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Patent
Cerus Corporation | Date: 2016-06-24

Provided herein are compositions and kits including a pathogen-inactivated cryoprecipitate suitable for infusion into a subject at least 1 day after thawing. The methods are useful in the efficient preparation of cryoprecipitates with desirable characteristics, including pathogen-inactivated cryoprecipitates that are suitable for infusion into a subject at least 1 day after thawing.


News Article | May 3, 2017
Site: www.businesswire.com

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) today announced financial results for the first quarter ended March 31, 2017. “Coming out of our first quarter, we remain optimistic about our growth prospects over the next several years from major markets including the U.S., France and South Africa, but were not able to sign new contracts for the latter two geographies by now as we had previously expected. Therefore, though no less confident in our ability to capture this new business in the near to medium term, we believe it is prudent to adjust our 2017 product revenue guidance to a new range of $43 to 48 million dollars,” said William 'Obi' Greenman, Cerus’ president and chief executive officer. “In the U.S., we are seeing increasing awareness regarding the FDA’s pending final guidance on bacterial safety, and are encouraged by the urgency currently being expressed by blood centers to meet hospital demand for INTERCEPT platelets.” Product revenue recognized during the first quarter of 2017 was $7.0 million compared to $7.6 million during the same period in 2016. The Company experienced strong year-over-year growth for U.S. disposable kits, which was overshadowed by lighter demand for plasma products in EMEA and a weaker Euro compared to the U.S. Dollar. Reported product revenue was negatively affected by an approximate 3% weakening of the Euro compared to the U.S. dollar during the first quarter of 2017 as compared to the same period during 2016. The Company expects 2017 global product revenue in the range of $43 million to $48 million. Gross margins on product revenue for the first quarter of 2017 were 47%, compared to 44% for the first quarter of 2016. Gross margins for the first quarter of 2017 were positively impacted by a more favorable product mix, with higher gross margin platelet kits contributing proportionately more to sales during the first quarter of 2017 than in the prior year period. In addition, the Company realized manufacturing and inventory management efficiencies in the current period compared to the prior year period, which also contributed to the improved gross margins. Total operating expenses for the first quarter of 2017 were $22.8 million, compared to $18.7 million for the first quarter of 2016. Selling, general and administrative expenses increased primarily due to the Company’s increased commercial activity in the U.S. and to a lesser extent, the costs associated with administering the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA) for INTERCEPT red blood cell development. Research and development expenses increased as a result of increased costs associated with clinical development of the red blood cell system, pursuit of supplemental approvals for the platelet and plasma systems, and development activities under the BARDA agreement. Operating losses during the first quarter of 2017 were $18.1 million, compared to $15.3 million for the first quarter of 2016. Net loss for the first quarter of 2017 was $18.6 million, or $0.18 per diluted share, compared to a net loss of $16.9 million, or $0.17 per diluted share, for the first quarter of 2016. Net losses for the first quarter of 2016 were negatively impacted by non-cash income tax expense of $0.8 million. These tax items are largely the result of changes in the fair value of the Company’s marketable equity investment in Aduro Biotech, Inc. At March 31, 2017, the Company had cash, cash equivalents and short-term investments of $53.8 million compared to $71.6 million at December 31, 2016. At March 31, 2017, the Company had approximately $18.2 million in outstanding debt under its loan agreement with Oxford Finance. The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international). A replay will be available on the company’s website, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 41694810. The replay will be available approximately three hours after the call through May 17, 2017. 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 Red Blood Cell system is in clinical development. See http://www.cerus.com for information about Cerus. INTERCEPT and the 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 Cerus’ 2017 annual product revenue guidance and its expectations for U.S. revenue contribution in 2017 and the timing thereof; Cerus’ expectations regarding increased demand for INTERCEPT components in the U.S.; Cerus’ ability to capture new business in the near to medium; and the timing and likelihood of a future PMA submission to the FDA for the red blood cell system. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, including the risks that Cerus may not meet its adjusted revenue guidance for 2017 and/or realize meaningful revenue contributions from U.S. customers in 2017 or otherwise, particularly since Cerus cannot guarantee the volume or timing of commercial purchases, if any, that its U.S. customers may make under Cerus’ commercial agreements with these customers; risks associated with Cerus’ lack of commercialization experience in the United States and its ability to develop and maintain an effective and qualified U.S.-based commercial organization, as well as the resulting uncertainty of its ability to achieve market acceptance of and otherwise successfully commercialize the INTERCEPT Blood System for platelets and plasma in the United States, including as a result of licensure requirements that must be satisfied by U.S. customers prior to their engaging in interstate transport of blood components processed using the INTERCEPT Blood System; risks related to Cerus’ ability to commercialize the INTERCEPT Blood System in the United States without infringing on the intellectual property rights of others; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System is safe, effective and economical; the uncertain and time-consuming development and regulatory process, including the risks (a) that Cerus may be unable to comply with the FDA’s post-approval requirements for the INTERCEPT platelet and plasma systems, including by successfully completing required post-approval studies, which could result in a loss of U.S. marketing approval for the INTERCEPT platelet and/or plasma systems, (b) related to Cerus’ ability to expand the label claims and product configurations for the INTERCEPT platelet and plasma systems in the United States, which will require additional regulatory approvals and (c) that Cerus may be unable to file for CE Mark approval of the red blood cell system in Europe in the anticipated timeframe or at all, and even if filed, Cerus may be unable to obtain CE Mark approval, or any other regulatory approvals, of the red blood cell system in a timely manner or at all; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or weakening economic conditions in the markets where Cerus sells its products; Cerus’ reliance on third parties to market, sell, distribute and maintain its products; Cerus’ ability to maintain an effective manufacturing supply chain, including the ability of its manufacturers to comply with extensive FDA and foreign regulatory agency requirements; the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly for Cerus to produce, market and distribute its products; risks related to future opportunities and plans, including the uncertainty of future revenues and other financial performance and results, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 8, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.


