Fresenius Medical Care Showcases Global Research Leadership at World’s Largest Gathering of Kidney Professionals
Fresenius Researchers and Clinical Experts from across the Globe Present More Than 75 Abstracts at the American Society of Nephrology’s 2017 Kidney Week Symposium, Demonstrating Commitment to Innovating Healthcare through ScienceNovember 02, 2017 02:21 PM Eastern Daylight Time WALTHAM, Mass.--(EON: Enhanced Online News)--Fresenius Medical Care North America (FMCNA), the premier health care company focused on providing the highest quality care to people with renal and other chronic conditions, today announced that company researchers and clinical experts from across the globe will present 77 research abstracts at the 2017 American Society of Nephrology’s (ASN) Kidney Week Symposium, the largest and most influential gathering of kidney professionals in the world. Scheduled from Oct. 31 – Nov. 5, 2017, at the Ernest N. Morial Convention Center in New Orleans, the annual symposium draws more than 13,000 physicians, scientists and healthcare professionals from over 100 countries, this year accepting a total of 92 abstracts of research work conducted or sponsored by Fresenius Medical Care.“The breadth and depth of our leadership in advancing science into clinical practice underscores our mission to improve the lives of people with kidney and chronic diseases” “The scope of our research and quality improvement builds on our strength as the world’s largest, vertically integrated health care company,” said Bill Valle, chief executive officer of Fresenius Medical Care North America. “The data we collect allows us to use sophisticated predictive analytics to further enhance patient care at a personalized level and improve outcomes for our patients.”With a focus on chronic kidney disease (CKD), end-stage renal disease (ESRD) and adjacent medical conditions, the company’s research crosses seven diverse categories:Using science and technology to characterize and improve patient outcomes Driving advancements in management paradigms through value based care models Using predictive modeling for clinical decision support and better outcomes Characterizing the impacts of CKD options education on outcomes and modality selection Leveraging coordinated care initiatives to improve patient outcomes Defining outcomes related to the management of bone mineral metabolism in renal disease Identifying the influences of social determinants of health on clinical measures “The breadth and depth of our leadership in advancing science into clinical practice underscores our mission to improve the lives of people with kidney and chronic diseases,” says Franklin W. Maddux, MD, chief medical officer and executive vice president of clinical and scientific affairs for Fresenius Medical Care North America. “In blending patient perspectives with real world evidence and traditional research, we are able to translate science into clinical practice that ultimately improves the lives of the patients who entrust us with their care.”Highlights of key Fresenius Medical Care presentations at the 2017 ASN Kidney Week include:Association of Peridialytic Systolic Blood Pressure Change and Pre-dialysis Systolic Blood Pressures on Mortality among Hemodialysis Patients. This research investigated if blood pressure patterns before and changes during hemodialysis alter mortality rates. This oral presentation will be given by Hanjie Zhang, MS on Thursday, Nov. 2 at 5:42 p.m. in room 277 (TH-OR007). Quasi-continuous Monitoring of Intraperitoneal Volume Using Segmental Bioimpedance in Peritoneal Dialysis Patients. This research explored whether bioimpedance techniques can be used to monitor the dynamics of intraperitoneal volume. This oral presentation will be given by Fansan Zhu, PhD on Thursday, Nov. 2 at 5:54 p.m. in room 290 (TH-OR095). Impact of Transition of Care Visits on Readmission Rates in Dialysis Patients. This study investigated if introduction of value based transition of care visits after hospital admissions are associated with improved readmission rates. This oral presentation will be given by Terry L. Ketchersid, MD, MBA on Saturday, Nov. 4 at 5:30 p.m. in room 292 (SA-OR036). Factors Associated with Gastrointestinal Bleeding in End Stage Renal Disease Patients. This research investigated if demographic and clinical characteristics are predictive of gastrointestinal bleeding. This poster presentation will be given by Thomas C. Blanchard, PhD on Thursday, Nov. 2 from 10:00 a.m.-12:00 p.m. (TH-PO777). Effects of Predictive Modeling Assisted Care Interventions on Hospitalization Rates in Hemodialysis Patients. This research investigated the impacts of a pilot program that utilizes predictive modeling to assist in identification of patients at risk for hospitalization thereby allowing clinicians to intervene in a timely manner. This poster presentation will be given by David F. Sweet, MSN on Friday, Nov. 3 from 10:00 a.m.-12:00 p.m. (FR-PO897). In North America alone, Fresenius Medical Care’s research efforts involve the contributions of more than 1,200 employees, and the company’s contract clinical research division comprises a network of over 450 principal investigators at more than 260 sites representing 160 medical practices. The nature of dialysis care allows FMCNA to collect substantial amounts of data during routine treatments, including data on more than 1 million patients, more than 250 million dialysis treatments and billions of medication administrations and laboratory results.About Fresenius Medical Care North AmericaFresenius Medical Care North America is the premier health care company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers, as well as the country’s largest practice of hospitalist and post-acute providers, Fresenius Medical Care North America provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com.ContactsFresenius Medical Care North America Kate Dobbs Vice President of Corporate Communications firstname.lastname@example.org (781) 699-9039
