�Study results published show that treatment with Seretide�/Advair� (salmeterol/fluticasone propionate 50/500mcg) lavatory slow the progression of Chronic Obstructive Pulmonary Disease (COPD) by significantly lowering a patient's rate of lung function decline compared with those receiving placebo. [1] This is the first time a treatment has been shown to slow the decline in lung procedure and impact progression of this good lung disease, which accounts for more than than 3 million deaths worldwide each year.[2]
The results showed that treatment privy decrease the excess decline in lung function (deliberate by forced expiratory volume in 1 second [FEV1]) seen in patients with COPD by more than 50%, representing a pregnant slowing of disease progression. Those patients who received salmeterol/fluticasone propionate had a lower rate of pass up in lung function compared to those who received placebo (39mL vs 55mL per year [p
Data from this analysis also showed that salmeterol and fluticasone propionate given individually also significantly rock-bottom the pace of lung function decline, although to a lesser degree than the combination (42mL vs 55 mL per class with placebo; p =0.003).1
Commenting on the results, Professor Bartolome Celli, Pulmonary and Critical Care division, Caritas-St Elizabeth's Medical Centre, Boston, Massachusetts, USA, extremity of the TORCH study steering citizens committee and lead author aforementioned, "These findings further boom the proved benefit that patients surviving with COPD can get from discourse with the combination of salmeterol/fluticasone propionate. COPD has a inadequate prognosis, so actually having a treatment that can slow the progression of the disease for patients is a significant development."
"As leaders in the respiratory field, GSK is excited about these findings. It is beneficial news for patients that treatment with Seretide/Advair has for the first time been shown to help slow the progression of their disease, in addition to improving their lung function and reducing exacerbations," commented Darrell Baker, Senior Vice President, Respiratory Medicines Development Centre, GSK. He continued, "Long-term studies, such as TORCH, offer physicians and researchers valuable insights into the management and mechanisms of COPD. Moving forward, GSK remains attached to conducting research to expand farther our savvy of the management of COPD."
FEV1 is accepted to be an important indicator of COPD progression and the almost accurate clinical measure of lung function. To-date smoking cessation has been the only intervention that has been once and for all shown to alter the rate of decline in FEV1.
The original findings from TORCH demonstrated that treatment with salmeterol/fluticasone propionate resulted in a trend towards a reduction in all-cause deathrate, although the mortality benefit did not reach statistical significance. In addition, the study confirmed that handling with salmeterol/fluticasone propionate provides improvements in lung function over trey years and reduces the rate of exacerbations, even when there is no previous exacerbation history in COPD patients. [3] TORCH continues to generate important findings and data regarding the efficient management of COPD.
About Seretide (Europe only)
Seretide was sanctioned in the European Union in 2003 for the symptomatic treatment of severe COPD; i.e. for patients with a FEV1
About Advair in COPD (US only)
Advair Diskus 250/50 is indicated for the maintenance treatment of air flow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Advair Diskus 250/50 is also indicated to shorten exacerbations in patients with a history of exacerbations. Advair Diskus 250/50 is the exclusively approved strength for COPD in the U.S., because an efficacy advantage of the higher strength Advair Diskus 500/50 over Advair Diskus 250/50 has not been demonstrated.
About Seretide in COPD (Korea only)
Seretide Diskus 250/50 is indicated for the maintenance treatment of airflow blockage in patients with COPD, including chronic bronchitis and/or emphysema in Korea. Seretide Diskus 250/50 is the only sanctioned strength for COPD in the Korea.
