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Pharma Cold Chain Distribution: Big Pharma, MHRA and Leading Logistics Companies to Meet in London This December at SMi's Cold Chain Distribution SMi Group reports: World Courier, Finnair, MHRA, IATA, Teva, GSK, J&J, Sanofi will meet in London this December at Cold Chain Distribution 2016. London, United Kingdom, November 30, 2016 --( Just a fortnight remains until the SMi Group opens their doors to host the 11th annual conference on Cold Chain Distribution. This year’s event will bring over 120 attendees from all over the world including senior representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments. Further information available at www.coldchain-distribution.com/PrCom. Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more. The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PrCom. "The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair Confirmed attendees include key decision makers from Accord Healthcare, Actelion Pharmaceuticals UK, Al Medicines, Alliance Healthcare, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Brussels Airport Company, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Eli Lilly Italia SpA, Envirotainer, Exelsius, Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Novartis Business Services, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more. “We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” - David Spillett, Key Account Director, World Courier Further information available at www.coldchain-distribution.com/PrCom. Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier. Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, NEFTAG, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport. 11th Annual Cold Chain Distribution Conference and Exhibition Park Plaza Victoria, London, UK 12th-13th December, 2016 www.coldchain-distribution.com/PrCom Sponsors/Exhibitors: Contact Alia Malick on amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum on fbegum@smi-online.co.uk Media Enquiries: Contact Julia Rotar on jrotar@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk. London, United Kingdom, November 30, 2016 --( PR.com )-- Over the last 24 months, the new logistics hubs have been established around the globe by forwarders and distributors, in order to service and support a more round-the-clock global network for pharmaceutical product supply. Nonetheless, challenges remain with the increasingly fragile biologics product and tightened GDP regulations.Just a fortnight remains until the SMi Group opens their doors to host the 11th annual conference on Cold Chain Distribution. This year’s event will bring over 120 attendees from all over the world including senior representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments.Further information available at www.coldchain-distribution.com/PrCom.Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more.The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PrCom."The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, FinnairConfirmed attendees include key decision makers from Accord Healthcare, Actelion Pharmaceuticals UK, Al Medicines, Alliance Healthcare, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Brussels Airport Company, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Eli Lilly Italia SpA, Envirotainer, Exelsius, Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Novartis Business Services, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more.“We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” - David Spillett, Key Account Director, World CourierFurther information available at www.coldchain-distribution.com/PrCom.Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier.Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, NEFTAG, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport.11th Annual Cold Chain Distribution Conference and ExhibitionPark Plaza Victoria, London, UK12th-13th December, 2016www.coldchain-distribution.com/PrComSponsors/Exhibitors: Contact Alia Malick on amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum on fbegum@smi-online.co.ukMedia Enquiries: Contact Julia Rotar on jrotar@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk. Click here to view the list of recent Press Releases from SMi Group


SMi Group reports: World Courier, Finnair, MHRA, IATA, Teva, GSK, J&J, Sanofi will meet in London this December at Cold Chain Distribution 2016 London, United Kingdom, November 17, 2016 --( 11th annual Cold Chain Distribution, taking place in London, UK, on the 12th and 13th of December, brings together 100+ representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments! Further information available at www.coldchain-distribution.com/PRCom Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more. The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PRCom “The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair. Confirmed attendees include key decision makers from Accord Healthcare, Al Medicines, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Envirotainer, Exelsius , Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more! “We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” -David Spillett, Key Account Director, World Courier. Further information available at www.coldchain-distribution.com/PRCom Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier. Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport. 11th Annual Cold Chain Distribution Conference and Exhibition Park Plaza Victoria, London, UK 12th-13th December, 2016 www.coldchain-distribution.com/PRCom Sponsors/Exhibitors: Contact Alia Malick at +44 (0) 7827 6168, amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum at +44 (0) 20 7827 6184, fbegum@smi-online.co.uk Media Enquiries: Contact Julia Rotar at jrotar@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, November 17, 2016 --( PR.com )-- Over the last 24 months, new logistics hubs have been established around the globe by forwarders and distributors, in order to service and support a more round-the-clock global network for pharmaceutical product supply. Nonetheless, challenges remain with the increasingly fragile biologics product and tightened GDP regulations.11th annual Cold Chain Distribution, taking place in London, UK, on the 12th and 13th of December, brings together 100+ representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments!Further information available at www.coldchain-distribution.com/PRComCold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more.The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PRCom“The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair.Confirmed attendees include key decision makers from Accord Healthcare, Al Medicines, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Envirotainer, Exelsius , Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more!“We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” -David Spillett, Key Account Director, World Courier.Further information available at www.coldchain-distribution.com/PRComCold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier.Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport.11th Annual Cold Chain Distribution Conference and ExhibitionPark Plaza Victoria, London, UK12th-13th December, 2016www.coldchain-distribution.com/PRComSponsors/Exhibitors: Contact Alia Malick at +44 (0) 7827 6168, amalick@smi-online.co.ukDelegates/Groups: Contact Fateja Begum at +44 (0) 20 7827 6184, fbegum@smi-online.co.ukMedia Enquiries: Contact Julia Rotar at jrotar@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


