On January 6, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported an update on its business performance, including preliminary net product sales results of INGREZZA (valbenazine) for 2021, and key clinical development milestones for 2022 and 2023 (Press release, Neurocrine Biosciences, JAN 6, 2022, View Source [SID1234598334]). Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences, will discuss these updates as part of a webcast presentation at the 40th Annual J.P. Morgan Healthcare Conference to be held virtually on Monday, January 10 at 11:15 a.m. Eastern Time, followed by a Question and Answer session at approximately 11:35 a.m. Eastern Time.
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Preliminary Fourth Quarter 2021 INGREZZA (valbenazine) Net Product Sales (Unaudited) Highlights
Unaudited preliminary fourth quarter 2021 INGREZZA net sales were approximately $301 million and $296 million on an inventory adjusted basis
Fourth quarter 2021 INGREZZA net sales and total prescriptions grew 25% and 32% respectively vs. fourth quarter of 2020
Quarterly growth driven by record patients on therapy exiting 2021
Commercial expansion to better meet the needs of healthcare professionals across diverse sites of care on track for completion by the end of Q1 2022
The Company plans to provide full-year 2022 INGREZZA sales guidance on its Q4 and FY 2021 Earnings Call on February 11, 2022
"Our fourth quarter and full-year results highlight INGREZZA’s return to growth in a challenging environment. We exited 2021 helping more patients with tardive dyskinesia than ever before. Furthermore, we now have 13 clinical programs in mid-to-late-stage studies which will generate important data readouts over the next two years," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "This year, our priorities are focused on INGREZZA and continuing to advance our broad pipeline. We are uniquely positioned to drive INGREZZA growth and reinvest in our pipeline to develop potential best-in-class medications that are focused on neurological, neuro-endocrine and psychiatric disorders for patients who deserve better treatment options."
Expected Future Milestones and Key Activities
Program
Indication
Milestones / Key Activities
Valbenazine*
(VMAT2 Inhibitor)
Chorea in Huntington Disease
File Supplemental New Drug Application in Second Half (2H) 2022
Adjunctive Treatment of Schizophrenia
Initiate 2nd Registrational Study in 2022; Top-Line Registrational Data in 2023
Dyskinesia Due to Cerebral Palsy
Top-Line Registrational Data in 2023
NBI-827104**
(Selective T-Type CaV
Channel Blocker)
Essential Tremor
Top-Line Phase 2 Data in Mid-2022
Rare Pediatric Epilepsy: CSWS
Top-Line Phase 2 Data in 2H 2022
NBI-1117568†
(Selective M4 Agonist)
Treatment of Schizophrenia
Initiate Phase 2 Study in 2022
New Chemical Entity
Neurological or Psychiatric Indication
Initiate Phase 1 Study in 2022
Crinecerfont
(CRF1 Receptor Antagonist)
Congenital Adrenal Hyperplasia (Adult)
Top-Line Registrational Data in 2023
Congenital Adrenal Hyperplasia (Pediatric)
Top-Line Registrational Data in 2023
NBI-1065845‡
(AMPA Potentiator)
Inadequate Response to Treatment in
Major Depressive Disorder
Phase 2 Data in 2023
NBI-1065846‡
(GPR-139 Agonist)
Anhedonia in Depression
Phase 2 Data in 2023
NBI-921352∝
(Selective NaV1.6 Channel
Blocker)
Focal Onset Seizure in Adults
Phase 2 Data in 2023
Key: VMAT2 = Vesicular Monoamine Transporter 2; CaV = Calcium Channel, Voltage-Gated; CSWS = Epileptic Encephalopathy with Continuous Spike and Wave During Sleep; M4= M4 Muscarinic Receptor; CFR1 = Corticotropin-Releasing Factor Type 1; AMPA = Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid; GPR = Orphan G Protein Coupled Receptor; NaV1.6 = Sodium Channel, Voltage-Gated
Neurocrine Bioscience Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia;
** In-Licensed from Idorsia Pharmaceuticals; † In-Licensed from Sosei Group Corporation; ‡ Partnered with Takeda Pharmaceutical Company Limited; ∝ In-Licensed from Xenon Pharmaceuticals
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is an involuntary movement disorder characterized by uncontrollable, abnormal and repetitive movements of the torso, extremities and/or face, which can include hand or foot movements, rocking of the torso, lip smacking, grimacing, tongue protrusion, facial movements or blinking, as well as puckering and pursing of the lips. The condition is associated with taking certain mental health medicines such as antipsychotics, which are commonly prescribed to treat mental illnesses such as bipolar disorder, depression and schizophrenia. 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.