AMSTERDAM & FLORENCE, Italy–(BUSINESS WIRE)–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.

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).

Contacts

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