Chapman R.W.,John Radcliffe Hospital | Stanghellini V.,S. Orsola Malpighi University Hospital | Geraint M.,Norgine Ltd | Halphen M.,Norgine Ltd
American Journal of Gastroenterology | Year: 2013

OBJECTIVES:Polyethylene glycol (PEG) 3350 plus electrolytes (PEG 3350+E) is an established treatment for constipation and has been proposed as a treatment option for constipation associated with irritable bowel syndrome (IBS-C). This study aimed to compare the efficacy and safety of PEG 3350+E vs. placebo in adult patients with IBS-C.METHODS:Following a 14-day run-in period without study medication, patients with confirmed IBS-C were randomized to receive PEG 3350+E (N=68) or placebo (N=71) for 28 days. The primary endpoint was the mean number of spontaneous bowel movements (SBMs) per day in the last treatment week.RESULTS:In both groups, mean weekly number of SBMs (±s.d.) increased from run-in. The difference between the groups in week 4 (PEG 3350+E, 4.40±2.581; placebo, 3.11±1.937) was statistically significant (95% confidence interval: 1.17, 1.95; P<0.0001). Although mean severity score for abdominal discomfort/pain was significantly reduced compared with run-in with PEG 3350+E, there was no difference vs. placebo. Spontaneous complete bowel movements, responder rates, stool consistency, and severity of straining also showed superior improvement in the PEG 3350+E group over placebo in week 4. The most common drug related treatment-emergent adverse events were abdominal pain (PEG 3350+E, 4.5%; placebo, 0%) and diarrhoea (PEG 3350+E, 4.5%; placebo, 4.3%).CONCLUSIONS:In IBS-C, PEG 3350+E was superior to placebo for relief of constipation, and although a statistically significant improvement in abdominal discomfort/pain was observed compared with baseline, there was no associated improvement compared with placebo. PEG 3350+E is a well-established and effective treatment that should be considered suitable for use in IBS-C. © 2013 by the American College of Gastroenterology.


Cinca R.,Victor Babes University of Medicine and Pharmacy Timisoara | Chera D.,Pierrel Research HP RO SRL | Gruss H.-J.,Witten/Herdecke University | Halphen M.,Norgine Ltd
Alimentary Pharmacology and Therapeutics | Year: 2013

