Alnylam Reports that ALN-CC5 Achieves Up to 99 Percent Knockdown of Serum C5 and Up to 98 Percent Inhibition of Serum Hemolytic Activity with Durability Supportive of Once Monthly and Possibly Once Quarterly Subcutaneous Dose Regimen

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. Keppra (Levetiracetam) with free prescription (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today positive interim results from its ongoing Phase 1/2 clinical study with ALN-CC5, an investigational RNAi therapeutic targeting complement C5 for the treatment of complement mediated diseases. Buy Motrin (Ibuprofen) with free prescription These new clinical data were presented at the American Society of Hematology (ASH) 2015 Annual Meeting, held December 5 – 8 in Orlando, Florida. Buy Plavix (Clopidogrel) with free prescription New results show that ALN-CC5 achieved up to 99 percent knockdown of serum C5 and up to 98 percent inhibition of serum hemolytic activity, an assay for complement activity. About Intal with no Rx In addition, ALN-CC5 administration resulted in low levels of residual C5, which – based on comparisons from separate studies – were at or below the estimated levels of free C5 observed at therapeutic doses of eculizumab, an approved anti-C5 monoclonal antibody. Cardizem (Diltiazem) without Rx The effects of ALN-CC5 were also found to be highly durable, with C5 knockdown and complement inhibition results supporting a once monthly and possibly a once quarterly subcutaneous dose regimen. Buy Horse Chestnut online Importantly, ALN-CC5 was shown to be generally well tolerated, with no clinically significant, drug-related adverse events to date. http://doctor-answers.blogspot.com/ Consistent with previous guidance, the company remains on track to initiate dosing by year’s end in Part C of the Phase 1/2 study, which is being conducted in patients with paroxysmal nocturnal hemoglobinuria (PNH), and expects to present initial results from this part of the study in mid-2016. “We believe that these new ALN-CC5 results meet our goal of achieving both inhibition of serum hemolytic activity at the 80% target level and highly robust knockdown of serum C5 to residual levels at or below those estimated – in separate studies –for free C5 at therapeutic doses of eculizumab. We’re also very pleased with the consistency and durability of ALN-CC5 clinical activity, which we believe supports at least a once monthly, and possibly a once quarterly subcutaneous dose regimen,” said Akshay Vaishnaw, M.D., Ph.D., Executive Vice President of R&D and Chief Medical Officer of Alnylam. “With these data in hand, we’re now transitioning our study to PNH patients, and plan to initiate dosing by the end of this year. We look forward to presenting initial results from this new stage of our Phase 1/2 study, including effects of ALN-CC5 on levels of lactate dehydrogenase (LDH) – a disease marker of endogenous red blood cell hemolysis – in mid-2016.” “Significant progress has been made in the treatment of complement-mediated diseases, including PNH, but we continually strive for even further improvements for our patients. In this regard, I believe that a new medicine providing both a consistent level of inhibition of complement activity and infrequent subcutaneous dosing would be a welcome addition to the treatment landscape,” said Peter Hillmen, MB ChB, F.R.C.P., F.R.C.Path., Ph.D., Professor of Experimental Haematology and Honorary Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, U.K. “I am encouraged by the data from this ongoing Phase 1/2 trial, and, in particular, the results showing very low residual levels of serum C5. If these results can be duplicated in patients with PNH, I believe ALN-CC5 has the potential to offer a novel therapeutic option for these patients.” New data were presented in a poster at ASH, and include updated data (N=20) from the single ascending dose (SAD) cohorts, as well as initial data (N=12) from multiple ascending dose (MAD) cohorts. Safety data are as of a cutoff date of October 19, 2015, and clinical activity data are as of a cutoff date of up to November 6, 2015. Alnylam and collaborators will discuss these new clinical results with ALN-CC5 at the company’s upcoming R&D Day, to be held on Thursday, December 10, 2015, at the Sofitel New York in New York City. This event will be webcast live on the Investors section of the company’s website, .alnylam.com. An audio replay of the event will be available on the Alnylam website approximately 90 minutes after the event. Preliminary Phase 1/2 Study Clinical Activity Results In the SAD cohorts (N=20), ALN-CC5 achieved potent and dose-dependent knockdown of serum C5 of up to 99 percent, with a mean maximum knockdown of 98 ± 0.3 percent (p less than 0.01 compared with placebo) in the top dose cohort. After a single dose, nadir levels of residual C5 as low as 1.1 microgram/milliliter (mcg/mL) were achieved. This level of residual C5 in healthy volunteers is at or below the levels of free C5 estimated for eculizumab at therapeutic drug concentrations in an earlier published study in patients with atypical hemolytic uremic syndrome (aHUS)1. Maximal effects on C5 knockdown were achieved starting on day 20, and lasted for several months. For example, an up to 97.8 percent knockdown of serum C5 was still maintained at day 98 after just a single dose of drug in the top dose cohort. The company believes that the durable and clamped nature of C5 knockdown supports a once monthly and possibly a once quarterly, fixed dose subcutaneous regimen. In addition, single dose administration of ALN-CC5 was associated with potent, dose-dependent, and durable inhibition of complement activity. In particular, a single ALN-CC5 dose resulted in an up to 95 percent inhibition of complement alternative pathway (CAP) activity, an up to 97 percent inhibition of complement classical pathway (CCP) activity, and an up to 79 percent inhibition of serum hemolytic activity (mean maximum 74 ± 4.2 percent). In addition, as with C5 knockdown, the inhibitory effects of ALN-CC5 toward complement activity were found to be highly durable, lasting for several months after just a single dose. In MAD cohorts (N=12) receiving five weekly doses of ALN-CC5, an up to 99 percent knockdown of serum C5 was achieved with a mean maximum knockdown of 98 ± 0.2 percent (p less than 0.01 compared with placebo) in the top dose cohort. Following ALN-CC5 administration, nadir levels of residual C5 as low as 0.6 mcg/mL were observed. Regarding effects on complement activity, multiple doses of ALN-CC5 resulted in an up to 97 percent inhibition of CAP activity, an up to 97 percent inhibition of CCP activity, and an up to 98 percent inhibition of serum hemolytic activity (mean maximum 84 ± 7.6 percent). These effects on complement activity were statistically significant (p less than 0.05 compared with placebo). The level of CAP inhibition achieved in these healthy volunteers is comparable to results seen in people with homozygous C5 deficiency2,3, which highlights the highly robust knockdown of serum C5 levels achieved with ALN-CC5. Furthermore, multiple dose administration of ALN-CC5 achieved the 80 percent target level of serum hemolytic activity inhibition previously correlated with LDH reductions in PNH patients4. Finally, after the last dose of ALN-CC5, C5 knockdown and inhibition