SAN DIEGO, Aug. 1, 2016 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (NASDAQ:OREX) today announced that wholly owned
subsidiary Orexigen Therapeutics Ireland Ltd. and Laboratorios
Farmacéuticos Rovi, S.A. (ROVI) have executed a commercialization
and distributorship agreement for Mysimba® (naltrexone HCl /
bupropion HCl prolonged release) in Spain. 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). Founded in 1946 and headquartered in Madrid, Spain, ROVI has a diversified
pharmaceutical portfolio.
"We are excited to work with ROVI to bring Mysimba to the
Spanish market as a differentiated new treatment option to address
the significant and growing problem of obesity there," said
Michael Narachi, CEO of Orexigen.
"With this agreement, Orexigen's first in Western Europe, we are continuing to execute
on the company's ex-U.S. commercial strategy to expand the
availability of Contrave® and Mysimba for patients and physicians
by establishing agreements that support the drug's
commercialization in additional territories worldwide."
Juan López-Belmonte Encina, Chief
Executive Officer of ROVI, commented: "We are very excited to offer
specialist physicians this new pharmacological alternative for
treating obesity. Obesity is a modern disease which is becoming
increasingly prevalent among the adult population. This new
partnership advances our long-term objective to improve patients'
quality of life. In addition, we expect Mysimba to contribute to
the Group's revenue in the next few years, strengthening our
specialty pharmaceutical product portfolio."
Orexigen's ex-U.S. strategy is to establish commercial and
distribution partnerships in which Orexigen and the local partner
share value equally. Under the terms of the ROVI agreement, ROVI
will be responsible for all commercialization activity and
expenses. Orexigen will supply Mysimba tablets to ROVI for an
upfront fee, a transfer price, and various potential commercial
milestone payments. ROVI expects to begin marketing Mysimba by
year-end 2016.
Obesity and related comorbidities are a significant health
problem in Spain, where
approximately 53% of adults are overweight or obese, according to
recent statistics from the National Health Institute.
About Pharmaceutical Laboratories ROVI, SA
Laboratorios Farmacéuticos Rovi, S.A. is an integrated and
specialized Spanish pharmaceutical company engaged in the research,
development, manufacturing and commercialization of small molecules
and biological medical specialties, both its own pharmaceutical
products and products licensed externally from companies including
Servier, Novartis and Merck. ROVI has commercial expertise across
therapeutic areas including endocrinology, cardiology and
respiratory, among others. ROVI was founded in 1946 and reported
revenues exceeding €246M in 2015.
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.
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 the growth of the obesity problem in
Spain; the potential for Mysimba
to contribute to the Group's revenue in the next few years; the
potential for ROVI to begin marketing Mysimba in Spain by year-end 2016. 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. following the
transition from Takeda; 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 May 6,
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.
Contacts:
McDavid Stilwell
Corporate Communications and Business Development
Orexigen Therapeutics, Inc.
+1-858-875-8629
mstilwell@orexigen.com
Julie Normart
BrewLife (Media Contact for Orexigen)
+1-415-946-1087
jnormart@brewlife.com
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SOURCE Orexigen Therapeutics, Inc.