Lundbeck Completes Acquisition of Chelsea Therapeutics
NORTHERA™ (droxidopa) is expected to be available to patients in the U.S.
during the fall of this year
DEERFIELD, Ill. -- June 24, 2014
H. Lundbeck A/S (Lundbeck) today announced that it has completed its
acquisition of Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP)
(Chelsea) for USD 6.44 per share in cash and non-transferable contingent value
rights that may pay up to an additional USD 1.50 per share upon achievement of
certain sales milestones, in each case without interest and subject to any
required withholding of taxes. As a result of the acquisition, Chelsea became
a wholly-owned indirect subsidiary of Lundbeck, and shares of Chelsea common
stock will no longer be listed on the NASDAQ Capital Market.
“The acquisition of Chelsea and its lead therapy NORTHERA is a perfect fit for
Lundbeck in the U.S., given our track record supporting people living with
central nervous system (CNS) disorders that are often overlooked or
misunderstood,” said Staffan Schüberg, president of Lundbeck in the U.S. “Over
the past five years, we’ve brought three therapies to the U.S. for people
living with rare neurological disorders where there is a significant unmet
need – not only for therapies – but for education and resources. Similarly,
with today’s announcement, we’re ready to partner with healthcare
professionals, advocacy groups and families to support adults living with
symptomatic neurogenic orthostatic hypotension.”
Lundbeck expects to make NORTHERA available in the U.S. through specialty
pharmacies in the fall of 2014. NORTHERA was approved by the U.S. Food and
Drug Administration (FDA) in February 2014 and is indicated for the treatment
of orthostatic dizziness, lightheadedness, or the “feeling that you are about
to black out” in adult patients with symptomatic neurogenic orthostatic
hypotension caused by primary autonomic failure (Parkinson's disease, multiple
system atrophy, and pure autonomic failure), dopamine beta-hydroxylase
deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond two
weeks of treatment has not been demonstrated. The continued effectiveness of
NORTHERA should be assessed periodically.^1 Please see below for Important
Safety Information including NORTHERA’s boxed warning for supine hypertension.
Click here for NORTHERA Prescribing Information on the FDA’s DailyMed website.
NOH is a chronic condition that is caused by an underlying neurogenic
disorder, such as Parkinson's disease, multiple system atrophy or pure
autonomic failure.^2 Symptoms of NOH include dizziness, lightheadedness,
blurred vision, fatigue and fainting episodes when a person assumes a standing
“Our passion to bring NORTHERA to the U.S. has been fueled by the unmet need
among patients, pressing our sense of urgency throughout the clinical
development process,” said Joseph G. Oliveto, president & chief executive
officer of Chelsea Therapeutics. “We are thrilled that Lundbeck will carry
this passion forward, given the company’s track record of bringing therapies
to people with rare diseases, supporting patient communities and investing in
research, development and education.”
The NORTHERA approval was granted under the FDA’s accelerated approval
program, which allows for conditional approval of a medicine that fills a
serious unmet medical need, provided additional confirmatory studies are
“We applaud Chelsea’s expertise and diligence in securing FDA approval of
NORTHERA, and are eager to begin the next phase of the therapy’s clinical
development program,” said Torsten Madsen, chief medical officer and vice
president of U.S. Drug Development at Lundbeck. “Lundbeck’s team of physicians
and research scientists will partner with the neurology community to conduct
further studies aimed at better understanding the long-term use of NORTHERA.”
Individuals with questions about NORTHERA can reach Lundbeck at 855-351-2879.
About symptomatic neurogenic orthostatic hypotension (NOH)
Symptomatic NOH is a chronic condition that is caused by an underlying
neurogenic disorder, such as Parkinson's disease, multiple system atrophy or
pure autonomic failure.^2 Symptoms of NOH include dizziness, lightheadedness,
blurred vision, fatigue, and fainting episodes when a person assumes a
standing position.^2 These symptoms often impair activities that require
standing or walking for both short and long periods of time.^2,3 NOH is
commonly seen in patients with Parkinson’s disease, multiple system atrophy or
pure autonomic failure.^4
Important Safety Information
WARNING: SUPINE HYPERTENSION
Monitor supine blood pressure prior to and during treatment and more
frequently when increasing doses. Elevating the head of the bed lessens the
risk of supine hypertension, and blood pressure should be measured in this
position. If supine hypertension cannot be managed by elevation of the head of
the bed, reduce or discontinue NORTHERA.
WARNINGS AND PRECAUTIONS
*Supine Hypertension: NORTHERA therapy may cause or exacerbate supine
hypertension in patients with NOH, which may increase cardiovascular risk
if not well-managed.
*Hyperpyrexia and Confusion: Postmarketing cases of a symptom complex
resembling neuroleptic malignant syndrome (NMS) have been reported in
Japan with NORTHERA use. Observe patients carefully when the dosage of
NORTHERA is changed or when concomitant levodopa is reduced abruptly or
discontinued, especially if the patient is receiving neuroleptics. NMS is
an uncommon but life-threatening syndrome characterized by fever or
hyperthermia, muscle rigidity, involuntary movements, altered
consciousness, and mental status changes. The early diagnosis of this
condition is important for the appropriate management of these patients.
*Ischemic Heart Disease, Arrhythmias, and Congestive Heart Failure:
NORTHERA therapy may exacerbate symptoms in patients with existing
ischemic heart disease, arrhythmias, and congestive heart failure.
