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`N e w s R e l e a s e
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`Contact: Susan Adler
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` Vice President, Corporate Communications
`508-481-6700
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`susan.adler@sunovion.com
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`Julissa Viana
`Director, Communications
`201-850-9220
`julissa.viana@sunovion.com
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`FDA APPROVES ONCE-DAILY LATUDA® (lurasidone HCl) FOR
`THE TREATMENT OF PATIENTS WITH SCHIZOPHRENIA
`Four Positive Placebo-Controlled Trials Confirmed the Efficacy of LATUDA
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`Marlborough, Mass., October 28, 2010 – Sunovion Pharmaceuticals Inc. (Sunovion) today announced
`that the U.S. Food and Drug Administration (FDA) has approved LATUDA® (lurasidone HCl) tablets for
`the treatment of schizophrenia. LATUDA is an oral, once-daily atypical antipsychotic, offering a first-line
`treatment option for patients with schizophrenia and is expected to be available in the U.S. during the first
`quarter of 2011.
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`“LATUDA marks both a significant achievement for our company as well as the first FDA approval for
`Sunovion since becoming the U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.,” said Masayo
`Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. “With this approval,
`we’ve taken another big step towards becoming a truly competitive global company by enhancing the
`presence of Sunovion in the United States.”
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`Schizophrenia is a chronic, disabling and serious brain disorder that affects approximately 2.4 million
`American adults or 1 in 100 people. Schizophrenia is characterized by symptoms such as hallucinations,
`delusions, disorganized thinking, lack of emotion, lack of energy, as well as problems with memory, attention
`and the ability to plan, organize and make decisions.
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`“LATUDA offers a once-daily treatment option that has been shown to be both effective and tolerable,
`adding to psychiatrists’ ability to address the challenging therapeutic needs of people with schizophrenia,”
`said Antony Loebel, M.D., executive vice president, Clinical Research and Medical Affairs at Sunovion
`Pharmaceuticals Inc.
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`The FDA reviewed data from more than 40 clinical trials involving approximately 2,700 LATUDA-
`treated adult subjects. The efficacy of LATUDA for the treatment of schizophrenia was established
`in four pivotal, 6-week placebo-controlled clinical trials. In these studies, LATUDA demonstrated
`significantly greater improvement versus placebo on the primary efficacy measures [the Positive
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`Exhibit 2141
`Slayback v. Sumitomo
`IPR2020-01053
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`and Negative Syndrome Scale (PANSS) total score and the Brief Psychiatric Rating Scale-derived
`from PANSS (BPRSd)] at study endpoint. A total of five clinical trials contributed to the
`understanding of the tolerability and safety profile of LATUDA.
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`“Schizophrenia is associated with severe and debilitating symptoms such as delusions, hallucinations and
`disorganized thinking, and it can often have a devastating impact on patients and their families,” said
`Herbert Meltzer, M.D., professor of psychiatry and pharmacology, Vanderbilt University School of
`Medicine. “Based on the results of the clinical trials, LATUDA represents an important addition to the
`treatment of schizophrenia.”
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`About LATUDA
`LATUDA is an atypical antipsychotic indicated for the treatment of patients with schizophrenia. The
`efficacy of LATUDA in schizophrenia was established in four 6-week controlled studies of adult patients
`with schizophrenia. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has
`not been established in controlled studies. Therefore, the physician who elects to use LATUDA for
`extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual
`patient.
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`Please read the full Prescribing Information at www.LATUDA.com, including Boxed Warning.
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`Dosage and Administration
`The recommended starting dose of LATUDA is 40 mg once daily. LATUDA should be taken with food.
`Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg/day
`to 120 mg/day. In the 6-week controlled trials, there was no suggestion of added benefit with the 120
`mg/day dose, but there was a dose-related increase in certain adverse reactions. Therefore, the
`maximum recommended dose is 80 mg/day.
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`IMPORTANT SAFETY INFORMATION FOR LATUDA
`Increased Mortality in Elderly Patients with Dementia-Related Psychosis
`(cid:120) Elderly patients with dementia-related psychosis treated with antipsychotic drugs are
`at an increased risk of death.
`(cid:120) Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in
`patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-
`treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients
`(cid:120) Over the course of a typical 10-week controlled trial, the rate of death in drug-treated
`patients was about 4.5% compared to a rate of 2.6% in the placebo group
`(cid:120) Although the causes of death were varied, most of the deaths appeared to be either
`cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in
`nature.
`(cid:120) LATUDA is not approved for the treatment of patients with dementia-related psychosis
`Contraindications: LATUDA is contraindicated in any patient with a known hypersensitivity to lurasidone
`HCl or any components in the formulation. LATUDA should not be used in combination with a strong
`CYP3A4 inhibitor or inducer.
`Cerebrovascular Adverse Events: In placebo-controlled trials with risperidone, aripiprazole, and
`olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse
`reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to
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`placebo-treated subjects. LATUDA is not approved for the treatment of patients with dementia-related
`psychosis.
`Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported
`with administration of antipsychotic drugs, including LATUDA. NMS can cause hyperpyrexia, muscle
`rigidity, altered mental status, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac
`dysrhythmia. Additional signs may include elevated creatine phosphokinase, myoglobinuria
`(rhabdomyolysis), and acute renal failure. Management should include immediate discontinuation of
`antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment
`and medical monitoring, and treatment of any concomitant serious medical problems.
`Tardive Dyskinesia (TD): The risk of developing TD and the potential for it to become irreversible may
`increase as the duration of treatment and the total cumulative dose increase. However, the syndrome can
`develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing
`should be consistent with the need to minimize TD. If signs and symptoms appear, discontinuation should
`be considered.
`Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases associated with ketoacidosis,
`hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Patients
`with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics should
`undergo fasting blood glucose testing at the beginning of and during treatment. Any patient treated with
`atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria,
`polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with
`atypical antipsychotics should also undergo fasting blood glucose testing. In some cases, hyperglycemia
`has resolved when the atypical antipsychotic was discontinued; however, some patients required
`continuation of antidiabetic treatment despite discontinuation of the antipsychotic drug.
`Weight Gain: In short-term schizophrenia studies, there were differences in mean weight gain between
`LATUDA-treated and placebo-treated patients. The proportion of patients with a (cid:149)7% increase in body
`weight was 5.6% versus 4.0% for placebo-treated patients. In longer-term studies (primarily open-label
`extension studies), LATUDA was associated with a mean change in weight of -0.38 kg at week 24 (n =
`531), -0.47 kg at week 36 (n = 303) and -0.71 kg at week 52 (n = 244).
`Orthostatic Hypotension Syncope, and Other Hemodynamic Effects: LATUDA may induce
`orthostatic hypotension and syncope. LATUDA should be used with caution in patients with known
`cardiovascular disease, cerebrovascular disease, or conditions that predispose them to hypotension and
`in the elderly. LATUDA should be used cautiously when treating patients who receive treatment with
`other drugs that can induce hypotension, bradycardia, respiratory or central nervous system depression.
`Monitoring of orthostatic vital signs should be considered in all such patients, and a dose reduction should
`be considered if hypotension occurs.
`Leukopenia, Neutropenia, and Agranulocytosis: In clinical trial and postmarketing experience, events
`of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Patients with a
`preexisting low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their
`complete blood count (CBC) monitored frequently during the first few months of therapy, and LATUDA
`should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.
`Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, LATUDA can elevate
`prolactin levels, and the elevation can persist during chronic administration. Galactorrhea, amenorrhea,
`gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds
`The proportion of patients with prolactin elevations (cid:149) 5× ULN was 3.6% for LATUDA-treated patients
`versus 0.7% for placebo-treated patients. This proportion was greater in female patients. In the longer-
`term studies (primarily open-label extension studies), LATUDA was associated with a median change in
`prolactin of -1.9 ng/mL at week 24 (n = 188), -5.4 ng/mL at week 36 (n=189) and -3.3 ng/mL at week 52
`(n = 243).
`Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that
`lower seizure threshold (eg, Alzheimer’s dementia).
`Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.
`Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those
`with advanced Alzheimer’s dementia. LATUDA is not indicated for the treatment of dementia-related
`psychosis, and should not be used in patients at risk for aspiration pneumonia.
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`Potential for Cognitive and Motor Impairment: Somnolence and sedation were reported in patients
`treated with LATUDA. Patients should be cautioned about performing activities requiring mental alertness,
`such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain
`that LATUDA therapy does not affect them adversely.
`Body Temperature Regulation: Appropriate care is advised when prescribing LATUDA for patients who
`will be experiencing conditions that may contribute to an elevation in core body temperature, eg,
`exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic
`activity, or being subject to dehydration.
`Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk
`patients should accompany drug therapy. Prescriptions for LATUDA should be written for the smallest
`quantity of tablets in order to reduce the risk of overdose.
`Alcohol: Given the primary CNS effects of LATUDA, caution should be used when it is taken in
`combination with alcohol.
`Commonly Observed Adverse Reactions ((cid:149)5% and at least twice that for placebo): The most
`commonly observed adverse reactions associated with the use of LATUDA versus placebo in short-term
`clinical studies were somnolence, akathisia, nausea, parkinsonism, and agitation.
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`Before prescribing LATUDA, please read the full Prescribing Information at www.LATUDA.com,
`including Boxed Warning.
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`About Sunovion Pharmaceuticals Inc. (Sunovion)
`Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing
`therapeutic products that advance the science of medicine in the central nervous system (CNS) and
`respiratory disease areas and improve the lives of patients and their families. Sunovion’s drug
`development program, together with its corporate development and licensing efforts, has yielded a
`portfolio of pharmaceutical products including LATUDA® brand lurasidone HCl, LUNESTA® brand
`eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol
`tartrate inhalation aerosol, BROVANA® brand aformoterol tartrate inhalation solution, OMNARIS® brand
`ciclesonide nasal spray and ALVESCO® brand ciclesonide HFA inhalation aerosol.
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`Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma Co., Ltd., is
`headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals Inc. is available
`at www.sunovion.com.
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`About Dainippon Sumitomo Pharma Co., Ltd. (DSP)
`DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of
`pharmaceutical, animal health and food and specialty products. DSP aims to produce innovative
`pharmaceutical products in the CNS field, which has been designated as the key therapeutic area and will
`also focus in on other specialty disease categories with significant unmet medical needs, which are
`designated as frontier therapeutic areas. DSP is based on the merger in 2005 between Dainippon
`Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, DSP has more than 7,000
`employees worldwide. Additional information about DSP is available through its corporate website at
`www.ds-pharma.com.
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`LATUDA® is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd. Sunovion Pharmaceuticals
`Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. LUNESTA, XOPENEX, XOPENEX
`HFA and BROVANA are registered trademarks of Sunovion Pharmaceuticals Inc. OMNARIS and
`ALVESCO are registered trademarks of Nycomed GmbH.
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`For a copy of this release or any recent release,
`visit Sunovion’s web site at www.sunovion.com.
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