U.S. Food and Drug Administration Approves Gilead’s Zydelig® (idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Zydelig® (idelalisib) 150 mg tablets for the treatment of three B-cell blood cancers. Zydelig is indicated in combination with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy and as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. Accelerated approval was granted for FL and SLL based on overall response rate. Zydelig is a first-in-class inhibitor of PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells. This press release has an accompanying Smart Marketing Page providing further details about the organization, products and services introduced below. You can access the Smart Marketing Page via the following link: smp.newshq.businesswire.com/pages/f89vj38d2m1w9d47j. “Zydelig is a much needed new treatment option for appropriate patients with CLL and these indolent lymphomas who have experienced relapses and have limited, if any, treatment options,” said Bruce Cheson, MD, Professor of Medicine, Head of Hematology and Director of Hematology Research at Lombardi Comprehensive Cancer Center at Georgetown University, and a principal investigator on the Zydelig pivotal Phase 3 trial in CLL. “In clinical studies among patients with relapsed CLL, FL and SLL, Zydelig produced strong responses, including a significant improvement in progression-free survival in CLL. I believe it helps fill a significant unmet need for these patients.” Over 200,000 Americans are living with CLL, FL or SLL, slow-growing incurable blood cancers that can lead to life-threatening complications such as anemia, serious infection and bone marrow failure requiring treatment. Relapse commonly occurs after initial chemoimmunotherapy and many patients with relapsed CLL, FL or SLL are unable to tolerate chemotherapy, which may limit their treatment options. “Gilead is committed to the development of novel cancer therapies and we are proud to have this opportunity to make a difference in the lives of people living with these cancers,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “We extend our thanks to the many physicians and patients who participated in Zydelig clinical trials, and are now focused on making this medicine available to patients as expeditiously as possible.” The product’s approval in CLL is supported primarily by data from a randomized, placebo-controlled Phase 3 trial (Study 116) of Zydelig plus rituximab in 220 patients with relapsed CLL who were not able to tolerate standard chemotherapy. Study 116 was stopped early in October 2013 by an independent Data Monitoring Committee due to a highly statistically significant benefit in progression-free survival (PFS) in the Zydelig arm as compared to those receiving rituximab alone (hazard ratio = 0.18 (95 percent CI: 0.10, 0.32), p<0.0001). Median PFS was not reached in the Zydelig plus rituximab arm (95 percent CI: 10.7 months, NR) and was 5.5 months in the placebo plus rituximab arm (95 percent CI: 3.8, 7.1). The FDA granted Zydelig a Breakthrough Therapy designation for relapsed CLL, a designation granted to drug candidates that may offer major advances in treatment over existing options. Zydelig’s accelerated approval in FL and SLL, two types of indolent non-Hodgkin lymphoma, is supported by data from a single-arm Phase 2 study (Study 101-09) of Zydelig monotherapy in patients refractory to rituximab and alkylating-agent-containing chemotherapy (FL: n=72; SLL: n=26). In the study, Zydelig achieved an overall response rate of 54 percent (range: 42-66 percent) and 58 percent (range: 37-77 percent), respectively, in FL and SLL patients. Of the responses seen in FL patients, 8 percent (n=6) were complete responses; all 15 responses in SLL patients were partial responses. The median duration of response was 11.9 months in SLL patients (range: 0.0, 14.7 months) and median duration of response was not reached in FL patients (range: 0.0, 14.8 months). Improvement in patient survival or disease related symptoms has not been established in these indications. Results of Study 116 and Study 101-09 were published in The New England Journal of Medicine in March 2014. Zydelig has a BOXED WARNING in its product label regarding the risks of fatal and serious toxicities: hepatic, severe diarrhea, colitis, pneumonitis and intestinal perforation; see below for Important Safety Information, including contraindications and warnings and precautions. FDA has also approved a risk evaluation and mitigation strategy (REMS) for Zydelig. The purpose of the Zydelig REMS is to inform healthcare providers of the serious risks of hepatotoxicity, severe diarrhea, colitis, pneumonitis and intestinal perforation. Additional information about the Zydelig REMS program can be found at .ZydeligREMS.com. The most common adverse reactions (incidence >=20 percent; all grades) in patients given Zydelig with or without rituximab are diarrhea, pyrexia, fatigue, nausea, cough, abdominal pain, chills and rash. The most common lab abnormalities (incidence >=30 percent; all grades) in clinical studies were neutropenia, hypertriglyceridemia, hyperglycemia and ALT/AST elevations (indicators of liver function). U.S. Patient Support Program Gilead is committed to ensuring that patients with CLL, FL and SLL can access Zydelig and has launched Zydelig AccessConnect™ to provide assistance to appropriate patients who are uninsured, underinsured or who need financial assistance to pay for the medicine. The program consists of an integrated offering of support services for patients and providers, including: Access to dedicated case specialists to help patients and their providers with insurance-related needs, including identifying coverage options. The Zydelig Co-pay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per monthly co-pay. Gilead will provide support to independent non-profit organizations that provide assistance for eligible federally-insured and privately-insured patients who need help covering out-of-pocket medication costs. Eligible patients who have been prescribed Zydelig for an FDA-approved indication and who are experiencing insurance coverage delays greater than five business days may receive a 30-day supply of Zydelig while coverage is established. Patients enrolled into Zydelig AccessConnect will receive the support needed to connect with a specialty pharmacy based on the policies of their individual health plan. The AccessConnect Patient Assistance Program will provide Zydelig at no charge for eligible patients with no other insurance options. Information about how to apply for any of these forms of assistance, and more information on authorized distributors and specialty pharmacies can be found at .zydeligaccessconnect.com or by calling 1-844-6ACCESS (1-844-622-2377) between 8 a.m. and 8 p.m. ET. About Zydelig (idelalisib) Zydelig is an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that plays a role in the activation, proliferation