Shionogi Concludes a Contract for the Commercialization of Rizmoic® (naldemedine), an Opioid-Induced Constipation Therapeutic Agent, in Germany, the UK, and the Netherlands
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced today that Shionogi concluded a distribution contract with Sandoz (Headquarters: Holzkirchen, Germany; CEO a.i: Francesco Balestrieri hereinafter “Sandoz”) for the sale of Rizmoic® (naldemedine) for the treatment of opioid-induced constipation (OIC) in adult patients previously treated with a laxative in the key European markets of Germany, the UK, and the Netherlands, plus right of first refusal for certain other European markets.
Sandoz has a strong presence in the European market for opioid analgesics, as well as a complementary strategic focus on innovative therapeutic alternatives to combat opioid dependency. According to this contract, Sandoz will commercialize Rizmoic® in Germany, the UK, and the Netherlands, and Shionogi will be responsible for its manufacturing and development. Dr. John Keller, Chief Executive Officer of Shionogi B.V., the subsidiary of Shionogi in Europe, said “Through this contract, we are able to bring together Sandoz’s commercial expertise in Europe, particularly in the field of opioid analgesics with the OIC treatment know-how of Shionogi, which has been developing naldemedine globally. We therefore expect Rizmoic® to contribute significantly to OIC treatment in clinical settings in European countries in the future.”
On February 22, 2019, the European Commission (EC) granted the Marketing Authorization (MA) for Rizmoic® for the treatment of OIC in adult patients who have previously been treated with a laxative.1, 2 Rizmoic® is planned to be launched in Germany and the UK in 2019 and in the Netherlands in 2020. Rizmoic® was launched under the brand name Symproic® in Japan in June 2017, and in the United States in October 2017.3,4 Shionogi plans to initiate a clinical study of naldemedine in paediatric patients with OIC in EU, in accordance with an agreed paediatric investigation plan, as well as a clinical study in adult patients with post-operative ileus.
Shionogi's research and development efforts target pain/central nervous system (CNS) as one of its priority areas in the mid-term business plan, SGS2020, in which Shionogi has positioned “Grow sustainably as a drug discovery-based pharmaceutical company contributing to a more vigorous society through improved healthcare” as its vision. Shionogi constantly strives to improve the quality of life of patients who suffer from pain or side effects of analgesics by bringing forth innovative drugs.
About Opioid-induced Constipation
Constipation is one of the most commonly reported side effects associated with opioid treatment, particularly among patients with chronic non-cancer pain and patients with cancer pain.5 OIC is a result of increased fluid absorption and reduced gastro-intestinal (GI) motility due to mu-opioid receptor binding in the GI tract. OIC is defined as a change in bowel habits that is characterized by any of the following after initiating opioid therapy: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency.6 In patients receiving opioid therapy for chronic non-cancer pain, the prevalence of OIC ranges from approximately 40-60 percent.7
Rizmoic® (naldemedine) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative. Rizmoic® is a peripherally acting mu-opioid receptor antagonist (PAMORA) that has been developed by Shionogi as a once-daily treatment of OIC. The efficacy and safety of naldemedine have been evaluated in randomized, double-blinded, placebo-controlled studies in adult patients with OIC who have chronic non-cancer pain or who have cancer pain.8-12 Rizmoic® is expected to be a new treatment option that can improve the quality of life significantly in patients with OIC in pain management with opioid analgesics.
Shionogi & Co., Ltd. (“Shionogi”) is a Japanese major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases and pain/CNS disorders. For more information on Shionogi, please visit http://www.shionogi.co.jp/en/. Shionogi B.V. is the European subsidiary of Shionogi & Co., Ltd. based in Amsterdam, Netherlands. For more information on Shionogi B.V. please visit http://www.shionogi.eu/.
Forward Looking Statement
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
1. Release on February 22, 2019
Shionogi announces European Union Marketing Authorisation for Rizmoic® (naldemedine) for the treatment of opioid-induced constipation in adults previously treated with a laxative
2. SmPC, Rizmoic®, Shionogi, Feb 2019
3. Release on June 7, 2017
Opioid-Induced Constipation therapeutic agent ‘Symproic® (naldemedine) Tablets 0.2mg’ launched in Japan
4. Release on October 12, 2017
Shionogi Inc. and Purdue Pharma L.P. Announce U.S. Availability of Symproic® (naldemedine) for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain
5. Sehgal N, et al. Chronic pain treatment with opioid analgesics benefits versus harms of long-term therapy. Expert Rev Neurother. 2013;13:1201-1220.
6. Camilleri M, et al. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014;26: 1386-1395.
7. Coyne E, et al. Opioid-Induced constipation among patients with chronic Noncancer pain in the United States, Canada, Germany and the United Kingdom: Laxative use, response and symptom burden over time. Pain. 2015;16:1551–1565.
8. Hale M, et al. Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2): two multicentre, phase3, double-blind, randomised, parallel-group trials. Lancet Gastroenterol Hepatol. 2017. Published online May 30, 2017.
9. Webster L, et al. Long term use of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: a randomized, double-blind, placebo-controlled phase 3 study. Pain. 2018. Published online February 6 2018.
10. Bowers B, et al. The evolving role of long-term pharmacotherapy for opioid-induced constipation in patients being treated for noncancer pain. Jour Pharm Practice. 2017.
11. Katakami N, et al. Randomized phase III and extension studies: efficacy and impacts on quality of life of naldemedine in subjects with opioid-induced constipation and cancer. Ann Oncol. 2018. Published online Apr 18, 2018.
