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

Orange Acquires Basefarm Holding and Becomes a European Leader in Cloud Computing Services for the Enterprise Sector16.7.2018 07:22Pressemelding

Following a competitive tender process initiated by Abry Partners for its stake in Basefarm, the Orange Group, through its enterprise subsidiary Orange Business Services, has announced today the signature of a contract to acquire 100% of the company’s capital for an enterprise value of 350 million euros. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005214/en/ Basefarm is a leading European player in cloud-based infrastructure and services, as well as the management of critical applications and data analysis. The company, which recorded revenues of over 100 million euros in 2017, has enjoyed strong growth since 2015. Basefarm has a strong operational presence in several European countries, particularly in Norway, Sweden, the Netherlands, Austria and in Germany, where it boasts a cutting-edge big data activity. Its business proposition lies at the forefront of the most innovative services in cloud computing, Big Data a

Spirit AeroSystems and Norsk Titanium Announce Start of Production Qualification for Commercial Aircraft Parts16.7.2018 07:00Pressemelding

Spirit AeroSystems [NYSE: SPR] and Norsk Titanium US Inc. (NTi), have reached an agreement to initiate qualification of Spirit’s first additive-manufactured, titanium, structural component for the Boeing 787. This qualification will validate NTi’s production and industrialization processes, integrate Spirit’s workscope of machining final parts from additively manufactured near-net shapes and verify material and final part conformity to requirements. “Spirit has had a comprehensive and long relationship with Norsk Titanium, and this part will be our first additive structural titanium component incorporated into a commercial airplane program,” said Spirit AeroSystems Senior Vice President of Fabrication and Supply Chain Management, Ron Rabe. NTi is the world’s first FAA-approved, OEM qualified, supplier of additive-manufactured, structural titanium components. NTi’s proprietary Rapid Plasma Deposition™ (RPD™) process has been in serial production of Boeing 787 titanium components since A

New Study Investigates the Utility of Masimo PVi® as Part of Goal-Directed Fluid Management in Patients Undergoing Colorectal Surgery16.7.2018 05:00Pressemelding

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Kocaeli University in Turkey compared the performance of conventional fluid management (CFM) to goal-directed fluid management (GDFM) using Masimo PVi® (pleth variability index, measured noninvasively and continuously using SET® pulse oximetry sensors) in patients undergoing elective colorectal surgery. The primary points of comparison were the amount of crystalloids administered and blood lactate and serum creatinine levels during the intraoperative period.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180715005048/en/ Masimo Radical-7® with PVi®, SpHb®, and RD rainbow SET™ Sensor (Photo: Business Wire) In the study, Dr. Cesur and colleagues, noting the importance of intraoperative fluid management in terms of postoperative organ perfusion and complications, sought to compare the effects of CFM (guided by clinical asse

Alipay and Singapore Tourism Board join hands to boost Chinese tourist spending16.7.2018 02:00Pressemelding

Alipay, the world’s leading mobile and online payment and lifestyle platform operated by Ant Financial Services Group, together with the Singapore Tourism Board (STB), have launched a series of joint marketing initiatives aimed at raising destination awareness of Singapore and driving tourist spending among Chinese visitors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180715005021/en/ Alipay and STB signed a Memorandum of Understanding (MOU) in September 2017 to enhance Chinese tourists’ overall experience in Singapore. Under the MOU, both parties agreed, among other things, to explore co-investing in joint-marketing initiatives to encourage Chinese tourists to spend with Alipay while in Singapore. Since signing the MOU, Alipay has experienced double-digit growth in user spending. China has also become Singapore’s top market in 2017 for both tourism receipts and visitor arrivals, contributing S$4.2 billion in tourism rece

Koza Altin Welcomes Court’s Rejection of Akin Ipek’s Share Purchase Agreement13.7.2018 15:58Pressemelding

A Turkish Court has found against businessman Akin Ipek this week – ruling that a share purchase agreement, which he had submitted as vital evidence in support of his case against the Turkish state, is null and void. The matter was brought to the Ankara Commercial Court in March 2017 by Koza Holding (parent company of Koza Altin) which, according to Mr Ipek’s share purchase agreement, purportedly transferred all of its shares to Ipek Investment Limited. Koza Holding filed the lawsuit for legal recognition that the share purchase agreement is void. The ruling in Turkey follows on from an earlier judgment set down by the English High Court, which rejected Mr Ipek’s attempt to use up to £3m of UK subsidiary Koza Ltd’s money to fund a claim against the Turkish State at the International Centre for Settlement of Investment Disputes (ICSID). In the English ruling, Deputy Judge Richard Spearman QC declared the “authenticity” of the share purchase agreement as “open to very serious doubt”. The

Mindbreeze Positioned in the Leaders Quadrant of the Gartner’s 2018 Magic Quadrant for Insight Engines13.7.2018 15:27Pressemelding

Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for leading international companies, announced today that Gartner, Inc. has positioned Mindbreeze in the Leaders quadrant of the 2018 Magic Quadrant for Insight Engines. Mindbreeze is positioned highest on the ability to execute axis. The research and advisory firm Gartner, Inc. evaluated 13 different providers from all over the world. “Understanding the meaning of information is a key priority for today’s customers. Mindbreeze InSpire leverages the full power of our sophisticated AI engine to provide actionable insights and answers ̶ not just more data. Seeing our position in the Magic Quadrant, my first reaction was ‘AWESOME’. Insight Engine was positioned the highest on the ability to execute axis and we believe that's exactly what sets us apart from our competitors. We made the bold move to focus on product innovatio