SAN DIEGO, March 12, 2018 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (NASDAQ: OREX), a biopharmaceutical company
focused on the treatment of obesity, announced today that it has
elected to file a voluntary petition under Chapter 11 of the
Bankruptcy Code in the U.S. Bankruptcy Court for the District of
Delaware. Orexigen also intends to
file a motion seeking authorization to pursue an auction and sale
process under Section 363 of the U.S. Bankruptcy Code. The proposed
bidding procedures, if approved by the court, would require
interested parties to submit binding offers to acquire
substantially all of Orexigen's assets, which would be purchased
free and clear of the company's indebtedness and other liens and
interests. Such parties could include strategic and financial
buyers, and the process is expected to proceed according to the
following timeline:
- Bids expected to be submitted by May 21,
2018
- Structured auction targeted to commence no later than
May 24, 2018
- Sale intended to be concluded by July 2,
2018
"The Board and management team have thoroughly assessed all of
our strategic options and believe that this process represents the
best possible solution for Orexigen, taking into account our
financial needs," said Michael
Narachi, President and CEO of Orexigen. "While we have been
working closely with our noteholders and have the support of a
controlling number of senior secured noteholders, our debt covenant
requirements and near-term cash flow needs have necessitated the
protection afforded by a court-driven process."
Narachi continued, "Orexigen was founded on the premise of
helping to improve the health and lives of patients struggling to
lose weight. This mission has been at the core of creating
patient-centric solutions that help customers and patients in
meaningful and relevant ways. Since the launch of Contrave, nearly
800,000 patients in the U.S. have benefitted1, and,
through a successful transaction process, we intend that this
growing patient demand will continue to be served."
Orexigen has filed a series of motions with the court seeking to
ensure the continuation of normal operations during this process.
Orexigen has the support of a controlling number of its senior
secured noteholders for this process, who have made a $35 million financing commitment. The company
believes that this commitment provides it with sufficient liquidity
to conduct its business in an uninterrupted manner, fund its
chapter 11 case, including the sale of its assets, and to continue
to meet its operational and financial obligations, including:
continued servicing of distributors, wholesalers and global
partners to ensure timely fulfillment of orders and shipments of
Contrave® (naltrexone HCl and bupropion HCl extended
release)/Mysimba™ (naltrexone HCl and bupropion HCl prolonged
release); the timely payment of employee wages and salaries; and
satisfaction of other obligations to patients and physicians who
depend on this important therapy. In addition, to attempt to
preserve the value of its net operating losses, Orexigen has filed
a motion with the court to establish limitations on trading in
Orexigen's common stock by beneficial owners of at least 4.5% of
Orexigen's common stock during the pendency of the bankruptcy
proceedings.
Additional information about this process and proposed asset
sale, as well as other documents related to the restructuring and
reorganization proceedings, is available through Orexigen's claims
agent Kurtzman Carson Consultants LLC at
www.kccllc.net/orexigen.
Orexigen's legal counsel is Hogan Lovells US LLP and its
financial advisors are Perella Weinberg Partners LP and Ernst &
Young LLP.
The petition was filed in United
States Bankruptcy Court for the District of Delaware, Case No. 18-10518.
Recent Business Highlights
- Contrave is the No.1 prescribed weight loss brand in the
U.S.
- >2.3M prescriptions have been
written in the U.S. since launch
- >100,000 unique U.S. prescribers of Contrave since
launch
- 23% year-over-year TRx growth in the U.S. in 2017
- 21% year-over-year TRx growth in the U.S. in 2018 to date
- All-time highs in weekly TRx volume (19,247), branded TRx
market share (48.7%) and telemedicine/home delivery volume (2,288)
achieved in early March 2018
- 2017 U.S. Contrave net sales of ~$75M compared to ~$47M2 in 2016
- 2017 global supply revenue from international partners of
~$13M compared to ~$5M in 2016
- Implemented streamlined and innovative U.S. commercial model,
with expected annual savings of ~$40M
in 2018, under the current plan, compared to 2017
- Launched in 24 of 68 partnered countries, with an additional 14
launches currently planned in 2018
- U.S. market exclusivity solidified through 2030 following
favorable ruling in patent litigation
- Recent FDA acceptance of a significantly more efficient
approach for completion of a cardiovascular outcomes post marketing
requirement
- Source: IQVIA NPA data Sept 2014
through Jan 2018 and the IQVIA
Persistence and Adherence study conducted June 2016
- Includes net sales as reported by our former partner pursuant
to the terms of our former collaboration agreement for periods
prior to the completed acquisition of Contrave, coupled with net
sales as recorded by Orexigen after the completed acquisition of
Contrave.
