Business Wire

Ferring Pharmaceuticals announces approval of new tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label in MRP countries in Europe

Del

Ferring Pharmaceuticals today announced that the tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label has received approval in the MRP countries in Europe.

The approval is based on data from the OPTIMA clinical trial demonstrating that the PICOPREP® tailored dosing regimen was superior in providing good to excellent visibility in the entire colon compared to the currently approved PICOPREP® day-before dosing regimen1.

In the tailored dosing regimen, the time of administration of the two sachets is set according to the time of the colonoscopy for a more tailored approach. The first sachet is to be taken 10 to 18 hours before, and the second sachet 4 to 6 hours before the colonoscopy in line with guideline recommendations3-5.

The time interval between the last dose of the bowel preparation and the colonoscopy procedure can be considered the most important determinant of colon cleansing quality2, with shorter time intervals associated with colon cleansing of higher quality2-5.

“The approval is a significant milestone in aligning the label with the guideline recommendations of shorter time interval between the last dose of the bowel preparation and the colonoscopy procedure3-5,” said Pascal Danglas, MD, Chief Medical Officer, Ferring Pharmaceuticals. “Compared to the current day-before dosing regimen, tailored dosing of PICOPREP® results in higher quality colon cleansing enabling more successful colonoscopies1.”

- Ends -

About PICOPREP® (sodium picosulfate, magnesium oxide, citric acid):

PICOPREP® (sodium picosulfate 10mg, magnesium oxide 3.5mg, citric acid 12g), a dual action laxative medication, is used to clean the bowel prior to X-ray examination, endoscopy and surgery when judged clinically necessary. PICOPREP® has approved dosing for children as of 1 year old and adults. This product is sold in some countries under the trademarks PICO-SALAX®, PICOLAX® or PREPOPIK®.

About OPTIMA trial:

The OPTIMA trial, started in 2014, enrolled 204 patients in Germany, France and the Netherlands. Patients were randomised (2:1) to either the PICOPREP tailored dosing regimen or PICOPREP day-before dosing regimen for colon cleansing in preparation for colonoscopy. Primary endpoint was the overall colon cleansing efficacy based on total Ottawa Scale (OS) scores. Key secondary endpoint was the responder status for ascending colon based on OS. Other secondary endpoints were responder status for mid (transverse, descending) and recto-sigmoid colon. Convenience, satisfaction, impact on daily activities, safety and tolerability were also evaluated.

About Ferring Pharmaceuticals:

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology-oncology, gastroenterology, endocrinology and orthopaedics. Ferring Pharmaceuticals has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring Pharmaceuticals or its products please visit www.ferring.com.

References:

1. Kiesslich R, Angelin C, Raymond K, et al. A randomised, assessor-blinded, multicentre trial comparing the efficacy, safety, and tolerability of a new tailored dosing regimen to day-before dosing regimen of colon cleansing agent used before colonoscopy. J Crohn Colitis 2016;10,suppl.1:S278.

2. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.

3. Hassan C, Bretthauer M, Kaminski MF, et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline Endoscopy 2013;45:142-150.

4. Mathus-Vliegen E, Pellise M, Heresbach D, et al. Consensus guidelines for the use of bowel preparation prior to colonic diagnostic procedures: colonoscopy and small bowel video capsule endoscopy Curr Med Res Opin 2013; 29: 931 – 945.

5. Johnson DA, Barkun AN, Cohen LB, et al. Optimizing adequacy of bowel cleansing for colonoscopy recommendations from the US Multi-Society Task Force on colorectal cancer. Gastroenterology 2014;147:903–924.

Contact information

Ferring Pharmaceuticals
Helen Gallagher
Tel. +41 58 301 00 51
helen.gallagher@ferring.com
or
Nicole Barraud-Estoppey
Tel. +41 58 301 00 53
nicole.barraud-estoppey@ferring.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage22.2.2018 06:00Pressemelding

Ferring Pharmaceuticals and MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., through its MSD for Mothers initiative, today announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO). CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH).2,3 Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.2,3 This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221006496/en/ Each year, 14 million mothers are affected by PPH.4 As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09.1 Even when women survive, PPH can result in the need for serious medical interventions, including surgica

The Nippon Foundation: Project to Map Ocean Floor by 2030 Now Operational22.2.2018 05:00Pressemelding

