NEW HAVEN, Conn., Aug. 10, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), 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 June 30, 2020, and
provided a review of recent accomplishments and anticipated
upcoming milestones.
Vlad Coric, M.D. Chief Executive
Officer, commented, "This has been an unprecedented quarter in so
many ways. We are pleased to report the Company is excelling
in achieving our goals across multiple areas: the launch trajectory
of Nurtec ODT is exceeding initial expectations with net sales in
the second quarter of $9.7M; we
continue to make progress in advancing our clinical trials and have
a robust pipeline; and the strategic financing of up to
$950M dollars that we announced on
Friday puts us in a strong financial position to execute on our
long-term growth plans. Biohaven has a strong portfolio of product
opportunities and we believe one of the most promising neuroscience
pipelines. We are in a strong position to grow the global value of
our CGRP targeting franchise, and we will continue to focus on our
R&D efforts on delivering best-in-class therapies for patients
suffering from neurologic and neuropsychiatric disorders."
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 with
product label claims including return to normal functioning and
sustain durability of efficacy up to 48 hours. Early adoption among
physicians and patients has been strong, with consistent
week-over-week prescription growth since launch (excluding the
Memorial Day and 4th of July holidays).
Second Quarter and Recent Business Highlights
Strong uptake of NURTEC ODT post-launch – The launch of
NURTEC ODT proceeded at a strong pace, despite the difficult
circumstances caused by the COVID-19 pandemic. Early success
resulted from pivoting quickly to prioritize virtual channels of
engagement to drive health care provider awareness and trial,
accelerate patient activation, and establish broad product access
at pharmacies. NURTEC ODT's differentiated clinical profile 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. Second quarter prescriptions totaled
46,314 fueled by strong oral anti-CGRP class growth, in which
NURTEC ODT out-performed competition and achieved "new to brand"
market leadership.
BJ Jones, Chief Commercial Officer, stated, "Migraine is a large
market affecting approximately 40 million Americans. Many
patients are dissatisfied with the trade-off in efficacy and
tolerability that they have to make with the older treatments in
this class. This market is seeing new treatments for the first time
in decades, and we believe that given the high level of patient and
physician satisfaction with the efficacy and safety of NURTEC ODT
that significant growth remains ahead. We believe that NURTEC ODT
is a best in class CGRP therapy and is highly differentiated from
our competitors, including the following advantages: NURTEC ODT is
a simple to use oral, rapidly dissolving pill with a fast onset of
action, returns patients to normal functioning within 60 minutes,
and has sustained effects out to 48hrs after a single dose."
Verdiperstat Phase 3 enrollment – In July, the Company
announced it completed enrollment in the M-STAR study, an
international Phase 3 clinical trial evaluating the safety and
efficacy of verdiperstat in multiple system atrophy (MSA), a rare,
rapidly progressive and fatal neuroinflammatory disease with no
cure or effective treatments ahead of schedule. Verdiperstat has
received Orphan Drug and Fast Track designations for MSA from the
U.S. Food and Drug Administration (FDA), as well as Orphan Drug
designation from the European Medicines Agency.
Entered into $500.0 million
non-dilutive term loan financing facility – In August, the
Company entered into a 5-year senior secured credit facility with
Six Street Specialty Lending, Inc., a subsidiary of 6th
Street Partners, as administrative agent and various lenders to
extend the Company up to $500.0
million. A total of $375M was
immediately available to The Company upon closing. The Company drew
$275.0 million in gross proceeds with
the additional $100.0 million
available at the Company's discretion. The remaining $125.0 million is available when net sales from
NURTEC ODT during 1Q2021 or 2Q2021 achieves at least $45.0 million. Borrowings under the credit
facility will accrue interest at a current rate of 10% (calculated
at 3-month LIBOR, subject to a floor of 1%, plus 9%). The
Company has the option, and has elected in its first drawdown, to
defer 4% of the interest for 2 years via payment in kind (PIK) to
the lenders. The facility will amortize at 5% of the outstanding
balance beginning at year 4, and at 10% in year 5.
Announced $450 million funding
agreement with Royalty Pharma—comprising of $250 million zavegepant funding agreement and
$200 million Series B preferred share
purchase agreement – In August, the Company announced it sold
tiered, sales-based participation rights up to 3% on annual
worldwide net sales of products containing zavegepant and 0.4%
sales-based participation rights on annual worldwide net sales of
NURTEC ODT to Royalty Pharma for $250.0
million. The Company also announced that Royalty Pharma will
purchase Series B preferred shares of the Company for a total of
$200.0 million between March 2021 and December
2024. In return, Biohaven will pay Royalty Pharma a series
of equal, fixed payments between 2025 and 2030 with an internal
rate of return of approximately 12%.