About Contrave and Mysimba
Contrave, marketed as Mysimba in the European Union, is a
prescription-only, FDA-approved weight-loss medication believed to
work on two areas of the brain—the hunger center and the reward
system—to reduce hunger and help control cravings. The exact
neurochemical effects of Contrave/Mysimba leading to weight loss
are not fully understood. Contrave/Mysimba contains two medicines,
bupropion, a relatively weak inhibitor of the neuronal reuptake of
dopamine and norepinephrine and naltrexone, an opioid
antagonist.
Contrave, approved by the FDA in September 2014, is indicated 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 European Union, Mysimba was approved in
March 2015.
Orexigen is committed to helping eligible patients learn about
Contrave and recommends patients in the U.S. visit www.contrave.com
for additional information.
For full U.S. prescribing information please visit
www.contrave.com.
Important Safety Information for CONTRAVE and MYSIMBA (per
U.S. prescribing information)
(naltrexone HCl and bupropion HCl) 8 mg/90 mg
extended-release tablets
One of the ingredients in CONTRAVE, bupropion, may increase
the risk of suicidal thinking in children, adolescents, and young
adults. CONTRAVE patients should be monitored for suicidal
thoughts and behaviors. In patients taking bupropion
for smoking cessation, serious neuropsychiatric adverse events have
been reported. CONTRAVE is not approved for use in children
under the age of 18.
Stop taking CONTRAVE and call a healthcare provider right
away if you have any of the following symptoms, especially if they
are new, worse, or worry you: thoughts about suicide or dying;
attempts to commit suicide; depression; anxiety; feeling agitated
or restless; panic attacks; trouble sleeping (insomnia);
irritability; aggression, anger, or violence; acting on dangerous
impulses; an extreme increase in activity and talking (mania);
other unusual changes in behavior or mood.
Do not take CONTRAVE if you have uncontrolled high blood
pressure; have or have had seizures; use other medicines that
contain bupropion such as WELLBUTRIN, APLENZIN or ZYBAN; have or
have had an eating disorder; are dependent on opioid pain medicines
or use medicines to help stop taking opioids such as methadone or
buprenorphine, or are in opiate withdrawal; drink a lot of alcohol
and abruptly stop drinking; are allergic to any of the ingredients
in CONTRAVE; or are pregnant or planning to become pregnant.
Before taking CONTRAVE, tell your healthcare provider about
all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
Do not take any other medicines while you are taking CONTRAVE
unless your healthcare provider says it is okay.
Tell your healthcare provider about all of your medical
conditions including if you have: depression or other mental
illnesses; attempted suicide; seizures; head injury; tumor or
infection of brain or spine; low blood sugar or low sodium; liver
or kidney problems; high blood pressure; heart attack, heart
problems, or stroke; eating disorder; drinking a lot of alcohol;
prescription medicine or street drug abuse; are 65 or older;
diabetes; pregnant; or breastfeeding.
CONTRAVE may cause serious side effects, including:
Seizures. There is a risk of having a seizure when
you take CONTRAVE. If you have a seizure, stop taking CONTRAVE,
tell your healthcare provider right away.
Risk of opioid overdose. Do not take large amounts
of opioids, including opioid-containing medicines, such as heroin
or prescription pain pills, to try to overcome the opioid-blocking
effects of naltrexone.
Sudden opioid withdrawal. Do not use any type of
opioid for at least 7 to 10 days before starting
CONTRAVE.
Severe allergic reactions. Stop taking CONTRAVE and
get medical help immediately if you have any signs and symptoms of
severe allergic reactions: rash, itching, hives, fever, swollen
lymph glands, painful sores in your mouth or around your eyes,
swelling of your lips or tongue, chest pain, or
trouble breathing.
Increases in blood pressure or heart rate.
Liver damage or hepatitis. Stop taking CONTRAVE if
you have any symptoms of liver problems: stomach area pain lasting
more than a few days, dark urine, yellowing of the whites of your
eyes, or tiredness.
Manic episodes.
Visual problems (angle-closure glaucoma). Signs and
symptoms may include: eye pain, changes in vision, swelling or
redness in or around the eye.
Increased risk of low blood sugar (hypoglycemia) in people
with type 2 diabetes mellitus who also take medicines to treat
their diabetes (such as insulin or sulfonylureas).
The most common side effects of CONTRAVE include nausea,
constipation, headache, vomiting, dizziness, trouble sleeping, dry
mouth, and diarrhea.
These are not all the possible side effects of CONTRAVE. Tell
your healthcare provider about any side effect that bothers you or
does not go away.
