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NEUROCRINE BIOSCIENCES, INC.

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Neurocrine Biosciences : to Present New INGREZZA« (valbenazine) and ONGENTYS« (opicapone) Data at the MDS Virtual Congress 2021

09/10/2021 | 09:25am EST

SAN DIEGO, Sept. 10, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present new data from its movement disorder treatments for tardive dyskinesia (TD) and Parkinson's disease at the International Parkinson and Movement Disorder Society's (MDS) Virtual Congress 2021 being held September 17–22, 2021.

Data include a post hoc analysis from KINECT 4, a long-term Phase 3 study, demonstrating robust clinically meaningful reductions in TD symptoms at 48 weeks with once-daily INGREZZA® (valbenazine) capsules. Data show some patients met the criteria for TD remission within one year of once-daily INGREZZA treatment. Additionally, an oral presentation will introduce a new pooled data analysis from the BIPARK-1 and BIPARK-2 Phase 3 studies evaluating effects on sleep of ONGENTYS® (opicapone) compared to placebo in people with Parkinson's disease and motor fluctuations. Further, a poster presentation will feature new data from a Phase 1 open-label study assessing the effect of ONGENTYS on levodopa levels when administered as a once-daily add-on therapy to oral levodopa/carbidopa extended-release capsules, the first study to evaluate both formulations together.

"We look forward to sharing data that helps further characterize the real-world experience of patients treated with INGREZZA and ONGENTYS with the movement disorder neurology community," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "The analyses presented reflect our commitment to better understanding the unmet needs of individuals living with the complex and debilitating disorders of tardive dyskinesia and Parkinson's disease." 

Presentations include:

INGREZZA – Tardive Dyskinesia

  • Impacts of Tardive Dyskinesia (TD) Symptoms on Patients: Analysis of a TD-Specific Patient-Reported Outcome (Poster # 89)
  • Patterns of Improvement with Valbenazine in Patients with Tardive Dyskinesia (Poster # 346)
  • Reanalysis of a Patient-Reported Outcome (Tardive Dyskinesia Impact Scale) Shows Positive Results (Poster # 88)

ONGENTYS – Parkinson's Disease (in collaboration with BIAL)

  • Effects of Opicapone on Sleep Patterns in Patients with Parkinson's Disease and Motor Fluctuations (Poster # 396)
  • Effects of Once-Daily Opicapone 50 mg on the Pharmacokinetics of Levodopa Administered as Carbidopa/Levodopa Extended-Release Capsules: An Open-Label Phase 1 Study (Poster # 507)
  • Evaluating Patients' Preferences for Parkinson's Disease Treatments (Poster # 337)
  • A Longitudinal Real-World Study of Opicapone in Patients with Parkinson's Disease and Motor Fluctuations (Poster # 410)

A full list of all abstracts being presented by Neurocrine Biosciences at the MDS Virtual Congress 2021 are available here.

About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (like antipsychotics) that help control dopamine receptors in the brain. Antipsychotics commonly prescribed to treat mental illnesses such as depression, bipolar disorder, schizophrenia and schizoaffective disorder, and certain medications to treat upset stomach, nausea and vomiting may also cause TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S.

About INGREZZA® (valbenazine) Capsules 
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is an FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts. 

INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with most psychiatric medications such as antipsychotics or antidepressants. 

Important Information

Approved Use 

INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). 

It is not known if INGREZZA is safe and effective in children. 

IMPORTANT SAFETY INFORMATION 

Do not take INGREZZA if you:

  • are allergic to valbenazine, or any of the ingredients in INGREZZA. 

INGREZZA may cause serious side effects, including

  • Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you. 
  • Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation. 
    Symptoms of QT prolongation may include:
    • fast, slow, or irregular heartbeat
    • shortness of breath
    • dizziness or fainting
  • Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
  • Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. 
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. 

The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision. 

These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Please see accompanying INGREZZA full Product Information.  

About Parkinson's Disease
Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disorder that affects approximately 1 million people in the U.S. and 6 million people worldwide. Parkinson's disease is associated with low dopamine levels produced in the brain. Dopamine helps transmit signals between the areas of the brain that control all purposeful movements, including talking, walking and writing. As Parkinson's disease progresses, dopamine production steadily decreases, resulting in increased problems with motor symptoms including slowed movement (bradykinesia), tremor, rigidity, impaired posture and balance, and difficulty with speech and writing.

There is presently no cure for Parkinson's disease and management of the disease consists of the use of treatments that attempt to control motor symptoms primarily through dopaminergic mechanisms. The current gold standard for treatment of motor symptoms is levodopa/carbidopa. While levodopa/carbidopa improves patients' motor symptoms, as the disease progresses, the beneficial effects of levodopa begin to wear off more quickly. Patients then experience motor fluctuations throughout the day between "on" time, periods when the medication is working and Parkinson's disease symptoms are controlled, and "off" time, when the medication is not working and motor symptoms return.

About ONGENTYS® (opicapone) Capsules 
ONGENTYS is a once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain.

In June 2016, BIAL – Portela & CA, S.A. (BIAL) received approval from the European Commission for ONGENTYS as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. BIAL currently markets ONGENTYS in several European countries. Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada.

Important Information

Approved Use
ONGENTYS® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson's disease (PD) who are having "OFF" episodes.

It is not known if ONGENTYS is safe and effective in children.

Important Safety Information
Do not take ONGENTYS if you:

  • take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor.
  • have a tumor that secretes hormones known as catecholamines.

Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you:

  • have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help you sleep or that makes you feel sleepy.
  • have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping.
  • have a history of uncontrolled sudden movements (dyskinesia).
  • have had hallucinations or psychosis.
  • have liver or kidney problems.
  • are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).

ONGENTYS and other medicines may affect each other causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.

What should I avoid while taking ONGENTYS?
Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.

What are the possible side effects of ONGENTYS?
ONGENTYS may cause serious side effects, including:

  • Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS or other medicines used to treat Parkinson's disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS are higher if you take other medicines that cause drowsiness.
  • Low blood pressure or dizziness, light headedness, or fainting.
  • Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often.
  • Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior.
  • Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges.

Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.

The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.

These are not all of the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see ONGENTYS full Product Information.

About Neurocrine Biosciences
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from Neurocrine's products and product candidates. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the COVID-19 pandemic and efforts to mitigate its spread on our business; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on BIAL for manufacturing activities for ONGENTYS, and our ability to manage BIAL; risks that clinical development activities may not be completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended June 30, 2021. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

Cision
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SOURCE Neurocrine Biosciences, Inc.


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