Jim Engelhart, Chief Financial
Officer, commented "These financings provide Biohaven with the
funds to advance our Zavegepant development pipeline for migraine
and non-migraine indications as well as support the Company's
commercialization efforts for our growing Nurtec business. We
are excited to expand our partnership with Royalty Pharma and look
forward to our new relationship with 6th Street
Partners, both highly respected firms and leaders in their fields
of providing non-dilutive financing alternatives for
companies. These transactions allow Biohaven to maintain a
strong balance sheet while executing on these important
programs."
Bob Hugin appointed to Board
of Directors – In June, Mr. Hugin joined Biohaven's board.
Mr. Hugin previously spent 19 years at Celgene, including serving
as Chairman and CEO, and was instrumental in the company's
strategic growth and global expansion. Mr. Hugin also
previously served as the Chairman of the Board of the
Pharmaceutical Research and Manufacturers of America.
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. Biohaven expects
to reach significant pipeline milestones with its CGRP receptor
antagonists, glutamate modulators, and myeloperoxidase inhibitors
in the coming quarters. Certain timelines noted below were
extended due to delays caused by the current COVID-19 pandemic.
Biohaven expects to:
- Expand and grow NURTEC ODT commercialization/sales in the acute
treatment of migraine.
- File an sNDA for NURTEC ODT for the preventive treatment of
migraine indication before year end.
- Initiate two Phase 3 clinical trials for troriluzole in OCD in
2020 after receiving feedback from the FDA in an End of Phase 2
meeting.
- Complete last patient, last visit in the ongoing troriluzole
Phase 2/3 Alzheimer's disease trial in 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 fourth 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.
- Report topline of verdiperstat for the treatment of MSA
expected in the fourth quarter of 2021.
- 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.
Second Quarter Financial Results
Product Revenues, Net: We recorded net product
revenues of $9.7 million in the
second quarter of 2020, net of sales allowances and rebates,
related to sales of NURTEC ODT.
Cash Position: Cash and restricted cash as
of June 30, 2020, was $263.9 million, compared
to $429.2 million as of March 31, 2020. In addition,
the Company has access to $725.0
million of the total $950.0
million non-equity-based financings entered into with Sixth
Street and RPI in August.
Research and Development (R&D) Expenses: R&D
expenses, including non-cash share-based compensation costs, were
$42.4 million for the three months
ended June 30, 2020, compared to
$176.0 million for the three months
ended June 30, 2019. The decrease of
$133.6 million was primarily due to
the $105.0 million purchase of a
priority review voucher to expedite the regulatory review of
rimegepant ODT formulation, filing fees of $7.6 million related to our rimegepant NDA
submission, accruals of development milestones payable to BMS in
the amount of $11.5 million, and
$5.6 million non-cash expense related
to our agreement with Fox Chase for our TDP-43 assets, all only
occurring in the three months ended June 30,
2019. Non-cash share-based compensation expense was
$6.4 million for the three months
ended June 30, 2020, a decrease of
$3.9 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 $124.8
million for the three months ended June 30, 2020, compared to $23.2 million for the three months ended
June 30, 2019. The increase of
$101.6 million was primarily due to
increases in spending to support the commercial launch of NURTEC
ODT in 2020. Less than half of the SG&A expense, or
approximately $50 million, was for
commercial organization personnel costs, excluding non-cash
share-based compensation expense. Non-cash share-based
compensation expense was $5.3 million
for the three months ended June 30,
2020, a decrease of $1.9
million as compared to the same period in 2019.
Net Loss: Biohaven reported a net loss
attributable to common shareholders for the three months ended
June 30, 2020 of $180.9 million, or $3.08 per share, compared to $211.1 million,
or $4.67 per share for the same period in 2019.
Non-GAAP adjusted net loss for the three months ended June 30, 2020 was $150.0
million, or $2.55 per share,
compared to $59.6 million, or $1.32 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, losses from our equity
method investment, expense related to non-routine priority review
voucher acquisition, accrued development milestone payments, and
the one-time issuance of common shares to Fox Chase. 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 2Q2020
results today at 8:00 a.m. EST. 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 13707340. 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
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 owed, (iii) changes in the fair value of our
derivative liability, which does not correlate to our actual cash
payment obligations in the relevant periods, (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, (v) expense related to non-routine
priority review voucher acquisition, (vi) non-routine accrued
development milestone payments, and (vii) one-time issuance of
common shares to Fox Chase.