of complement activity were highly durable, with effects lasting several months. For example, after five weekly doses in the 200 mg cohort, an up to 98.3 percent knockdown of serum C5 was maintained at day 112. Preliminary Phase 1/2 Safety Results All safety results remain blinded as to treatment allocation. Single and multiple weekly subcutaneous doses of ALN-CC5 or placebo were generally well tolerated with no clinically significant, drug-related adverse events (AEs) reported to date. There were no serious adverse events (SAEs), study discontinuations, or clinically significant laboratory findings. In Part A of the study, a total of 29 AEs were observed, all of them mild or moderate in severity, of which 3 were deemed possibly related to ALN-CC5 or placebo. Two patients experienced mild, transient injection site reactions (ISRs). In Part B of the study, a total of 30 AEs were observed, all of them mild or moderate in severity, of which 12 AEs were deemed possibly related to ALN-CC5 or placebo. Four subjects experienced mild, transient ISRs. ALN-CC5 Phase 1/2 Study Design The ongoing Phase 1/2 trial of ALN-CC5 is being conducted in three parts. Parts A and B are randomized (3:1, drug:placebo), double-blind, placebo-controlled, SAD and MAD studies, respectively, which will enroll up to a total of 60 healthy adult volunteers. These parts of the study are designed to evaluate safety and tolerability of single and multiple subcutaneous doses of ALN-CC5. Additional objectives include clinical activity as measured by knockdown of serum C5 and levels of residual C5. In addition, additional objectives include measurement of effects on inhibition of serum complement activity, including measurements of CAP and CCP activity, and serum hemolytic activity. A total of 5 SAD cohorts were enrolled in the study, with fixed doses ranging from 50 to 900 mg. A total of 3 MAD cohorts have been enrolled in the study with fixed doses of 100, 200 or 400 mg, where subjects are receiving once weekly, subcutaneous doses of ALN-CC5 or placebo for 5 weeks. Part C is an open-label, multi-dose study in patients with PNH, to assess safety, tolerability, and clinical activity of ALN-CC5, administered for up to 13 weeks. This part of the study will include an exploratory evaluation of ALN-CC5 effects on levels of LDH, a measure of endogenous red blood cell hemolysis. About ALN-CC5 ALN-CC5 is an investigational RNAi therapeutic targeting the C5 component of the complement pathway, currently in early stage clinical development for the treatment of complement-mediated diseases. The safety and efficacy of ALN-CC5 have not been evaluated by the U.S. Food and Drug Administration or any other health authority. The complement system plays a central role in immunity as a protective mechanism for host defense, but its dysregulation results in life-threatening complications in a broad range of human diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic-uremic syndrome (aHUS), myasthenia gravis, neuromyelitis optica, membranous nephropathy, amongst others. Complement component C5, which is predominantly expressed in liver cells, is a genetically and clinically validated target; loss of function human mutations are associated with an attenuated immune response against certain infections and intravenous anti-C5 monoclonal antibody (mAb) therapy has demonstrated clinical activity and tolerability in a number of complement-mediated diseases. A subcutaneously administered RNAi therapeutic that silences C5 represents a novel approach to the treatment of complement-mediated diseases. ALN-CC5 utilizes Alnylam s ESC-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency and durability and a wide therapeutic index. Genzyme Alliance In January 2014, Alnylam and Genzyme, a Sanofi company, formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in North America and Western Europe, while Genzyme obtained the right to access certain programs in Alnylam s current and future Genetic Medicines pipeline, including ALN-CC5, in the rest of the world. In certain defined instances, Genzyme has co-development/co-commercialization and/or global product rights. Genzyme s rights are structured as an opt-in that is triggered upon achievement of human proof-of-principle. About RNAi RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAind comprise Alnylam s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way. About Alnylam Pharmaceuticals Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines. Alnylam’s pipeline of investigational RNAi therapeutics is focused in 3 Strategic Therapeutic Areas (STArs): Genetic Medicines, with a broad pipeline of RNAi therapeutics for the treatment of rare diseases; Cardio-Metabolic Disease, with a pipeline of RNAi therapeutics toward genetically validated, liver-expressed disease targets for unmet needs in cardiovascular and metabolic diseases; and Hepatic Infectious Disease, with a pipeline of RNAi therapeutics that address the major global health challenges of hepatic infectious diseases. In early 2015, Alnylam launched its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics as a whole new class of innovative medicines. Specifically, by the end of 2020, Alnylam expects to achieve a company profile with 3 marketed products, 10 RNAi therapeutic clinical programs – including 4 in late stages of development – across its 3 STArs. The company’s demonstrated commitment to RNAi therapeutics has enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen, Roche, Takeda, Kyowa Hakko Kirin, Cubist, GlaxoSmithKline, Ascletis, Monsanto, The Medicines Company, and Genzyme, a Sanofi company. In addition, Alnylam holds an equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 200 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, Cell, New England Journal of Medicine, and The Lancet. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information about Alnylam’s pipeline of investigational RNAi therapeutics, please visit .alnylam.com. Alnylam Forward Looking Statements Various statements in this release concerning Alnylam s future expectations, plans and prospects, including without limitation, Alnylam s views with respect to the potential for RNAi therapeutics, including ALN-CC5, expectations regarding the timing of clinical trials with ALN-CC5 and the reporting of clinical data from these trials, including the expected reporting of additional data from its ongoing Phase 1/2 trial in mid-2016, its expectations regarding its STAr pipeline growth strategy, and its plans regarding commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Alnylam s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its drug candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Alnylam s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, obtaining regulatory approval for products, competition from others using technology similar to Alnylam s and others developing products for similar uses, Alnylam s ability to manage operating expenses, Alnylam s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Alnylam s dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation to update any forward-looking statements. 1 Lathia et al., 2014; ASCPT Annual Meeting; Abstract #387 2 Seelen et al., J Immunol Methods;296:187-198 (2005) 3 Cugno et al., J Thromb Haemost;12:1440-8 (2014) 4 Hill et al., Blood;106:2559-2565 (2005)