Health Canada Approves Otsuka and Lundbeck's Abilify Maintena® (Aripiprazole Once Monthly) as Treatment for Bipolar I Disorder in Adults
MONTREAL--(EON: Enhanced Online News)--Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada announce that Health Canada issued a Notice of Compliance for ABILIFY MAINTENA (aripiprazole for prolonged release injectable suspension), approving a new indication for the maintenance monotherapy treatment of bipolar I disorder in adult patients.1“Abilify Maintena is a welcome and much needed option for treatment of patients with Bipolar 1 disorder. It addresses important concerns for patients and loved ones such as balancing efficacy, tolerability, and long term maintenance in an illness often characterized by recurrence, relapse and adherence” ABILIFY MAINTENA is a once-monthly injectable formulation for intramuscular use created by Otsuka and co-developed and co-commercialized with Lundbeck. In a placebo-controlled phase 3 trial, ABILIFY MAINTENA significantly reduced the risk of recurrence of any mood episode over 52 weeks compared to placebo.1“Abilify Maintena is a welcome and much needed option for treatment of patients with Bipolar 1 disorder. It addresses important concerns for patients and loved ones such as balancing efficacy, tolerability, and long term maintenance in an illness often characterized by recurrence, relapse and adherence”, said Dr. Ruth Baruch, Medical Director of the Community Mental Health Programs, Department of Psychiatry, Michael Garron Hospital and a lecturer at the University of Toronto.About Bipolar I DisorderBipolar I disorder is a recurrent and chronic mental illness characterized by episodes of mania (unusually high mood and energized/elated behavior) and depression (very sad, down, or hopeless periods).2Bipolar disorder affects almost 30 million people worldwide, and the estimated lifetime prevalence of bipolar I disorder in Canada is 0.87%. 3,4About ABILIFY MAINTENA® (aripiprazole once-monthly)ABILIFY MAINTENA (aripiprazole for prolonged release injectable suspension) is an atypical antipsychotic for intramuscular use. It was created by Otsuka in Japan and has been co-developed and co-commercialized by the alliance between Otsuka and Lundbeck. ABILIFY MAINTENA was approved in Canada in 2014 for the treatment of adults with schizophrenia.1ABILIFY MAINTENA is a sterile lyophilized powder that when reconstituted with sterile water for injection, forms a suspension that can be administered by injection once a month (the initial injection is accompanied by an overlapping 14-day dosing of oral antipsychotic treatment). Subsequent doses of ABILIFY MAINTENA provide uninterrupted medication coverage for up to 30 days.1Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared to placebo. ABILIFY MAINTENA is not indicated for the treatment of elderly patients with dementia. ABILIFY MAINTENA safety and efficacy have not been established in patients <18 or ≥65 years of age. ABILIFY MAINTENA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole.For more information about ABILIFY MAINTENA, please visit: http://otsukacanada.com/docs/default-source/default-document-library/product-monographs/abilify-maintena-approved-pm-e.pdf?sfvrsn=10About OtsukaOtsuka Pharmaceutical Co., Ltd., is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing health care company that commercializes Otsuka medicines in Canada. OCPI aims to improve the quality of life and health of patients through its commitments to neuroscience, cardiovascular health, oncology and nephrology. OCPI was established in 2010, with headquarters in Saint-Laurent, Quebec.OCPI is part of Otsuka Pharmaceutical Co., Ltd., a wholly owned subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately CAD 14.5 billion (USD 11 billion) in 2016. All Otsuka stories start by taking the road less travelled.Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Canada at www.otsukacanada.comAbout LundbeckH. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia.Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.2 billion).A division of Denmark-based H. Lundbeck A/S, Lundbeck Canada Inc. has been a trusted source of innovative new treatments for Canadians since 1995 with headquarters in Montreal. Originally focused on providing products for the treatment of diseases such as depression, anxiety, Alzheimer's disease and schizophrenia, Lundbeck Canada also offers new cancer therapies for the treatment of chronic lymphocytic leukemia and non-Hodgkin lymphoma. A patient-focused partner in Canadian health care, Lundbeck Canada's mission is to improve the quality of life for people living with brain diseases and cancer.References1. ABILIFY MAINTENA® (aripiprazole) 2017 full product monograph.2. National Institute of Mental Health. Bipolar disorder. https://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml.3. Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet 2016;387(10027):1561-72.4. McDonald KC, Bulloch AGM, Duffy A, Bresee L, Williams JVA, Lavorato DH, & Patten SB. Prevalence of Bipolar I and II Disorder in Canada. Can J Psychiatry. 2015 Mar; 60(3): 151–156.