Use of CONTRAVE
CONTRAVE is a prescription weight-loss medicine that may help
some adults with a body mass index (BMI) of
30 kg/m2 or greater (obese), or adults with a BMI
of 27 kg/m2 or greater (overweight) with at least
one weight-related medical problem such as high blood pressure,
high cholesterol, or type 2 diabetes, lose weight and keep the
weight off.
- CONTRAVE should be used with a reduced-calorie diet and
increased physical activity
- It is not known if CONTRAVE changes your risk of heart problems
or stroke or of death due to heart problems or stroke
- It is not known if CONTRAVE is safe and effective when taken
with other prescription, over-the-counter, or herbal weight-loss
products
CONTRAVE is not approved to treat depression or other mental
illnesses, or to help people quit smoking (smoking
cessation). One of the ingredients in CONTRAVE, bupropion, is
the same ingredient in some other medicines used to treat
depression and to help people quit smoking.
Ask your doctor or healthcare professional if CONTRAVE is
right for you. Please see Full Prescribing
Information, including Medication Guide,
for CONTRAVE.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1‑800‑FDA‑1088.
About Obesity & Weight Loss
Obesity is a serious and rising health epidemic and has been
declared a disease by the American Medical Association. It is
estimated that about 110 million adults are overweight or
struggling with obesity; however, only 3% are treated with a
prescription weight loss medicine. By 2030, the percentage of
Americans who struggle with obesity could reach 51 percent.
Obesity can increase the risk of heart disease, type 2 diabetes,
some types of cancer, sleep apnea, and a variety of other
conditions. Weight loss is complex and for many people diet
and exercise alone may not be enough. Two areas of the brain
play an important role in weight loss. The hypothalamus, your
hunger center, regulates hunger and the mesolimbic reward system
can cause cravings even when you are not hungry. Other areas
of the brain may be involved.
About Orexigen Therapeutics,
Inc.
Orexigen Therapeutics, Inc. is a biopharmaceutical
company focused on the treatment of weight loss and obesity.
The company's mission is to help improve the health and lives of
patients struggling to lose weight. Orexigen's first product,
Contrave® (naltrexone HCl and bupropion HCl extended release), was
approved in the U.S. in September 2014. In the European
Union, the medicine has been approved under the brand name Mysimba™
(naltrexone HCl/ bupropion HCl prolonged release). Millions around
the globe continue to face challenges of weight loss.
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.
As a patient-centric company, Orexigen continues to focus not
only on innovating medicine for the treatment of obesity, but to
also offer unique resources and healthcare delivery options to
improve the patient experience. 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 the company's
current beliefs and expectations. These forward-looking
statements include statements regarding: the company's plans to
sell substantially all of its assets pursuant to Chapter 11 of the
U.S. Bankruptcy Code and its expectation that the auction process
will enable the company to sell those assets in an orderly manner
and maximize value for the company's stakeholders; the potential
success of marketing and commercialization of Contrave/Mysimba in
the United States and elsewhere;
the continued supply of Contrave to distributors, wholesalers,
global partners and patients; expectations regarding Orexigen's
future sales and potential future growth; and other statements
regarding the company's strategy and future operations, performance
and prospects.
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 various risks and
uncertainties, including, without limitation: the potential adverse
impact of the Chapter 11 filings on the company's liquidity and
results of operations; changes in the company's ability to meet its
financial obligations during the Chapter 11 process and to maintain
contracts that are critical to its operations; the outcome and
timing of the Chapter 11 process and the proposed auction and asset
sale; the effect of the Chapter 11 filings and proposed asset sale
on the company's relationships with vendors, regulatory
authorities, employees and other third parties; possible
proceedings that may be brought by third parties in connection with
the Chapter 11 process or the proposed asset sale; uncertainty
regarding obtaining bankruptcy court approval of a sale of the
company's assets or other conditions to the proposed asset sale;
the timing or amount of any distributions to the company's
stakeholders; and other risks described in the company'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.
Further information regarding these and other risks impacting
the company are included under the heading "Risk Factors" in
Orexigen's Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on November
14, 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.
Orexigen Investor Contact:
Tom Lynch
EVP, Chief Administrative Officer & General Counsel
+1-858-875-8600
investorrelations@orexigen.com
Orexigen Media Contact:
Erika Hackmann
Y&R
+1-917-538-3375
erika.hackmann@yr.com
Sale Process Contact:
Perella Weinberg Partners LP
Peter Schwaikert
(646) 708-8780
pschwaikert@pwpartners.com
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SOURCE Orexigen Therapeutics, Inc.