and viability of B cells, a critical component of the immune system. PI3K delta signaling is active in many B-cell leukemias and lymphomas, and by inhibiting the protein, Zydelig blocks several cellular signaling pathways that drive B-cell viability. Zydelig is indicated in combination with rituximab for the treatment of relapsed chronic lymphocytic leukemia in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities and as monotherapy for relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior therapies. The FL and SLL indications were granted accelerated approval based on overall response rate; improvement in patient survival or disease related symptoms has not been established in these indications. Continued approval for these indications is contingent upon verification of clinical benefit in confirmatory trials. Zydelig is available as 150 mg and 100 mg tablets, administered orally twice-daily; 150 mg is the recommended starting dose (see Important Safety Information below for dose modification instructions). Important Safety Information BOXED WARNING: FATAL and SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS and INTESTINAL PERFORATION Fatal and/or serious hepatotoxicity occurred in 14 percent of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended. Fatal, serious, and/or severe diarrhea or colitis occurred in 14 percent of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig as recommended. Fatal and serious pneumonitis can occur. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig as recommended. Fatal and serious intestinal perforation can occur in Zydelig-treated patients. Discontinue Zydelig for intestinal perforation. Contraindications History of serious allergic reactions, including anaphylaxis and toxic epidermal necrolysis (TEN) Warnings and Precautions Hepatotoxicity: Findings were generally observed within the first 12 weeks of treatment and reversed with dose interruption. Upon rechallenge at a lower dose, ALT/AST elevations recurred in 26 percent of patients. In all patients, monitor ALT/AST every 2 weeks for the first 3 months, every 4 weeks for the next 3 months, and every 1 to 3 months thereafter. If ALT/AST is >3x upper limit of normal (ULN), monitor for liver toxicity weekly. If ALT/AST is >5x ULN, withhold Zydelig and monitor ALT/AST and total bilirubin weekly until resolved. Discontinue Zydelig for recurrent hepatotoxicity. Avoid concurrent use with other hepatotoxic drugs. Severe diarrhea or colitis: Grade 3+ diarrhea can occur at any time and responds poorly to antimotility agents. Avoid concurrent use with other drugs that cause diarrhea. Pneumonitis: Evaluate for pneumonitis in patients presenting with pulmonary symptoms such as cough, dyspnea, hypoxia, interstitial infiltrates on radiologic exam, or oxygen saturation decline by >=5 percent. Intestinal perforation: Advise patients to promptly report any new or worsening abdominal pain, chills, fever, nausea, or vomiting. Severe cutaneous reactions: One case of TEN occurred in a study of Zydelig in combination with rituximab and bendamustine. Other severe or life-threatening (grade >=3) cutaneous reactions have been reported. Monitor patients for the development of severe cutaneous reactions and discontinue Zydelig if a reaction occurs. Anaphylaxis: Serious allergic reactions including anaphylaxis have been reported. Discontinue Zydelig permanently and institute appropriate supportive measures if a reaction occurs. Neutropenia: Treatment-emergent grade 3-4 neutropenia occurred in 31 percent of Zydelig-treated patients in clinical trials. In all patients, monitor blood counts >=every 2 weeks for the first 3 months. In patients with neutrophil counts <1.0 Gi/L, monitor weekly. Embryo-fetal toxicity: Zydelig may cause fetal harm. Women who are or become pregnant while taking Zydelig should be apprised of the potential hazard to the fetus. Advise women to avoid pregnancy while taking Zydelig and to use effective contraception during and at least 1 month after treatment with Zydelig. Adverse Reactions Most common adverse reactions (incidence >=20 percent; all grades) in clinical studies, when used alone or in combination with rituximab, were diarrhea, pyrexia, fatigue, nausea, cough, pneumonia, abdominal pain, chills and rash. Most frequent serious adverse reactions (SAR) in clinical studies in combination with rituximab were pneumonia (17 percent), pyrexia (9 percent), sepsis (8 percent), febrile neutropenia (5 percent), and diarrhea (5 percent); SAR were reported in 49 percent of patients and 10 percent of patients discontinued due to adverse reactions. Most frequent SAR in clinical studies when used alone were pneumonia (15 percent), diarrhea (11 percent) and pyrexia (9 percent); SAR were reported in 50 percent of patients and 53 percent of patients discontinued or interrupted therapy due to adverse reactions. Most common lab abnormalities (incidence >=30 percent; all grades) in clinical studies were neutropenia, hypertriglyceridemia, hyperglycemia and ALT/AST elevations. Drug Interactions CYP3A inducers: Avoid coadministration with strong CYP3A inducers. CYP3A inhibitors: When coadministered with strong CYP3A inhibitors, monitor closely for Zydelig toxicity. CYP3A substrates: Avoid coadministration with CYP3A substrates. Dosage and Administration Adult starting dose: One 150 mg tablet twice daily, swallowed whole with or without food. Continue treatment until disease progression or unacceptable toxicity. The safe dosing regimen for patients who require treatment longer than several months is unknown. Dose modification: Consult the Zydelig full Prescribing Information for dose modification and monitoring recommendations for the following specific toxicities: pneumonitis, ALT/AST elevations, bilirubin elevations, diarrhea, neutropenia and thrombocytopenia. For other severe or life-threatening toxicities, withhold Zydelig until toxicity is resolved and reduce the dose to 100 mg, twice daily, upon resuming treatment. If severe or life-threatening toxicities recur upon rechallenge, Zydelig should be permanently discontinued. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific. Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of Zydelig over other therapies and may therefore be reluctant to prescribe the product. In addition, European and other regulatory agencies may not approve Zydelig in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. Further, additional studies of Zydelig may produce unfavorable results. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. U.S. full prescribing information, including BOXED WARNING for Zydelig is available at .gilead.com. Zydelig and AccessConnect are registered trademarks and trademarks of Gilead Sciences, Inc. For more information on Gilead Sciences, please visit the company’s website at .gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Navidea Biopharmaceuticals Announces 2014 Annual Meeting Results

DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the results of voting at its 2014 Annual Meeting of Stockholders (the Annual Meeting) held July 17, 2014. Approximately 79 percent of outstanding shares were represented at the meeting. At the Annual Meeting, Navidea’s stockholders: Elected Michael M. Goldberg M.D. to the Navidea Board of Directors to serve for a term of three years; Voted in support of the Board-sponsored proposal to approve the Company’s 2014 Stock Incentive Plan; Approved, on an advisory basis, the compensation of the Company’s named executive officers; and, Ratified the appointment of BDO USA, LLP to act as the Company’s independent registered public accounting firm for 2014. The final results are subject to verification by the independent election inspectors and will be reported in a Form 8-K to be filed by Navidea with the Securities and Exchange Commission in the next few days. Following the formal business portion of the Annual Meeting, Dr. Michael Goldberg, Navidea Interim CEO, and other members of the Navidea executive team made a series of presentations to stockholders in attendance at the Annual Meeting, including overviews on the following: Lymphoseek® (technetium Tc-99m tilmanocept) Injection U.S. commercialization, label expansion and global partnering activities; Manocept™ CD206 targeting platform update, including a discussion of the new R-NAV venture; and, Neurodegenerative pipeline development status. About Navidea Biopharmaceuticals Inc. Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is developing multiple precision diagnostic products and platforms, including Manocept™, NAV4694, NAV5001, and NAV1800 (RIGScan™), to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making and, ultimately, patient care. Lymphoseek® (technetium Tc-99m tilmanocept) Injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013. For more information, please visit .navidea.com. The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