About COPD
COPD is a preventable and treatable disease state commonly caused by smoking, it is characterised by airflow limitation that is not fully reversible. [5] Itis a worldwide killer, beingness responsible for the deaths of over 3 trillion people a year2 - more than lung crab and breast cancer combined. [6],[7] It is now becoming clear that inflammation is at the core of the disease, [8] driving disease progress and existence present at all stages, [9] simply COPD is also a multi-component disease involving airline structural changes, mucociliary dysfunction and respiratory tract inflammation, all leading to airflow limit, together with an important systemic component. [10],[11],[12] Clinically, the components of COPD contribute to progressive changes in lung function, symptoms and exacerbations (defined as a deterioration in symptoms), which affect patients' health status and ultimately survival. [13]
About TORCH
The TORCH study was the first-class honours degree, multicentre, randomised, double-blind, parallel-group, placebo-controlled sketch to prospectively compare the effects of salmeterol alone, fluticasone propionate alone, a fixed-dose combination of salmeterol and fluticasone propionate, and placebo on mortality in patients with moderate to severe copd. Primary publication of results from the TORCH study were published in the New England Journal of Medicine in February 2007 and represented a landmark, as the study provided important elucidation concerning the role of pharmacotherapy in the clinical management of COPD.3
GlaxoSmithKline one of the world's leading research-based pharmaceutical and healthcare companies is committed to up the quality of human life by enabling citizenry to do more, feel better and live yearner. For further information please visit http://www.gsk.com
References
The rate of decline in lung mapping in healthy patients has been estimated at ~30mL/year (James AL, Palmer LJ, Kicic E, et al. 2005. Lange P, Parner J, Vestbo J. 1998)). Treatment with salmeterol/fluticasone propionate reduced the difference between the decline seen in COPD patients compared to those on placebo by more than half
[1] Celli BR, et al. Effect of Pharmacotherapy on Rate of Decline of Lung Function in COPD: Results from the TORCH Study. Am. J. Respir. Crit. Care Med. 2008:200712-1869OC.
[2] WHO. Chronic Obstructive Pulmonary Disease (COPD): Fact Sheet No. 315. In: WHO, editor. COPD, 2008.
[3] Calverley PMA, et al. Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease. N Engl J Med 2007;356(8):775-789.
[4] Final Variation Assessment Report Seretide Diskus/Viani Diskus Seretide Evohaler/Viani Evohaler (fluticasone proprionate/salmeterol xinafoate).
[5] Celli BR, et al. Standards for the diagnosis and handling of patients with COPD: a compendious of the ATS/ERS military position paper. Eur Respir J 2004;23(6):932-946.
[6] WHO. The World Health Report 2002. Reducing risks, promoting healthy life. Geneva: World Health Organization, 2002.
[7] Ferlay J. Cancer Incidence, mortality and prevalence world. IARC CancerBase No.5. Lyon: IARC Press, 2004.
[8] Halpin DM, Miravitlles M. Chronic obstructive pulmonary disease: the disease and its burden to society. RPLC227% Am Thorac Soc 2006;3(7):619-23.
[9] Hogg JC, et al. The nature of small-airway obstruction in chronic obstructive pulmonary disease. N Engl J Med 2004;350(26):2645-53.
[10] Agusti AG, et al. Systemic effects of continuing obstructive pulmonary disease. Eur Respir J 2003;21(2):347-60.
[11] Agusti AG. COPD, a multicomponent disease: implications for management. Respir Med 2005;99(6):670-82
[12] Wouters EF, et al. Systemic effects in COPD. Chest 2002;121(5 Suppl):127S-130S.
[13] Global Strategy for the diagnosis, Management and prevention of COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2007.
Cautionary statement regarding advanced statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that whatsoever forward-looking statements or projections made by GSK, including those made in this announcement, ar subject to risks and uncertainties that may case actual results to differ materially from those jutting. Factors that may move GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.
More info
Friday 22 August 2008
Tuesday 12 August 2008
Key Clinical Studies Of Regeneron's ARCALYST (rilonacept) For Treatment Of CAPS Published
� Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced the publication of the results of trey studies which supported the U.S. Food and Drug Administration (FDA) regulatory meekness for ARCALYST� (rilonacept) Injection for Subcutaneous Use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).
