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
36th 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
- Continued launch progress through tardive dyskinesia disease
state education and enhanced brand awareness
- Execution of post-marketing clinical studies
- Presentations at key scientific annual meetings, including
American Academy of Neurology, American Psychiatry Association,
International Parkinson and Movement Disorder Society
INGREZZA for Tourette Syndrome
- Phase II trial enrollment with data expected late 2018
Elagolix in Collaboration with AbbVie
- Elagolix for endometriosis PDUFA decision in Q2 2018
- Elagolix for uterine fibroids Phase III data Q1 2018 with
expected 2019 NDA filing
Opicapone for Parkinson's Disease
- FDA meeting for determination of NDA path forward in
January 2018
Congenital Adrenal Hyperplasia (CAH)/NBI-74788
- Phase IIa data for CAH (adults) in 1H 2018
- Phase II initiation for CAH (pediatric) in 2H 2018
- Phase III initiation for CAH (adults) in 2H 2018
New Internally Discovered Program
- IND submission and initiation of a Phase I
trial
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.
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
our preliminary financial information, to the benefits to be
derived from Neurocrine's products and product candidates,
including INGREZZA; the value INGREZZA and our product candidates
may bring to patients; the success of the continued launch of
INGREZZA; and the timing of completion of clinical and other
development activities. Among the factors that could cause actual
results to differ materially from those indicated in the
forward-looking statements are: risks and uncertainties associated
with items that may be identified during its financial statement
closing process that cause adjustments to the estimates included in
this press release; Neurocrine's future financial and operating
performance; risks and uncertainties associated with the
commercialization of INGREZZA, including the likelihood of
continued revenue growth of INGREZZA; risks or uncertainties
related to the development of the Company's product candidates;
risks and uncertainties relating to competitive products and
technological changes that may limit demand for INGREZZA or a
product candidate; risks associated with the Company's dependence
on third parties for development and manufacturing activities
related to INGREZZA and the Company's product candidates, and the
ability of the Company to manage these third parties; risks that
the FDA or other regulatory authorities may make adverse decisions
regarding INGREZZA or the Company's product candidates; risks
associated with the Company's dependence on AbbVie for the
development and commercialization of elagolix; risks that clinical
development activities may not be completed on time or at all;
risks that clinical development activities may be delayed for
regulatory 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 benefits of the agreements with BIAL and Mitsubishi
Tanabe may never be realized; risks associated with the Company's
dependence on BIAL for tech transfer, development and manufacturing
activities related to opicapone; risks associated with the
Company's dependence on Mitsubishi Tanabe for the development and
commercialization of valbenazine in Japan and other Asian countries; risks that
INGREZZA 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 the Company's
periodic reports filed with the Securities and Exchange Commission,
including without limitation the Company's Quarterly Report on Form
10-Q for the quarter ended September
30, 2017. Neurocrine disclaims any obligation to
update the statements contained in this press release after the
date hereof.
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SOURCE Neurocrine Biosciences, Inc.