NEW HAVEN, Conn., Nov. 9, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurological diseases
including rare disorders, today reported financial results for the
third quarter ended September 30,
2021, and provided a review of recent accomplishments and
anticipated upcoming milestones.
"We are ecstatic with the success that our platform continued to
achieve over the quarter, with NURTEC ODT impressively surpassing
revenue expectations, and becoming the market leader in oral CGRP
targeting migraine therapies," said Vlad
Coric, M.D., Chief Executive Officer of Biohaven. "We are
further encouraged by the overwhelmingly positive patient
experience to date, recognizing the value of providing a solution
that will further improve the quality of life of those who are now
able to prevent the debilitating effects of migraine. While there
remains significant upside for NURTEC ODT across new geographies
and patient demographics given the expanded preventive treatment
use, we also look forward to the continuous progress made outside
of our CGRP franchise and within our broad pipeline."
Dr. Coric continued, "We are also excited to have announced a
strategic collaboration with pharmaceutical powerhouse Pfizer for
the global commercialization ex-US of NURTEC ODT, validating the
medicine's dual therapy potential and highlighting our commitment
to the more than 1 billion patients worldwide suffering with
migraine."
Third Quarter and Recent Business Highlights
Continued strong uptake of NURTEC ODT – Following
the landmark approval of NURTEC ODT for the preventive treatment of
migraine in May, we believe NURTEC ODT will continue its impressive
growth as the first and only medication approved to both treat and
prevent migraine attacks. NURTEC ODT has now achieved over
1,100,000 prescriptions, and over 53,000 unique prescribers to
date, an increase of 15,000 prescribers from the second quarter
signaling traction with physicians. The $136
million in net product revenues for the quarter represents a
46% increase from net product revenues over the second quarter,
significantly exceeding expectations. We saw a continuation of the
improvement in net price realization in the third quarter 2021, as
compared to the first quarter of 2021.
We believe there continues to be a significant market
opportunity for oral CGRP targeting agents ahead, with a potential
$4-5 billion annual market in the US
alone. We will continue to invest in NURTEC's long term success,
driving its growth outside of the U.S. and continuing to expand
commercial payer coverage.
Entered into second amendment to term loan financing
facility – In September 2021, the
Company, Biohaven Pharmaceuticals, Inc., a wholly-owned subsidiary
of the Company (together with the Company, the "Borrowers"), and
certain other of the Company's subsidiaries entered into an
Amendment No. 2 (the "Second Amendment") to its Financing Agreement
dated as of August 7, 2020 with Sixth
Street Specialty Lending, Inc. Pursuant to the Second Amendment,
the parties agreed, among other things, to increase the total size
of the credit facility by $250.0
million to $750.0 million, and
reduce the interest rate margin (as defined in the Sixth Street
Financing Agreement) by 0.75% on the amounts made available under
the amendment and the remaining $100.0
million not previously drawn on the August 2020 agreement. On closing of the
amendment, the Company drew $125.0
million made available from the amendment, and the
$100.0 million remaining under the
August 2020 agreement. The
remaining $125.0 million available
under the facility remains available at the Company's discretion
until December 31, 2021.
Presented expanded NURTEC ODT and intranasal zavegepant data
at the International Headache Society – European Headache
Federation Joint Congress – In September, the Company presented
17 abstracts, including three late-breaking abstracts and four oral
presentations, highlighting the efficacy and safety of NURTEC ODT
as both an acute and preventive treatment of migraine. Within the
Phase 2/3 study, preventive effects of rimegepant were evident as
early as the first week of treatment and sustained after 12 weeks.
Results from an open label safety study of rimegepant demonstrated
its preventive benefits when dosed on an as needed basis to treat
migraine attacks, expressed as median time to 30% and 50% reduction
in monthly migraine days observed to decrease at 12 weeks and 32
weeks respectively. Within the Phase 2/3 dose-ranging study
evaluating the safety, efficacy and tolerability of intranasal
zavegepant, it was found that both 10 mg and 20 mg doses were
superior to placebo on the coprimary endpoints of pain freedom.
Lastly, health economics and outcomes research posters highlighted
the association between migraine-related absenteeism, healthcare
utilization and cost of care.
Phase 3 clinical trial of verdiperstat in MSA did not
statistically differentiate from placebo on the study's
prespecified primary or secondary efficacy measures – In
September, the Company announced that verdiperstat did not
demonstrate efficacy for the treatment of multiple system atrophy
(MSA). Although the mechanism of action for verdiperstat,
myeloperoxidase inhibition, was shown not to be effective for MSA,
Biohaven maintains that there remains a strong rationale of
targeting brain inflammation in other disease states. An
ongoing clinical trial evaluating the efficacy of verdiperstat in
amyotrophic lateral sclerosis (ALS) is being conducted in
collaboration with the Sean M. Healey & AMG Center for ALS at
Massachusetts General Hospital and is expected to complete
enrollment in the fourth quarter of 2021.
