Business Wire

SHIONOGI AND MOLTENI CONCLUDE A CONTRACT FOR THE COMMERCIALIZATION OF RIZMOIC® (NALDEMEDINE), AN OPIOID-INDUCED CONSTIPATION THERAPEUTIC AGENT IN ITALY AND POLAND

Jaa

SHIONOGI B.V., the European subsidiary of SHIONOGI & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") and L. MOLTENI & C. DEI F.LLI ALITTI SOCIETÀ DI ESERCIZIO S.P.A. (Headquarters: Florence, Italy; Managing Director : Giuseppe Seghi Recli, hereafter “Molteni”) announced today that Shionogi and Molteni concluded a contract for the distribution and sale of RIZMOIC® (naldemedine) for the treatment of opioid-induced constipation (OIC) in adult patients previously treated with a laxative in the two key European markets, Italy and Poland.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190521005648/en/

Shionogi has built a strong heritage in research-based medicine. The company’s research and development efforts target pain/central nervous system as one of its priority areas in the mid-term business plan. The company constantly strives to improve the quality of life of patients who suffer from pain or side effects of analgesics by bringing forth innovative drugs.

Molteni is a specialty leader in the field of opioid treatments in Europe and is committed to researching and developing novel solutions for the treatment of moderate to severe pain and addiction, to safeguard patients’ quality of life and care. According to this contract, Molteni will distribute and sell RIZMOIC® in Italy and Poland and Shionogi will co-promote the product in Italy with Molteni.

Dr. John Keller, Chief Executive Officer of Shionogi B.V., the subsidiary of Shionogi in Europe, said “This partnership marks another key milestone for the launch of RIZMOIC ® in Europe. By partnering with Molteni, we are combining our extensive knowledge of opioid pain management to ensure more patients experiencing OIC can have access to this important treatment option. The co-promotion of Shionogi and Molteni in Italy offers a synergic partnership to maximise the value of existing commercial structures”.

Molteni’s Managing Director, Giuseppe Seghi Recli, commented, “We are delighted to partner with Shionogi on such a promising new molecule for the treatment of OIC and we believe that the outstanding commitment shown by both parties since the beginning of our discussion will significantly contribute to raising a new patient’s awareness capable to tackle this disabling and under diagnosed pathology.”

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 Italy and Poland in 2020. RIZMOIC® was launched under the brand name Symproic® in Japan in June 2017, and in the United States in October 2017.3-5

Shionogi plans to initiate a clinical study of naldemedine in paediatric patients with OIC in the EU, in accordance with an agreed paediatric investigation plan, as well as a clinical study in adult patients with post-operative ileus.

END

References
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. [online] Available at: https://www.ema.europa.eu/documents/product-information/rizmoic-epar-product-information_en.pdf [Accessed 20 May 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. Release on April 11, 2019
Shionogi Announces Licensing of Symproic® (naldemedine) to BioDelivery Sciences International Inc.
6. Sehgal N, et al. Chronic pain treatment with opioid analgesics benefits versus harms of long-term therapy. Expert Rev Neurother. 2013;13:1201-1220.
7. Camilleri M, et al. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014;26: 1386-1395.
8. 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.
9. 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.
10. 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 2018.
11. 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.
12. 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.
13. 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).

Contact information

Shionogi Europe
Dr. Mark Hill, Shionogi
mark.hill@shionogi.eu
Mirjam Korn, Shionogi
mirjam.korn@shionogi.eu

Shionogi & Co., Ltd.
Corporate Communications Department
Telephone: +81-6-6209-7885

Molteni Italy
Ufficio stampa – Chapter4
Tel. +39 -02 36795940
Elena Santoro - santoro@chapter4.it
Flavia Testorio - testorio@chapter4.it

Tietoja julkaisijasta

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

 5G Arrives in Asia as Operators Invest Billions Rolling out Next Generation Networks, Finds New GSMA Study26.6.2019 04:00:00 EESTTiedote

Asia’s mobile operators are set to invest $370 billion building-out new 5G networks between 2018 and 2025, according to the latest Asia Pacific edition of the GSMA’s Mobile Economy series, published at MWC19 Shanghai today. The world’s first nationwide 5G networks went live in South Korea earlier this year, and it is anticipated that 24 Asia Pacific markets will have launched 5G by 2025. It is forecast that 5G will contribute almost $900 billion to the region’s economy over the next 15 years. China is currently testing 5G across all major cities and provinces, including Shanghai, ahead of commercial launches next year. It is forecast that 28 per cent of China’s mobile connections will be running on 5G networks by 2025, accounting for about a third of all 5G connections globally by this point. “Although 4G still has plenty of headroom for growth across Asia, operators in the region are now investing billions in building-out advanced 5G networks that are facilitating an array of new serv