Imeglimin’s Innovative Mitochondria-Targeted Mechanism of Action Recognized by the Scientific Committee of the World Mitochondria Society

LYON, France--(BUSINESS WIRE)--POXEL SA (Euronext: POXEL) a biopharmaceutical company focused on the development of innovative drugs to treat type 2 diabetes, today announced that the Company’s presentation, ‘Imeglimin, a New Mitochondria Targeted Agent for Type 2 Diabetes Treatment’, was selected as the Best Short Oral Communication at the 6th World Congress on Targeting Mitochondria in Berlin, Germany, 30 October, 2015. Buy Frumil (Amiloride And Furosemide) with no prescription The presentation was awarded for providing insights into the unique mitochondrial mechanism of action for Imeglimin, Poxel’s first-in-class oral anti-diabetic agent leading to its ability to increase both glucose-dependent insulin secretion and sensitivity, the two key defects of type 2 diabetes. About Pepcid (Famotidine) with no Rx The congress is organized by the World Mitochondria Society (WMS) and headed by the Society’s President, Professor Volkmar Weissig. About Methotrexate () without Rx It covers a variety of new strategies and innovations as well as clinical applications in mitochondrial medicine. “We are truly honored and thankful to the WMS Scientific Committee for this award that recognizes the quality of our work and the innovative mechanism of action of our drug candidate, Imeglimin, a new antidiabetic agent, targeting the mitochondria for the management of type 2 diabetes,” stated Sebastien Bolze, Ph.D., EVP Non-Clinical Development and CSO of Poxel. “Each year, the WMS recognizes a company which has made significant contributions to translating their research into real applications for the management and prevention of disease progression,” stated Marvin Edeas, M.D., Ph.D., Professor and Chairman of the World Mitochondria Society. Buy Ibandronate Sodium with no Rx “As chairman of the scientific committee, I was highly intrigued by the study presented by Dr. Claritin (Loratadine) with no Rx Bolze. Buy Green Tea online He clearly outlined how this new drug can modulate mitochondria function and how these effects can affect insulin sensitivity and secretion. http://medical-reviews.blogspot.com Additionally, the effects on oxidative stress reduction and cell protection were also highlighted.” About the World Mitochondria Society The World Mitochondria Society (WMS) was founded in 2010 by Professor Marvin Edeas. The idea of WMS is to bring a new level of understanding of mitochondria science out of the classical existing point of view. The WMS organizes Targeting Mitochondria World Congress each year in Berlin. WMS is a non-profit international organization. In no case, part of its assets or incomes shall benefit to any private or individual partnership or corporation. About Poxel Poxel uses its unique development expertise in metabolism to advance a pipeline of truly novel products currently focused on type 2 diabetes. Our first-in-class lead product, Imeglimin, targeting mitochondrial dysfunction, has successfully completed Phase 2 development in the US and EU and has entered clinical development in Japanese subjects. We are advancing our second program, PXL770, a direct AMPK activator, through clinical proof-of-concept. We will generate further growth through strategic partnerships and pipeline development. (Euronext: POXEL, .poxel.com)

Pemphigus - Pipeline Review, H2 2015 - 8 Companies & 10 Drug Profiles

. Buy Forskohlii online About Phenergan (Promethazine) without prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/6sdzrj/pemphigus) has announced the addition of the "Pemphigus - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Pemphigus, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. http://future-pharmaceuticals.blogspot.com Buy Halonix without Rx About Dexone (Dexamethasone) It also reviews key players involved in the therapeutic development for Pemphigus and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. Detrol La (Tolterodine) with no prescription Rheumatrex (Methotrexate) without Rx It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development Almirall, S.A. Biogen, Inc. Genmab A/S HanAll Biopharma Co., Ltd. Immunomedics, Inc. Momenta Pharmaceuticals, Inc. Novartis AG PinCell srl Drug Profiles ADP-31415 Antibody for Autoimmune Disorders and Inflammation DP-C006 HL-161 ofatumumab PC-111 rituximab T-Cell Therapy for Pemphigus Vulgaris VAY-736 veltuzumab For more information visit .researchandmarkets.com/research/6sdzrj/pemphigus

Dako, an Agilent Technologies Company, Announces FDA Approval of New Test for Lung Cancer Patients

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Global Drug Delivery in Cancer Market Study 2015-2024 - Updated Technologies, Markets and Companies Analysis

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LabCorp's Zero Coupon Convertible Subordinated Notes Due 2021 to Accrue Contingent Interest

BURLINGTON, N.C.--(BUSINESS WIRE)--Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) announced today that for the period of September 12, 2015 to March 11, 2016, its Zero Coupon Convertible Subordinated Notes due 2021 (Zero Coupon Notes) will, subject to the terms of the Zero Coupon Notes, accrue contingent cash interest at a rate of no less than 0.125% of the average market price of a Zero Coupon Note for the five trading days ended September 9, 2015, in addition to the continued accrual of the original issue discount. Ziac (Biosoprolol - Hydrochlorothiazide) with no prescription Contingent cash interest, which the Company has determined to be approximately $1.98 per Note, will be payable to holders of the Zero Coupon Notes as of the record date, which is February 25, 2016. Buy Betagan (Levobunolol) without prescription The payment of contingent cash interest is expected to be made on March 11, 2016. About LabCorp® Laboratory Corporation of America® Holdings, an S&P 500 company, is the world’s leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics, and end-to-end drug development support through Covance Drug Development. Buy Cozaar (Losartan) with free prescription LabCorp is a pioneer in commercializing new diagnostic technologies and is improving people’s health by delivering the combination of world-class diagnostics, drug development and knowledge services. Febuxostat With combined revenue pro forma for the acquisition of Covance in excess of $8.5 billion in 2014 and more than 48,000 employees in over 60 countries, LabCorp offers innovative solutions to healthcare stakeholders. Buy Mellaril (Thioridazine) with free prescription LabCorp clients include physicians, patients and consumers, biopharmaceutical companies, government agencies, managed care organizations, hospitals, and clinical labs. Buy Cascara Sagrada online To learn more about Covance Drug Development, visit .covance.com. http://webmd-help.blogspot.com To learn more about LabCorp and LabCorp Diagnostics, visit .labcorp.com. This press release contains forward-looking statements including with respect to estimated 2015 guidance and the impact of various factors on operating results. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace, adverse actions of governmental and other third-party payers and the results from the Company’s acquisition of Covance. Actual results could differ materially from those suggested by these forward-looking statements. Further information on potential factors that could affect LabCorp’s operating and financial results is included in the Company’s Form 10-K for the year ended December 31, 2014, and the Company’s Form 10-Q for the quarter ended June 30, 2015, including in each case under the heading risk factors, and in the Company’s other filings with the SEC, as well as in the risk factors included in Covance’s filings with the SEC. The information in this press release should be read in conjunction with a review of the Company’s filings with the SEC including the information in the Company’s Form 10-K for the year ended December 31, 2014, and subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Samenvatting ADC Therapeutics haalt 88 mln. dollar op voor antilichaam-medicijnverbindingen tegen kanker