Upcoming Milestones:
Biohaven is continuing to support the launch of NURTEC ODT for
the acute and preventive treatment of migraine, as well as develop
our 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.
Biohaven expects to:
- Continue to advance the commercialization of NURTEC ODT
(rimegepant) for the acute and preventive treatment of migraine
outside of the U.S.
- Report topline of intranasal zavegepant in the acute treatment
of migraine in the fourth quarter of 2021.
- Complete enrollment of verdiperstat for the treatment of ALS in
the fourth quarter of 2021.
- Marketing Authorization Application for rimegepant dual
activity, inclusive of acute and prevention of migraine expected
regulatory approval in the first half of 2022.
- Report topline of NURTEC ODT for the acute treatment of
migraine in China and Korea in the
first half of 2022.
- Report topline of troriluzole in Spinocerebellar Ataxia in the
first half of 2022.
- Report topline of troriluzole in OCD in the second half of
2022.
Third Quarter Financial Results
Product Revenues, Net: Net product revenue was
$135.7 million for the three months
ended September 30, 2021, compared to
$17.7 million for the three months
ended September 30, 2020. The
increase of $118.1 million in net
product revenues is due to both increased NURTEC ODT sales volume
and improvements in net price realization due to decreases in sales
allowances during the three months ended September 30, 2021, compared to the three months
ended September 30, 2020. Sales
allowances and accruals mostly consisted of patient affordability
programs, distribution fees and rebates.
Cash, Restricted Cash, and Marketable
Securities: Cash, restricted cash, and marketable
securities as of September 30, 2021, was $523.9 million,
compared to $368.0 million as of June 30, 2021. In
addition, the Company has access to $125.0
million in available borrowing under our credit facility,
and Series B preferred share forward contracts with quarterly cash
proceeds totaling $147.2 million
until the fourth quarter of 2024.
Research and Development (R&D) Expenses: R&D
expenses, including non-cash share-based compensation costs, were
$85.7 million for the three months
ended September 30, 2021, compared to
$57.0 million for the three months
ended September 30, 2020. The
increase of $28.6 million was
primarily due to an increase in both late-stage product candidates
and preclinical research. Non-cash share-based compensation expense
was $13.1 million for the three
months ended September 30, 2021, an
increase of $7.9 million as compared
to the same period in 2020.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses, including non-cash share-based compensation
costs, were $164.5 million for the
three months ended September 30,
2021, compared to $119.5
million for the three months ended September 30, 2020. The increase of $45.0 million was primarily due to increases in
spending to support increased commercial sales of NURTEC ODT for
the three months ended September 30,
2021, compared to the three months ended September 30, 2020. Less than half of the
SG&A expense was for commercial organization personnel costs,
excluding non-cash share-based compensation expense. Non-cash
share-based compensation expense was $14.9
million for the three months ended September 30, 2021, an increase of $5.5 million as compared to the same period in
2020.
Net Loss: Biohaven reported a net loss
attributable to common shareholders for the three months ended
September 30, 2021, of $171.8 million, or $2.63 per share, compared to $195.2 million,
or $3.27 per share for the same period in 2020.
Non-GAAP adjusted net loss for the three months ended September 30, 2021 was $125.1 million, or $1.91 per share, compared to $159.5 million,
or $2.67 per share for the same period in 2020. 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 mandatorily
redeemable preferred shares and liability related to sale of future
royalties, changes in the fair value of derivatives, gains or
losses from equity method investment, collaboration and license
upfront expenses, and accrued development milestone payments. A
reconciliation of the GAAP financial results to non-GAAP financial
results is included in the tables below.
Conference Call Information
As previously announced, the Company will hold a conference call
to discuss its third quarter 2021 results today at 8:00 a.m. EDT. To access the call, please dial
877-407-9120 (domestic) or 412-902-1009 (international). The
conference call webcast, and accompanying slide presentation, can
be accessed through the "Investors" section of Biohaven's website
at www.biohavenpharma.com. To ensure a timely connection, it is
recommended that participants register at least 15 minutes prior to
the scheduled webcast. A replay of the call will be made available
for two weeks following the conference call. To hear a replay of
the call, dial 877-660-6853 (domestic) or 201-612-7415
(international) with conference ID 13723890. An archived webcast
will be available on Biohaven's website.