Amgen And Novartis Announce Expanded Collaboration With Banner Alzheimer's Institute In Pioneering Prevention Program
Parties to Collaborate on a New Generation Study 2, Assessing Whether Investigational Drug CNP520 Can Prevent or Delay the Symptoms of Alzheimer's Disease Clinical Trial is Part of the Generation Program, Which Includes Cognitively Healthy People at Genetic Risk of Developing Alzheimer's Disease Generation Study 2 Aims to Include a Broader High-Risk Population, as Compared to the Ongoing Generation Study 1 44 Million People Globally are Estimated to Have Alzheimer's Disease or a Related Dementia, With One New Case Diagnosed Every Three Seconds(1,2) THOUSAND OAKS, Calif. , Nov. 2, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Novartis today announced an expanded collaboration with the Banner Alzheimer's Institute (BAI) to initiate a new trial - the Alzheimer's Prevention Initiative (API) Generation Study 2. This trial follows the launch of the Generation Study 1, and will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer's disease symptoms in a high-risk population. BACE1 is an enzyme that plays an important role in the production of Amyloid ß, a protein which accumulates in the brains of individuals with Alzheimer's disease years before clinical symptoms begin. More information on the sites participating in Generation Study 2 can be found at ClinicalTrials.gov and in the website www.GenerationProgram.com. "As a leader in the challenging fight to unlock the biology of serious illnesses like Alzheimer's disease, we are pleased to support the launch of the Generation Study 2 with our partners at Novartis and Banner Alzheimer's Institute to further explore promising potential therapeutic options for this highly debilitating disease," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "Through the unique combination of genetic testing and counseling in cognitively healthy adults, the Generation Study 2 exhibits an innovative clinical approach that may offer insight towards Alzheimer's prevention for those at highest risk for developing the disease." The Generation Study 2 started enrolling participants in the United States (U.S.) in August 2017 , and will eventually include more than 180 sites in more than 20 countries around the world. This five-year study will recruit approximately 2,000 cognitively healthy participants, ages 60 to 75, who are at high risk of developing Alzheimer's based on their age and who carry either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene with evidence of elevated brain amyloid. This is different from the Generation Study 1, which only targeted those who carry two copies of the APOE4 gene. APOE4 is the major genetic risk factor for late-onset Alzheimer's disease. Roughly one in four people carry a single copy of the APOE4 gene, but only about two percent of the world's population carry two copies.3 Eligible participants will be randomized to receive placebo or one of two doses of CNP520 (15 mg or 50 mg), co-developed by Amgen and Novartis . "This expanded collaboration builds upon the API Generation Study 1 which launched last year, and is another step in our effort to take clinical trials to a critical new stage," said Pierre N. Tariot , M.D., co-director of API and director of BAI, a division of Banner Health , one of the largest nonprofit healthcare systems in the U.S. "This approach continues to shift the Alzheimer's research paradigm from reversing disease damage to attacking its root cause before symptoms surface. It is our hope that by conducting research targeting the disease at earlier stages, we will have a better chance of delaying or preventing the onset of the disease." Participants will be recruited via multiple venues, including the Alzheimer's Prevention Registry's GeneMatch program (www.endALZnow.org/GeneMatch) in the U.S. GeneMatch is a first-of-its-kind program designed to identify a large group of people interested in volunteering for Alzheimer's prevention research studies, based in part on their APOE genetic information. About the Generation Program The Generation Program consists of two pivotal Phase 2/3 studies. The studies are testing whether investigational anti-amyloid treatments might prevent or delay the emergence of symptoms of Alzheimer's disease in people at particularly high risk for developing the disease at older ages because of their genetic status. The Generation Study 2 is examining whether the BACE1 inhibitor CNP520 can prevent or delay the onset of the symptoms of the disease in individuals who are at high risk of developing Alzheimer's because of their age and because they carry either one or two copies of the APOE4 gene. Those with one copy will require evidence of elevated brain amyloid. About Alzheimer's Prevention Initiative The Alzheimer's Prevention Initiative (API) is an international collaborative research effort formed to launch a new era of Alzheimer's prevention research. Led by the Banner Alzheimer's Institute, the API conducts prevention trials in cognitively healthy people at increased genetic risk for Alzheimer's disease. It will continue to establish the brain imaging, biological and cognitive measurements needed to rapidly test promising prevention therapies and provide registries to support enrollment in future prevention trials. API is intended to provide the scientific means, accelerated