Monday, August 4, 2014

Certara Launches D360 in Japan to Improve Drug Discovery and Development Productivity


TOKYO & ST. LOUIS--(BUSINESS WIRE)--Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced the launch in Japan of D360, its integrated solution for the query, analysis and visualization of drug discovery and development data. D360 is used by scientists in both discovery and pre-clinical research. It allows them to search, analyze and share their data without the need for constant IT support, helping to shorten the drug discovery cycle. In preclinical drug discovery, searching historical control data to answer questions from regulatory agencies often requires the manual review of multiple study reports, which can entail days or weeks of effort. With D360, scientists can obtain the necessary cross-study data views in minutes, allowing them to provide an immediate response to regulatory bodies, and avoiding costly delays in approval processes and disruptions to ongoing work. In early phase discovery research, scientists use D360 to get a comprehensive view of all project-relevant data, in which data summarization is performed, according to corporate standard scientific business rules, at the click of a button. Decision making at project meetings becomes more efficient since the effort required for data collation is practically eliminated. Consistent data presentation minimizes discussion about data collation methods, and the ability to drill down on aggregated data and use follow-on queries allows supporting information to be obtained in situ. “We are proud to introduce D360 to the Japanese market,” said Certara CEO Edmundo Muniz, M.D., Ph.D. “D360 is a well-established, trusted drug discovery and development data access and analysis solution that can help pharma and biotech companies to improve the time to and accuracy of their go/no-go product decisions by providing scientists with on-demand access to their desired data in their preferred format.” D360 is already deployed in life sciences research organizations of all sizes including six top 15 pharma companies. D360 is being used by a variety of disciplines at organizations such as Pfizer, Boehringer Ingelheim, Medivir AB, Plexxikon, and Agios to provide: one-click access to project data views for discovery scientists; ad-hoc query capabilities for molecular design and hypothesis testing; real-time preclinical study monitoring; and cross-study analysis of pre-clinical data. Certara currently has more than 200 clients in Japan, including all the top 20 Japanese pharmaceutical companies. D360 will be deployed and supported by the Certara KK office in Tokyo, which was established in 2011. About Certara Certara is the leading global technology-enabled drug development and drug safety consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit .certara.com.

Allied Minds and Bristol-Myers Squibb Form New Enterprise to Advance Discoveries of Biopharmaceutical Innovations at Leading U.S. Academic Research Institutions


BOSTON & NEW YORK--(BUSINESS WIRE)--Allied Minds (LSE: ALM) and Bristol-Myers Squibb Company (NYSE: BMY) today announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the U.S. Allied-Bristol Life Sciences LLC will focus on efficiently and effectively converting discoveries from university research institutions into therapeutic candidates for clinical development, and ultimately approved therapies that address serious diseases. For programs identified by the new enterprise, university researchers will be able to access Bristol-Myers Squibb’s drug discovery research expertise, and Allied Minds’ financial and management experience. “The innovations developed in U.S. research institutions represent an important resource for scientific advancement, as well as economic development and financial returns,” said Chris Silva, Chief Executive Officer of Allied Minds. “Our partnership with Bristol-Myers Squibb combines complementary strengths, resources, reach and expertise to create an exciting new paradigm in the drug development space.” “Allied-Bristol Life Sciences LLC brings together cutting-edge ideas, BioPharma experience and drug discovery expertise focused on maximizing the potential of new scientific approaches to addressing serious disease,” said Carl Decicco, senior vice president and Head of Discovery, Bristol-Myers Squibb. “We believe this new venture will enhance the translation of early-stage academic research and will ultimately help advance important potential new medicines more efficiently.” Under the terms of the agreement, the companies have jointly formed and funded Allied-Bristol Life Sciences LLC, which will work with university researchers to identify discoveries it believes has promising therapeutic and commercial potential, and will support the research and development needed to take these early-stage opportunities from initial feasibility to pre-clinical candidacy. Allied Minds and Bristol-Myers Squibb together will form and fund new companies to conduct feasibility and full-phase discovery programs. Once a program succeeds in identifying a pre-clinical candidate, Bristol-Myers Squibb will have the option to acquire the company from Allied-Bristol Life Sciences LLC under pre-agreed terms. About Allied Minds Allied Minds (LSE: ALM) is an innovative U.S. science and technology development and commercialization company. Operating since 2006, the company forms, funds, manages and builds products and businesses based on innovative technologies developed at leading U.S. universities and federal research institutions. Allied Minds serves as a diversified holding company that supports its businesses and product development with capital, central management and shared services. More information about the Boston-based company can be found at .alliedminds.com. Allied Minds’ investment model is to form, fund, manage and build companies and jobs for the long term. The company takes a majority ownership stake in each business it establishes, and provides funding and central management so that it’s intimately involved at each stage of strategy and growth. Allied Minds currently works with more than 33 leading universities, several of which exceed $1 billion each in annual research spending, as well as 32 federal research centers and laboratories managed by the U.S. Departments of Defense and Energy on a similar commercialization structure. It currently has 18 operating companies in the U.S. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit .bms.com or follow us on Twitter at twitter.com/bmsnews. Allied Minds Forward-Looking Statement This press release contains statements that are or may be forward-looking statements, including statements that relate to the company’s future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risk and uncertainties described in the risk factors included in the company’s regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law, regulatory requirement, the Prospectus Rules, the Listing Rules and the Disclosure and Transparency Rules, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Bristol-Myers Squibb Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the programs mentioned in this release will lead to identifying a pre-clinical candidate. Nor is there any guarantee that if one is identified, Bristol-Myers Squibb will exercise its option to acquire it, or that it will lead to an approved product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb s Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Medivir licenses Respiratory Syncytial Virus drug program from Boehringer Ingelheim