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 non-GAAP financial measures. In particular, Biohaven 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, Biohaven believes the presentation
of non-GAAP adjusted net loss and adjusted net loss per share, when
viewed in conjunction with GAAP results, provides investors with a
more meaningful understanding of ongoing operating performance.
These measures exclude (i) non-cash share-based compensation, which
is substantially dependent on changes in the market price of common
shares, (ii) 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 owed, (iii) changes in the fair value of derivative
liability, which does not correlate to actual cash payment
obligations in the relevant periods, (iv) gains or losses from
equity method investment, which are non-cash and based on the
financial results and valuation of another company that we did not
manage or control, (v) collaboration and license upfront expenses,
which the Company does not believe are normal, recurring operating
expenses due to their nature, variability of amounts, and lack of
predictability as to occurrence and/or timing, and (vi) non-routine
accrued development milestone expenses.
Biohaven believes the presentation of these non-GAAP financial
measures provides useful information to management and investors
regarding Biohaven's 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 Biohaven's ongoing operating performance and are
better able to compare Biohaven's performance between periods. In
addition, these non-GAAP financial measures are among those
indicators Biohaven 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 and preventive 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 and CGRP-mediated
neuroimmune/neuroinflammatory diseases; glutamate modulation for
obsessive-compulsive disorder, Alzheimer's disease, and
spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for
amyotrophic lateral sclerosis. More information about
Biohaven is available at www.biohavenpharma.com.
Forward-Looking Statements
This news release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
The use of certain words, including "believe", "continue", "may",
"will" and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements
involve substantial risks and uncertainties, including statements
that are based on the current expectations and assumptions of
Biohaven's management about NURTEC ODT as an acute treatment for
patients with migraine and preventive treatment for migraine.
Factors that could affect these forward-looking statements include
those related to: Biohaven's ability to effectively commercialize
NURTEC ODT, delays or problems in the supply or manufacture of
NURTEC ODT, complying with applicable U.S. regulatory requirements,
the expected timing, commencement and outcomes of Biohaven's
planned and ongoing clinical trials, the timing of planned
interactions and filings with the FDA, the timing and outcome of
expected regulatory filings, the potential commercialization of
Biohaven's product candidates, the potential for Biohaven's product
candidates to be first in class or best in class therapies and the
effectiveness and safety of Biohaven's product candidates. Various
important factors could cause actual results or events to differ
materially from those that may be expressed or implied by
forward-looking statements. Additional important factors to be
considered in connection with forward-looking statements are
described in the "Risk Factors" section of Biohaven's Annual Report
on Form 10-K for the year ended December 31,
2020, filed with the Securities and Exchange Commission on
March 1, 2021, and in Biohaven's
subsequent filings with the Securities and Exchange Commission. The
forward-looking statements are made as of this date and Biohaven
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
|
(Amounts in
thousands, except share and per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Product revenue,
net
|
|
$
|
135,740
|
|
|
$
|
17,664
|
|
|
$
|
272,496
|
|
|
$
|
28,513
|
|
Cost of goods
sold
|
|
25,514
|
|
|
4,244
|
|
|
55,715
|
|
|
7,726
|
|
Gross
profit
|
|
110,226
|
|
|
13,420
|
|
|
216,781
|
|
|
20,787
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
85,664
|
|
|
57,044
|
|
|
270,203
|
|
|
155,539
|
|
Selling, general and
administrative
|
|
164,511
|
|
|
119,533
|
|
|
494,091
|
|
|
339,936
|
|
Total operating
expenses
|
|
250,175
|
|
|
176,577
|
|
|
764,294
|
|
|
495,475
|
|
Loss from
operations
|
|
(139,949)
|
|
|
(163,157)
|
|
|
(547,513)
|
|
|
(474,688)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(9,047)
|
|
|
(4,608)
|
|
|
(24,614)
|
|
|
(4,835)
|
|
Interest expense on
mandatorily redeemable preferred shares
|
|
(8,144)
|
|
|
(7,310)
|
|
|
(24,129)
|
|
|
(19,864)
|
|
Interest expense on
liability related to sale of future royalties
|
|
(15,488)
|
|
|
(11,955)
|
|
|
(43,495)
|
|
|
(31,950)
|
|
Change in fair value
of derivatives
|
|
(1,893)
|
|
|
(1,940)
|
|
|
(3,593)
|
|
|
(7,071)
|
|
Gain (loss) from
equity method investment
|
|
—
|
|
|
(607)
|
|
|
5,261
|
|
|
(3,472)
|
|
Other expense,
net
|
|
(5)
|
|
|
(3,062)
|
|
|
(4,756)
|
|
|
(3,278)
|
|
Total other income
(expense), net
|
|
(34,577)
|
|
|
(29,482)
|
|
|
(95,326)
|
|
|
(70,470)
|
|
Loss before (benefit)
provision for income taxes
|
|
(174,526)
|
|
|
(192,639)
|
|
|
(642,839)
|
|
|
(545,158)
|
|
(Benefit) provision
for income taxes
|
|
(2,198)
|
|
|
3,989
|
|
|
5,976
|
|
|
5,341
|
|
Net loss
|
|
(172,328)
|
|
|
(196,628)
|
|
|
(648,815)
|
|
|
(550,499)
|
|
Less: Net loss
attributable to non-controlling interests
|
|
(512)
|
|
|
(1,439)
|
|
|
(1,412)
|
|
|
(1,439)
|
|
Net loss attributable
to Biohaven Pharmaceutical Holding Company Ltd.