Two studies were published in the August 2008 outcome of Arthritis and Rheumatism, the flagship publication of the American College of Rheumatology. The first study was the preliminary trial to measure the shock of ARCALYST on markers of excitement, clinical response, and safety and the second was the pivotal efficacy and safety clinical trial of ARCALYST. A third sketch, conducted to develop and validate a key symptoms assessment scale for CAPS patients and subsequently utilised as the primary endpoint measure in the polar clinical subject of ARCALYST, was published online in the August 2008 issue of Current Medical Research and Opinion.
ARCALYST, besides known as interleukin-1 (IL-1) Trap, is a targeted inhibitor of IL-1, which is the key driver of inflaming in CAPS. ARCALYST is the merely therapy sanctioned for patients with CAPS, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. CAPS represent a group of rare, inherited, auto-inflammatory weather condition characterized by life-long, repeated symptoms of rash, fever/chills, joint hurting, eye redness/pain, and fatigue. Intermittent, tumultuous exacerbations or flares lav be triggered at whatsoever time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. The relative incidence of CAPS has been reported to be around one in 1,000,000 citizenry in the United States.
"The ultimate goal of our exploit over the last ten years has been to find an effective therapy for Cryopyrin-Associated Periodic Syndromes. We began by characterizing the unusual clinical features and debilitating impact of CAPS and then discovered the inherent genetic fundament of the disease. A major concern was whether a pharmaceutic company would expend the significant resources necessary to develop a treatment for a disease that has been diagnosed in only a few hundred patients in the United States," stated Hal Hoffman, M.D., Associate Professor, University of California, San Diego and a preeminent expert on CAPS. "These publications highlight that scientists, clinicians, and industry tin collaborate to efficiently, still rigorously, develop therapies for rare diseases with meaning unmet medical need. As a consequence of this collaboration, patients with CAPS now receive an approved treatment available that backside help them to effectively manage their disease."
In the initial, open-label airplane pilot evaluation of ARCALYST� (rilonacept), five patients with the Familial Cold Auto-inflammatory Syndrome (FCAS) sub-type of CAPS experienced a marked improvement in symptoms with a corresponding simplification in markers of inflaming. Based upon these convincing findings, a pivotal clinical program was designed to support a registration filing. In ordering to develop a ground for mensuration symptom rigorousness as reported by CAPS patients in a disease that waxes and wanes from twenty-four hours to day, an observational, non-pharmacologic cogitation was conducted in 48 patients with either FCAS or Muckle-Wells Syndrome (MWS). Systematic evaluation of a series of patient-reported outcomes tools resulted in the development of a validated CAPS symptoms measurement official document with high internal consistence and dependability.
In the pivotal, randomized, double-blind clinical study, 47 patients with FCAS or MWS were randomized to receive either ARCALYST or placebo for six weeks. Patients treated with ARCALYST experienced an 84 percentage statistically significant improvement in overall symptom scores versus baseline, whereas those treated with placebo did non experience a significant improvement in their symptoms (13 percent improvement). Ninety-six percent of patients receiving ARCALYST experienced at least a 30 percentage improvement in symptoms during this six-week phase of the study. All patients were later given single-blind ARCALYST for nine weeks. Patients were then re-randomized to either ARCALYST or placebo and evaluated over a subsequent nine-week period. Patients odd on ARCALYST continued to experience symptom control, whereas those receiving placebo experient a statistically significant worsening of their CAPS symptoms. The nigh commonly reported adverse reactions reported with ARCALYST were injection-site reaction and upper berth respiratory parcel infection.
"The development serve for ARCALYST for the treatment of CAPS highlights Regeneron's boilersuit approach to drug maturation - to develop drugs targeted at well-documented mediators of disease, focus clinical development on diseases in which those biologic mediators play a primary implicit in role, set up clinical proof of concept, and then strive to conduct efficient, pivotal studies with well-validated clinical endpoints," stated George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "In this type, recognizing that IL-1 is an active mediator of inflammatory disease, we developed ARCALYST to potently inhibit IL-1 in the bloodstream before it can bond to its receptors. Once it was recognized that the genetical mutation associated with CAPS is associated with IL-1 overproduction, we rapidly initiated a pilot study to determine the clinical impact of IL-1 inhibition with ARCALYST. Based upon the clear-cut responses experienced by the CAPS patients in the pilot study, we then developed a validated instrument to assess the severity of CAPS symptoms over metre and introduced that cat's-paw into deuce randomized, placebo-controlled pivotal study phases."
