NEW HAVEN, Conn., Oct. 5, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN; the "Company" or
"Biohaven"), a biopharmaceutical company with a portfolio of
innovative, late-stage product candidates, today announced
preliminary net product revenue of NURTEC ODT (rimegepant) for
the third quarter of 2021.
Based on preliminary unaudited financial information, the
Company reported $136 million in net product revenue from
sales of NURTEC ODT in the third quarter of 2021. Total
prescriptions of NURTEC ODT from product launch to date (as of
September 30, 2021) were over
1,000,000, with approximately 46,000 unique prescribers.
The foregoing information reflects the Company's estimate with
respect to net product revenue for NURTEC ODT based on currently
available information, which is preliminary and unaudited, is not a
comprehensive statement of the Company's financial results and is
subject to completion of the Company's financial closing
procedures. The Company's final results which will be issued upon
completion of its closing procedures may vary from these
Vlad Coric, M.D., Chief Executive
Officer of Biohaven commented, "NURTEC ODT has become the market
leader in oral CGRP targeting migraine therapies and we are
thrilled to report preliminary net product revenue increased by 46%
versus second quarter 2021, reaching $136 million in the third
quarter. As the first and only dual-therapy medication indicated to
both treat and prevent migraines, NURTEC ODT has redefined the
treatment paradigm for individuals suffering from migraine.
Finally, patients have a single medication that can both treat and
prevent migraine attacks, allowing patients and their doctors the
ability to easily customize migraine therapy as needed."
Approximately 40 million people in the U.S. and approximately
one billion individuals worldwide suffer from migraine. Migraine is
the 3rd most prevalent illness in the world and the World Health
Organization classifies migraine as one of the 10 most disabling
BJ Jones, Chief Commercial Officer, added, "We continue to
receive overwhelmingly positive feedback from patients and
healthcare providers about the ability of NURTEC ODT to treat and
prevent migraine with a single medication. Our team remains
passionate about improving the lives of patients by delivering this
first and only dual-therapy migraine medicine."
NURTEC ODT 75 mg is the only migraine medication approved as a
dual therapy for both acute and preventive treatment, and is the
first oral CGRP receptor antagonist approved for the
preventive treatment of migraine. NURTEC ODT targets a root cause
of migraine by reversibly blocking CGRP receptors, thereby
inhibiting the biologic cascade that results in a migraine attack.
A single dose of NURTEC ODT can deliver fast pain relief with some
patients returning to normal function by 60 minutes and has a
lasting effect of up to 48 hours for many patients. NURTEC ODT can
be taken up to once daily, up to 18 doses/month, as needed to stop
migraine attacks or taken every other day to help prevent migraine
attacks and reduce the number of monthly migraine days.
NURTEC ODT does not have addiction potential and is not associated
with medication overuse headache or rebound headache.
NURTEC ODT was approved by the U.S. Food and Drug Administration
(FDA) for the acute treatment of migraine in February 2020 and for the preventive treatment of
episodic migraine in May 2021 with
commercial launch commencing within weeks of the approvals.
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; 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.
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: the
preliminary nature of net product revenue for NURTEC ODT,
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 Biohaven, 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, including the need for any REMS or Advisory Committee
meetings, 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. 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 Biohaven's Annual Report on Form 10-K 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.
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.
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
Please click here for full Prescribing Information and
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC.
Neuroinnovation is a trademark of Biohaven Pharmaceutical
Holding Company Ltd.
Dr. Vlad Coric
Chief Executive Officer
Sam Brown Inc.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.