|
|
$
|
(171,816)
|
|
|
$
|
(195,189)
|
|
|
$
|
(647,403)
|
|
|
$
|
(549,060)
|
|
Net loss per share
attributable to Biohaven Pharmaceutical Holding Company Ltd. —
basic and diluted
|
|
$
|
(2.63)
|
|
|
$
|
(3.27)
|
|
|
$
|
(10.09)
|
|
|
$
|
(9.42)
|
|
Weighted average
common shares outstanding—basic and diluted
|
|
65,389,574
|
|
|
59,677,989
|
|
|
64,193,090
|
|
|
58,282,697
|
|
|
|
|
BIOHAVEN
PHARMACEUTICAL HOLDING COMPANY LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Amounts in
thousands)
|
|
|
|
September 30,
2021
|
|
December 31,
2020
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
501,409
|
|
|
$
|
132,149
|
|
Marketable
securities
|
|
19,031
|
|
|
223,185
|
|
Trade receivables,
net
|
|
252,952
|
|
|
120,111
|
|
Inventory
|
|
74,864
|
|
|
39,563
|
|
Prepaid
expenses
|
|
61,698
|
|
|
76,682
|
|
Other current
assets
|
|
34,427
|
|
|
11,716
|
|
Total current
assets
|
|
944,381
|
|
|
603,406
|
|
Property and
equipment, net
|
|
10,409
|
|
|
9,340
|
|
Equity method
investment
|
|
—
|
|
|
1,176
|
|
Intangible assets,
net
|
|
56,968
|
|
|
39,087
|
|
Other
assets
|
|
119,437
|
|
|
33,966
|
|
Total
assets
|
|
$
|
1,131,195
|
|
|
$
|
686,975
|
|
Liabilities and
Shareholders' Deficit
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
49,437
|
|
|
$
|
48,476
|
|
Accrued expenses and
other current liabilities
|
|
350,339
|
|
|
166,630
|
|
Current portion of
mandatorily redeemable preferred shares
|
|
62,500
|
|
|
62,500
|
|
Total current
liabilities
|
|
462,276
|
|
|
277,606
|
|
Long-term
debt
|
|
619,267
|
|
|
267,458
|
|
Liability related to
sale of future royalties, net
|
|
357,655
|
|
|
328,350
|
|
Mandatorily
redeemable preferred shares, net
|
|
144,333
|
|
|
111,591
|
|
Derivative
liability
|
|
15,050
|
|
|
14,190
|
|
Obligation to perform
R&D services
|
|
47,155
|
|
|
932
|
|
Other long-term
liabilities
|
|
16,666
|
|
|
19,037
|
|
Total
liabilities
|
|
1,662,402
|
|
|
1,019,164
|
|
Contingently
redeemable non-controlling interests
|
|
60,000
|
|
|
60,000
|
|
Total shareholders'
deficit attributable to Biohaven Pharmaceutical Holding Company
Ltd.
|
|
(587,976)
|
|
|
(390,370)
|
|
Non-controlling
interests in consolidated subsidiaries
|
|
(3,231)
|
|
|
(1,819)
|
|
Total shareholders'
deficit
|
|
(591,207)
|
|
|
(392,189)
|
|
Total liabilities and
shareholders' deficit
|
|
$
|
1,131,195
|
|
|
$
|
686,975
|
|
|
|
|
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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss:
|
|
|
|
|
GAAP net loss
attributable to Biohaven Pharmaceutical Holding Company
Ltd.