Summary Background Constipation is a common condition for which PEG 3350 is an established treatment and prucalopride has recently been approved for this indication. Aim To compare the efficacy, safety and impact on quality of life (QoL) of PEG 3350 plus electrolytes (PEG 3350+E) vs. prucalopride in females with chronic constipation (CC) in whom laxatives have previously failed to provide adequate relief. Methods In this single-centre, randomised, double-blind, double-dummy study, patients with CC [<3 spontaneous complete bowel movements (SCBM)/week] remained in a controlled environment and received either a 26 g split dose of PEG 3350+E (N = 120) or 1-2 mg prucalopride (N = 120) daily for 28 days following a 14-day run-in period. The primary endpoint was the proportion of patients having ≥3 SCBMs during the last treatment week. Results Non-inferiority of PEG 3350+E to prucalopride was demonstrated in the per-protocol population [difference, 10.1% (66.67% vs. 56.52%), 97.5% lower confidence interval (CI) -2.7%, above the preset margin of -20%] and approached superiority in the modified intent-to-treat population (difference, 9.8%, 97.5% lower CI, -3.1%). Statistically significant differences in favour of PEG 3350+E were observed for most secondary variables (bowel movements, stool weight, consistency, time to next SCBM, patient perception of straining and completeness of defecation). Colonic transit time was dramatically reduced in both arms. Both treatments were well tolerated. Conclusion PEG 3350+E was at least as effective as and generally better tolerated than prucalopride as a treatment for chronic constipation in this study population (NCT01251822; http://www.clinicaltrials.gov). © 2013 Blackwell Publishing Ltd.


Gruss H.-J.,Witten/Herdecke University | Cockett A.,Norgine Ltd | Leicester R.J.,St Georges Hospital
Journal of Medical Economics | Year: 2012

Objective: With the availability of several bowel cleansing agents, physicians and hospitals performing colonoscopies will often base their choice of cleansing agent purely on acquisition cost. Therefore, an easy to use budget impact model has been developed and established as a tool to compare total colon preparation costs between different established bowel cleansing agents. Methods: The model was programmed in Excel and designed as a questionnaire evaluating information on treatment costs for a range of established bowel cleansing products. The sum of costs is based on National Health Service reference costs for bowel cleansing products. Estimations are made for savings achievable when using a 2-litre polyethylene glycol with ascorbate components solution (PEGASC) in place of other bowel cleansing solutions. Test data were entered into the model to confirm validity and sensitivity. The model was then applied to a set of audit cost data from a major hospital colonoscopy unit in the UK. Results: Descriptive analysis of the test data showed that the main cost drivers in the colonoscopy process are the procedure costs and costs for bed days rather than drug acquisition costs, irrespective of the cleansing agent. Audit data from a colonoscopy unit in the UK confirmed the finding with a saving of £107,000 per year in favour of PEGASC when compared to sodium picosulphate with magnesium citrate solution (NaPicMgCit). For every patient group the model calculated overall cost savings. This was irrespective of the higher drug expenditure associated with the use of PEGASC for bowel preparation. Savings were mainly realized through reduced costs for repeat colonoscopy procedures and associated costs, such as inpatient length of stay. Conclusions: The budget impact model demonstrated that the primary cost driver was the procedure cost for colonoscopy. Savings can be realized through the use of PEGASC despite higher drug acquisition costs relative to the comparator products. From a global hospital funding perspective, the acquisition costs of bowel preparations should not be used as the primary reason to select the preferred treatment agent, but should be part of the consideration, with an emphasis on the clinical outcome. © 2012 Informa UK Ltd All rights reserved.


Halphen M.,Norgine Ltd | Heresbach D.,Center Hospitalier Of Cannes | Gruss H.-J.,Witten/Herdecke University | Belsey J.,JB Medical Ltd
Gastrointestinal Endoscopy | Year: 2013

Background: Variations in bowel cleansing quality before colonoscopy can cause confounding of results within clinical trials and inappropriate treatment decisions in clinical practice. A new tool - the Harefield Cleaning Scale - has been developed, which addresses the limitations of existing scales. Objective: Validation exercise for the new cleansing scale. Design: Retrospective validation study. Setting: Various colonoscopy units in France. Patients: Patients who had a total of 337 colonoscopies recorded. Intervention: Video-recorded colonoscopy. Main Outcome Measurements: Comparisons of 2 scoring systems to assess direct correlation, interrater reliability, internal consistency, and test-retest reliability, based on assessment of video recordings from 337 colonoscopies. Results: Correlation analysis for expert scores by using the 2 scales yielded a Spearman correlation coefficient of 0.833. Similarly, the comparison of the segmental sum score revealed a Spearman correlation coefficient of -0.778. Cross-tabulation for successful colon cleansing was 92.88% versus unsuccessful colon cleansing in 7.12%. Reliability assessment indicated an acceptable internal consistency with a Cronbach alpha coefficient of 0.81. Test-retest reliability demonstrated an overall agreement of 0.639 (kappa statistic). Receiver operating characteristic analysis versus Aronchick Scale scores yielded an area under the curve of 0.945, with sensitivity of 99% and specificity of 83% at the optimum score cut-off point. Limitations: Test-retest reliability was assessed by using a different patient population to the other measures. There were insufficient patient numbers to assess performance by using adenoma detection rate. Conclusion: This validation analysis has demonstrated that the Harefield Cleansing Scale is a robust, reliable, and consistent tool that has the potential to improve the effective standardization of bowel preparation assessment in both clinical and research practice. © 2013 American Society for Gastrointestinal Endoscopy.