Methods and devices are provided for reducing the concentration of low molecular weight compounds in a biological composition containing cells while substantially maintaining a desired biological activity of the biological composition. The device comprises highly porous adsorbent particles, and the adsorbent particles are immobilized by an inert matrix. The matrix containing the particles is contained in a housing, and the particles range in diameter from about 100 m to about 1500 m. The device can be used to adsorb and remove a pathogen-inactivating compounds from a biological composition such as a blood product.


Patent
Cerus Corporation | Date: 2014-10-31

The present invention provides pathogen-inactivated red blood cell compositions suitable for infusion into a subject.


DecisionDatabases.com offer Zika Virus Vaccine Market Research Report. This Report covers the complete Industry Outlook, Growth, Size, Share and Forecast Till 2022. The report on global zika virus vaccine market evaluates the growth trends of the industry through historical study and estimates future prospects based on comprehensive research. The report extensively provides the market share, growth, trends and forecasts for the period 2015-2022. The market size in terms of revenue (USD MN) is calculated for the study period along with the details of the factors affecting the market growth (drivers and restraints). A glimpse of the major drivers and restraints affecting this market is mentioned below: A. Drivers > Rising cases of zika virus > Pharmaceutical companies investing in R&D of vaccines for zika virus B. Restraints > High investment cost in R&D and manufacturing of zika virus vaccines Furthermore, the report quantifies the market share held by the major players of the industry and provides an in-depth view of the competitive landscape. This market is classified into different segments with detailed analysis of each with respect to geography for the study period 2015-2022. The comprehensive value chain analysis of the market will assist in attaining better product differentiation, along with detailed understanding of the core competency of each activity involved. The market attractiveness analysis provided in the report aptly measures the potential value of the market providing business strategists with the latest growth opportunities. The report classifies the market into different segments based on region. This segment is studied in detail incorporating the market estimates and forecasts at country level. The segment analysis is useful in understanding the growth areas and probable opportunities of the market. The report also covers the complete competitive landscape of the worldwide market with company profiles of key players such as Bharat Biotech International Pvt. Ltd., Cerus Corporation, GlaxoSmithKline plc, Immunovaccine Inc., Inovio Pharmaceuticals, Inc., NewLink Genetics Corp. and Sanofi S.A. A detailed description of each has been included, with information in terms of H.Q, future capacities, key mergers & acquisitions, financial overview, partnerships, collaborations, new product launches, new product developments and other latest industrial developments. 1. INTRODUCTION 2. EXECUTIVE SUMMARY  3. MARKET ANALYSIS 4. ZIKA VIRUS VACCINE MARKET ANALYSIS BY GEOGRAPHY 5. COMPETITIVE LANDSCAPE OF THE ZIKA VIRUS VACCINE COMPANIES 6. COMPANY PROFILES OF THE ZIKA VIRUS VACCINE INDUSTRY DecisionDatabases.com is a global business research reports provider, enriching decision makers and strategists with qualitative statistics. DecisionDatabases.com is proficient in providing syndicated research report, customized research reports, company profiles and industry databases across multiple domains. Our expert research analysts have been trained to map client’s research requirements to the correct research resource leading to a distinctive edge over its competitors. We provide intellectual, precise and meaningful data at a lightning speed.


