Full Press Release Details
SAN DIEGO , Jan. 7, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX ) today announced an update on its business performance, including preliminary sales results for 2017 and key program initiatives for 2018. Kevin Gorman , CEO of Neurocrine, will discuss these updates as part of a webcast presentation at the 36 th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 8 at 3:00 p.m. PT ( 6:00 p.m. ET ).
"In 2017, we made exceptional progress as an organization with the launch of INGREZZA, aiding adult patients suffering from tardive dyskinesia. Our fourth quarter sales reflect continued strong prescription growth for INGREZZA which more than offset the net sales impact from the transition to the 80 mg capsules. Increase in psychiatrist and neurologist uptake reflects expanded brand awareness with positive treatment outcomes," said Kevin Gorman , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Entering 2018, we are excited about our opportunities to continue our INGREZZA launch and clinical development efforts in Tourette syndrome as well as achieving meaningful pipeline milestones in collaboration with AbbVie for elagolix in both endometriosis and uterine fibroids."
Preliminary Fourth Quarter and Full-Year 2017 Sales Results (Unaudited) Based on preliminary unaudited financial information, the Company expects net product sales of INGREZZA ® (valbenazine) to be approximately $64 million for the fourth quarter ended December 31 , 2017. Total Company revenues for the fourth quarter are expected to be approximately $94 million inclusive of a $30 million milestone payment received from AbbVie for the FDA's acceptance of the elagolix endometriosis NDA in the fourth quarter.
Preliminary full-year unaudited net product sales of INGREZZA are expected to be approximately $116 million and total Company revenues of approximately $161 million inclusive of $45 million revenue recognized from our collaboration agreements with AbbVie and Mitsubishi Tanabe Pharma Corporation.
No similar net product sales were reported for the comparable periods of 2016. INGREZZA capsules were made available for commercial distribution on May 1, 2017 , and the Company recognizes revenue using a sell-in methodology when products are delivered to select pharmacies or distributors.
2018 Expected Program Milestones INGREZZA for Tardive Dyskinesia
INGREZZA for Tourette Syndrome
Elagolix in Collaboration with AbbVie
Opicapone for Parkinson's Disease
Congenital Adrenal Hyperplasia (CAH)/NBI-74788
New Internally Discovered Program
Management Update In a separate press release issued today, Neurocrine also announced the retirement of Christopher O'Brien , M.D., in February 2018 and the appointment of Eiry W. Roberts, M.D., as Chief Medical Officer.
About INGREZZA ® (valbenazine) Capsules INGREZZA, a selective 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 trunk, extremities and/or face.
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 Warnings & Precautions Somnolence 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.
QT Prolongation 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.
Adverse Reactions 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-FDA-1088.
Please see INGREZZA full Prescribing Information at www.INGREZZA.com/HCP
About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA ® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. The Company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and INGREZZA, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome.
Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at http://www.neurocrine.com .
SOURCE Neurocrine Biosciences, Inc.