approval pathway with the cooperation of the regulatory agencies and enrollment resources needed to evaluate the range of promising Alzheimer's prevention therapies and find ones that work. For more information, go to www.banneralz.org. About Amgen and Novartis Neuroscience Collaboration Since 2015, Amgen and Novartis have collaborated to develop and commercialize pioneering treatments in the field of migraine and Alzheimer's disease. This includes investigational Amgen drugs in the migraine field, including AimovigTM (erenumab) (Biologics License Application accepted by the FDA in July 2017 ) and AMG 301 (currently in Phase 1 development). In April 2017 , the collaboration was expanded to include co-commercialization of Aimovig in the U.S. For the migraine programs, Amgen retains exclusive commercialization rights in the U.S. (other than for Aimovig) and Japan , and Novartis has exclusive commercialization rights in Europe , Canada and rest of world. The companies are also collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in Alzheimer's disease. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
The New England Journal of Medicine Publishes First Phase 3 Study Results of SPINRAZA® for the Treatment of Spinal Muscular Atrophy
AMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE)--Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the end of study results from ENDEAR, the Phase 3 study of SPINRAZA® (nusinersen) for the treatment of spinal muscular atrophy (SMA), were published today in The New England Journal of Medicine. SPINRAZA is the first and only approved treatment for SMA. The full manuscript titled, “Nusinersen Versus Sham Control in Infantile-Onset Spinal Muscular Atrophy,” appears in the November 2 issue of The New England Journal of Medicine .“The publication of the ENDEAR study results in The New England Journal of Medicine underscores the clinical benefit and safety of SPINRAZA and highlights the therapeutic potential of this breakthrough treatment for people living with SMA, a debilitating and often fatal disease,” said Richard Finkel, M.D., chief, division of neurology, department of pediatrics, Nemours Children’s Hospital in Orlando, FL. “As a practicing physician, I have observed the profound impact this treatment can offer to individuals with SMA and their families. I feel privileged to have played a role in SPINRAZA’s development, and to have watched this therapy bring the first real sense of optimism to the SMA community.”The two pre-specified ENDEAR primary endpoints were percentage of motor milestone responders, defined as improvements in motor milestone categories in the Hammersmith Infant Neurological Examination (HINE), and time to death or permanent ventilation. The final analysis demonstrated that a greater proportion of infants treated with SPINRAZA were motor milestone responders, compared to untreated infants (51% vs. 0%, P<0.001), including full head control, ability to roll over, and independent sitting and standing.SPINRAZA also met the pre-specified primary endpoint of death or permanent ventilation in the end of study analysis, demonstrating a statistically significant 47% reduction in the risk of death or use of permanent assisted ventilation (P=0.005) and 76% reduction for those with shorter disease duration.SPINRAZA demonstrated a favorable benefit-risk profile. Safety data was consistent with those expected in the general SMA infant population and were similar to those reported in an open-label study in infantile-onset SMA.“The data published in The New England Journal of Medicine further emphasize the benefit SPINRAZA can provide to individuals with SMA, as the first and only approved SMA treatment in multiple countries. At the end of the ENDEAR study, most infants receiving SPINRAZA showed meaningful benefit, regardless of their age or stage of the disease,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We are incredibly grateful for the support of the scientists, clinical investigators, and the individuals and families who participated in the studies and continue to contribute to the largest clinical development program to date for the treatment of SMA.”“The study results demonstrate that SPINRAZA has the potential to impact the course of the disease for people with SMA,” said C. Frank Bennett, Ph.D., senior vice president of research and leader of the neurological disease franchise at Ionis. “SPINRAZA is the first approved treatment for SMA, and we look forward to the potential of antisense technology to treat patients with other neurological diseases who currently have no therapeutic options.”The SPINRAZA clinical development program includes over five years of data and is the largest body of evidence for an interventional approach in SMA. Following the positive interim analysis, Biogen ended the ENDEAR study early so that all participants could have the option to receive SPINRAZA in the SHINE open-label extension study. In addition to SHINE, Biogen continues to collect and evaluate data to provide a deeper understanding of the efficacy and safety of SPINRAZA across SMA populations.For more information about SPINRAZA and prescribing information in the United States, please visit www.SPINRAZA.com. Prescribing information in the European Union is available at http://www.ema.europa.eu/ema/.About ENDEAR ENDEAR is a randomized, double-blind, sham-procedure