NEW
HAVEN, Conn., April 17,
2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN)
("Biohaven"), a global clinical-stage biopharmaceutical company,
today announced that Nick Kozauer, M.D. has joined its executive
leadership team as Senior Vice President for Clinical Development
and Regulatory Strategy.
Dr. Kozauer comes to Biohaven after an accomplished career at
the U.S. Food and Drug Administration (FDA) where he served in
positions of increasing responsibility, most recently as Director
of the Division of Neurology 2 in the Office of New Drugs. During
his tenure at the FDA, Dr. Kozauer led the division responsible for
the regulation of all Investigational New Drug (IND) applications,
New Drug Applications (NDAs), and Biological Licensing Applications
(BLAs) for drugs being developed and/or approved for the treatment
of neuroimmunologic conditions, epilepsies, migraine, stroke,
traumatic brain injury, inner ear disorders, and other
products.
Vlad Coric, M.D., Chairman and
Chief Executive Officer of Biohaven, commented, "It is a great
honor to welcome Dr. Kozauer to the Biohaven team. Dr. Kozauer is a
true clinician-researcher who has supervised and reviewed the
approval of over 15 marketed drugs during his tenure at the FDA.
His knowledge and expertise in the regulatory process, as well as
his deep experience in diseases including neuroimmunology and
epilepsy, will only strengthen Biohaven's ability to efficiently
advance our robust pipeline of compounds and deliver novel
treatments in high unmet need areas in neuroscience for patients
and their families. Dr. Kozauer has already positively impacted
patient care during his time at the FDA and we are excited to have
him on our team to help us innovate new therapies."
Prior to joining the FDA, Dr. Kozauer worked in academia at the
Johns Hopkins Memory Center at the Copper Ridge Institute where he
oversaw clinical care of patients with Alzheimer's disease and
other dementias, and in private practice focusing on complex
neuropsychiatric conditions. Dr. Kozauer completed his residency
and fellowship training at Georgetown
University Medical Center and Johns
Hopkins, respectively, and received his M.D. from
Rutgers-New Jersey Medical School.
Dr. Kozauer stated, "I am energized by the opportunity to work
with such an experienced, dynamic, and patient-focused group of
individuals pursuing groundbreaking science to develop a broad
range of therapies for serious diseases with unmet medical needs.
The team at Biohaven has demonstrated its ability to bring
innovative medicines to patients and has an exciting portfolio
including immune modulating agents, ion channel activators,
myostatin targeting agent and other investigational drugs targeting
ultra-rare diseases."
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. Biohaven's experienced management team brings with
it a track record of delivering new drug approvals for products for
diseases such as migraine, depression, bipolar and schizophrenia.
The company is advancing a pipeline of 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, myostatin inhibition for neuromuscular
diseases, and brain-penetrant TYK2/JAK1 inhibition for
immune-mediated brain disorders. Biohaven's portfolio of early- and
late-stage product candidates also includes discovery research
programs focused on TRPM3 channel activation for neuropathic pain,
CD-38 antibody recruiting, bispecific molecules for multiple
myeloma, antibody drug conjugates (ADCs), and extracellular target
degrader platform technology (MoDEā¢) with potential application in
neurological disorders, cancer, and autoimmune diseases.
Forward-looking Statements
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 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 Food and Drug
Administration; 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 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.
MoDEs is a trademark of Biohaven Therapeutics Ltd.
Biohaven Contacts:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
201-248-0741
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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SOURCE Biohaven Ltd.