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
Process Systems Enterprise: gPROMS FormulatedProducts 1.4 Includes Enhanced Capabilities Linking Digital Design to Digital Operations19.4.2019 10:58:00 EEST | Tiedote
Process Systems Enterprise (PSE), the Advanced Process Modelling company, today released version 1.4 of gPROMS FormulatedProducts, the mechanistic model-based environment for integrated digital design of robust formulated products and their manufacturing processes, and related digital process operation. This release introduces major enhancements to both the gPROMS FormulatedProducts model libraries and the underlying gPROMS platform 6.0, including morphological crystallizer and sensor models to capture particle size and shape evolution, enhanced continuous direct compression models and improved wet granulation models. Platform enhancements include support for cluster computing, to significantly speed up execution of parameter estimation and other complex numerical solutions, and comprehensive global system analysis of dynamic systems for rapid exploration of the time-varying decision space and systematic risk and uncertainty analysis. Version 1.4 also introduces two key usability enhan
LOXAM Contributes to the Reconstruction of Notre Dame De Paris Cathedral19.4.2019 10:44:00 EEST | Tiedote
In the wake of the Notre Dame de Paris blaze on Monday 15 April, Loxam the leading equipment rental company in Europe is playing its part in the reconstruction project of the partly destroyed cathedral. A rental operator in the construction equipment, LOXAM pledges to provide, free of charge, machines to the companies and tradesmen who will take part in these restoration works for the scheduled duration of five years. “Notre Dame de Paris Cathedral is the legacy of accomplished builders that we ought to preserve. As a committed rental operator, Loxam wishes to contribute to the rehabilitation of this monument by providing equipment for an overall 10-million € value over the upcoming five years” Gérard DEPREZ, President of LOXAM, indicates. With a fleet of over 200,000 machines, Loxam is meeting the needs of all tradesmen operating on this worksite. View source version on businesswire.com: https://www.businesswire.com/news/home/20190419005025/en/ Contact information PRESS : Virginie Ada
IFF to Release First Quarter 2019 Results May 618.4.2019 23:15:00 EEST | Tiedote
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of scent, taste, and nutrition, announced that it will release its first quarter 2019 earnings results following the market close on Monday, May 6, 2019. The management team will host a live webcast on Tuesday, May 7, 2019 at 10:00 a.m. ET to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) is a leading innovator of scent, taste, and nutrition, with 97 manufacturing facilities, 105 R&D centers, and 39,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for exploration dri
Gilead Sciences to Release First Quarter 2019 Financial Results on Thursday, May 2, 201918.4.2019 23:05:00 EEST | Tiedote
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2019 financial results will be released on Thursday, May 2, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the first quarter 2019 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 5259422 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, May 4, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID
Andersen Global Expands Africa Presence; Signs Collaboration Agreement in Economic Hub of South Africa18.4.2019 16:30:00 EEST | Tiedote
Andersen Global is excited to announce the addition of its first collaborating firm in South Africa. Tabacks Attorneys and Corporate Law Advisors, headquartered in Johannesburg, South Africa, has signed a Collaboration Agreement with Andersen Global, an international association of member and collaborating firms. South Africa marks the tenth country in Africa in which Andersen Global has a presence. Led by Chairman David Woodhouse, Tabacks has a team of 27 lawyers who offer legal assistance and commercial advice to a diverse clientele in construction, manufacturing, energy, mining, explosives, retail, hospitality, logistics, pharmaceutical, property and banking industries. The firm is considered a leading law firm in South Africa, and its practice areas include competition law, commercial law, mining, employment law, environmental health & safety law, tax and litigation. “The global economy is rapidly changing, which brings unique challenges to corporate and commercial law,” said David
Amazon and Google Announce Official YouTube Apps to Launch on Fire TV; Prime Video App Coming to Chromecast and Android TV18.4.2019 16:00:00 EEST | Tiedote
Today, Amazon (NASDAQ: AMZN) and Google (NASDAQ: GOOGL) announced that in the coming months, the two companies will launch the official YouTube app on Amazon Fire TV devices and Fire TV Edition smart TVs, as well as the Prime Video app for streaming to Chromecast and Chromecast built-in devices. In addition, Prime Video will be broadly available across Android TV device partners, and the YouTube TV and YouTube Kids apps will also come to Fire TV later this year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190418005212/en/ “We are excited to work with Amazon to launch the official YouTube apps on Fire TV devices worldwide,” said Heather Rivera, Global Head of Product Partnerships at YouTube. “Bringing our flagship YouTube experience to Amazon Fire TV gives our users even more ways to watch the videos and creators they love.” “We’re excited to bring the Prime Video app to Chromecast and Android TV devices, and to give our c
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