SAN DIEGO, Dec. 8, 2016 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (NASDAQ:OREX) today announced that its wholly
owned subsidiary Orexigen Therapeutics Ireland Ltd. and Consilient
Health Ltd. have executed a commercialization and distributorship
agreement for Mysimba® (naltrexone HCl / bupropion HCl prolonged
release) in the UK and Ireland.
Mysimba is approved by the European Medicines Agency, as an adjunct
to a reduced-calorie diet and increased physical activity, 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). Founded in 2005,
Consilient is one of the fastest growing pharmaceutical companies
in the UK with sales and marketing teams dedicated to working with
primary care prescribers and payers across the UK and Ireland.
"Consilient has a strong presence in primary care, notably in
women's health and bone health, and we are pleased to work with
them for the commercialization of Mysimba in the UK and
Ireland," said Michael Narachi, CEO of Orexigen. "With this
agreement, we continue to expand availability of Mysimba in
Europe, where the drug is already
approved, and have signed an agreement that will increase product
revenue in 2017. We continue to accelerate the progress on our
ex-U.S. commercial strategy by expanding the availability of
Contrave® and Mysimba for patients and physicians with agreements
that support the drug's commercialization in additional territories
worldwide."
Orexigen's strategy outside the U.S. is to establish commercial
and distribution partnerships in which Orexigen and the local
partner share value equally. Under the terms of the agreement with
Consilient, Consilient will be responsible for all
commercialization activity and expenses. Orexigen will supply
Mysimba tablets to Consilient for a transfer price and potential
regulatory and commercial milestone payments. Consilient expects
Mysimba to be available in the UK and Ireland in the second quarter of 2017.
Ahmed Al-Derzi, Chief Executive
Officer of Consilient, said, "We are very excited to have the
opportunity to bring Mysimba to patients in the UK and Ireland. Obesity is a significant and growing
issue in our countries, and Mysimba is an important new therapy to
help address the problem. The product fits well with our focus on
bringing innovative solutions for unmet patient needs and
leveraging our team's strong skills in successfully launching new
prescription medicines."
Obesity and related comorbidities are a significant health
problem in the UK and Ireland. According to the World Health
Organization, 28.1% of adults in the UK and 25.6% of adults in
Ireland are obese.1 The
rate of obesity has more than doubled in the last 25 years,
according to the UK Government Office for Science. The NHS
estimates direct costs attributable to overweight and obesity in
the UK are projected to reach £10 billion per year by 2050 and that
wider costs to society and business are estimated to reach £49.9
billion per year.2
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 Consilient Health Ltd.
Consilient Health was
established in 2005 and has its headquarters in Ireland. The
company is an independent, dynamic and rapidly growing
pharmaceutical company with a successful portfolio in Women's
Health, Bone Health and generic products. With operations in the
UK, Ireland and the Nordics,
Consilient Health delivers quality, reliability and value for all
its customers. www.consilienthealth.com.
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 and became the most prescribed
branded obesity medication in the United
States in June 2015. 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
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 and
timing of commercialization of Mysimba in the UK and Ireland; the potential for the sale of Mysimba
in the UK and Ireland to increase
product revenue in 2017; the potential to receive regulatory and
commercial milestone payments from Consilient; 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 will not be successful, particularly in the U.S.; the
capabilities of our existing distribution partners and the ability
to obtain partnerships and marketing authorizations globally;
competition in the global obesity market, particularly from
existing therapies; additional analysis of the interim results or
the final data from the terminated Light Study, including
safety-related data, and the additional CVOT may produce negative
or inconclusive results, or may be inconsistent with the conclusion
that the interim analysis was successful; our ability to retain
ownership of Contrave and Mysimba and create value in certain
markets outside of the United
States; 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 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; the therapeutic and commercial value of Contrave; our
ability to successfully acquire, develop and market additional
product candidates or approved products; our ability to maintain
sufficient capital to fund our operations for the foreseeable
future; estimates of the capacity of manufacturing and other
facilities to support Contrave; 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-Q filed with the Securities and
Exchange Commission on November 7,
2016 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.
SOURCE Orexigen Therapeutics, Inc.
References:
- WHO Global Health Observatory data repository
http://apps.who.int/gho/data/view.main.2450A?lang=en. Accessed
6 Dec 2016.
- Government Office for Science Tackling obesities: future
choices – project report (2nd ed.) 17 October 2007
Contacts:
Jason Keyes
Chief Financial Officer
Orexigen Therapeutics, Inc.
+1-858-875-8600
jkeyes@orexigen.com
Julie Normart
BrewLife (Media Contact for Orexigen)
+1-415-946-1087
jnormart@brewlife.com
Ahmed Al- Derzi
Chief Executive Officer
Consilient Health Limited
+44 (0)203 751 1888
Louise Blakeborough
Chapter Five (Media Contact for Consilient Health Ltd)
+44 (0)7831 444789
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SOURCE Orexigen Therapeutics, Inc.