Bayer Pharma

Wuppertal, Germany

Bayer Pharma

Wuppertal, Germany
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DARMSTADT, Deutschland, 20. April 2017 /PRNewswire/ -- Merck, ein führendes Wissenschaft- und Technologieunternehmen, gab heute bekannt, dass BioInvent International AB, ein schwedisches Unternehmen, das neuartige immunregulatorische Antikörper zur Krebsbehandlung entwickelt, sein Arzneimittelwerk mit einer kompletten Serie von Mercks Mobius® Einweg-Bioreaktoren ausstattet. BioInvent fügt seiner vorgeschalteten Einrichtung in Lund, Schweden, 3-, 50-, 200- und 1000-Liter Bioreaktoren hinzu, was deren Kapazität erweitert und die Flexibilität und Skalierbarkeit verbessert.  Mercks Portfolio aus 3- bis 2000-Liter Mobius® Einweg-Bioreaktoren verschafft branchenführende Vorteile für mehr Flexibilität und Fortbestand beim Ausbau, was den Bedarf zur Neuschulung der Bediener beim Ausbau reduziert. „Unser komplettes Portfolio aus Einwegtechnik erfüllt den Bedarf von sowohl neuen biopharmazeutischen Unternehmen als auch etablierten Arzneimittelentwicklern wie BioInvent, die ihre Produktivität steigern möchten," sagte Udit Batra, Vorstandsmitglied bei Merck und CEO des Life Science-Geschäftszweigs bei Merck. „Wir liefern das volle Spektrum an Bioreaktoren, Service und Support, was BioInvent helfen wird, die Entwicklung seiner innovativen Therapeutik zu beschleunigen." Die Aufrüstung des BioInvent Werks auf einen 1000-Liter Einweg-Bioreaktor wird es dem Unternehmen ermöglichen, die Produktionsanforderungen seiner eigenen, neuartigen Antikörperentwicklungsprojekte wie auch die seiner Kunden weltweit zu erfüllen. „BioInvent arbeitet seit mehr als 30 Jahren an der Entwicklung und Fertigung von Antikörpern, und als wir uns zur Neuausstattung unseres Einwegproduktionswerks entschlossen hatten, stellten wir sehr hohe Ansprüche," sagte Kristoffer Rudenholm Hansson, stellvertretender Direktor der Technical Operations bei BioInvent. „Mercks Einweg-Bioreaktoren konnten unseren derzeitigen und künftigen Bedarf mit einem voll skalierbaren System am effektivsten erfüllen." Alle Pressemitteilungen von Merck werden zeitgleich mit der Veröffentlichung auf der Merck Website per E-Mail versandt. Gehen Sie zu www.merckgroup.com/subscribe, um sich online zu registrieren, Ihre Einstellungen zu ändern oder sich abzumelden. Informationen zu Merck Merck ist ein führendes Wissenschafts- und Technologieunternehmen in den Bereichen Healthcare, Life Science und Performance Materials. Rund 50.000 Mitarbeiter arbeiten daran, Technologien weiterzuentwickeln, die das Leben bereichern – von biopharmazeutischen Therapien zur Behandlung von Krebs oder Multipler Sklerose über wegweisende Systeme für die wissenschaftliche Forschung und Produktion bis hin zu Flüssigkeitskristallen für Smartphones und LCD-Fernseher. 2016 verzeichnete Merck Umsätze in Höhe von 15,0 Milliarden € aus 66 Ländern. Gegründet 1668 ist Merck das älteste pharmazeutisch-chemische Unternehmen der Welt. Die Gründerfamilie ist bis heute Mehrheitseigentümerin des börsennotierten Konzerns. Merck besitzt die globalen Rechte am Namen und der Marke Merck. Einzige Ausnahmen sind die USA und Kanada, wo das Unternehmen als EMD Serono, MilliporeSigma und EMD Performance Materials auftritt. Informationen zu BioInvent BioInvent International AB (OMXS: BINV) befasst sich mit der Entdeckung und Entwicklung von neuartigen, erstmaligen immunregulatorischen Antikörpern zur Krebsbehandlung. Die klinischen Programme des Unternehmens sind BI-1206, was derzeit in Phase I/II für Non-Hodgkin-Lymphom und chronisch lymphatische Leukämie ist, und TB-403, in Zusammenarbeit mit Oncurious und gegenwärtig in Phase I/II für Medulloblastom. BioInvent bietet ein großartiges, präklinisches Portfolio, das auf den neuartigen immunmodulatorischen Antikörpern basiert, deren Ziel regulatorische T-Zellen (T-regs) und mit der Tumorbildung verbundene myeloide Zellen sind. Im Dezember 2016 unterzeichnete das Unternehmen eine Vereinbarung zur strategischen Forschungskollaboration mit Pfizer Inc. BioInvent steht zudem in Zusammenarbeit mit führenden akademischen Einrichtungen wie der University of Southampton, dem englischen Krebsforschungsinstitut Cancer Research UK und Penn Medicine. BioInvent erzielt Umsätze aus globalen Partnerschaften, zu denen Bayer Pharma, Daiichi Sankyo und Mitsubishi Tanabe Pharma zählen, sowie auf seinem Fertigungswerk zur Produktion von Antikörpern für Forschungszwecke bis hin zu klinischen Studien des Spätstadiums.


