NEW HAVEN, Conn., April 7, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced a
collaboration with Cove, a company providing specialized care and
access to innovative treatments for migraine sufferers via
telemedicine services in the United
States. The collaboration seeks to facilitate telemedicine
evaluation for migraine sufferers while patients are increasingly
looking to remote evaluations during this time of unprecedented
decreased access to routine office visits.
The intent of this initiative is to further expand patients'
access to migraine treatments, like NURTEC™ ODT, an orally
disintegrating tablet recently approved for the acute treatment of
migraine in adults. Using Cove, patients consult with independent
healthcare providers and may be prescribed NURTEC ODT along
with other migraine treatments which provides patients an
important alternative to in-office doctor visits. NURTEC ODT is the
first calcitonin gene-related peptide (CGRP) receptor antagonist
and the first branded medication available through Cove.
BJ Jones, Chief Commercial Officer of Migraine and Common
Diseases commented, "Biohaven is committed to providing people with
migraine innovative options for accessing healthcare, particularly
given the challenges facing patients in the current healthcare
environment. During this period, patients may experience an
increase in attacks and it is important to keep those suffering
from migraine functioning normally, and out of doctor
offices/emergency rooms to comply with travel restrictions. By
making NURTEC ODT available through Cove's platform, we can provide
migraine patients with another option to access doctors and
treatment from the safety and comfort of their
homes."
The U.S. Food and Drug Administration (FDA) approved NURTEC ODT
for the acute treatment of migraine in adults on February 27, 2020. NURTEC ODT, which disperses
almost instantly in a person's mouth without the need for water,
works by blocking the CGRP receptor, treating a root cause of
migraine. NURTEC ODT is not indicated for the preventive treatment
of migraine.
Cove General Manager, Caroline
Hofmann, added, "There's no one size fits all solution for
migraine sufferers. They deserve to have as many options as
possible to find the right one for them. We're excited to be able
to offer NURTEC ODT on Cove and make this innovative treatment more
accessible than ever through our telemedicine platform, during this
stressful time when migraine sufferers need it the most."
Alicia Torborg, Executive
Director, Association of Migraine Disorders, said, "Especially
during this trying time, we all need to help patients get the care
that they need when they need it. Telemedicine will help to fill
this gap and may very well be the way of our future."
The collaboration with Cove is an expansion of existing
tools to enhance access to NURTEC ODT for appropriate migraine
patients. Existing offerings include a two-dose complementary
sample pack available with a
prescription from healthcare providers, a patient starter kit
and a co-pay card where commercially insured patients can pay as
little as $0 per month for NURTEC
ODT. Patients using Cove will be eligible for the co-pay card.
More information about NURTEC ODT and available patient savings
and access programs can be found at 1-833-4NURTEC and
www.nurtec.com.
Migraine patients interested in Cove's services can start the
consultation here.
NURTEC ODT is not an opioid or narcotic, does not have addiction
potential and is not scheduled as a controlled substance by the
U.S. Drug and Enforcement Administration.
NURTEC ODT is contraindicated in patients with a history of
hypersensitivity to rimegepant, NURTEC ODT, or to any of its
components. Hypersensitivity reactions with dyspnea and severe
rash, including delayed serious hypersensitivity days after
administration, occurred in less than 1% of subjects taking NURTEC
ODT in clinical studies.
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.
The most common adverse reaction was nausea (2% in patients who
received NURTEC ODT compared to 0.4% in patients who received
placebo). 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.
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.
Please click here for full Prescribing information.
About Cove
Cove is a full-service healthcare company
that offers personalized treatment solutions for migraine
sufferers. Cove aims to empower migraine sufferers by providing
direct access to high-quality, affordable migraine care,
personalized to each customer and their specific needs. In addition
to NURTEC ODT, Cove offers acute and preventative treatments for
migraine, anti-nausea medications, and clinically-proven
supplements. For more information, visit www.withcove.com.
About Biohaven
Biohaven is a biopharmaceutical company
focused on the development and commercialization of innovative
best-in-class therapies to improve the lives of patients with
debilitating neurological and neuropsychiatric diseases. 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: calcitonin gene-related peptide (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. For more information, visit
www.biohavenpharma.com.
Forward Looking Statement
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", "on track", "expects" and
"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. 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 filed with the Securities and Exchange Commission on
February 26, 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.
NURTEC is a trademark of Biohaven Pharmaceutical Holding Company
Ltd.
Biohaven Contacts:
Dr. Vlad
Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
(312) 961-2502
Cove Contacts:
Caroline
Hofmann
General Manager, Cove
caroline@thirtymadison.com
Josie Zohny
Thirty Madison
josie@thirtymadison.com
(917) 742-3777
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.