controlled 13-month study in individuals with infantile-onset spinal muscular atrophy (SMA). The end of study efficacy analysis included all patients (n=121) who had their final study visit after the interim analysis (n=78) and had the opportunity to attend the six-month study visit assessment. ENDEAR had two primary efficacy endpoints. The first was the proportion of Hammersmith Infant Neurological Examination (HINE) motor milestone responders. The HINE is a reliable and clinically validated tool to assess motor milestone achievement in infants. The second primary efficacy endpoint was event-free survival, defined as the time to death or permanent assisted ventilation (tracheostomy or ≥16 hours of ventilator support per day continuously for >21 days in the absence of an acute reversible event).SPINRAZA Program Status SPINRAZA is the first and only approved medicine for the treatment of SMA and is currently approved in the United States, the European Union, Brazil, Japan, Switzerland, and Canada. Biogen has submitted regulatory filings in additional countries and plans to initiate additional filings in other countries.Globally, starting in 2016, in response to the urgent need for treatment for the most severely affected individuals living with SMA, Biogen sponsored one of the largest, pre-approval Expanded Access Programs (EAP) in rare disease, free of charge.Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis, a leader in antisense therapeutics. Biogen and Ionis conducted an innovative clinical development program that moved SPINRAZA from its first dose in humans in 2011 to its first regulatory approval in five years.About SMA 1-5 SMA is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy and weakness. Ultimately, individuals with the most severe type of SMA can become paralyzed and have difficulty performing the basic functions of life, like breathing and swallowing.Due to a loss of, or defect in, the SMN1 gene, people with SMA do not produce enough survival motor neuron (SMN) protein, which is critical for the maintenance of motor neurons. The severity of SMA correlates with the amount of SMN protein. People with Type 1 SMA, the form that requires the most intensive and supportive care, produce very little SMN protein and do not achieve the ability to sit without support or live beyond two years without respiratory support. People with Type 2 and Type 3 SMA produce greater amounts of SMN protein and have less severe, but still life-altering forms of SMA.About SPINRAZA ® (nusinersen) SPINRAZA is being developed globally for the treatment of SMA.SPINRAZA is an antisense oligonucleotide (ASO), using Ionis’ proprietary antisense technology, that is designed to treat SMA caused by mutations or deletions in the SMN1 gene located in chromosome 5q that leads to SMN protein deficiency. SPINRAZA alters the splicing of SMN2 pre-mRNA in order to increase production of full-length SMN protein.6 ASOs are short synthetic strings of nucleotides designed to selectively bind to target RNA and regulate gene expression. Through use of this technology, SPINRAZA has the potential to increase the amount of full-length SMN protein in individuals with SMA.SPINRAZA must be administered via intrathecal injection, which delivers therapies directly to the cerebrospinal fluid (CSF) around the spinal cord,7 where motor neurons degenerate in individuals with SMA due to insufficient levels of SMN protein.8SPINRAZA demonstrated a favorable benefit-risk profile. The most common adverse reactions reported for SPINRAZA were upper respiratory infection, lower respiratory infection, and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients. Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some ASOs. Individuals may be at increased risk of bleeding complications. Renal toxicity has been observed after administration of some ASOs. SPINRAZA is present in and excreted by the kidney.About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman and Nobel Prize winners Walter Gilbert and Phillip Sharp, today Biogen has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics. We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.About Ionis Pharmaceuticals, Inc. Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases. Using its proprietary antisense technology, Ionis has created a large pipeline of first-in-class or best-in-class drugs, with over three dozen drugs in development.SPINRAZA® (nusinersen) has been approved in global markets for the treatment of spinal muscular atrophy (SMA). Biogen is responsible for commercializing SPINRAZA. Drugs that have successfully completed Phase 3 studies include inotersen, an antisense drug Ionis is developing to treat patients with hereditary TTR amyloidosis (hATTR), and volanesorsen, an antisense drug discovered by Ionis and co-developed by Ionis and Akcea Therapeutics to treat patients with either familial chylomicronemia syndrome or familial partial lipodystrophy. Akcea, an affiliate of Ionis, is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders. If approved, volanesorsen will be commercialized through Ionis’ affiliate, Akcea. Volanesorsen filings for marketing approval have been submitted in the U.S., EU and Canada. Inotersen is progressing toward regulatory filings for marketing authorization. Ionis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Ionis is available at www.ionispharma.com.
