Lundbeck and Merck Sign Exclusive Commercialization 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 September 1, 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 SYCRESTin the EUat the beginning of 2011.

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Tuesday, October 12, 2010 5:00 am EDT

Dateline:

WHITEHOUSE STATION, N.J.

Public Company Information:

NYSE:
MRK
"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."

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--H. Lundbeck A/S (Lundbeck) and Merck, known outside the United States and Canada as MSD, today announced a commercialization 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 commercialize 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 area."

"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

SYCREST, an atypical antipsychotic medication, received marketing approval in the EU on September 1 for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The marketing approval applies to all 27 EU member states.

In the United States, asenapine is marketed as SAPHRIS. It was approved by the U.S. Food and Drug Administration (FDA) on August 13, 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 September 7, 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-adminsitered 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.

About MSD

Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename 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.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. The forward-looking statements may include statements regarding product development, product potential, the company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2009 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

SAPHRIS® and SYCREST® are registered trademarks of N.V. Organon, a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

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Contact:

Lundbeck Contacts
Media:
Mads Kronborg, +45 36 43 28 51
Stine Hove Marsling, +45 36 43 28 33
Investors:
Jacob Tolstrup, +45 36 43 30 79
Palle Holm Olesen, +45 36 43 24 26
Magnus Thorstholm Jensen, +45 36 43 38 16
Merck Contacts
Media:
Ian McConnell, 908-423-3046
Investors:
Joe Romanelli, 908-423-5088

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