Biohaven believes the presentation of these non-GAAP financial
measures provides useful information to management and investors
regarding Biohaven'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 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 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 MPO inhibition for
multiple system atrophy and 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 potential
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 our 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, 2019,
filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report
on Form 10-Q for the quarter ended June 30,
2020. 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 AND COMPREHENSIVE
LOSS
|
(Amounts in
thousands, except share and per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Product revenue,
net
|
|
9,698
|
|
|
—
|
|
|
10,849
|
|
|
—
|
|
Cost of goods
sold
|
|
3,058
|
|
|
—
|
|
|
3,482
|
|
|
—
|
|
Gross
profit
|
|
6,640
|
|
|
—
|
|
|
7,367
|
|
|
—
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
42,425
|
|
|
175,977
|
|
|
98,495
|
|
|
216,980
|
|
Selling, general and
administrative
|
|
124,802
|
|
|
23,231
|
|
|
220,403
|
|
|
36,689
|
|
Total operating
expenses
|
|
167,227
|
|
|
199,208
|
|
|
318,898
|
|
|
253,669
|
|
Loss from
operations
|
|
(160,587)
|
|
|
(199,208)
|
|
|
(311,531)
|
|
|
(253,669)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(172)
|
|
|
—
|
|
|
(227)
|
|
|
—
|
|
Non-cash interest
expense on mandatorily
redeemable preferred shares
|
|
(6,993)
|
|
|
(3,955)
|
|
|
(12,554)
|
|
|
(3,955)
|
|
Non-cash interest
expense on liability related to
sale of future royalties
|
|
(11,570)
|
|
|
(5,155)
|
|
|
(19,995)
|
|
|
(11,972)
|
|
Change in fair value
of derivative liability
|
|
650
|
|
|
(1,263)
|
|
|
(5,131)
|
|
|
(1,263)
|
|
Loss from equity
method investment
|
|
(1,485)
|
|
|
(1,415)
|
|
|
(2,865)
|
|
|
(2,315)
|
|
Other
|
|
(119)
|
|
|
(16)
|
|
|
(216)
|
|
|
(33)
|
|
Total other expense,
net
|
|
(19,689)
|
|
|
(11,804)
|
|
|
(40,988)
|
|
|
(19,538)
|
|
Loss before provision
for income taxes
|
|
$
|
(180,276)
|
|
|
$
|
(211,012)
|
|
|
(352,519)
|
|
|
(273,207)
|
|
Provision for income
taxes
|
|
658
|
|
|
58
|
|
|
1,352
|
|
|
167
|
|
Net loss and
comprehensive loss
|
|
$
|
(180,934)
|
|
|
$
|
(211,070)
|
|
|
$
|
(353,871)
|
|
|
$
|
(273,374)
|
|
Net loss per share —
basic and diluted
|
|
$
|
(3.08)
|
|
|
$
|
(4.67)
|
|
|
$
|
(6.15)
|
|
|
$
|
(6.11)
|
|
Weighted average
common shares outstanding—
basic and diluted
|
|
58,742,329
|
|
|
45,226,434
|
|
|
57,577,384
|
|
|
44,736,971
|
|
BIOHAVEN
PHARMACEUTICAL HOLDING COMPANY LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Amounts in
thousands)
|
|
|
|
June 30,
2020
|
|
December 31,
2019
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash
|
|
$
|
261,061
|
|
|
$
|
316,727
|
|
Trade receivables,
net
|
|
44,796
|
|
|
—
|
|
Inventories
|
|
8,970
|
|
|
—
|
|
Prepaid expenses and
other current assets
|
|
47,735
|
|
|
11,554
|
|
Total current
assets
|
|
362,562
|
|
|
328,281
|
|
Property and
equipment, net
|
|
8,979
|
|
|
8,152
|
|
Equity method
investment
|
|
2,473
|
|
|
5,338
|
|
Intangible assets,
net
|
|
40,535
|
|
|
—
|
|
Other
assets
|
|
9,706
|
|
|
2,493
|
|
Total
assets
|
|
$
|
424,255
|
|
