Lundbeck and Merck sign exclusive commercialisation agreement for SYCREST® (asenapine) sublingual tablets in all markets outside of the United States, China and Japan
* SYCREST(®) received European Union (EU) approval from European Medicines
Agency (EMA) on 1 September, 2010 for the treatment of moderate to severe
manic episodes associated with bipolar I disorder in adults.
* The adult bipolar mania market in the European Union is still quite
undertreated - asenapine represents another treatment option for appropriate
patients within this undertreated population
* Lundbeck expects to launch SYCREST(®) in the EU at the beginning of 2011.
H. Lundbeck A/S (Lundbeck) and Merck & Co. (Merck), also known outside the
United States and Canada as MSD, today announced a commercialisation agreement
for SYCREST® (asenapine) sublingual tablets (5 mg, 10 mg). Under the terms of
the agreement, Lundbeck will pay an undisclosed fee as well as product supply
payments in exchange for exclusive commercial rights to SYCREST® in all markets
outside the United States, China and Japan. Lundbeck expects to launch SYCREST®
in the European Union (EU), where it is already approved at the beginning of
2011. Merck will retain exclusive commercial rights to asenapine in the United
States, China and Japan. Merck has launched asenapine in the United States under
the brand name SAPHRIS® (asenapine) sublingual tablets (5 mg, 10 mg).
"We are very pleased to be collaborating with Lundbeck on this important
commercial milestone. Lundbeck has extensive experience in psychiatry and is the
ideal partner to provide physicians and their patients with access to this
important medicine in the markets where they will commercialise SYCREST(®),"
said Beverly Lybrand, senior vice president and general manager, neuroscience
and ophthalmology, Merck. "Merck will continue to focus our efforts on marketing
SAPHRIS(®) in the United States, as part of our ongoing commitment to
researching, developing and delivering medicines in the neurosciences disease
areas."
"This agreement highlights our strategic focus on late-stage specialty central
nervous system (CNS) products and our ambition to provide long-term growth
opportunities for Lundbeck," said Ulf Wiinberg, president & chief executive
officer at Lundbeck. "We are very pleased to include SYCREST(®) in our existing
portfolio of specialty CNS products and see great opportunities to leverage our
highly dedicated sales infrastructure."
About SYCREST(®)/SAPHRIS(®)
SYCREST(®), an atypical antipsychotic medication, received marketing approval in
the EU on 1 September 2010 for the treatment of moderate to severe manic
episodes associated with bipolar I disorder in adults. The marketing approval
applied to all 27 EU member states.
In the United States, SYCREST(®) is marketed as SAPHRIS(®). It was approved by
the U.S. Food and Drug Administration (FDA) on 13 August 2009 for the acute
treatment of schizophrenia in adults and for the acute treatment of manic or
mixed episodes associated with bipolar I disorder with or without psychotic
features in adults. On 7 September 2010, two supplemental new drug applications
(sNDA's) for SAPHRIS(®) were approved in the United States to expand the
product's indications to the treatment of schizophrenia in adults, as
monotherapy for the acute treatment of manic or mixed episodes associated with
bipolar I disorder in adults, and as adjunctive therapy with either lithium or
valproate for the acute treatment of manic or mixed episodes associated with
bipolar I disorder in adults.
Additional regulatory applications for asenapine are pending in other markets.
Important Safety Information
Elderly patients with dementia-related psychosis - Elderly patients with
dementia-related psychosis treated with antipsychotic substances are at an
increased risk of death. Sycrest is not approved for the treatment of patients
with dementia-related psychosis and is not recommended for use in this
particular group of patients.
Neuroleptic Malignant Syndrome - Neuroleptic Malignant Syndrome (NMS),
characterised by hyperthermia, muscle rigidity, autonomic instability, altered
consciousness and elevated serum creatine phosphokinase levels, has been
reported to occur with antipsychotics, including asenapine. Additional clinical
signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. If a
patient develops signs and symptoms indicative of NMS Sycrest must be
discontinued.
Seizures - In clinical trials, cases of seizure were occasionally reported
during treatment with asenapine. Therefore, Sycrest should be used with caution
in patients who have a history of seizure disorder or have conditions associated
with seizures.
Suicide - The possibility of a suicide attempt is inherent in psychotic
illnesses and bipolar disorder and close supervision of high-risk patients
should accompany treatment.
Orthostatic hypotension - Asenapine may induce orthostatic hypotension and
syncope, especially early in treatment, probably reflecting its α1 adrenergic
antagonist properties. Elderly patients are particularly at risk for
experiencing orthostatic hypotension. In clinical trials, cases of syncope were
occasionally reported during treatment with Sycrest. Sycrest should be used with
caution in elderly patients and in patients with known cardiovascular disease
(e.g., heart failure, myocardial infarction or ischemia, conduction
abnormalities), cerebrovascular disease, or conditions that predispose the
patient to hypotension (e.g., dehydration and hypovolemia).
