- Broad therapeutic research and development portfolio
includes more than 13 clinical and pre-clinical programs with a
focus on neuroscience and rare disorders including epilepsy, pain
and mood disorders, obsessive compulsive disorder (OCD),
spinocerebellar ataxia (SCA) and spinal muscular atrophy
(SMA).
- Excitement mounting for clinical stage neuroscience program
in Kv7 Ion Channel Modulation which targets key subunits involved
in neuronal signaling and plays a critical role in regulating the
hyperexcitable state in epilepsy and potentially other central
nervous system (CNS) disorders.
- Biohaven retains Board and key management team with
established legacy of bringing the market-leading medicine NurtecĀ®
ODT (rimegepant) to patients; Names Bruce Car, Ph.D. as Chief
Scientific Officer; Irfan Qureshi,
M.D. as Chief Medical Officer; and Tanya
Fischer, M.D., Ph.D. as Chief Development Officer and Head
of Translational Medicine.
NEW
HAVEN, Conn., Oct. 4, 2022
/PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) launched today as a new
publicly traded company focused on delivering innovative
life-changing treatments for neurological and neuropsychiatric
diseases, including rare disorders, leveraging its proven drug
development capabilities and proprietary technology platforms to
advance a pipeline of best-in-class therapies. As of today,
Biohaven has officially begun operating as a separate independent
entity as part of the acquisition agreement with Pfizer in
May 2022. The company, led by
Vlad Coric, M.D. as Chairman and
Chief Executive Officer, launched with approximately
$257.8 million in cash at the
distribution and no debt.
Dr. Coric commented, "As Biohaven embarks on a new path today, I
am extremely proud of our track record of innovation and success
rapidly developing, commercializing and delivering therapeutic
breakthrough medicines. We continue our unwavering commitment to
patients that aligns with our vision of winning with cutting-edge
science. I am enthusiastic about continuing to lead our team in
new, exciting directions as we strive to bring best-in-class
therapies to patients for a broad range of diseases with few or no
treatment options. If past is prologue, this proven team will
continue to succeed in achieving its mission for patients,
shareholders and employees."
Biohaven has a history of successful drug development and
commercialization. The company received two U.S. Food and Drug
Administration (FDA) approvals and a European Medicines Agency
(EMA) approval for two indications for Nurtec ODT (rimegepant), the
leading novel calcitonin gene-related peptide (CGRP) receptor
antagonist for the treatment of migraine in adults and the first
and only therapy that both treats and prevents migraine attacks.
Since its launch in 2020, Nurtec ODT has been market leader and the
#1 prescribed novel migraine treatment, outperforming much larger
pharmaceutical company competitors. Beyond Nurtec ODT, the FDA
filed and accepted for review Biohaven's New Drug Application (NDA)
submission for zavegepant nasal spray with a Prescription Drug User
Fee Act ("PDUFA") goal date set for the first quarter of 2023. If
approved, zavegepant would be the only FDA-approved CGRP receptor
antagonist in an intranasal formulation, giving patients a new
treatment option that provides ultra-rapid pain relief in as little
as 15 minutes that lasts through 48 hours after a single dose. With
the acquisition by Pfizer for a total consideration of
approximately $13B including payoff
of existing debt, Pfizer will now exclusively commercialize and
develop the Biohaven CGRP franchise globally. Pfizer owns
approximately 3% of the new spinoff company Biohaven Ltd.
Advancing a Broad Portfolio of
Innovative Candidates
Biohaven plans to advance a broad portfolio of early- and
late-stage innovative product candidates targeting neurological and
neuropsychiatric diseases, including rare disorders with unmet
medical needs. Therapeutic development will focus on treatments for
epilepsy, pain and mood disorders, obsessive compulsive disorder
(OCD), spinocerebellar ataxia (SCA) and spinal muscular atrophy
(SMA).
Biohaven develops drug candidates based on its proprietary,
technology platforms, including its lead program in Kv7 Ion Channel
Modulation for epilepsy and other central nervous system disorders
associated with pathological hyperactivity. Key clinical
development programs underway that leverage these proprietary
technology platforms, include the following:
- Glutamate modulation for SCA and OCD
- Myostatin inhibition for neuromuscular diseases, and
potentially for diabetes and weight loss
- Novel immune modulation platform targeting CD-38 for multiple
myeloma
The company's robust research capabilities complement its
clinical development and commercial expertise with the goal of
expanding the product pipeline to address strategic disease
adjacencies, including pain, smooth muscle disorders and
immunological disease. Initially, discovery research programs
will focus on advancing Kv7 ion channel activation across multiple
therapeutic indications, TRPM3 ion channel activation for
neuropathic pain and degrader platforms to target immunology and
oncology inflammatory disorders and antibody linker
technologies.