About Cryopyrin-Associated Periodic Syndromes (CAPS)
Recently, aesculapian researchers have identified and described a group of rare, hereditary, auto-inflammatory disorders, known as Cryopyrin-Associated Periodic Syndromes or CAPS. Three related conditions make up the broader disease known as CAPS: Familial Cold Auto-inflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal-Onset Multisystem Inflammatory Disease (NOMID). ARCALYST has not been studied in patients with NOMID.
CAPS are characterized by womb-to-tomb, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by photo to chilling temperatures, tenseness, exercise, or other unknown stimuli.
CAPS are generally caused by autosomal-dominant mutations (changes) in the NLRP-3 (previously known as CIAS1) gene and resultant alterations in the protein, cryopyrin, which it encodes. Cryopyrin, active in circulating infection-fighting white descent cells, controls the production of a protein called interleukin-1 (IL-1). As part of the body's infection-fighting defense system, IL-1 circulates throughout the body and can trigger inflammatory reactions when it binds to inflammatory cells. Researchers have found that alterations in the cryopyrin protein pencil lead to overrun of IL-1, resulting in an inflammatory response and the symptoms of CAPS. Most, just not all, patients with CAPS have the NLRP-3 gene sport.
Important Information About ARCALYST� (rilonacept)
ARCALYST is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. IL-1 blockade may interfere with immune response to infections. Serious, dangerous infections give been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient ps a serious infection. Taking ARCALYST with tumor necrosis factor inhibitors is not recommended because this may addition the peril of grave infections. Treatment with ARCALYST should non be initiated in patients with active or chronic infections. Patients should non receive a live vaccinum while pickings ARCALYST. It is recommended that patients receive all recommended vaccinations prior to initiation of treatment with ARCALYST. Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted. Hypersensitivity reactions associated with ARCALYST organization have been rare. Please see the full Prescribing Information for ARCALYST, available online at http://www.regeneron.com/ARCALYST-fpi.pdf.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully unified biopharmaceutical society that discovers, develops, and commercializes medicines for the treatment of serious aesculapian conditions. In addition to ARCALYST� (rilonacept) Injection for Subcutaneous Use, its first-class honours degree commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. Additional information around Regeneron and recent newsworthiness releases are available on Regeneron's web site at http://www.regeneron.com.
Forward Looking Statement
This news program release discusses historical information and includes forward-looking statements about Regeneron and its products, exploitation programs, monetary resource, and clientele, all of which affect a number of risks and uncertainties, such as risks associated with preclinical and clinical development of Regeneron's drug candidates, determinations by regulative and administrative governmental government which may delay or restrict Regeneron's ability to continue to develop or commercialize its product and drug candidates, competing drugs that ar superior to Regeneron's ware and dose candidates, precariousness of market acceptance of Regeneron's product and drug candidates, unlooked-for expenses, the availability and cost of capital, the costs of developing, producing, and marketing products, the potential for any collaborationism agreement, including Regeneron's agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. A more than complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2007 and Form 10-Q for the quarter ending June 30, 2008. Regeneron does not guarantee any obligation to update publicly whatsoever forward-looking statement, whether as a event of new information, future events, or otherwise unless required by law.
Biosector 2
More info
Two studies were published in the August 2008 outcome of Arthritis and Rheumatism, the flagship publication of the American College of Rheumatology. The first study was the preliminary trial to measure the shock of ARCALYST on markers of excitement, clinical response, and safety and the second was the pivotal efficacy and safety clinical trial of ARCALYST. A third sketch, conducted to develop and validate a key symptoms assessment scale for CAPS patients and subsequently utilised as the primary endpoint measure in the polar clinical subject of ARCALYST, was published online in the August 2008 issue of Current Medical Research and Opinion.