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Global mTORC-2 Inhibitors Pipeline Insights Review 2015

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Global Emesis Pipeline Insights Review 2015

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Celiac Disease Clinical Trials - Global Review, H1, 2015

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Riassunto Takeda presenta una richiesta di nuovo farmaco per ixazomib, per il trattamento dei pazienti con mieloma multiplo recidivato/refrattario

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Myeloproliferative Disorders Pipeline Insights

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Vesey Street Capital Partners Affiliate Acquires Leading Provider of Continuing Medical Education

NEW YORK--(BUSINESS WIRE)--An affiliate of Vesey Street Capital Partners L.L.C. Demadex (Torsemide) (VSCP), a private equity firm dedicated to middle market health care services investments, today announced the acquisition of Imedex, LLC (“Imedex”), a provider of accredited, independent Continuing Medical Education (CME) to industry professionals via in-person conferences and online education forums. About Rulide (Roxithromycin) with free Rx Located in Alpharetta, Georgia, Imedex was previously a subsidiary of AmerisourceBergen, a global pharmaceutical sourcing and distribution service company. “Imedex plays a critical role educating physicians in key specialty areas within the healthcare spectrum, including oncology, hematology, and gastroenterology. Parafon Forte (Chlorzoxazone) with free Rx The Company’s leading industry presence and world class content will provide significant growth over the long-term. Cytotec with no Rx We view this as an excellent platform acquisition and hope to deploy additional capital through industry consolidation opportunities,” said Adam Feinstein, Founder and General Partner of Vesey Street Capital Partners. Andrew “Andy” Schutt, the former General Manager and Vice President of Imedex, was named as the Company’s Chief Executive Officer. Buy Ampicillin (Acillin) with no Rx Mr. Buy Psoriasis online Schutt, said, “We welcome VSCP as a partner and look forward to expanding our market presence through strategic investments. http://allegra-opinion.blogspot.com VSCP’s vast experience operating in the physician, payor and hospital markets will provide valuable insight as we move forward as an independent provider.” Steve Geringer has been named Chairman of Imedex Holdco, LLC. Mr. Geringer is Chairman of AmSurg Corporation (NASDAQ: AMSG), a nationwide provider of ambulatory surgery centers and outsourced physician services; a Director of Addus HomeCare Corp. (NASDAQ: ADUS), a provider of home and community-based services; and a Director of a variety of other companies in the health care industry, successfully building shareholder value throughout his career. “Imedex is a strategic platform with a significant opportunity to grow its accredited physician-oriented CME programs which serve the global pharmaceutical market. We are confident that under Andy’s leadership, the Imedex team will further enhance its leadership position and realize its growth potential,” said Mr. Geringer. ABOUT VESEY STREET CAPITAL PARTNERS L.L.C. Vesey Street Capital Partners (VSCP) is a private equity firm founded in 2014 with a dedicated focus on middle market health care services. VSCP’s focused strategy is centered upon investing primarily in founder owned businesses and corporate carve-outs that create value for hospitals, physicians, payors and post-acute care providers by enhancing operating efficiencies, improving quality of care, reducing costs and increasing revenue. VSCP has significant experience in healthcare services and creates value for portfolio companies by leveraging its vast network of industry relationships and its distinguished investor group consisting of healthcare leaders, health care companies and family offices. The acquisition of Imedex, LLC through its affiliate Imedex Holdco, LLC represents the firm’s second investment following last year’s recapitalization of ScribeAmerica, the nation’s leading provider of medical scribe services, .scribeamerica.com. For more information on Vesey Street Capital Partners, visit .vscpllc.com. ABOUT IMEDEX, LLC Imedex is an established leader in the independent accredited health care education industry. The Company’s programs focus on improving patient care around the world through live events and online courses. CME credits are required for practicing physicians and the conferences provide a forum for physicians to interact and exchange ideas and best practices. Since its inception in 2001, Imedex has organized 50,000 e-learning experiences annually and more than 97,000 live meeting attendees in 29 countries. The Company has a global footprint and operates in the United States, Europe and Asia. The Company recently hosted the ESMO 17th World Congress on Gastrointestinal Cancer in Barcelona, Spain, which was attended by ~3,300 physicians.

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Type 2 diabetes linked with reduced cognitive function

