NEW HAVEN, Conn., Jan. 6, 2022 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates, today announced preliminary net
product revenue of NURTEC ODT (rimegepant) for the fourth
quarter of 2021.
Based on preliminary unaudited financial information, the
Company reported approximately $190 million in net product
revenue from sales of NURTEC ODT in the fourth quarter of 2021 and
approximately $462 million in net
product revenue for 2021. There were no material changes in channel
inventory days over the course of the year.
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
preliminary estimates.
Vlad Coric, M.D., Chairman and
Chief Executive Officer of Biohaven commented, "NURTEC ODT has
changed the treatment paradigm for migraine with its dual-acting,
acute and preventive indications. NURTEC ODT established itself as
the market leading novel migraine therapy in 2021 and generated an
impressive $462 million in net
product revenue for the year. The dual indications offer healthcare
providers and their patients a single treatment they can customize
to treat and prevent migraine attacks. We remain steadfast in our
commitment to the migraine community to support programs that drive
awareness of migraine and the importance of effective treatment to
reduce disability."
Approximately 40 million people in the U.S. and more
than one billion individuals worldwide suffer from migraine.
Migraine is the third most prevalent illness in the world and the
World Health Organization classifies migraine as one of the 10 most
disabling medical illnesses.
BJ Jones, Chief Commercial Officer, Migraine & Common
Disease, added, "Every day we hear from patients and healthcare
providers about the benefits of using NURTEC ODT to help stop a
migraine attack quickly and prevent the next one. The overwhelming
number of patients that share the positive impact that NURTEC ODT
has for them continues to inspire our team to do more to help those
suffering from migraine. Our team is dedicated to continuing to
deliver NURTEC ODT to as many patients as possible, especially
during times of stress in the pandemic."
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 key driver
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.
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
NeuroinnovationTM 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.
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: 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 the
Company's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on November 9,
2021. 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.
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.
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC.
Neuroinnovation is a trademark of Biohaven Pharmaceutical
Holding Company Ltd.
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/biohaven-announces-preliminary-4q2021-and-full-year-net-product-revenue-for-nurtec-odt-market-leading-novel-migraine-therapy-301455426.html
SOURCE Biohaven Pharmaceutical Holding Company Ltd.