Independent Study Shows New Data on Shortened DAPT in STEMI Patients with Medtronic Resolute Integrity Drug-Eluting Stent
DAPT-STEMI Late-Breaker at TCT Reveals Results of Shortened DAPT Duration in Higher-Risk Patients DUBLIN and DENVER - November 1, 2017 - Investigators today unveiled clinical data from the independently run DAPT-STEMI trial, which found no difference in patient outcomes between six-and 12-month dual anti-platelet therapy (DAPT) duration in ST-Elevation Myocardial Infarction (STEMI) patients implanted with the Resolute(TM) Integrity(TM) Drug-Eluting Stent (DES). The results help inform physician decision making around the use of newer-generation DES in high-risk patients who typically receive a longer DAPT regimen after percutaneous coronary intervention (PCI). The DAPT-STEMI trial was presented today during a Late-Breaking Clinical Trial session at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting. The DAPT-STEMI trial evaluated 1,100 STEMI patients who were treated with the Resolute Integrity DES. Event-free patients (N=870) at six months were randomized 1:1 to either stop dual antiplatelet therapy (and receive aspirin only) or continue DAPT (receive aspirin plus a second anti-platelet medicine) to 12-months. The primary non-inferiority endpoint - composite of all-cause mortality, myocardial infarction, revascularization, stroke, or TIMI major bleeding - was met at two years showing no difference between the six-month and 12-month DAPT arms (P=0.004 for non-inferiority). "These data help expand the growing body of clinical evidence that may support physicians in tailoring DAPT regimens for patients," said Dr. Elvin Kedhi, M.D., Ph.D., interventional cardiologist at Isala Hartcentrum in Zwolle, the Netherlands, principal investigator of the trial and presenter of the data at TCT. "We believe the results from DAPT-STEMI, in addition to the future outcomes from the RESOLUTE ONYX ONE study, will help to inform DAPT guidelines for newer-generation DES." STEMI results from the blockage (thrombosis) of a major coronary artery. Consequently, these patients remain at higher risk following PCI due to this high thrombotic risk. Contemporary guidelines suggest STEMI patients receive 12-months of DAPT after PCI. After PCI, approximately 20 percent of patients interrupted or discontinued DAPT early for a variety of reasons within one year as shown in the RESOLUTE Pooled Analysis.1 "Physicians are the ultimate DAPT decision-makers, therefore it's critical that we invest in providing relevant and clinically meaningful evidence around DAPT duration," said Martin Rothman, M.D., vice president, medical affairs for the Coronary and Structural Heart division, which is part of the Cardiac and Vascular Group at Medtronic. "We look forward to continuing this important research with the upcoming enrollment initiation of our ONYX ONE study that will evaluate one-month DAPT with the Resolute Onyx DES in patients at a high bleeding risk." Stents from the Resolute DES family have been implanted in approximately seven million patients around the world, one million of whom have been implanted with the latest generation Resolute Onyx DES. The Resolute Onyx DES received CE (Conformité Européene) Mark in September 2014 and FDA approval in April 2017. The Resolute Integrity and Resolute Onyx stents are not indicated for the treatment of STEMI patients in the United States. However, the Resolute family of stents received CE Mark to treat patients with Acute Coronary Syndrome (ACS), which includes STEMI. In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. About Medtronic Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. - end - 1 Kandzari D. Pharmacodynamic considerations and clinical impact of dual antiplatelet therapy interruption after Resolute zotarolimus-eluting stent implantation. ACC 2014.
