP® HIV 1/2 Assay was accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostics. “In August 2016, Chembio completed an equity financing which provided gross proceeds of approximately $13.8 million, which provides the Company with capital needed to advance its product development programs and invest in the sales and operational infrastructure needed to support sustained growth. Also in August 2016, Chembio was awarded a contract for up to $13.2 million in total funding from the U.S. Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA) to develop and commercialize the Company’s DPP® Zika IgM/IgG Assay and Zika-related products. “Subsequent to the 2016 third–quarter end, Chembio entered into an agreement to acquire RVR Diagnostics Sdn Bhd (RVR), a Malaysian, privately-held manufacturer and distributor of POC diagnostic tests for infectious diseases. Subject to satisfaction of conditions to closing, completion of the RVR acquisition will provide the Company with a strategically located and cost-effective manufacturing facility, an additional revenue source, and the potential to accelerate important product registrations in Southeast Asia, which we believe will be important in serving a number of global markets.” Addressing the company’s financial results, Mr. Sperzel commented, “Despite reporting a decrease in product sales for both the second and third quarters of 2016, a quarter-over-quarter analysis shows sales growth with total revenues for the third quarter of 2016 up 15% and product sales for the third quarter of 2016 up 23%, as compared to the second quarter of 2016. In the United States, sales of the HIV 1/2 STAT-PAK® Assay increased 44% as compared to the third quarter of 2015, and increased 21% as compared to the second quarter of 2016. This growth provides strong evidence that we are effectively rebuilding the U.S. HIV STAT-PAK® business, since we took back the U.S. distribution rights to this product in June 2014. We are also seeing encouraging U.S. sales of the HIV 1/2 SURE CHECK® Assay since we took back distribution rights to this product at the end of May 2016. Through the Company’s achievements in strengthening commercial infrastructure, securing regulatory approvals, improving its balance sheet, obtaining a multi-million dollar grant from the U.S. Government, and establishing operations in the growing Asian market, we believe Chembio is on a path to establish a global operation with potential for growth in several important markets.” Selected Summary Financial Information comparing the 2016 third quarter to the 2015 third quarter: Selected Summary Financial Information comparing the first nine months of 2016 to the first nine months of 2015: Third Quarter: Total revenues in the 2016 third quarter of $3.75 million decreased 45.6% compared with $6.89 million in the prior-year period. Product sales in the 2016 third quarter of $2.50 million decreased 59.7% compared with $6.21 million in the prior-year period. R&D milestone, and grant and royalty revenues in the 2016 third quarter of $1,244,000 increased 83.4% compared with $678,000 in the prior-year period. Gross margin dollars in the 2016 third quarter of $1.95 million decreased 32.9% compared with $2.91 million in the prior-year period, due primarily to decreased product revenues. Product gross margin dollars in the 2016 third quarter of $0.71 million decreased 68.3% compared with $2.23 million in the prior-year period, which also was primarily due to the decreased product revenues. R&D expenses in the 2016 third quarter of $2.26 million increased 44.2%, compared with $1.57 million in the prior-year period. This increase is due primarily to increased clinical trial expenses as well as R&D activities for projects and grants. Selling, general and administrative expenses in the 2016 third quarter of $1.83 million decreased 4.5% compared with $1.92 million in the prior-year period, largely due to decreased commissions, which were due to decreased sales in Brazil, as well as decreases in stock-based compensation, travel, entertainment and trade shows, consulting, and other expenses, which were partially offset by increases in wages and related costs, marketing materials, professional fees and investor relations expenses. Operating loss in the 2016 third quarter was $2,144,000, compared with an operating loss of $579,000 in the prior-year period. Net loss in the 2016 third quarter was $2,138,000, or $0.19 per diluted share, compared with net loss of $437,000, or $0.05 per diluted share, in the prior-year period. First Nine Months: Total revenues in the 2016 first nine months of $13.61 million decreased 31.4% compared with $19.83 million in the prior-year period. Product sales in the 2016 first nine months of $10.45 million decreased 42.4% compared with $18.15 million in the prior-year period. R&D milestone, and grant and royalty revenues in the 2016 first nine months of $3,161,000 increased 87.2% compared with $1,689,000 in the prior-year period. Gross margin dollars in the 2016 first nine months of $6.70 million decreased 22.3% compared with $8.62 million in the prior-year period, due primarily to the decrease in product sales. The amount of product gross margin in the 2016 first nine months of $3.54 million decreased 48.9% compared with $6.93 million in the prior-year period. R&D expenses in the 2016 first nine months of $6.27 million increased 27.6%, compared with $4.91 million in the prior-year period. This increase is due primarily to increased R&D activities for projects and grants. Selling, general and administrative expenses in the 2016 first nine months of $5.43 million decreased 10.3%, compared with $6.06 million in the prior-year period, largely due to decreased commissions on sales in Brazil, decreased wages and related costs, stock-based compensation, consulting and travel, entertainment and trade shows, which were partially offset by increases in marketing materials, investor relations expenses and professional fees. Operating loss in the 2016 first nine months was $4,998,000, compared with an operating loss of $2,352,000 in the prior-year period. Net loss in the 2016 first nine months was $10,789,000, or $1.06 per diluted share, compared with net loss of $1,748,000, or $0.18 per diluted share, in the prior-year period. The net loss in the 2016 period includes a tax provision for the recording of a valuation allowance on the Company's deferred tax asset of $5,801,000. Valuation Allowance The Company elected, based on accounting guidance, to record a full Valuation Allowance ("VA") on its Deferred Tax Asset ("DTA"). Chembio's