Researchers have revealed that over just 2 years, the ability of people with type 2 diabetes to regulate their blood flow is reduced, impairing the cognitive and executive skills. The study focused on older adults, assessing participants with an average age of 66. When blood flow is regulated normally, the brain can redistribute blood to areas that become more active during specific tasks. "People with type 2 diabetes have impaired blood flow regulation," explains study author Dr. About Combivir (Lamivudine - Zidovudine) with free Rx Vera Novak, from Harvard Medical School in Boston, MA. Buy Starlix (Nateglinide) without prescription "Our results suggest that diabetes and high blood sugar impose a chronic negative effect on cognitive and decision-making skills." Type 2 diabetes has previously been established as an independent risk for the development of both cognitive impairment and dementia. About Shuddha guggulu () with free prescription In their study, published in Neurology, the researchers wanted to investigate how inflammation, blood flow regulation in the brain and cognitive decline were related in people with the metabolic disorder. The researchers examined a small cohort of 40 people - 19 with type 2 diabetes and 21 without diabetes. About Cyclessa with free prescription The average age of the participants was 66. Asendin (Amoxapine) with no Rx The participants that had type 2 diabetes had all been treated for the disease for more than 5 years, receiving an average of 13 years of treatment. For the study, the researchers conducted an array of tests on the participants. Buy PMS Relief online They assessed their cognitive and memory functions while also taking magnetic resonance imaging (MRI) scans and blood tests to measure brain volume, blood flow and inflammation. http://doctor-answers.blogspot.com/ After 2 years, the researchers repeated the tests. They found that the participants with type 2 diabetes experienced a reduction in their capacity to regulate the blood flow in their brains. These participants also performed worse in the cognitive and memory function tests. Participants whose blood flow regulation was poorest at the start of the study experienced the greatest declines in their ability to perform basic routine tasks such as bathing and cooking, defined as decline in executive function. Additionally, the researchers found that the participants who experienced the highest levels of inflammation also had the greatest decreases in blood flow regulation, regardless of whether their diabetes and blood pressure were well controlled or not. Blood flow regulation monitoring could help predict cognitive changes Over the 2 years of the study, there was a marked difference in the learning and memory skills of the participants with type 2 diabetes compared with those without the disease. Average test scores fell by 12%, from 46 to 41, among those with type 2 diabetes while the scores of those without diabetes remained steady at 55 points. Among the participants with type 2 diabetes, the researchers found that blood flow regulation decreased by around 65% overall. "Early detection and monitoring of blood flow regulation may be an important predictor of accelerated changes in cognitive and decision-making skills," Dr. Novak suggests. Only conducting the tests on the participants twice, at the start of the study and 2 years later, means that the study does not reveal much about how cognitive and executive function in people with type 2 diabetes alters over time. The authors partially acknowledge this limitation, stating another study involving a larger sample size and longer duration is required to shed further light on the time sequence of the relationship between blood flow regulation and the disease. Other limitations of the study are that the researchers did not measure for other factors that could have contributed to cognitive impairment among the participants and that younger participants were not involved in the study. Despite these, the authors believe that their research provides clinical evidence regarding the mechanisms of the long-term effects of type 2 diabetes on the brain, with implications for health care and future treatment for older people with the disease. Recently, Medical News Today reported on a study suggesting that high levels of blood sugar could be a cause of Alzheimer s disease. Written by James McIntosh

Scientists isolate unwanted marijuana side effects

Scientists have successfully isolated the medical benefits of cannabis from its unwanted side effects. Augmentin (Amoxicillin And Clavulanate) without prescription Scientists have successfully isolated the unwanted side effects of cannabis from its medical benefits. Researchers from both the University of East Anglia (UEA), in the UK and University of Pompeu Fabra in Barcelona, Spain, carried out their research on mice and discovered how the main psychoactive ingredient in cannabis, tetrahydrocannabinol, or delta-9-tetrahydrocannabino (THC), is triggered by a pathway that is separate from its other effects. Buy Viagra Sublingual (Sildenafil Citrate) with no Rx The latest findings, published in PLOS Biology, come from a team who previously found that THC reduced tumor growth in cancer patients. Buy Singulair (Montelukast) with no prescription It is hoped the new findings can aid the development of cannabis for medical use, without the risk of its unwanted side effects. Scientists discovered the pathway used for THC involves both a cannabinoid and serotonin receptor. About Colchicine without prescription When blocked, it was discovered THC still exerted several beneficial effects, including pain relief, while also avoiding the impairment of memory, which is a common side effect of cannabis use. Celexa (Citalopram) Researchers undertook behavioral studies in mice and investigating how their brain pathways operate under the effect of THC. Buy Natural Menopause Relief online They found that one serotonin receptor, 5HT2AR, reduced some of the effects of THC - such as its amnesiac effect - but still retained medical benefits, such as pain relief. http://doctoranswers.wordpress.com A study published this year warned of the dangers of a chronic use of cannabis during adolescence with memory problems. The latest study will add further weight to an already highly contested topic. The potential beneficial medical effects and dangers of cannabis use has rarely strayed from the public s eye. Twenty-three US States and the District of Columbia have already passed legislation allowing the use of cannabis for medical use. Furthermore, Oregon has recently become the fourth US State, after Alaska, Colorado and Washington, to legalize the drug for recreational use, and studies are increasingly delving further into the full effects of the drug. Dr. Peter McCormick from UEA s School of Pharmacy, stated this research is important for future development of treatment as it identifies THC s unwanted side effects while maintaining pain reduction. However, Dr. McCormick was quick to warn of the dangers of individuals self-medicating, but stated he hopes the research would lead to a "safe synthetic equivalent being available in the future." Written by Peter Lam

Epilepsy 'increases risk of death' among pregnant women

Pregnant women may have greater risk of adverse complications and death during delivery if they have epilepsy, according to a new study published in JAMA Neurology. Researchers found pregnant women with epilepsy are at greater risk of maternal death and delivery complications than those without the disorder. Epilepsy is brain disorder characterized by abnormal nerve cell activity that causes seizures. Amaryl (Glimepiride) with no prescription It is estimated that around 3 million adults and children in the US have the condition, with around 150,000 new cases diagnosed each year. According to the study researchers, including Sarah MacDonald of the Harvard T.H. Buy Xenical (Orlistat) with free Rx Chan School of Public Health in Boston, MA, around 0.3-0.5% of all pregnancies occur among women with epilepsy. While it is understood that epilepsy can raise the risk of pregnancy- and delivery-related complications, such as fetal injury and preterm birth, MacDonald and colleagues note that there is inadequate data quantifying these risks. "With approximately half a million women with epilepsy of reproductive age in the US, and 25,000 offspring born to these women annually, there is considerable need to understand the risks of pregnancy in this population," they note. The researchers set out to address this data gap, analyzing the hospital records of almost 4.2 million women in the US who gave birth between 2007 and 2011. About DDAVP (Desmopressin) without prescription Of these women, 14,151 had epilepsy. Applying these figures nationwide, the researchers say their study represents 69,385 women with epilepsy and 20,449,532 women without the condition. Incidence of delivery complications was recorded, including Cesarean delivery, preterm birth, preeclampsia, stillbirth and maternal death, and length of hospital stay was also assessed. 10-fold greater risk of maternal death for women with epilepsy The researchers found that the rate of maternal death was much higher among women with epilepsy than those without. There was a rate of 6 deaths per 100,000 pregnancies among women without the brain disorder, while there were 80 deaths per 100,000 pregnancies for women with epilepsy - representing more than a 10-fold greater risk of maternal death. In addition, the team found women with epilepsy were at greater risk of other complications, including preterm labor, preeclampsia and stillbirth. Buy Clomipramine without prescription These women were also more likely to need Cesarean delivery and have longer hospital stays than those without epilepsy. While the researchers are unsure exactly why women with epilepsy are at higher risk of delivery complications and maternal death, they say their findings are of concern: "Regardless of the specific cause, the point that women recorded as having epilepsy have an increased risk of mortality remains a clinically relevant message suggesting that increased attention should be paid. The disproportionate burden of maternal morbidity and mortality among women with epilepsy suggests that these are high-risk patients who may best be cared for in medical centers with subspecialty expertise in neurology, maternal-fetal medicine and critical care." They add that further research is needed to determine the mechanisms underlying their findings and to identify interventions that might improve pregnancy outcomes for women with epilepsy. In an editorial linked to the study, Dr. About Cialis Strong Pack-30 () without Rx Jacqueline A. Buy Mixed Tocopherols online French, of the NYU Langone School of Medicine in New York, NY, and Dr. http://future-pharmaceuticals.blogspot.com Kimford Meador, of the Stanford University School of Medicine, CA, say the findings from MacDonald and colleagues "provide important new information" about pregnancy risks for women with epilepsy. They note, however, that the study raises more questions than it provides answers. "Most WWE [women with epilepsy] have uncomplicated pregnancies," they add. "We need to understand the mechanisms underlying these risks, including death, so that we can identify the specific population at risk and devise interventions to reduce these risks. Future studies need to confirm and build on the present findings to improve the care of WWE during pregnancy." In January, a study published in the journal Neurology claimed people with epilepsy who sleep on their stomach may be at greater risk of sudden unexpected death than those who sleep in other positions. Written by Honor Whiteman