|
$
|
344,264
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
17,044
|
|
|
$
|
14,071
|
|
Accrued expenses other
current liabilities
|
|
118,123
|
|
|
52,102
|
|
Current portion of
mandatorily redeemable preferred shares
|
|
31,250
|
|
|
—
|
|
Total current
liabilities
|
|
166,417
|
|
|
66,173
|
|
Liability related to
sale of future royalties, net
|
|
160,805
|
|
|
144,111
|
|
Mandatorily
redeemable preferred shares, net
|
|
127,771
|
|
|
103,646
|
|
Derivative
liability
|
|
—
|
|
|
37,690
|
|
Other long-term
liabilities
|
|
4,728
|
|
|
68
|
|
Total
liabilities
|
|
459,721
|
|
|
351,688
|
|
Total shareholders'
deficit
|
|
(35,466)
|
|
|
(7,424)
|
|
Total liabilities and
shareholders' deficit
|
|
$
|
424,255
|
|
|
$
|
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
June 30,
|
|
Year Ended June
30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss:
|
GAAP net
loss
|
|
$
|
(180,934)
|
|
|
$
|
(211,070)
|
|
|
$
|
(353,871)
|
|
|
$
|
(273,374)
|
|
Add: non-cash
share-based compensation expense
|
|
11,762
|
|
|
17,554
|
|
|
28,641
|
|
|
24,884
|
|
Add: non-cash
interest expense on mandatorily
redeemable preferred shares
|
|
6,993
|
|
|
3,955
|
|
|
12,554
|
|
|
3,955
|
|
Add: non-cash
interest expense on liability related
to sale of future royalties
|
|
11,342
|
|
|
5,155
|
|
|
19,995
|
|
|
11,972
|
|
Add: change in
fair value of derivative liability
|
|
(650)
|
|
|
1,263
|
|
|
5,131
|
|
|
1,263
|
|
Add: loss from
equity method investment
|
|
1,485
|
|
|
1,415
|
|
|
2,865
|
|
|
2,315
|
|
Add: expense
related to priority review voucher
acquisition
|
|
—
|
|
|
105,000
|
|
|
—
|
|
|
105,000
|
|
Add: accrued
development milestone payments
|
|
—
|
|
|
11,500
|
|
|
—
|
|
|
11,500
|
|
Add: one-time
issuance of common shares to Fox
Chase
|
|
—
|
|
|
5,600
|
|
|
—
|
|
|
5,600
|
|
Non-GAAP adjusted net
loss
|
|
$
|
(150,002)
|
|
|
$
|
(59,628)
|
|
|
$
|
(284,685)
|
|
|
$
|
(106,885)
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss per share — basic and
diluted:
|
GAAP net loss per share
— basic and diluted
|
|
$
|
(3.08)
|
|
|
$
|
(4.67)
|
|
|
$
|
(6.15)
|
|
|
$
|
(6.11)
|
|
Add: non-cash
share-based compensation expense
|
|
0.20
|
|
|
0.39
|
|
|
0.51
|
|
|
0.55
|
|
Add: non-cash
interest expense on mandatorily
redeemable preferred shares
|
|
0.12
|
|
|
0.09
|
|
|
0.22
|
|
|
0.09
|
|
Add: non-cash
interest expense on liability related
to sale of future royalties
|
|
0.19
|
|
|
0.11
|
|
|
0.35
|
|
|
0.27
|
|
Add: change in
fair value of derivative liability
|
|
(0.01)
|
|
|
0.03
|
|
|
0.09
|
|
|
0.03
|
|
Add: loss from
equity method investment
|
|
0.03
|
|
|
0.03
|
|
|
0.05
|
|
|
0.05
|
|
Add: expense
related to priority review voucher
acquisition
|
|
—
|
|
|
2.32
|
|
|
—
|
|
|
2.35
|
|
Add: accrued
development milestone payments
|
|
—
|
|
|
0.25
|
|
|
—
|
|
|
0.26
|
|
Add: one-time
issuance of common shares to Fox
Chase
|
|
—
|
|
|
0.12
|
|
|
—
|
|
|
0.13
|
|
Non-GAAP adjusted net
loss per share — basic and
diluted
|
|
$
|
(2.55)
|
|
|
$
|
(1.32)
|
|
|
$
|
(4.94)
|
|
|
$
|
(2.39)
|
|
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 Consumer Important Safety Information,
full Prescribing Information and Patient Information.
Biohaven Contac
Dr. Vlad
Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.