DARMSTADT, Allemagne, 20 avril 2017 /PRNewswire/ -- Merck, une grande entreprise spécialisée en sciences et en technologies, a annoncé aujourd'hui que BioInvent International AB, une entreprise suédoise qui développe de nouveaux anticorps immuno-régulateurs pour traiter le cancer, améliore et agrandit son usine de fabrication de médicaments avec une gamme complète de bioréacteurs à usage unique Mobius® de Merck. BioInvent va ajouter des bioréacteurs de 3, 50, 200 et 1 000 litres à son usine en amont située à Lund, en Suède, et va ainsi élargir sa capacité et améliorer la flexibilité et l'évolutivité. Le portefeuille des bioréacteurs de 3 à 2 000 litres à usage unique Mobius® de Merck offre des avantages pionniers sur le secteur qui présentent une plus grande flexibilité et continuité pour l'échelonnement, ce qui réduit le besoin de nouvelle formation des opérateurs pendant les processus d'échelonnement. « Notre portefeuille complet de technologies à usage unique répond aux besoins des sociétés biopharmaceutiques émergentes et des développeurs de médicaments bien établis comme BioInvent, qui cherchent à accroître leur productivité », a déclaré Udit Batra, membre du conseil d'administration de Merck et PDG du secteur d'activité des sciences de la vie de Merck. « Nous fournissons une gamme complète de bioréacteurs, de services et de soutien qui aideront BioInvent à accélérer les thérapies innovantes tout au long de la ligne de développement ». L'amélioration de l'installation de BioInvent qui inclura un bioréacteur à usage unique de 1 000 litres permettra à l'entreprise de répondre aux exigences de production pour ses propres projets de développement de nouveaux anticorps et pour ceux des clients que l'entreprise sert dans le monde entier. « BioInvent découvre et fabrique des anticorps depuis plus de 30 ans et lorsque nous avons décidé de moderniser notre installation de production à usage unique, nous avons établi des exigences très strictes », a déclaré Kristoffer Rudenholm Hansson, vice-président des opérations techniques chez BioInvent. « Les bioréacteurs à usage unique de Merck ont répondu le plus efficacement à nos besoins actuels et futurs grâce à un système entièrement évolutif ». Toutes les nouveautés de Merck sont distribuées par courriel dès qu'elles sont disponibles sur le site web de Merck. Veuillez aller sur www.merckgroup.com/subscribe pour vous inscrire, changer votre choix ou arrêter ce service. À propos de Merck Merck est une société à la pointe de l'industrie scientifique et technologique, spécialisée dans les soins de santé, les sciences de la vie et les matériaux de performance. Près de 50 000 employés travaillent au développement de technologies visant à améliorer et prolonger la vie : de thérapies biopharmaceutiques de traitement du cancer ou de la sclérose en plaques aux systèmes de pointe pour la recherche et la production scientifique, en passant par les cristaux liquides pour smartphones et téléviseurs LCD. En 2016, Merck a généré 15 milliards EUR de chiffre d'affaires dans 66 pays. Fondée en 1668, Merck est la plus ancienne société pharmaceutique et chimique mondiale. La famille fondatrice reste propriétaire majoritaire du groupe de sociétés cotées en bourse. Merck possède les droits mondiaux sur le nom et la marque Merck. Les seules exceptions sont les États-Unis et le Canada où l'entreprise exerce ses activités sous les noms d'EMD Serono, Millipore Sigma et EMD Performance Materials. À propos de BioInvent BioInvent International AB (OMXS : BINV) est une entreprise axée sur la découverte et le développement d'anticorps immuno-régulateurs novateurs de pointe pour traiter le cancer. Les programmes cliniques de la société sont BI-1206, actuellement en phase I / II pour le lymphome non hodgkinien et la leucémie lymphatique chronique et TB-403, en collaboration avec Oncurious, actuellement en phase I / II pour le médulloblastome. BioInvent possède un portefeuille préclinique très stimulant basé sur de nouveaux anticorps immuno-modulateurs qui visent des cellules T régulatrices (T-regs) et des cellules myéloïdes associées aux tumeurs. En décembre 2016, la société a signé une collaboration de recherche stratégique avec Pfizer Inc. BioInvent travaille également avec des institutions universitaires de premier plan, dont l'Université de Southampton, Cancer Research UK et Penn Medicine. BioInvent génère des chiffres d'affaires provenant de partenariats mondiaux, dont Bayer Pharma, Daiichi Sankyo et Mitsubishi Tanabe Pharma et de son usine de fabrication qui produit des anticorps pour la recherche jusqu'à des essais cliniques en phase avancée.