ARCALYST, besides known as interleukin-1 (IL-1) Trap, is a targeted inhibitor of IL-1, which is the key driver of inflaming in CAPS. ARCALYST is the merely therapy sanctioned for patients with CAPS, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. CAPS represent a group of rare, inherited, auto-inflammatory weather condition characterized by life-long, repeated symptoms of rash, fever/chills, joint hurting, eye redness/pain, and fatigue. Intermittent, tumultuous exacerbations or flares lav be triggered at whatsoever time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. The relative incidence of CAPS has been reported to be around one in 1,000,000 citizenry in the United States.
"The ultimate goal of our exploit over the last ten years has been to find an effective therapy for Cryopyrin-Associated Periodic Syndromes. We began by characterizing the unusual clinical features and debilitating impact of CAPS and then discovered the inherent genetic fundament of the disease. A major concern was whether a pharmaceutic company would expend the significant resources necessary to develop a treatment for a disease that has been diagnosed in only a few hundred patients in the United States," stated Hal Hoffman, M.D., Associate Professor, University of California, San Diego and a preeminent expert on CAPS. "These publications highlight that scientists, clinicians, and industry tin collaborate to efficiently, still rigorously, develop therapies for rare diseases with meaning unmet medical need. As a consequence of this collaboration, patients with CAPS now receive an approved treatment available that backside help them to effectively manage their disease."
In the initial, open-label airplane pilot evaluation of ARCALYST� (rilonacept), five patients with the Familial Cold Auto-inflammatory Syndrome (FCAS) sub-type of CAPS experienced a marked improvement in symptoms with a corresponding simplification in markers of inflaming. Based upon these convincing findings, a pivotal clinical program was designed to support a registration filing. In ordering to develop a ground for mensuration symptom rigorousness as reported by CAPS patients in a disease that waxes and wanes from twenty-four hours to day, an observational, non-pharmacologic cogitation was conducted in 48 patients with either FCAS or Muckle-Wells Syndrome (MWS). Systematic evaluation of a series of patient-reported outcomes tools resulted in the development of a validated CAPS symptoms measurement official document with high internal consistence and dependability.
In the pivotal, randomized, double-blind clinical study, 47 patients with FCAS or MWS were randomized to receive either ARCALYST or placebo for six weeks. Patients treated with ARCALYST experienced an 84 percentage statistically significant improvement in overall symptom scores versus baseline, whereas those treated with placebo did non experience a significant improvement in their symptoms (13 percent improvement). Ninety-six percent of patients receiving ARCALYST experienced at least a 30 percentage improvement in symptoms during this six-week phase of the study. All patients were later given single-blind ARCALYST for nine weeks. Patients were then re-randomized to either ARCALYST or placebo and evaluated over a subsequent nine-week period. Patients odd on ARCALYST continued to experience symptom control, whereas those receiving placebo experient a statistically significant worsening of their CAPS symptoms. The nigh commonly reported adverse reactions reported with ARCALYST were injection-site reaction and upper berth respiratory parcel infection.
"The development serve for ARCALYST for the treatment of CAPS highlights Regeneron's boilersuit approach to drug maturation - to develop drugs targeted at well-documented mediators of disease, focus clinical development on diseases in which those biologic mediators play a primary implicit in role, set up clinical proof of concept, and then strive to conduct efficient, pivotal studies with well-validated clinical endpoints," stated George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "In this type, recognizing that IL-1 is an active mediator of inflammatory disease, we developed ARCALYST to potently inhibit IL-1 in the bloodstream before it can bond to its receptors. Once it was recognized that the genetical mutation associated with CAPS is associated with IL-1 overproduction, we rapidly initiated a pilot study to determine the clinical impact of IL-1 inhibition with ARCALYST. Based upon the clear-cut responses experienced by the CAPS patients in the pilot study, we then developed a validated instrument to assess the severity of CAPS symptoms over metre and introduced that cat's-paw into deuce randomized, placebo-controlled pivotal study phases."