Vertex Announces New 0,000 Program to Support the Work of the Next Generation of Cystic Fibrosis Researchers
The Vertex Research Innovation Award (RIA) Program Will Now Provide up to M in Grants Over the Next Five Years to New Postdoctoral and Faculty Researchers from Around the World BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today a new 0,000 program to support the work of young faculty who are newly establishing independent research programs in cystic fibrosis (CF). The program furthers Vertex's commitment to the next generation of CF researchers by expanding the existing CF Research Innovation Awards (RIA) program, which supports the work of postdoctoral researchers. Applicants from across the globe may apply now through January 8, 2018 . Together, these programs will provide up to million in grants over the next five years and are part of Vertex's recently announced 10-year, 0 million corporate giving commitment. The Vertex CF Research Innovation Awards are highly competitive grants created to inspire and support M.D.s and Ph.Ds. who are working to advance the understanding of CF and establish their careers as CF researchers. The awards fall into two categories: Independent and Mentored. Independent Research Innovation Awards provide grants of 0,000 dispersed over three years to support newly independent faculty members as they establish their own research programs with outstanding promise in CF. Up to two awards will be given annually in this category. Mentored Research Innovation Awards provide grants of up to 5,000 dispersed over two years to support mentored projects with established CF researchers. Up to four awards in this category will be given annually. "Vertex invests in science to create transformative medicines for people with serious diseases, and the next generation of scientists are needed to make this vision a reality," said David Altshuler , M.D., Ph.D., Executive Vice President, Global Research and Chief Scientific Officer of Vertex. "Supporting the development of young physician researchers and scientists is critical to continued advancement of our understanding of the disease, and to ensure people living with cystic fibrosis have the best care for the future." Reviewed and selected by an independent steering committee, applications for 2018 are now being accepted until January 8, 2018 . For additional information and to apply please visit www.cfresearchinnovationaward.com. About Cystic Fibrosis Cystic fibrosis is a rare, life-threatening genetic disease affecting approximately 75,000 people in North America, Europe and Australia. CF is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, lead to CF by creating defective or too few CFTR proteins at the cell surface. The defective or missing CFTR protein results in poor flow of salt and water into or out of the cell in a number of organs, including the lungs. This leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median predicted age of survival for a person born today with CF is 41 years, but the median age of death is 27 years. About Vertex Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases. Founded in 1989 in Cambridge, Mass. , Vertex today has research and development sites and commercial offices in the United States , Europe , Canada and Australia . For eight years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com. Vertex in the Community Vertex has made a 10-year, 0 million corporate giving commitment focused on providing patient and caregiver support including access to our medicines; expanding our commitment to science, technology, engineering, arts and math (STEAM) education; developing young physicians and scientists; and investing in our communities. Vertex Is All In for CF The CF community motivates Vertex employees each and every day - to dig deeper, to do more, to explore the "what ifs," and to push the boundaries of what we know. We aim to discover and develop medicines that will treat the underlying cause of CF for the vast majority of people with the disease, and our ultimate goal is to cure it. Beyond our transformational medicines, we help people with CF lead active lives and pursue higher education, and we fund independent research and innovative patient centric programs. To learn more please visit www.vrtxallincf.com. (VRTX-GEN)View source version on businesswire.com: http://www.businesswire.com/news/home/20171101005954/en/ Vertex Pharmaceuticals Incorporated Chris Stamm , 617-341-6992 (US) email@example.com Source: Vertex Pharmaceuticals Incorporated
ASTRAZENECA PROVIDES UPDATE ON TRALOKINUMAB PHASE III PROGRAMME IN SEVERE, UNCONTROLLED ASTHMA
AstraZeneca and its global biologics research and development arm, MedImmune, today announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, in severe, uncontrolled asthma. In STRATOS 2, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate (AAER), the primary endpoint, in patients with severe, uncontrolled asthma and elevated levels of a biomarker, Fractional exhaled Nitric Oxide (FeNO), compared to placebo. In TROPOS, tralokinumab did not achieve a statistically-significant reduction in oral corticosteroid (OCS) use, the primary endpoint, when added to the standard of care, in patients dependent on OCS. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "The results are disappointing as we had hoped that tralokinumab would benefit patients with severe asthma, which is a complex disease with limited treatment options today." FeNO is a well-established biomarker for airway inflammation and was identified in the previous pivotal trial (STRATOS 1) as most likely to predict an enhanced response to tralokinumab. The safety and tolerability findings in STRATOS 2 and TROPOS were consistent with those observed in previous trials with tralokinumab. Full data from STRATOS 1, STRATOS 2 and TROPOS will be presented at a forthcoming medical meeting. About Severe Asthma Asthma affects 315 million individuals worldwide, and up to 10% of asthma patients have severe asthma, which may be uncontrolled despite high doses of standard-of-care asthma controller medicines and can require the use of chronic OCS. Severe, uncontrolled asthma is debilitating and potentially fatal with patients experiencing frequent exacerbations and significant limitations on lung function and quality of life. Severe, uncontrolled asthma can lead to a dependence on OCS, with systemic steroid exposure potentially leading to serious short- and long-term adverse effects, including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, cardiovascular disease and immunosuppression. There is also a significant physical and socio-economic burden of severe, uncontrolled asthma with these patients accounting for 50% of asthma-related costs.
