NEW HAVEN, Conn., April 7, 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 first quarter of 2021.
Based on preliminary unaudited financial information, the
Company reported $43.8 million in net
product revenue from sales of NURTEC ODT in the first quarter of
2021. Total prescriptions of NURTEC ODT from product launch to date
(as of March 31, 2021) were over
500,000, with over 30,000 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 that will be issued upon
completion of its closing procedures may vary from these
preliminary estimates.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven commented, "Despite the typical first quarter
insurance dynamics associated with new year prior
authorizations/deductibles and the winter surge of COVID-19
affecting prescription volumes, NURTEC ODT continues to grow
quarter over quarter in both prescription volume and net revenue.
Our commercial team continues to build strong momentum for the
brand as we also receive positive feedback from patients and
physicians regarding the important role that NURTEC ODT is playing
in the acute treatment of migraine. The impressive market
growth of NURTEC ODT reflects the significant unmet need that
exists for patients suffering from the debilitating effects of
acute migraine, our strong commercial and managed markets team, and
the differentiated product label compared to competitors. We're
proud of our commercial and R&D team members who remain
dedicated to delivering this important medication to patients and
we look forward to improved market dynamics as COVID-19 subsides
with the increasing rollout of multiple vaccines."
BJ Jones, Chief Commercial Officer, added, "NURTEC ODT
continues to demonstrate strong prescription growth and increases
in quarterly net revenue. We are beginning to see in-market
dynamics improve as the vaccines roll out and look forward to
continued market growth for this important new acute treatment of
migraine."
Rimegepant is marketed as NURTEC ODT, and is the first and only
calcitonin gene-related peptide (CGRP) receptor antagonist
available in an orally disintegrating tablet (ODT) designed for
rapid onset of action and sustained efficacy for 48 hours.
Rimegepant was approved by the U.S. Food and Drug Administration
(FDA) for the acute treatment of migraine in February 2020, with commercial launch commencing
the second week of March 2020.
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.
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 revenues 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. 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
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. The safety of treating up to 15 migraines
in a 30-day period has been established. 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
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.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.