News Article | November 3, 2016
Site: www.businesswire.com

CONCORD, Calif.--(BUSINESS WIRE)--$CERS--Cerus Corporation Reports Third Quarter 2016 Results


CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) today provided an update on the timeline for the INTERCEPT Blood System for Red Blood Cells (RBCs) in Europe. The target timing for CE Mark submission has been extended, and the company’s European red cell study in chronic anemia patients has completed enrollment. Due to the need for additional time to complete quality control tests on the Chemistry, Manufacturing, and Control (CMC) registration lots required for regulatory submission, the company now plans to provide an update on new submission timing on its 4Q16 earnings call in early March. The CE Mark process for the INTERCEPT Blood System for Red Blood Cells includes review and approval by both TŰV SŰD as the Notified Body and Irish Health Products Regulatory Authority (HPRA) as the Competent Authority. Accordingly, a new submission filing date will need to be scheduled with TŰV SŰD Product Service GmbH. Cerus’ SPARC trial (A Randomized Controlled Study to Evaluate Efficacy and Safety of INTERCEPT Treated Red Blood Cells in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion) has now reached its enrollment target of at least 70 evaluable patients, and the company expects that study data will be available in time to support its anticipated European product launch. The SPARC study is being conducted in transfusion-dependent thalassemia major patients, an inherited blood disorder of abnormal hemoglobin resulting in excessive destruction of red blood cells. “Chronic anemia patients such as those with thalassemia major and sickle cell disease require more blood transfusions than almost any other patient group, putting them at elevated lifetime risk for exposure to existing and emerging pathogens,” said Richard Benjamin, Cerus' chief medical officer. “Our ability to provide safety and efficacy data generated by the chronic anemia study at the time of our anticipated product launch will be an important supplement to the clinical data already included for submission.” The SPARC study is a randomized, crossover trial in which patients receive two periods of transfusion support, consisting of one period each of conventional and INTERCEPT-treated RBCs over approximately 6 - 9 months in total. The primary efficacy endpoint is hemoglobin usage and the primary safety endpoint is immunogenicity. Hemoglobin usage was selected as the primary efficacy endpoint because it is correlated with the ability of transfused red blood cells to oxygenate tissues, persist in circulation, and suppress endogenous erythropoiesis. This endpoint is clinically relevant because hemoglobin consumption is correlated with iron burden, an important complication for patients despite availability of chelation therapies. Red blood cells are disc-shaped cells containing hemoglobin which deliver oxygen from the lungs to all body tissues. Red blood cells are the most frequently transfused blood component, with over 80 million units transfused globally each year. Patients typically receive red blood cell transfusions to offset blood loss after trauma and during surgery, or to increase hemoglobin levels in patients with hereditary anemia. ABOUT THE INTERCEPT BLOOD SYSTEM FOR RED BLOOD CELLS Cerus reported positive results of the INTERCEPT Blood System for Red Blood Cells from a European Phase III acute clinical trial in 2015. If approved, the INTERCEPT Blood System for RBCs will be the only system commercially available in Europe to enhance the safety of red blood cell transfusions through pathogen inactivation. In addition to plans to submit for CE Mark registration in Europe, Cerus is also currently in dialogue with the U.S. Food & Drug Administration regarding a protocol design for a Phase III pivotal red blood cell study to be conducted in the continental United States. 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 red blood cell system 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 Cerus’ plans to pursue CE Mark approval in Europe for the red blood cell system and the timing thereof; the potential for CE Mark approval for and commercial launch of Cerus’ red blood cell product in Europe; and Cerus’ plans to present data regarding the study results from its study in transfusion-dependent thalassemia major patients. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the uncertain and time-consuming regulatory process, including completion of all of the CMC activities necessary to support a regulatory submission; that Cerus may be unable to file for CE Mark approval of the red blood cell system in Europe in the anticipated timeframe or at all, and even if filed, that Cerus may be unable to obtain CE Mark approval, or any other regulatory approvals, of the red blood cell system in a timely manner or at all; Cerus’ belief that the results from its clinical trial will support its CE Mark submission, Cerus’ development of the INTERCEPT Blood System for red blood cells and its therapeutic potential, the risks associated with the uncertainty of clinical trial results, 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 September 30, 2016, filed with the SEC on November 4, 2016. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.


CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that William “Obi” Greenman, president and chief executive officer, is scheduled to present a corporate update at the Cowen and Company 37th Annual Health Care Conference at 10:00 am ET on Wednesday, March 8, 2017. A live webcast of the presentation will be available on the Investor Relations page of the Cerus web site at http://www.cerus.com/ir. A replay will be available for approximately two weeks following the completion of the event. 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 red blood cell system is in clinical development. See http://www.cerus.com for information about Cerus. INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.