Molecule found that helps BRCA gene resist cancer treatment

. http://doctorconsult.wordpress.com n a new study they report in the journal Molecular Cell, scientists describe how they identified a small molecule that helps the BRCA2 gene do its job. Levitra Soft (Vardenafil) BRCA2 is a tumor suppressor gene that in some mutated forms can cause breast and ovarian cancer in as many as 60% of women. The researchers say understanding how cancer cells repair DNA breaks will help develop new ways to counter resistance to chemotherapy. Like normal cells, cancer cells need to repair DNA to survive. Buy Apcalis Oral Jelly (Tadalafil) with no Rx This is somewhat of a paradox - in their case, they are concerned with maintaining the integrity of "faulty" DNA. DNA repair in cells - both healthy and cancerous - is controlled by genes, including BRCA genes. Decades ago, scientists discovered that variants of BRCA1 and BRCA2 genes are markers for increased risk of breast cancer. Buy Dulcolax (Bisacodyl) without prescription According to the National Cancer Institute, together, BRCA1 and BRCA2 mutations account for about 20-25% of hereditary breast cancers and about 5-10% all breast cancers. About Ciclohale with no prescription In addition, mutations in these genes account for around 15% of all ovarian cancers. Breast and ovarian cancers involving BRCA1 and BRCA2 mutations tend to develop earlier in life than their non-hereditary counterparts. BRCA mutations are also known to play a role in ovarian, prostate and pancreatic cancers. While chemotherapy drugs can be effective for fighting cancer in people with BRCA mutations, there is a tendency for the cancer to develop resistance to the drugs. Buy Dramamine (Dimenhydrinate) with free Rx The BRCA proteins develop secondary mutations that continue to promote cancer growth. Findings point to a way to counter drug resistance in BRCA cancers Now, scientists at Yale School of Medicine in New Haven, CT, have pinpointed a key molecule called co-factor DSS1 that helps the BRCA2 gene to repair DNA. They note how "DSS1 acts as a DNA mimic," and without it, BRCA2 mutations cannot do their job of repairing DNA - which is key to the survival of cancer cells. The team says the findings point to a possible way to decrease drug resistance in cancers involving BRCA genes. Senior author Patrick Sung, a professor of molecular biophysics and biochemistry, suggests drugs that interfere with DSS1 function could be developed and used with existing drugs to overcome this resistance, and explains: "We can design specific targets for drug development only if we fully understand the key players and how they work in the pathway for repairing DNA breaks." Grants from the National Institutes of Health helped fund the study. Meanwhile, Medical News Today recently learned about new research that suggests daily aspirin may prevent breast cancer development and recurrence. Buy Liquid Cold & Flu online Researchers writing in the journal Laboratory Investigation describe how daily low-dose aspirin almost halved tumor growth in mice with breast cancer. Written by Catharine Paddock PhD

Preclinical trial data brings new hope for HIV vaccine

Publishing data from preclinical trials in nonhuman primates in the journal Science, Crucell Holland B.V, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, reveal encouraging results for their HIV vaccine. "Our ultimate goal is to develop a vaccine that prevents HIV in the first place," says Dr. Zyvox (Linezolid) with free prescription Paul Stoffels of Johnson & Johnson. "Despite great progress in HIV treatments," says Dr. Avelox (Moxifloxacin) with no prescription Paul Stoffels, chief scientific officer and worldwide chairman of pharmaceuticals at Johnson & Johnson, "HIV remains one of the greatest global health threats of our time with millions continuing to be infected each year." "Our ultimate goal is to develop a vaccine that prevents HIV in the first place," Dr. Buy Revia (Naltrexone) without prescription Stoffels continues. About Cerazette without Rx "By Janssen collaborating with multiple stakeholders on new tools, we hope one day to help eradicate HIV." Repeated attempts to develop an effective HIV vaccine over the past 30 years have so far been unsuccessful. Buy Epivir (Lamivudine) with free prescription Previously, Medical News Today has looked at studies examining the reasons why experimental HIV vaccines are famously prone to "backfiring." However, last month, Science and the journal Cell published the results from studies investigating an immunogen that may be effective as the first in a series of immunizations against HIV. Buy Kidney Problems online This immunogen, called eOD-GT8 60mer, was designed by a team at The Scripps Research Institute s International AIDS Vaccine Initiative. Risk of infection per exposure estimated to be 100-fold lower Speaking to NBC News about the new vaccine, Hanneke Schuitemaker, vice president in charge of developing viral vaccines at drug company Janssen, said that "based on epidemiological data, we estimate that the risk of a person to become infected per exposure is about 100-fold lower." According to the results of the preclinical trial, the vaccine provided "complete protection" to the 12 nonhuman primate trial subjects from becoming infected with simian immunodeficiency virus (SIV) - the nonhuman primate equivalent of HIV. http://webmd-board.blogspot.com The primates were each exposed to the virus six times. The study results suggest there is also a strong link between the vaccine s protective ability and the number of antibody functions to fight the virus. The vaccine developers cite this "polyfunctionality" as evidence that the vaccine may be effective in human subjects. "We are very encouraged by the results of this preclinical HIV vaccine study, and the findings lead to a clear path forward for evaluating this HIV vaccine candidate in humans," says lead author Dr. Dan H. Barouch, PhD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and professor of medicine at Harvard Medical School, both in Boston, MA. Currently, 400 volunteers are being recruited in the US and Rwanda for a phase 1 trial of the vaccine in humans. Different components of the vaccine are also currently being evaluated in ongoing phase 1 clinical studies. However, this has not been the only big piece of HIV vaccine news this week. HIV vaccine researcher jailed for falsifying data On Wednesday, The Washington Post reported that a former Iowa State University researcher, Dong Pyou Han, had been jailed for falsifying HIV vaccine research. Han spiked rabbit blood with human antibodies, which gave a false impression that the rabbits in his team s studies were mounting an immune response that was neutralizing the HIV virus they were infected with. Han began spiking the rabbit blood in 2008, reportedly to cover up the accidental contamination of blood samples. However, it was not until 2013 - when Harvard researchers attempted to validate the team s results - that human antibodies were discovered in the samples, which unraveled the deception. Sentenced to 4 and a half years in prison, Han has also been ordered to repay the $7.2 million in federal government grant funds that his team received using the falsified results. He has also been banned for pursuing federal research grants for 3 years. Written by David McNamee

