SAN DIEGO, March 27, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (NASDAQ: OREX) today announced that its wholly
owned subsidiary, Orexigen Therapeutics Ireland Ltd., and Bruno
Farmaceutici S.p.A. (Bruno) have executed a distributorship
agreement for Mysimba® (naltrexone HCl / bupropion HCl
prolonged release) in Italy.
Mysimba is approved by the European Medicines Agency for the
management of weight in adult patients (≥18 years) with an initial
Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2
to < 30 kg/m2 (overweight) in the presence of one or more
weight-related co-morbidities (e.g., type 2 diabetes,
dyslipidaemia, or controlled hypertension). Bruno
manufactures and markets pharmaceutical products including drugs
for treatment of diabetes.
"Bruno Farmaceutici S.p.A. is an outstanding partner to bring
Mysimba to the Italian market," said Mike
Narachi, CEO of Orexigen. "This agreement, our fourth
partnership in Europe, brings us
into another major European market. As we continue to advance
our ex-U.S. commercialization strategy, we now have partnerships in
a total of 39 countries worldwide and strong alliance management
capabilities to support our partners in bringing
Contrave® and Mysimba to patients who struggle to lose
weight."
Under the terms of the agreement, Bruno will be responsible for
all commercialization activity and expenses. Orexigen will
supply Mysimba to Bruno for a negotiated transfer price and upfront
milestone payments at signing and first commercial sale.
Additional payments will be based on sales levels. Bruno
expects that Mysimba will be available for patients in Italy in the fourth quarter of this year.
Obesity and related comorbidities are a significant health
problem in Italy, where over 40%
of adults are overweight or struggle with obesity, according to the
Organisation of Economic Co‑operation and Development
(OECD)1. The World Health
Organization2 predicts that obesity rates will continue
to climb in Italy.
About Bruno Farmaceutici S.p.A.
Bruno Farmaceutici
S.p.A., based in Rome, Italy, is a
privately owned pharmaceutical company that has a commercial
presence in Diabetes, Cardiology and Endocrinology. Bruno
currently markets over 25 prescription products in the Italian
market and also has active partnerships with MerckSerono, Alcon and
Ferrer.
About Mysimba
Mysimba is approved in the European
Union for use as an adjunct to a reduced-calorie diet and increased
physical activity for chronic weight management in adults with an
initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27
kg/m2 or greater (overweight) in the presence of at least one
weight-related comorbid condition (e.g., hypertension, type 2
diabetes mellitus or dyslipidemia). In the United States, the drug is approved as
Contrave (naltrexone HCl / bupropion HCl extended release).
The exact neurochemical effects of Mysimba / Contrave leading to
weight loss are not fully understood. Mysimba / Contrave has two
components: naltrexone, an opioid antagonist, and bupropion, a
relatively weak inhibitor of the neuronal reuptake of dopamine and
norepinephrine. Nonclinical studies suggest that naltrexone and
bupropion have effects on two separate areas of the brain involved
in the regulation of food intake: the hypothalamus (appetite
regulatory center) and the mesolimbic dopamine circuit (reward
system).
Four 56-week multicenter, double-blind, placebo-controlled Phase
3 clinical trials were conducted to evaluate the effect of Mysimba
/ Contrave in conjunction with lifestyle modification in 4,536
subjects randomized to Mysimba / Contrave or placebo. In these
studies, the most common adverse reactions (>5 percent) seen in
patients taking Mysimba / Contrave included nausea, constipation,
headache, vomiting, dizziness, insomnia, dry mouth, and
diarrhea.
The clinical trial program also included a double-blind,
placebo-controlled cardiovascular outcomes trial known as the Light
Study. The primary objective of this study was to evaluate
the occurrence of major adverse cardiovascular events (MACE) in
overweight and obese adults with cardiovascular risk factors
receiving Contrave. A second study, designed to address
post-approval requirements in both Europe and the
United States, is planned in order to further evaluate
cardiovascular outcomes.
