Preliminary Fourth Quarter and Full-Year 2019 INGREZZA® (valbenazine) Net Product Sales and Financial Results (Unaudited)
Based on preliminary unaudited financial information, the Company expects INGREZZA net product sales for the three months and full-year ended
- Continued strength in new patient additions
- End of fourth quarter days-on-hand channel inventory increased relative to the third quarter due to timing of quarter-end purchases resulting in an approximate
- INGREZZA net product sales per prescription of
Preliminary unaudited cash and marketable securities balance as of
"Our results reflect our team's dedication to educating healthcare providers and patients about tardive dyskinesia as seen in the growing number of patients receiving treatment with INGREZZA. We still have a lot of work to do as a majority of people suffering from tardive dyskinesia remain undiagnosed and untreated," said
2020 INGREZZA Net Product Sales Outlook
During the first quarter of 2020, the Company expects INGREZZA net product sales to be impacted as a result of payer-related seasonal dynamics, gross-to-net discount increases from payer and
2020 Expected Milestones and Key Activities
INGREZZA (valbenazine) for Tardive Dyskinesia
- "Talk About TD" disease state awareness campaign
- Continued execution of post-marketing clinical studies, including RE-KINECT, the largest real-world study in patients with possible tardive dyskinesia
- Presentations at key scientific annual meetings, including
- Regulatory submissions for approval by Mitsubishi Tanabe in ASEAN territory
Valbenazine for Chorea in Huntington Disease
- Advance the current Phase III study recruitment and initiate open label portion of study during 1H 2020
Elagolix in Collaboration with
- Prescription Drug User Fee Act (PDUFA) date in Q2 2020 of elagolix for uterine fibroids
- Continued launch of ORILISSA® (elagolix) to treat moderate to severe pain associated with endometriosis by
Opicapone for Parkinson's Disease
- PDUFA date of
- Preparation for commercial launch
- Presentations at key scientific annual meetings, including AAN, MDS
Crinecerfont (NBI-74788) for Congenital Adrenal Hyperplasia (CAH)
- Phase IIa data (adults) oral presentation in March at
- Global registrational study initiation (adults) in mid-2020
- Advancement of pediatric plan including Phase IIa study
NBIb-1817 (VY-AADC) for Parkinson's Disease
- Present 3yr follow up data from study PD-1101 at appropriate medical conference
- Implement amended protocol for RESTORE-1 registration trial by mid-year based upon feedback from the U.S. Food and Drug Administration (
- Initiate RESTORE-II registration trial in 2H 2020
NBI-921352 (XEN901) for Epilepsy
- File Investigational New Drug (IND) application with the
ACT-709478 for Epilepsy
- Upon IND application acceptance by the
- A Phase II study in a rare pediatric epilepsy is planned in 2H 2020
About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first 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 in Neurocrine's laboratories, 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 psychiatric medications such as antipsychotics or antidepressants.
Important Safety Information
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.
Warnings & Precautions
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
INGREZZA may cause Parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-
Please see INGREZZA full Prescribing Information at www.INGREZZA.com/PI.
About Neurocrine Biosciences, Inc.
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: our preliminary unaudited financial information; the benefits to be derived from our products and product candidates, including INGREZZA and our partnered product, ORILISSA; the value INGREZZA, ORILISSA, and/or our product candidates may bring to patients; the continued success of the launch of INGREZZA;
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Neurocrine Biosciences, Inc., Navjot Rai (Media), 858-617-7623, email@example.com; Todd Tushla (Investors), 858-617-7143, firstname.lastname@example.org