12. Satomi E, et al. Efficacy and tolerability of naldemedine in patient with cancer and opioidinduced constipation: A pooled subgroup analysis of 2 randomised placebo-controlled studies. Ann Oncol. 2018. 29 (suppl 8).
Shionogi & Co., Ltd.
Corporate Communications Department
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Three Finalists Selected Following GA-ASI’s Blue Magic Belgium Event15.6.2019 14:00:00 EEST | Tiedote
Three finalists have been selected from GA-ASI’s Blue Magic Belgium event with the goal of supporting GA-ASI and the development of MQ-9B SkyGuardian Remotely Piloted Aircraft (RPA) for Belgium. The three Belgian companies selected are AIRobot, ALX Systems, and Hexagon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190615005003/en/ "We were very impressed by the many talented companies and particularly by the innovative concepts presented by these three finalists," said Linden Blue, CEO, GA-ASI. (Photo: Business Wire) AIRobot, a company based at DronePort in Sint Truiden, Belgium, focuses on developing drone performance equipment for easy, precise and safe professional operations, while specializing in Artificial Intelligence (AI) for processing hyper-spectral imagery. ALX Systems is an Unmanned Aircraft System (UAS) solution provider based in Liège, Belgium and specializing in AI for processing Full Motion Video. Hexagon’s
World’s First E-Money License for Blockchains Issued to Monerium15.6.2019 11:35:00 EEST | Tiedote
Monerium ehf. has received a license from the Financial Supervisory Authority of Iceland to issue e-money on blockchains through its subsidiary, Monerium EMI ehf. The full license is the world’s first e-money license for blockchains issued under EU e-money regulations. The license is passportable within the largest global economic zone, the European Economic Area, and to external jurisdictions subject to regulatory approval and destination country regulations. Designed as a digital alternative to cash, e-money is a proven framework for digital fiat currency already in use for pre-paid cards and mobile wallets. By issuing e-money on blockchains, Monerium removes the need for intermediaries and provides the ability to automate financial transactions in many sectors, including payments, trade finance, securities settlement, and ecommerce. At the same time, e-money on blockchains extends Satoshi Nakamoto’s vision of online peer-to-peer currency transactions to a regulated form of digital f
Mattel® Unveils Hot Wheels™ id, Groundbreaking New Play System Bringing Together Physical and Digital Play, Available Exclusively at Apple.com, Select Apple Stores and on the App Store14.6.2019 16:00:00 EEST | Tiedote
Mattel, Inc. (NASDAQ: MAT) today announced the launch of Hot Wheels id, the evolution of the beloved brand that generations of kids have played with to ignite their challenger spirit. Through innovative vehicle play, Hot Wheels id brings together physical and digital in a Mixed Play experience with uniquely identifiable vehicles, a smart Race Portal, Smart Track, and digital hub, so you can build your personalized fleet, measure your performance, and compete like never before. Hot Wheels id is available starting June 14th exclusively at Apple.com, select Apple stores and on the App Store. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190614005084/en/ Hot Wheels Race Portal™ scans your Hot Wheels id vehicles into the app, tracks speed and counts laps via infrared sensors, and easily connects with your classic Hot Wheels track. (Photo: Business Wire) For the first time in history, kids can scan their Hot Wheels id cars digita
S BLOCK Co-host With World Blockchain Forum Singapore & World Blockchain Award Asia14.6.2019 15:45:00 EEST | Tiedote
Asia's highly anticipated blockchain event World Blockchain Forum · Singapore & World Blockchain Award · Asia will be held on June 22-23, 2019 at the Marina Bay Sands in Singapore. The conference will bring together more than 4,000 global elites from government, associations, regulatory agencies, investment institutions, blockchain project parties, financial technology, and media to discuss industry trends and innovations, jointly recognizing industry pioneers and contributions to promote the industry and achieve healthy and rapid development! The World Blockchain Forum Singapore & World Blockchain Award Asia will be co-hosted by S BLOCK. As a fast-growing digital asset management platform, S BLOCK was developed for the blockchain industry. This rapidly growing platform aims to serve the digital financial ecosystem and aims to commercialize by the end of 2019. The slogan of S BLOCK is “unleash your digital asset.” The platform also provides investors access to mainstream cryptocurrenci
Janssen Reports Top-Line Phase 3 Results for TREMFYA® (guselkumab) in Adults with Active Psoriatic Arthritis14.6.2019 14:39:00 EEST | Tiedote
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20% improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER programme were consistent with previous studies of guselkumab and current prescribing information.1 The DISCOVER programme comprises the first-ever Phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, and data will be presented at upcoming scientific medical meetings. Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for
Velodyne Features Advanced Lidar for Port Terminal Automation at TOC Europe14.6.2019 13:00:00 EEST | Tiedote
Velodyne Lidar, Inc. (Stand A50) will demonstrate how its smart, powerful lidar solutions can advance port terminal automation at TOC Europe in Rotterdam, 18-20 June. Velodyne will highlight customer applications that show how its lidar sensors can be used in crane steering, container handling, internal terminal vehicles (ITV), automated guided vehicles (AGV), forklifts, and terminal security/yard monitoring systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190614005040/en/ DGWorld solutions demonstrate how Velodyne’s intelligent lidar sensors are helping port and terminal operators deliver consistent service quality and achieve increased safety. (Photo: Business Wire) DGWorld (Stand B21A), a Dubai-based Velodyne integrator, will showcase autonomous taxis, ITVs, AGVs, and terminal operation vehicles that use Velodyne lidar sensors to run autonomously. These vehicles use advanced artificial intelligence (AI), automation
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme