NEW HAVEN, Conn., May 7,
2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd.
(NYSE: BHVN, the "Company"), a commercial-stage
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurological and
neuropsychiatric diseases, today reported financial results for the
quarter ended March 31, 2020, and
provided a review of recent accomplishments and anticipated
upcoming milestones.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven, commented, "The first quarter of 2020
represented a transformational period for Biohaven as the FDA's
approval of NURTEC™ ODT (rimegepant) delivered on our promise to
patients and investors to advance new treatments to patients
disabled from migraine. NURTEC ODT is the first and only
calcitonin gene-related peptide (CGRP) receptor antagonist
available in an orally disintegrating tablet (or ODT) for the acute
treatment of migraine, and the only oral CGRP-receptor antagonist
with product label claims including return to normal functioning
and sustained durability of efficacy up to 48 hours after a single
dose. We believe that NURTEC ODT represents a best-in-class oral
migraine treatment and that our product will differentiate from
competitors in multiple ways. Our early prescription metrics show
that NURTEC ODT has the potential to be a market leader in the
class of new treatments for migraine and we believe it will be a
key driver of revenue growth for Biohaven in the years to come. We
are well-funded and without the near-term need for capital;
however, if we determine that we need to raise additional capital
we will consider various, less dilutive alternative sources of
financing now that we have an approved drug in our portfolio."
Dr. Coric added, "Launching NURTEC ODT during these
unprecedented times was a tremendous step forward for Biohaven and
for patients suffering from migraines. Our commercial team
demonstrated that we can deliver important medicines like NURTEC
ODT to patients even under the most challenging situations and our
R&D team showed that nothing would get in the way of their
operational excellence to ensure patients continued to safely
receive their investigational drugs and participate in four ongoing
pivotal clinical trials. In the months ahead, we look forward
to patient focused mission of improving the treatment of migraine
with NURTEC ODT and advancing our late-stage portfolio of
investigational agents for neurologic and neuropsychiatric
disorders."
First Quarter and Recent Business Highlights
FDA-approved NURTEC ODT for the acute treatment of migraine
in adults – On February 27, 2020,
the U.S. Food and Drug Administration (FDA) approved NURTEC ODT for
the acute treatment of migraine in adults. On March 12, 2020, NURTEC ODT became commercially
available in U.S. pharmacies. NURTEC ODT offers fast pain relief
and can return patients to normal function within one hour while
delivering sustained efficacy that lasts up to 48 hours for many
patients. In the first full six weeks of launch, NURTEC ODT was the
fastest growing new treatment for migraine during that time period
with over 6,000 prescriptions written to date by over 1,000 health
care providers. For more information about NURTEC ODT, see "About
NURTEC ODT" below in this release.
Biohaven began collaboration with Cove, a leading migraine
telemedicine platform – In April, Biohaven announced a
collaboration with Cove, a company providing specialized care and
access to innovative treatments for migraine sufferers via
telemedicine services in the United
States. The collaboration seeks to facilitate telemedical
evaluation for migraine sufferers while patients are increasingly
looking to remote evaluations during this time of unprecedented
decreased access to routine office visits.
Using Cove, patients consult with independent healthcare
providers and may be prescribed NURTEC ODT along with other
migraine treatments, providing patients an important alternative to
in-office doctor visits. The collaboration with Cove is an
expansion of the NURTEC ODT access toolbox, helping Biohaven
deliver migraine relief to patients.
Pivotal Trial Demonstrates Oral NURTEC Is Effective in
Preventive Treatment of Migraine – Episodic and chronic
migraine patients treated only every other day with oral NURTEC
(rimegepant 75 mg) demonstrated superiority over placebo on the
primary endpoint of reduction in the mean number of migraine days
per month. Patients receiving NURTEC 75 mg every other day
experienced a statistically significant 4.3 day reduction from
baseline in monthly migraine days, compared to a 3.5 day reduction
in the placebo group, p < 0.01. Additionally, NURTEC 75 mg
showed superiority compared to placebo on the key secondary outcome
measure assessing the proportion of patients who achieved a ≥50%
reduction in moderate-to-severe migraine days per month.
Approximately 49.1% of patients treated with NURTEC 75 mg showed a
≥50% reduction from their baseline number of moderate-to-severe
migraine days compared to 41.5% of placebo-treated patients, p <
0.05. The magnitude of the reduction in mean number of migraine
days per month and almost half of subjects demonstrating a ≥50%
reduction from their baseline number of moderate-to-severe migraine
days demonstrated similar results to what has been reported with
injectable preventive treatments, but with NURTEC offering the
potential of a simple to use, oral medication that may confer such
preventive effects with only every other day dosing.
NURTEC is the first CGRP targeting therapy to complete pivotal
trials that demonstrate efficacy in both acute and preventive
treatment of migraine. NURTEC is part of Biohaven's NOJECTION™ CGRP
antagonist platform and the first to show "dual-therapy action"
with acute and preventive treatment benefits.
Biohaven will advance intranasal vazegepant into Phase 3 for
acute migraine following successful meeting with FDA – In
March, the Company reported it will advance vazegepant into Phase 3
following a successful end of Phase 2 meeting with the FDA. In the
meeting, the Company addressed all issues raised by the FDA and
will now advance the 10 mg dose of intranasal vazegepant into a
double-blind, placebo-controlled Phase 3 clinical trial. In topline
results from a pivotal Phase 2/3 trial in December 2019, vazegepant achieved statistical
superiority to placebo on the co-primary endpoints of pain freedom
and freedom from most bothersome symptom at 2 hours. Vazegepant is
a third generation, high affinity, selective and structurally
unique, small molecule CGRP receptor antagonist from Biohaven's
NOJECTION™ Migraine Platform and the only intranasal CGRP receptor
antagonist in late stage development.
Committed to advancing the science of potential novel
treatments for COVID-19 with internal compounds and through a
pre-existing investment in Kleo Pharmaceuticals, Inc. – In
April, Biohaven received a May Proceed letter from the FDA
following submission of its Pre-IND/IND material to the FDA for the
initiation of a Phase 2 study of vazegepant, a CGRP antagonist, for
the treatment of COVID-19 infection-associated pulmonary
complications.The vazegepant trial in COVID-19 associated pulmonary
inflammation has been initiated and the first several patients
treated. Kleo Pharmaceuticals pursuing monoclonal antibody
enhancers (MATEs) to neutralize COVID-19 virus and other small
molecule, novel anti-viral approaches. In March, Kleo
Pharmaceuticals, Inc. announced a research collaboration with
South Korea-based Green Cross
LabCell (GCLC) to rapidly advance testing of both companies'
technology platforms in combination as a potential therapy for
COVID-19 patients. Kleo will combine its antibody recruiting
molecule technology with GCLC's off the shelf natural killer (NK)
cell therapy.
Verdiperstat received Fast Track designation for MSA – In
March, Biohaven's myeloperoxidase (MPO) inhibitor, verdiperstat,
received Fast Track designation from the FDA for the treatment of
multiple system atrophy (MSA). Verdiperstat is a potential
first-in-class, oral, brain-penetrant, irreversible inhibitor of
MPO, an enzyme that acts as a key driver of pathological oxidative
stress and inflammation in the brain. A Phase 3, multinational
clinical trial is currently ongoing to evaluate the efficacy of
verdiperstat in MSA across approximately 50 sites in the United States and Europe.
Michael Heffernan appointed to
Board of Directors – In January, Mr. Heffernan joined
Biohaven's board. A trained pharmacist and seasoned pharmaceutical
executive with over 25 years of commercial experience, Mr.
Heffernan began his career in numerous sales and marketing roles at
Eli Lilly and Company before becoming Founder and CEO of Collegium
(Nasdaq: COLL), where he remains Chairman of its Board of
Directors.
Raised $283.3 million in net
proceeds from public offering of common shares – Biohaven
raised $283.3 million in net proceeds
from a public offering of common shares, including the exercise of
the underwriter's option to purchase additional common shares. This
financing will support the launch of NURTEC™ ODT.
Upcoming Milestones
Biohaven is continuing to support the launch of NURTEC ODT and
develop its product candidates through clinical and preclinical
programs in a number of common and rare disorders. The Company
expects to reach significant pipeline milestones with its CGRP
receptor antagonists, glutamate modulators, and myeloperoxidase
inhibitors in the coming quarters. Certain timelines noted
below have been extended due to delays caused by the current
COVID-19 pandemic.
The Company expects to:
- Progress rimegepant commercialization in the acute treatment of
migraine and progress the preventive treatment of migraine
indication to an sNDA filing.
- Report Phase 2/3 topline data for troriluzole in OCD in the
third quarter of 2020.
- Complete last patient, last visit (LPLV) in the ongoing
troriluzole Phase 2/3 Alzheimer's disease trial by the fourth
quarter of 2020 and report topline data by the first quarter of
2021.
- Complete enrollment in Phase 3 trial of troriluzole in
Spinocerebellar Ataxia in the third quarter of 2020.
- Continue enrolling patients in Phase 2 proof of concept trial
evaluating the safety and efficacy of rimegepant in patients with
treatment refractory trigeminal neuralgia.
- Continue enrolling patients in Phase 3 clinical trial for the
treatment of MSA, a rare, rapidly progressive and fatal
neuroinflammatory disease with no cure or effective
treatments.
- Conduct ongoing non-clinical studies defined under the
scientific research agreement with University
of Connecticut to support the advancement of UC1MT, a
therapeutic antibody targeting extracellular metallothionein.
First Quarter Financial Results
Product Revenues, Net: We recorded net product
revenues in the first quarter of 2020 following the approval of
NURTEC ODT by the FDA on February 27,
2020 and its subsequent commercial launch in the U.S. in
March 2020. During the three months
ended March 31, 2020, we recognized
$1.2 million of product revenues, net
of sales allowances and rebates, related to sales of NURTEC ODT. A
majority of the revenue from sales of NURTEC ODT was attributable
to channel building by distributors upon launch of the product.
Cash Position: Cash and restricted cash as
of March 31, 2020, was $429.2 million, compared
to $317.7 million as of December 31, 2019. The
increase of $111.5 million was
primarily due to $283.3 million
in net proceeds from the January 2020
offering of common shares, including the full exercise of the
underwriter's option to purchase additional common shares,
partially offset by cash used in operations to execute our
commercial launch of NURTEC ODT, including prepaid advertising and
other costs, advance our broad pipeline of late-stage product
candidates, and satisfy milestone obligations triggered by the FDA
approval and launch of NURTEC ODT. In addition to cash on
hand at March 31, 2020, at the
Company's option, it may access up to an aggregate of $75 million under its existing financing
agreement with Royalty Pharma, Inc., subject to customary closing
conditions.
Research and Development (R&D) Expenses: R&D
expenses, including non-cash share-based compensation costs, were
$56.1 million for the three months
ended March 31, 2020, compared to
$41.0 million for the three months
ended March 31, 2019. The increase of
$15.1 million was primarily due to
$5.5 million in costs related to
process validation batches of NURTEC ODT, expensed as R&D
rather than commercial costs prior to FDA approval of rimegepant,
and increased expenses from later stage trials in our troriluzole
programs of $7.8 million.
Non-cash share-based compensation expense was $6.3 million for the three months ended
March 31, 2020, an increase of
$2.6 million as compared to the same
period in 2019.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses, including non-cash
share-based compensation costs, were $95.6
million for the three months ended March 31, 2020, compared to $13.5 million for the three months ended
March 31, 2019. The increase of
$82.1 million was primarily due to
increases in spending to support the commercial launch of NURTEC
ODT. Less than half of the SG&A expense, or approximately
$35 million, was for commercial
organization personnel costs, excluding non-cash share-based
compensation expense. Non-cash share-based compensation
expense was $10.6 million for
the three months ended March 31,
2020, an increase of $7.0
million as compared to the same period in 2019.
Net Loss: The Company reported a net loss
attributable to common shareholders for the three months ended
March 31, 2020 of $172.9 million, or $3.07 per share, compared to $62.3 million,
or $1.41 per share for the same period in 2019.
Non-GAAP adjusted net loss for the three months ended March 31, 2020 was $134.9
million, or $2.39 per share,
compared to $47.3 million, or $1.07 per share for
the same period in 2019. These non-GAAP adjusted net loss and
non-GAAP adjusted net loss per share measures, more fully described
below under "Non-GAAP Financial Measures," exclude non-cash
share-based compensation charges, non-cash interest expense related
to the accounting for our mandatorily redeemable preferred shares
and liability related to sale of future royalties, changes in the
fair value of our derivative liability, and losses from our equity
method investment. A reconciliation of the GAAP financial results
to non-GAAP financial results is included in the tables below.
Non-GAAP Financial Measures
This press release includes financial results prepared in
accordance with accounting principles generally accepted in
the United States (GAAP), and also
certain historical non-GAAP financial measures. In particular, the
Company has provided non-GAAP adjusted net loss and adjusted net
loss per share, adjusted to exclude the items below. Non-GAAP
financial measures are not an alternative for financial measures
prepared in accordance with GAAP. However, the Company believes the
presentation of non-GAAP adjusted net loss and adjusted net loss
per share, when viewed in conjunction with our GAAP results,
provides investors with a more meaningful understanding of our
ongoing operating performance. These measures exclude (i) non-cash
share-based compensation that are substantially dependent on
changes in the market price of our common shares, (ii) non-cash
interest expense related to the accounting for our mandatorily
redeemable preferred shares and liability related to sale of future
royalties, which are in excess of the actual interest owned, (iii)
changes in the fair value of our derivative liability, which does
not correlate to our actual cash payment obligations in the
relevant periods, and (iv) losses from equity method investment,
because it generates non-cash losses, which are based on the
financial results of another company that we do not manage or
control.
The Company believes the presentation of these non-GAAP
financial measures provides useful information to management and
investors regarding the Company's financial condition and results
of operations. When GAAP financial measures are viewed in
conjunction with these non-GAAP financial measures, investors are
provided with a more meaningful understanding of the Company's
ongoing operating performance and are better able to compare the
Company's performance between periods. In addition, these non-GAAP
financial measures are among those indicators the Company uses as a
basis for evaluating performance, and planning and forecasting
future periods. These non-GAAP financial measures are not intended
to be considered in isolation or as a substitute for GAAP financial
measures. A reconciliation between these non-GAAP measures and the
most directly comparable GAAP measures is provided later in this
press release.
About Biohaven
Biohaven is a commercial-stage
biopharmaceutical company with a portfolio of innovative,
best-in-class therapies to improve the lives of patients with
debilitating neurological and neuropsychiatric diseases, including
rare disorders. Biohaven's neuroinnovation portfolio includes
FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of
migraine and a broad pipeline of late-stage product candidates
across three distinct mechanistic platforms: CGRP receptor
antagonism for the acute and preventive treatment of migraine;
glutamate modulation for obsessive-compulsive disorder, Alzheimer's
disease, and spinocerebellar ataxia; and myeloperoxidase (MPO)
inhibition for multiple system atrophy and amyotrophic lateral
sclerosis. More information about Biohaven is available at
www.biohavenpharma.com.
Catalent is the leading global provider of advanced delivery
technologies and development solutions for drugs, biologics and
consumer health products. With over 85 years serving the industry,
Catalent has proven expertise in bringing more customer products to
market faster, enhancing product performance and ensuring reliable
clinical and commercial product supply. Zydis is a registered
trademark of Catalent. For more information, visit
www.catalent.com.
Forward-Looking Statements
This news release includes
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements involve substantial risks and uncertainties, including
statements that are based on the current expectations and
assumptions of the Company's management. All statements, other than
statements of historical facts, included in this press release
regarding the Company's business and product candidate plans and
objectives are forward-looking statements. Forward-looking
statements include those related to: commercialization and sales of
NURTEC ODT and the potential approval and commercialization of
other product candidates, the effect of the ongoing COVID-19
pandemic on the Company, the expected timing, commencement and
outcomes of the Company's planned and ongoing clinical trials, the
timing of planned interactions and filings with the FDA, the timing
and outcome of expected regulatory filings, including the
need for any REMS or Advisory Committee meetings, the potential for
the Company's product candidates to be first in class or best in
class therapies and the effectiveness and safety of the Company's
product candidates. The use of certain words, including "believe",
"continue", "may", "on track", "expects" and "will" and similar
expressions, are intended to identify forward-looking statements.
Various important factors could cause actual results or events to
differ materially from those that may be expressed or implied by
our forward-looking statements. Additional important factors to be
considered in connection with forward-looking statements are
described in the "Risk Factors" section of the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on February 26, 2020 and
the Company's Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020. The forward-looking
statements are made as of this date and the Company does not
undertake any obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
BIOHAVEN
PHARMACEUTICAL HOLDING COMPANY LTD. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (Amounts in thousands, except share and per share
amounts) (Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2020
|
|
2019
|
Product revenue,
net
|
|
$
|
1,151
|
|
|
$
|
—
|
|
Cost of goods
sold
|
|
424
|
|
|
—
|
|
Gross profit
|
|
727
|
|
|
—
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
56,070
|
|
|
41,003
|
|
General and
administrative
|
|
95,601
|
|
|
13,458
|
|
Total operating
expenses
|
|
151,671
|
|
|
54,461
|
|
Loss from
operations
|
|
(150,944)
|
|
|
(54,461)
|
|
Other income
(expense):
|
|
|
|
|
Non-cash interest
expense on mandatorily redeemable preferred shares
|
|
(5,561)
|
|
|
—
|
|
Non-cash interest
expense on liability related to sale of future royalties
|
|
(8,425)
|
|
|
(6,817)
|
|
Change in fair value of
derivative liability
|
|
(5,781)
|
|
|
—
|
|
Loss from equity method
investment
|
|
(1,380)
|
|
|
(900)
|
|
Other
|
|
(152)
|
|
|
(17)
|
|
Total other expense,
net
|
|
(21,299)
|
|
|
(7,734)
|
|
Loss before provision
for income taxes
|
|
$
|
(172,243)
|
|
|
$
|
(62,195)
|
|
Provision for income
taxes
|
|
694
|
|
|
109
|
|
Net loss and
comprehensive loss
|
|
$
|
(172,937)
|
|
|
$
|
(62,304)
|
|
Net loss per share —
basic and diluted
|
|
$
|
(3.07)
|
|
|
$
|
(1.41)
|
|
Weighted average
common shares outstanding—basic and diluted
|
|
56,412,439
|
|
|
44,242,070
|
|
BIOHAVEN
PHARMACEUTICAL HOLDING COMPANY LTD. CONDENSED
CONSOLIDATED BALANCE SHEETS (Amounts in
thousands)
|
|
|
|
March 31,
2020
|
|
December 31,
2019
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash
|
|
$
|
428,239
|
|
|
$
|
316,727
|
|
Trade receivables,
net
|
|
4,337
|
|
|
—
|
|
Inventories
|
|
4,582
|
|
|
—
|
|
Prepaid expenses and
other current assets
|
|
37,288
|
|
|
11,554
|
|
Total current
assets
|
|
474,446
|
|
|
328,281
|
|
Property and
equipment, net
|
|
8,933
|
|
|
8,152
|
|
Equity method
investment
|
|
3,958
|
|
|
5,338
|
|
Intangible assets,
net
|
|
41,259
|
|
|
—
|
|
Other
assets
|
|
4,073
|
|
|
2,493
|
|
Total
assets
|
|
$
|
532,669
|
|
|
$
|
344,264
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
29,703
|
|
|
$
|
14,071
|
|
Accrued expenses other
current liabilities
|
|
76,770
|
|
|
52,102
|
|
Current portion of
mandatorily redeemable preferred shares
|
|
15,625
|
|
|
—
|
|
Total current
liabilities
|
|
122,098
|
|
|
66,173
|
|
Liability related to
sale of future royalties, net
|
|
151,454
|
|
|
144,111
|
|
Mandatorily
redeemable preferred shares, net
|
|
136,404
|
|
|
103,646
|
|
Derivative
liability
|
|
650
|
|
|
37,690
|
|
Other long-term
liabilities
|
|
105
|
|
|
68
|
|
Total
liabilities
|
|
410,711
|
|
|
351,688
|
|
Total shareholders'
equity
|
|
121,958
|
|
|
(7,424)
|
|
Total liabilities and
shareholders' equity
|
|
$
|
532,669
|
|
|
$
|
344,264
|
|
|
|
|
|
|
BIOHAVEN
PHARMACEUTICAL HOLDING COMPANY LTD. RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL MEASURES (Amounts in
thousands, except share and per share
amounts) (Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2020
|
|
2019
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss:
|
GAAP net
loss
|
|
$
|
(172,937)
|
|
|
$
|
(62,304)
|
|
Add: non-cash
share-based compensation expense
|
|
16,879
|
|
|
7,330
|
|
Add: non-cash interest
expense on mandatorily redeemable preferred shares
|
|
5,561
|
|
|
—
|
|
Add: non-cash interest
expense on liability related to sale of future royalties
|
|
8,401
|
|
|
6,817
|
|
Add: change in fair
value of derivative liability
|
|
5,781
|
|
|
—
|
|
Add: loss from equity
method investment
|
|
1,380
|
|
|
900
|
|
Non-GAAP adjusted net
loss
|
|
$
|
(134,935)
|
|
|
$
|
(47,257)
|
|
|
|
|
|
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss per share — basic and
diluted:
|
GAAP net loss per share
— basic and diluted
|
|
$
|
(3.07)
|
|
|
$
|
(1.41)
|
|
Add: non-cash
share-based compensation expense
|
|
0.31
|
|
|
0.17
|
|
Add: non-cash interest
expense on mandatorily redeemable preferred shares
|
|
0.10
|
|
|
—
|
|
Add: non-cash interest
expense on liability related to sale of future royalties
|
|
0.15
|
|
|
0.15
|
|
Add: change in fair
value of derivative liability
|
|
0.10
|
|
|
—
|
|
Add: loss from equity
method investment
|
|
0.02
|
|
|
0.02
|
|
Non-GAAP adjusted net
loss per share — basic and diluted
|
|
$
|
(2.39)
|
|
|
$
|
(1.07)
|
|
About NURTEC ODT
NURTEC™ ODT (rimegepant) is the first
and only calcitonin gene-related peptide (CGRP) receptor antagonist
available in a quick-dissolve ODT formulation that is approved by
the U.S. Food and Drug Administration (FDA) for the acute treatment
of migraine in adults. The activity of the neuropeptide CGRP is
thought to play a causal role in migraine pathophysiology. NURTEC
ODT is a CGRP receptor antagonist that works by reversibly blocking
CGRP receptors, thereby inhibiting the biologic activity of the
CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg,
taken as needed, up to once daily. For more information about
NURTEC ODT, visit www.nurtec.com.
About Migraine
Nearly 40 million people in the U.S.
suffer from migraine and the World Health Organization classifies
migraine as one of the 10 most disabling medical illnesses.
Migraine is characterized by debilitating attacks lasting four to
72 hours with multiple symptoms, including pulsating headaches of
moderate to severe pain intensity that can be associated with
nausea or vomiting, and/or sensitivity to sound (phonophobia) and
sensitivity to light (photophobia). There is a significant unmet
need for new acute treatments as more than 90 percent of migraine
sufferers are unable to work or function normally during an
attack.
About CGRP Receptor Antagonism
Small molecule CGRP
receptor antagonists represent a novel class of drugs for the
treatment of migraine. This unique mode of action potentially
offers an alternative to current agents, particularly for patients
who have contraindications to the use of triptans, or who have a
poor response to triptans or are intolerant to them.
Indication
NURTEC ODT is indicated for the acute
treatment of migraine with or without aura in adults.
Limitations of Use
NURTEC ODT is not indicated for the
preventive treatment of migraine.
Important Safety Information
Contraindications: Hypersensitivity to NURTEC ODT or any of
its components.
Warnings and Precautions: If a serious
hypersensitivity reaction occurs, discontinue NURTEC ODT and
initiate appropriate therapy. Serious hypersensitivity
reactions have included dyspnea and rash, and can occur days after
administration.
Adverse Reactions: The most common adverse reaction
was nausea (2% in patients who received NURTEC ODT compared to 0.4%
in patients who received placebo). Hypersensitivity,
including dyspnea and rash, occurred in less than 1% of patients
treated with NURTEC ODT.
Drug Interactions: Avoid concomitant administration
of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate
inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid
another dose of NURTEC ODT within 48 hours when it is administered
with moderate inhibitors of CYP3A4.
Use in Specific Populations:
- Pregnant/breast feeding: It is not known if NURTEC ODT can harm
an unborn baby or if it passes into breast milk.
- Hepatic impairment: Avoid use of NURTEC ODT in persons with
severe hepatic impairment.
- Renal impairment: Avoid use in patients with end-stage renal
disease.
Please click here for full Prescribing information.
You are encouraged to report side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 or report side effects to Biohaven at
1-833-4Nurtec.
Please click here for full Prescribing information and Patient
Information.
Biohaven Contact
Dr. Vlad
Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.