Samenvatting EPIRUS Biopharmaceuticals benoemt nieuwe leden raad van bestuur

. BOSTON--(BUSINESS WIRE)--Mark H.N. Corrigan, Julie H. McHugh, en William Hunter zijn leden van EPIRUS Biopharmaceuticals raad van bestuur. Dat maakte het in Boston gevestigde bedrijf, dat zich richt op de ontwikkeling en commercialisering van monoklonale antistoffen, dinsdag bekend. De benoeming volgt op de succesvolle fusie van het bedrijf met Zalicus, die dinsdag van kracht ging. "We zijn zeer verheugd dat we Mark, Julie en Bill in onze raad van bestuur hebben", zei president en CEO Amit Munshi in een reactie. "Hun expertise en aanwijzingen zijn van onschatbare waarde voor onze missie om een bedrijf van wereldklasse te worden." Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.

FDA Grants Special Protocol Assessment (SPA) Agreement for Starpharma Phase 3 Recurrent BV Trial

MELBOURNE, Australia--(BUSINESS WIRE)--Starpharma Holdings Ltd (ASX:SPL) (OTCQX:SPHRY) today announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel® bacterial vaginosis (BV) product for the prevention of recurrent BV. The favourable SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product. The granting of SPA agreement by the FDA follows the earlier agreement of the European Medicines Agency (EMA) on the design of the phase 3 studies. Starpharma will now commence its two pivotal phase 3 clinical trials of VivaGel® for the prevention of recurrent BV at sites in North America, Europe and Asia. The two phase 3, double-blind, randomised, placebo-controlled trials will be identical in design and will compare the rate of BV recurrence in women using VivaGel® to the rate of recurrence in women using a placebo gel during a 16 week treatment period. Approximately 600 women will be recruited into each study. Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “Receiving agreement on the SPA is an important and very positive development as it effectively eliminates the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreed trial design. This significantly reduces overall development risk for VivaGel®. SPA agreement from the FDA is protected by US law and gives Starpharma certainty and confidence that the studies will support a regulatory submission for the approval of VivaGel® for the prevention of recurrent BV in the US.” VivaGel® (SPL7013, astodrimer sodium) is a non-antibiotic agent formulated as a vaginally applied gel for prevention of BV recurrence. It is also being developed for the management of BV symptoms, which include unpleasant vaginal odour and discharge, and regulatory submissions to support the symptomatic relief indication are also planned for 2HCY14. There are no approved products for the prevention of recurrent BV and so VivaGel® will be a world-first therapy for this troublesome condition. Bacterial vaginosis affects around 1 in 3 women and recurs in approximately 50 per cent of women within 12 months. In the previous exploratory phase 2 clinical trial, more than 80 per cent of women receiving 1% VivaGel® remained BV-free at 16 weeks and the product also provided protection against the occurrence of BV symptoms. Formal market research with both patients and clinicians and from Key Opinion Leaders strongly supports the demand for a product such as VivaGel® in the management of BV. About BV Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age affecting around 30% of women in the US. It is a highly recurrent condition with 50-60% of sufferers having it recurrently. Bacterial vaginosis is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman s vagina). Smoking and the use of some hygiene products are linked to a higher risk of developing BV. BV results in unpleasant and embarrassing symptoms such as odour and vaginal discharge. It has been linked to still birth, pregnancy complications, pelvic inflammatory disease, and lower rates of fertility. It also is associated with increased susceptibility of women to HIV and other STIs, and an increased risk of transmission of HIV from women to men.