News Article | February 21, 2017
Site: www.businesswire.com

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that its fourth quarter and year end results for 2016 will be released on Tuesday, March 7, 2017, after the close of the stock market. The company will host a conference call and webcast at 4:15 PM ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international). A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 95465206. The replay will be available approximately three hours after the call through March 21, 2017. 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 red blood cell system is in clinical development. See http://www.cerus.com for information about Cerus. INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.


News Article | February 20, 2017
Site: www.prnewswire.co.uk

According to a new market research report "Apheresis Market by Product (Plasma & Component Separator, Hemoperfusion, and Disposable), Procedure (Therapeutic, Photopheresis, and Donor), Application (Plasmapheresis, Plateletpheresis), Technology (Centrifuge, Membrane Separation) - Global Forecast to 2021" published by MarketsandMarkets, the global market is projected to reach USD 2.06 Billion by 2021, at a CAGR of 7.7% from 2016 to 2021. Browse 174 market data Tables and 47 Figures spread through 212 Pages and in-depth TOC on "Apheresis Market" Early buyers will receive 10% customization on this report. The rising incidence of chronic lifestyle diseases such as diabetes, kidney disorders, & respiratory diseases, increasing demand for blood components, and favorable reimbursement scenario are the key factors driving the growth of the market. However, scarcity of qualified donors and the high cost of apheresis machines & procedures are restraining the growth of this market. In this report, the market is majorly segmented by product, procedure, technology, application, and region. Based on product, the market is segmented into devices and disposables. The disposables segment accounted for the largest share and will be the fastest growing market during the forecast period. This is attributed to the increasing demand for disposables and rising preference for apheresis blood collection. On the basis of procedure, the market is segmented into automated/donor apheresis and therapeutic apheresis. Therapeutic apheresis is further segmented into therapeutic plasma exchange (TPE), therapeutic cytapheresis, photopheresis, and extracorporeal immunoadsorption (ECI). In 2015, therapeutic plasma exchange segment accounted for the largest share of the market. The large share of this segment is attributed to the increasing prevalence and incidence of various blood disorders such as sickle-cell anemia and leukemia. The photopheresis segment is expected to register the highest CAGR during the forecast period due to the increasing demand for photopheresis in organ transplant rejection treatment. In 2015, North America accounted for the largest share of the market, followed by Europe. The presence of established distribution channels, growing applications of apheresis products in plasma collection and fractionation, and rising number of hemophilic patients are driving the growth of the North American apheresis market. The Asia-Pacific region is expected to witness the highest growth in this market majorly due to improving healthcare infrastructure and growing economies in China and India. In addition, manufacturers are increasingly focusing on strengthening their presence in emerging APAC countries. The global Apheresis Market is highly competitive in nature, with the top five companies accounting for the major market share in 2015. Some of the key players in this market are Haemonetics Corporation (U.S.), Fresenius Medical Care (Germany), Terumo BCT, Inc. (U.S.), Asahi Kasei Medical Co., Ltd. (Japan), Kawasumi Laboratories Inc. (Japan), Cerus Corporation (U.S.), B. Braun Melsungen AG (Germany), HemaCare Corporation (U.S.), Kaneka Corporation (Japan), and Nikkiso Co., Ltd. (Japan). These leading players primarily focused on product launches, acquisitions, agreements, collaborations, partnerships, and expansions to help growth in the market. U.S. Therapeutic Plasma Exchange Market by Indication (Neurological & Autoimmune Disorders), Procedures & Patients (Guillain-Barré Syndrome, Multiple Sclerosis, Myasthenia Gravis, Thrombotic Thrombocytopenic Purpura, Glomerulonephritis) - Forecasts to 2021 MarketsandMarkets is the largest market research firm worldwide in terms of annually published premium market research reports. Serving 1700 global fortune enterprises with more than 1200 premium studies in a year, M&M is catering to a multitude of clients across 8 different industrial verticals. We specialize in consulting assignments and business research across high growth markets, cutting edge technologies and newer applications. Our 850 fulltime analyst and SMEs at MarketsandMarkets are tracking global high growth markets following the "Growth Engagement Model - GEM". The GEM aims at proactive collaboration with the clients to identify new opportunities, identify most important customers, write "Attack, avoid and defend" strategies, identify sources of incremental revenues for both the company and its competitors. M&M's flagship competitive intelligence and market research platform, "RT" connects over 200,000 markets and entire value chains for deeper understanding of the unmet insights along with market sizing and forecasts of niche markets. The new included chapters on Methodology and Benchmarking presented with high quality analytical infographics in our reports gives complete visibility of how the numbers have been arrived and defend the accuracy of the numbers. We at MarketsandMarkets are inspired to help our clients grow by providing apt business insight with our huge market intelligence repository. Connect with us on LinkedIn @ http://www.linkedin.com/company/marketsandmarkets

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