*Allergic Reactions: This product contains FD&C Yellow No. 5 (tartrazine),
which may cause allergic-type reactions (including bronchial asthma) in
certain susceptible persons. Although the overall incidence of FD&C Yellow
No. 5 (tartrazine) sensitivity in the general population is low, it is
frequently seen in patients who also have aspirin hypersensitivity.
*The most common adverse reactions (greater than 5%) were headache,
dizziness, nausea, hypertension, and fatigue.
*Administering NORTHERA in combination with other agents that increase
blood pressure (e.g., norepinephrine, ephedrine, midodrine and triptans)
would be expected to increase the risk for supine hypertension.
Dopa-decarboxylase inhibitors may require dose adjustments for NORTHERA.
USE IN SPECIFIC POPULATIONS
*Clinical experience with NORTHERA in patients with severe renal function
impairment (GFR less than 30 mL/min) is limited. There are no adequate and
well-controlled trials of NORTHERA in pregnant women. Women who are
nursing should choose nursing or NORTHERA. The safety and effectiveness of
NORTHERA in pediatric patients have not been established. No overall
differences in safety or effectiveness were observed between subjects aged
75 years and older and younger subjects in clinical trials, but greater
sensitivity of some older individuals cannot be ruled out.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company
specialized in brain diseases. For more than 50 years, we have been at the
forefront of research within neuroscience. Our development and distribution of
pioneering treatments continue to make a difference to people living with
brain diseases. Our key areas of focus are alcohol dependence, Alzheimer’s
disease, depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s
disease, schizophrenia and stroke.
Our approximately 6,000 employees in 57 countries are engaged in the entire
value chain throughout research, development, production, marketing and sales,
and are committed to improving the quality of life of people living with brain
diseases. Our pipeline consists of several late-stage development programs and
our products are available in more than 100 countries. We have research
centers in China, Denmark and the United States, and production facilities in
China, Denmark, France, Italy and Mexico. Lundbeck generated revenue of DKK
15.3 billion in 2013 (EUR 2.0 billion; USD 2.7 billion).
Lundbeck’s shares are listed on the stock exchange in Copenhagen under the
symbol “LUN”. Lundbeck has a sponsored Level 1 ADR program listed in the US
(OTC) under the symbol “HLUYY”. For additional information, we encourage you
to visit our corporate site www.lundbeck.com.
About Lundbeck in the U.S.
Based in Deerfield, Ill., Lundbeck U.S. was formed in 2009 as a wholly-owned
subsidiary of H. Lundbeck A/S in Denmark.With a focus on accelerating
advances in brain disorders, employees are engaged in the research,
development, production, marketing and sale of innovative therapies that
fulfill unmet medical needs among people living with challenging and sometimes
rare neurologic and psychiatric disorders. In its late-stage research
pipeline, the company has neurology compounds under investigation for
Alzheimer’s disease, stroke and epilepsy, in addition to therapies in
development for mental health disorders. With a special commitment to the
lives of patients, families and caregivers, Lundbeck actively engages in
hundreds of initiatives each year that support our patient communities. To
learn more, visit us at www.LundbeckUS.com and connect with us on Twitter at
Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our
expectations or forecasts of future events such as new product introductions,
product approvals and financial performance.
Such forward-looking statements are subject to risks, uncertainties and
inaccurate assumptions. This may cause actual results to differ materially
from expectations and it may cause any or all of our forward-looking
statements here or in other publications to be wrong. Factors that may affect
future results include interest rate and currency exchange rate fluctuations,
delay or failure of development projects, production problems, unexpected
contract breaches or terminations, government-mandated or market-driven price
decreases for Lundbeck's products, introduction of competing products,
Lundbeck's ability to successfully market both new and existing products,
exposure to product liability and other lawsuits, changes in reimbursement
rules and governmental laws and related interpretation thereof, unexpected
growth in costs and expenses, the possibility that the expected benefits of
the acquisition of Chelsea may not materialize as expected, the impact of the
current economic environment, fluctuations in operating results, market
acceptance of NORTHERA, and other risks that are described in Chelsea’s Annual
Report on Form 10-K for the year ended December 31, 2013 and Chelsea’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2014. Lundbeck
undertakes no obligation to update these forward-looking statements except to
the extent otherwise required by law.
Certain assumptions made by Lundbeck are required by Danish Securities Law for
full disclosure of material corporate information. Some assumptions, including
assumptions relating to sales associated with product that is prescribed for
unapproved uses, are made taking into account past performances of other
similar drugs for similar disease states or past performance of the same drug
in other regions where the product is currently marketed. It is important to
note that although physicians may, as part of their freedom to practice
medicine in the United States, prescribe approved drugs for any use they deem
appropriate, including unapproved uses, at Lundbeck, promotion of unapproved
uses is strictly prohibited.
^1 NORTHERA (droxidopa) [package insert]. Charlotte, NC: Chelsea Therapeutics,
Inc; February 2014.
^2 Freeman R. Neurogenic Orthostatic Hypotension. N Engl J Med.
^3 Kaufmann H, Malamut R, Norcliffe-Kaufmann L, et al. The Orthostatic
Hypotension Questionnaire (OHQ): Validation of a Novel Symptom Assessment
Scale. Clin Auton Res. 2012;22:79–90.
^4 Goldstein DS, Sharibi Y. Neurogenic Orthostatic Hypotension. Circulation.
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