About Cryopyrin-Associated Periodic Syndromes (CAPS)
Recently, aesculapian researchers have identified and described a group of rare, hereditary, auto-inflammatory disorders, known as Cryopyrin-Associated Periodic Syndromes or CAPS. Three related conditions make up the broader disease known as CAPS: Familial Cold Auto-inflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal-Onset Multisystem Inflammatory Disease (NOMID). ARCALYST has not been studied in patients with NOMID.
CAPS are characterized by womb-to-tomb, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by photo to chilling temperatures, tenseness, exercise, or other unknown stimuli.
CAPS are generally caused by autosomal-dominant mutations (changes) in the NLRP-3 (previously known as CIAS1) gene and resultant alterations in the protein, cryopyrin, which it encodes. Cryopyrin, active in circulating infection-fighting white descent cells, controls the production of a protein called interleukin-1 (IL-1). As part of the body's infection-fighting defense system, IL-1 circulates throughout the body and can trigger inflammatory reactions when it binds to inflammatory cells. Researchers have found that alterations in the cryopyrin protein pencil lead to overrun of IL-1, resulting in an inflammatory response and the symptoms of CAPS. Most, just not all, patients with CAPS have the NLRP-3 gene sport.
Important Information About ARCALYST� (rilonacept)
ARCALYST is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. IL-1 blockade may interfere with immune response to infections. Serious, dangerous infections give been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient ps a serious infection. Taking ARCALYST with tumor necrosis factor inhibitors is not recommended because this may addition the peril of grave infections. Treatment with ARCALYST should non be initiated in patients with active or chronic infections. Patients should non receive a live vaccinum while pickings ARCALYST. It is recommended that patients receive all recommended vaccinations prior to initiation of treatment with ARCALYST. Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted. Hypersensitivity reactions associated with ARCALYST organization have been rare. Please see the full Prescribing Information for ARCALYST, available online at http://www.regeneron.com/ARCALYST-fpi.pdf.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully unified biopharmaceutical society that discovers, develops, and commercializes medicines for the treatment of serious aesculapian conditions. In addition to ARCALYST� (rilonacept) Injection for Subcutaneous Use, its first-class honours degree commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. Additional information around Regeneron and recent newsworthiness releases are available on Regeneron's web site at http://www.regeneron.com.
Forward Looking Statement
This news program release discusses historical information and includes forward-looking statements about Regeneron and its products, exploitation programs, monetary resource, and clientele, all of which affect a number of risks and uncertainties, such as risks associated with preclinical and clinical development of Regeneron's drug candidates, determinations by regulative and administrative governmental government which may delay or restrict Regeneron's ability to continue to develop or commercialize its product and drug candidates, competing drugs that ar superior to Regeneron's ware and dose candidates, precariousness of market acceptance of Regeneron's product and drug candidates, unlooked-for expenses, the availability and cost of capital, the costs of developing, producing, and marketing products, the potential for any collaborationism agreement, including Regeneron's agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. A more than complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2007 and Form 10-Q for the quarter ending June 30, 2008. Regeneron does not guarantee any obligation to update publicly whatsoever forward-looking statement, whether as a event of new information, future events, or otherwise unless required by law.
Biosector 2
More info
Wednesday 6 August 2008
Kanye West, Nine Inch Nails � But Not Barack Obama � Close Out Lollapalooza 2008
CHICAGO � In the end, there was no Barack Obama. Only Kanye West. And Trent Reznor. No one really seemed to mind this.
Lollapalooza 2008 wrapped up Sunday night not with an appearance by the junior senator from the great state of Illinois (as had been rumored all weekend), but rather, with a much-hyped encounter between homecoming king Kanye and Reznor's rejuvenated Nine Inch Nails, both of whom came equipped with big-budget stage shows, stentorian soundscapes and more than a few blinding lights.
