NEW HAVEN, Conn., Jan. 25, 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 fourth quarter of 2020.
Based on preliminary unaudited financial information, the
Company reported $35 million in net
product revenue from sales of NURTEC ODT in the fourth quarter of
2020, representing a 98% increase from the previous quarter.
Total prescriptions of NURTEC ODT for the full year 2020 were over
337,000, with over 24,000 unique prescribers. There were no
material changes in channel inventory between third and fourth
quarter.
The foregoing information reflects the Company's estimate with
respect to net product revenue for NURTEC ODT based on currently
available unaudited information. This 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 will be issued upon completion of its
closing procedures and may vary from these preliminary
estimates.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven commented, "The launch of NURTEC ODT continues
to build strong momentum, despite continued headwinds from the
pandemic, as reflected by strong fourth quarter net product
revenue. We continue to hear 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 have been
dedicated to delivering this important medication to patients
despite the challenges of the past year."
BJ Jones, Chief Commercial Officer, added, "Even in the
unprecedented market conditions of a global pandemic, our
commercial team remained committed to the needs of patients
suffering from migraine, creating demand and access to
NURTEC ODT significantly outperforming our initial volume
projections during the first three quarters of launch. We look
forward to continuing to grow the market for NURTEC ODT in the
acute treatment of migraine, especially as in-market dynamics
improve as the vaccines roll out and the impact of the COVID-19
pandemic is expected to attenuate later this year."
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. 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.
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 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 February
26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020 filed with the
Securities and Exchange Commission on November 9, 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.
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.