Shaw M.,Norgine Ltd | Pediconi C.,Norgine Ltd | McVey D.,Norgine Ltd | Mondou E.,Tranzyme Inc | And 3 more authors.
Diseases of the Colon and Rectum | Year: 2013

Background: Gastrointestinal recovery is a critical milestone after bowel resection with postoperative ileus resulting in increased risk of complications and prolonged hospitalization. Objective: The aim of this study is to evaluate the efficacy and safety of ulimorelin, a ghrelin receptor agonist given postoperatively in 2 identically designed phase 3 studies (ClinicalTrials.gov NCT01285570 and NCT01296620). Design: This investigation is designed as a multicenter, double-blind, randomized, parallel-group study. Settings: This study involves hospital inpatients. Patients: Adult patients undergoing partial bowel resection were included. Intervention: Thirty-minute intravenous infusions (160 μg/kg, 480 μg/kg ulimorelin, or placebo) once daily were started within 60 minutes after the end of surgery and ended at the first of the following: primary efficacy end point fulfilled (defined below), hospital discharge, or 7 days treatment. Main Outcome Measures: The primary efficacy end point was the time from the end of surgery to the composite end point of the later of first bowel movement and tolerance of solid food. Safety was assessed with the use of standard assessments including adverse events and laboratory tests. Results: Ulimorelin Study of Efficacy and Safety 007, n = 332 patients; Ulimorelin Study of Efficacy and Safety 008, n = 330 patients: in both studies, the primary efficacy end point and the secondary efficacy outcomes, which included postsurgical time to first bowel movement, tolerance of solid food, and discharge eligibility, did not differ significantly among patients treated with either dose of ulimorelin versus placebo. Rates of serious adverse events were comparable across all treatment groups. There was no statistically significant difference from placebo in regard to events of interest, namely nausea, vomiting, ileus as an adverse event, nasogastric tube reinsertion, anastomotic complications, and infections. Limitations: A possible limitation is the variance inherent in surgery and comorbidities. Conclusions: Although the efficacy of ulimorelin in reducing the duration of postoperative ileus was not demonstrated in these studies, intravenous ulimorelin at doses of 160 μg/kg and 480 μg/kg was generally well tolerated in postcolectomy patients. Similar to other promotility agents, ulimorelin may find an application in other indications better suited to its attributes. Copyright © The ASCRS 2013.


Gruss H.J.,ICON Clinical Research | Pediconi C.,Norgine Ltd | Jacobs A.,Dianthus Medical Ltd
Colorectal Disease | Year: 2014

Aims: NRL001 is a highly specific α1-adrenoceptor agonist currently under evaluation for the treatment of faecal incontinence caused by a weak internal anal sphincter. The aim of this meta-analysis was to quantify the effect of NRL001 on cardiovascular parameters including heart rate, blood pressure and QT interval. Methods: Data from the four Phase I healthy volunteer studies SUM (NCT00857467), SURD (NCT01099670), SUSD (NCT00850590) and SAGE (NCT01099683) were pooled and analyses were performed on individual subject data. Mixed effects regression analysis was used to determine the effect of NRL001 on heart rate, blood pressure and QT intervals. A multivariate statistical model was used to determine the effect of covariates on heart rate. Results: Subjects given NRL001 experienced a dose related decrease in heart rate of up to 9.48 bpm compared with subjects in the placebo arms. No statistically significant evidence for a threshold effect was found. There was no clear evidence of dose effect of NRL001 on blood pressure. QT interval increased in all NRL001 subject as expected; QTCF also showed a statistically significant increase. However, QTCB was shortened with no significant treatment effect. Conclusions: NRL001 was found to have a dose-dependent effect on heart rate; however clinically-relevant bradycardia was not reported, indicating the decrease in heart rate was not of clinical significance. Furthermore, no clinically-significant drug effect on blood pressure or mean arterial pressure was observed. QT intervals were affected by changes in heart rate. However, trends were dependant on the correction factor used. No consistent QT effect was observed, but a thorough QTC study will be required to confirm the effects of rectally applied NRL001. © 2014 The Association of Coloproctology of Great Britain and Ireland.