Research and Markets Hemiplegia Global Clinical Trials Review, H1, 2014

. Buy Inositol online About Renagel (Sevelamer Hydrochloride) with no prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/pjpzq2/hemiplegia_global) has announced the addition of the "Hemiplegia Global Clinical Trials Review, H1, 2014" report to their offering. Our clinical trial report, Hemiplegia Global Clinical Trials Review, H1, 2014" provides data on the Hemiplegia clinical trial scenario. http://allegra-opinion.blogspot.com Buy Renova (Tretinoin) with free prescription This report provides elemental information and data relating to the clinical trials on Hemiplegia. About Prevacid (Lansoprazole) It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Hemiplegia. Buy Celebrex This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by Our team of industry experts. Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type Listings of discontinued trials (suspended, withdrawn and terminated) Reasons to buy Understand the dynamics of a particular indication in a condensed manner Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more Obtain discontinued trial listing for trials across the globe Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies For more information visit .researchandmarkets.com/research/pjpzq2/hemiplegia_global

PPD Honored for Communications Promoting the Value of Clinical Trials

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) today announced the company has been recognized with awards for excellence in multimedia and digital communications that demonstrate the importance of clinical research in developing life-changing medical treatments. PPD recently earned four Telly Awards and three Web Health Awards. “Multimedia platforms are powerful tools we use to educate, enlighten and inspire people about clinical research and the mission, vision and values of PPD,” said Elizabeth Kuronen, PPD’s vice president of strategic communications and marketing. “As a gateway to understanding PPD and the important work we do, our digital presence must be engaging to a broad range of stakeholders. These awards highlight PPD’s commitment to spreading the word about life-saving clinical trials.” PPD earned two Telly Awards for “PPD Brings Life-changing Therapies to Market,” a video featuring company employees describing their passion for clinical research. The company also received two Bronze Telly Awards for a video exploring a state-of-the-art, current Good Manufacturing Practice (cGMP) facility, the “PPD cGMP Laboratory Tour” video. PPD earned a Web Health Award for the company’s main website, which details clinical research service offerings, therapeutic expertise and the drug development process. The Web Health Awards also recognized the PPD Beach2Battleship Triathlon microsite and mobile site, which showcases PPD’s annual iron-distance triathlon and signature public education campaign spotlighting the role clinical trials play in improving health and saving lives. The Telly Awards, founded in 1979, honor outstanding commercials, programs, videos and films, and receive more than 12,000 annual entries that are judged by advertising and production professionals to recognize distinction in creative work. Now in its 16th year, the Web Health Awards program celebrates high-quality digital resources for consumers and health professionals as determined by a panel of industry professionals who review hundreds of entries based on content, format and success in reaching the target audience. About PPD PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 13,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit .ppdi.com. Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about PPD’s communications awards and their potential value, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: rapid technological advances that make our services or capabilities less competitive; the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; risks associated with acquisitions and investments; PPD’s ability to win new business; the ability to control SG&A spending; compliance with drug development regulations; changes in the regulation of the drug development process; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; risks associated with and dependence on strategic relationships; and actual operating performance. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD’s estimates or views as of any date subsequent to the date hereof.

Wolters Kluwer Health Partners with Universidade Anhembi Morumbi to Promote Use of Electronic Drug Information in Brazil

