Shionogi and Ferrer Conclude a Contract for the Promotion in Spain of ▼ RIZMOIC® (naldemedine), a Therapeutic Agent for Opioid-Induced Constipation

AMSTERDAM & BARCELONA, Spain–(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 Ferrer (Headquarters: Barcelona, Spain; CEO: Mario
Rovirosa) announced today that Shionogi and Ferrer concluded an
exclusive promotion agreement for RIZMOIC® (naldemedine) in
Spain for the treatment of opioid-induced constipation (OIC) in adult
patients previously treated with a laxative.

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 therapeutic areas of interest. 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

Ferrer’s activity covers the entire health spectrum in Spain and many
other countries worldwide, including expertise in pain management by
opioid treatment. The company’s strong commitment to improving the
wellbeing of society and its integrated model spanning from R&D through
to distribution, ensures their range of products offer real benefits in
rapidly changing environments.

Dr. John Keller, Chief Executive Officer of Shionogi B.V., the
subsidiary of Shionogi in Europe, said “We are delighted to
collaborate with Ferrer in Spain. This collaboration marks an additional
key milestone for the launch of RIZMOIC®
Europe. Ferrer is a company that is well trusted and highly respected,
with not only an established commercial structure that is ideal for the
introduction of RIZMOIC
®, but also a deep knowledge of
pain management that augments and aligns with our own.”

Ferrer’s Chief Executive Officer, Mario Rovirosa, commented, “We are
pleased to partner with Shionogi on this promising treatment which has
the potential to make a real impact on the lives of many people
currently suffering from OIC across Spain. This partnership allows us to
introduce an innovative treatment to reduce the burden in this disease
area. Moreover, this agreement complements our expertise in the field of
pain relief”.

On February 18, 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 Spain 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


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.6 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.7 In patients
receiving opioid therapy for chronic non-cancer pain, the prevalence of
OIC ranges from approximately 40-60 percent.8

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.9-13
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.

▼ This medicinal product is subject to additional monitoring. Detailed
information on this medicinal product is available on the website of the
European Medicines Agency

About Shionogi
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, gynaecology 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
Shionogi B.V. is the European subsidiary of Shionogi & Co., Ltd. based
in Amsterdam, Netherlands. For more information on Shionogi B.V. please

About Ferrer
Founded in Spain in 1959, Ferrer is a
privately-held international pharmaceutical company headquartered in
Barcelona. It is active throughout the full value chain, from R&D to
international distribution. It is present in more than 110 countries,
with 19 international affiliates. Ferrer is active in the
pharmaceutical, health, fine chemical and food sectors, key areas for
contributing to people’s health and wellbeing. Since the beginning,
Ferrer has been committed to the research and development of innovative
medicinal products and to maintain a solid industrial structure.
Ferrer’s activity across the entire healthcare spectrum includes
prescription drugs, hospital products and diagnostics. For more
information on Ferrer, please visit

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

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:
[Accessed 20 May 2019].
Release on June 7, 2017

Opioid-Induced Constipation therapeutic
agent ‘Symproic® (naldemedine) Tablets 0.2mg’ launched in
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
Release on April 11, 2019

Shionogi Announces Licensing of
Symproic® (naldemedine) to BioDelivery Sciences International
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.
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.
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 opioid induced constipation: A pooled subgroup analysis of 2
randomised placebo-controlled studies. Ann Oncol. 2018. 29 (suppl 8).


Shionogi Europe
Dr. Mark Hill, Shionogi,
Korn, Shionogi,

Shionogi & Co., Ltd.
Corporate Communications Department

Ferrer BD and Licensing
Ana Aliaga, Ferrer,

Ferrer Corporate Communications
Gorka Ortiz de Zárate,

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