The Nippon Foundation Chairman Yohei Sasakawa announced at a press conference today that The Nippon Foundation – GEBCO Seabed 2030 Project is now operational. The Project will realize Mr. Sasakawa’s vision of mapping the entire ocean floor by 2030. The Nippon Foundation has pledged US$2 million annually, and is calling for additional support from the global ocean community. Mr. Sasakawa noted, “The Nippon Foundation alone cannot achieve the objectives of this ambitious project. We will need the support of diverse stakeholders, including maritime corporations and technical experts. It is crucial that the ocean community comes together to achieve this goal”. He was joined by leading ocean-mapping experts, who emphasized that understanding the bathymetry of the global ocean is imperative for improving maritime navigation, and also for enhancing our ability to predict climate change and monitor marine biodiversity and resources. A comprehensive map of the seafloor will assist global effort

Vertex Initiates First Phase 3 Study of VX-659, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis21.2.2018 21:01Pressemelding

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it is initiating the first Phase 3 study of VX-659, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation. The study will enroll 360 patients, and the primary endpoint of the study is the mean absolute change from baseline in percent predicted forced expiratory volume in one second (ppFEV1) at week four of treatment. The study is designed to support the submission of a New Drug Application (NDA) in the U.S. using data from the 4-week primary efficacy endpoint together with safety data through 12 weeks of treatment. “Our goal is to bring the best triple combination to patients as rapidly as possible, and this first Phase 3 study of VX-659 in combination with tezacaftor and ivacaftor is a significant step toward that goal,” said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical

Universal Laser Systems® Expands Portfolio of Laser Material Processing Systems with the ULTRA Platform Series21.2.2018 18:00Pressemelding

ULTRA platform-based laser systems are designed and ideally suited for precision laser cutting, laser ablation, and laser surface modification in manufacturing, research and development, academic research and prototyping environments. Major features of the series include rapid, high-accuracy laser beam positioning, and the flexibility to be configured with 9.3 and 10.6 µm CO2 lasers and 1.06 µm fiber lasers. All lasers are air-cooled in a range of power from 10 to 150 watts for CO2 and 40 to 50 watts for fiber lasers. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005364/en/ The ULTRA 9MW offers MultiWave processing of thin materials. (Photo: Business Wire) The variety of wavelengths and power ranges make the ULTRA platforms highly effective in the areas of organic material modification, including plastic films, industrial fabrics, engineering plastics, laminating adhesives, composite materials, and many others utilized

Luxoft One of Six Companies Collaborating with Amazon Web Services to Accelerate Blockchain Adoption21.2.2018 16:30Pressemelding

Luxoft Holding Inc (NYSE:LXFT), a global IT service provider, announces today that it is collaborating with Amazon Web Services (AWS) to enable corporates to adopt blockchain and Distributed Ledger Technologies (DLT). Luxoft is one of six IT and consulting services companies to make its blockchain advisory and development services available to AWS users. “We are very excited to be working with AWS to help users engage with blockchain and DLTs,” said Vasiliy Suvorov, Vice President of Technology Strategy at Luxoft. “Blockchain is about removing data silos, improving trust and operational efficiencies. By using AWS to deploy and integrate DLTs into day-to-day processes, businesses can revolutionize how they operate.” Luxoft helps accelerate the deployment and integration of blockchain and DLT-based projects on AWS and is already working on a number of DLT projects using the cloud. For example, Luxoft is building a healthcare claims processing system for a leading healthcare provider usin

Westinghouse Electric Company to Provide Engineering Support at Vandellós 1 in Partnership with EDF21.2.2018 16:30Pressemelding

Westinghouse Electric Company and Electricité de France (EDF), in partnership, announced today that they have been awarded a contract from Empresa Nacional de Residuos Radiactivos (ENRESA), the Spanish agency responsible for radioactive waste management and nuclear plant decommissioning. The agreement covers a four-year engineering support contract for the latency phase of the dismantling and decommissioning project at Vandellós I Nuclear Power Station in Spain and includes the preparation of technical and licensing documentation. “We are extremely pleased that ENRESA has selected Westinghouse and EDF to continue supporting the decommissioning activities at Vandellós I Nuclear Power Station,” said Yves Brachet, Westinghouse vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “This contract further demonstrates Westinghouse’s global capabilities and expertise in providing innovative decommissioning solutions.” Sylvain Granger, head of EDF's decommi