About Orexigen Therapeutics
Orexigen
Therapeutics, Inc. is a biopharmaceutical company focused on
the treatment of obesity. Orexigen's first product,
Contrave® (naltrexone HCl and bupropion HCl extended
release), was approved in the United
States in September 2014. In the European Union, the
drug has been approved under the brand name Mysimba®
(naltrexone HCl/ bupropion HCl prolonged release). Orexigen
is undertaking a range of development and commercialization
activities, both on its own and with strategic partners, to bring
Contrave / Mysimba to patients around the world. Further
information about Orexigen can be found at www.orexigen.com
and further information about Contrave can be found at
www.contrave.com.
Forward-Looking Statements
Orexigen cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "indicates," "will," "should,"
"intends," "potential," "suggests," "assuming," "designed" and
similar expressions are intended to identify forward-looking
statements. These statements are based on our current beliefs and
expectations. These forward-looking statements include statements
regarding: the potential for Mysimba to improve the quality of life
for patients who are overweight or struggle with obesity; the
potential for and timing of commercialization of Mysimba by Bruno
in Italy; the expectation to progress with our ex-U.S.
commercial alliances in 2017; and the potential for a second study
to further evaluate cardiovascular outcomes of Mysimba. The
inclusion of forward-looking statements should not be regarded as a
representation by Orexigen that any of its plans will be achieved.
Actual results may differ materially from those expressed or
implied in this release due to the risk and uncertainties inherent
in the Orexigen business, including, without limitation: the
potential that the marketing and commercialization of
Contrave/Mysimba will not be successful, particularly, with respect
to Contrave, in the U.S. following the launch of the
patient-focused marketing campaign; the Company's ability to obtain
and maintain partnerships and marketing authorization globally; our
ability to adequately inform consumers about Contrave; our ability
to successfully commercialize Contrave with a specialty sales force
in the United States; our ability
to successfully complete the post-marketing requirement studies for
Contrave; the capabilities and performance of various third parties
on which we rely for a number of activities related to the
manufacture, development and commercialization of Contrave/Mysimba;
the therapeutic and commercial value of Contrave/Mysimba;
competition in the global obesity market, particularly from
existing and generic therapies; the Company's failure to
successfully acquire, develop and market additional product
candidates or approved products; our ability to obtain and maintain
global intellectual property protection for Contrave and Mysimba;
legal or regulatory proceedings against Orexigen, as well as
potential reputational harm, as a result of misleading public
claims about Orexigen; our ability to maintain sufficient capital
to fund our operations for the foreseeable future; the potential
for a Delaware court to determine
that one or more of the patents are not valid or that Actavis'
proposed generic product is not infringing each of the patents at
issue; and other risks described in Orexigen's filings with
the Securities and Exchange Commission. You are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and Orexigen undertakes no
obligation to revise or update this news release to reflect events
or circumstances after the date hereof, except as required by law.
Further information regarding these and other risks is
included under the heading "Risk Factors" in Orexigen's Annual
Report on Form 10-K which we intend to file with
the Securities and Exchange Commission on or about
March 29, 2017 and its other
reports, which are available from the SEC's website
(www.sec.gov) and on Orexigen's website (www.orexigen.com) under
the heading "Investors." All forward-looking statements are
qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of Section 21E of
the Private Securities Litigation Reform Act of 1995.
Contacts:
Jason Keyes
Chief Financial Officer
Orexigen Therapeutics, Inc.
+1-858-875-8600
jkeyes@orexigen.com
Erika Hackmann
Y&R PR (Media Contact for Orexigen)
+1-917-538-3375
erika.hackmann@yr.com
1 European Association for the Study of Obesity;
Obesity in Italy
http://easo.org/media-portal/country-spotlight/obesity-in-italy/.
Accessed March 21, 2017
2 World Health Organization; Nutrition, Physical
Activity and Obesity Italy
http://www.euro.who.int/__data/assets/pdf_file/0018/243306/Italy-WHO-Country-Profile.pdf.
Accessed March 21, 2017
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SOURCE Orexigen Therapeutics, Inc.