Visionary Team of Accomplished
Executives Poised to Deliver Best-in-Class Therapies
Biohaven emerges with a strong foundation supported by a highly
experienced leadership team and a legacy of bringing to market
best-in-class therapies to people in need. The Biohaven Board of
Directors remains the same. Irfan
Qureshi, M.D. is promoted to Chief Medical Officer
(previously Senior Vice President of Neurology at Biohaven). And
Tanya Fischer, M.D., Ph.D. is
appointed Chief Development Officer and Head of Translational
Medicine (previously at Alnylam Pharmaceuticals, Sanofi and
Bristol-Myers Squibb).
Bruce Car, Ph.D. joins Biohaven
as the new Chief Scientific Officer. Dr. Car brings more than 28
years of experience in the pharmaceutical industry having held
numerous scientific leadership positions at Bristol-Myers Squibb
and Dupont in which he was closely involved in advancing
approximately 250 drug candidates contributed from early discovery
and business development through to the registration of
approximately 18 medicines across multiple therapeutic areas. He
most recently served as Chief Scientific Officer of Agios
Pharmaceuticals where his focus was on genetically defined diseases
and oncology.
Dr. Coric said, "Bruce has tremendous experience in drug
discovery and development and a passion for addressing unmet needs
across multiple therapeutic areas including neuroscience, oncology,
immunology and rare diseases. We are delighted to welcome Bruce to
our team as we chart a new course for Biohaven harnessing the
potential of scientific innovation to transform the treatment of
diseases with significant unmet need."
"Our patient focus, highly innovative science and medicine, and
uniquely well-honed drug-hunting skills, are unmatched," said Dr.
Bruce Car. "We have created a high
value portfolio that addresses patient needs in innovative ways. We
look forward to this next chapter with refreshed vision and
optimism."
Matthew Buten, Chief Financial
Officer, commented, "Our new spinoff company is well poised to
build on the legacy of Biohaven -- the potential of our proven
team, our incredible pipeline and passion of our patient mission
will propel us forward. We have spent the last several months
preparing for the future, and we will continue to maintain the same
fiscal discipline and prudent capital management strategy we
employed in years past and will seek creative, tactical financing
strategies in the years ahead to support our research, development
and commercialization efforts."
About Biohaven
Biohaven is a global clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
life-changing therapies for people with debilitating neurological
and neuropsychiatric diseases, including rare disorders. The
company is advancing a pipeline of best-in-class therapies for
diseases with little or no treatment options, leveraging its proven
drug development capabilities and proprietary platforms, including
Kv7 ion channel modulation for epilepsy and neuronal
hyperexcitability; glutamate modulation for obsessive-compulsive
disorder and spinocerebellar ataxia and myostatin inhibition for
neuromuscular diseases. Biohaven's portfolio of early- and
late-stage product candidates also includes discovery research
programs focused on TRPM3 channel activation for neuropathic pain
and CD-38 antibody recruiting, bispecific molecules for multiple
myeloma. More information about Biohaven is available at
www.biohaven.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 "continue", "plan", "will",
"believe", "may", "expect", "anticipate" and similar expressions,
is intended to identify forward-looking statements. Investors are
cautioned that any forward-looking statements, including statements
regarding the future development, timing and potential marketing
approval and commercialization of of development candidates are not
guarantees of future performance or results and involve substantial
risks and uncertainties. Actual results, developments and events
may differ materially from those in the forward-looking statements
as a result of various factors including: 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; complying with applicable U.S. regulatory requirements;
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. Additional important factors to
be considered in connection with forward-looking statements are
described in Biohaven's filings with the Securities and Exchange
Commission, including within the sections titled "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations". The forward-looking statements are made as
of the date of this new release, 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
For more information about NURTEC ODT, visit www.nurtec.com.
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.
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.
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.
Investor Contact:
Jennifer Porcelli
Vice-President, Investor Relations
jennifer.porcelli@biohavenpharma.com
Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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