But that's where the similarities ended. Just about any way you slice it, West and NIN ar about as diametrically opposed as, articulate, Obama and John McCain, and that held true in Grant Park. West's set was a reflection of the man himself � bombastic and cocky one moment (lots of crowd-pleasing, cell-phone-in-the-air moments and big, magnanimous, large production), disarmingly earnest and emotional the following (he dedicated the set to his late mother, Donda, and made several mentions of her passim). Reznor and company chose the opposite approach, bringing out both the power tools and the ProTools, delivering a performance that veered wildly between bludgeoning guitars and jazzy bleep-bloop, and basically scrambling everything you thought process you knew about the dark prince of industrial rock.
So wHO won? Depends on whom you ask. While we're at it, what about the 40-or-so other acts of the Apostles on the bill? (Don't worry, we'll get to them in due time.)
West's fans would probably tell you it was the Louis Vuitton Don in a landslide; after all, he packed the most everything into his 90 minutes. The show was a somewhat stripped-down version of his current Glow in the Dark Tour, and piece there were no holograms or lunar landscapes on hand, thither were inactive a whole lot of seizure-inducing strobes, moody lighting and wheeling fog, not to citation a space age backing band, complete with robo-suited guitar players and 23rd century female singers in foot-high shoulder pads.
(See all of our photos from Lollapalooza 2008 right here.)
Taking the stage attended by a wall of pulsing synths and chimes, and bathed in an eerie white light, West started things off with a languorous take on "Good Morning," waving to the tens of thousands staring up at him (tens of thousands of hands waved back). At song's eats (and packed a huge crowd) while flanked by iI (fake) leaf-blower-wielding cops, world Health Organization pelted ecstatic partiers with confetti, glitter, silly string, toilet newspaper publisher and, at the end of the set, inexplicably, a full-sized river raft.
Chromeo and the Black Kids performed at adjoining stages and had pretty much everyone throwing their workforce in the air with reckless abandon. Saul Williams did his usual death-disco thing. The National were somber, reedy and solid as invariably. Mark Ronson threw everything but the proverbial kitchen sink into his evening set (including one of the dudes from Phantom Planet). And Lolla faves Gnarls Barkley � sans matching costumes this time around � slinked their way through a soulful, simmering mark, highlighted by Cee-Lo's keening take on Radiohead's "Reckoner."
And when you've got all that � plus so, so much more we didn't tied get to mention � who of necessity the presumptive Democratic presidential nominee? Kanye, Trent and Obama in a tripartite battle for fest-closing brag rights? That probably would've been overkill.
More info
Rogier Van Gaal
Artist: Rogier Van Gaal
Genre(s):
New Age
Discography:
Collection 1998-2002
Year: 2002
Tracks: 15
Behind the Big Voice: David Archuleta
'Twilight' Masterminds Catherine Hardwicke, Stephenie Meyer Take In Wild Comic-Con, Talk Movie's Music
SAN DIEGO — Many years ago, Leonard Cohen sang around "The Sisters of Mercy," who were "waiting for me, when I thought that I just can't go on."
On Thursday, that persona was taken on by author Stephenie Meyer and manager Catherine Hardwicke, who arrived at Comic-Con as deputy mothers for the whitney Moore Young Jr. stars of Hollywood's hottest new franchise. Thousands of die-hard fans screamed their names, and stars Robert Pattinson and Taylor Lautner expressed nervousness backstage around the largest public appearance of their young careers. But the Sisters of Mercy gave them pointers, shepherded them up the steps and aided them when they thought they just couldn't go on.
Moments after the madness, MTV News caught up with the Sisters as they walked around arm in arm, wearing matching pins that scan "Comic-Con Virgins." True friends brought together for the cause of the Cullens, they rundle to us about the shape-shifting "Bella's Lullaby," sloughing tears over Pattinson, and their shared out secret: They were both nervous as hell backstage too.
MTV: Guys, I take to tell you: I've been coming to Comic-Con for septet straight age now. I've seen Hall H panels with huge stars for huge movies. But I've never seen anything like all that craziness.
Catherine Hardwicke: That is really cool to hear!