HUDDINGE, Sweden--(BUSINESS WIRE)--Regulatory News: Medivir AB (STO:MVIR-B) today announces that it has entered a license agreement with Boehringer Ingelheim International GmbH for exclusive, global rights to a drug program for the treatment and prevention of Respiratory Syncytial Virus (RSV) infection. “RSV is respiratory pathogen that can cause life-threatening infections, especially in children, the elderly and the immunocompromised. It is a major, underserved disease area today, with no effective treatment available” said Maris Hartmanis, Medivir’s CEO. “The in-licensing of this program illustrates Medivir’s strategic intent to enhance its R&D pipeline with high-value, commercial opportunities.” The program includes novel compounds that inhibit the RSV fusion protein, which is a key mediator of viral entry into host cells and a target for new medicines. About Coumadin (Warfarin) “We are very pleased to have secured this program from Boehringer Ingelheim and to have the opportunity to build upon the impressive research already conducted” said Richard Bethell Medivir’s EVP, Discovery Research. Buy Cozaar (Losartan) “We can now look forward to advancing potential new drugs for the benefit of vulnerable patients.” Under the terms of the agreement Medivir receives an exclusive, global license to research, develop, manufacture and commercialise RSV drugs resulting from Boehringer Ingelheim’s program. Compazine (Prochlorperazine) Boehringer Ingelheim receives an upfront payment and future success milestones as well as royalties on sales. About RSV Human respiratory syncytial virus is the main viral cause of respiratory tract infection in infants, the elderly and the severely immunocompromised. About Deltasone with free Rx Almost all children will have been infected with RSV by the time of their second birthday. Buy Separation Anxiety online It has been estimated that RSV resulted in around 33.8 million lower respiratory tract infections in children younger than 5 years in 2005, with 3.4 million requiring hospitalization and between 66,000 and 199,000 child deaths (Nair et al. http://medicalhelper.wordpress.com 2010). Today only one drug is approved for therapeutic use – ribavirin – but its use is limited by a complex administration procedure, limited efficacy, high cost and toxic side effects. A humanised monoclonal antibody is available for prophylatic use, but it is approved only for prevention of RSV infection in infants that are at very high risk of serious lower respiratory tract disease following infection by RSV. Patients urgently need new, safe and effective drug options for the treatment and prevention of RSV infection. About Medivir Medivir is an emerging and profitable research-based pharmaceutical company with an established marketing and sales organisation in the Nordics with a broad portfolio of prescription pharmaceuticals. Medivir receives royalty from Johnson & Johnson global sales of the hepatitis C pharmaceutical Olysio. In addition, revenues for sales of Olysio in the Nordic region is generated through the companies own sales and marketing organisation. Medivir’s research and development portfolio of pharmaceuticals is based on the company’s expertise in polymerase and protease drug targets for different disease areas. The company’s current research and development is focused on infectious diseases, bone related disorders, neuropathic pain and oncology. Medivir is listed on the Nasdaq OMX Mid-Cap list. This information was brought to you by Cision news.cision.com