Gilead reicht bei US-amerikanischer Food and Drug Administration Zulassungsantrag f"ur Einzeltabletten-HIV-Therapie mit Rilpivirin, Emtricitabin und Tenofovir Alafenamid (R/F/TAF) als neues Arzneimittel ein

FOSTER CITY, Kalifornien--(BUSINESS WIRE)--Das Unternehmen Gilead Sciences, Inc. Buy Truvada (Tenofovir Emtricitabine) without Rx (NASDAQ: GILD) hat heute bekanntgegeben, dass es bei der US-amerikanischen Food and Drug Administration (FDA) einen Zulassungsantrag (New Drug Application, NDA) f"ur ein Einzeltablettenprogramm mit einmal t"aglicher Verabreichung eingereicht hat. About Clomid (Clomiphene) without prescription Emtricitabin 200 mg und Tenofovir Alafenamid (TAF) 25 mg von Gilead werden dabei mit Rilpivirin 25 mg (R/F/TAF) von Janssen Sciences Ireland UC, einem der Janssen Pharmaceutica Unternehmen von Johnson & Johnson, kombiniert. About Acai berry () with free Rx Damit sollen Infektionen mit HIV-1 bei erwachsenen Patienten und Jugendlichen ab zw"olf Jahren behandelt werden. Buy Carbamazepine with no Rx Die mit der NDA eingereichten Daten unterst"utzen die Gabe von R/F/TAF bei Patienten, die HIV-behandlungsunerfahren oder virologisch unterdr"uckt sind und ihr aktuelles antiretrovirales Behandlungsprogramm wechseln wollen. Eine von Knight Therapeutics im November 2014 erhaltene Zusage f"ur ein Vorrangverfahren wurde zusammen mit der NDA f"ur R/F/TAF bei der FDA eingereicht. Buy Herbal Max Gun Power () Gem"ass dem Prescription Drug User Fee Act (PDUFA) liegt das erwartete Zieldatum f"ur die NDA f"ur R/F/TAF sechs Monate nach der Annahme der Einreichung durch die FDA. „R/F/TAF ist die dritte TAF-basierte Einreichung von Gilead in weniger als einem Jahr, und wir freuen uns darauf, Menschen, die mit HIV leben, eine weitere effektive Behandlungsoption mit g"unstigem Sicherheitsprofil anbieten zu k"onnen”, sagte Dr. Buy Hair Vitamins online Norbert Bischofberger, Executive Vice President Forschung und Entwicklung und Chief Scientific Officer bei Gilead Sciences. http://webmdhelp.wordpress.com „Die R/F/TAF-Einreichung stellt ausserdem die n"achste Kooperation von Gilead mit Janssen im Rahmen unserer gemeinsamen Bestrebungen dar, die HIV-Behandlung f"ur bestimmte Patienten zu verst"arken und eventuell zu verbessern.” TAF ist ein neuartiger, in der Erprobungsphase befindlicher NRTI (nukleosidischer reverser Transkriptasehemmer), der in klinischen Studien eine hohe antivirale Wirksamkeit bei einer zehnmal geringeren Dosis als Viread® (Tenofovirdisoproxilfumarat, TDF) von Gilead, sowie verbesserte Nieren- und Knochenwerte im Labor gegen"uber TDF in Kombination mit anderen antiretroviralen Wirkstoffen ergeben hat. Ausser R/F/TAF befinden sich auch zwei weitere HIV-Therapien auf TAF-Basis im Pr"ufverfahren bei der FDA. Im November 2014 reichte Gilead eine NDA f"ur ein Einzeltablettenprogramm mit einmal t"aglicher Verabreichung bestehend aus Elvitegravir 150 mg, Cobicistat 150 mg, Emtricitabin 200 mg und TAF 10 mg (E/C/F/TAF) ein. Im April 2015 reichte Gilead eine weitere NDA f"ur zwei Dosen eines Pr"ufpr"aparats mit einer festen Dosis einer Kombination aus Emtricitabin und Tenofovir Alafenamid (200/10 mg und 200/25 mg) (F/TAF) f"ur die Gabe in Kombination mit anderen antiretroviralen Wirkstoffen gegen HIV ein. Gem"ass dem PDUFA hat die FDA als erwartetes Zieldatum f"ur E/C/F/TAF den 5. November 2015 und f"ur F/TAF den 7. April 2016 gesetzt. Die Antr"age auf Marktzulassung in der Europ"aischen Union wurden f"ur E/C/F/TAF am 23. Dezember 2014 und f"ur F/TAF am 28. Mai 2015 vollst"andig validiert. Gilead plant, im dritten Quartal 2015 einen Zulassungsantrag f"ur R/F/TAF in der Europ"aischen Union einzureichen. Der aktuelle NDA wird durch eine Bio"aquivalenzstudie unterst"utzt, mit der bewiesen wurde, dass mit R/F/TAF die gleichen Emtricitabin- und TAF-Wirkstoffspiegel im Blut erzielt werden, wie mit E/C/F/TAF (TAF-Dosierung von 10 mg), und die gleichen Rilpivirin-Wirkstoffspiegel, wie nur mit einer 25 mg Dosis Rilpivirin (Edurant®). Die Sicherheit und Wirksamkeit von TAF wird durch eine Reihe klinischer Studien bei verschiedenen HIV-Patienten unterst"utzt, darunter behandlungsunerfahrenen Erwachsenen und Heranwachsenden, virologisch unterdr"uckten Erwachsenen, die die Therapie gewechselt haben, sowie Erwachsenen mit leichten bis mittelschweren Nierenfunktionsst"orungen. Im Rahmen von Studien f"uhrte eine TAF-basierte Behandlung (als E/C/F/TAF gegeben) zu keiner geringeren Wirksamkeit und zu verbesserten Nieren- und Knochenwerten gegen"uber einer TDF-basierten