Stephenie Meyer: You can construe our pins: We're both Comic-Con virgins, so we have no idea.
MTV: How did it feel to walk out onstage in front of 6,D screaming Twilighters?
Meyer: I was terrified. We were backstage when we heard all the screaming, and then walking up those stairs [onto the stage] was scary.
Hardwicke: And then you see all those cool lightbulbs flashing at you! I thought it was a cool light bear witness. I was like, "Yeah!"
MTV: Of course, we have to ask you close to Robert. His appearance was like sightedness Elvis participate the edifice. How do you finger about all the tending he's getting?
Meyer: The
What Is A Year Of Human Life Worth? Updating The Renal Dialysis Cost-Effectiveness Standard
� A quality-adjusted year of human life is worth $129,090, according to a study to appear in Value in Health.
Chris Lee of The Wharton School of the University of Pennsylvania and Glenn Chertow and Stefanos Zenios of Stanford University sought to find the worth of a year of human life, a figure which can be used to inform decisions such as the determination of compensation when life is lost to accidents or mishaps, the pricing and coverage of medical procedures and the pursuit of expensive but life-saving public programs.
Within the medical establishment, the cost-effectiveness of ratio of renal dialysis has been widely used as a proxy for the worth of a year of human life ever since Medicare made a landmark decision in the 1970s to cover dialysis for anyone who needed it regardless of age, a move marking a unique instance of universal health care in the United States. The figure of $50,000-100,000, however, is based on a small study in the 1980s and is not reflective of the practice patterns and technology of dialysis in use today, and this study updates to that figure to $129,090 by using a simulation model and data from more than one million patients in the United States.
Renal dialysis is the main form of treatment for more than half a million patients suffering from end-stage renal disease in the United States. End-stage renal disease is one of the most significant sources of expenditures for Medicare and is currently accounting for more than $30 billion of Medicare's yearly spending.
Professor Lee of The Wharton School comments "The figure of $129,090 is obviously a population average, but the range is extremely wide because of idiosyncratic differences among patients. In using any threshold to determine coverage, some patients will inevitably be excluded. This prompted us to develop a percentile approach to setting the threshold. The use of percentiles focuses on the fraction of patients covered rather than the last one or two cases that are too cost-ineffective to cover."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Value in Health Volume 12 Issue 1 - January/February 2009
ABSTRACT
http://www.ispor.org
More info
Chris Lee of The Wharton School of the University of Pennsylvania and Glenn Chertow and Stefanos Zenios of Stanford University sought to find the worth of a year of human life, a figure which can be used to inform decisions such as the determination of compensation when life is lost to accidents or mishaps, the pricing and coverage of medical procedures and the pursuit of expensive but life-saving public programs.
Within the medical establishment, the cost-effectiveness of ratio of renal dialysis has been widely used as a proxy for the worth of a year of human life ever since Medicare made a landmark decision in the 1970s to cover dialysis for anyone who needed it regardless of age, a move marking a unique instance of universal health care in the United States. The figure of $50,000-100,000, however, is based on a small study in the 1980s and is not reflective of the practice patterns and technology of dialysis in use today, and this study updates to that figure to $129,090 by using a simulation model and data from more than one million patients in the United States.
Renal dialysis is the main form of treatment for more than half a million patients suffering from end-stage renal disease in the United States. End-stage renal disease is one of the most significant sources of expenditures for Medicare and is currently accounting for more than $30 billion of Medicare's yearly spending.
Professor Lee of The Wharton School comments "The figure of $129,090 is obviously a population average, but the range is extremely wide because of idiosyncratic differences among patients. In using any threshold to determine coverage, some patients will inevitably be excluded. This prompted us to develop a percentile approach to setting the threshold. The use of percentiles focuses on the fraction of patients covered rather than the last one or two cases that are too cost-ineffective to cover."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Value in Health Volume 12 Issue 1 - January/February 2009
ABSTRACT
http://www.ispor.org
More info
Subscribe to:
Posts (Atom)