Tardive dyskinesia - Medicinal products with dopamine receptor antagonistic
properties have been associated with the induction of tardive dyskinesia
characterised by rhythmical, involuntary movements, predominantly of the tongue
and/or face. In clinical trials, cases of tardive dyskinesia were occasionally
reported during treatment with asenapine. The onset of extrapyramidal symptoms
is a risk factor for tardive dyskinesia. If signs and symptoms of tardive
dyskinesia appear in a patient on Sycrest, discontinuation of treatment should
be considered.
Hyperprolactinaemia - Increases in prolactin levels were observed in some
patients with Sycrest. In clinical trials, there were few adverse reactions
related to abnormal prolactin levels reported.
QT interval - Clinically relevant QT prolongation does not appear to be
associated with asenapine. Caution should be exercised when Sycrest is
prescribed in patients with known cardiovascular disease or family history of QT
prolongation, and in concomitant use with other medicinal products thought to
prolong the QT interval.
Hyperglycaemia and diabetes mellitus - Hyperglycaemia or exacerbation of pre-
existing diabetes has occasionally been reported during treatment with
asenapine. Assessment of the relationship between atypical antipsychotic use and
glucose abnormalities is complicated by the possibility of an increased
background risk of diabetes mellitus in patients with schizophrenia or bipolar
disorder and the increasing incidence of diabetes mellitus in the general
population. Appropriate clinical monitoring is advisable in diabetic patients
and in patients with risk factors for the development of diabetes mellitus.
Dysphagia - Esophageal dysmotility and aspiration have been associated with
antipsychotic treatment. Cases of dysphagia were occasionally reported in
patients treated with Sycrest.
Body temperature regulation - Disruption of the body's ability to reduce core
body temperature has been attributed to antipsychotic medicines. From the
clinical trials, it is concluded that clinically relevant body temperature
dysregulation does not appear to be associated with asenapine. Appropriate care
is advised when prescribing Sycrest for patients who will be experiencing
conditions that may contribute to an elevation in core body temperature, e.g.
exercising strenuously, exposure to extreme heat, receiving concomitant
medicinal products with anticholinergic activity or being subject to
dehydration.
Patients with severe hepatic impairment - Asenapine exposure is increased 7 fold
in patients with severe hepatic impairment (Child-Pugh C). Therefore, Sycrest is
not recommended in such patients.
Parkinson's disease and dementia with Lewy bodies - Physicians should weigh the
risks versus the benefits when prescribing antipsychotic medicinal products,
including Sycrest, to patients with Parkinson's disease or dementia with Lewy
Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant
Syndrome as well as having an increased sensitivity to antipsychotics.
Manifestation of this increased sensitivity can include confusion, obtundation,
postural instability with frequent falls, in addition to extrapyramidal
symptoms.
Drug Interactions - Caution should be used when asenapine is taken in
combination with other centrally acting medicinal products. Patients should be
advised to avoid alcohol while taking Sycrest. Additionally, Sycrest should be
co-administered cautiously with fluvoxamine (a CYP1A2 inhibitor) and with
medicinal products that are both substrates and inhibitors of CYP2D6 (e.g.,
paroxetine).
For full prescribing information, please refer to the Summary of Product
Characteristics.
SAPHRIS(®) and SYCREST(®) are registered trademarks of N.V. Organon, a
subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
Merck contacts
Investors: Media:
Joe Romanelli Ian McConnell
+1 908 423 5088 +1 908 423 3046
Lundbeck contacts
Investors: Media:
Jacob Tolstrup Mads Kronborg
Vice President, Corporate Relations Media Relations Manager
+45 36 43 30 79 +45 36 43 28 51
Palle Holm Olesen Stine Hove Marsling
Chief Specialist, Investor Relations External Communication Specialist
+45 36 43 24 26 +45 36 43 28 33
Magnus Thorstholm Jensen
Investor Relations Officer
+45 36 43 38 16
About MSD (Merck & Co.)
Today's MSD is a global healthcare leader working to help the world be well.
MSD is a trade name of Merck & Co., Inc. with headquarters in Whitehouse
Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic
therapies, and consumer care and animal health products, we work with customers
and operate in more than 140 countries to deliver innovative health solutions.
We also demonstrate our commitment to increasing access to healthcare through
far-reaching policies, programs and partnerships. For more information visit
www.msd.com
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical
company highly committed to improve the quality of life for people suffering
from central nervous system (CNS) disorders. For this purpose Lundbeck is
engaged in the research and development, production, marketing and sale of
pharmaceuticals across the world, targeted at disorders like depression and
anxiety, schizophrenia, insomnia, Huntington's, epilepsies, Alzheimer's and
Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and
employs today approximately 5,900 people worldwide. Lundbeck is one of the
world's leading pharmaceutical companies working with CNS disorders. In 2009,
the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD
2.6 billion). For more information, please visit www.lundbeck.com.
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