HUDSON, Ohio--(BUSINESS WIRE)--Wolters Kluwer Health, a leading global provider of information for healthcare professionals and students, announced today a ground-breaking partnership with Universidade Anhembi Morumbi to offer drug information resources and help educate healthcare students and professionals in Brazil. Wolters Kluwer Health will provide complimentary access to its online global drug information reference solution, Lexicomp® Online™, to Anhembi for use in its pharmacy, medical and nursing courses. In exchange, Anhembi will provide training to Brazilian healthcare professionals who subscribe to Lexicomp Online so they can help enhance patient care by taking advantage of the complete depth of Lexicomp drug content and interactive tools. Universidade Anhembi Morumbi, a member of Laureate International Universities, is ranked one of the top three private universities in Sao Paulo state, Brazil. Students in the health sciences program across the university’s six campuses will be given access to Lexicomp Online, which will be specifically incorporated into curricula to assist with pharmacology research and to help answer practical clinical questions about medication dosing, conversions, and administration. Fifty instructors within Anhembi healthcare programs will also be given complimentary subscriptions to Lexicomp® Mobile Apps for on-the-go access to clinical content and tools to support both academic course planning and patient care in their practice. Healthcare professionals throughout Brazil who subscribe to Lexicomp solutions will be able to attend special dedicated training courses featuring clinical simulations conducted by Anhembi. “We are excited to partner with a forward-thinking institution like Anhembi and impressed by the university’s commitment to advancing healthcare in Brazil,” stated Steven Kerscher, Vice President & General Manager, Clinical Drug Information, Wolters Kluwer Health, Clinical Solutions. “Through its training programs, Anhembi is working to create a generation of tech-savvy clinicians invested in improving patient outcomes with relevant and timely Lexicomp drug content and tools designed for the point of care.” “The healthcare professionals and students in Universidade Anhembi Morumbi will be one step ahead on drugs assistance, thanks to this new partnership with Wolters Kluwer Health,” commented Myrian Kazumi Sano, Pharmacy Professor. “Students will become acquainted with the skills of efficiently searching the literature and critically analyzing information to provide comprehensive, objective, and unbiased drug content to healthcare professionals and to ensure that the patient uses the medication in the best possible manner. This partnership will also allow Anhembi Morumbi’s faculty to have access to updated and accurate drug information and to provide an excellent training environment to prepare our students to meet the challenges of their future careers.” About Wolters Kluwer Health Wolters Kluwer Health is a leading global provider of information, business intelligence and point-of-care solutions for the healthcare industry. Serving more than 150 countries worldwide, clinicians rely on Wolters Kluwer Health’s market leading information-enabled tools and software solutions throughout their professional careers from training to research to practice. Major brands include Health Language®, Lexicomp®, Lippincott Williams & Wilkins, Medicom®, Medi-Span®, Medknow, Ovid®, Pharmacy OneSource®, ProVation® Medical and UpToDate®. Wolters Kluwer Health is part of Wolters Kluwer, a market-leading global information services company. Wolters Kluwer had 2013 annual revenues of €3.6 billion (US$4.7 billion), employs approximately 19,000 people worldwide, and maintains operations in over 40 countries across Europe, North America, Asia Pacific, and Latin America. Follow our official Twitter handle: @WKHealth.

Strong Data from Lagova™ Phase II Clinical Study Presented during Webcast

OPKO Health, Inc. a multinational biopharmaceutical and diagnostics company, yesterday hosted a webcast presenting outstanding interim six-month results from a Phase 2 study of its long-acting human growth hormone product Lagova to treat pediatric growth hormone deficiency disorder (GHD).

“The outstanding interim Phase II results allow for dose selection for a Phase III study which is anticipated to start in 2015.”

During the webcast, Dr. Ron Rosenfeld, Chairman of OPKO Biologic’s Scientific Advisory Board and professor emeritus of Pediatrics at both Stanford University and Oregon Health and Science University, highlighted the superior interim results from the study. About Motrin (Ibuprofen) with no prescription In particular, Dr. Rosenfeld, a pioneer in the recombinant human growth hormone field, noted that the mean height velocity achieved with each of the three different doses of Lagova administered in the study was “actually quite dramatic, ranging from 12.25 centimeters to almost 15.5 centimeters. Every child enrolled in the study experienced a significant improvement in height velocity from weekly administration of Lagova,” he noted.
“OPKO believes there is a significant market opportunity with Lagova, as compliance with daily injections is problematic. Non-compliance leads to a significant decrease in growth response in both adults and children, which is well evidenced by current clinical literature,” said OPKO’s CEO, Phillip Frost, M.D. Myambutol (Ethambutol) “The outstanding interim Phase II results allow for dose selection for a Phase III study which is anticipated to start in 2015.”
Unlike other pediatric long-acting growth hormone deficiency clinical trials, the Lagova Phase II trials also included a direct comparator arm at the same population with similar baseline values. Children were given daily administration of growth hormone at a dosage of 0.24 mg/kg per week, but administered daily in a traditional manner. Buy Effexor (Venlafaxine) with free prescription There was no statistically significant difference among any of the three dosage strengths of Lagova used in the study versus the comparator arm.
As any Phase III trial for a long-acting recombinant human growth hormone will likely require proof of non-inferiority against a comparator arm of daily administered growth hormone, this is an important distinction that gives OPKO great confidence in designing its non-inferiority pivotal Phase III study for Lagova. Acyclovir Had OPKO utilized historical database comparisons as utilized in other pediatric GHD clinical trials versus an actual comparator arm, annualized height velocity for Lagova at all three dosage strengths would have been notably superior, exceeding comparable age-matched historical controls, as published by Bakker (2008) and Ranke (2010) for the same GHD patient population by approximately 30%.
Lagova uses OPKO Biologics’ novel CTP technology which attaches a short naturally occurring peptide to the natural human growth hormone. Approximately 75% of the injected protein in Lagova is the actual native growth hormone, altogether resulting in a highly water soluble compound that can be delivered in high concentrations using a very thin 31 gauge needle to patients of a wide range of body weights and ages by a single, weekly injection. Buy Vitamins online As expected, the safety profile from the six-month data was excellent. No serious adverse events were reported. There were no episodes of either lipoatrophy or lipodystrophy and there were no injection site tolerability issues. More importantly, long term safety is supported by the pharmacokinetic and pharmacodynamics profiles; there was no accumulation and no over-exposure of IGF-1.