Therapie im Labor (verabreicht als E/C/F/TDF oder Stribild®®). Die R/F/TAF-Einreichung ist der aktuellste Schritt im Rahmen einer erweiterten Entwicklungs- und Vermarktungsvereinbarung zwischen Gilead und Janssen, die 2009 begr"undet wurde. Laut dieser Vereinbarung und vorbehaltlich der Zulassung des Produktes wird Gilead f"ur die Herstellung und Registrierung, den Vertrieb und die Vermarktung des Arzneimittelregimes in den meisten L"andern zust"andig sein. Janssen wird es auf etwa 17 M"arkten vertreiben und Mitinhaber der Herstellungsrechte f"ur einige zentrale M"arkte wie die Vereinigten Staaten sein. Die Vereinbarung wurde erstmals f"ur die Entwicklung und Vermarktung von Complera® geschlossen. Dieses Medikament wird in der Europ"aischen Union unter der Bezeichnung Eviplera® vermarktet. Ein viertes Programm auf TAF-Basis mit TAF, Emtricitabin und Cobicistat von Gilead, sowie Darunavir (D/C/F/TAF) von Janssen, befindet sich unter einer anderen Lizenzvereinbarung ebenfalls in der Entwicklung. Im Rahmen der Vereinbarung "ubertr"agt Gilead die Weiterentwicklung des Arzneiregimes sowie, vorbehaltlich der beh"ordlichen Zulassung, die Herstellung, Registrierung, den Vertrieb und die Vermarktung des Produkts weltweit an Janssen. Medikamente auf TAF-Basis sind Pr"ufpr"aparate, deren Wirksamkeit und Vertr"aglichkeit noch nicht nachgewiesen wurde. "Uber Gilead Sciences Gilead Sciences ist ein Biopharmaunternehmen, das innovative Arzneimittel f"ur medizinische Bereiche erforscht, entwickelt und vermarktet, in denen ungedeckter Bedarf besteht. Das Unternehmen hat es sich zur Aufgabe gemacht, die Versorgung lebensbedrohlich erkrankter Patienten zu verbessern. Gilead ist in "uber 30 L"andern weltweit t"atig und hat seinen Hauptsitz in Foster City im US-Bundesstaat Kalifornien. Zukunftsgerichtete Aussagen Diese Pressemitteilung enth"alt zukunftsgerichtete Aussagen im Sinne des Private Securities Litigation Reform Act von 1995, die Risiken, Ungewissheiten und anderen Faktoren unterliegen, wie etwa dem Risiko, dass es Gilead nicht gelingt, innerhalb des angestrebten Zeitrahmens einen Zulassungsantrag f"ur R/F/TAF bei der Europ"aischen Union einzureichen. Des Weiteren k"onnten die Genehmigungen f"ur F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF und andere auf F/TAF basierende Medikamente seitens der FDA und anderer Aufsichtsbeh"orden nicht innerhalb des derzeit erwarteten Zeitrahmens eingehen oder auch ganz ausbleiben, und Marktzulassungen k"onnten, falls sie gew"ahrt werden, signifikanten Beschr"ankungen in der Verwendung unterliegen. Das Ergebnis k"onnte sein, dass F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF und andere Medikamente auf F/TAF-Basis nie erfolgreich vermarktet werden. Diese Risiken, Unsicherheiten und anderen Faktoren k"onnten dazu f"uhren, dass tats"achliche Ergebnisse wesentlich von den im Rahmen der zukunftsgerichteten Aussagen in Aussicht gestellten Resultaten abweichen. Die Leser werden darauf hingewiesen, sich nicht ungeb"uhrlich auf diese zukunftsgerichteten Aussagen zu verlassen. Einzelheiten zu diesen und weiteren Risiken sind im Jahresbericht von Gilead auf Formblatt 10-Q f"ur das am 31. M"arz 2015 zu Ende gegangene Quartal enthalten, der bei der US-B"orsenaufsichtsbeh"orde SEC (Securities and Exchange Commission) eingereicht worden ist. Alle zukunftsgerichteten Aussagen beruhen auf Informationen, die Gilead gegenw"artig vorliegen, und das Unternehmen "ubernimmt keine Verpflichtung zur Aktualisierung solcher zukunftsgerichteter Aussagen. Die vollst"andigen Verschreibungsinformationen zu Viread, Complera und Stribild f"ur die USA, einschliesslich einer BLACK-BOX-WARNUNG, finden sich unter .gilead.com. Edurant ist ein eingetragenes Warenzeichen von Johnson & Johnson oder verbundenen Unternehmen. Viread, Complera, Stribild und Eviplera sind eingetragene Warenzeichen von Gilead Sciences, Inc., oder verbundenen Unternehmen. Weitere Informationen zu Gilead Sciences erhalten Sie auf der Website des Unternehmens unter .gilead.com. Folgen Sie Gilead auf Twitter (@GileadSciences) oder wenden Sie sich an die Gilead-Abteilung f"ur "offentliche Angelegenheiten unter 1-800-GILEAD-5 oder 1-650-574-3000. Die Ausgangssprache, in der der Originaltext ver"offentlicht wird, ist die offizielle und autorisierte Version. "Ubersetzungen werden zur besseren Verst"andigung mitgeliefert. Nur die Sprachversion, die im Original ver"offentlicht wurde, ist rechtsg"ultig. Gleichen Sie deshalb "Ubersetzungen mit der originalen Sprachversion der Ver"offentlichung ab.