-
Agreement with Shionogi to
commercialize Rizmoic® (naldemedine) in Germany, UK and
Netherlands, plus right of first refusal for certain other European
markets
-
Rizmoic® is an
innovative medicine for treating constipation caused by opioid pain
relief medicines, in patients who have previously been treated with
a laxative
-
Agreement reinforces Sandoz
anti-pain franchise and commitment to pioneer access to healthcare
in areas of unmet medical need
HOLZKIRCHEN, April 11 2019 -
Sandoz today announces that it has signed an agreement with
Shionogi & Co Ltd for commercialization of Rizmoic®
(naldemedine) in the key European markets of Germany, the UK and
the Netherlands, plus right of first refusal for certain other
European markets.
Rizmoic®, a once-daily
200-microgram oral tablet discovered and developed by Shionogi, is
an innovative medicine indicated to treat opioid induced
constipation (OIC) in adult patients previously treated with a
laxative. Shionogi announced on February 22, 2019 that it had
received EU marketing authorization for Rizmoic®.
OIC is a prevalent and distressing side-effect of
opioid therapy that does not respond reliably to treatment with
conventional laxatives[1].
"Our purpose at Sandoz is to pioneer access by
focusing increasingly on differentiated, value-added therapeutics
that can make a real difference when it comes to meeting unmet
medical needs," said Francesco Balestrieri, Sandoz CEO a.i.
He added: "This agreement represents a significant
step forward for that strategy and for patients in Europe,
reinforcing our long-term commitment to building a leading
anti-pain franchise and complementing our portfolio dedicated to
minimizing the side-effects of opioid use."
Sandoz has a strong presence in the European
market for anti-pain therapeutics, as well as a complementary
strategic focus on innovative therapeutic alternatives to combat
opioid dependency. This year saw the US launch of two such
products, including the first prescription digital therapeutic in
this field.
Under the terms of the agreement, Sandoz will be
responsible for commercializing Rizmoic® in
Germany, the UK and the Netherlands and Shionogi will be
responsible for its manufacturing and development. Further details
of the deal are not being disclosed.
About Rizmoic® (naldemedine)
Naldemedine is a peripherally-acting mu-opioid receptor antagonist
(PAMORA) that has been developed by Shionogi as a once-daily
treatment for OIC. The efficacy and safety of naldemedine have been
evaluated in randomized, double-blind, placebo-controlled studies
in adult OIC patients in different countries who have chronic
non-cancer pain or cancer. OIC is a change in bowel movements
caused by opioid therapy that is characterized by any of the
following: reduced bowel movement frequency, development or
worsening of straining to pass bowel movements, a sense of
incomplete rectal evacuation, or harder stool consistency [2].
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform
Act of 1995. Forward-looking statements can generally be identified
by words such as "drives," "portfolio," "commitment," "purpose,"
"pioneer," "focusing," "can," "step forward," "strategy,"
"commitment," "launch," "will," "may," "potential," or
similar terms, or by express or implied discussions regarding
potential launches, marketing clearances and authorizations, new
indications or labeling for naldemedine or the other products
described in this press release, or regarding potential future
revenues from such products or the collaboration with Shionogi.
Such forward-looking statements are based on our current beliefs
and expectations regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements.
You should not place undue reliance on these statements. There is
no guarantee that the collaboration with Shionogi will achieve any
or all of its intended goals and objectives, or within any
particular time frame. Neither can there be any guarantee that
naldemedine will be successfully launched in the defined European
markets, in the expected time frame, or at all. Nor can there be
any guarantee that naldemedine, the other products described in
this press release, or the collaboration with Shionogi will be
commercially successful in the future. In particular, our
expectations regarding such products and the collaboration with
Shionogi could be affected by, among other things, the
uncertainties inherent in research and development, including
clinical trial results and additional analysis of existing clinical
data; regulatory actions or delays or government regulation
generally; global trends toward health care cost containment,
including government, payor and general public pricing and
reimbursement pressures and requirements for increased pricing
transparency; the particular prescribing preferences of physicians
and patients; competition in general, including potential approval
of additional competing versions of such products; our ability to
obtain or maintain proprietary intellectual property protection;
litigation outcomes, including intellectual property disputes or
other legal efforts to prevent or limit each of Sandoz or Shionogi
from marketing its products; general political, economic and
industry conditions; safety, quality or production issues;
potential or actual data security and data privacy breaches, or
disruptions of our information technology systems, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About Sandoz
Sandoz, a Novartis division, is a global leader in generic
pharmaceuticals and biosimilars and a pioneer in the emerging field
of prescription digital therapeutics. Our purpose is to pioneer
access to healthcare by developing and commercializing novel,
affordable approaches that address unmet medical need. Our broad
portfolio of high-quality medicines, covering all major therapeutic
areas and increasingly focused on value-adding differentiated
medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is
headquartered in Holzkirchen, in Germany's Greater Munich
area.
Sandoz is on Twitter. Sign up to follow @Sandoz global at
http://twitter.com/Sandoz_Global.
References
[1] Coyne E, et al. Opioid-Induced constipation among patients with
chronic Non-cancer pain in the United States, Canada, Germany and
the United Kingdom: Laxative use, response and symptom burden over
time. Pain. 2015;16:1551-1565.)
[2] Camilleri M, Drossman D.A, Becker G, Webster L.R, Davies A.N,
Mawe G.M. Emerging treatments in neurogastroenterology: a
multi-disciplinary working group consensus statement on
opioid-induced constipation. Neurogastroenterology
Motil. 26, 1386 1395.
# # #
Novartis Media
Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric
Althoff |
|
Chris
Lewis |
|
Novartis
Global
Media Relations |
|
Sandoz
Global Communications |
|
+41 61
324 7999 (direct) |
|
+49 174
244 9501 (mobile) |
|
+41 79
593 4202 (mobile) |
|
chris.lewis@sandoz.com |
|
eric.althoff@novartis.com |
|
|
|
Novartis Investor
Relations
Central investor relations line: +41 61 324
7944
E-mail: investor.relations@novartis.com
Central |
|
North
America |
|
Samir
Shah |
+41 61
324 7944 |
Richard
Pulik |
+1 212
830 2448 |
Pierre-Michel Bringer |
+41 61
324 1065 |
Cory
Twining |
+1 212
830 2417 |
Thomas
Hungerbuehler |
+41 61
324 8425 |
|
|
Isabella
Zinck |
+41 61
324 7188 |
|
|
Media release (PDF)