NEW HAVEN, Conn., May 15, 2017 /PRNewswire/ -- (NYSE:
BHVN) -- Biohaven Pharmaceutical Holding Company Ltd.
(Biohaven) announced today that the U.S. Food and Drug
Administration (FDA) has granted the company Fast Track Designation
for Biohaven's product candidate trigriluzole (BHV-4157) for the
potential treatment of Spinocerebellar Ataxia (SCA).
Trigriluzole previously received Orphan Drug Designation from
the FDA for the treatment of SCA in 2016. Biohaven is currently
conducting a Phase 2/3 clinical trial in patients with SCA, with
topline results expected in 2018.
SCA is a rare, debilitating neurodegenerative disorder that is
estimated to affect approximately 22,000 people in the United States. Standard of care treatment
is supportive and no medications are currently approved for
patients with this debilitating condition.
"This Fast Track Designation from the FDA recognizes the high
unmet medical need in patients with SCA," said Vlad Coric, M.D., CEO of Biohaven. "Fast
track designation will help facilitate Biohaven's development of
trigriluzole, and potentially expedite future regulatory review of
trigriluzole for patients with SCA."
Phase 2/3 Clinical Trial of Trigriluzole
Biohaven initiated a randomized clinical trial of trigriluzole
in patients with SCA in December 2016. Target enrollment is
approximately 120 patients, with topline results expected in the
first quarter of 2018. The study is designed to evaluate the safety
and efficacy of trigriluzole for acute symptomatic treatment in
this patient population. We believe that, if successful, this Phase
2/3 clinical trial will be the only pivotal trial necessary to
support regulatory approval in SCA.
"Given the severe nature of this disease and the inadequacy of
palliative treatments for patients with SCA we are endeavoring to
complete our study as soon as possible," said Robert Berman, M.D., Chief Medical Officer at
Biohaven.
About Trigriluzole
Trigiluzole is a novel tripeptide prodrug being developed by
Biohaven and represents more than six years of chemistry
development and research into over 300 drug candidates.
Biohaven anticipates that trigriluzole will be designated as a new
chemical entity (NCE) and has received orphan drug designation from
the FDA for the treatment of SCA.
About Fast Track Designation
As one of its Expedited Programs for Serious Conditions, the FDA
grants Fast Track Designation to "facilitate the development and
expedite the review of drugs to treat serious conditions and fill
an unmet medical need" in order to make important new drugs
available to patients earlier. According to the FDA, a drug that
receives Fast Track Designation is eligible for some or all of the
following:
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval;
- More frequent written communication from FDA about such things
as the design of the proposed clinical trials and use of
biomarkers;
- Eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met; and
- Eligibility for Rolling Review, which means that a drug company
can submit completed sections of its New Drug Application (NDA) for
review by FDA, rather than waiting until every section of the NDA
is completed before the entire application can be reviewed. NDA
review usually does not begin until the drug company has submitted
the entire application to the FDA.
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a
portfolio of innovative, late-stage product candidates targeting
neurological diseases, including rare disorders. Biohaven has
licensed intellectual property from companies and institutions
including Bristol-Myers Squibb Company, AstraZeneca AB,
Yale University, Catalent, ALS
Biopharma LLC and Massachusetts General Hospital. Biohaven is a
company organized under the laws of the British Virgin Islands and its United States operations are based in
New Haven, Connecticut.
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 potential effects of Fast Track
Designation, including the possibility of expedited regulatory
review, as well as the Company's plans and objectives, expectations
and assumptions of management are forward-looking statements. The
use of certain words, including the words "estimate," "intend,"
"expect," "believe," "anticipate," "will, "potential," "plan,"
"could," "may" and similar expressions are intended to identify
forward-looking statements. The Company may not actually achieve
the plans, intentions or expectations disclosed in the
forward-looking statements and you should not place undue reliance
on the Company's 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 including the fact that the grant of Fast Track
Designation does not guarantee that we will experience a faster
development process, review or approval of trigriluzole compared to
conventional FDA procedures, the possibility that the FDA could
withdraw Fast Track Designation if it believes that it is no longer
supported by data from our trigriluzole clinical development
program and those factors described in the "Risk Factors" section
of the Company's final prospectus dated May
3, 2017, filed with the Securities and Exchange Commission
on May 5, 2017. The forward-looking
statements are made as of this date and the Company 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.
Contact
Dr. Vlad Coric
Chief Executive Officer
Biohaven Pharmaceutical Holding Company Ltd.
Phone: (203) 404-0410
Email: vlad.coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.