SHIONOGI-B.V.

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.

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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).

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Contact:

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