"Indian Generic Regorafenib, Manufactured By Bayer Pharma AG"


News Article | May 24, 2017
Site: www.prnewswire.com

CTCs are promising biomarkers for detection and diagnosis of systemic cancers. CTCs could potentially help physicians and scientists plot the molecular signature of an individual's tumor over time, monitor tumor responsiveness to therapy, and identify targets for the development of personalized therapies. To date, the infrequent detection of CTCs has hindered clinical implementation and potential use in liquid biopsies for cancer diagnosis and therapy.1 Terumo BCT's Spectra Optia® Apheresis System, an FDA-cleared and CE marked device for use in therapeutic apheresis and cell collection procedures, is currently used in hospitals and apheresis centers around the world. Spectra Optia will be incorporated into CANCER-ID research efforts that will evaluate diagnostic leukapheresis (DLA) as a means to capture and harvest larger numbers of CTCs1. This research may identify a role for the Spectra Optia system in future diagnostic processes. Terumo BCT is pleased to partner with CANCER-ID, furthering the consortium's mission of developing standards and conducting clinical validation to enable broad adoption of reliable molecular analyses from liquid biopsies. "We are delighted to be included in CANCER-ID as an industry partner and to provide the Spectra Optia system as a potential new tool for physicians as they seek to improve the diagnosis and treatment of disease. As a partner to the consortium, we further our commitment to research and innovation that advances personalized medicine with a specific focus on immuno-oncology," says Monte Smith, Vice President, Global Therapeutic Systems, Terumo BCT. According to Dr. Thomas Schlange, Senior Biomarker Scientist, Global Biomarker Research, Bayer Pharma AG, "CANCER-ID is an excellent example of a public-private partnership enabling collaborative research to develop modern cancer therapy. This consortium brings together an international team of global biomarker experts that extends far beyond the scope of traditional 'one-on-one' industry-academia collaborations." CANCER-ID's initial evaluation phase will be followed by a clinical phase, running until 2020, with a goal to establish the use of liquid biopsies in evaluating the progress of lung and breast cancer treatments. Disclaimer: This press release reflects the author's view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein. About Terumo BCT Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers. About the Innovative Medicines Initiative (IMI)            This CANCER-ID project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115749. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. IMI is working to improve health by accelerating the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organizations and medicines regulators. IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU's research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects 'in kind', for example by donating their researchers' time or providing access to research facilities or resources. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/terumo-bct-joins-cancer-id-consortium-300462885.html