About Lagova (hGH-CTP)
In June 2013, OPKO initiated a multi-center worldwide pivotal Phase 3 clinical trial in adults for its proprietary long-acting version of hGH-CTP (Lagova). Medical Helper Lagova has been awarded orphan drug designation in the U.S. and Europe for both adults and children with growth hormone deficiency.
ABOUT OPKO HEALTH
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. 
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected results and benefits of Lagova, including its safety and efficacy, whether OPKO's clinical trials for adult and pediatric growth hormone deficiency will generate data to support marketing approval, whether a single injection of Lagova can replace seven consecutive daily injections of currently marketed hGH, whether Lagova will have low immunogenecity, the expected commencement date for the Phase 3 clinical trial for Lagova in pediatric patients, whether Lagova will be successfully developed or commercialized, expectations regarding the product and its market potential, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that the Phase 3 clinical trials for the Lagova product may not be successful or achieve the expected results or effectiveness, and may not generate data that would support the approval or marketing of this product for the indications being studied, that others may develop products which are superior to Lagova, and that Lagova may not have advantages or prove to be superior over presently marketed products or products introduced in the future. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Pfizer Presents Detailed Results From Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of Prevenar 13

Pfizer Inc. today presented detailed results of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects, demonstrating that Prevenar 13^* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. This trial is the first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive vaccine-type pneumococcal CAP. Furadantin (Nitrofurantoin) without prescription Results were presented during the late-breaker session at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014.

“This study demonstrated that vaccination with Prevenar 13 can prevent a significant portion of pneumococcal community-acquired pneumonia in adults aged 65 and older, which is an important global public health goal”

CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) also met both of its secondary study objectives –significant reduction in (i) non-bacteremic/non-invasive vaccine-type pneumococcal CAP and (ii) vaccine-type invasive pneumococcal disease (IPD).
Regarding the study’s primary objective, there were 45.56 percent fewer first episodes of vaccine-type CAP among Prevenar 13-vaccinated subjects than in subjects who received placebo (P=0.0006). Buy Geodon (Ziprasidone) without Rx Regarding the study’s secondary objectives, the Prevenar 13 group experienced 45.00 percent fewer first episodes of non-bacteremic/non-invasive vaccine-type CAP (P=0.0067) and 75.00 percent fewer first episodes of vaccine-type IPD (P=0.0005) compared with the placebo group. The safety profile of Prevenar 13 in this study was consistent with studies previously conducted in adults.
Additional data showed reductions in vaccine-type CAP, non-bacteremic/non-invasive vaccine-type CAP, and vaccine-type IPD for up to four years after vaccination among subjects who received Prevenar 13.
“With the aging of the population, hospitalizations due to pneumococcal pneumonia represent a growing burden to public health systems. Medrol Active (Methylprednisolone) with no prescription Evidence from this study is particularly important for a population in which age-related decline of the immune system makes it difficult to prevent disease,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development, Pfizer.
“This study demonstrated that vaccination with Prevenar 13 can prevent a significant portion of pneumococcal community-acquired pneumonia in adults aged 65 and older, which is an important global public health goal,” said principal investigator Prof. A-Ret without prescription Marc Bonten, professor of Molecular Epidemiology of Infectious Diseases, Department of Medical Microbiology, Julius Center for Health Sciences & Primary Care, University Medical Center Utrecht in the Netherlands.
The CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) study data will be an important part of any consideration of potential new or updated recommendations for Prevenar 13 in adults. Other key factors also are expected to be taken into consideration, including the current burden of pneumococcal disease in adults.
About CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)
In 2011, Prevnar 13 was licensed by the U.S. Food and Drug Administration under an accelerated approval process to address an unmet medical need in older adults. Buy Vitamins online As a requirement of the accelerated approval pathway, Pfizer conducted CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) to verify clinical benefit.
This was a parallel-group, randomized, placebo-controlled, double-blind, single-center trial in which subjects aged 65 years and older were randomly assigned to receive a single dose of either Prevnar 13 or placebo. A total of 84,496 subjects were enrolled. The trial was conducted by Julius Clinical, a spin-off of the Julius Center for Health Sciences and Primary Care, a division of the University Medical Center Utrecht in the Netherlands. Fifty-eight sentinel hospitals were used for the surveillance of CAP and IPD.
Vaccine-type CAP (VT-CAP) was defined as CAP caused by any Streptococcus pneumoniae serotype included in the vaccine. Non-bacteremic/noninvasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Doctor Online Consultation Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.
About Pneumococcal Disease
Pneumococcal disease refers to a group of illnesses caused by S. pneumoniae bacteria.¹ Invasive pneumococcal disease occurs when bacteria enter the bloodstream, or another site that is normally sterile.² Non-invasive pneumococcal pneumonia occurs when the bacteria cause infection in the lungs but are not detected in the blood concurrently.¹ In adults, pneumonia is the most common presentation of pneumococcal disease.¹ For every one case of invasive pneumococcal pneumonia in adults, it is estimated that at least three cases of non-invasive pneumococcal pneumonia occur.³ While non-invasive forms of pneumococcal disease are typically more common, the invasive types of disease are generally more severe.⁴
About Prevenar 13
Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States and Japan. It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 640 million doses of Prevenar 7-valent/Prevenar 13 have been distributed worldwide. In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, and is also approved in the United States and European Union (EU) for use in older children and adolescents aged 6 to 17 years. Recently, Prevenar 13 was also approved in the EU for use in adults 18 to 49 years of age.
INDICATIONS FOR PREVNAR 13^®

• Prevnar 13^® is a vaccine approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This indication is based upon immune responses to the vaccine
• For children 6 weeks through 17 years of age, Prevnar 13^® is approved for the prevention of invasive disease caused by the 13 vaccine strains, and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains
• Prevnar 13^® is not 100% effective and will only help protect against the 13 strains included in the vaccine
• Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known

IMPORTANT SAFETY INFORMATION

• Prevnar 13^® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13^® or any diphtheria toxoid–containing vaccine
• Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response
• In adults, immune responses to Prevnar 13^® were reduced when given with injected seasonal flu vaccine
• In adults, the common side effects were pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills, or rash
• A temporary pause of breathing following vaccination has been observed in some infants born prematurely
• The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
• In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
• Ask your health care provider about the risks and benefits of Prevnar 13^®. Only a health care provider can decide if Prevnar 13^® is right for you

Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.allwebrx.com.
DISCLOSURE NOTICE: The information contained in this release is as of March 12, 2014. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevnar 13/Prevenar 13, including its potential benefits, and about the CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) trial. Such risks and uncertainties include, among other things, uncertainty concerning the commercial impact of the results of the trial; uncertainty concerning whether and when regulatory authorities in various jurisdictions will update the label and vaccine technical committees in various jurisdictions will update their recommendations with respect to the use of Prevnar 13/Prevenar 13 in adults based on the results of the CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) trial and other factors; whether and when regulatory submissions may be made in jurisdictions other than the U.S. for Prevenar 13 for the prevention of pneumococcal pneumonia in adults caused by the 13 serotypes in Prevenar 13, and whether and when regulatory authorities in such jurisdictions will approve any such submissions, as well as their decisions regarding labeling and other matters that could affect the availability and commercial potential of that additional indication for Prevenar 13 in those jurisdictions; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and in its subsequent reports on Form 10-Q and Form 8-K.
 Trademark. Prevnar 13^® is the trade name in the United States, Canada, and Taiwan.