DTA was primarily based on the Company's Net Operating Loss (NOL) carryforwards. Based primarily on the fact that the Company believes, given information available to it at this time, that it is more likely than not that the deferred tax asset will not be realized in the foreseeable future, the Company concluded that it was appropriate to record a full VA against its DTA. This resulted in a tax provision in the second quarter of 2016 of $5.96 million and for the nine months ended September 30, 2016 of $5.80 million. This VA does not affect the Company's ability to use its NOLs in the future. Balance Sheet Highlights: The Company had cash and cash equivalents of $12.17 million as of September 30, 2016, compared with $5.38 million as of December 31, 2015. The increase was primarily due to net cash raised in the sale of common stock, partially offset by cash used in operating activities for the nine months of 2016. Our working capital increased by $8.06 million from $9.48 million as of December 31, 2015 to $17.54 million. In early August 2016, the Company sold 2,300,000 common shares for a total of $13.8 million, which after expenses resulted in approximately $12.5 million in net funds to the Company. Conference Call To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until November 17, 2016 at 11:59 p.m. ET by dialing (877) 481-4010 from the U.S. or (919) 882-2331 from outside the U.S. and entering conference ID: 10129. The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=175428. An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Chembio's website at www.chembio.com. To listen to the live call, please go to the website 15 minutes prior to its start to register, download, and install the necessary audio software. A replay will be available on the website for a limited time. About Chembio Diagnostics Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors. The Company's SURE CHECK® HIV 1/2 Assay previously has been exclusively sold in the U.S. as Clearview® Complete HIV 1/2 Assay. Chembio has developed a patented point-of-care (POC) test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products. Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com. Forward-Looking Statements Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.
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 | November 7, 2016
The first of five early stage clinical trials to test the safety and ability of an investigational Zika vaccine candidate called the Zika Purified Inactivated Virus (ZPIV) vaccine to generate an immune system response has begun at the Walter Reed Army Institute of Research (WRAIR) Clinical Trial Center in Silver Spring, Maryland. Scientists with WRAIR, part of the U.S. Department of Defense (DoD), developed the vaccine. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is co-funding the Phase 1 clinical trial with WRAIR, serving as the regulatory sponsor and providing other support. The experimental ZPIV vaccine is based on the same technology WRAIR used in 2009 to successfully develop a vaccine for another flavivirus called Japanese encephalitis. The ZPIV vaccine contains whole Zika virus particles that have been inactivated, meaning that the virus cannot replicate and cause disease in humans. However, the protein shell of the inactivated virus remains intact so it can be recognized by the immune system and evoke an immune response. NIAID partially supported the preclinical development of the ZPIV vaccine candidate, including safety testing and non-human primate studies that found that the vaccine induced antibodies that neutralized the virus and protected the animals from disease when they were challenged with Zika virus. WRAIR, NIAID and the Biomedical Advanced Research and Development Authority (BARDA) part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) have established a joint Research Collaboration Agreement to support the development of this vaccine. "We urgently need a safe and effective vaccine to protect people from Zika virus infection as the virus continues to spread and cause serious public health consequences, particularly for pregnant women and their babies," said NIAID Director Anthony S. Fauci, M.D. "We are pleased to be part of the collaborative effort to advance this promising candidate vaccine into clinical trials." Led by WRAIR principal investigator Maj. Leyi Lin, M.D., the new study aims to enroll 75 people ages 18 to 49 years with no prior flavivirus infection. Flaviviruses include Zika virus, yellow fever virus, dengue virus, Japanese encephalitis virus and West Nile virus. Participants will be randomly divided into three groups: the first group (25 participants) will receive two intramuscular injections of the ZPIV test vaccine or a placebo (saline) 28 days apart; the other two groups (25 participants each) will receive a two-dose regimen of a Japanese encephalitis virus vaccine or one dose of a yellow fever vaccine before beginning the two-dose ZPIV vaccine regimen. Investigators chose to administer additional flavivirus vaccines because U.S. service members are often vaccinated against these diseases before deploying to Zika-endemic areas. Additionally, a subgroup of 30 of the participants who receive the two-dose ZPIV regimen will receive a third dose one year later. All participants in the trial will receive the same ZPIV dose at each injection (5 micrograms). A DoD Research Monitor, an independent physician not associated with the protocol, will monitor the conduct of the trial and report any safety issues to the WRAIR Institutional Review Board. Another independent group, the Safety Monitoring Committee, will also monitor participant safety, review data and report any issues to NIAID. As the regulatory sponsor, NIAID ensures the trial follows the study protocol and informs the FDA of any significant adverse events or risks. NIAID also maintains the Investigational New Drug (IND) application for the candidate vaccine. The WRAIR study is expected to be completed by fall 2018. Four additional Phase 1 studies to evaluate the ZPIV investigational vaccine are expected to launch in the coming months. These include BARDA is funding the advanced development of the ZPIV vaccine candidate through a six-year contract with Sanofi Pasteur, which established a collaborative research and development agreement with WRAIR to accelerate further development of the vaccine. NIAID conducts and supports research--at NIH, throughout the United States, and worldwide--to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www. .
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.