|
|
$
|
(171,816)
|
|
|
$
|
(195,189)
|
|
|
$
|
(647,403)
|
|
|
$
|
(549,060)
|
|
Add: non-cash
share-based compensation expense
|
|
27,966
|
|
|
14,565
|
|
|
102,278
|
|
|
43,206
|
|
Add: non-cash interest
expense on mandatorily redeemable preferred shares
|
|
—
|
|
|
7,310
|
|
|
7,943
|
|
|
19,864
|
|
Add: non-cash interest
expense on liability related to sale of future royalties
|
|
13,165
|
|
|
11,288
|
|
|
37,313
|
|
|
31,283
|
|
Add: change in fair
value of derivatives
|
|
1,893
|
|
|
1,940
|
|
|
3,593
|
|
|
7,071
|
|
Add: (gain) loss from
equity method investment
|
|
—
|
|
|
607
|
|
|
(5,261)
|
|
|
3,472
|
|
Add: collaboration and
license upfront expenses
|
|
3,686
|
|
|
—
|
|
|
11,629
|
|
|
—
|
|
Add: accrued
development milestone payments
|
|
—
|
|
|
—
|
|
|
5,500
|
|
|
—
|
|
Non-GAAP adjusted net
loss attributable to Biohaven Pharmaceutical Holding Company
Ltd.
|
|
$
|
(125,106)
|
|
|
$
|
(159,479)
|
|
|
$
|
(484,408)
|
|
|
$
|
(444,164)
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss per share — basic and
diluted:
|
|
|
|
|
GAAP net loss per share
attributable to Biohaven Pharmaceutical Holding Company Ltd. —
basic and diluted
|
|
$
|
(2.63)
|
|
|
$
|
(3.27)
|
|
|
$
|
(10.09)
|
|
|
$
|
(9.42)
|
|
Add: non-cash
share-based compensation expense
|
|
0.43
|
|
|
0.25
|
|
|
1.59
|
|
|
0.74
|
|
Add: non-cash interest
expense on mandatorily redeemable preferred shares
|
|
—
|
|
|
0.12
|
|
|
0.12
|
|
|
0.34
|
|
Add: non-cash interest
expense on liability related to sale of future royalties
|
|
0.20
|
|
|
0.19
|
|
|
0.58
|
|
|
0.54
|
|
Add: change in fair
value of derivatives
|
|
0.03
|
|
|
0.03
|
|
|
0.06
|
|
|
0.12
|
|
Add: (gain) loss from
equity method investment
|
|
—
|
|
|
0.01
|
|
|
(0.08)
|
|
|
0.06
|
|
Add: collaboration and
license upfront fees
|
|
0.06
|
|
|
—
|
|
|
0.18
|
|
|
—
|
|
Add: accrued
development milestone payments
|
|
—
|
|
|
—
|
|
|
0.09
|
|
|
—
|
|
Non-GAAP adjusted net
loss per share attributable to Biohaven Pharmaceutical Holding
Company Ltd. — basic and diluted
|
|
$
|
(1.91)
|
|
|
$
|
(2.67)
|
|
|
$
|
(7.55)
|
|
|
$
|
(7.62)
|
|
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
with or without aura and the preventive treatment of episodic
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 to treat or every other day to
help prevent migraine attacks. For more information about NURTEC
ODT, visit www.nurtec.com. The most common adverse reaction
was nausea and abdominal pain/indigestion. 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.
Indication
NURTEC ODT orally disintegrating tablets is a prescription
medicine that is used to treat migraine in adults. It is for the
acute treatment of migraine attacks with or without aura and the
preventive treatment of episodic migraine. It is not known if
NURTEC ODT is safe and effective in children.
Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC
ODT (rimegepant) or any of its ingredients.
Before you take NURTEC ODT, tell your healthcare provider
(HCP) about all your medical conditions, including if you:
- have liver problems,
- have kidney problems,
- are pregnant or plan to become pregnant,
- breastfeeding or plan to breastfeed.
Tell your HCP about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
NURTEC ODT may cause serious side effects including allergic
reactions, including trouble breathing and rash. This can happen
days after you take NURTEC ODT. Call your HCP or get emergency help
right away if you have swelling of the face, mouth, tongue, or
throat or trouble breathing. This occurred in less than 1% of
patients treated with NURTEC ODT.
The most common side effects of NURTEC ODT were
nausea (2.7%) and stomach pain/indigestion (2.4%). These are not
the only possible side effects of NURTEC ODT. Tell your HCP if you
have any side effects.
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
For Media
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of
Biohaven Pharmaceutical Holding Company Ltd.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.