News Article | May 24, 2017
Site: www.prnewswire.co.uk

Cancer treatment is often hampered by late diagnosis, lack of prognostic indicators, and limited ability to monitor and personalize treatment. The goal of the consortium is to establish the clinical utility of liquid biopsies which are non-invasive blood tests that detect circulating tumor cells (CTCs) and fragments of tumor DNA that are shed into the blood from the primary tumor or metastatic sites. CTCs are promising biomarkers for detection and diagnosis of systemic cancers. CTCs could potentially help physicians and scientists plot the molecular signature of an individual's tumor over time, monitor tumor responsiveness to therapy, and identify targets for the development of personalized therapies. To date, the infrequent detection of CTCs has hindered clinical implementation and potential use in liquid biopsies for cancer diagnosis and therapy.1 Terumo BCT's Spectra Optia® Apheresis System, an FDA-cleared and CE marked device for use in therapeutic apheresis and cell collection procedures, is currently used in hospitals and apheresis centers around the world. Spectra Optia will be incorporated into CANCER-ID research efforts that will evaluate diagnostic leukapheresis (DLA) as a means to capture and harvest larger numbers of CTCs1. This research may identify a role for the Spectra Optia system in future diagnostic processes. Terumo BCT is pleased to partner with CANCER-ID, furthering the consortium's mission of developing standards and conducting clinical validation to enable broad adoption of reliable molecular analyses from liquid biopsies. "We are delighted to be included in CANCER-ID as an industry partner and to provide the Spectra Optia system as a potential new tool for physicians as they seek to improve the diagnosis and treatment of disease. As a partner to the consortium, we further our commitment to research and innovation that advances personalized medicine with a specific focus on immuno-oncology," says Monte Smith, Vice President, Global Therapeutic Systems, Terumo BCT. According to Dr. Thomas Schlange, Senior Biomarker Scientist, Global Biomarker Research, Bayer Pharma AG, "CANCER-ID is an excellent example of a public-private partnership enabling collaborative research to develop modern cancer therapy. This consortium brings together an international team of global biomarker experts that extends far beyond the scope of traditional 'one-on-one' industry-academia collaborations." CANCER-ID's initial evaluation phase will be followed by a clinical phase, running until 2020, with a goal to establish the use of liquid biopsies in evaluating the progress of lung and breast cancer treatments. Disclaimer: This press release reflects the author's view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein. About Terumo BCT Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers. About the Innovative Medicines Initiative (IMI)            This CANCER-ID project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115749. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. IMI is working to improve health by accelerating the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organizations and medicines regulators. IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU's research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects 'in kind', for example by donating their researchers' time or providing access to research facilities or resources.


News Article | May 24, 2017
Site: en.prnasia.com

LAKEWOOD, Colo., May 24, 2017 /PRNewswire/ -- Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, today announced it has joined CANCER-ID, a public-private European consortium working to establish standard protocols and clinical validation for blood-based biomarkers of cancer. CANCER-ID is funded by the Innovative Medicines Initiative (IMI), bringing together 38 partners from 13 countries. Cancer treatment is often hampered by late diagnosis, lack of prognostic indicators, and limited ability to monitor and personalize treatment. The goal of the consortium is to establish the clinical utility of liquid biopsies which are non-invasive blood tests that detect circulating tumor cells (CTCs) and fragments of tumor DNA that are shed into the blood from the primary tumor or metastatic sites. CTCs are promising biomarkers for detection and diagnosis of systemic cancers. CTCs could potentially help physicians and scientists plot the molecular signature of an individual's tumor over time, monitor tumor responsiveness to therapy, and identify targets for the development of personalized therapies. To date, the infrequent detection of CTCs has hindered clinical implementation and potential use in liquid biopsies for cancer diagnosis and therapy.1 Terumo BCT's Spectra Optia® Apheresis System, an FDA-cleared and CE marked device for use in therapeutic apheresis and cell collection procedures, is currently used in hospitals and apheresis centers around the world. Spectra Optia will be incorporated into CANCER-ID research efforts that will evaluate diagnostic leukapheresis (DLA) as a means to capture and harvest larger numbers of CTCs1. This research may identify a role for the Spectra Optia system in future diagnostic processes. Terumo BCT is pleased to partner with CANCER-ID, furthering the consortium's mission of developing standards and conducting clinical validation to enable broad adoption of reliable molecular analyses from liquid biopsies. "We are delighted to be included in CANCER-ID as an industry partner and to provide the Spectra Optia system as a potential new tool for physicians as they seek to improve the diagnosis and treatment of disease. As a partner to the consortium, we further our commitment to research and innovation that advances personalized medicine with a specific focus on immuno-oncology," says Monte Smith, Vice President, Global Therapeutic Systems, Terumo BCT. According to Dr. Thomas Schlange, Senior Biomarker Scientist, Global Biomarker Research, Bayer Pharma AG, "CANCER-ID is an excellent example of a public-private partnership enabling collaborative research to develop modern cancer therapy. This consortium brings together an international team of global biomarker experts that extends far beyond the scope of traditional 'one-on-one' industry-academia collaborations." CANCER-ID's initial evaluation phase will be followed by a clinical phase, running until 2020, with a goal to establish the use of liquid biopsies in evaluating the progress of lung and breast cancer treatments. Disclaimer: This press release reflects the author's view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein. About Terumo BCT Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers. About the Innovative Medicines Initiative (IMI)            This CANCER-ID project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115749. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. IMI is working to improve health by accelerating the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organizations and medicines regulators. IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU's research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects 'in kind', for example by donating their researchers' time or providing access to research facilities or resources.


SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) today reported financial results and provided a corporate update for the quarter ended March 31, 2017. “During the first quarter of 2017 we continued to focus on regulatory activities for betrixaban and AndexXa™. Our goal is to gain approval for both products this year in the United States and in 2018 in the European Union,” said Bill Lis, chief executive officer of Portola. “Both are highly anticipated by the medical community because they are potentially life-saving medicines in indications where currently there are no approved therapies.” First Quarter 2017 Financial Results Collaboration and license revenue earned under Portola's collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals and Daiichi Sankyo was $5.1 million for the first quarter of 2017 compared with $8.3 million for the first quarter of 2016. Total operating expenses for the first quarter of 2017 were $45.7 million, compared with $73.6 million for the same period in 2016. Total operating expenses for the first quarter of 2017 included $9.0 million in stock-based compensation expense, compared with $7.1 million for the same period in 2016. Research and development expenses were $30.6 million for the first quarter of 2017, compared with $58.8 million for the first quarter of 2016. The decrease in R&D expenses was largely attributable to the termination of manufacturing activities on the 6x2000 liter, or Line C, manufacturing process in the third quarter of 2016, and decreased program costs related to betrixaban and cerdulatinib. Selling, general and administrative expenses for the first quarter of 2017 were $15.0 million, compared with $14.8 million for the same period in 2016. For the first quarter of 2017, Portola reported a net loss of $41.7 million, or $0.74 net loss per share, compared with a net loss of $65.0 million, or $1.15 net loss per share, for the same period in 2016. Shares used to compute net loss per share attributable to common stockholders were 56.7 million for the first quarter of 2017, compared with 56.4 million for the same period in 2016. Cash, cash equivalents and investments at March 31, 2017 totaled $318.2 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. Conference Call Details The live conference call today, Monday, May 8, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 8594347. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call. About Portola Pharmaceuticals, Inc.     Portola Pharmaceuticals is a biopharmaceutical company developing products that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three investigational programs, including: betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and, cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola also is co-developing Syk-selective inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma. Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the timing of our regulatory events, the potential of our product candidates to advance the field of thrombosis and benefit patients and statements regarding the timing and ability to achieve other milestones and events. Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, regulatory developments in the United States and foreign countries; our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) today reported financial results and provided a corporate update for the quarter ended March 31, 2017. “During the first quarter of 2017 we continued to focus on regulatory activities for betrixaban and AndexXa™. Our goal is to gain approval for both products this year in the United States and in 2018 in the European Union,” said Bill Lis, chief executive officer of Portola. “Both are highly anticipated by the medical community because they are potentially life-saving medicines in indications where currently there are no approved therapies.” First Quarter 2017 Financial Results Collaboration and license revenue earned under Portola's collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals and Daiichi Sankyo was $5.1 million for the first quarter of 2017 compared with $8.3 million for the first quarter of 2016. Total operating expenses for the first quarter of 2017 were $45.7 million, compared with $73.6 million for the same period in 2016. Total operating expenses for the first quarter of 2017 included $9.0 million in stock-based compensation expense, compared with $7.1 million for the same period in 2016. Research and development expenses were $30.6 million for the first quarter of 2017, compared with $58.8 million for the first quarter of 2016. The decrease in R&D expenses was largely attributable to the termination of manufacturing activities on the 6x2000 liter, or Line C, manufacturing process in the third quarter of 2016, and decreased program costs related to betrixaban and cerdulatinib. Selling, general and administrative expenses for the first quarter of 2017 were $15.0 million, compared with $14.8 million for the same period in 2016. For the first quarter of 2017, Portola reported a net loss of $41.7 million, or $0.74 net loss per share, compared with a net loss of $65.0 million, or $1.15 net loss per share, for the same period in 2016. Shares used to compute net loss per share attributable to common stockholders were 56.7 million for the first quarter of 2017, compared with 56.4 million for the same period in 2016. Cash, cash equivalents and investments at March 31, 2017 totaled $318.2 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. Conference Call Details The live conference call today, Monday, May 8, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 8594347. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call. About Portola Pharmaceuticals, Inc.     Portola Pharmaceuticals is a biopharmaceutical company developing products that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three investigational programs, including: betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and, cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola also is co-developing Syk-selective inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma. Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the timing of our regulatory events, the potential of our product candidates to advance the field of thrombosis and benefit patients and statements regarding the timing and ability to achieve other milestones and events. Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, regulatory developments in the United States and foreign countries; our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) today reported financial results and provided a corporate update for the quarter ended March 31, 2017. “During the first quarter of 2017 we continued to focus on regulatory activities for betrixaban and AndexXa™. Our goal is to gain approval for both products this year in the United States and in 2018 in the European Union,” said Bill Lis, chief executive officer of Portola. “Both are highly anticipated by the medical community because they are potentially life-saving medicines in indications where currently there are no approved therapies.” First Quarter 2017 Financial Results Collaboration and license revenue earned under Portola's collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals and Daiichi Sankyo was $5.1 million for the first quarter of 2017 compared with $8.3 million for the first quarter of 2016. Total operating expenses for the first quarter of 2017 were $45.7 million, compared with $73.6 million for the same period in 2016. Total operating expenses for the first quarter of 2017 included $9.0 million in stock-based compensation expense, compared with $7.1 million for the same period in 2016. Research and development expenses were $30.6 million for the first quarter of 2017, compared with $58.8 million for the first quarter of 2016. The decrease in R&D expenses was largely attributable to the termination of manufacturing activities on the 6x2000 liter, or Line C, manufacturing process in the third quarter of 2016, and decreased program costs related to betrixaban and cerdulatinib. Selling, general and administrative expenses for the first quarter of 2017 were $15.0 million, compared with $14.8 million for the same period in 2016. For the first quarter of 2017, Portola reported a net loss of $41.7 million, or $0.74 net loss per share, compared with a net loss of $65.0 million, or $1.15 net loss per share, for the same period in 2016. Shares used to compute net loss per share attributable to common stockholders were 56.7 million for the first quarter of 2017, compared with 56.4 million for the same period in 2016. Cash, cash equivalents and investments at March 31, 2017 totaled $318.2 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. Conference Call Details The live conference call today, Monday, May 8, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 8594347. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call. About Portola Pharmaceuticals, Inc.     Portola Pharmaceuticals is a biopharmaceutical company developing products that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three investigational programs, including: betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and, cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola also is co-developing Syk-selective inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma. Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the timing of our regulatory events, the potential of our product candidates to advance the field of thrombosis and benefit patients and statements regarding the timing and ability to achieve other milestones and events. Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, regulatory developments in the United States and foreign countries; our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) today reported financial results and provided a corporate update for the quarter ended March 31, 2017. “During the first quarter of 2017 we continued to focus on regulatory activities for betrixaban and AndexXa™. Our goal is to gain approval for both products this year in the United States and in 2018 in the European Union,” said Bill Lis, chief executive officer of Portola. “Both are highly anticipated by the medical community because they are potentially life-saving medicines in indications where currently there are no approved therapies.” First Quarter 2017 Financial Results Collaboration and license revenue earned under Portola's collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals and Daiichi Sankyo was $5.1 million for the first quarter of 2017 compared with $8.3 million for the first quarter of 2016. Total operating expenses for the first quarter of 2017 were $45.7 million, compared with $73.6 million for the same period in 2016. Total operating expenses for the first quarter of 2017 included $9.0 million in stock-based compensation expense, compared with $7.1 million for the same period in 2016. Research and development expenses were $30.6 million for the first quarter of 2017, compared with $58.8 million for the first quarter of 2016. The decrease in R&D expenses was largely attributable to the termination of manufacturing activities on the 6x2000 liter, or Line C, manufacturing process in the third quarter of 2016, and decreased program costs related to betrixaban and cerdulatinib. Selling, general and administrative expenses for the first quarter of 2017 were $15.0 million, compared with $14.8 million for the same period in 2016. For the first quarter of 2017, Portola reported a net loss of $41.7 million, or $0.74 net loss per share, compared with a net loss of $65.0 million, or $1.15 net loss per share, for the same period in 2016. Shares used to compute net loss per share attributable to common stockholders were 56.7 million for the first quarter of 2017, compared with 56.4 million for the same period in 2016. Cash, cash equivalents and investments at March 31, 2017 totaled $318.2 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. Conference Call Details The live conference call today, Monday, May 8, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 8594347. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call. About Portola Pharmaceuticals, Inc.     Portola Pharmaceuticals is a biopharmaceutical company developing products that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three investigational programs, including: betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and, cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola also is co-developing Syk-selective inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma. Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the timing of our regulatory events, the potential of our product candidates to advance the field of thrombosis and benefit patients and statements regarding the timing and ability to achieve other milestones and events. Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, regulatory developments in the United States and foreign countries; our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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