Phunware Offers Phun Utility Token Globally26.6.2019 03:48:00 EESTTiedote

Phunware, Inc. (NASDAQ: PHUN) (the “Company”), a fully-integrated enterprise cloud platform for mobile that provides products, solutions, data and services for brands worldwide, announced that Phun utility tokens are now available for purchase in international markets. “Phun is a new utility token that enables the international community to participate in our blockchain-enabled data exchange and mobile loyalty ecosystem as we drive towards mainstream global adoption and future exchange listings,” said Randall Crowder, Chief Operating Officer of Phunware. Phunware is an Austin, Texas, headquartered Company with 10 years of success working with the world’s largest organizations. Whether it is enabling immersive gaming and movie experiences for Paramount Pictures International, powering Juniper, Cisco or HP Aruba hardware for app-enabled location services or integrating Electronic Health Records (EHRs) like Epic or Cerner for patient experiences in healthcare, Phunware’s Multiscreen as a

CORRECTING and REPLACING I Squared Capital to Sell Cube Hydro to Ontario Power Generation26.6.2019 02:02:00 EESTTiedote

Sixth paragraph should read: Centerview Partners acted as financial advisor and Sidley Austin LLP, Troutman Sanders LLP, and Davis Polk & Wardwell LLP served as legal counsel to I Squared Capital on this transaction (instead of Centerview Partners acted as financial advisor and Sidley Austin LLP, Troutman Sanders LLP, and David Polk & Wardwell LLP served as legal counsel to I Squared Capital on this transaction). The corrected release reads: I SQUARED CAPITAL TO SELL CUBE HYDRO TO ONTARIO POWER GENERATION I Squared Capital, through its ISQ Global Infrastructure Fund I, announced today that it has reached an agreement to sell its hydropower platform, Cube Hydro Partners and its affiliate, Helix Partners (taken together, Cube Hydro), to Ontario Power Generation (OPG) through its U.S. hydroelectric platform. Cube Hydro owns 385 megawatts of hydro capacity on ten river systems in five states, with 19 small to mid-sized, run-of-the-river and peaking hydro plants. “This is the third portfoli

Results of the MSCI 2019 Market Classification Review26.6.2019 01:15:00 EESTTiedote

MSCI Inc. (NYSE:MSCI), a leading provider of critical decision support tools and services for the global investment community, announces today that it will reclassify the MSCI Kuwait Index to Emerging Markets status, subject to omnibus account structures and same National Investor Number (NIN) cross trades being made available for international institutional investors before the end of November 2019. MSCI will communicate its final decision by December 31, 2019. “Kuwait’s Market Development Project has set the path for the seamless implementation of numerous regulatory and operational enhancements in the Kuwaiti equity market. These enhancements have significantly increased the accessibility level of the Kuwaiti equity market for international institutional investors and resulted in broad positive feedback from these investors on our reclassification proposal,” said Sebastien Lieblich, Global Head of Equity Solutions and Chairman of the MSCI Equity Index Committee. Mr. Lieblich added,

I Squared Capital to Sell Cube Hydro to Ontario Power Generation25.6.2019 22:41:00 EESTTiedote

I Squared Capital, through its ISQ Global Infrastructure Fund I, announced today that it has reached an agreement to sell its hydropower platform, Cube Hydro Partners and its affiliate, Helix Partners (taken together, Cube Hydro), to Ontario Power Generation (OPG) through its U.S. hydroelectric platform. Cube Hydro owns 385 megawatts of hydro capacity on ten river systems in five states, with 19 small to mid-sized, run-of-the-river and peaking hydro plants. “This is the third portfolio company realization in the last twelve months based on the I Squared Capital platform approach, with a total of over $2.8 billion in realized enterprise value,” said Sadek Wahba, Chairman and Managing Partner of I Squared Capital. The other two platforms developed and recently sold by I Squared Capital include Lincoln Clean Energy (a leading onshore wind developer in the U.S. with 800 megawatts) to Ørsted, and Amplus Solar (the preeminent provider of rooftop solar systems for the Indian commercial and in

AerSale Acquires Qwest Air Parts, Inc. to Expand Airframe Parts Sales25.6.2019 22:03:00 EESTTiedote

AerSale ®, a global supplier of aircraft, engines, used serviceable material (USM), and maintenance, repair, and overhaul (MRO) services, announced today it has acquired aircraft parts distributor Qwest Air Parts, Inc. Based in Memphis, Tennessee, Qwest is a recognized leader in aircraft dismantlement and the refurbishment and resale of USM. Qwest has disassembled over 200 aircraft, offers 24/7 AOG service, and operates a teardown facility in Crestview, Florida. Gary Jones, Qwest’s founder, President and CEO, will continue to lead Qwest, which will operate as a stand-alone independent subsidiary of AerSale. The acquisition of Qwest will add scale and reach to AerSale’s already significant airframe USM offerings. Furthermore, Qwest’s recently certified repair station, Q2 Aviation LLC, will supplement AerSale’s growing MRO platform. “As a proven leader in aircraft parts distribution, Qwest is an optimal partner to help further expand our large inventory of high-demand USM, which we cost-

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