MiMedx Agrees To Lawsuit Settlement With Halo Wound Solutions
PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today that the Company has agreed to a confidential settlement of the lawsuit the Company filed against BioResolutions LLC d/b/a Halo Wound Solutions (Halo) and one of the Halo executives.MiMedx filed its lawsuit against Halo and its executive, Tracy Lucas, in January 2017. In its suit, MiMedx alleged that Lucas used MiMedx trade secrets and other confidential, proprietary business information to unlawfully solicit the sales of Halo's medical products with the assistance of MiMedx employees, and tortiously interfered with MiMedx's contracts with its employees. Mr. Lucas is a former employee of MiMedx. MiMedx alleged that during and after Mr. Lucas' employment with MiMedx, Halo and Mr. Lucas engaged in wrongful conduct with MiMedx employees, knowing they were actively employed by MiMedx and knowing that MiMedx employees have contractual and legal obligations to the Company.In addition to an undisclosed monetary settlement, other settlement terms were reached. Certain of these additional settlement terms include: for a period of two years Halo will not sell amniotic tissue products, human tissue/skin substitute products to MiMedx' existing customers; and for a two-year period, Halo will not solicit MiMedx employees to work for Halo in any fashion or to leave MiMedx's employment. Luke Esslinger, President and CEO of Halo, stated, "I apologize that this situation arose. To our knowledge, MiMedx was not aware that its employees were selling third party products or services, including Halo products. We realize now that MiMedx firmly disapproves of its employees selling our products and that such a situation had the potential to create a conflict with the rightful obligations these employees had with their employer, MiMedx."Parker H. "Pete" Petit, MiMedx Chairman and CEO, said, "We are pleased to have another one of these lawsuits behind us. We have reached an amicable and favorable settlement with Halo. I applaud Halo for dealing with this in a professional manner and treating it as a learning experience for their future business activities.""We have been very effective in continuing our growth trajectory and sustaining our operational excellence, in spite of these corporate distractions. Our constant focus has been on growing our business for the benefit of our customers and their patients, employees and shareholders. I could not be more proud and complementary of our organization for its continued concentration on our business while these distractions are being resolved," added Bill Taylor, MiMedx President and COO.About MiMedx MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.Important Cautionary Statement This press release includes forward-looking statements, including statements regarding potential outcomes of legal actions. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that different or additional facts may be discovered that change conclusions, and the risks of litigation. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
Kirin-Amgen Joint Venture To Become Wholly-Owned Subsidiary Of Amgen
0 Million Payment to be Funded From Joint Venture's Existing Cash Holdings Kyowa Hakko Kirin to Continue as Licensee in Asia THOUSAND OAKS, Calif. , Oct. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Amgen and Kirin Holdings (Kirin) have agreed that Kirin-Amgen, a joint venture between the two companies, will redeem Kirin's shares in the joint venture and, as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen . Kirin-Amgen was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of EPOGEN® (epoetin alfa). Over time, the scope of the collaboration was expanded to include NEUPOGEN® (filgrastim), Neulasta® (pegfilgrastim), Aranesp® (darbepoetin alfa), Nplate® (romiplostim) and brodalumab. Kirin-Amgen holds the intellectual property for each of these products and, in exchange for royalty rights, licensed the associated marketing rights in certain Asian countries to Kyowa Hakko Kirin (KHK), Kirin's pharmaceutical subsidiary, and in other territories to Amgen . "Our historic partnership with Kirin played a pivotal role in the growth of Amgen from a small, venture-backed start-up to one of the world's largest biotechnology companies," said Robert A. Bradway , chairman and chief executive officer at Amgen . "I would like to thank Kirin for more than three decades of partnership, which has enabled us to reach patients suffering from serious illness around the world with meaningful therapies. We look forward to continuing what has been Amgen's longest-running collaboration through our ongoing relationship with KHK." Under the terms of the agreement, the Kirin-Amgen joint venture will pay 0 million to Kirin. Amgen will make additional payments to Kirin upon the occurrence of certain sales (valued by Amgen at approximately million ). As sole shareholder of Kirin-Amgen, Amgen will own the product rights and remaining cash held by Kirin-Amgen. License agreements between Kirin-Amgen and KHK in certain Asian territories will remain in place. The transaction will be effective upon the fulfillment or waiver of certain conditions contained in the agreement, including the receipt of all necessary approvals from governmental authorities. The transaction is expected to close during either the fourth quarter of 2017 or the first quarter of 2018. Goldman Sachs & Co. LLC is acting as exclusive financial advisor to Amgen in connection with this transaction. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen . All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen , including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. CONTACT: Amgen , Thousand Oaks Kristen Davis : 805-447-3008 (media) Kristen Neese : 805-313-8267 (media)