Biohaven Expands Executive Leadership Team with Appointment of Nick Kozauer M.D. as Senior Vice President for Clinical Development and Regulatory Strategy

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 (MoDE™) 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

[email protected]

201-248-0741

Mike Beyer

Sam Brown Inc.

[email protected]

312-961-2502

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SOURCE Biohaven Ltd.