Bell D.,Bio Kinetic Europe Ltd | Pediconi C.,Norgine Ltd | Jacobs A.,Dianthus Medical Ltd
Colorectal Disease | Year: 2014

Aims: The application of α-adrenoceptor agonists can improve faecal incontinence symptoms. The aim of this study was to investigate the pharmacokinetic and systemic effects of NRL001 administered as different strengths in 1 or 2 g suppositories. Methods: This randomised, double-blind, placebo controlled study included 48 healthy subjects. Group 1 consisted of two cohorts of 12 subjects administered either four single doses of 1 or 2 g rectal suppository with either 5, 7.5 or 10 mg NRL001, or matching placebo. Group 2 consisted of two cohorts of 12 subjects administered either four single doses of 1 or 2 g rectal suppository with either 10, 12.5 or 15 mg NRL001, or matching placebo. Doses were given in an escalating manner with placebo at a random position within the sequence. Results: Tmax was at ~4.5 h post-dose for all NRL001 doses. Median AUC0-tz, AUC0-∞ and Cmax increased with increasing dose for both suppository sizes. The estimate of ratios of geometric means comparing 2 g with 1 g suppository, and regression analysis for dose proportionality, was close to 1 for the variables AUC0-tz, AUC0-∞ and Cmax (P > 0.05). For both suppository sizes, 20-min mean pulse rate was significantly decreased compared with placebo with all doses (P < 0.05). Blood pressure decreased overall. There were 144 adverse events (AEs) and no serious AEs reported during the study. All AEs were mild in severity. Conclusions: The regression analysis concluded that the doses were dose proportional. © 2014 The Association of Coloproctology of Great Britain and Ireland.


Belsey J.D.,JB Medical Ltd | Geraint M.,Norgine Ltd | Dixon T.A.,JB Medical Ltd
International Journal of Clinical Practice | Year: 2010

It is unclear how polyethylene glycol (PEG) laxatives compare with other classes of laxative in terms of efficacy. To assess efficacy of PEG vs. placebo and active comparators in adults with non-organic constipation. Text Word searches were carried out on MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Clinical Trials and Google Scholar databases covering the period January 1970 to October 2009. Search terms were (constipation) AND (randomised OR randomized) AND (PEG OR polyethylene OR macrogol OR movicol OR idrolax OR miralax OR transipeg OR forlax OR colyte OR golytely OR isocolan OR nulytely) NOT colonoscopy. Only published randomised controlled trials, with a parallel-group or cross-over design, comparing oral PEG with placebo or a comparator laxative in adults with a history of non-organic constipation, were included. The frequency of defaecation in each arm, on completion of the protocol-defined treatment duration was extracted. All pooled analyses were based on random effect models. Of the 20 qualifying studies, 10 were vs. placebo, seven were vs. lactulose, and four were vs. other agents. One study compared PEG, placebo and lactulose. PEG treatment resulted in a highly significant increase in defaecations/week over placebo (all studies: additional 1.98 stools/week; p = 0.0003, high-quality studies: additional 2.34 stools/week; p = 0.0001) and over lactulose (all studies: additional 1 stool/week; p = 0.0017, high-quality studies: additional 1.65 stools/week; p = 0.021). This meta analysis is the only quantitative statistical analysis to have been published in the field. PEG was found to be a more effective laxative than lactulose in adult patients with constipation. © 2010 Blackwell Publishing Ltd.

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